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Amendments to PIPEDA, Bill S-4

https://policybase.cma.ca/en/permalink/policy11194
Date
2014-06-09
Topics
Health information and e-health
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Date
2014-06-09
Topics
Health information and e-health
Ethics and medical professionalism
Text
The Canadian Medical Association (CMA) is pleased to make submissions on Bill S-4. CMA has followed the history of PIPEDA and participated in the studies of various Standing Committees, most notably and recently in 2007 to the House of Commons Standing Committee on Access to Information, Privacy and Ethics. CMA is pleased that amendments to PIPEDA are once again being considered. The Canadian Medical Association represents over 80,000 physicians in Canada. Privacy is an important value to physicians and the patients to whom they serve. This is reflected in our Code of Ethics and policies, in particular, Principles for the Protection of Patients' Personal Health Information and Statement of Principles: The Sale and Use of Data on Individual Physicians' Prescribing. Physicians are also required to abide by privacy and confidentiality standards of practice. Thus, the CMA has a strong interest and valuable insights into the topic of personal information and privacy with respect to health information. We thank the Standing Committee for the opportunity to comment on the proposed amendments to PIPEDA. Our key comments are outlined below: Issue 1: CMA supports the existing legislative framework on the collection, use and disclosure of personal information produced by an individual in the course of their employment, business or profession ("work product") and suggests further amendments focus on strengthening it further. CMA supports the current standing of work products, that work products are considered to be personal information. That is, we support the framework defining personal information as information about an identifiable individual and that there is no carved out definition or exemption for "work product". CMA supports the position of the Office of Privacy Commissioner's following its 2007 investigation on work products, that they should not be exempted for two main reasons: * The exemption is not needed, and it would be inconsistent with the balanced approach in the current definition of personal information. The current definition of personal information and the approach to deciding issues based on that definition have worked well. They have promoted a level of privacy protection that balances the right of privacy in personal information with the needs of organizations for the reasonable and appropriate collection, use and disclosure of personal information. ...Because the concept of "work product" is ambiguous, excluding it from the definition of personal information could have unpredictable consequences that would diminish privacy unnecessarily. * (http://www.priv.gc.ca/parl/2007/sub_070222_03_e.asp) It is the CMA's position that work products should be considered personal information and given the section 7 amendments, work products should only be collected, used or disclosed without consent only if it is consistent with the purposes for which the information was produced. In the case of physicians, a prime example of a physician's work product is prescribing information. Prescribing information is a synthesis of assessing patients - by probing into their health, familial, social and sometimes financial background - infused with medical knowledge, skill and competencies resulting in a diagnosis and treatment plan, which often includes prescribing a medication or test. Not only is the physician's prescribing information a product of physicians' work but would not exist but for a trusting physician-patient relationship wherein the patient's private and personal information are shared under circumstances of vulnerability and trust. The outcome is that this is personal information. Prescribing information is about an individual: it includes the name of the patient, the name of the prescribing physician, and the drug name, dosage, amount and frequency; giving major clues as to what the patient's health issue(s) are. For further clarity, however, CMA recommends that physician information, and physician work products, should be specifically recognized within the legislation as personal information. To this end, we would propose that the following addition be made to the definition section under personal health information: Section 2.(1) "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual; CMA supports the amendments to subsections 7(1)-(3) of the Act that any subsequent collection, use and disclosure of work products without consent must be related to the original purpose (of collection, use and disclosure). This relationship reflects the government's understanding and faithfulness to privacy principles. This is particularly critical when dealing with health information, and is even more critical in today's world given the ease of linking information through advancements in technology. In the absence of a causal relationship, personal information should not be used for system performance, commercial enterprise, data brokering, research, assessment or other purposes. CMA recommends that the legislation should go further and allow persons who believe that protection cannot be afforded under the legislation that they have the authority to refuse to communicate the information. This is the conceptual approach taken in Quebec's Act Respecting the Protection of Personal Information in the Private Sector wherein persons have an opportunity to refuse that professional information (as defined therein) be used for commercial purposes. Physicians are constantly writing prescriptions and such information should only be used for other purposes in the interests of patients and the health care system, and not to serve commercial interests or marketing strategies. If physicians do not feel that such protection is afforded patients, then they should be permitted to refuse that such information be collected, used or disclosed. Patient privacy should be primary. And finally, addressing work products in legislation clears up past differences of interpretation by Privacy Commissioners thus, providing certainty and clarity to the public. Recommendation 1: That Section 2. (1) "personal health information", be amended to read as follows: "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual; Issue 2: CMA is pleased to see a section on breaches of security safeguards and recommends greater specificity. As noted above, physicians have responsibilities as data stewards and custodians of health information. As such, CMA supports breach notification measures that would enhance and protect patient privacy. In principle, we support the proposed amendments of breach disclosures to the Privacy Commissioner, to individuals and to organizations. However, CMA is concerned that meeting the requirements may be confusing. For example, in the health care context, it is easy to surmise that all health information is "sensitive". A far more difficult matter is determining whether the risk reaches the threshold of "significant harm" and the "probability" that the information "will be misused". The result being that incidental disclosures will be reported causing unnecessary concern and confusion in the patient population. Further specificity is recommended and we suggest something akin to Ontario's Personal Health Information Protection Act, 2004 (PHIPA). The PHIPA is an act specifically dealing with personal health information. One of its purposes is "to establish rules for the collection, use and disclosure of personal health information about individuals that protect the confidentiality of that information and the privacy of individuals with respect to that information, while facilitating the effective provision of health care" (section 1a ). The PHIPA notification provision states that the individual shall be notified "...at the first reasonable opportunity if the information is stolen, lost or accessed by unauthorized persons", [section 12(2)]. CMA is unaware of any concerns with this approach. The language of PIPIEDA is one of reasonable belief of real risk of significant harm to an individual. The issue is the test for required notification of patients for incidental inadvertent breaches and decreasing "notification fatigue". To illustrate the issue, if physicians were told today that patient data could be retrieved from the drums of discarded photocopiers and printers, it would be inappropriate for legislation to suggest that the entire patient population during the life of the photocopier or printer be notified. To this end, we recommend that there be acknowledgement that in some circumstances notification may not be required. The probability of misuse under PIPEDA is more ambiguous than the PHIPA test. Under PHIPA, the approach is more objective in that the data must be stolen, lost or accessed by unauthorized persons. To our knowledge, the Ontario model has been in place for almost a decade with no significant issues and thus we submit is one that works. In other jurisdictions (eg., Newfoundland and Labrador, Nova Scotia, New Brunswick) with health privacy legislation, there is acknowledgement of trying to balance notification and those breaches unlikely to result in harm by directly indicating when notification is not required. Recommendation 2: CMA recommends that the statute move towards a more objective test and acknowledge that there are situations when notice is not required. Issue 3: CMA supports disclosure without consent under limited circumstances, but finds the current list of disclosures overly inclusive. Health information is considered highly sensitive information and is initially collected for the purpose of individual patient health care. It should only be disclosed with consent and in only some exceptions without consent. The PIPEDA amendments for disclosure without consent have been broadened. Privacy, confidentiality and trust are the foundations of the patient-physician relationship. Without these fundamental values in play, open and honest communications cannot occur and patients would not receive the care they require. Both the patient and the physician have significant investment in the relationship. CMA respects the requirements to disclose information without consent under certain premises, such as required by court order or statute. However, any kind of activity requiring physicians to disclose patient's information without consent for the purposes of advancing a government or institution's goal could jeopardize the relationship. Both the patient's consent and the physician's consent should be required if there is potential to disturb this relationship. The physician is fiduciary of the relationship and is appropriately situated to assess and determine whether disclosure will disturb the relationship. While CMA acknowledges that certain situations may require that disclosure occur without consent (eg. purposes of investigating fraud, national security, abuse or as legally required), disclosure for less malicious activities (e.g., breaches of an agreement, insurance claims) ought to require a court order or warrant. For example, under the proposed section 7(3)(d.1) if a physician were in default of a contract with a technology company supplying electronic medical record software or app to his/her clinic, the company could disclose health information without consent for the "purposes of investigating a breach of an agreement". While we appreciate that there is a caveat that disclosure without advising the patient can only occur if there is a reasonable expectation that the disclosure would compromise the investigation, we submit that leaving the determination of what is "reasonable" to an interested party to the breach is unfair to all. Another example, if a physician is a witness to a dispute between an employer and union representing an employee for denial of long term disability by an insurance company, and has filed a witness statement which includes a medical report he/she wrote to the employer's insurance company, under the proposed section 7(3)(e.1) disclosure of health information without consent is permitted in order to assess, process or settle an insurance claim. CMA is concerned that the disclosure amendments are overly broad and do not differentiate sufficiently between highly time sensitive or grossly malicious situations, and those where it is merely expedient or an administrative encumbrance to seek consent. In addition, the disclosure requirements are framed in permissive (ie., may) and not mandatory language (ie., shall). This is very problematic when the "organization" is a physicians' clinic unless the physician's own consent is made as a pre-condition. CMA believes this suggestion is a progressive one in keeping with the broadened disclosure amendments. Physicians are in a relationship of trust and take seriously the protection of patient privacy and confidentiality, for which they are trained and are ethically and legally required to protect. To place physicians in a position which might entail breaching this trust may impact the confidence of the physician and the patient in the patient-physician relationship which is required to properly formulate appropriate treatment plans; thus, negatively impacting the health of Canadians. Recommendation 3: That disclosures of health information without consent require a warrant or subpoena or court order. Furthermore, disclosures of health information require the physician's consent that in his/her opinion the disclosure does not harm the patient-physician relationship. And, finally any broadened disclosure situations be restricted to criminal activity or that impacting national security. Conclusion Once again, CMA appreciates the opportunity to provide comment as part of the committee's study of Bill S-4. CMA is prepared to work with Parliament, governments, health professionals and the public in ensuring legislative frameworks for the collection, usage and disclosure of personal information for legitimate and reasonable purposes.
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Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act)

https://policybase.cma.ca/en/permalink/policy11297
Date
2014-10-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-10-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of House of Commons Standing Committee on Public Safety and National Security's study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1 Prior to a discussion on CMA's position regarding the substance of Bill C-2, the CMA firstly recommends that legislation pertaining to harm reduction services requires study by parliamentary committees responsible for health or social matters in addition to public safety. Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite. The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3 In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.* CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult. Public health approach to addiction Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components. Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program). Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5 Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential. Harm reduction is part of health practice Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms. Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs. The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. Physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9 Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10 Supervised Consumption Sites are evidence-based Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment. Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12 Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services. Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15 Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been: * A reduction in the overall rate of needle sharing in the area;19 * A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21 * Increased access to addiction counseling and increased enrolment in detox programs;22 23 * Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24 * Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and * No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26 * Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28 Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence. Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety. Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation. The CMA has the following concerns with Bill C-2: 1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation." 2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation. 3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances". 4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need. It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services. * "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services. 1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4 2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23 5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967 6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf 8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf 9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf 10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm 14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services 15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics 16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf 17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404. 19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18. 20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351. 21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7. 22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919. 23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence. 24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36. 25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34. 26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76. 28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36. 29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. 30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction. 31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374. 32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136 33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) 34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).
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Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act)

https://policybase.cma.ca/en/permalink/policy11519
Date
2015-05-14
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2015-05-14
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act) Canadian Medical Association Submission to the Senate Standing Committee on Legal and Constitutional Affairs On behalf of its more than 82,000 members and the Canadian public, CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. The CMA is a voluntary professional organization representing the majority of Canada's physicians and comprising 12 provincial and territorial divisions and 51 national medical organizations. The Canadian Medical Association (CMA) provides this brief for consideration as part of the Senate Standing Committee on Legal and Constitutional Affairs study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1 Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite. The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3 In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.* CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult. Public health approach to addiction Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components. Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program). Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5 Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential. Harm reduction is part of health practice Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms. Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs. The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. Physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9 Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10 Supervised Consumption Sites are evidence-based Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment. Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12 Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services. Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15 Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been: * A reduction in the overall rate of needle sharing in the area;19 * A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21 * Increased access to addiction counseling and increased enrolment in detox programs;22 23 * Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24 * Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and * No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26 * Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28 Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence. Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety. Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation. The CMA has the following concerns with Bill C-2: 1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation." 2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation. 3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances". 4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need. It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services. * "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services. 1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4 2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23 5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967 6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf 8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf 9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf 10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm 14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services 15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics 16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf 17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404. 19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18. 20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351. 21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7. 22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919. 23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence. 24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36. 25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34. 26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76. 28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36. 29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. 30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction. 31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374. 32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136 33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) 34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).
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Bill C-17 An Act to amend the Food and Drugs Act

https://policybase.cma.ca/en/permalink/policy11196
Date
2014-06-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-06-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, which proposes amendments to the Food and Drugs Act. The CMA has over 80,000 physician-members. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Prescription medication has a very important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. As such, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription medication. Over the last several years, the CMA has prepared several briefs and reports on pharmaceutical medication and prescribing-related issues.1 It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan. The CMA supports a robust legislative framework and unbiased, evidence-based system for the oversight of pharmaceutical products. As outlined below, the CMA has identified opportunities to strengthen elements of Bill C-17 toward this end. 1) Clarify ministerial authority and responsibility The current legislative limit to the health minister's authorities is troubling. The CMA, along with many other stakeholders, has long called for an expansion of ministerial authorities related to the pharmaceutical legislative framework, including both pre- and post-approval, in support of patient safety. The CMA supports the underlying intent to expand the authority of the health minister to require the submission of information, modify the label or replace the package, to order a recall or relocation of a product. However, the CMA has two concerns regarding the limitations to this expanded authority (section 3, proposed new FDA sections 21.1, 21.2 and 21.3): * Firstly, that the threshold for the new authorities in section 3 (new proposed section 21.1, 21.2, and 21.3 of the FDA) may be too high. The term "serious risk of injury to health" will be the standard for these new ministerial powers and may limit the authority of the minister to take action when the concern may be serious, but not necessarily permanently debilitating or life threatening. * Secondly, that the minister is not required to take any of the actions proposed in Bill C-17 even if the threshold is met (these sections specify that the minister "may" take the specified action, rather than the minister "shall"). While seemingly minor, the difference between "may" and "shall" is the difference between having the authority to take action and being responsible to take this action. This difference is critical to a robust legislative framework for patient safety. Recommendation 1 In order to clarify the health minister's authority to take appropriate measures to protect patient safety, the CMA recommends that the standard "a serious risk of injury to human health" in section 3 proposed new FDA section 21.1 and "serious or imminent risk of injury to health" in section 3 proposed new FDA section 21.3 be amended to ensure an appropriate threshold that does not constrain ministerial authority. Recommendation 2: To ensure that the health minister has the clear responsibility to take appropriate measures to protect patient safety, the CMA recommends that the word "may" is replaced with "shall" in section 3, proposed new FDA sections 21.1, 21.2 and 21.3. 2) Oversight of natural health products The extensive use of natural health products, such as vitamins and herbal medicines, is partially due to a belief that such products are "natural" and thus low risk. Increasingly, it has become clear that these products can have adverse effects, including drug interactions. However, relatively little is known about the adverse effects associated with natural health products due to its limited legislative and regulatory requirements, including reporting. To ensure that patient safety risks associated with natural health products are addressed, these products should be included in the new patient safety legislation, as proposed in the previous iteration of this legislation in 2008, Bill C-51 An act respecting foods, therapeutic products and cosmetics. The CMA encourages the Health Committee to include natural health products within the scope of Bill C-17, as a first step toward ensuring that natural health products are subject to the same regulatory requirements and oversight as are prescription and over-the-counter pharmaceuticals in order to promote patient safety. Recommendation 3: The ministerial authorities and measures proposed in Bill C-17 should be extended to include natural health products and, as such, CMA recommends that the definition of "therapeutic product" in section 2(3), be amended to include natural health products. 3) Comprehensive post-market surveillance and response system The CMA has advocated for significant improvements to Health Canada's post-market surveillance and response system in light of significant shortcomings. A) Increasing accountability and public transparency Robust accountability and transparency are important elements in the legislative framework governing the post-market surveillance and response system. The 2011 report of the Office of the Auditor General of Canada (OAG) highlighted significant concerns regarding this system, not least of which being Health Canada's failure to meet its own benchmarks in reviewing and responding to pharmaceutical safety issues. While there was no assessment of the benchmarks themselves, as is typical with an audit, the OAG report highlighted a number of issues with Health Canada's approach to measuring its performance against its benchmarks. Following the publication of the OAG audit report, Health Canada's 2013-14 Main Estimates and Report of Plans and Priorities2 shows cuts in both budget and staff allocation for health products (which includes drug oversight). The 2011 OAG report states that "Canada's small population reduces the likelihood of serious, rare adverse drug reactions being identified in this country; therefore, the capacity to search and analyze foreign reports electronically would contribute to more comprehensive safety monitoring."3 Of note, the audit found that Health Canada "does not take timely action in its regulatory activities" (...). "In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information."4 Despite Health Canada's March 2013 update on its efforts to address the OAG recommendations5 the status of the improvements to the reporting tools, timeliness of information or quality of information provided to practitioners and patients remains unclear. The preceding paragraphs capture a number of issues pertaining to the post-approval surveillance and response system; it is imperative that Health Canada not only address these issues, but that Health Canada has adequate resources to do so. This is paramount prior to any consideration of expanding the input of reporting data. Recommendation 4: The CMA recommends that Bill C-17 be amended to require Health Canada undertake public consultations in establishing its performance benchmarks related to adverse drug reaction reporting, analysis and response communication. Recommendation 5: The CMA recommends that Bill C-17 be amended to establish a new public reporting requirement of its performance in meeting its performance benchmarks. B) Improving the reporting and communication system The CMA cautions against the advancement of new legislative authority with respect to mandatory reporting of serious adverse drug reactions prior to the improvement of the system and model currently in place. Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction report has been received. Monitoring capacity requires rigorous data analysis and, to be useful in preventing further adverse events, it must be timely. As well, it should also provide information about a drug's efficacy and effectiveness. When new information is uncovered about a prescription drug, it is important that health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information in a manner that allows them to incorporate it into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Such feedback will encourage further reporting. In order to improve patient safety, the CMA recommends that Health Canada's establish a model that includes: * Making it easier for physicians and other health professionals to report adverse drug reactions by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Currently the existing system imposes an unnecessary administrative burden that comes at the expense of time dedicated to patient care. * Making the reporting process even more efficient by incorporating it directly into the Electronic Health Record systems. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of reports over the past 10 years, but being able to connect patient information with drugs they are taking, reporting of adverse drug reactions and safety information would improve care on the front line. * Augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report adverse drug reactions in detail, and who would be committed to assiduous reporting. * Linking to international post-approval surveillance systems, thus increasing the body of data at researchers' disposal, as well as the capacity for meaningful analysis. Health Canada should take a leadership role in ensuring that the public has access to appropriate information on drugs and drug safety, engaging civil society at the appropriate phases of the process. In providing this information, Health Canada should consider the management and communication of risk, and take into account the diversity of Canada's population. Access to accurate, unbiased information allows people to make decisions regarding their own health. In addition to ensuring a comprehensive model is in place, it is essential that there be more clarity in Bill C-17 regarding what constitutes a "prescribed health care institution". There are very different changes to the system that would need to be in place should it refer to tertiary care hospitals, community hospitals, clinics or doctors in family practice. Bill C-17 must not place an unnecessary administrative burden, which would ultimately fall on health professionals. Further, it is unclear whether a cost assessment of the proposed new requirements for health care institutions with respect to provincial/territorial resources has been undertaken. Only those health care institutions that are best positioned to improve the quantity and quality of reporting should be required to report. Another term that requires clarification in the legislation is "serious adverse drug reaction". It should be clear whether it means adverse drug reactions that require visits to emergency departments or hospitalization, or whether there are other criteria to define it. Recommendation 6: The CMA recommends that Bill C-17 be amended to require that Health Canada implement comprehensive post-surveillance monitoring and reporting model that includes: * Accessible, comprehensive and user-friendly reporting tools that are clinically relevant and linked to electronic health records; * Rigorous and timely analysis of reports for the early identification and response to emerging drug safety threats; and * Communication of timely, user-friendly and clinically-relevant information to health care practitioners and the public. Recommendation 7: The CMA recommends amendment of Bill C-17 section 5, proposed new FDA section 21.8, to require that an assessment by the minister for reporting regulations be undertaken following a prescribed period after this new model is established; that this assessment precede the coming into force of expanded mandatory reporting. Recommendation 8: The CMA recommends that essential terminology be defined in Bill C-17, including (a) "serious adverse drug reaction" and (b) "health care institution". Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective. 1 Canadian Medical Association (2005) Building a Comprehensive Post-Market Surveillance System. CMA's Response to Health Canada's Discussion Paper 'Designing a Mandatory System for Reporting Serious Adverse Reactions'. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2005/English/Mandatory_Response.pdf Canadian Medical Association (2014) Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/SOCI_BriefEnglish-Final.pdf Canadian Medical Association (2008) Post-Market Surveillance of Pharmaceutical Products. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf Canadian Medical Association (2012) Prescription Drugs: Clinical Trials and Approval. CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-ClinicalTrials_en.pdf Canadian Medical Association (2012) Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-Pharmaceuticals-Oct2012_en.pdf Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/CMA_SubmissiontoHealthCanada-CDSA_Modernization.pdf Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2013/Prescription-Drug-Abuse_en.pdf 2 Health Canada (2013) 2013-14 Report on Plans and Priorities. Government of Canada. http://www.hc-sc.gc.ca/ahc-asc/alt_formats/pdf/performance/estim-previs/plans-prior/2013-2014/report-rapport-eng.pdf (pg 30) 3 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 21) 4 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 2) 5 Health Canada (2013) Update and response to OAG recommendations for the regulation of pharmaceutical drugs in Fall 2011. Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/oag-bvg-eng.php
Documents
Less detail

Bill C-45: The Cannabis Act

https://policybase.cma.ca/en/permalink/policy13723
Date
2017-08-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-08-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The CMA is pleased to provide this submission to the House of Commons Standing Committee on Health on Bill C-45, the Cannabis Act. The CMA has long-standing concerns about the health risks associated with consuming cannabis,i particularly in its smoked form.1,2 Children and youth are especially at risk for cannabis-related harms, given their brains are undergoing rapid and extensive development. i The term cannabis is used, as in Bill C-45: that is, referring to the cannabis plant or any substance or mixture that contains any part of the plant. ii The plant contains at least 750 chemicals, of which there are over 100 different cannabinoids. Madras BK. Update of cannabis and its medical use. Agenda item 6.2. 37th Meeting of the Expert Committee on 1 Canadian Medical Association. Health risks and harms associated with the use of marijuana. CMA submission to the House of Commons Standing Committee on Health. Ottawa: The Association; 27 May 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2017 Jul 27). 2 Canadian Medical Association. A public health perspective on cannabis and other illegal drugs. CMA submission to the Special Senate Committee on Illegal Drugs. Ottawa: The Association; 11 Mar 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2017 Jul 27). 3 Canadian Medical Association. Bill C-2 An Act to Amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the House of Commons Standing Committee on Public Safety and National Security. Ottawa: The Association; 28 Oct 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/CMA_Brief_C-2_Respect%C3%A9-for_Communities_Act-English.pdf (accessed 2017 Jul 27). 4 Harm Reduction International. What is harm reduction? A position statement from Harm Reduction International. London, UK: Harm Reduction International; 2017. Available: www.hri.global/what-is-harm-reduction (accessed 2017 Jul 27). 5 Riley D, O’Hare P. Harm reduction: history, definition and practice. In: Inciardi JA, Harrison LD, editors. Harm reduction: national and international perspectives. Thousand Oaks, CA: Sage Publications; 2000. 6 Fischer B, Russel C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health 2017;107(8):e1–e12. 7 Canadian Medical Association. Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on Cannabis Legalization and Regulation. Ottawa: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27). 8 Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): 2015 summary. Ottawa: Government of Canada; 2017. Available: www.canada.ca/en/health-canada/services/canadian-tobacco-alcohol-drugs-survey/2015-summary.html (accessed 2017 Jul 27). 9 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS): summary of results for 2012. Ottawa: Health Canada; 2014. Available: www.canada.ca/en/health-canada/services/health-concerns/drug-prevention-treatment/drug-alcohol-use-statistics/canadian-alcohol-drug-use-monitoring-survey-summary-results-2012.html (accessed 2017 Jul 27). 10 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: http://apps.who.int/iris/bitstream/10665/251056/1/9789241510240-eng.pdf?ua=1 (accessed 2017 Jul 27). 11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016. 12 Government of Canada. Legislative background: an Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). Ottawa: Government of Canada; 2017. 13 An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, Bill C-45, First Reading 2017 Apr 13. 14 Crean RD, Crane NA, Mason BJ. An evidence based review of acute and long-term effects of cannabis use on executive cognitive functions. J Addict Med 2011;5(1):1–8. The CMA’s approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA believes that harm reduction encompasses policies, goals, strategies and programs directed at decreasing adverse health, social and economic consequences of drug use for the individual, the community and the society while allowing the user to continue to use drugs, not precluding abstinence.3,4 Specifically, the CMA recommends a multi-faceted cannabis public health strategy that prioritizes impactful and realistic goals before, and certainly no later than, any legalization of cannabis.5 We propose that the first goal should be to develop educational interventions for children, teenagers and young adults. Other goals relate to data collection; monitoring and surveillance; ensuring a proportionate balance between enforcement harms and the direct and indirect harms caused by cannabis use; and research. There is an ongoing need for research into the medicinal and harmful effects of cannabis use. As noted by the Lower-Risk Cannabis Use Guidelines, 6 there is limited evidence on such subjects as synthetic cannabinoids; practices like “deep inhalation” to increase the psychoactive effects of cannabis; and the combination of risky behaviours, like early-onset and frequent use, associated with experiencing acute or chronic health problems.6 Since 2002, the CMA has taken a public health perspective regarding cannabis and other illegal drugs. More recently, the CMA endorsed the Lower-Risk Cannabis Use Guidelines, and we submitted 22 recommendations to the Task Force on Cannabis Legalization and Regulation (“the Task Force”).7 Overview According to the recent Canadian Tobacco, Alcohol and Drugs Survey, cannabis is the most used illicit drug in Canada.8 In particular, 25%–30% of adolescents or youth report past-year cannabis use.9 This concerns the CMA. The increasing rate of high usage, despite the fact that non-medical use of cannabis is illegal, coupled with cannabis’ increased potency (from 2% in 1980 to 20% in 2015 in the United States),10 the complexity and versatility of the cannabis plant,ii the variable quality of the end product, and variations in the frequency, age of initiation Drug Dependence, Department of Essential Medicines and Health Products, World Health Organization; 2015. Available: www.who.int/medicines/access/controlled-substances/6_2_cannabis_update.pdf (accessed 2017 Jul 27). and method of use make it difficult to study the full health impacts and produce replicable, reliable scientific results. The CMA submits, therefore, that any legalization of cannabis for non-medical use must be guided by a comprehensive cannabis public health strategy and include a strong legal-regulatory framework emphasizing harm reduction principles. Given that the Task Force employed a minimizing of harms approach11 and given how the proposed legislation aligns with the Task Force’s recommendations,12 the bill addresses several aspects of a legal-regulatory framework “to provide legal access to cannabis and to control and regulate its production, distribution and sale.”13 This work provides the starting point for creating a national cannabis public health strategy. The CMA has long called for a comprehensive drug strategy that addresses addiction, prevention, treatment, enforcement and harm reduction.3 There are, however, key public health initiatives that the Canadian government has not adequately addressed and should be implemented before, or no later than, the implementation of legislation. One such initiative is education. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. Supporting a Legal-Regulatory Framework that Advances Public Health and Protection of Children and Youth From a health perspective, allowing any use of cannabis by people under 25 years of age, and certainly those under 21 years of age, is challenging for physicians given the effects on the developing brain.1,3,14 The neurotoxic effect of cannabis, especially with persistent use, on the adolescent brain is more severe than on the adult brain.15,16 15 Meier MH, Caspi A, Ambler A, et al. Persistent cannabis users show neuropsychological decline from childhood to midlife. Proc Natl Acad Sci USA 2012;109(40):E2657–64 16 Crépault JF, Rehm J, Fischer B. The cannabis policy framework by the Centre for Addiction and Mental Health: a proposal for a public health approach to cannabis policy in Canada. Int J Drug Policy 2016;34:1–4. 17 Pope HG Jr, Gruber AJ, Hudson JI, et al. Early-onset cannabis use and cognitive deficits: What is the nature of the association? Drug Alcohol Depend 2003;69(3):303–310. 18 Gruber SA, Sagar KA, Dahlgren MK, et al. Age of onset of marijuana use and executive function. Psychol Addict Behav 2011;26(3):496–506. 19 National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington (DC): The National Academies Press; 2017. 20 Canadian Cancer Society. 2017 federal pre-budget submission. Canadian Cancer Society submission to the Standing Committee on Finance. 2014 Aug. Available: www.ourcommons.ca/Content/Committee/421/FINA/Brief/BR8398102/br-external/CanadianCancerSociety-e.pdf (accessed 2017 Jul 27). 21 Health Canada. Backgrounder: legalizing and strictly regulating cannabis: the facts. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/health-canada/news/2017/04/backgrounder_legalizingandstrictlyregulatingcannabisthefacts.html (accessed 2017 Jul 27) 22 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet 2009;374(9698):1383–91. 23 Statistics Canada. Canadian Community Health Survey: Mental Health, 2012. The Daily. 2013 Sep 18. Statistics Canada cat. No. 11-001-X. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2017 Jul 27). 24 Miech RA, Johnston LD, O’Malley PM, Bachman JG, Schulenberg, JE. Monitoring the future national survey results on drug use, 1975–2010. Vol 1: Secondary students. Ann Arbor: Institute for Social Research, University of Michigan; 2011. 25 Spithoff S, Kahan M. Cannabis and Canadian youth: evidence, not ideology. Can Fam Physician 2014;60(9):785–7. 26 Health Canada. Strong foundation, renewed focus: an overview of Canada’s Federal Tobacco Control Strategy 2012–2017. Ottawa: Health Canada; 2012. Available: www.canada.ca/content/dam/canada/health-canada/migration/healthy-canadians/publications/healthy-living-vie-saine/tobacco-strategy-2012-2017-strategie-tabagisme/alt/tobacco-strategy-2012-2017-strategie-tabagisme-eng.pdf (accessed 2017 Jul 27). 27 Controlled Drugs and Substances Act, SC 1996, c 19, s 9. Further, neurological studies have shown that adolescent-onset cannabis use produces greater deficits in executive functioning and verbal IQ and greater impairment of learning and memory than adult-onset use.17,18 This underscores the importance of protecting the brain during development. Since current scientific evidence indicates that brain development is not completed until about 25 years of age,19 this would be the ideal minimum age for legal cannabis use. Youth and young adults are among the highest users of cannabis in Canada. Despite non-medical use of cannabis being illegal in Canada since 1923, usage has increased over the past few decades. The CMA recognizes that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach.3 Harm reduction is not one of polarities rather it is about ensuring the quality and integrity of human life and acknowledging where the individual is at within his/her community and society at large.5 The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug’s physiological harm. The Canadian government has recognized this disproportionality for over 15 years. Since 2001, there have been two parliamentary committee reportsiii and two billsiv introduced to decriminalize possession of small amounts of cannabis (30 g). It was recommended that small amounts of cannabis possession be a “ticketable” offence rather than a criminal one. iii House of Commons Special Committee on the Non-Medical Use of Drugs (2001) and the Senate Special Committee on Illegal Drugs (2002). iv An Act to amend the Contraventions Act and the Controlled Drugs and Substances Act (Bill C-38), which later was reintroduced as Bill C-10 in 2003. v For example, the Substance Use and Addictions Program (SUAP), a federal contributions program, is delivered by Health Canada to strengthen responses to drug and substance use issues in Canada. See Government of Canada. Substance Use and Addictions Program. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/services/health/campaigns/canadian-drugs-substances-strategy/funding/substance-abuse-addictions-program.html (accessed 2017 Jul 27). Given all of the above, the CMA recommends that the age of legalization should be 21 years of age and that the quantities and the potency of cannabis be more restricted to those under age 25. Supporting a Comprehensive Cannabis Public Health Strategy with a Strong, Effective Education Component The CMA recognizes that Bill C-45 repeals the prohibition against simple possession while increasing penalties against the distribution and sale of cannabis to young people, but this is not enough to support a harm reduction approach. We note that the Federal Tobacco Control Strategy, with its $38 million budget, is intended to help reduce smoking rates and change Canadians’ perceptions toward tobacco.20 Similarly, there are extensive education programs concerning the dangers of alcohol, particularly for young people.v The government of Canada has proposed a modest commitment of $9.6 million to a public awareness campaign to inform Canadians, especially youth, of the risks of cannabis consumption, and to surveillance activities.21 A harm reduction strategy should include a hierarchy of goals with an immediate focus on groups with pressing needs. The CMA submits that young people should be targeted first with education. The lifetime risk of dependence to cannabis is estimated at 9%, increasing to almost 17% in those who initiate use in adolescence.22 In 2012, about 1.3% of people aged 15 years and over met the criteria for cannabis abuse or dependence — double the rate for any other drug — because of the high prevalence of cannabis use.23 The strategy should include the development of educational interventions, including skills-based training programs, social marketing interventions and mass media campaigns. Education should focus not only on cannabis’ general risks but also on its special risks for the young and its harmful effects on them. This is critical given that for many, the perception is that (i) legalization of possession for both adults and young people translates into normalization of use and (ii) government control over the source of cannabis for sale translates into safety of use. Complicating this has been the fear-mongering messaging associated with illegal drugs. The evidence shows that fewer adolescents today believe that cannabis use has any serious health risks24 and that enforcement policies have not been a deterrent.25 Having an appropriate education strategy rolled out before legalization of possession would reduce the numbers of uninformed young recreational users. It would also provide time to engage in meaningful research on the impact of the drug on youth. Such strategies have been successful in the past; for example, the long-termvi Federal Tobacco Control Strategy has been credited with helping reduce smoking rates to an all-time low in Canada.26 vi The Federal Tobacco Control Strategy was initiated in 2001 for 10 years and renewed in 2012 for another five years. The Lower-Risk Cannabis Use Guidelines were developed as a “science-based information tool for cannabis users to modify their use toward reducing at least some of the health risks.”6 The CMA urges the government to support the widespread dissemination of this tool and incorporation of its messages into educational efforts. Other strategies must include plain packaging and labelling with health information and health warnings. Supporting a One-System Approach. Alternatively, a Review of Legislation in Five Years The CMA believes that once the act is in force, there will be little need for two systems (i.e., one for medical and one for non-medical cannabis use). Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization (some people may self-medicate with cannabis to alleviate symptoms but may be reluctant to raise the issue with their family physician for fear of being stigmatized), and for those who wish to use it for other purposes. The medical profession does not need to continue to be involved as a gatekeeper once cannabis is legal for all, especially given that cannabis has not undergone Health Canada’s usual pharmaceutical regulatory approval process. The Task Force’s discussion reflects the tension it heard between those who advocated for one system and those who did not. One concern raised by patients was about the stigma attached to entering retail outlets selling non-medical cannabis. The CMA submits that this concern would be alleviated if the federal government continued the online purchase and mail order system that is currently in place. Given that there is a lack of consensus and insufficient data to calculate how much of the demand for cannabis will be associated with medical authorization, the Task Force recommended that two systems be established, with an obligation to review — specifically, a program evaluation of the medical access framework in five years.11 If there are two systems, then in the alternative, the CMA recommends a review of the legislation within five years. This would allow time to ensure that the provisions of the act are meeting their intended purposes, as determined by research on the efficacy of educational efforts and other research. Five-year legislative reviews have been previously employed, especially where legislation must balance individual choice with protecting public health and public safety.vii For example, like Bill C-45, the purpose of the Controlled Drugs and Substances Act is to protect public health and public safety.27 Its review within five years is viewed as allowing for a thorough, evidence-based analysis to ensure that the provisions and operations of the act are meeting their intended purpose(s).viii Furthermore, a harm reduction approach lends itself to systematic evaluation of the approach’s short- and long-term impact on the reduction of harms.5 vii Several federal acts contain review provisions. Some examples include the Controlled Drugs and Substances Act, SC b1996, c 19, s 9 (five-year review); the Preclearance Act, SC 1999, c 20, s 39 (five-year review); the National Defence Act, RSC 1985, c N-5, s 273.601(1) (seven-year review); the Public Servants Disclosure Protection Act, SC 2005, c 46, s 54 (five-year review); and the Red Tape Reduction Act, SC 2015, c 12 (five-year review). viii The 2012 amendments to the Controlled Drugs and Substances Act were adopted from Bill S-10, which died on order papers in March 2011. The Senate Standing Committee on Legal and Constitutional Affairs reviewed Bill S-10 and recommended that the review period should be extended from two to five years as two years is not sufficient to allow for a comprehensive review. See Debates of the Senate, 40th Parliament, 3rd Session, No 147:66 (2010 Nov 17) at 1550; see also Senate Standing Committee on Legal and Constitutional Affairs, Eleventh Report: Bill S-10, An Act to Amend the Controlled Drugs and Substances Act and to Make Related and Consequential Amendments to Other Acts, with Amendments (2010 Nov 4). The CMA, therefore, submits that if a two-system approach is implemented when the legislation is enacted, the legislation should be amended to include the requirement for evaluation within five years of enactment. Criteria for evaluation may include the number of users in the medical system and the number of physicians authorizing medical cannabis use. The CMA would expect to be involved in the determination of such criteria and evaluation process. Conclusion Support has risen steadily in Canada and internationally for the removal of criminal sanctions for simple cannabis possession, as well as for the legalization and regulation of cannabis’ production, distribution and sale. The CMA has long-standing concerns about the health risks associated with consuming cannabis, especially by children and youth in its smoked form. Weighing societal trends against the health effects of cannabis, the CMA supports a broad legal-regulatory framework as part of a comprehensive and properly sequenced public health approach of harm reduction. Recommendations 1. The CMA recommends that the legalization age be amended to 21 years of age, to better protect the most vulnerable population, youth, from the developmental neurological harms associated with cannabis use. 2. The CMA recommends that a comprehensive cannabis public health strategy with a strong, effective health education component be implemented before, and no later than, the enactment of any legislation legalizing cannabis. 3a. The CMA recommends that there be only one regime for medical and non-medical use of cannabis, with provisions for the medical needs of those who would not be able to acquire cannabis in a legal manner (e.g., those below the minimum age). 3b. Alternatively, the CMA recommends that the legislation be amended to include a clause to review the legislation, including a review of having two regimes, within five years.
Documents
Less detail

Bill C-45: The Cannabis Act

https://policybase.cma.ca/en/permalink/policy13861
Date
2018-04-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2018-04-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The CMA is pleased to provide this submission to the Senate Standing Committee, Social Affairs, Science &Technology on Bill C-45, the Cannabis Act. The CMA has long-standing concerns about the health risks associated with consuming cannabis,i particularly in its smoked form.1,2 Children and youth are especially at risk for cannabis-related harms, given their brains are undergoing rapid and extensive development. The CMA's approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA believes that harm reduction encompasses policies, goals, strategies and programs directed at decreasing adverse health, social and economic consequences of drug use for the individual, the community and the society while allowing the user to continue to use drugs, not precluding abstinence.3,4 Specifically, the CMA recommends a multi-faceted cannabis public health strategy that prioritizes impactful and realistic goals before, and certainly no later than, any legalization of cannabis.5 We propose that the first goal should be to develop educational interventions for children, teenagers and young adults. Other goals relate to data collection; monitoring and surveillance; ensuring a proportionate balance between enforcement harms and the direct and indirect harms caused by cannabis use; and research. There is an ongoing need for research into the medicinal and harmful effects of cannabis use. As noted by the Lower-Risk Cannabis Use Guidelines, 6 there is limited evidence on such subjects as synthetic cannabinoids; practices like "deep inhalation" to increase the psychoactive effects of cannabis; and the combination of risky behaviours, like early-onset and frequent use, associated with experiencing acute or chronic health problems.6 Since 2002, the CMA has taken a public health perspective regarding cannabis and other illegal drugs. More recently, the CMA endorsed the Lower-Risk Cannabis Use Guidelines, and we submitted 22 recommendations to the Task Force on Cannabis Legalization and Regulation ("the Task Force").7 Overview According to the recent Canadian Tobacco, Alcohol and Drugs Survey, cannabis is the most used illicit drug in Canada.8 In particular, 25%-30% of adolescents or youth report past-year cannabis use.9 This concerns the CMA. The increasing rate of high usage, despite the fact that non-medical use of cannabis is illegal, coupled with cannabis' increased potency (from 2% in 1980 to 20% in 2015 in the United States),10 the complexity and versatility of the cannabis plant,ii the variable quality of the end product, and variations in the frequency, age of initiation and method of use make it difficult to study the full health impacts and produce replicable, reliable scientific results. The CMA submits, therefore, that any legalization of cannabis for non-medical use must be guided by a comprehensive cannabis public health strategy and include a strong legal-regulatory framework emphasizing harm reduction principles. Given that the Task Force employed a minimizing of harms approach11 and given how the proposed legislation aligns with the Task Force's recommendations,12 the bill addresses several aspects of a legal-regulatory framework "to provide legal access to cannabis and to control and regulate its production, distribution and sale."13 This work provides the starting point for creating a national cannabis public health strategy. The CMA has long called for a comprehensive drug strategy that addresses addiction, prevention, treatment, enforcement and harm reduction.3 There are, however, key public health initiatives that the Canadian government has not adequately addressed and should be implemented before, or no later than, the implementation of legislation. One such initiative is education. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. Supporting a Legal-Regulatory Framework that Advances Public Health and Protection of Children and Youth From a health perspective, allowing any use of cannabis by people under 25 years of age, and certainly those under 21 years of age, is challenging for physicians given the effects on the developing brain.1,3,14 The neurotoxic effect of cannabis, especially with persistent use, on the adolescent brain is more severe than on the adult brain.15,16 Further, neurological studies have shown that adolescent-onset cannabis use produces greater deficits in executive functioning and verbal IQ and greater impairment of learning and memory than adult-onset use.17,18 This underscores the importance of protecting the brain during development. Since current scientific evidence indicates that brain development is not completed until about 25 years of age,19 this would be the ideal minimum age for legal cannabis use. Youth and young adults are among the highest users of cannabis in Canada. Despite non-medical use of cannabis being illegal in Canada since 1923, usage has increased over the past few decades. The CMA recognizes that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach.3 Harm reduction is not one of polarities rather it is about ensuring the quality and integrity of human life and acknowledging where the individual is at within his/her community and society at large.5 The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug's physiological harm. The Canadian government has recognized this disproportionality for over 15 years. Since 2001, there have been two parliamentary committee reportsiii and two billsiv introduced to decriminalize possession of small amounts of cannabis (30 g). It was recommended that small amounts of cannabis possession be a "ticketable" offence rather than a criminal one. Given all of the above, the CMA recommends that the age of legalization should be 21 years of age and that the quantities and the potency of cannabis be more restricted to those under age 25. Supporting a Comprehensive Cannabis Public Health Strategy with a Strong, Effective Education Component The CMA recognizes that Bill C-45 repeals the prohibition against simple possession while increasing penalties against the distribution and sale of cannabis to young people, but this is not enough to support a harm reduction approach. We note that the Federal Tobacco Control Strategy, with its $38 million budget, is intended to help reduce smoking rates and change Canadians' perceptions toward tobacco.20 Similarly, there are extensive education programs concerning the dangers of alcohol, particularly for young people.v The government of Canada has proposed a modest commitment of $9.6 million to a public awareness campaign to inform Canadians, especially youth, of the risks of cannabis consumption, and to surveillance activities.21 A harm reduction strategy should include a hierarchy of goals with an immediate focus on groups with pressing needs. The CMA submits that young people should be targeted first with education. The lifetime risk of dependence to cannabis is estimated at 9%, increasing to almost 17% in those who initiate use in adolescence.22 In 2012, about 1.3% of people aged 15 years and over met the criteria for cannabis abuse or dependence - double the rate for any other drug - because of the high prevalence of cannabis use.23 The strategy should include the development of educational interventions, including skills-based training programs, social marketing interventions and mass media campaigns. Education should focus not only on cannabis' general risks but also on its special risks for the young and its harmful effects on them. This is critical given that for many, the perception is that (i) legalization of possession for both adults and young people translates into normalization of use and (ii) government control over the source of cannabis for sale translates into safety of use. Complicating this has been the fear-mongering messaging associated with illegal drugs. The evidence shows that fewer adolescents today believe that cannabis use has any serious health risks24 and that enforcement policies have not been a deterrent.25 Having an appropriate education strategy rolled out before legalization of possession would reduce the numbers of uninformed young recreational users. It would also provide time to engage in meaningful research on the impact of the drug on youth. Such strategies have been successful in the past; for example, the long-termvi Federal Tobacco Control Strategy has been credited with helping reduce smoking rates to an all-time low in Canada.26 The Lower-Risk Cannabis Use Guidelines were developed as a "science-based information tool for cannabis users to modify their use toward reducing at least some of the health risks."6 The CMA urges the government to support the widespread dissemination of this tool and incorporation of its messages into educational efforts. Other strategies must include plain packaging and labelling with health information and health warnings. Supporting a One-System Approach. Alternatively, a Review of Legislation in Five Years The CMA believes that once the act is in force, there will be little need for two systems (i.e., one for medical and one for non-medical cannabis use). Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization (some people may self-medicate with cannabis to alleviate symptoms but may be reluctant to raise the issue with their family physician for fear of being stigmatized), and for those who wish to use it for other purposes. The medical profession does not need to continue to be involved as a gatekeeper once cannabis is legal for all, especially given that cannabis has not undergone Health Canada's usual pharmaceutical regulatory approval process. The Task Force's discussion reflects the tension it heard between those who advocated for one system and those who did not. One concern raised by patients was about the stigma attached to entering retail outlets selling non-medical cannabis. The CMA submits that this concern would be alleviated if the federal government continued the online purchase and mail order system that is currently in place. Given that there is a lack of consensus and insufficient data to calculate how much of the demand for cannabis will be associated with medical authorization, the Task Force recommended that two systems be established, with an obligation to review - specifically, a program evaluation of the medical access framework in five years.11 If there are two systems, then in the alternative, the CMA recommends a review of the legislation within five years. This would allow time to ensure that the provisions of the act are meeting their intended purposes, as determined by research on the efficacy of educational efforts and other research. Five-year legislative reviews have been previously employed, especially where legislation must balance individual choice with protecting public health and public safety.vii For example, like Bill C-45, the purpose of the Controlled Drugs and Substances Act is to protect public health and public safety.27 Its review within five years is viewed as allowing for a thorough, evidence-based analysis to ensure that the provisions and operations of the act are meeting their intended purpose(s).viii Furthermore, a harm reduction approach lends itself to systematic evaluation of the approach's short- and long-term impact on the reduction of harms.5 The CMA, therefore, submits that if a two-system approach is implemented when the legislation is enacted, the legislation should be amended to include the requirement for evaluation within five years of enactment. Criteria for evaluation may include the number of users in the medical system and the number of physicians authorizing medical cannabis use. The CMA would expect to be involved in the determination of such criteria and evaluation process. Conclusion Support has risen steadily in Canada and internationally for the removal of criminal sanctions for simple cannabis possession, as well as for the legalization and regulation of cannabis' production, distribution and sale. The CMA has long-standing concerns about the health risks associated with consuming cannabis, especially by children and youth in its smoked form. Weighing societal trends against the health effects of cannabis, the CMA supports a broad legal-regulatory framework as part of a comprehensive and properly sequenced public health approach of harm reduction. Recommendations 1. The CMA recommends that the legalization age be amended to 21 years of age, to better protect the most vulnerable population, youth, from the developmental neurological harms associated with cannabis use. 2. The CMA recommends that a comprehensive cannabis public health strategy with a strong, effective health education component be implemented before, and no later than, the enactment of any legislation legalizing cannabis. 3a. The CMA recommends that there be only one regime for medical and non-medical use of cannabis, with provisions for the medical needs of those who would not be able to acquire cannabis in a legal manner (e.g., those below the minimum age). 3b. Alternatively, the CMA recommends that the legislation be amended to include a clause to review the legislation, including a review of having two regimes, within five years. i The term cannabis is used as in Bill C-45: that is, referring to the cannabis plant or any substance or mixture that contains any part of the plant. ii The plant contains at least 750 chemicals, of which there are over 100 different cannabinoids. Madras BK. Update of cannabis and its medical use. Agenda item 6.2. 37th Meeting of the Expert Committee on Drug Dependence, Department of Essential Medicines and Health Products, World Health Organization; 2015. Available: www.who.int/medicines/access/controlled-substances/6_2_cannabis_update.pdf (accessed 2017 Jul 27). iii House of Commons Special Committee on the Non-Medical Use of Drugs (2001) and the Senate Special Committee on Illegal Drugs (2002). iv An Act to amend the Contraventions Act and the Controlled Drugs and Substances Act (Bill C-38), which later was reintroduced as Bill C-10 in 2003. v For example, the Substance Use and Addictions Program (SUAP), a federal contributions program, is delivered by Health Canada to strengthen responses to drug and substance use issues in Canada. See Government of Canada. Substance Use and Addictions Program. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/services/health/campaigns/canadian-drugs-substances-strategy/funding/substance-abuse-addictions-program.html (accessed 2017 Jul 27). vi The Federal Tobacco Control Strategy was initiated in 2001 for 10 years and renewed in 2012 for another five years. vii Several federal acts contain review provisions. Some examples include the Controlled Drugs and Substances Act, SC b1996, c 19, s 9 (five-year review); the Preclearance Act, SC 1999, c 20, s 39 (five-year review); the National Defence Act, RSC 1985, c N-5, s 273.601(1) (seven-year review); the Public Servants Disclosure Protection Act, SC 2005, c 46, s 54 (five-year review); and the Red Tape Reduction Act, SC 2015, c 12 (five-year review). viii The 2012 amendments to the Controlled Drugs and Substances Act were adopted from Bill S-10, which died on order papers in March 2011. The Senate Standing Committee on Legal and Constitutional Affairs reviewed Bill S-10 and recommended that the review period should be extended from two to five years as two years is not sufficient to allow for a comprehensive review. See Debates of the Senate, 40th Parliament, 3rd Session, No 147:66 (2010 Nov 17) at 1550; see also Senate Standing Committee on Legal and Constitutional Affairs, Eleventh Report: Bill S-10, An Act to Amend the Controlled Drugs and Substances Act and to Make Related and Consequential Amendments to Other Acts, with Amendments (2010 Nov 4). 1 Canadian Medical Association. Health risks and harms associated with the use of marijuana. CMA submission to the House of Commons Standing Committee on Health. Ottawa: The Association; 27 May 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2017 Jul 27). 2 Canadian Medical Association. A public health perspective on cannabis and other illegal drugs. CMA submission to the Special Senate Committee on Illegal Drugs. Ottawa: The Association; 11 Mar 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2017 Jul 27). 3 Canadian Medical Association. Bill C-2 An Act to Amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the House of Commons Standing Committee on Public Safety and National Security. Ottawa: The Association; 28 Oct 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/CMA_Brief_C-2_Respect%C3%A9-for_Communities_Act-English.pdf (accessed 2017 Jul 27). 4 Harm Reduction International. What is harm reduction? A position statement from Harm Reduction International. London, UK: Harm Reduction International; 2017. Available: www.hri.global/what-is-harm-reduction (accessed 2017 Jul 27). 5 Riley D, O'Hare P. Harm reduction: history, definition and practice. In: Inciardi JA, Harrison LD, editors. Harm reduction: national and international perspectives. Thousand Oaks, CA: Sage Publications; 2000. 6 Fischer B, Russel C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health 2017;107(8):e1-e12. 7 Canadian Medical Association. Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada - Task Force on Cannabis Legalization and Regulation. Ottawa: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27). 8 Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): 2015 summary. Ottawa: Government of Canada; 2017. Available: www.canada.ca/en/health-canada/services/canadian-tobacco-alcohol-drugs-survey/2015-summary.html (accessed 2017 Jul 27). 9 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS): summary of results for 2012. Ottawa: Health Canada; 2014. Available: www.canada.ca/en/health-canada/services/health-concerns/drug-prevention-treatment/drug-alcohol-use-statistics/canadian-alcohol-drug-use-monitoring-survey-summary-results-2012.html (accessed 2017 Jul 27). 10 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: http://apps.who.int/iris/bitstream/10665/251056/1/9789241510240-eng.pdf?ua=1 (accessed 2017 Jul 27). 11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016. 12 Government of Canada. Legislative background: an Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). Ottawa: Government of Canada; 2017. 13 An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, Bill C-45, First Reading 2017 Apr 13. 14 Crean RD, Crane NA, Mason BJ. An evidence based review of acute and long-term effects of cannabis use on executive cognitive functions. J Addict Med 2011;5(1):1-8. 15 Meier MH, Caspi A, Ambler A, et al. Persistent cannabis users show neuropsychological decline from childhood to midlife. Proc Natl Acad Sci USA 2012;109(40):E2657-64 16 Crépault JF, Rehm J, Fischer B. The cannabis policy framework by the Centre for Addiction and Mental Health: a proposal for a public health approach to cannabis policy in Canada. Int J Drug Policy 2016;34:1-4. 17 Pope HG Jr, Gruber AJ, Hudson JI, et al. Early-onset cannabis use and cognitive deficits: What is the nature of the association? Drug Alcohol Depend 2003;69(3):303-310. 18 Gruber SA, Sagar KA, Dahlgren MK, et al. Age of onset of marijuana use and executive function. Psychol Addict Behav 2011;26(3):496-506. 19 National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington (DC): The National Academies Press; 2017. 20 Canadian Cancer Society. 2017 federal pre-budget submission. Canadian Cancer Society submission to the Standing Committee on Finance. 2014 Aug. Available: www.ourcommons.ca/Content/Committee/421/FINA/Brief/BR8398102/br-external/CanadianCancerSociety-e.pdf (accessed 2017 Jul 27). 21 Health Canada. Backgrounder: legalizing and strictly regulating cannabis: the facts. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/health-canada/news/2017/04/backgrounder_legalizingandstrictlyregulatingcannabisthefacts.html (accessed 2017 Jul 27) 22 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet 2009;374(9698):1383-91. 23 Statistics Canada. Canadian Community Health Survey: Mental Health, 2012. The Daily. 2013 Sep 18. Statistics Canada cat. No. 11-001-X. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2017 Jul 27). 24 Miech RA, Johnston LD, O'Malley PM, Bachman JG, Schulenberg, JE. Monitoring the future national survey results on drug use, 1975-2010. Vol 1: Secondary students. Ann Arbor: Institute for Social Research, University of Michigan; 2011. 25 Spithoff S, Kahan M. Cannabis and Canadian youth: evidence, not ideology. Can Fam Physician 2014;60(9):785-7. 26 Health Canada. Strong foundation, renewed focus: an overview of Canada's Federal Tobacco Control Strategy 2012-2017. Ottawa: Health Canada; 2012. Available: www.canada.ca/content/dam/canada/health-canada/migration/healthy-canadians/publications/healthy-living-vie-saine/tobacco-strategy-2012-2017-strategie-tabagisme/alt/tobacco-strategy-2012-2017-strategie-tabagisme-eng.pdf (accessed 2017 Jul 27). 27 Controlled Drugs and Substances Act, SC 1996, c 19, s 9.
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Canadian Medical Association submission to the Standing Senate Committee on Banking, Trade and Commerce: Higher rate now: Why excise tax on tobacco is long overdue for an increase

https://policybase.cma.ca/en/permalink/policy11129
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study of Bill C-31 the Budget Implementation Bill, in particular the section concerned with tobacco taxation. Tobacco use is still the number one cause of preventable disease and death in Canada, claiming 37,000 or more Canadians' lives every year. It is a major risk factor for the chronic diseases that burden Canadians and their health care system, and it costs the country over $17 billion per year for medical treatment, social assistance, lost productivity and reduced quality of life. While progress has been made in lowering smoking rates and changing attitudes towards smoking much work remains - nearly 4.6 million Canadians still smoke. Physicians have been warning of the dangers of smoking for over 50 years. Canada's doctors treat the harmful effects of tobacco use every day in their offices, and see first-hand the devastation it causes to patients and their families. The CMA has consistently recommended tough legislative and regulatory measures to control tobacco use. Comprehensive tobacco control efforts must include legislation, regulation, together with public education and smoking cessation programs. Impact of Price on Smoking Research has shown that an increase in cigarette prices has an impact on reducing both the number of cigarettes smoked and smoking prevalence rates. Permanent, inflation-adjusted increases in cigarette prices, which could be achieved by increasing cigarette taxes, will contribute to reducing cigarette smoking rates in Canada. Youth are up to three times more sensitive to price than adults, with a 10 per cent price increase estimated to reduce youth smoking prevalence by 5 per cent or more and also to reduce cigarette consumption among continuing young smokersi With the current smoking rate of 20 per cent among Canadian young adults, higher than the smoking rate for the rest of Canada which is 16 per cent, additional initiatives to reduce smoking in this population are urgently required. Research has also shown that persons of low socioeconomic status are more responsive to price than the general population but it is less clear on the impact on long-term heavy smokers and aboriginal smokersii Estimates imply that the long-run effect of a permanent price increase is approximately double the short-run impact. Thus, a 10 per cent increase in cigarette price is expected to reduce the prevalence of cigarette smoking by approximately 8 per cent in the long run.iii Excise Tax Adjustments The current proposal to adjust the domestic rate of excise duty on tobacco products to account for inflation and eliminate the preferential excise duty treatment of tobacco products available through duty free markets will increase the cost of cigarettes and other tobacco products like fine-cut tobacco for use in roll-your-own cigarettes, chewing tobacco and cigars. For example, the government has stated that the excise "duty free" rate for cigarettes will increase from $15.00 to $21.03 per carton of 200 cigarettes. The commitment to make an automatic inflation adjustment every 5 years is a means to ensure that tobacco tax rates retain their real value in the future. The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. This proposal represents a positive step toward the development of a federal integrated tobacco tax strategy for both domestic and imported products, and speaks to the importance of the relationship between health policy and tax policy. Unintended Consequences There is a risk that a rise in tobacco taxes with the resultant rise in the cost of smoking will lead to an increase in the smuggling of lower-cost cigarettes. To avoid potential unintended consequences, such as smuggling, the CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders. In addition, all levels of government should take the most stringent measures possible to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. Investing Tobacco Taxes in Health Promotion The Minister of Finance has estimated that increasing tobacco taxes, including excise taxes on tobacco products, will increase federal tax revenues by $96 million in 2013-14, 685 million in 2014-15 and $660 million in 2015-16. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The federal government should place a high priority for funding tobacco prevention and evidence-based cessation programs for young Canadians as early as primary school age. For these, substantial and sustainable funding is required. A portion of these tobacco taxes should also be used to defray the costs of tobacco interventions, including physician-based clinical tobacco intervention services and up to 12 weeks stop-smoking medication annually per smoker. We encourage the government to focus their efforts on "high-risk" and "hard-to-reach" populations. Research For Canada's Tobacco Control strategy to continue to reduce smoking rates in Canada we must continue to assess evolving best practices in smoking cessation programs, and conduct research on the impact of policies on high risk populations. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. This evidence comes from surveying Canadians on smoking behavior, conducting research and evaluation, and keeping track of trends and emerging issues. Conclusion The CMA supports increasing the excise duty on tobacco products. An increase in the excise duty tax on tobacco products is long overdue and a welcome contribution to efforts already underway to further reduce smoking rates in Canada. Summary of Recommendations The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. The CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders to avoid potential unintended consequences, such as smuggling. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. i The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula ii Effects of Tobacco Taxation and Pricing on Smoking Behavior in High Risk Populations: A Knowledge Synthesis Pearl Bader, David Boisclair, Roberta Ferrence Int J Environ Res Public Health. 2011 November; 8(11): 4118-4139. Published online 2011 October 26. doi: 10.3390/ijerph8114118 PMCID: PMC3228562 iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula
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CMA Letter to the Senate Committee on Legal and Constitutional Affairs regarding Bill C-2, An Act to amend the Criminal Code and to make consequential amendments to other Acts

https://policybase.cma.ca/en/permalink/policy9110
Last Reviewed
2020-02-29
Date
2008-02-19
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2020-02-29
Date
2008-02-19
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide comments to the Senate Committee on Legal and Constitutional Affairs concerning its study of Bill C-2 (An Act to amend the Criminal Code and to make consequential amendments to other Acts). We will confine our comments to the portion of the proposed legislation that relates to impaired driving. Canada's physicians support measures aimed at reducing the incidence of drug-impaired driving. We believe impaired driving, whether by alcohol or another drug, to be an important public health issue for Canadians that requires action by all governments and other concerned groups. Published reports indicate that the prevalence of driving under the influence of cannabis is on the rise in Canada. We note that: * Results from the Canadian Addictions Survey suggest that 4% of the population have driven under the influence of cannabis in the past year, an increase from the 1.5% in 2003 and that rates are higher among young people.1 * It was estimated that in 2003, 27.45% of traffic fatalities involved alcohol, 9.15% involved alcohol and drugs, and 3.66% involved drugs alone while 13.71% of crash injuries involved only alcohol, 4.57% involved alcohol and drugs, and 1.83% involved drugs alone.2 * In a 2002 survey, 17.7% of drivers reported driving within 2 hours of using a prescribed medication, over-the-counter remedy, marijuana, or other illicit drug during the past 12 months. * These results suggest that an estimated 3.7 million Canadians drove after taking some medication or drug that could potentially affect their ability to drive safely. * The most common drugs used were over-the-counter medications (15.9%), prescription drugs (2.3%), marijuana (1.5%), and other illegal drugs (0.9%). * Young males were most likely to report using marijuana and other illegal drugs. * While 86% of the drivers were aware that a conviction for impaired driving results in a criminal record, 66% erroneously believed that the penalties for drug-impaired driving were less severe than those for alcohol-impaired driving. In fact, the penalties are identical. * Over 80% of drivers agreed that drivers suspected of being under the influence of drugs should be required to participate in physical coordination testing for drug impairment. However, only about 70% of drivers agreed that all drivers involved in a serious collision or suspected of drug impairment should be required to provide a blood sample.3 The CMA has, on several occasions, provided detailed recommendations on legislative changes concerning impaired driving. In 1999, the CMA presented a brief to the House of Commons Standing Committee on Justice and Human Rights during its review of the impaired driving provisions of the Criminal Code. While our 1999 brief focused primarily on driving under the influence of alcohol, many of the recommendations are also relevant to the issue of driving under the influence of drugs. In June 2007, the CMA provided comments to the Standing Committee on Justice and Human Rights of the House of Commons during their study of Bill C-32 (An Act to amend the Criminal Code (impaired driving) and to make consequential amendments to other Acts) which was later incorporated in the omnibus Bill now before your Committee. Last year, the CMA published the 7th edition of its guide, Determining Medical Fitness to Operate Motor Vehicles. It includes chapters on the importance of screening for alcohol or drug dependency and states that the abuse of such substances is incompatible with the safe operation of a vehicle. This publication is widely viewed by clinical and medical-legal practitioners as the authoritative Canadian source on the topic of driver competence. While changing the Criminal Code is an important step, the CMA believes further actions are also warranted. In our 2002 presentation to the Special Senate Committee on Illegal Drugs, the CMA put forth our long standing position regarding the need for a comprehensive long-term effort that incorporates both deterrent legislation and public awareness and education campaigns. We believe such an approach, together with comprehensive treatment and cessation programs, constitutes the most effective policy in attempting to reduce the number of lives lost and injuries suffered in crashes involving impaired drivers. Drug-impaired drivers may be occasional users of drugs or they may also suffer from substance dependence, a well-recognized form of disease. Physicians should be assisted to screen for drug dependency, when indicated, using validated instruments. Government must create and fund appropriate assessment and treatment interventions. Physicians can assist in establishing programs in the community aimed at the recognition of the early signs of dependency. These programs should recognize the chronic, relapsing nature of drug addiction as a disease, as opposed to simply viewing it as criminal behaviour. While supporting the intent of the proposed legislation, the CMA urges caution on several significant issues, with regard to Clause 20 that amends the act as follows: 254.1 (1) The Governor in Council may make regulations (a) respecting the qualifications and training of evaluating officers; (b) prescribing the physical coordination tests to be conducted under paragraph 254(2)(a); and (c) prescribing the tests to be conducted and procedures to be followed during an evaluation under subsection 254(3.1). CMA contends that it is important that medical professionals and addiction medicine specialists in particular, should be consulted regarding the training offered to officers to conduct roadside assessment and sample collection. Provisions in the Act conferring upon police the power to compel roadside examination raises the important issue of security of the person and the privacy of health information. As well, information obtained at the roadside is personal medical information and regulations must ensure that it be treated with the same degree of confidentiality as any other element of an individual's medical record. Thus, the CMA would respectfully submit that Clause 25 of Bill-C2 on the issue of unauthorized use or disclosure of the results needs to be strengthened because the wording is too broad, unduly infringes privacy and shows insufficient respect for the health information privacy interests at stake. For instance, clause 25(2) would permit the use, or allow the disclosure of the results "for the purpose of the administration or enforcement of the law of a province". This latter phrase needs to be narrowed in its scope so that it would not, on its face, encompass such a broad category of laws. Moreover, clause 25(4) would allow the disclosure of the results "to any other person, if the results are made anonymous and the disclosure is made for statistical or other research purposes" CMA would expect the federal government to exercise great caution in this instance, particularly since the results could concern individuals who are not actually convicted of an offence. One should query whether the Clause 25(4) should even exist in a Criminal Code as it would not appear to be a matter required to be addressed. If it is, then CMA would ask the government to conduct a rigorous privacy impact assessment on these components of the Bill, studying in particular, such matters as sample size, degree of anonymity, and other privacy related issues, especially given the highly sensitive nature of the material. CMA would ask whether clause 25(5) should specify that the offence for improper use or disclosure should be more serious than a summary conviction. Finally, it is important to base any roadside testing methods and threshold decisions on robust biological and clinical research. CMA also notes with interest Clause 21, specifically the creation of a new offence of being "over 80" (referring to 80mg of alcohol in 100ml of blood, or a .08 blood alcohol concentration level or BAC) and causing an accident that results in bodily harm which will carry a maximum sentence of 10 years and life imprisonment for causing an accident resulting in death. (Clause 21) We would also urge the Committee to take the opportunity that the review of this proposed legislation provides to recommend to Parliament a lower BAC level. Since 1988 the CMA has supported 50 mg% as the general legal limit. Studies suggest that a BAC limit of 50 mg% could translate into a 6% to 18% reduction in total motor vehicle fatalities or 185 to 555 fewer fatalities per year in Canada.4 A lower limit would recognize the significant detrimental effects on driving-related skills that occur below the current legal BAC.5 In our 1999 response to the Standing Committee on Justice and Human Rights' issue paper on impaired driving6 and again in 2002 when we joined forces with Mothers Against Drunk Driving (MADD), CMA has consistently called for the federal government to reduce Canada's legal BAC to .05. Canada continues to lag behind countries such as Austria, Australia, Belgium, Denmark, France and Germany, which have set a lower legal limit. 7 CMA expressed the opinion that injuries and deaths resulting from impaired driving must be recognized as a major public health concern. Therefore we once again recommend lowering the legal BAC limit to 50 mg%. or .05%. We also wanted to note our support for Clause 23 which addresses the issue of liability by extending the existing umbrella of immunity for qualified medical practitioners to the new provision under 254(3.4) 23. Subsection 257(2) of the Act is replaced by the following: (2) No qualified medical practitioner by whom or under whose direction a sample of blood is taken from a person under subsection 254(3) or (3.4) or section 256, and no qualified technician acting under the direction of a qualified medical practitioner, incurs any criminal or civil liability for anything necessarily done with reasonable care and skill when taking the sample. Finally, CMA believes that comprehensive long-term efforts that incorporate deterrent legislation, such as Bill C-2, must be accompanied by a public awareness and education strategy. This constitutes the most effective long-term approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers. The CMA supports this multidimensional approach to the issue of the operation of a motor vehicle regardless of whether impairment is caused by alcohol or drugs. Again, the CMA appreciates the opportunity to provide input into the legislative proposal on drug-impaired driving. We stress that these legislative changes alone would not adequately address the issue of reducing injuries and fatalities due to drug-impaired driving, but support their intent as a partial, but important measure. Yours sincerely, Brian Day, MD President 1 Bedard, M, Dubois S, Weaver, B. The impact of cannabis on driving, Canadian Journal of Public Health, Vol 98, 6-11, 2006 2 G. Mercer, Estimating the Presence of Alcohol and Drug Impairment in Traffic Crashes and their Costs to Canadians: 1999 to 2003 (Vancouver: Applied Research and Evaluation Services, 2005). 3 D. Beirness, H. Simpson and K. Desmond, The Road Safety Monitor 2002: Drugs and Driving (Ottawa: Traffic Injury Research Foundation, 2003). Online: www.trafficinjuryResearch.com/whatNew/newsItemPDFs/RSM_02_Drugs_and_ Driving.pdf 4 Mann, Robert E., Scott Macdonald, Gina Stoduto, Abdul Shaikh and Susan Bondy (1998) Assessing the Potential Impact of Lowering the Blood Alcohol Limit to 50 MG % in Canada. Ottawa: Transport Canada, TP 13321 E. 5 Moskowitz, H. and Robinson, C.D. (1988). Effects of Low Doses of Alcohol on Driving Skills: A Review of the Evidence. Washington, DC: National Highway Traffic Safety Administration, DOT-HS-800-599 as cited in Mann, et al., note 8 at page 12-13 6 Proposed Amendments to the Criminal Code of Canada (Impaired Driving): Response to Issue Paper of the Standing Committee on Justice and Human Rights. March 5, 1999 7 Mann et al
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CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology - Prescription Drugs: Clinical Trials and Approval

https://policybase.cma.ca/en/permalink/policy10437
Date
2012-05-09
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-05-09
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Good afternoon. My name is Dr. Maura Ricketts and I am the Director of Public Health for the Canadian Medical Association. The CMA appreciates the opportunity to appear before this Committee today as part of your study of clinical trials and drug approvals. The CMA represents more than 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with all Canadians, for the highest standards of health and health care. Because prescription drugs are an essential component of health care, the CMA has developed a considerable body of policy on pharmaceutical issues. This work can be distilled into one fundamental principle: The CMA believes that our country requires a National Pharmaceutical Strategy to ensure every individual has timely access to safe, effective and affordable prescription drugs. Despite the commitment in the 2004 Health Accord to the creation of such a strategy, Canadians continue to wait for government leadership on this issue. Drugs replace more costly and invasive medical interventions. They are an essential tool in the physician's tool box. To ensure safety and effectiveness, the CMA also believes in the need for a strong, unbiased, evidence-based system for research and approval. This is at the heart of our commitment to patient-centred care. In evaluating whether to prescribe a new drug to a patient, a physician will weigh several factors: Does this product offer any benefits over what I am prescribing now? Will it be more effective? Will this new drug be safer? Will it solve any tricky clinical problems, such as drug interactions, or reduce side effects that prevent a medication from being used properly? The physician may also ask: What is the evidence that this new drug is an improvement? Can I trust the evidence? Where can I get access to accurate, reliable information and data on this drug? Pre-approval drug research must provide answers to these fundamental questions. Clinical Trials I will now focus on two particular issues of concern to practising physicians with regard to clinical trials: * First, what is being compared to what? Clinical trials may be sufficient for Health Canada's regulatory purposes, but may provide only part of the information a physician needs. For example, is a new cholesterol drug effective on all patients, or only on some of them? Would other patients derive equal benefit from an already existing drug, or from a lifestyle change such as diet or exercise? The CMA recommends that researchers compare a new product to other drugs on the market - and to other interventions, as well. * Second, is timely, reliable and objective information available on all clinical trial results, not just the positive ones? Canadians need to be informed when a drug has performed disappointingly in trials if they are to make informed decisions about their health care. The CMA, therefore, recommends the results of all clinical trials, not just those with positive results, be made available to health professionals and the public. I would like to add that the current documentation is not very user-friendly. We recommend that Health Canada prepare summaries of the most essential data, not only for physicians, but for all Canadians to be able to access this information. The Drug Approval Process Turning now to the drug approval process, the CMA believes the following principles should apply: * The primary criteria for approval should be whether the drug improves health outcomes and offers an improvement over products currently on the market. * The review process should be as timely as is consistent with ensuring optimal health outcomes and the safety of the drug supply. * The review process should be impartial and founded on the best available scientific evidence. * The review process should be open and transparent. * Finally, approval of a drug is not an endpoint, but rather one step in that drug's life cycle. It is not uncommon to identify serious safety hazards after a drug has been approved, because that's when it first goes into wide use. It is important that the approval process be complemented by a rigorous and vigilant post-market surveillance process. We look forward to presenting our recommendations on this subject to your Committee at a future session. Before closing, I would like to briefly address two other matters: First, the issue of drugs for rare disorders. We are aware that the current clinical trial and approval processes, which place a high value on studies with large population samples, may be unable to adequately capture the value of drugs that are prescribed to only a handful of people. Some patient groups active in the area of rare disorders, such as the Canadian MPS Society and Alpha-1 Canada, have shared their concerns about this with us. These groups, along with the Canadian Organization for Rare Disorders, have been advocating for years for a fair process for evaluating drugs for rare diseases. Because Canada doesn't have a rare disorders strategy, Canadian patients have access to fewer therapies than patients in other developed countries. The issue of how to approve drugs for rare disorders merits closer consideration. The CMA recommends that the federal government develop a policy on drugs for rare disorders that encourages their development, call for ongoing evaluation of their effectiveness, and ensures fairness so that all patients who might benefit have reasonable access to them. The second matter is that Health Canada's review process provides little guidance on another question which physicians are increasingly asking: Can my patient afford this drug? It is not sufficient that the Common Drug Review conducts reviews of the cost effectiveness of drugs and that provincial/territorial formularies undertake similar studies, as the fact remains that cost is one of the factors physicians need to consider when deciding whether to prescribe a new drug. This is especially true in the case of new biologics, which are very expensive. Canadian doctors believe that the difficulty of making effective prescribing decisions without information about cost needs to be overcome. This only underscores the necessity of a National Pharmaceutical Strategy. Thank you. We would be happy to answer your questions.
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CMA Response: Health Canada's Medical Marijuana Regulatory Proposal

https://policybase.cma.ca/en/permalink/policy10702
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association welcomes the opportunity to comment on proposed changes to Health Canada's Marihuana for Medical Purposes Regulations, published in the Canada Gazette, Part I on December 15, 2012. CMA provided comments on the proposed changes when Health Canada first announced them in June 2011. Our position on these changes, and indeed on the entire Medical Marihuana Access Program (MMAP), has been consistent since the program was initiated. We remain deeply concerned that, though the program has made a physician's authorization the key to a patient's access to medical marijuana, physicians and other health professionals have little to no evidence-based information about its use as medical therapy. As our President, Dr. Anna Reid, noted in December, the regulatory proposals are "equivalent to asking doctors to prescribe while blindfolded." Health Canada gives two reasons for its regulatory proposal: first, to address concerns about the safety of home grow-ops; and secondly, to reduce the cost of administering a program that has proven more popular than anticipated. Neither of these reasons is related to improving patient care or advancing our clinical knowledge of marijuana as a medical treatment. CMA understands that many Canadians suffer constant pain from chronic or terminal illnesses and are searching for anything that will provide relief. We know that some patients find that use of marijuana relieves their symptoms and that some health professionals also believe it has therapeutic value. However, we are concerned that these claims remain inadequately supported by scientific research. Controlled studies of medical marijuana have been published recently and some have shown benefits. However, these studies are few in number, of short duration and with small samples, and knowledgeable clinicians say that more research is required. In addition, some say that marijuana has become more potent since it became a popular recreational drug in the 1960s, though others disagree,1 and growers say they can develop strains tailored to the needs of individual medical users.2 Though these claims are part of the popular understanding of medical marijuana, there is no scientifically valid evidence that supports them. What Physicians Have Told Us In May 2012, CMA surveyed members of its "e-panel" of physicians to obtain more information about their attitudes and needs regarding medical marijuana. The survey received just over 600 responses out of more than 2,200, for a 27 per cent response rate. Among the findings: * About 70 per cent of respondents had been asked by patients to approve medical marijuana, though only four per cent said they were asked to do so "often." Of those who were asked, one-third reported that they "never" supported such requests, while 18 per cent "usually" did so. * 64 per cent of respondents were concerned that patients who request medical marijuana may actually be using it for recreational purposes; * A large majority of respondents said they would find more information on the appropriate use of marijuana for medicinal purposes, and on its therapeutic benefits and risks, useful or very useful. * About two-thirds agreed or strongly agreed that they would feel more comfortable if: o Physicians wishing to use medical marijuana in their practices were required to undergo special training and licensing; and, o Health Canada offered them protection from liability. * In open-ended questions, some respondents expressed favourable views on marijuana's medical benefits. However, a larger number expressed concern over its harmful effects, such as: psychotic symptoms, especially in younger people; potential for addiction and dependency; and the risks to lung health from smoking it or any other substance. Marijuana is Not Like Other Therapeutic Products Theoretically, marijuana, when used for medicinal purposes, is regulated under the Food and Drugs Act. However, because of its unique legal position, Health Canada has exempted it from the applications of the Act and its regulations, and it has not undergone the scrutiny of benefits and risks required of other therapeutic products approved for use in Canada, be they prescription-only or over-the-counter. According to the Food and Drugs Act (FDA), all drugs requiring a health professional's authorization must be approved for use by Health Canada, based on evidence of effectiveness obtained from controlled clinical trials, which remain the best currently available means of validating knowledge. In addition, Health Canada has a system of post-market surveillance to keep track of problems that arise with prescription drugs in real-world use. Though the CMA has been critical of some aspects of this system,3 we acknowledge that it has added to our body of knowledge on drug safety risks. If marijuana were not an illegal product, it might have been assessed through some form of pre-approval and post-approval surveillance. By exempting marijuana from the FDA's pre-approval and post-approval requirements, Health Canada has lost an opportunity to improve our knowledge of the drug's therapeutic uses. The Views of Canadians A recent online survey conducted by Ipsos-Reid on behalf of the CMA provides insight into the views of Canadians on Health Canada's regulatory proposal.4 The survey found: * 92 per cent of Canadians think it is very or somewhat important that Health Canada not remove itself from its oversight role until guidelines are put in place for physicians; * 90 per cent believe that research on the effectiveness, safety and risks of medical marijuana is needed before Health Canada removes itself from the authorization process; * 85 per cent of Canadians believe medical marijuana should be subject to the same rigorous testing and approval standards as other medicines; * 79 per cent agree that Health Canada has a responsibility to maintain its role in the authorization process.; The Role of the Physician The CMA cannot with certainty predict the consequences of these regulatory changes for the practising physician (and, if the regulations are approved, for the nurse practitioner as well). However, we have several causes for concern: * The gatekeeper role of health professionals: The most significant change, from our point of view, is that Health Canada is removing itself from the approval process, making it a transaction between the patient, the practitioner and the licensed producer. In addition, Section 125 of the regulatory proposal would reduce the content of the authorization form, from its current two-page format to a brief document requiring little more information than is required for a standard medical prescription. We are concerned that these changes will put an even greater onus on physicians than do the current regulations. The CMA agrees with the Federation of Medical Regulatory Authorities that the lack of evidence to support the use of marijuana for medicinal purposes signifies that it is not a medical intervention. In our opinion, putting physicians in the role of gatekeeper for access to marijuana is inappropriate and may be an abdication of responsibility on Health Canada's part.5 Such a move could increase physicians' liability risk and put them at odds with their medical regulatory authorities, which have no choice but to continue to advise physicians to exercise extreme caution. The CMA believes, as does the Canadian Medical Protective Association, that a drug's approval under the Food and Drugs Act does not impose a legal obligation on physicians or nurse practitioners to authorize its use if, in their judgment, it is clinically inappropriate. The Ontario Court of Appeal reached a similar decision recently in the case of R. v. Mernagh. * Protection of Physician Privacy. Under the proposed regulations, health information and physician data - such as the patient's name and date of birth, or the provider's licence number - will be collected by licensed producers who may not be subject to the same regulatory and privacy constraints as the health care sector. The draft regulations also indicate that the licensed producer is expected to confirm that the data on the "medical document" is correct and complete - in other words, health providers who authorize medical marijuana use will receive correspondence from the producer. We are very concerned about the risks this would pose to the privacy of patient and health care provider information. We believe Health Canada should conduct a privacy impact assessment of its proposed regulations or, if it has done so, to share the results. * Physicians as Dispensers. Section 124 of the proposed regulations would allow authorized health care practitioners to "sell, provide or administer dried marijuana." This is contrary to Article 46 of the CMA Guidelines for Physicians in Interactions with Industry, which states that "Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party."6 * Other possible consequences. We are also concerned about other potential consequences of the regulatory changes. Will more people go to health professionals requesting an authorization, on the assumption that the new regulations will make it easier to get? Will entrepreneurs seize the opportunity to establish "dispensaries" whose intended clientele are not those in legitimate medical need, as recent news stories have suggested?7 Will medical marijuana advocates put increased pressure on physicians to authorize its use? Meeting the Information Needs of Physicians In one respect, Health Canada has listened to physicians' concerns regarding the lack of evidence about medical marijuana, and acknowledged the need to remedy this problem. Though it is not addressed in the draft regulations, Health Canada has established an Expert Advisory Committee (EAC) to help provide comprehensive information to health professionals. The CMA has attended meetings of this committee in an observer capacity, suggested the names of practising physicians to serve as members, and made a presentation to the committee at its meeting in November 2012. If the EAC follows the CMA's suggestions, it will consider actively supporting the following activities: * Funding of scientific research on the clinical risks and benefits of marijuana; * Knowledge translation activities to convert this research into accessible, user-friendly tools for education and practice; * Development of best practice guidelines in the therapeutic use of marijuana. Though this guideline would of necessity be based on "C" level evidence, it would be an improvement on what now exists; and * Support for a compulsory training and licensing program for physicians wanting to authorize marijuana for medicinal purposes. The CMA believes that the EAC should be given the mandate and resources to undertake these activities. Conclusion Health Canada's stated mission is to help the people of Canada maintain and improve their health. The CMA believes that if Health Canada wants its Medical Marihuana Access Program to serve this mission, it should not withdraw from administering the program, leaving it to health professionals working within a large knowledge gap. Rather, it should support solid research into the use of marijuana as medication and make a commitment to share this knowledge with the health professional community and to support best clinical practices. 1 Bonsor K: "How marijuana works". Accessed at http://science.howstuffworks.com/marijuana5.htm 2 http://medicalmarijuana.ca/learning-center/marijuana-strains 3 CMA Submission to the House of Commons Standing Committee on Health: Post-Market Surveillance of Prescription Drugs (February 28, 2008). Accessed at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf 4 Online survey of 1,000 Canadians the week of Feb. 24, 2013 conducted by Ipsos-Reid. Summary report of the poll can be accessed at www.cma.ca/advocacy/cma-media-centre. 5 Letter to Health Canada from Yves Robert, MD, President of the Federation of Medical Regulatory Authorities of Canada, November 4, 2011. 6 CMA. 2004. Guidelines for Physicians in Interactions with Industry. Guideline can be accessed online: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf 7 Lee J. "Ross Rebagliati to Open medical marijuana franchise." Vancouver Sun. January 23, 2013. Accessed at http://www.vancouversun.com/health/Ross+Rebagliati+open+medical+marijuana+franchise/7860946/story.html
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CMA’s formal submission to the Federal External Panel on assisted dying

https://policybase.cma.ca/en/permalink/policy11750
Last Reviewed
2019-03-03
Date
2015-10-19
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2019-03-03
Date
2015-10-19
Topics
Ethics and medical professionalism
Text
Dear Members of the Federal External Panel: On behalf of the Canadian Medical Association (CMA), I appreciate the opportunity to provide input toward the Federal External Panel's national consultation to support the federal government's legislative response following the Supreme Court of Canada's ruling in Carter v. Canada. As the national professional association representing Canada's physicians, the CMA has played an important role in leading the public dialogue on end-of-life care, including assisted dying. In 2014, the CMA led a national consultation on end-of-life care which included a series of public and member town hall consultations across the country. This national dialogue focused on three main issues: advance care planning, palliative care, and physician-assisted dying. As highlighted in the summary report (enclosed as Appendix 1), the Canadian public emphasized the need for strict protocols and safeguards if the law on physician-assisted dying were to change. This initial consultation provided valuable insights to inform the concurrent CMA's in-depth and comprehensive consultation with its membership as well as medical and health stakeholders as an intervener before the Supreme Court and following the Carter decision. This consultation included engagement of the CMA's Ethics Committee, policy debates as part of the CMA's Annual Meetings in 2014 and 2015, in-person member forums across the country, and an online dialogue. The consultation was critical to the development of the CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying (enclosed as Appendix 2). These recommendations, guided by a set of ten foundational principles, address patient eligibility for access to and assessment for assisted dying, procedural safeguards for eligibility criteria, the roles and responsibilities of the attending and consulting physicians, and the issue of conscientious objection. Taken together, these recommendations form the CMA's position on the forthcoming legislative and regulatory framework to govern assisted dying in Canada. In addition to our recommendations, we would like to highlight key points that are of particular relevance to physicians: NATIONAL, PAN-CANADIAN LEGISLATIVE AND REGULATORY FRAMEWORK The CMA strongly recommends the establishment of national and coordinated legislative and regulatory processes and systems in response to the Carter decision. The CMA is deeply concerned that in the absence of federal action to support the establishment of national guidelines for assisted dying, a patchwork of differing and potentially conflicting approaches could emerge across jurisdictions. Legislative action at the federal level is needed to provide further clarity for physicians and their patients and support the promulgation of a coordinated and consistent approach across all jurisdictions in Canada. The CMA has been working with the medical regulatory colleges at the national level to mitigate this risk through the development of the CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying which has encouraged similar efforts by the regulatory colleges. In addition to these initiatives, federal action is required. CONSCIENTIOUS OBJECTION As the Federal External Panel is aware, the Carter decision emphasizes that any regulatory or legislative response must seek to reconcile the Charter rights of patients (wanting to access assisted dying) and physicians (who choose not to participate in assisted dying on grounds of conscientious objection). The notion of conscientious objection is not monolithic. While some conceptions of conscience encompass referral, others view referral as being connected to, or as akin to participating in, a morally objectionable act. It is the CMA's position that an effective reconciliation is one that respects, and takes account of, differences in conscience, while facilitating access on the principle of equity. To this end, the CMA's membership strongly endorses the recommendation on conscientious objection as set out in section 5.2 of the CMA's enclosed Principles-based Recommendations for a Canadian Approach to Assisted Dying. ADDITIONAL SUPPORTS The CMA recognizes, and supports addressing, the need to develop education materials for physicians. To this end, the CMA is actively developing education modules for physicians following an environmental scan of existing courses and discussions with other jurisdictions (e.g., the Royal Dutch Medical Association). The CMA has the support of the Royal College of Physicians and Surgeons of Canada, the College of Family Physicians of Canada, and the Canadian Medical Protective Association to lead this initiative. Finally, as previously stated, the CMA strongly encourages the federal government to make the report of the Federal External Panel publicly available once final. The CMA urges the members of the Federal External Panel to support this recommendation to the federal government. Thank you once again for the opportunity to provide input. The CMA looks forward to our meeting with the Federal External Panel on October 20, 2015. Sincerely, Cindy Forbes, MD, CCFP, FCFP President Jeff Blackmer MD, MHSc, FRCPC Vice-President, Medical Professionalism Enclosed: Appendix 1 - Summary Report: End-of-Life Care A National Dialogue (please see pdf for link to document) Appendix 2 - CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying Principles-based Recommendations for a Canadian Approach to Assisted Dying On Feb. 6, 2015, the Supreme Court of Canada unanimously struck down the law prohibiting assisted dying. The court suspended that decision for 12 months. This has provided an opportunity for the Canadian Medical Association (CMA) to build on its past work and pursue further consultation with provincial and territorial medical associations, medical and non-medical stakeholders, members, legislatures and patients for processes, whether legal, regulatory or guidelines, that respect patients' needs and reflects physicians' perspectives. The goal of this process is twofold: (a) discussion and recommendations on a suite of ethical-legal principles and (b) input on specific issues that are particularly physician-sensitive and are worded ambiguously or not addressed in the Court's decision. The touch points are reasonable accommodation for all perspectives and patient-centeredness. For purposes of clarity, CMA recommends national and coordinated legislative and regulatory processes and systems. There should be no undue delay in the development of these laws and regulations. The principles are not designed to serve as a tool for legislative compliance in a particular jurisdiction or provide a standard of care. Rather, the CMA wishes to provide physicians with guidance and a vision of what physicians might strive for to further their professional and legal obligations in a complex area. The CMA recommends adopting the following principles-based approach to assisted dying in Canada: Foundational principles The following foundational principles underpin CMA's recommended approach to assisted dying. Proposing foundational principles is a starting point for ethical reflection, and their application requires further reflection and interpretation when conflicts arise. 1. Respect for patient autonomy: Competent adults are free to make decisions about their bodily integrity. Specific criteria are warranted given the finality of assisted dying. 2. Equity: To the extent possible, all those who meet the criteria for assisted dying should have access to this intervention. Physicians will work with relevant parties to support increased resources and access to high quality palliative care, and assisted dying. There should be no undue delay to accessing assisted dying, either from a clinical, system or facility perspective. To that end, the CMA calls for the creation of a separate central information, counseling, and referral service. 3. Respect for physician values: Physicians can follow their conscience when deciding whether or not to provide assisted dying without discrimination. This must not result in undue delay for the patient to access these services. No one should be compelled to provide assistance in dying. 4. Consent and capacity: All the requirements for informed consent must clearly be met, including the requirement that the patient be capable of making that decision, with particular attention to the context of potential vulnerabilities and sensitivities in end of life circumstances. Consent is seen as an evolving process requiring physicians to continuously communicate with the patient. 5. Clarity: All Canadians must be clear on the requirements for qualification for assisted dying. There should be no "grey areas" in any legislation or regulations. 6. Dignity: All patients, their family members or significant others should be treated with dignity and respect at all times, including throughout the entire process of care at the end of life. 7. Protection of patients: Laws and regulations, through a carefully designed and monitored system of safeguards, should aim to minimize harm to all patients and should also address issues of vulnerability and potential coercion. 8. Accountability: An oversight body and reporting mechanism should be identified and established in order to ensure that all processes are followed. Physicians participating in assisted dying must ensure that they have appropriate technical competencies as well as the ability to assess decisional capacity, or the ability to consult with a colleague to assess capacity in more complex situations. 9. Solidarity: Patients should be supported and not abandoned by physicians and health care providers, sensitive to issues of culture and background, throughout the dying process regardless of the decisions they make with respect to assisted dying. 10. Mutual respect: There should be mutual respect between the patient making the request and the physician who must decide whether or not to perform assisted dying. A request for assisted dying is only possible in a meaningful physician-patient relationship where both participants recognize the gravity of such a request. Recommendations Based on these principles, the Supreme Court decision in Carter v. Canada (2015)1 and a review of other jurisdictions' experiences, CMA makes the following recommendations for potential statutory and regulatory frameworks with respect to assisted dying. We note that this document is not intended to address all potential issues with respect to assisted dying, and some of these will need to be captured in subsequent regulations. 1. Patient eligibility for access to assisted dying 1.1 The patient must be a competent adult who meets the criteria set out by the Supreme Court of Canada decision in Carter v. Canada (2015. 1.2 Informed decision * The attending physician must disclose to the patient information regarding their health status, diagnosis, prognosis, the certainty of death upon taking the lethal medication, and alternatives, including comfort care, palliative and hospice care, and pain and symptom control. 1.3 Capacity * The attending physician must be satisfied that: - the patient is mentally capable of making an informed decision at the time of the request(s) - the patient is capable of giving consent to assisted dying, paying particular attention to the potential vulnerability of the patient in these circumstances - communications include exploring the priorities, values and fears of the patient, providing information related to the patient's diagnosis and prognosis, treatment options including palliative care and other possible interventions and answering the patient's questions * If either or both the attending physician or the consulting physician determines that the patient is incapable, the patient must be referred for further capacity assessment. * Only patients on their own behalf can make the request while competent. 1.4 Voluntariness * The attending physician must be satisfied, on reasonable grounds, that all of the following conditions are fulfilled: - The patient's decision to undergo assisted dying has been made freely, without coercion or undue influence from family members, health care providers or others. - The patient has a clear and settled intention to end his/her own life after due consideration. - The patient has requested assisted dying him/herself, thoughtfully and repeatedly, in a free and informed manner. 2. Patient eligibility for assessment for decision-making in assisted dying Stage 1: Requesting assisted dying 1. The patient submits at least two oral requests for assisted dying to the attending physician over a period of time that is proportionate to the patient's expected prognosis (i.e., terminal vs non-terminal illness). CMA supports the view that a standard waiting period is not appropriate for all requests. 2. CMA recommends generally waiting a minimum of 14 days between the first and the second oral requests for assisted dying. 3. The patient then submits a written request for assisted dying to the attending physician. The written request must be completed via a special declaration form that is developed by the government/department of health/regional health authority/health care facility. 4. Ongoing analysis of the patient's condition and ongoing assessment of requests should be conducted for longer waiting periods. Stage 2: Before undertaking assisted dying 5. The attending physician must wait no longer than 48 hours, or as soon as is practicable, after the written request is received. 6. The attending physician must then assess the patient for capacity and voluntariness or refer the patient for a specialized capacity assessment in more complex situations. 7. The attending physician must inform the patient of his/her right to rescind the request at any time. 8. A second, independent, consulting physician must then also assess the patient for capacity and voluntariness. 9. Both physicians must agree that the patient meets eligibility criteria for assisted dying to proceed. 10. The attending physician must fulfill the documentation and reporting requirements. Stage 3: After undertaking assisted dying 11. The attending physician, or a physician delegated by the attending physician, must take care of the patient until the patient's death. 3. Role of the physician 3.1 The attending physician must be trained to provide assisted dying. 3.2 Patient assessment * The attending physician must determine if the patient qualifies for assisted dying under the parameters stated above in Section 1. * The attending physician must ensure that all reasonable treatment options have been considered to treat physical and psychological suffering according to the patient's need, which may include, independently or in combination, palliative care, psychiatric assessment, pain specialists, gerontologists, spiritual care, and/or addiction counseling. 3.3 Consultation requirements * The attending physician must consult a second physician, independent of both the patient and the attending physician, before the patient is considered eligible to undergo assisted dying. * The consulting physician must - Be qualified by specialty or experience to render a diagnosis and prognosis of the patient's illness and to assess their capacity as noted in Stage 2 above. 3.4 Opportunity to rescind request * The attending physician must offer the patient an opportunity to rescind the request at any time; the offer and the patient's response must be documented. 3.5 Documentation requirements * The attending physician must document the following in the patient's medical record: - All oral and written requests by a patient for assisted dying - The attending physician's diagnosis and prognosis, and their determination that the patient is capable, acting voluntarily and has made an informed decision - The consulting physician's diagnosis and prognosis, and verification that the patient is capable, acting voluntarily and has made an informed decision - A report of the outcome and determinations made during counseling - The attending physician's offer to the patient to rescind the request for assisted dying - A note by the attending physician indicating that all requirements have been met and indicating the steps taken to carry out the request 3.6 Oversight body and reporting requirements * There should be a formal oversight body and reporting mechanism that collects data from the attending physician. * Following the provision of assisted dying, the attending physician must submit all of the following items to the oversight body: - Attending physician report - Consulting physician report - Medical record documentation - Patient's written request for assisted dying * The oversight body would review the documentation for compliance * Provincial and territorial jurisdictions should ensure that legislation and/or regulations are in place to support investigations related to assisted dying by existing provincial and territorial systems * Pan-Canadian guidelines should be developed in order to provide clarity on how to classify the cause on the death certificate 4. Responsibilities of the consulting physician * The consulting physician must verify the patient's qualifications including capacity and voluntariness. * The consulting physician must document the patient's diagnosis, prognosis, capacity, volition and the provision of information sufficient for an informed decision. The consulting physician must review the patient's medical records, and should document this review. 5. Moral opposition to assisted dying 5.1 Moral opposition by a health care facility or health authority * Hospitals and health authorities that oppose assisted dying may not prohibit physicians from providing these services in other locations. There should be no discrimination against physicians who decide to provide assisted dying. 5.2 Conscientious objection by a physician * Physicians are not obligated to fulfill requests for assisted dying. There should be no discrimination against a physician who chooses not to participate in assisted dying. In order to reconcile physicians' conscientious objection with a patient's request for access to assisted dying, physicians are expected to provide the patient with complete information on all options available to them, including assisted dying, and advise the patient on how they can access any separate central information, counseling, and referral service. 1 Carter v. Canada (Attorney General), [2015] 1 SCR 331, 2015 SCC 5 (CanLII)
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CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts

https://policybase.cma.ca/en/permalink/policy13641
Date
2017-04-07
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-04-07
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
CMA Submission: CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts Submission to the Senate Standing Committee on Social Affairs, Science and Technology On behalf of its more than 85,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. April 7, 2017 The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. Introduction The Canadian Medical Association (CMA) is pleased to provide this submission to the Senate Social Affairs, Science and Technology Committee for its study of Bill S-5, An Act to amend the Tobacco Act and the Non-Smokers Health Act and to make consequential amendments to other Acts. We support the government’s effort to implement a new legislative and regulatory framework to address vaping products and related matters. Vaping products, such as electronic cigarettes (or e-cigarettes) replicate the act and taste of smoking but do not contain tobacco. We also recognize that the federal government is attempting to find a balance between regulating vaping devices and making them available to adults. Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. Our most recent efforts centred on our participation in the 2016 Endgame Summit, held late last year in Kingston, Ontario. This brief will focus on three areas: supporting population health; the importance of protecting youth; and, the promotion of vaping products. Overview Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Smoking has been on the decline in Canada the most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014.1 Many strong laws and regulations have already been enacted but some areas remain to be addressed and strengthened especially as the tobacco industry continues to evolve. Electronic cigarettes and vaping represents the next step in that evolution. 1 Statistics Canada. Smoking, 2015 Health Fact Sheets Canadian Community Health Survey, 2015 82-625-X March 22, 2017 While Canada is to be congratulated on its success to date, it needs to maintain an environment that encourages Canadians to remain tobacco-free if smoking prevalence is to be reduced further in Canada. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Supporting Population Health The arrival of vaping products in Canada placed them in a “grey zone” with respect to legislation and regulation. Clarification of their status is crucial from a public health perspective because of their growing popularity, particularly among youth.2 E-cigarettes have both defenders and opponents. Proponents say they are safer than tobacco cigarettes since they do not contain the tar and other toxic ingredients that are the cause of tobacco related disease. Indeed, some believe they serve a useful purpose as a harm reduction tool or cessation aid (though it is forbidden to market them as such since that claim has never been approved by Health Canada). 2 Czoli CD., Hammond D., White CM., Electronic cigarettes in Canada: Prevalence of use and perceptions among youth and young adults. Can J Public Health 2014;105(2):e97-e102 3 Filippos FT., Laverty AA., Gerovasili V, et al. Two-year trends and predictors of e-cigarette use in 27 European Union member states. Tob Control 2017;26:98-104 4 Malas M., van der Tempel J., Schwartz R., et al. Electronic cigarettes for smoking cessation: A systematic review. Nicotine & Tobacco Research 2016, 1-12 doi:10.1093/ntr/ntw119 5 Ibid 6 Ibid 7 Ibid Opponents are concerned that the nicotine delivered via e-cigarettes is addictive and that the cigarettes may contain other toxic ingredients such as nitrosamines. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to the use of tobacco by people who might otherwise have remained smoke-free. This issue will be addressed later in this brief. This difference of opinion certainly highlights the need for more research into the harms and benefits of vaping products and the factors that cause people to use them.3 Encouraging smokers to move from combustible tobacco products to a less harmful form of nicotine may be a positive step. However the current available evidence is not yet sufficient to establish them as a reliable cessation method. A systematic review published by M. Malas et al. (2016) concluded that while “a majority of studies demonstrate a positive relationship between e-cigarette use and smoking cessation, the evidence remains inconclusive due to the low quality of the research published to date.”4 Indeed, some are helped by these devices to quit smoking but “more carefully designed and scientifically sound studies are urgently needed to establish unequivocally the long-term cessation effects of e-cigarettes and to better understand how and when e-cigarettes may be helpful.”5 The authors found that the evidence examining e-cigarettes as an aid to quitting smoking was determined to be “very low to low.”6 A similar result was found for their use in reducing smoking; the quality of the evidence was revealed as being “very low to moderate.”7 This conclusion is supported by another review conducted by the University of Victoria (2017). It too indicates that there are not enough studies available to fully determine the efficacy of vaping devices as a tobacco cessation device.8 This review also noted that there is “encouraging evidence that vapour devices can be at least as effective as other nicotine replacements.”9 8 O’Leary R., MacDonald M., Stockwell T., & Reist D. (2017) Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. Victoria, BC: Centre for Addiction Research for BC 9 Ibid 10 El Dib R. Suzumura EA., Akl EA, et al. Electronic nicotine delivery systems and/or electronic non-nicotine delivery systems for tobacco or reduction: A systematic review and meta-analysis. BMJ Open 2017;7: e012680. Doi10:1136/bmjopen-2016-012680 Another review by R. El Dib et al. (2017) reinforces these findings. Limited evidence was also found with respect to the impact of electronic devices to aide cessation. They also noted that the data available from randomized control trials are of “low certainty” and the “observational studies are of very low certainty.”10 The wide range of devices available makes it very difficult to test which are the most effective in helping cessation efforts. Many of the studies are on older devices so it is possible that as second-generation technology becomes available they will prove to be more successful. In view of this uncertainty, the CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. Physicians need to be confident that if they recommend such therapy to their patients it will have the desired outcome. To that end, we are pleased that Health Canada will continue to require manufacturers to apply for authorization under the Food and Drugs Act to sell products containing nicotine and make therapeutic claims. Risk and Safety In addition to the discussion concerning the usefulness of vaping devices as cessation devices, concerns from a public health standpoint involve the aerosol or vapour produced by heating the liquids used in these devices, and the nicotine some may contain. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine and/or flavourings that are intended to boost their appeal to young people. The CMA is concerned that not enough is known about the safety of the ingredients in the liquids being used in vaping devices. While it is the case that because e-cigarettes heat rather than burn the key constituent, they produce less harmful toxins and are much safer than conventional cigarettes. Research in the UK suggested that “long-term Nicotine Replacement Therapy (NRT)-only and e-cigarette-only use, but not dual-use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.”11 However, this study has been criticized because “it only looked at a few toxins and didn’t test for any toxins that could be produced by e-cigarettes.”12 11 Shahab L, Goniewicz M., Blount B., et al. Nicotine, carcinogen, and toxin exposure in long-term e-cigarette and nicotine replacement therapy users. Annals of Internal Medicine doi:10.7326/M16-1107 7 February 2017 12 Collier R. E-cigs have lower levels of harmful toxins. CMAJ 2017 February 27;189:E331. doi: 10.1503/cmaj.1095396 13 Sleiman M., Logue J., Montesinos VN. et al. Emmissions from electronic cigarettes : Key parameters affecting the release of harmful chemicals. Environmental Science and Technology July 2016 doi:10.1021/acs.est.6b01741 14 Ibid 15 England LJ., Bunnell RE., et al. Nicotine and the developing human. Am J. Prev Med 2015 16 Editorial. Use of Electronic Cigarettes by Adolescents. Journal of Adolescent Health 57 (2015) 569-570 The variety of flavourings and delivery systems available make it imperative that the risks associated with these products be fully understood. As one study noted “analysis of e-liquids and vapours emitted by e-cigarettes led to the identification of several compounds of concern due to their potentially harmful effects on users and passively exposed non-users.”13 The study found that the emissions were associated with both cancer and non-cancer health impacts and required further study.14 There is another aspect of the public health question surrounding vaping devices. There is data to support the idea that “nicotine exposure during periods of developmental vulnerability (e.g., fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development.”15 Therefore it is imperative that pregnant women and youth be protected. There is not enough known about the effects of long-term exposure to the nicotine inhaled through vaping devices at this time.16 Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. Protecting Youth The CMA is encouraged by the government’s desire to protect youth from developing nicotine addiction and inducements to use tobacco products. Young people are particularly vulnerable to peer pressure, and to tobacco industry marketing tactics. The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco and have been drawn to vaping devices, discouraging them from starting to use them and persuading them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. These programs should be available continuously in schools and should begin in the earliest grades. The “cool/fun/new” factor that seems to have developed around vaping devices among youth make such programs all the more imperative.17 17 Khoury M., Manlhiot C., et al Reported electronic cigarette use among adolescents in the Niagara region of Ontario. CMAJ 2016 DOI:10.1503/cmaj.151169 18 U.S. National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA-8029A. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016. The CMA recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. We are pleased to see that Bill S-5 aims to restrict access to youth, including prohibiting the sale of both tobacco and vaping products in vending machines as well as prohibiting sales of quantities that do not comply with the regulations. In fact, the CMA recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. The more restricted is availability, the easier it is to regulate. The CMA considers prohibiting the promotion of flavours in vaping products that may appeal to youth, such as soft drinks and cannabis, to be a positive step. A recent report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.”18 We are therefore pleased that sales of vaping products via the internet will be restricted through prohibiting the sending and delivering of such products to someone under the age of 18. This will be critical to limiting the tobacco industry’s reach with respect to youth. There have also been arguments around whether vaping products will serve as gateways to the use of combusted tobacco products. The University of Victoria (2017) paper suggests this isn’t the case; it notes that “there is no evidence of any gateway effect whereby youth who experiment with vapour devices are, as a result, more likely to take up tobacco use.”19 They base this on the decline in youth smoking while rates of the use of vaping devices rise.20 Others contend that vaping is indeed a gateway, saying it acts as a “one-way bridge to cigarette smoking among youth. Vaping as a risk factor for future smoking is a strong, scientifically-based rationale for restricting access to e-cigarettes.”21 Further, in a “national sample of US adolescents and young adults, use of e-cigarettes at baseline was associated with progression to traditional cigarette smoking. These findings support regulations to limit sales and decrease the appeal of e-cigarettes to adolescents and young adults.”22 19 Op cit. O’Leary R., MacDonald M., Stockwell T., & Reist D. (2017) Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. 20 Ibid 21 Miech R., Patrick ME., O’Malley PM., et al E-cigarette use as a predictor of cigarette smoking: results from a 1-year follow-up of a national sample of 12th grade students. Tob. Control 2017;0:1-6. doi:10.1136/tobaccocontrol-2016-053291 22 Primack BA., Soneji S., Stoolmiller M., et al Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr. 2015;169(11): 1018-1023.doi:10.1001/jamapediatrics.2015.1742 23 Hoek J., Thrul J. Ling P. Qualitative analysis of young adult ENDS users’ expectations and experiences. BMJ Open 2017;7:e014990.doi:10 24 Ibid However, there may be a role for vaping products in relation to young users. A New Zealand study conducted among young adults that examined how electronic nicotine delivery systems (ENDS) were used to recreate or replace smoking habits. It found that study participants “used ENDS to construct rituals that recreated or replaced smoking attributes, and that varied in the emphasis given to device appearance.”23 Further, it was suggested that ascertaining how “ENDS users create new rituals and the components they privilege within these could help promote full transition from smoking to ENDS and identify those at greatest risk of dual use or relapse to cigarette smoking.”24 The CMA believes that further research is needed on the question of the use of vaping products as a gateway for youth into combustible tobacco products. Recommendations: 1) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 2) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 3) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. Promotion of Vaping Products The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words “this product is injurious to your health” printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” The CMA would like to see the proposed plain packing provisions for tobacco be extended to vaping products as well. The inclusion of the health warning messages on vaping products is a good first step but efforts should be made to ensure that they are of similar size and type as those on tobacco as soon as possible. The restrictions being applied to the promotion of vaping products is a positive step, especially those that could be aimed at youth, but they do not go far enough. The CMA believes the restrictions on promotion should be the same as those for tobacco products. As the WHO/U.S. National Cancer Institute has already demonstrated, e-cigarette retailers are very good at using social media to promote their products, relying on appeals to lifestyle changes to encourage the use of their products. The CMA is also concerned that e-cigarette advertising could appear in locations and on mediums popular with children and youth if they are not prohibited explicitly in the regulations. This would include television and radio advertisements during times and programs popular with children and youth, billboards near schools, hockey arenas, and on promotional products such as t-shirts and ball caps. As efforts continue to reduce the use of combustible tobacco products there is growing concern that the rising popularity of vaping products will lead to a “renormalization” of smoking. In fact, worry has been expressed that the manner they have been promoted “threaten(s) to reverse the successful, decades-long public health campaign to de-normalize smoking.”25 A recent US study indicated that students that use vaping products themselves, exposure to advertising of these devices, and living with other users of vaping products is “associated with acceptability of cigarette smoking, particularly among never smokers.”26 Further research is needed to explore these findings. 25 Fairchild AL., Bayer R., Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med 370:4 January 23, 2014 26 K. Choi et al. Electronic nicotine delivery systems and acceptability of adult smoking among Florida youth: Renormalization of Smoking? Journal of Adolescent Health (2016) 1-7 Recommendations: 1) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 2) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 3The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. Conclusion Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Our members see the devastating effects of tobacco use every day in their practices and to that end the CMA has been working for decades toward the goal of a smoke-free Canada. The tobacco industry continues to evolve and vaping represents the next step in that evolution. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Bill S-5 is another step in that journey. Researchers have identified potential benefits as well as harms associated with these products that require much more scrutiny. The association of the tobacco industry with these products means that strong regulations, enforcement, and oversight are needed. Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.
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CMA’s Recommendations for Bill S-5 An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts

https://policybase.cma.ca/en/permalink/policy13918
Date
2018-02-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Date
2018-02-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Standing Committee on Health for its study of Bill S-5, An Act to amend the Tobacco Act and the Non-Smokers Health Act and to make consequential amendments to other Acts. We support the government’s effort to implement a new legislative and regulatory framework to address vaping products and related matters. Vaping products, such as electronic cigarettes (or e-cigarettes) replicate the act and taste of smoking but do not contain tobacco. We also recognize that the federal government is attempting to find a balance between regulating vaping devices and making them available to adults. Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. Our most recent efforts centred on our participation in the 2016 Endgame Summit, held late last year in Kingston, Ontario. This brief will focus on three areas: supporting population health; the importance of protecting youth; and, the promotion of vaping products. Overview Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Smoking has been on the decline in Canada the most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014.1 Many strong laws and regulations have already been enacted but some areas remain to be addressed and strengthened especially as the 1 Statistics Canada. Smoking, 2015. Health Fact Sheets. Statistics Canada Cat. 82-625-X. Ottawa: Statistics Canada; 2016. Available: http://www.statcan.gc.ca/pub/82-625-x/2017001/article/14770-eng.htm (accessed 2018 Feb 1). 2 Czoli CD, Hammond D, White CM. Electronic cigarettes in Canada: Prevalence of use and perceptions among youth and young adults. Can J Public Health. 2014;105(2):e97-e102. 3 Filippos FT, Laverty AA, Gerovasili V, et al. Two-year trends and predictors of e-cigarette use in 27 European Union member states. Tob Control. 2017;26:98-104. 4 Malas M, van der Tempel J, Schwartz R, Minichiello A, Lightfoot C, Noormohamed A, et al. Electronic cigarettes for smoking cessation: A systematic review. Nicotine Tob Res. 2016;18(10):1926–36. 5 O’Leary R, MacDonald M, Stockwell T, Reist D. Clearing the air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. Victoria, BC: Centre for Addictions Research of BC; 2017. Available: http://ectaofcanada.com/clearing-the-air-a-systematic-review-on-the-harms-and-benefits-of-e-cigarettes-and-vapour-devices/ (accessed 2018 Feb 1). 6 El Dib R, Suzumura EA, Akl EA, Gomaa H, Agarwal A, Chang Y, et al. Electronic nicotine delivery systems and/or electronic non-nicotine delivery systems for tobacco smoking cessation or reduction: a systematic review and meta-analysis. BMJ Open. 2017 23;7:e012680. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5337697/pdf/bmjopen-2016-012680.pdf (accessed 2018 Feb 1). 7 Shahab L, Goniewicz M, Blount B, et al. Nicotine, carcinogen, and toxin exposure in long-term e- cigarette and nicotine replacement therapy users: A cross sectional study. Annals of Internal Medicine. 2017;166(6):390-400. 8 Collier R. E-cigs have lower levels of harmful toxins. CMAJ. 2017 Feb 27;189:E331. 9 Sleiman M, Logue J, Montesinos VN, et al. Emissions from electronic cigarettes: Key parameters affecting the release of harmful chemicals. Environmental Science and Technology. 2016 Jul 27;50(17):9644-9651. 10 England LJ, Bunnell RE, Pechacek TF, Tong VT, McAfee TA. Nicotine and the developing human: A neglected element in the electronic cigarette debate. Am J Prev Med. 2015 Aug;49(2):286-93. 11 Foulds J. Use of Electronic Cigarettes by Adolescents. J Adolesc Health. 2015 Dec;57(6):569-70. 12 Khoury M, Manlhiot C, Fan CP, Gibson D, Stearne K, Chahal N, et al. Reported electronic cigarette use among adolescents in the Niagara region of Ontario. CMAJ. 2016 Aug 9;188(11):794-800. 13 U.S. National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA- 8029A. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016. 14 Miech R, Patrick ME, O’Malley PM, Johnston LD. E-cigarette use as a predictor of cigarette smoking: results from a 1-year follow-up of a national sample of 12th grade students. Tob Control. 2017 Dec;26(e2):e106–11. 15 Primack BA, Soneji S, Stoolmiller M, Fine MJ, Sargent JD. Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr. 2015 Nov;169(11):1018–23. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800740/pdf/nihms768746.pdf (accessed 2018 Feb 1). 16 Hoe J, Thrul J, Ling P. Qualitative analysis of young adult ENDS users’ expectations and experiences. BMJ Open. 2017;7:e014990. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353280/pdf/bmjopen-2016-014990.pdf (accessed 2018 Feb 1). 17 Fairchild AL, Bayer R, Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med. 2014 Jan 23;370:4 Available: http://www.nejm.org/doi/pdf/10.1056/NEJMp1313940 (accessed 2018 Feb 1). 18 Choi K, Grana R, Bernat D. Electronic nicotine delivery systems and acceptability of adult cigarette smoking among Florida youth: Renormalization of smoking? J Adolesc Health. 2017 May;60(5):592–8. tobacco industry continues to evolve. Electronic cigarettes and vaping represents the next step in that evolution. While Canada is to be congratulated on its success to date, it needs to maintain an environment that encourages Canadians to remain tobacco-free if smoking prevalence is to be reduced further in Canada. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Supporting Population Health The arrival of vaping products in Canada placed them in a “grey zone” with respect to legislation and regulation. Clarification of their status is crucial from a public health perspective because of their growing popularity, particularly among youth.2 E-cigarettes have both defenders and opponents. Proponents say they are safer than tobacco cigarettes since they do not contain the tar and other toxic ingredients that are the cause of tobacco related disease. Indeed, some believe they serve a useful purpose as a harm reduction tool or cessation aid (though it is forbidden to market them as such since that claim has never been approved by Health Canada). Opponents are concerned that the nicotine delivered via e-cigarettes is addictive and that the cigarettes may contain other toxic ingredients such as nitrosamines. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to the use of tobacco by people who might otherwise have remained smoke-free. This issue will be addressed later in this brief. This difference of opinion certainly highlights the need for more research into the harms and benefits of vaping products and the factors that cause people to use them.3 Encouraging smokers to move from combustible tobacco products to a less harmful form of nicotine may be a positive step. However the current available evidence is not yet sufficient to establish them as a reliable cessation method. A systematic review published by M. Malas et al. (2016) concluded that while “a majority of studies demonstrate a positive relationship between e-cigarette use and smoking cessation, the evidence remains inconclusive due to the low quality of the research published to date.”4 Indeed, some are helped by these devices to quit smoking but “more carefully designed and scientifically sound studies are urgently needed to establish unequivocally the long-term cessation effects of e-cigarettes and to better understand how and when e-cigarettes may be helpful.”4 The authors found that the evidence examining e-cigarettes as an aid to quitting smoking was determined to be “very low to low.”4 A similar result was found for their use in reducing smoking; the quality of the evidence was revealed as being “very low to moderate.”4 This conclusion is supported by another review conducted by the University of Victoria (2017). It too indicates that there are not enough studies available to fully determine the efficacy of vaping devices as a tobacco cessation device.5 This review also noted that there is “encouraging evidence that vapour devices can be at least as effective as other nicotine replacements.”5 Another review by R. El Dib et al. (2017) reinforces these findings. Limited evidence was also found with respect to the impact of electronic devices to aide cessation. They also noted that the data available from randomized control trials are of “low certainty” and the “observational studies are of very low certainty.”6 The wide range of devices available makes it very difficult to test which are the most effective in helping cessation efforts. Many of the studies are on older devices so it is possible that as second-generation technology becomes available they will prove to be more successful. In view of this uncertainty, the CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. Physicians need to be confident that if they recommend such therapy to their patients it will have the desired outcome. To that end, we are pleased that Health Canada will continue to require manufacturers to apply for authorization under the Food and Drugs Act to sell products containing nicotine and make therapeutic claims. Risk and Safety In addition to the discussion concerning the usefulness of vaping devices as cessation devices, concerns from a public health standpoint involve the aerosol or vapour produced by heating the liquids used in these devices, and the nicotine some may contain. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine and/or flavourings that are intended to boost their appeal to young people. The CMA is concerned that not enough is known about the safety of the ingredients in the liquids being used in vaping devices. While it is the case that because e-cigarettes heat rather than burn the key constituent, they produce less harmful toxins and are much safer than conventional cigarettes. Research in the UK suggested that “long-term Nicotine Replacement Therapy (NRT)-only and e-cigarette-only use, but not dual-use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.”7 However, this study has been criticized because “it only looked at a few toxins and didn’t test for any toxins that could be produced by e- cigarettes.”8 The variety of flavourings and delivery systems available make it imperative that the risks associated with these products be fully understood. As one study noted “analysis of e-liquids and vapours emitted by e-cigarettes led to the identification of several compounds of concern due to their potentially harmful effects on users and passively exposed non-users.”9 The study found that the emissions were associated with both cancer and non-cancer health impacts and required further study.9 There is another aspect of the public health question surrounding vaping devices. There is data to support the idea that “nicotine exposure during periods of developmental vulnerability (e.g., fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development.”10 Therefore it is imperative that pregnant women and youth be protected. There is not enough known about the effects of long-term exposure to the nicotine inhaled through vaping devices at this time.11 Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. Protecting Youth The CMA is encouraged by the government’s desire to protect youth from developing nicotine addiction and inducements to use tobacco products. Young people are particularly vulnerable to peer pressure, and to tobacco industry marketing tactics. The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco and have been drawn to vaping devices, discouraging them from starting to use them and persuading them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. These programs should be available continuously in schools and should begin in the earliest grades. The “cool/fun/new” factor that seems to have developed around vaping devices among youth make such programs all the more imperative.12 The CMA recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. We are pleased to see that Bill S-5 aims to restrict access to youth, including prohibiting the sale of both tobacco and vaping products in vending machines as well as prohibiting sales of quantities that do not comply with the regulations. In fact, the CMA recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. The more restricted is availability, the easier it is to regulate. The CMA considers prohibiting the promotion of flavours in vaping products that may appeal to youth, such as soft drinks and cannabis, to be a positive step. A recent report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.”13 We are therefore pleased that sales of vaping products via the internet will be restricted through prohibiting the sending and delivering of such products to someone under the age of 18. This will be critical to limiting the tobacco industry’s reach with respect to youth. There have also been arguments around whether vaping products will serve as gateways to the use of combusted tobacco products. The University of Victoria (2017) paper suggests this isn’t the case; it notes that “there is no evidence of any gateway effect whereby youth who experiment with vapour devices are, as a result, more likely to take up tobacco use.”5) They base this on the decline in youth smoking while rates of the use of vaping devices rise.Error! Bookmark not defined. Others contend that vaping is indeed a gateway, saying it acts as a “one-way bridge to cigarette smoking among youth. Vaping as a risk factor for future smoking is a strong, scientifically-based rationale for restricting access to e-cigarettes.”14 Further, in a “national sample of US adolescents and young adults, use of e-cigarettes at baseline was associated with progression to traditional cigarette smoking. These findings support regulations to limit sales and decrease the appeal of e- cigarettes to adolescents and young adults.”15 However, there may be a role for vaping products in relation to young users. A New Zealand study conducted among young adults that examined how electronic nicotine delivery systems (ENDS) were used to recreate or replace smoking habits. It found that study participants “used ENDS to construct rituals that recreated or replaced smoking attributes, and that varied in the emphasis given to device appearance.”16 Further, it was suggested that ascertaining how “ENDS users create new rituals and the components they privilege within these could help promote full transition from smoking to ENDS and identify those at greatest risk of dual use or relapse to cigarette smoking.”16 The CMA believes that further research is needed on the question of the use of vaping products as a gateway for youth into combustible tobacco products. Recommendations: 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. Promotion of Vaping Products The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words “this product is injurious to your health” printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” The CMA would like to see the proposed plain packing provisions for tobacco be extended to vaping products as well. The inclusion of the health warning messages on vaping products is a good first step but efforts should be made to ensure that they are of similar size and type as those on tobacco as soon as possible. The restrictions being applied to the promotion of vaping products is a positive step, especially those that could be aimed at youth, but they do not go far enough. The CMA believes the restrictions on promotion should be the same as those for tobacco products. As the WHO/U.S. National Cancer Institute has already demonstrated, e- cigarette retailers are very good at using social media to promote their products, relying on appeals to lifestyle changes to encourage the use of their products. The CMA is also concerned that e-cigarette advertising could appear in locations and on mediums popular with children and youth if they are not prohibited explicitly in the regulations. This would include television and radio advertisements during times and programs popular with children and youth, billboards near schools, hockey arenas, and on promotional products such as t-shirts and ball caps. As efforts continue to reduce the use of combustible tobacco products there is growing concern that the rising popularity of vaping products will lead to a “renormalization” of smoking. In fact, worry has been expressed that the manner they have been promoted “threaten(s) to reverse the successful, decades-long public health campaign to de- normalize smoking.”17 A recent US study indicated that students that use vaping products themselves, exposure to advertising of these devices, and living with other users of vaping products is “associated with acceptability of cigarette smoking, particularly among never smokers.”18 Further research is needed to explore these findings. Recommendations: 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. Conclusion Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Our members see the devastating effects of tobacco use every day in their practices and to that end the CMA has been working for decades toward the goal of a smoke-free Canada. The tobacco industry continues to evolve and vaping represents the next step in that evolution. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Bill S-5 is another step in that journey. Researchers have identified potential benefits as well as harms associated with these products that require much more scrutiny. The association of the tobacco industry with these products means that strong regulations, enforcement, and oversight are needed. Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.
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CMA's Submission to the House of Commons Standing Committee on Health: Drug Shortages

https://policybase.cma.ca/en/permalink/policy10382
Date
2012-03-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-03-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Health Committee for consideration as part of its study on drug supply in Canada. The severe impact of the disruption in production at one pharmaceutical company's manufacturing facility has demonstrated the significant shortcomings in how drug shortages are managed in Canada. This submission focuses on what is needed to ensure Canada's health care system delivers patient-centred care. In order to deliver the best possible care to patients, physicians require timely, comprehensive and accurate information about current and anticipated drug supply shocks and constraints. With this objective in mind, we have provided input to the government and to the pharmaceutical industries. Further, Canada requires an uninterrupted supply of medically necessary medication for patients. Impacts on Patients and the Health Care System Canada's doctors are deeply concerned about the persistent shortages of drugs that they and their patients are encountering. Prescription drugs can prevent serious disease, reduce hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Pharmaceuticals benefit the health care system by reducing costs in other areas such as hospital stays and disability payments. Disruptions in the supply of pharmaceuticals can impact patient care, patient health and the efficiency of the overall health care system. At the CMA, patient organizations are telling us about the anxiety, pain and harm that drug shortages are inflicting on patients. Below are excerpts of these experiences: * According to the Brain Injury Association of Canada: "Any drug medication shortage endangers Canadian patients. In the brain injury community, anti-depressants are prescribed to some, as is pain medication, so if there is a shortage some members in the community will be endangered even if the medication is altered." * The interim-president of the Canadian Arthritis Patient Alliance, Louise Bergeron, wrote CMA to say: "Actually, I have had this happen to me on three occasions and it is quite scary when you know you will not have access to certain drugs for an extended period of time, since you know your health will be on the line." * Sharon Baxter, Executive Director, of the Canadian Hospice Palliative Care Association, says: "All are encouraging the government to find a solution very quickly as pain medication at the end of life is essential and urgent. I don't think we are at the stage where people are dying without access, but getting to that end is totally unacceptable in a country like Canada." Among the impacts of drug shortages are: * delays in access to needed medication; * delays or disruptions to clinical treatment; * delayed or cancelled surgeries; * loss of therapeutic effectiveness when an appropriate alternate therapy is not available; * increased risk of side effects when alternate therapies are used; and * increased non-compliance when patients, particularly those on long-term therapy, find it harder to comply with a new medication regime. Any one of these situations can impact patient health, particularly in patients with complex problems. In many instances, this in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments. In a survey of physicians conducted by the CMA in 2011, two-thirds of respondents said that the shortage of generic drugs had had negative consequences for their patients or practice. Of these physicians, 22 per cent indicated that the consequences were that their patient suffered clinical deterioration because an alternate drug was substituted. Similarly, in a survey of pharmacists by the Canadian Pharmacists Association in 2011, 69 per cent of respondents indicated that they believed that patients' health outcomes had been adversely affected by drug shortages. Notably, of the physicians who indicated the shortage of generics resulted in consequences to their patients or practice, 28 per cent reported that their patient did not fill the substitution prescription due to the cost of the medication. Numerous respondents raised concerns about the financial impact of substitute medications on patients. Survey responses also shed light on the increased demand on the health care system created by the lack of information on drug shortages provided to physicians. When physicians are not made aware of a drug shortage, and prescribe that medication, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Better informing physicians about drug shortages can reduce demand on the health care system by eliminating the inefficiencies associated with drug shortages. Scope of Drug Shortages In an attempt to outline the scope of the problem, the Canadian Agency for Drugs and Technologies in Health (CADTH) stated that: "It is difficult to quantify and determine the extent of drug shortages in Canada because manufacturers are not required to report disruptions in drug supply to Health Canada and because there is no single accountable Canadian organization that provides system-wide drug distribution oversight."i Surveys by the CMA and the Canadian Pharmacists Association (CPA) shed light on the lack of drug shortages management in Canada. Taken together, the results of these surveys paint an alarming picture of drug shortages management in Canada and underscore the need to improve our system. In terms of notification, the majority of physicians and pharmacists indicated they never (51 per cent and 29 per cent) or infrequently (32 per cent and 33 per cent) receive advance notice of shortages. Ironically, given the high proportion of pharmacists reporting they never or infrequently receive notice, 65 per cent of physicians indicated that they receive notification from pharmacists. Meanwhile, 30 per cent of physicians also indicated that they were notified of drug shortages by their patients. Alarmingly, 81 per cent of the pharmacists surveyed indicated they had trouble locating medications to fill a prescription during their last shift prior to completing the survey and 93 per cent had difficulty over the week prior. This is not a new problem, but since we surveyed CMA members in the fall of 2011, the situation has worsened. Currently about 250 medications are listed on Canadian drug shortage websites. Before the dire impact of the loss of production at Sandoz, Canadian hospitals were already dealing with shortages in the supply of sterile injectables - critical in specialties like surgery, oncology and anesthesia. What Canada's Doctors Require to Provide Care Physicians have expressed their frustration at the time it takes to find an appropriate drug for substitution - time taken from the physician, the pharmacy and the patient. Time better spent with patients is being used by physicians to work with pharmacists to identify alternative drugs and therapies. Of greatest concern are those drugs that are single sourced. When single source medications are in short supply, there are no clear substitutes. The impact of this is being felt now in hospitals across the country as they grapple with the loss of numerous Sandoz products and are forced to ration the remaining stock. The majority of physicians surveyed by the CMA indicated that greater knowledge of drug supply issues would allow them to deliver better patient care. To this end, the CMA strongly supports the development of a comprehensive system for monitoring and responding to domestic shortages of medically necessary drugs. Canada needs a sustainable, adequately resourced system to: identify shortages, rapidly and proactively inform health care professionals, and respond quickly to allocate supply as needed to resolve shortages. The CMA has provided input to both industry and government on the key information needs of doctors. These are: * Information about the product in short supply; * Expected duration of the shortage; * Therapeutic alternatives; * Regions affected; * Notification of the end of the shortage. While the recent establishment of the online inventories by the pharmaceutical industry associations marks an improvement in Canada's management of drug shortages, significant issues remain to be addressed. These include the need for: complete and more consistent information; automatic notifications to alert physicians, pharmacists and other health care providers; a mechanism to prevent potential disruptions; and a mechanism to seek new or interim sources of supply during a shortage. The CMA recognizes that other countries are also grappling with drug shortages. Canada must also work with its partners abroad to find an international solution to this phenomenon. Conclusion Drug shortages management in Canada has significant shortcomings that impact patients, doctors and the health care system. With the current shortage of injectable drugs teetering on the verge of a crisis, quick action and cooperation are required to address the supply shock. The CMA calls on Members of Parliament to exercise leadership to ensure that Canada's health care providers have access to the information necessary for them to care for their patients, and that Canadians have access to medically necessary drugs. i Canadian Agency for Drugs and Technologies in Health. (2011) "Environmental Scan: Drug Supply Disruptions." Ottawa: CADTH, accessed online at: http://www.cadth.ca/media/pdf/Drug_Supply_Disruptions_es-18_e.pdf, 1.
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CMA's Submission to the Senate Committee on Social Affairs, Science and Technology as part of its study on prescription pharmaceuticals: Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety

https://policybase.cma.ca/en/permalink/policy11125
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this submission to the Senate Standing Committee on Social Affairs, Science and Technology for consideration as part of its study on prescription pharmaceuticals in Canada. In this phase, the Committee is studying the unintended consequences of pharmaceuticals, and witnesses to date have identified a broad range of such consequences. In recognition of the important role of prescription medication in patient care, the CMA has developed an extensive body of policy on pharmaceutical medication and prescribing-related issues, some of which we have shared with this Committee on previous occasions. Physicians are concerned that all Canadians have access to medically-necessary medication that is safe, effective, affordable, appropriately prescribed and administered, and part of a comprehensive, patient-centered health care and treatment plan. In this brief, the CMA identifies and discusses five issues that are unintended consequences of prescription pharmaceuticals related to public health, quality care and patient safety. These are: addressing shortages in the supply of prescription pharmaceuticals; addressing the abuse and misuse of prescription medication; improved post-market surveillance and reporting tools; supporting optimal prescribing; and, addressing gaps in insurance coverage. 1) Addressing shortages in the supply of prescription medication Over the past few years Canada's doctors have become deeply concerned about the persistent shortages of prescription medication. Drug shortages have serious consequences for patient care. For example, if a patient on long-term therapy has been stabilized on a drug which becomes unavailable, and is switched to another drug that produces poorer results, this can lead to a decline in health status. The cost of the substitute medication might be beyond a patient's financial capacity. In some cases a therapeutic alternative may not be available at all. The CMA has participated on a Multi Stakeholder Working Group on Drug Shortages, with Health Canada, the pharmaceutical industry and health professional organizations, to establish a Canadian drug shortage reporting website. Although a drug shortage reporting website has been established, there is significant room for improvement. While this website may provide information on products in shortage, it is not clear that all shortages are reported, no mechanism for redress is identified, and most importantly drug shortages are persisting. The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. One frequently cited reason for shortages is product manufacturing disruptions, such as the 2011 production stoppage at a Sandoz facility in Quebec which resulted in a scramble to find alternate sources of many essential medications. Such disruptions are of particular concern when the drugs in question have been "single sourced" due to government bulk purchasing policies, and no clear substitutes are available. Therefore, the CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The CMA continues to call on governments and manufacturers to take meaningful action to address the impacts of shortages includingdeveloping appropriate mitigation strategies to reduce the number of drug shortages in Canada and their impact on patient health and patient care. To support this goal, the CMA recommends that the Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) Addressing the misuse and abuse of prescription medication The use of prescription opioid pain relievers is on the rise, in Canada and internationally. Latest reports indicate that Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Canada's physicians are concerned about the abuse and misuse of prescription medication for a number of reasons. For one, physicians need to assess the condition of patients who request the medication, and consider whether the use is clinically indicated and whether the benefits outweigh the risks. This can be challenging as there is no objective test for assessing pain, and therefore the prescription of opioids rests to a great extent on mutual trust between the physician and the patient. For another, physicians may need to prescribe treatment for patients who become addicted to the medications. Finally, they are vulnerable to patients who forge their signatures or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. Opioid prescription pharmaceuticals are legal products intended for legitimate therapeutic purposes, such as pain management or palliative and end-of-life care. However, they may also be used for recreational purposes or to feed an addiction. It must be recognized that it is addiction which drives the drugs' illegal acquisition through means such as doctor-shopping, forging prescribers' signatures, or buying from street dealers or the Internet. The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. Such a strategy should include: a) Programs to prevent misuse: The aim of prevention programs should be to reduce both recreational use and inappropriate therapeutic use. Awareness programs and social marketing campaigns could include: * Information on the benefits and harms of prescription drug misuse, and signs of abuse, addiction or overdose; * Instructions regarding safe storage and disposal. This is important since young recreational users frequently report that they obtain drugs from the family medicine cabinet. CMA supports national prescription drug "take back" days, and recommends that patients be educated about the importance of returning unused prescription drugs to the pharmacy. b) Measures to reduce the risk of overdose: Overdose deaths due to opioid use have grown dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. However, opioid overdoses can be prevented with appropriate medication and prompt emergency response. c) Access to treatment services: A national strategy should also improve patient access to specialized pain management services, and to treatment for opioid addiction. Many believe that if specialized pain treatments were widely available, patients and prescribers would be less likely to rely solely on medication to treat their often debilitating pain. d) A pan-Canadian prescription monitoring program: Programs to monitor the prescribing of opioids and other controlled substances exist in most provinces, but they vary in quality, in the nature of the information they require, and in the purpose for which data is collected. The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. This should include the development of national standards for prescription monitoring, to ensure that all jurisdictions across Canada are collecting the same information in a standard way. Standardization of surveillance and monitoring systems can have a number of positive effects, including: * Identifying fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * Deterring inter-provincial fraud. * Supporting professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, supporting researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on prescription drug abuse issues, and we hope that this will result in a coherent national system for monitoring and surveillance, and thus to improved knowledge about the nature of the problem and its most effective solutions. 3) Improving post-market surveillance and reporting tools Health Canada has traditionally approved drugs for general use based on clinical trials that tend to be of short duration and have relatively few participants. As a result, when a prescription pharmaceutical comes on the market there is still limited information about its safety or effectiveness, and there is a need to keep gathering information from people who are using it in "real-world" conditions. As a consequence, adverse drug reactions (ADRs) are all too common in Canada; according to the Canadian Institute for Health Information, one in 200 patients over 65 are hospitalized because of adverse reactions to their medication. As such, CMA once again recommends that Health Canada work to strengthen the capacity of its post-market surveillance system by ensuring that it includes: a) Comprehensive processes for gathering drug safety and effectiveness data: Since most safety data reaches Health Canada in the form of spontaneous adverse drug reaction (ADR) reports, reporting processes should make it easier for physicians and other health professionals to report ADRs voluntarily, by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Ideally, ADR reporting could be incorporated directly into the Electronic Medical Record (EMR) as this is developed. Spontaneous reports could be augmented with information gathered through other, more systematic means such as formal post-market studies. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety: The monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received are critical elements of the post-surveillance system. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. c) Communication of useful information to health care providers and the public: When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. The CMA supports the expanded ministerial authorities of recall proposed in Bill C-17, the Protecting Canadians from Unsafe Drugs Act, and the intent to address the short-comings of Canada's post-market surveillance system. We will be providing comments on this legislation in the near future. 4) Supporting Optimal Prescribing In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm. The CMA encourages collaborative efforts toward the achievement of this ideal. For example, medication misuse among seniors is a major concern. According to a 2011 report from the Canadian Institute for Health Information (CIHI), 62% of seniors on public drug programs use five or more drug classes, and nearly 30% of those 85 and older have claims for 10 or more prescription drugs. Heavy medication use by people over 65 has a number of consequences: * The risk of adverse drug reactions is several-fold higher for older patients than for younger; * Medication regimes, particularly for those taking several drugs a day on different dosage schedules, can be confusing and lead to errors or non-adherence; and, * Patients may receive prescriptions from multiple providers who, if they have not been communicating with each other, may not know what other medications have been prescribed. This increases the risk of duplicate prescriptions, harmful drug interactions and other medication errors. It is to address such concerns that the CMA developed its 2010 position statement: "A Prescription for Optimal Prescribing This statement recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. This strategy should include, among other elements: a) Provision of Relevant, Objective Information: The CMA supports the development and dissemination of information for prescribers that is based on the best available scientific evidence, relevant to clinical practice, and easy to incorporate into a practitioner's daily workflow. At present, physicians receive much of their information from pharmaceutical manufacturers. Since manufacturers have generous budgets to support their information dissemination, their campaigns are impressive and effective; but their impartiality has frequently been called into question. Objective, evidence-based information to health professionals on prescription drugs and their uses could be disseminated in the following ways: * Well-crafted online continuing medical education (CME), funded by objective sources. * Academic detailing, in which teams of experts visit prescribers to provide impartial prescribing advice. Academic detailing programs have demonstrated success; but because they are expensive and labour intensive, it has often been difficult to persuade governments to invest in them. * Making drug information available to prescribers at the point of care, through such means as mobile phone apps and electronic health records. * Programs that monitor a prescriber's habits and compare them to those of peers. CMA encourages such programs if their purpose is to educate rather than to enforce a certain behaviour. Information for prescribers should be augmented by unbiased, up-to-date, practical information for consumers about prescription drugs and their appropriate use. b) Support e-prescribing. Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system could: * List all the drugs a patient is taking, and identify duplicate prescriptions for the same drug from different providers, thus helping to reduce medication error and prescription fraud; * Incorporate decision-support tools; for example, a warning could appear on the screen if a physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. * Improve decision making and communication between providers, providing all of a patient's caregivers access to a common, comprehensive medication profile; and * Increase convenience for the patient and eliminate illegible handwriting, which is a major cause of medication error. The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 5) Addressing gaps in insurance coverage for prescription medication Finally, another consequence of the increased role of pharmaceuticals in health care is that, because they are not generally covered by the Canada Health Act, many Canadians, particularly those in the lowest income groups, are unable to afford them. Data from the 2007 Community Health Survey estimate that 1 in 10 Canadians does not adhere to their prescription regimes for reasons of cost. The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies. Conclusion As previously mentioned, CMA has focussed its discussion of unintended consequences on recommendations to support public health, quality care, and patient safety. The CMA commends the Committee for making this issue the subject of study, and hope that our recommendations, and those of other witnesses, will lead to action to address the unintended consequences of prescription pharmaceuticals in Canada. Summary of Recommendations 1) The CMA recommends that the Senate Social Affairs, Science and Technology Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. 3) The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. 4) The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports * Analyze the data that has been gathered, in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. 5) The CMA recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. 6) The CMA supports the development and dissemination of prescribing information that is: * based on the best available scientific evidence; * relevant to clinical practice; and, * easy to incorporate into a physician's workflow. 7) The CMA calls on governments to support and deliver funding for impartial continuing medical education programs on optimal prescribing. 8) The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 9) The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.
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CMA's Submission to the Senate Committee on Social Affairs, Science and Technology - Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals

https://policybase.cma.ca/en/permalink/policy10631
Date
2012-10-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-10-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association is pleased to take part in the second phase of the study of prescription pharmaceuticals by the Senate Standing Committee on Social Affairs, Science and Technology. During the first phase, we presented the CMA's policy position regarding clinical trials and the process for approving new drugs for use. In this phase we will discuss our position and recommendations on post-approval surveillance of prescription drugs. The Canadian Medical Association represents 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Prescription drugs are a very important part of high quality and cost-effective health care. They can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Therefore, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription drugs. The essence of our position is contained in our first recommendation: Recommendation 1: The CMA recommends that federal and provincial/territorial governments collaborate to develop and implement a national pharmaceutical strategy to ensure that every Canadian has timely access to an adequate supply of safe and effective prescription drugs. This recommendation has two elements: "safe and effective" and "adequate supply," both of which we will discuss in this submission. 2) Ensuring Safety and Effectiveness As we have previously told this Committee, the CMA supports a robust regulatory framework and system for researching and approving new pharmaceutical products. But however strong Canada's pre-approval system is, it will not identify all potential problems with a new drug. Pre-approval clinical trials tend to focus on small numbers of patients, and exclude vulnerable groups such as children and the elderly. They also tend to be of short duration, whereas in the real world, patients may take these drugs for years. As a consequence, problems with a drug are often identified only after widespread, long-term use in the general population. For this reason, it is essential that Canada have in place a robust regulatory framework that includes a timely system to monitor the performance of prescription drugs after they come on the market. The Government of Canada has taken several recent steps to enhance its drug surveillance system. In 2009, it established the Drug Safety and Effectiveness Research Network. In 2008, it introduced Bill C-51, An Act to Amend the Food and Drugs Act, to improve drug safety and effectiveness monitoring by Health Canada. Unfortunately, the bill died with the 2008 election call and has not been re-introduced. That is why we are pleased that the Senate has chosen to re-open this issue. What would a comprehensive post-approval surveillance regulatory framework and system look like? In order to effectively monitor the safety and effectiveness of the country's drug supply, the CMA believes it should include: a) Comprehensive processes for gathering drug safety and effectiveness data In gathering data about adverse drug reactions (ADRs) in Canada, Health Canada has traditionally relied on spontaneous reports from manufacturers and health professionals. The government could enhance its capacity to gather information by: * making it easier for physicians and other health professionals to report ADRs voluntarily. This can be accomplished by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of ADR reports over the past 10 years. The reporting process could be made even more efficient by incorporating it directly into the Electronic Medical Record (EMR) as this is developed. * augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report ADRs in detail, and who, because of these contractual obligations, would be committed to assiduous reporting. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety. Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. Post-market monitoring should do more than identify safety risks. It should also provide information about a drug's efficacy and effectiveness. Does it achieve the health outcome for which it is being marketed? Does it perform better than other drugs or therapies for the same condition? c) Communication of useful information to health care providers and the public. When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Recommendation 2: The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports; * Analyze the data that has been gathered in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. d) Increased regulatory authority for Health Canada Drug safety is a serious issue; recent research has revealed that nearly a quarter of new drugs approved in Canada will eventually receive a serious safety warning1. Given the potential risks to patient safety we believe Health Canada should have the legal authority to take strong action when a safety problem is identified. The CMA recommends that Health Canada should be given the authority to: * require post-market studies of newly approved drugs if clinical trials identify possible safety risks; * require manufacturers to disclose information if Health Canada thinks it germane to making a decision in the interest of patient safety; and * take action if post-market research uncovers new safety concerns. This could mean ordering changes to product labels, or pulling a product off the market. Granting Health Canada this regulatory authority is only the first step. Health Canada should not hesitate to use this authority if the situation warrants. 3) Ensuring an Adequate Drug Supply In the past few years Canada's doctors have become deeply concerned about the persistent shortages of drugs that they and their patients are encountering. In a survey of physicians conducted by the CMA in September 2012, two-thirds of respondents said that the shortage of drugs was a significant issue in terms of its impact on patient care and outcomes. Of these physicians, 70 per cent indicated that their patient received a less effective medication, and 20 per cent had patients who had suffered clinical deterioration because an alternate drug was substituted. This in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments. Twenty-three per cent reported that their patient suffered financially due to the cost of the substituted medication, since many of the drugs in short supply are older, low-cost generics. The lack of information about shortages compounds the stress of dealing with them. When physicians prescribe a medication, unaware that it is in short supply, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Physicians have expressed their frustration at the time it takes to find an appropriate substitute drug - time which could better be spent in patient care. As a consequence, the CMA strongly supports the development of a comprehensive system for monitoring domestic shortages of medically necessary drugs. To be of greatest benefit to doctors, such a system should include: * Information about the product in short supply; * Expected duration of the shortage; * Therapeutic alternatives; * Regions affected; * Notification of the end of the shortage. Although pharmaceutical industry associations and drug manufacturers are now supporting a drug shortage reporting website (http://www.drugshortages.ca/drugshortages.asp), there is room for improvement. The reporting website does not yet capture all of the drug product shortages. It must become more user friendly for health practitioners and the public, with search and sort functions to easily find product listings. In addition, a mechanism to obtain information on possible therapeutic substitutions would be of value to practitioners. Recommendation 3: The CMA recommends that Health Canada work with provincial and territorial governments, industry groups and health professionals to enhance the current system for reporting drug shortages and ensure its sustainability. Finally, while a reporting system to provide information to health professionals and Canadians on drug shortages is valuable, it is essential that Canada address the root causes of drug shortages. A review of the supply processes, both domestic and international, is strongly recommended. While the CMA acknowledges that provinces are responsible for purchasing drugs, we believe that solutions will be stronger if all provinces, and the federal government, work together on them. And since drug shortages are an international concern, it is the responsibility of the Government of Canada to work with other countries in seeking solutions. Recommendation 4: The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. 4) Other Important Elements of a National Pharmaceutical Strategy As Recommendation 1 states, the CMA believes that Canada's federal and provincial/territorial governments should implement a national pharmaceutical strategy, one of whose objectives would be to ensure an adequate supply of prescription drugs. The strategy should address other important objectives, as well, notably: * ensuring comprehensive prescription drug coverage for all Canadians. According to a recent CMA survey, one in 10 Canadians has gone without a prescription drug because they couldn't afford it. Governments should work with private insurers and other stakeholders to develop a system to provide equitable, comprehensive prescription drug coverage to all Canadians. * encouraging optimal prescribing by health professionals. To accomplish this, the CMA has recommended a strategy that includes education, user-friendly guidelines and practice tools, and the provision of impartial information to health professionals and the public. 5) Conclusion Once again, we commend the Senate Social Affairs Committee for bringing this issue to your table. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective and in adequate supply. 1 Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012;():1-2. doi:10.1001/archinternmed.2012.4444.
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CMA submission to the study of Bill C-37

https://policybase.cma.ca/en/permalink/policy13617
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of the Senate Committee on Legal and Constitutional Affairs’ study of Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts.1 1 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 The CMA is deeply concerned with the opioid crisis in Canada, with unprecedented levels of harms, including overdose deaths. The crisis is taking a toll on individuals, families and communities, as well as first responders and health professionals at the front lines. The most recent BC Coroner’s Report indicates there were about 3.6 illicit drug overdose deaths per day in February 2017, an increase of 72.9% over the number of deaths in February of last year.2 Other provinces are also facing critical situations. The CMA welcomes the introduction of Bill C-37, proposed by the Minister of Health to address various portions of the Controlled Drugs and Substances Act (CDSA), among other changes. * We are particularly appreciative, given that this is part of a new federal strategy that promises to “replace the existing National Anti-Drug Strategy with a more balanced approach (…) and restores harm reduction as a core pillar of Canada’s drug policy, alongside prevention, treatment and enforcement and supports all pillars with a strong evidence base.3 This is necessary to ensure a public health approach to drug use and addiction. * For further discussion of CMA’s position on addiction, harm reduction and supervised consumption sites, as well as terminology, such as supervised consumption sites or supervised injection sites, see CMA’s submission to the Senate Standing Committee on Legal and Constitutional Affairs. Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf This proposed legislation includes various objectives, including “to prohibit the unregistered import of pill presses, and remove the exception currently placed on border officers to only open mail weighing more than 30 grams,” (…) to “make it a crime to possess or transport anything intended to be used to produce controlled substances, allow for temporary scheduling of new psychoactive substances, and support faster and safer disposal of seized chemicals and other dangerous substances.”4 CMA is supportive of actions by the federal government that advance the work at national, provincial and local levels to address the opioid crisis. Application for a Supervised Consumption Site The objective of Bill C-37 that CMA would like to provide recommendations for is the one that seeks to “simplify the process of applying for an exemption that would allow certain activities to take place at a supervised consumption site, as well as the process of applying for subsequent exemptions.5 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 The Bill proposes to repeal the 26 requirements to apply for an exemption to the CDSA, in Section 56.1, established by the Respect for Communities Act (former Bill C-26). The CMA supports the repeal, as we have repeatedly called for the withdrawal of the amendments made by former Bill C-2, and their replacement with “legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.”7 Bill C-37 proposes to replace those 26 requirements with the five elements cited in the 2011 Supreme Court of Canada unanimous ruling on Insite8, Vancouver’s supervised injection site. These elements are, “evidence, if any, on: . the impact of such a facility on crime rates, . the local conditions indicating a need for such a supervised injection site, . the regulatory structure in place to support the facility, . the resources available to support its maintenance and . expressions of community support or opposition.”9 These elements are proposed to reduce the unnecessary obstacles and burdens on local health departments and community organizations that would deter the creation of new supervised consumption sites, even when the health and safety benefits have been clearly established. Because of this cumbersome process, the BC Ministry of Health recently authorized the creation of “overdose prevention sites” in various locations where there are concerning numbers of overdose deaths, while the ministry “wait(s) for Health Canada approval of supervised consumption services”.10 This was after the creation of unsanctioned popup sites by community groups in the downtown eastside.11 Only Insite and the Dr Peter Centre operate with approved exemptions to date, with Montreal having recently received approval for three sites.12 Many other applications have been submitted for sites in Vancouver, Victoria, Toronto and Ottawa, and others are in preparation. Although a welcome reduction to only five elements, the CMA believes that these elements require more clarity, as they can be subject to interpretation, and undue influence, and could still demand unnecessary and significant time and resources on the part of provincial and local agencies. As well, the present crisis would require an expedited process that would not delay local responses to the crisis. Hence, our first recommendation is that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. Further, CMA recommends that the elements required for an application for opening a supervised consumption site proposed in Bill C-37 be more clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. The central element to be considered is that of “the local conditions indicating a need for such a supervised injection site”. Local health authorities and community organizations struggle with the issues related to drug use, including rising rates of infections, overdoses and deaths, and this is the fundamental reason to open a supervised consumption site. The regulatory structure and the resources available to support a supervised consumption site’s maintenance are issues that local health authorities deal with regularly for any health service, given the need to provide care with reduced risk of liability. The impact of a facility on crime rates is difficult to quantify before such a site is created. Further, the government must consider the experience of the many sites both in Canada and internationally, where law and order have improved in the areas surrounding those sites. The Supreme Court stated that there has been “no discernible negative impact on the public safety and health objectives of Canada during its [Insite’s] eight years of operation.”13 As well, the crime rate is not only influenced by the existence or not of a site, but by many other factors, such as unemployment and enforcement resources. A site would necessarily be located where there are high rates of drug use, for the very purpose of offering people who use drugs much needed harm reduction and support services. The last element, expressions of community support or opposition, should not represent a burden to applicants. As stated in our brief on Bill C-2, “although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites and in European countries.”14 Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication.15 Bill C-2 is an example of how this element could be interpreted. There was an extensive list of letters of opinion required, including from representatives of local police and local and provincial governments (ministers of health and public safety), chief public health officer, professional licensing authorities for physicians and for nurses, as well as reports from community consultations.16 Such a requirement represented a cumbersome and unnecessary burden. The CMA looks forward to continued collaboration with the federal government and other organizations in the development of further action as part of the much needed comprehensive approach to address the opioid crisis. Recommendations 1. The CMA recommends that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. 2. The CMA recommends that the elements required for an exemption application to the CDSA to open a supervised consumption site, proposed in Bill C-37, be clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 7 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1
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The Health risks and harms associated with the use of marijuana

https://policybase.cma.ca/en/permalink/policy11138
Date
2014-05-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-05-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study on the health risks and harms associated with the use of marijuana. Marijuana, or cannabis, is a Schedule II drug under the Canadian Controlled Drugs and Substances Act, and growing, possessing, distributing and selling marijuana is illegal, subject to penalties. Despite that, according to the latest Canadian Alcohol and Drug Use Monitoring Survey1, about 10% of Canadians ages 15 years and over had used marijuana at least once in the past year. It is the second most used substance, following alcohol (at 78%). Even though there has been a decrease in marijuana use among youth (ages 15 to 24) in recent years, usage is still double that of the general population, at 20%. A quarter of youth that had used marijuana in the past 3 months, used it daily, however most use is infrequent and experimental. The average age of initiation is 16.1 years, and it is very concerning that continued use is most common among those who initiate use early. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.2 The 2012 Canadian Community Health Survey - Mental Health3 reported that 1.3% of people aged 15 and over met the criteria for cannabis abusea or dependenceb - double that of any other drugs. The lifetime risk of dependence is estimated at about 9%, increasing to almost 17% in those who initiate use in adolescence.4 Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine. CMA has longstanding concerns about the health risks associated with smoking marijuana. While our comments have more recently been made in the context of medical marijuana, the core issue is the same: marijuana usage poses serious health risks5. Teenagers are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. It is estimated that marijuana contains more than 400 active chemicals, including over 60 cannabinoids, of which delta-9 tetra-hydrocannabinol (THC) is the most often studied due to its psychoactive properties. The concentration of the various chemicals varies for different plants, batches and growth locations, and has varied over time. There is the potential for contamination by pesticides or other substances. Rates and quantities of components absorbed will also vary depending on whether the drug is smoked, used in food, inhaled with a vaporizer or applied topically. This is challenging for research on the health effects of marijuana. When marijuana is smoked, THC and other components are inhaled and absorbed through the lungs, rapidly entering the bloodstream. Effects are perceptible within seconds and fully apparent in a few minutes. The main feature of its use is that it produces a feeling of euphoria (or 'high') and sensory alterations, but it is also sought out to reduce pain, relieve anxiety, decrease vomiting and increase appetite. Adverse reactions can occur, such as drowsiness, sedation, blurred vision, photophobia, difficulty breathing and vomiting. However, its acute toxicity is extremely low, as no deaths directly due to acute cannabis use have been reported. Toxic dose-related effects that can occur include anxiety, panic, depression, paranoia or psychosis. Acute impairment typically clears 3-4 hours after use. Marijuana slows reaction times, impairs motor coordination and concentration as well as the completion of complex tasks. Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Student Alcohol and Drug Use6 report states that 14-21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug. Chronic use is more common among those that start using as young teens; those that are tobacco smokers and heavy alcohol consumers and have used other illegal drugs. People with a number of pre-existing diseases who are chronic smokers of marijuana are probably at increased risk of exacerbating the symptoms of their diseases. For example, adults with hypertension, ischaemic or cerebrovascular disease could be at increased risk due to the cardiovascular stimulatory effects of marijuana. There is an increased risk of psychosis, depression and anxiety, particularly among those who have a personal or family history. A persistent lack of energy in chronic users has been referred to as an "amotivational syndrome". Although cognitive impairments (loss of memory, focus and the ability to think and make decisions) are likely reversible a few weeks after discontinued use, this seems not to be true for those who began using in early teen years, while the brain is still developing. Smoke from marijuana preparations contains many of the same compounds as tobacco cigarettes including increased levels of tar. Smoking marijuana may be more harmful than tobacco, as it often involves unfiltered smoke and deeper, longer inhalation. Chronic users often have shortness of breath after exercise, coughing and chest tightness. It is probably associated with bronchitis and emphysema and may have risks for chronic lung disease and lung cancer, comparable to cigarette smoking. This is less of a problem for those that use vaporizers, as a harm reduction strategy. The use of marijuana during pregnancy has been shown to affect the development and learning skills of children, more noticeably from the age of three, with these effects lasting into the teen years. Studies have shown an increase in hyperactivity, inattention and impulsivity. These children will be more prone to addiction and mental health issues as well as decreased cognitive functioning, and could require supports when in school. Some studies point to a lower birth weight. Besides health concerns, marijuana use can lead to social and interpersonal problems, including difficulties at school, in relationships and with the law. Awareness of Canadians of the harms of marijuana is generally low. 7 Youth tend to emphasize the drug's ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There were also many myths, such as that it would counter cigarette effects, preventing cancer. Many stated that they did not consider marijuana as a drug because it was "natural" and relatively benign compared to other drugs. It is concerning that some teens said that marijuana actually made people better drivers by increasing their focus. There seems to be skepticism around prevention programs which aim exclusively at abstinence. Feedback has been that effective approaches would involve providing more fact-based information at an earlier age and using programs that aim at reducing the harms of using marijuana. It is essential that youth and users from other age groups be involved in the conceptualization and development of any such programs. CMA makes the following recommendations to the Committee: 1) Public Health Approach to Psychoactive Substance Use The CMA recommends that the federal government adopt a public health approach to increase the focus on preventing drug abuse, on treatment of addiction, on monitoring, surveillance and research and on harm reduction. Addiction should be recognized and treated as a serious, relapsing chronic disease, and substance use is a complex behaviour influenced by many factors. Therefore, a comprehensive multi-factorial strategy is necessary, and lessons can be learned from work that has been done to decrease tobacco and alcohol use and to reduce the harms related to these substances. A public health approach would place an increased focus on preventing drug abuse and dependence; on the availability of assessment, counselling and treatment services for those who wish to stop using; and on harm reduction to increase the safety for those that are using. It would seek to ensure the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation. The CMA believes that resources currently devoted to combating simple marijuana possession through the criminal law could be diverted to public health strategies, particularly for youth. A public health approach also includes efforts around the monitoring, surveillance and research of marijuana use to better inform the strategy. This is essential to better understand the short and long term harms as well as policy options to address prevention, treatment, harm reduction and enforcement. 2) Comprehensive Education and Awareness Program to Address Marijuana Use The CMA recommends that the federal government develop, in collaboration with the provinces and territories and key stakeholders, a comprehensive education and awareness program to minimize marijuana use. A comprehensive program to minimize marijuana use should include, but not be limited to: - Education and awareness raising of the known and potential harms of marijuana; - Strategies to prevent early use in adolescence; - Support for programs that decrease stigma associated with mental health and addiction; and - Support for health professionals' awareness and evidence-informed practice in the prevention, management and treatment of drug use. A specific focus on youth is essential, as they are not only more likely than adults to engage in risky drug use, particularly boys, but also disproportionately experience greater harms from that use. It is also particularly important for women of child bearing age, due to the risk to the fetus during pregnancy. Information that is tailored to the needs of specific populations will help people make informed choices. Efforts to prevent, reduce or delay the use of marijuana could result in a reduction of suffering and costs to the health care system. Health professionals must be involved and supported in this area, and it is important to ensure the availability of evidence informed clinical practice guidelines, practice tools and continuing medical education resources. 3) Driving Under the Influence Prevention The CMA recommends that the federal government continue to support, in collaboration with the provinces and territories and key stakeholders, strategies for the prevention of impaired driving. The CMA believes that comprehensive long-term efforts that incorporate both deterrent legislation and public awareness and education constitute the most effective approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers due to marijuana. Efforts to prevent, reduce or delay marijuana use, especially in youth, are particularly important. Education is also important as many are not aware that marijuana affects driving ability or even that there are procedures that the police can use to identify impairment due to psychoactive substances. The CMA supports a similar multidimensional approach such as has been adopted with alcohol and driving. However, the specificities of impairment due to marijuana must be understood and investments made in research. Collaboration with key stakeholders such as schools, drivers' education and licensing bodies, as well as enforcement organizations is essential. In conclusion, the Canadian Medical Association reiterates the concern of Canada's physicians around marijuana use, particularly by young people. We are committed to working with governments and stakeholders to address this issue. a Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs. b Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs. 1 Health Canada (2013) Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Retrieved from: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php 2 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf 3 Statistics Canada (2013) Canadian Community Health Survey - Mental Health. Retrieved from: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm 4 Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf 5 Beirness, D.J., & Porath-Waller, A.J. (2009). Clearing the smoke on cannabis: Cannabis use and driving. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11789-2009.pdf. Diplock, J., & Plecas, D. (2009). Clearing the smoke on cannabis: Respiratory effects of cannabis smoking. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11797-2009.pdf. Gordon, A.J., Conley, J.W. & Gordon, J.M. (2013) Medical consequences of marijuana use: a review of the current literature. Curr Psychiatry Rep 15:419. Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf Holmes, E., Vanlaar, W. & Robertson, R. (2014) The problem of youth drugged driving and approaches to prevention: a systematic literature review: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://ccsa.ca/Resource%20Library/CCSA-Youth-Drugged-Driving-technical-report-2014-en.pdf Kalant, H., & Porath-Waller, A.J. (2012). Clearing the smoke on cannabis: Medical use of cannabis and cannabinoids. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2012%20CCSA%20Documents/CCSA-Medical-Use-of-Cannabis-2012-en.pdf. Porath-Waller, A.J. (2013). Clearing the smoke on cannabis: Highlights. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2013%20CCSA%20Documents/CCSA-Clearing-Smoke-on-Cannabis-Highlights-2013-en.pdf. Porath-Waller, A.J. (2009a). Clearing the smoke on cannabis: Chronic use and cognitive functioning and mental health. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0115422009_e.pdf. Porath-Waller, A.J. (2009b). Clearing the smoke on cannabis: Maternal cannabis use during pregnancy. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0117832009_e.pdf. 6 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf 7 Cunningham, J.A., Blomqvist, J., Koski-Jannes, A., & Raitasalo, K. (2012). Societal Images of Cannabis use: Comparing Three Countries. Harm reduction journal, 9(1), 21-7517-9-21. Retrieved from: http://www.biomedcentral.com/content/pdf/1477-7517-9-21.pdf Porath-Waller, A., Brown, J., Frigon, A., & Clark, H. (2013). What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf Racine, S., Flight, J., & Sawka, E. (Eds.). (2006). Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://publications.gc.ca/site/eng/349980/publication.html
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Listening to our Patient's Concerns : Comments on Bill C 54 (Personal Information Protection and Electronic Document Act) : Submission to the House of Commons Standing Committee on Industry

https://policybase.cma.ca/en/permalink/policy1980
Last Reviewed
2019-03-03
Date
1999-03-18
Topics
Health care and patient safety
Health information and e-health
Ethics and medical professionalism
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2019-03-03
Date
1999-03-18
Topics
Health care and patient safety
Health information and e-health
Ethics and medical professionalism
Text
Over the last year, CMA has become increasingly concerned that debate on the issues concerning health information have been framed in terms of access to information with an attendant erosion of privacy and confidentiality. This one-sided approach comes at a time of expansion in our capacity to collect, store, merge, transfer and access information, coupled with trends both in the health care sector and generally related to the use of information To address these concerns and to ensure that privacy and confidentiality in the medical context are valued, protected and preserved, CMA developed and adopted a Health Information Privacy Code. This Code should form the basis of all legislation governing the collection, use and disclosure of health information. Health information is special by its nature. Rules relating to health information must be developed in recognition of its special nature. Ensuring protection of privacy and confidentiality of the patient record must take precedence over other considerations. Bill C-54 fails to do this. Bill C-54 is written from the perspective of encouraging commerce. It appears to have access to information as its dominant value. CMA considers the world of health care to be very different from that of commerce and consequently requiring distinct rules. Health information use must, in all but exceptional and justifiable circumstances, occur only under the strict control of the patient. The patient must be able to exercise control through voluntary, informed consent. Bill C-54 permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purpose. The evident lack of protection accorded health information based on such ground, is unacceptable. The absence of protection undermines the integrity of the patient-physician relationship and has the potential to erode the trust patients have in their physicians - a trust that is essential to patients’ willingness to provide the complete information needed to provide them with care. Moreover, distinctions must be made between a patient’s right to know what can or must happen to health information and the right to consent to such use. Not all purposes for the collection and use of health information are equal. Collection and use beyond the therapeutic context should be subjected to rigorous scrutiny before they are permitted to occur. Bill C-54 fails to make such a distinction and treats all purposes that could be identified for information collection or use as equal. Moreover, the Bill has no mechanism to distinguish legitimate purposes, which should be permitted from illegitimate purposes, which should not. In light of the clear deficits in Bill C-54 and the inadequate protection of patient privacy and health information confidentiality, CMA makes the following recommendations: That Bill C-54 be amended to incorporate specific provisions relating to health information and that the provisions of the CMA Code provide the basis of such provisions; and That the proposed rules for health legislation be subject to the legislative test found in CMA’s Code and formulated in light of this process; and That there be a clear definition of the information being accorded a right of privacy and that this definition, at least in the case of health information, include identifiable information, delinked information, anonymous information and any composite form produced when information is linked to any information about a person from any other source; and That, at least in connection with health information, the provisions of the Bill apply equally to the public and the private sectors. I. Introduction The Canadian Medical Association is the national voice of Canadian physicians. Our mission is to provide leadership for physicians and to promote the highest standard of health and health care for Canadians. The CMA is a voluntary professional organization representing the majority of Canada's physicians and comprising 12 provincial and territorial divisions and 43 affiliated medical organizations. On behalf of its 45,000 members and the Canadian public, CMA performs a wide variety of functions, including addressing the emerging issue of electronic health information and confidentiality and privacy. It is in this capacity that we present our position on Bill C 54, The Personal Information Protection and Electronic Documents Act. CMA commends the government for taking the first, important step of beginning the debate on the protection of personal information. The issues are complex and the interests at stake significant. CMA welcomes the opportunity to provide comments on Bill C-54. CMA hopes that its input will strengthen the Bill by ensuring that patient privacy and the confidentiality of medical records are adequately protected. In preparing this brief CMA has had the benefit of the final report of the federal Advisory Council on Health Infostructure, Canada Health Infoway: Paths to Better Health: Final Report. (“Advisory Council Report”) Where appropriate, CMA cites the findings contained in the report. CMA wishes to underscore the key themes of its brief: A. Health information is special by its nature. Rules relating to health information must be developed in recognition of its special nature. Ensuring protection of privacy and confidentiality of the patient record must take precedence over other considerations. Bill C-54 fails to do this. Bill C-54 is written from the perspective of encouraging commerce. It appears to have access to information as its dominant value. CMA considers the world of health care to be very different from that of commerce and consequently requiring distinct rules. B. Health information use must, in all but exceptional and justifiable circumstances, occur only under the strict control of the patient. The patient must be able to exercise control through voluntary, informed consent. Bill C-54 permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purpose. The evident lack of protection accorded health information based on such ground, is unacceptable. The absence of protection undermines the integrity of the patient-physician relationship and has the potential to erode the trust patients have in their physicians - a trust that is essential to patients’ willingness to provide the complete information needed to provide them with care. Moreover, distinctions must be made between a patient’s right to know what can or must happen to health information and the right to consent to such use. C. Not all purposes for the collection and use of health information are equal. Collection and use beyond the therapeutic context should be subjected to rigorous scrutiny before they are permitted to occur. Bill C-54 fails to make such a distinction and treats all purposes that could be identified for information collection or use as equal. Moreover, the Bill has no mechanism to distinguish legitimate purposes, which should be permitted from illegitimate purposes, which should not. This brief will first look at the apparent rationale of Bill C-54 and its potential application to health information. The brief will next describe why CMA considers health information to be special in nature and worthy of special protection. Finally, the brief reviews the difference in approach between Bill C-54 and CMA’s Health Information Privacy Code to illustrate that Bill C-54 provides inadequate protection to patient privacy and health record confidentiality. II. Rationale and Scope of Bill C-54 A. Rational of Bill C-54 The driving force behind Bill C-54 is the support and promotion of electronic commerce. The second part of the Bill is devoted to permitting electronic versions of documents and signatures to be legitimate or ‘originals’ if the provisions of the Act are followed. Part two of the Bill is quite distinct from part one and both parts could stand alone as separate pieces of legislation. Part two simply allows electronic versions of documents and signatures to be recognized as legitimate. On its face, this has little to do with the protection of personal information except to the extent that storage of documents in electronic form provides greater ability to access, link and merge information. Certainly, the Bill appears to draw on this connection by including, in its statement of purpose, the provision of a right of privacy in an era in which technology increasingly facilitates the collection and free flow of information. Part one concerns all forms of information, electronic and otherwise. It gives some protection to personal information by requiring consent in some instances. In CMA’s view, a fundamental difficulty with part one and the Bill in general is that it’s goal is to promote commerce and thus all information is implicitly considered as falling within the ‘commercial’ realm. In the case of health information this is surely not the case or the only consideration. Moreover, this creates a clash of values when applied to a health care system that is a public system. The Advisory Council Report takes a hard line on this issue and states that legislation respecting the privacy protection of health information, “should also contain a clear prohibition against all secondary commercial use of personal health information.” Because all information is subjected to similar rules, there is no attempt within the Bill to distinguish some purposes for collecting information from other purposes. The Bill takes the approach that the purposes should be known and documented. While not stated explicitly, the assumption is that all purposes identified are legitimate and are permitted. CMA has quite a different view when it comes to health information and will expound its view throughout this brief. B. Scope - Application to Medical Records CMA is uncertain whether or to what extent Bill C-54 will apply to health records. The full name of the Act states, in part: An Act to support and promote electronic commerce by protecting personal information that is collected, used or disclosed in certain circumstances.... What are these circumstances? Section 4(1) states that Part 1 (the part protecting personal information) applies in respect of personal information that: (a) the organization collects, uses or discloses in the course of commercial activities; (b) the organization collects, uses or discloses interprovincially or internationally; or (c) is about an employee of the organization and that the organization collects, uses or discloses in connection with the operation of a federal work, undertaking or business. It should further be noted that three years after the Act is in force it will apply equally to activities that occur strictly within the province unless there is legislation in the province that is substantially similar to the Bill (see sections 27(2)(d) and section 30). The first issue is the provision of section 4(1)(a) - collection, use and disclosure in the course of commercial activities. There seems to be an assumption on the part of government that this automatically excludes health records, (although the Act fails to define what is meant by commercial activity). Is this accurate or does the assumption fail to recognize that there is not a clear, unambiguous distinction between what might constitute commercial activity or other activity? There are two points to be made here. The first concerns clarity around where commercial ends and health care begins. Which health care settings that operate for profit are excluded from the Act? This question speaks to the difficulty of delineating what activity is considered health care and what activity is considered commercial. Moreover it recognizes that the increased encouragement to public/private funding of endeavours within the health care sector may make it increasingly difficult to make this distinction; for example in the area of research. The second concerns the movement of health information from the health care setting (recognizing that this is not easily distinguished from the commercial setting) to the commercial setting; for example, health information provided to insurance companies. When health care information is collected in a health care setting and transferred to a commercial setting, which rules apply - Bill C-54 or no rules? In CMA’s view, there is no clear way of distinguishing commercial activity from health care activity in a way that ensures that the health care record is subject to different rules than those pertaining to other records. Moreover, the dilemma for government is that even if such distinction could occur, would it be desirable that health records be subject to no rules? Put in another way, will those organizations that currently collect health care information be entitled to claim that since the information forms part of the health record they are not subject to the provisions of C-54? Under such a regime health care records would be subject to an even lower standard than that provided for information collected in the commercial context. In terms of the provisions of 4(1)(b) - interprovincial and international transfer of information. This appears to apply to all information. In the existing environment and developments such as the “health information highway,” interprovincial transfers of information, the capacity for the central collection and storage of information, mechanisms such as telephone and cable to transfer information and general trends related to population health, it seems likely that interprovincial traffic will grow rather than diminish. The significance of this section, therefore, cannot be underestimated. Finally, the provisions of 4(1)(c) may well contain health information about the employee. In preparing this brief CMA has assumed that the Bill will provide a scheme that applies to some health information. No doubt the extent of the federal governments ability to legislate in this area generally will be the subject of extensive debate. However, CMA has no comment on this debate and provides its opinion in the interests of ensuring that the rules that relate to health information are compatible with preserving the integrity of the patient-physician relationship and the protection of patient privacy and health information confidentiality. CMA considers that the government has an opportunity to provide Canadians with strong privacy rights in health information. Indeed, CMA believes that it is incumbent upon the government to do so. C. Scope - Government Excluded Bill C-54 expressly excludes a large part of government activity from its ambit. While government activity is to some extent governed by the Privacy Act, R.S.C. 1985, P-21, the rules of this act provide less protection than those of Bill C-54. Government should subject itself to at least the same rules that it requires of the private sector in so far as it is a collector and user of information. Moreover, CMA is of the view that government’s practices relating to the collection, storage, merging, transfer and use of health information must be subject to more stringent rules than those found in either the Privacy Act or Bill C-54. The Advisory Council Report also calls for the same rules to apply to the public and private sectors, rules that are more stringent than those found in the Privacy Act or Bill C-54. Therefore, CMA recommends: That, at least in connection with health information, the provisions of the Bill apply equally to the public and the private sectors. III. Considerations Regarding Patient Privacy and Confidentiality: Medical Context Versus Commercial Context A. CMA’s Opinion Over the last year, CMA has become increasingly concerned that debate on the issues concerning health information have been framed in terms of access to information with an attendant erosion of privacy and confidentiality. This one-sided approach comes at a time of expansion in our capacity to collect, store, merge, transfer and access information, coupled with trends both in the health care sector and generally related to the use of information To address these concerns and to ensure that privacy and confidentiality in the medical context are valued, protected and preserved, CMA developed and adopted a Health Information Privacy Code, which is appended to and forms part of this brief. In commenting on this Code the Advisory Council Report notes: The code represents an important contribution to the deliberations of Canadians and legislators on how to safeguard privacy across the health domain. There are a number of principles underpinning the Health Information Privacy Code: 1. The provision of health care to all Canadians irrespective of social circumstances or health status is a highly regarded value in Canadian society. The system is publicly funded and universally accessible. 2. The right of privacy is fundamental to a free and democratic society. 3. Rules relating to health information must recognize its special nature. Health information has a high level of sensitivity, it is confided or collected in circumstances of vulnerability and trust for the primary purpose of benefiting the patient. 4. Physicians now and historically promise that they will keep their patients’ information secret; this is a hallmark of the profession. 5. The patient-physician relationship is one of trust and a central feature of this trust is the belief in patients that information confided in or collected by physicians and other health care providers will be kept secret. 6. Patients believe that the information they disclose or that is gathered as a result of their seeking health care will be used to provide them with health care; uses beyond the provision of health care without knowledge or consent go beyond what a patient’s reasonable expectations were when information was disclosed or gathered and is a breach of the trust patients place in their physicians. 7. Except in very limited circumstances, consent is required for health information collection, use, disclosure or access for any purpose. 8. Information required to provide patients with the health care sought should be readily available to those who require it to provide an aspect of care. 9. Uses of health information for purposes other than the provision of health care to the person seeking care should be subject to rules that: - protect and promote privacy and confidentiality; - generally require express consent; - can be justified according to specific criteria. 10. Patients should know the uses to which their health information is put prior to their disclosure of it. 11. Patients may be reluctant to disclose information if they are concerned about the uses to which the information is put or the persons entitled to access it. B. Public Opinion To determine the public’s view on these issues, CMA commissioned Angus Reid to conduct research in two forms, quantative (survey) and qualitative (focus groups), and has found the following: 1. Patients believe that their health information will be kept confidential and consider this to be important. 2. Patients believe it important to know and control how their health information is shared with others. 3. Patients do not want their health information released to third parties (including governments and researchers) without their knowledge and consent. 4. Patients may have concerns about the release of delinked or anonymous information to third parties without their consent. 5. Patients may be reluctant to confide information as a result of concerns related to its use or disclosure. These findings are consistent with general findings relating to the public’s concerns about privacy and confidentiality. C. The Advisory Council Report The Advisory Council Report relates to the electronic health record. However, given the direction towards the greater use of technology and the underlying principles informing the Advisory Council, CMA believes that the recommendations are generalizable to all health information. A key principle of the Advisory Council is that access by health care professionals should be based on a need-to-know basis under the strict control of the patient. The Council, like CMA calls for scrutiny and justification of secondary uses of health information. The Council is opposed to the use of multipurpose identifiers on the grounds that it becomes too easy for government officials from one department to gain access to a person’s health record or combine a number of records to assemble a comprehensive profile. (Anecdotal evidence suggests that this concern may be justified and that there are insufficient safeguards preventing the flow of health information among government departments) The Council recommends that all governments ensure that they have legislation to address privacy protection specifically aimed at protecting personal health information through explicit and transparent mechanisms. Included in these mechanisms are: * The provision of a precise definition of free and informed consent, as well as a statement of principle that informed consent should be the basis for sharing personal health information; * Any exemption to the requirement of informed consent should be clearly set out in law. More specifically, legislative guidance should be provided on how to balance the right of privacy with the public good for research purposes to implement a coherent and harmonized pan-Canadian system for independent, ethical review. * There should be provisions regulating secondary uses of non-identifiable health information. These provisions should address privacy concern surrounding the degree to which data might be linked back to an identifiable individual. * Legislation should set clear limits on access to and use of health information by third parties outside the health care system. To prevent the serious invasions of privacy that can result from the unrestricted linking of personal health information with other kinds of information on the same individual, the legislation should contain provisions prohibiting the use for any other purpose of unique personal identifiers in health information systems. D. The Approach in Bill C-54 Bill C-54 is inadequate in its protection of health information. The Bill makes a meagre attempt at distinguishing among varying types of personal information and gives no additional protection to information that is highly sensitive (such as health information). The Bill permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purposes. In the context of health information, these grounds should be subject to intense scrutiny to determine their relevance and legitimacy. In CMA’s view and according to the tests established in the CMA’s Code, some of these grounds would not withstand such scrutiny. E. Conclusion CMA’s Code offers a template for the protection that should be accorded health information, a template that appears to have some public support and that strives to retain patient confidence in their physicians and the health care system. The Report of the Federal Advisory Council also recognizes that special rules are required for health information. The Council’s Report places strong emphasis on the protection of privacy, recognizes that as a general rule the flow of health information should be on a need-to-know basis and under the control of the patient through the exercise of free and informed consent and requires limits on the secondary use of health information. In CMA’s view, Bill C-54 should incorporate specific rules relating to health information and CMA’s Code should form the basis of these rules. CMA recommends: That Bill C-54 be amended to incorporate specific provisions relating to health information and that the provisions of the CMA Code provide the basis of such provisions. In addition, CMA’s Code provides a test that legislation addressing health information should be subjected to. This test (found in section 3.6 of the CMA Code) states: Any proposed or existing legislation or regulation made under legislative authority that permits or requires health information collection, use, disclosure or access shall be subjected to the following legislative test: (a) There must be demonstration that: (i) a patient privacy impact assessment has been conducted, the analysis has been made public and has been duly considered prior to the introduction of legislation [section 3.5 of the Code provides guidance with respect to the patient privacy impact assessment]; (ii) collection, use, disclosure and access will be limited to the greatest degree possible to ensure that * the collection of health information by persons external to the therapeutic context will neither trade on nor compromise the trust of the patient-physician relationship; * patients are not likely to be inhibited from confiding information for primary purposes; * the ability of physicians to discharge their fiduciary duties to patients will not be compromised; and, * patient vulnerability will not be exploited; (iii) collection, use, disclosure and access will be restricted to what is necessary for the identified purpose(s) and will not impede the confiding or collection of information for primary purposes; (iv) provisions exist for ensuring that patients are provided with knowledge about the purpose(s) and that, subject to 3.6(b), patient consent is clearly voluntary; (v) the means used are proportionate and the collection will be limited to purposes consented to or made known to the patient; (vi) the patient’s privacy will be intruded upon to the most limited degree possible in light of the purpose(s) consented to or made known to the patient; (vii) linkage of the health information will be limited; and (viii) unless clear and compelling reasons exist: * all reasonable steps will be taken to make health information anonymous; and * if it has been demonstrated that making health information anonymous would render it inadequate for legitimate uses, the information will be collected and stored in a deidentified-relinkable format. (b) When nonconsensual collection, use, disclosure or access is permitted or required by legislation or regulation that meets the requirements of the Code, the following conditions must also be met: (i) the right of privacy has to be violated because the purpose(s) could not be met adequately if patient consent is required; and (ii) the importance of the purpose(s) must be demonstrated to justify the infringement of the patient’s right of privacy in a free and democratic society. (c) Any legislative provision or regulation that permits or requires health information collection, use, disclosure or access nonconsensually shall not, without compelling reasons, be applied retroactively to existing health information. In its current form, Bill C-54 would not pass the scrutiny of the test. Consequently, CMA recommends: That the proposed rules for health legislation be subject to the legislative test found in CMA’s Code and formulated in light of this process. IV. Specific Comments on Bill C-54 From the Perspective of CMA’s Health Information Privacy Code This section highlights some key distinctions between the approach taken by Bill C-54 and CMA’s Health Information Privacy Code. The purpose of this section is to illustrate through examples the divergence of approaches taken with the ultimate aim of demonstrating that Bill C-54 is inadequate in the protection it accords health information. A. General Bill C-54 and CMA’s Health Information Privacy Code are based on the Canadian Standards Association’s Model Code for the Protection of Personal Information (CSA Code). Bill C-54 and the CMA Code also augment the CSA Code’s provisions where considered necessary. The need to extend the provisions of the CSA Code demonstrates that the CSA Code, being general in nature, provides inadequate protection to information in many instances. Although Bill C-54 and the CMA Code are based on the CSA Code, each takes a different approach to the ultimate protection accorded information. This divergence demonstrates that there are many ways to resolve issues left unresolved by the CSA Code. In other words, it is not a foregone conclusion that basing provisions on the CSA Code will result in appropriate or adequate protection of information. Rather, resolution of issues requires thought and deliberation and will depend in some measure on the primacy given to certain values. Bill C-54 appears to have given access primacy in the pursuit of commerce, whereas CMA gives privacy protection primacy in the pursuit of the provision of health care in accordance with physicians fiduciary obligations to patients and the integrity of the patient-physical relationship. CMA did not develop its approach in a vacuum. It reviewed and was inspired by the report of the House of Commons Standing Committee on Human Rights and the Status of Persons with Disabilities, entitled Privacy: Where Do We Draw the Line? This report articulates and makes explicit many of the issues that should be informing the current debate on Bill C-54. In addition, the Report of the Advisory Council takes a very different approach to Bill C-54. The Report recognizes the need to pay more than lip service to protecting privacy and confidentiality and recommends specific measures aimed at doing this. B. Information Protected Bill C-54 The Bill covers “personal information” which is defined to mean “information about an identifiable individual that is recorded in any form.” This definition raises a host of questions: 1. Does the Bill cover or not information that has been delinked to an identifiable individual but that could be relinked to identify them? 2. Does the Bill only exclude anonymous information - that is, information that could never be relinked to an indentifiable individual? And if so, is there an unjustified assumption that information can, in all cases, be rendered truly anonymous? 3. In the case of delinked and anonymous information, who decides that information about an identifiable individual can be rendered delinked or anonymous? The holder of the information or the person to whom the information pertains? 4. Is it accurate or reasonable to assume that people have no interest in information emanating from them once it has been rendered delinked or anonymous? CMA Health Information Privacy Code The CMA Code provides a broad definition of health information: Health information means any information about a patient that is confided or collected in the therapeutic context, including information created or generated from this information and information that is not directly or indirectly linked to the provision of health care. It includes all information formats. In addition, the CMA Code covers identifiable information, delinked information, anonymous information and any composite form that is produced when health information is linked to other information about the patient. CMA’s research indicates that patients may have an interest in their information when it is in delinked and anonymous formats. Advisory Council Report The Advisory Council Report addresses this issue in a number of ways. In making recommendations concerning the definition of health information the Report calls for legislation that embodies: a clear definition of health information, broad enough to incorporate health information collected in public and private systems and to ensure that equal obligations and penalties apply to both public and private sectors. The report recognizes a spectrum of data formats: completely anonymous, linked to pseudo-identities, code linked and reidentifiable, completely identifiable. In terms of sensitivity, the Report notes that information that can be re-identified is somewhat more sensitive that completely anonymous data or anonymous data linked to pseudo-identities and that completely identifiable health information is the most sensitive type of health information. The Report also notes that there can be some degree of risk of re-identification of what was believed to be anonymous data through such processes as data matching and the results of analysis using small cells. In this light, the Report recommends: A definition of personal health information, which takes into account the spectrum of potential identifiability in the case of health information. Furthermore, in the case of secondary uses of health information, the Report notes that provisions regulating secondary uses of non-identifiable health information must form part of the legislation. Such provisions should address privacy concerns surrounding the degree to which data might be linked back to an identifiable individual. The Report raises further issues relating to the use of delinked and anonymous data. The Report notes that there may be group interests and concerns regarding data collected and states: Privacy can also be a concern for groups such as Aboriginal and immigrant communities. These communities worry that research on their members could be released to the media without notice and used in a negative way. This emerging issue is growing in importance and, in the Council’s view, should be a serious consideration in the context of ethical reviews of proposed research projects. It is important to note that in these instances it is not the fact that data is linked to an identifiable individual that is of concern. Rather, it is the ability to accumulate, process and dissect information that has ramifications for an individual because they are part of a group segregated and identified by the research. Finally, the Report considers the use of person-based data but not people’s names, for statistical purposes and notes that this too raises concerns about privacy. The Report notes that: “These concerns have traditionally been seen as a tradeoff against data access for research and analysis in the public interest.” The Report restates this to provide a more positive view of privacy and states: “the best way for analysts to maintain the public’s consent to use sensitive (but anonymous) health data is to show the public that privacy, confidentiality and security are being taken seriously.” Recommendation That there be a clear definition of the information being accorded a right of privacy and that this definition, at least in the case of health information, include identifiable information, delinked information, anonymous information and any composite form produced when information is linked to any information about a person from any other source. C. Knowledge of Purpose Prior to Collection Bill C-54 Bill C-54 is ambiguous in its provisions relating to whether or not a person should know the purposes for which information will be used prior to disclosure. This is due in part to the use of the term “knowledge and consent” as one concept rather than distinguishing the knowledge requirement from the consent requirement. What a person should know in relation to the purposes information might be used or disclosed for, prior to its being given is distinct conceptually from whether the person must consent before information can be used or disclosed for a particular purpose. Schedule 1 of the Bill contains a number of principles. For the purposes of this brief the schedule will be referred to in terms of the principles (and their subparagraphs). Principle 2 addresses the identification of purposes that information will be used or disclosed for. Provided a purpose is identified it becomes a legitimate purpose under the Bill. Subparagraph 3 states that the identified purposes should be specified at or before the time of collection. Section 5(2) of the Bill states that the use of ‘should’ in schedule 1 indicates a recommendation and does not impose an obligation. Therefore, according to subparagraph 3, it is recommended but is not obligatory that disclosure occur. On the other hand, principle 3 addresses consent and appears to impose an obligation by stating that the knowledge and consent of the individual are required for the collection, use, or disclosure of personal information, except where inappropriate. Similarly subparagraph 2 appears to create something of an obligation by stating, “organizations shall make a reasonable effort to ensure that the individual is advised of the purposes for which the information will be used.” The relationship between these sections should be clarified and made consistent. CMA is pleased to note that principle 3 has been modified to define when, and only when, organizations may collect information without knowledge or consent. Section 7(1)(a) permits the collection of information without knowledge and consent when collection is clearly in the interests of the individual and consent cannot be obtained. The intent of this section could be made clearer, particularly in terms of who determines the “interests of the individual.” Otherwise this exception could give undesirable license to collect without knowledge or consent. The provision in section 7(1)(b) is more problematic. This section appears to favour withholding knowledge from an individual if such knowledge would compromise accuracy, defeat the purpose for collection or prejudice the use. In some instances it may well be that if an individual is provided with knowledge of the purposes for which information is collected and the uses to which it will be put, they may choose to withhold information rather than disclose it, and in doing so would clearly compromise accuracy, defeat the purpose for collection or prejudice the use the information will be put to. This is contrary to the principle found in principle 4.1 which recognizes that information should not be collected by misleading or deceiving individuals. The intent of this section should be far clearer and circumscribed in such a way as to make it clear that it is not permissible to withhold knowledge or not seek consent simply on the basis that if a person had knowledge they would not wish to disclose information. Section 7(1)(c) allows collection without knowledge or consent for journalistic, artistic or literary purposes. This provision is totally inappropriate in the case of health information. CMA Health Information Privacy Code The CMA Code is considerably more restrictive that Bill C-54. It recognizes that in the therapeutic context, health information is confided by or collected from patients under the patient presumption that it is necessary to meet his or her therapeutic needs. CMA also believes that the potential that health information may be subsequently collected, used, disclosed or accessed for other purposes without patient consent should be made known to patients before information is confided or collected for the primary therapeutic purpose. CMA further notes that it is not acceptable to withhold knowledge from patients deliberately out of concern that knowledge could inhibit them from confiding important information fully and truthfully. CMA limits the circumstances the nonconsensual collection of health information to those: 1. Permitted or required by legislation; 2. When ordered or decided by a court of law. Moreover, the CMA gives explicit direction to legislators with respect to the conditions under which legislation should permit or require health information collection (see section 3.6 of CMA Code). In the case of nonconsensual collection, the following conditions are stipulated: 1. The right of privacy has to be violated because the purposes could not be met adequately if patient consent is required; and 2. The importance of the purposes must be demonstrated to justify the infringement of the patient’s right of privacy in a free and democratic society. While Bill C-54 is clearly enabling the collection of information, it does not, in CMA’s opinion put sufficient emphasis on or provide protections that preserve privacy and confidentiality, especially in the medical context. D. Use Without Knowledge Or Consent Bill C-54 Once information has been collected and despite the, albeit inadequate, limits placed on collection without knowledge or consent, it can be put to even greater use than the purposes it has been collected for with or without knowledge or consent. Section 7(2) opens up dramatically the uses to which collected information may be put without either knowledge or consent. At a minimum and without little additional administrative effort, the enumerated grounds of section 7(2) (and 7(3))should be made known to an individual prior to their disclosure of information, which would be in keeping with the principle of openness and explicitness. Section 7(2)(a) allows use in connection with the investigation of an offence. In the medical context this might be problematic particularly if it is interpreted to impose an obligation. Generally, there is no obligation to assist in the investigation of an offence and indeed the fiduciary duty between patient and physician and the duty of confidentiality owed to the patient by the physician would suggest that physicians not offer information despite its usefulness. Section 7(2)(b) recognizes emergency situations. However, as worded, section 7(2)(b) would allow access to anyone’s information if it is for the purpose of acting in respect of an emergency threatening the life, health or security of an individual. The implications of this section should be carefully thought through. Do we really intend to give such a broad licence to access anyone’s information on the basis of an emergency. In CMA’s view there should be some limiting principle that takes into account the prevailing view that people generally are not required to go to the assistance of others (emergency or otherwise) and that information about oneself is considered worthy of protection against use or disclosure despite its potential benefit to others for example, genetic information or HIV, Hepatitis C status. Section 7(2)(c) is very problematic as it permits the use of “identifiable” information for a host of purposes, including statistical and research, when it is impractical to seek consent. Even though the Commissioner must be informed of the use before the information is used the Commissioner has no power to approve or reject the use, and since the use is legitimate under the Bill provided the Commissioner has been notified there would be no grounds open to the Commissioner to cause an audit to occur. This section gives significant scope to use information that has been collected without knowledge or consent and certainly in the case of health information is problematic. CMA Health Information Privacy Code The CMA Code makes a clear distinction between the primary purpose for the collection and use of health information and secondary purposes for its use. The key distinction between these two categories is that primary purposes relates to the provision of the health care benefit sought whereas secondary purposes are ends or aims that are not directly related to the provision of care. The CMA Code divides secondary purposes into two categories: 1. Secondary legislated purposes, those purposes that have been subjected to the legislative test specified in the Code and have subsequently been written into law; 2. Secondary nonlegislated purposes are any other purposes, such as education or research not governed by legislation, that meet the provisions of the CMA Code and the secondary nonlegislative test provided by the Code. The tests that CMA requires both to go through relate to: 1. Impact on privacy. 2. Impact on the patient-physician relationship, especially confidentiality and trust. 3. Impact on the willingness of patients to disclose information. 4. Impact on patients’ ability to receive care. 5. Evidence of broad public support for the measure. 6. The use will not exploit or compromise the trust of the patient-physician relationship. 7. Patient vulnerability will not be exploited. 8. Under most circumstances patients will be fully informed of the purpose and patient consent will be clearly voluntary. 9. Patient privacy will be intruded upon to the most limited degree possible. 10. Linkage of health information will be restricted and consented to by patients. In other words, CMA is not satisfied that any and all secondary purposes for the use of health information should be permitted. Rather, CMA seeks justification for the secondary use and assurance that the secondary use will neither impede nor undermine the patient-physician relationship and the provision of health care to the patient. Moreover, the CMA Code only permits use without consent if it is permitted or required by legislation or when ordered or decided by a court of law. The Advisory Council Report Like CMA, the Advisory Council Report makes distinctions among various types of uses. The report calls for legislation to clearly prohibit all secondary commercial use of personal health information. In addition, the Report recommends that there be provisions regulating secondary uses of non-identifiable health information and that such provisions should address privacy concerns surrounding the degree to which such data might be linked back to an identifiable individual. In this context, the Report recommends that legislation set clear limits on access to and use of health information by third parties outside the health care system. In addition the Report reviews the uses of health information for statistical and research purposes. The Report’s findings with respect to statistical use have already been discussed. In connection with research, the Report calls for a number of safeguards and restrictions: 1. Where the data sets used have a higher level of potential identifiability, “the general rule should be informed consent and stringent assurances about privacy protection and security arrangements are necessary before a researcher can have access to personally identifiable information.” 2. The Report recognizes that in some instances it may be impractical to obtain consent from patients. Whether in anonymous or identifiable form the Report requires that notice be given about the use of the information in either form. In the case of the use of identifiable information, the Report states that the research should be subject to independent ethics review with the onus on the person seeking to use the information without consent to demonstrate that: (a) a tangible public good of significant benefit will result; (b) consent is impossible to secure at a reasonable cost; (c) less identifiable data will not serve the same purpose; and (d) no harm can occur to any person directly or indirectly [note the above discussion on group privacy] as a result of this use of his or her personal information. E. Disclosure Without Knowledge Or Consent Bill C-54 The comments found under C. and D. above apply equally here. Section 7(3) adds further instances when collected information can be disclosed to others without knowledge or consent. CMA Code In the case of health information CMA takes a far more restrictive approach. In the case of use, disclosure or access the CMA Code states: The potential that health information, in whole or in part, may be subsequently collected, used, disclosed or accessed for other purposes without their consent, and what those purposes might be, must be made know to the patient by reasonable means before it is confided or collected for primary purposes. Moreover, the CMA Code recognizes that information disclosed by one organization is collected by another. The Code defines collection to mean: the act of accessing, receiving, compiling, gathering, acquiring or obtaining health information from any source, including third parties, and by any means. It includes information collected from the patient, as well as secondary collection of this information in whole or in part by another provider or user. The collecting organization should be bound by the provisions of the CMA Code, which generally requires consent for use for any purpose and always requires knowledge of the potential purposes that information will or must be put to prior to the information being disclosed. CMA’s Code states: Health information custodians must ensure that third parties privy to health information have adopted this Code or are bound by equivalent provisions. Finally, the CMA Code explicitly recognizes that information can be retrieved from a variety of sources to formulate records. Any and all such practices and the composite form developed are given the same degree of protection as that accorded the original data collected by or through the patient. F. Information Flow Within Organizations Bill C-54 Bill C-54 defines use to include, “the transfer of personal information within an organization.” Therefore, to the extent that Bill C-54 restricts the free flow of information it restricts in within an organization. In the health care context this is not a reasonable or desirable outcome. CMA Code The CMA Code recognizes that the free flow of health information is desirable to the extent that it furthers the provision of the health care benefit sought and that it occurs with patient consent. The CMA Code defines the primary purpose to mean: (i) Primary therapeutic purpose is the initial reason for a patient seeking or receiving care in the therapeutic context, and pertains to the delivery of health care to a particular patient with respect to the presenting health need or problem. It encompasses consultation with and referral to other providers on a need-to-know basis. (ii) Primary longitudinal purpose concerns developing composite health information about a particular patient, such as a detailed medical history, beyond direct application to the presenting health need or problem, in order to enhance ongoing care to that person. The Code goes on to state that: Health information collection, use, disclosure or access for the primary therapeutic and longitudinal purposes may be as extensive as necessary to fulfil these purposes and reflect the high level of trustworthiness and accountability of health professionals in the therapeutic context. And further states that: Security safeguards shall impede as little as possible health information collection, use, access and disclosure for primary purposes. Finally, in addressing consent the Code states: Consent to health information collection, use, disclosure and access for the primary therapeutic purpose may be inferred. Consent to subsequent collection, use, disclosure and access on a need-to-know basis by or to other physicians or health providers for this purpose, and for this purpose alone, may be inferred, as long as there is no evidence that the patient would not give express consent to share the information. G. Individual Access Bill C-54 Bill C-54 restricts the right of individual access to personal information. The grounds for denying access to information are inappropriate in the health care context. CMA Code The CMA Code follows the prevailing case law as it relates to medical records. Primarily this gives the patients a right of access to their record in all but very limited circumstances. These circumstances are, if there is a significant likelihood of a substantial adverse effect on the physical, mental or emotional health of the patient or substantial harm to a third party. The onus lies on the provider to justify denial of access. H. Accuracy and Amendment Bill C-54 Bill C-54 requires that information be as accurate, complete and up-to-date as possible and that it shall not be routinely updated unless this is necessary to fulfil the purpose for its collection. In so far as amendment is concerned, Bill C-54 permits amendment to the record in specified circumstances. CMA Code The CMA Code takes a different approach in light of the nature and purpose of health information. The Code recognizes that the “recording of statements of fact, clinical judgements and determinations or assessments should reflect as nearly as possible what has been confided by the patient and what has been ascertained, hypothesized or determined to be true using professional judgement.” In terms of amending the record in light of a patient’s request, the CMA Code seeks to preserve the original record but also note the patient’s concerns. To accommodate both requirements the CMA Code states: Patients who have reviewed their information and believe it to be inaccurately recorded or false have the right to suggest amendments and to have their amendments appended to the health information. I. Sensitivity Bill C-54 In a number of instances Bill C-54 and in particular schedule 1 recognize that medical records have a high level of sensitivity attached. Which in turns warrants special attention concerning consent, reasonable expectations, individual access and implicity, the degree of security that is appropriate. CMA Code The CMA Code seeks to recognize that while all health information is sensitive (when considered against other forms of information about individuals) there are also variations in the level of sensitivity in various aspects of the health record. The CMA Code defines the “sensitivity of health information” to refer to: the patient’s interest in keeping the information secret. It varies according to the nature of the information, its form, and the potential negative repercussions of its collection, use or disclosure on the patient’s interests. Under the Code’s consent provisions it is stated that: Although all health information is sensitive and should be treated as such, the more sensitive the health information is likely to be, given what is known about the circumstances or preferences of the patient, the more important it is to ensure that consent is voluntary and informed. With respect to security the Code states: The development of security safeguards with respect to levels of access for various users shall recognize the differences in the sensitivity of health information and permit access accordingly. V. Conclusions The increased capacity to collect, store, transfer, merge and access information coupled with trends that support increased use of and access to information have the potential to erode our traditional understanding and protection of privacy and confidentiality. The issues are complex and the choices we must make are difficult. Nevertheless, these issues should be squarely on the table and the choices that we make must be clear, transparent and defensible. Of paramount importance is that the public is not mislead into believing that their information is being protected or kept confidential when in fact it is not. Therefore, even to refer to Bill C-54 as the “Personal Information Protection and Electronic Documents Act” should be the subject of debate. Is the Bill truly about information protection or is it actually about permitting access to information? Bill C-54 presents one approach, an approach that values commerce and access. In CMA’s view the approach is totally inadequate when applied to health information. CMA also believes that the public would also find Bill C-54 inadequate. CMA presents a different approach, an approach that values privacy and the preservation of the trust and integrity of the patient-physician relationship. CMA believes that its approach would receive broad public support. Moreover, CMA believes that to the extent the CMA Code presents tests rather than conclusions, these tests should be administered in good faith prior to legislative initiatives related to health information or in the case of secondary usage of health information in general. CMA believes that its approach draws support from the Federal Advisory Council Report, which also recognizes the importance of preserving patient privacy and the confidentiality of the health record in an era of increased use of technology. Implicitly, the Report recognizes that the benefits of such technology cannot be realized if public support, based on assurance of privacy protection, cannot be secured. CMA urges this committee to implement CMA’s recommendations and in doing so provide the type of protection that health information deserves and that Canadians desire. VI. Summary of Recommendations That Bill C-54 be amended to incorporate specific provisions relating to health information and that the provisions of the CMA Code provide the basis of such provisions; and That the proposed rules for health legislation be subject to the legislative test found in CMA’s Code and formulated in light of this process; and That there be a clear definition of the information being accorded a right of privacy and that this definition, at least in the case of health information, include identifiable information, delinked information, anonymous information and any composite form produced when information is linked to any information about a person from any other source; and That, at least in connection with health information, the provisions of the Bill apply equally to the public and the private sectors.
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Mental Health, Mental Illness & Addiction : CMA Submission to the Standing Committee on Social affairs, Science and Technology

https://policybase.cma.ca/en/permalink/policy1950
Last Reviewed
2012-03-03
Date
2005-04-20
Topics
Population health/ health equity/ public health
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2012-03-03
Date
2005-04-20
Topics
Population health/ health equity/ public health
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Social Affairs, Science and Technology’s study of mental health, mental illness and addiction in Canada. The Committee is to be commended for their commitment to the examination of the state of mental health services and addiction treatment in Canada. The Interim Report Mental Health, Mental Illness and Addiction: Overview of Policies and Programs in Canada is a most comprehensive and thorough study. It highlights and reinforces the myriad of players, programs and services as well as the scope and breadth of concerns related to mental health/mental illness care. The Issues and Options paper cogently outlines all the major issues facing mental health, mental illness and addiction care today and provides a platform to stimulate an important public debate on the direction that should be taken to address mental health reform in Canada. The CMA was pleased to appear before the Committee during its deliberations in March of 2004 to speak to the issues facing mental health and mental illness care and put forward recommendations for action by the federal government. The CMA recommended: * developing legislative or regulatory amendments to ensure that psychiatric hospitals are subject to the five program criteria and the conditions of the Canada Health Act, * adjusting the Canada Health Transfer to provide net new federal cash for these additional insured services, * re-establishing an adequately resourced federal unit focussed on mental health, mental illness and addiction, * reviewing federal policies and programs to ensure that mental illness is on par, in terms of benefits, with other chronic diseases and disabilities, * mounting a national public awareness strategy to address the stigma associated with mental illness and addiction. The physicians of Canada continue to support these recommendations. While the Committee has asked for input on a number of important issues in its Issues and Options paper, CMA will focus on the role of the federal government in three areas: * national leadership and intergovernmental collaboration, * accessibility, * accountability. We understand that the Canadian Psychiatric Association, the College of Family Physicians of Canada and the Canadian Paediatric Society will, in their submissions to the Standing Committee, address specific issues of concern to the medical profession in the areas of primary care, child and adolescent mental health and mental illness services, and psychiatric care. The CMA supports the positions of these national specialty organizations. THE ROLE OF THE FEDERAL GOVERNMENT The economic burden of mental health problems is estimated, at a minimum, at $14.4 billion annually. 1 Mental illness and addiction affects one in five Canadians during their lifetime. According to a 2003 Canadian Community Health Survey, 2.6 million Canadians over the age of 15 reported symptoms consistent with mental illness during the past year. Mental illness impacts people in the prime of their life. Estimates from 1998 indicates that 24% of all deaths among those aged 15-24 and 16% of all deaths among those aged 25- 44 are from suicide 2. In contrast, the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS) that tragically, resulted in 483 cases and 44 deaths with an estimated economic impact in the Greater Toronto Area of 2 billion dollars served as the ‘wake-up call’ that galvanized the federal government into paying attention to public health in Canada. In the aftermath of SARS, the federal government appointed a Minister of State for Public Health, established the Public Health Agency of Canada and selected a Chief Public Health Officer for Canada. Nine hundred and sixty five million dollars has been invested by the federal government in public health in the two federal budgets following SARS and a new spirit of federal-provincial-territorial cooperation on public health issues has been spawned. The evidence of the enormous burden that mental illness and addiction places on Canadian society has been a clarion call to many concerned stakeholder organizations across the country to mobilize and search for solutions. It is astounding that the federal government has not heard the call. And it is hard to imagine just what more could constitute a ‘wake-up call’ for mental health care. In fact the federal government falls woefully short of fulfilling its responsibilities to the people of Canada. The Interim report of the Committee correctly outlines the state of fragmentation and gaps in services to those specific populations under direct federal jurisdiction. It also notes the ‘apparent ambivalence’ over the years by the federal government about the place of mental health services within publicly funded health care. This ambivalent approach also spills over to the broad national policies and programs of the federal government that can impact those suffering from mental illness, addiction or poor mental health. The federal government has systematically excluded mental health services since the earliest days of Medicare. Mental illness has been treated like a second class disease with little dedicated federal funding, and with programs and services not subject to national criteria or conditions as are set out in the Canada Health Act. In fact, the federal government could be seen as moving in reverse with the downgrading of mental health resources within Health Canada through the 1980s and 1990s. Leadership The CMA firmly believes that strong federal leadership is required to address the sometimes invisible epidemic of mental health problems and addiction in Canada.The government must lead by example and begin by ‘cleaning up its own backyard’ in terms of its direct role as service provider to those Canadians under its jurisdiction. It should take a ‘whole of government’ approach that recognizes the interplay of health services, education, housing, income, community and the justice system on mental health and mental illness care. Further, the federal government has a responsibility to ensure that there is equitable access to necessary services and supports across the county. This will require a strong degree of cooperation and collaboration among provinces and territories and the federal government. The federal, provincial and territorial governments must come together to develop a national action plan on mental health, mental illness and addiction modeled on the framework developed by the Canadian Alliance on Mental Illness and Mental Health in 2000. The CMA has noted the options put forward to elevate mental health, mental illness and addiction in government priorities: A Canada Mental Health Act or a Minister of State for mental health, mental illness and addiction. We continue to believe that an adequately resourced, dedicated federal centre focussed on mental health, mental illness and addiction must be established within Health Canada. This will ensure that mental health, mental illness and addiction are not seen as separate from the health care system but an integral component of acute care, chronic care and public health services. A centre with dedicated funding and leadership at the Associate Deputy Minister level is required to signal the intent of the government to seriously address mental health, mental illness and addiction in terms of both its direct and indirect roles. This centre must also have the authority to coordinate across all federal departments and lead F/P/T collaborations on mental health, mental illness and addiction. The responsibility of the provinces and territories for the delivery of services for mental illness and addiction within their jurisdictions is unquestioned. But, as CMA has noted in relation to the acute care and public health systems, we have a concern with the disparity of these services across the country. We believe that the federal government must take a lead role, working with the provinces and territories, in establishing mental health goals, standards for service delivery, disseminating best practices, coordinating surveillance and research, undertaking human resource planning and reducing stigma. It is unfortunate that the Council of Deputy Ministers of Health withdrew its support of the F/P/T Advisory Network on Mental Health in 1990. The lack of a credible and resourced F/P/T forum for information sharing, planning and policy formation has impeded inter-provincial cooperation and collaboration for over a decade. F/P/T collaboration is essential to ensure adequacy of services in all parts of the country and end the piecemeal approach to mental illness and addiction. It would also encourage pan Canadian research and knowledge transfer. The CMA therefore recommends: 1. That the federal government create and adequately resource a Centre for Mental Health within Health Canada led by an Associate Deputy Minister with a mandate to initiate and coordinate activity across all federal departments to address the federal government’s responsibilities to specific populations under its direct jurisdiction, to oversee national policies and programs that impact on mental health, mental illness and addiction and to support intergovernmental collaboration. 2. That the federal government re-establish and adequately resource the F/P/T Advisory Network on Mental Health with a broader mandate to encompass mental health, mental illness and addiction. 3. That the federal government work with the provinces, territories and the Canadian Alliance on Mental Illness and Mental Health to establish a Pan Canadian Mental Health, Mental Illness and Addiction Network to develop a national mental health strategy, mental health goals and action plan; and serve as a forum for inter-provincial cooperation and collaboration on mental health, mental illness and addiction. Accessibility Accessibility leads the way as the number one concern regarding the health care system for patients and their families. This concern is in no way lessened when we look at access to mental health and addiction services and programs. The CMA has long identified accessibility as an essential issue that must be addressed to improve the health care system. In recent years, public concern over timely access has been growing. Recent polling for the CMA has shown that a significant majority of Canadians have suffered increased pain and anxiety while waiting for health care services. 3 The same polling clearly demonstrated that the vast majority of Canadians attributed long waits for health care services to a lack of available health providers and infrastructure. More recently, another opinion poll found that Canadians gave the health care system an overall grade of “C” in terms of their confidence that the system will provide the same level and quality of service to future generations. 4 The 2003 Hospital Waiting Lists in Canada report released by the Fraser Institute included a psychiatry waiting list survey which revealed that wait times from referral by a GP ranges from a Canadian average of 8.5 weeks to 20 weeks in New Brunswick. Patients then face a further delay as they wait for appropriate treatment after they have been seen by the specialist. This wait can be anywhere from 4 weeks to 19 weeks depending on the treatment or program. 5 The 2004 National Physician Survey, a collaboration between the CMA, the Royal College of Physicians and Surgeons of Canada, and the College of Family Physicians of Canada, found that 65.6% of physicians rated accessibility to psychiatrists as fair or poor. 6 These statistics do not reflect those patients that do not make it on to lengthy waiting lists where access is effectively denied. In September 2004 the CMA released a national plan of action to address issues of accessibility, availability and sustainability across the health system 7 . Better Access Better Health lays out a number of recommendations designed to ensure that access exists at times of need, and to improve system capacity and the sustainability of the system. While Better Access Better Health speaks to the health care system writ large, the provision of mental health services and addiction treatment clearly falls under this umbrella. Specific recommendations detailed in the plan of action for pan-Canadian wait-time benchmarks, a health human resource reinvestment fund, expanding the continuum of care and an increase in federal “core’ funding commitments would all have a positive impact on the accessibility of mental health and addiction services. The review of mental health policies and programs in select countries (Report 2 of the Interim Report) is striking for the similarity of problems facing mental health care. In each of the four countries studied there is concern for the adequacy of resources as well as recognition of the need to coordinate and integrate service delivery. The CMA agrees with the Committee’s commentary that: “The means for achieving these objectives that stands out from our survey of four countries is to set actionable targets that engage the entire mental health community, and to establish measurable criteria for the ongoing monitoring of reform efforts. Comprehensive human resource planning in the mental health field, as well as adequate funding for research and its dissemination are also suggested as key elements of a national strategy to foster mental health and treat mental illness.” CMA strongly supports setting national standards and targets with regard to mental health services and addiction treatment, but it must be understood that standards and targets can not be established until we have a clear and accurate picture of the current situation in Canada. Pan-Canadian research is needed to determine the availability of services across the country. Surveillance of mental illness risk factors, outcomes and services is essential to guide appropriate development and delivery of programs. Research is also needed to determine ways of integrating the delivery of mental health services between institutional and community settings. The Health Transition Fund supported 24 projects between 1997 and 2001 that made a substantial contribution toward a practical knowledge base in mental health policy and practice. The 2000 Primary Health Care Transition Fund is also supporting projects in the mental health field. For those projects that are due to be completed in 2006, they should be encouraged to put in place a prospective evaluation framework to determine the feasibility and scalability of collaborative care initiatives. As noted in Better Access Better Health availability is first and foremost about the people who provide quality care and about the tools and infrastructure they need to provide it. The shortage of family practitioners, specialists, nurses, psychologists and other health care providers within the publicly funded health care system is certainly an impediment to timely access to care. A health human resources strategy for mental health, mental illness and addiction is a first step in finding a solution to the chronic shortage of health professionals. The CMA therefore recommends: 4. That the federal government, through the Institute of Neurosciences, Mental Health and Addiction, undertake a program of surveillance and research to determine actual availability of services for mental health, mental illness and addiction across the country. 5. That the federal government in consultation with provincial and territorial governments, health care providers and patients/clients establish national standards and targets for access to services. 6. That the Institute of Neurosciences, Mental Health and Addiction and the Institute of Health Services and Policy Research within Canadian Institutes of Health Research establish a joint competition for research on ways of integrating the delivery of mental health services between institutions and community settings. 7. That the federal government undertake an evaluation of those Health Transition Fund and Primary Health Care Transition Fund projects in the mental health, mental illness and addiction field to determine the feasibility and scalability of collaborative care initiatives. 8. That the federal government work with the provinces and territories to develop a health human resource strategy for the field of mental health, mental illness and addiction. Accountability In its presentation to the Committee in March of 2004, CMA recommended that the federal government make the legislative and/or regulatory amendments necessary to ensure that psychiatric hospital services are subject to the criteria and conditions of the Canada Health Act. This would accomplish two objectives. It would signal the federal government’s serious intent to address the historical imbalance in the treatment of mental health and illness care while at the same time increase the accountability of these institutions and services to the values espoused in the Canada Health Act. This would be a very positive step, but we must also develop accountability mechanisms that can measure the quality and effectiveness of the mental health services provided. Since 2000, First Ministers and their governments have committed to reporting on numerous comparable indicators on health status, health outcomes and quality of services. In September 2002, all 14 jurisdictions including the federal government, released reports covering some 67 comparable indicators. In November 2004, these governments released their second report covering 18 indicators with a focus on health system performance including primary health care and homecare. Unfortunately, mental illness--despite its magnitude--has received little attention in these reports. Of the now 70 indicators that have been developed, only 2 directly address mental illness (potential years of life lost due to suicide and prevalence of depression). Furthermore, no performance indicators related to mental health outcomes or wait times for mental health services have been included in these reports. This is one more example of the oversight of mental illness related issues and the vicious circle that exists since few indicators makes it difficult to present the case for greater attention. The lack of information on availability of services, wait times and health outcomes for mental health services compromises governments’ ability to establish a funding framework to allocate funding equitably. Research that will reveal gaps in service delivery, and the establishment of targets should allow governments to better calculate sustainable funding levels needed to build capacity in the mental health, mental illness and addiction fields. As important as it is to ensure that mental health and addiction services within the health system are available, accessible and adequately resourced we must not lose sight of the fact that to effectively address mental health, mental illness and addiction issues services from a broad range of government sectors are required. Therefore the proposed Associate Deputy Minister for Mental Health must be accountable to ensure collaboration across sectors within the federal government. As in public health in general, a clarification of the roles and responsibilities of the various levels and sectors of government and health providers involved in the provision of mental health, mental illness and addiction services would allow for greater accountability. The CMA therefore recommends: 9. That performance indicators for mental health services and support, based on the work of the F/P/T Advisory Network on Mental Health, are incorporated in the federal, provincial and territorial reporting of comparable indicators on health status, health outcomes and quality of services called for in the 2003 First Ministers’ Accord on Health Care Renewal. 10. The federal, provincial and territorial governments establish resource targets based on national standards for access to services and minimum wait times to determine and commit to sustainable funding levels. 11. That the Health Council of Canada report on the performance of the mental health, mental illness and addiction system. CONCLUSION The CMA welcomes the spotlight that the Committee has shone on the mental health, mental illness and addiction system in Canada and has been pleased to provide input on behalf of the physicians of Canada. The neglect of those impacted by mental illness and addiction must not be allowed to continue. It is unconscionable that millions of Canadians do not have access to the programs, treatments or supports that would ease their suffering. The federal government must recognize its responsibility towards these Canadians, embrace its leadership role and ensure that the mental health, mental illness and addiction system is placed on an equal footing within the health care system in Canada. Physicians are an integral part of the mental health, mental illness and addiction field. We are eager to work with governments and other concerned stakeholders to bring to fruition a national mental health strategy with mental health goals and an associated action plan that can effectively address the concerns of today and prepare the mental health, mental illness and addiction system for the future. CMA recommendations on Mental Health, Mental Illness and Addiction 1. That the federal government create and adequately resource a Centre for Mental Health within Health Canada led by an Associate Deputy Minister with a mandate to initiate and coordinate activity across all federal departments to address the federal government’s responsibilities to specific populations under its direct jurisdiction, to oversee national policies and programs that impact on mental health, mental illness and addiction, and to support intergovernmental collaboration. 2. That the federal government re-establish and adequately resource the F/P/T Advisory Network on Mental Health with a broader mandate to encompass mental health, mental illness and addiction. 3. That the federal government work with the provinces, territories and the Canadian Alliance on Mental Illness and Mental Health to establish a Pan Canadian Mental Health, Mental Illness and Addiction Network to develop a national mental health strategy, mental health goals and action plan; and serve as a forum for inter-provincial cooperation and collaboration on mental health, mental illness and addiction. 4. That the federal government, through the Institute of Neurosciences, Mental Health and Addiction, undertake a program of surveillance and research to determine actual availability of services for mental health, mental illness and addiction across the country. 5. That the federal government in consultation with provincial and territorial governments, health care providers and patients/clients establish national standards and targets for access to services. 6. That the Institute of Neurosciences, Mental Health and Addiction and the Institute of Health Services and Policy Research within Canadian Institutes of Health Research establish a joint competition for research on ways of integrating the delivery of mental health services between institutions and community settings. 7. That the federal government undertakes an evaluation of those Health Transition Fund and Primary Health Care Transition Fund projects in the mental health, mental illness and addiction field to determine the feasibility and scalability of collaborative care initiatives. 8. That the federal government works with the provinces and territories to develop a health human resource strategy for the field of mental health, mental illness and addiction. 9. That performance indicators for mental health services and support, based on the work of the F/P/T Advisory Network on Mental Health, are incorporated in the federal, provincial and territorial reporting of comparable indicators on health status, health outcomes and quality of services called for in the 2003 First Ministers’ Accord on Health Care Renewal. 10. The federal, provincial and territorial governments establish resource targets based on national standards for access to services and minimum wait times to determine and commit to sustainable funding levels. 11. That the Health Council of Canada report on the performance of the mental health, mental illness and addiction system. 1 Stephens T and Joubert N, The Economic Burden of Mental Health Problems in Canada, Chronic Disease in Canada, 2001:22 (1) 18-23. 2 Health Canada. A Report on Mental Illnesses in Canada. Ottawa, Canada 2002. 3 Health Care Access and Canadians, Ipsos-Reid for the CMA, 2004. 4 2004 National Report Card on the Sustainability of Health Care, Ipsos-Reid for the CMA, 2004. 5 Hospital Waiting Lists in Canada (13th edition), Critical Issues Bulletin, The Fraser Institute, October 2003. 6 National Physician Survey, Canadian Medical Association, Royal College of Physicians and Surgeons of Canada, College of Family Physicians of Canada, 2004, (http://www.cfpc.ca/nps/English/home.asp), accessed April 6, 2005. 7 Better Access Better Health: Accessible, Available and Sustainable Health Care For Patients, CMA September 2004 , attached as Appendix I.
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