Authorizing Cannabis for Medical Purposes
The legalization of cannabis for recreational purposes came into effect with the Cannabis Act in October 2018, and patients continue to have access to cannabis for therapeutic purposes. The Cannabis Regulations have replaced the Access to Cannabis for Medical Purposes Regulations. Patients can obtain cannabis for medical purposes when a physician or nurse practitioner provides a “medical document” , authorizing its use, and determining the daily dried cannabis dose in grams.
With the authorization, patients have the choice whether to (a) buy directly from a federally licensed producer; (b) register with Health Canada to produce a limited amount for personal consumption; (c) designate someone to produce it for them; or (d) buy cannabis at provincial or territorial authorized retail outlets or online sales platforms, if above the legal age limit.
While acknowledging the unique requirements of patients suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief, physicians remain concerned about the serious lack of clinical research, guidance and regulatory oversight for cannabis as a medical treatment. There is insufficient clinical information on safety and efficacy for most therapeutic claims. There is little information around therapeutic and toxic dosages and knowledge on interactions with medications. Besides the need for appropriate research, health practitioners would benefit from unbiased, accredited educational modules and decision support tools based on the best available evidence.
The Canadian Medical Association has consistently expressed concern with the role of gatekeeper that physicians have been asked to take as a result of court decisions. Physicians should not feel obligated to authorize cannabis for medical purposes.
Physicians who choose to authorize cannabis for their patients must comply with their provincial or territorial regulatory College's relevant guideline or policy. They should also be familiar with regulations and guidance, particularly:
Health Canada’s Information for Health Care Practitioners – Medical Use of Cannabis (monograph, summary and daily dose fact sheet),
the Canadian Medical Protective Association’s guidance;
the College of Family Physicians of Canada’s preliminary guidance Authorizing Dried Cannabis for Chronic Pain or Anxiety; and
the Simplified guideline for prescribing medical cannabinoids in primary care, published in the Canadian Family Physician.
The CMA recommends that physicians should:
Ensure that there is no conflict of interest, such as direct or indirect economic interest in a licensed cannabis producer or be involved in dispensing cannabis;
Treat the authorization as an insured service, similar to a prescription, and not charge patients or the licensed producer for this service;
Until such time as there is compelling evidence of its efficacy and safety for specific indications, consider authorizing cannabis only after conventional therapies are proven ineffective in treating patients’ conditions;
Have the necessary clinical knowledge to authorize cannabis for medical purposes;
Only authorize in the context of an established patient-physician relationship;
Assess the patient’s medical history, conduct a physical examination and assess for the risk of addiction and diversion, using available clinical support tools and tests;
Engage in a consent discussion with patients which includes information about the known benefits and adverse health effects of cannabis in its various forms (e.g., edibles), including the risk of impairment to activities such as driving and work;
Advise the patient regarding harm reduction strategies and the prevention of accidental exposure for children and other people;
Document all consent discussions in patients' medical records;
Reassess the patient on a regular basis for its effectiveness to address the medical condition for which cannabis was authorized, as well as for addiction and diversion, to support maintenance, adjustment or discontinuation of treatment; and
Record the authorization of cannabis for medical purposes similar to when prescribing a controlled medication.
The Cannabis Regulations provide some consistency with many established provincial and territorial prescription monitoring programs for controlled substances. Licensed producers of cannabis for medical purposes are required to provide information to provincial and territorial medical licensing bodies upon request, including healthcare practitioner information, daily quantity of dried cannabis supported, period of use, date of document and basic patient information. The Minister of Health can also report physicians to their College should there be reasonable grounds that there has been a contravention of the Narcotic Control Regulations or the Cannabis Regulations.
Approved by CMA Board February 2015
Latest update approved by CMA Board in February 2020
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).
The Canadian Medical Association (CMA) is pleased to provide its response to Health Canada's public consultation on the Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall), in reference to the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which came into force on November 6, 2014.
The CMA supports a robust legislative framework toward an unbiased, evidence-based system for the oversight of pharmaceutical products, which spans both the pre- and post-approval of these products, with the ultimate goal of patient safety. Prescription medication plays a critical role as part of a high-quality, patient-centred and cost-effective health care system. It is a priority to physicians that all Canadians have access to affordable, safe and effective prescription medications.
Stemming from this perspective, the CMA strongly welcomed the new ministerial authorities established by Vanessa's Law as an important contribution to patient safety and the effectiveness of Health Canada's oversight of prescription pharmaceuticals. With these new authorities now in effect, it is critical that implementation is comprehensive, effective and transparent. As such, CMA's response to this public consultation on the new Guide will focus on the need for:
* increased clarity on the thresholds that underpin the use of these new authorities,
* guidance on the notification of public, physicians and other health care practitioners, and
* a commitment to ongoing oversight and revision process of this guidance.
ISSUE 1: PROVIDE INCREASED CLARITY ON THE THRESHOLDS
In CMA's brief1 to the House of Commons Standing Committee on Health as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, key recommendations included clarification of both ministerial authority and responsibility in support of patient safety. The CMA supported the intent of the expansion of these powers, but expressed concern with the lack of clarity on the threshold required to be met to enable the use of these new authorities.
In order to ensure the consistent and effective implementation of these new ministerial authorities, the CMA considers it essential that the Guide provide more clarity on the threshold that enables the use of the new authorities, including the determination of serious risk.
To determine this threshold, Health Canada relies on experts to analyze scientific information and make a recommendation to the Minister.
The CMA recommends that guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
As the definition of "serious risk of injury to human health" is not provided in Vanessa's Law, it is critical that it be addressed in the Guide. Annex A of the Guide states that "the determination of whether a therapeutic product presents a serious risk is complex and is conducted on a case-by-case basis when new information becomes available", and puts forward a "non-exhaustive" list of elements to be considered. It also states that different weights would be attributed to different elements and suggests further contextual elements. The CMA is concerned that without a clear process for the determination of what constitutes a serious risk that subjectivity may have an undue role in this determination and there is the potential for a lack of consistency from case to case. Further, a detailed process is required to ensure that this threshold does not constrain ministerial authority when action is needed.
The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
ISSUE 2: INCLUDE GUIDANCE NOTIFICATION TO PUBLIC, PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS
The CMA is supportive of the guiding principles that should govern all decisions made by Health Canada acting as a regulatory decision-maker, i.e., that power is exercised in a process that is free from bias, based on evidence and in a transparent manner.
In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies2 and by Health Canada, when these new authorities are exercised.
Access to accurate, unbiased information is essential for people to make decisions about their own health.. A clear elaboration and articulation of the process and timelines for how and when public notification is issued in relation to the exercise of the new ministerial authorities is critical to ensure their comprehensive, effective and transparent implementation.
Also, when new information is discovered about a prescription medication, it is important that health professionals be informed as quickly and efficiently as possible.
As part of Health Canada's commitment to transparency, the CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
The U.S. Food and Drug Administration (U.S. FDA), for example, provides guidance and instructions on their public notification expectations in a situation where a product may pose a significant health hazard.3 In addition, there are different mechanisms of public notification, including 'mobile web' and alerts.
Finally, also consistent with the guidance of the U.S. FDA, the CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
ISSUE 3: SPECIFY THE OVERSIGHT AND REVISION OF THE GUIDANCE
As part of its public consultation outreach with stakeholders on this new guidance, Health Canada officials have described the Guide as an evergreen document that will be continually updated. The CMA is supportive of Health Canada's efforts to engage stakeholders and the public in the development and revision of this guidance.
To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
The CMA welcomed this opportunity to submit recommendations on how Health Canada may improve the Guide to New Authorities, which is critical to the comprehensive, effective and transparent implementation of the new authorities established by Vanessa's Law. The CMA looks forward to continued and ongoing collaboration with Health Canada on its implementation of these important new powers.
Overview of Recommendations
1. The CMA recommends that the guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
2. The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
3. In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies and by Health Canada when these new authorities are exercised.
4. The CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
5. The CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
6. To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
1 Canadian Medical Association (2014) Bill C-17 An Act to amend the Food and Drugs Act - Protecting Canadians from Unsafe Drugs. Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2014-09.pdf
2 Note: Throughout this submission, "companies" refers to whom the new ministerial powers apply outside of the regulator - as explained in the consultation document, in the case of s. 21.1 it is a "person" (can include an individual, a research institution, a corporation or an authorization holder), in the case of 21.2 it is the therapeutic product authorization holder, and in the case of s.21.3 it is a "person".
3 U.S. Food and Drug Administration (2015) Guidance for Industry: Product Recalls, Including Removals and Corrections. Retrieved from: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm
COMPLEMENTARY AND ALTERNATIVE MEDICINE
This statement discusses the Canadian Medical Association's (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA's position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should "consider first the well-being of the patient."1 The ethical principle of non-maleficence obliges physicians to reduce their patient's risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM.
CAM in Canada
CAM has been defined as "a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine."i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this analysis, the CMA divides CAM into four general categories:
* Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based.
* Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products.
* Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise.
* Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada.
Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the "holistic" concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM.
Toward Evidence-Informed Health Care
Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious.
The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below:
a) Research: Building an Evidence Base
To date, much of the public's information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public.
b) An Appropriate Regulatory Framework
Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments.
i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada.
The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products' safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include:
* manufacturing processes that ensure the purity, safety and quality of the product;
* labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6
The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm's length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8
The Canadian Medical Association advocates that foods fortified with "natural health" ingredients should be regulated as food products and not as natural health products
The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada's MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada.
ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge.
Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients.
Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to:
* Resist any influence or interference that could undermine their professional integrity;9
* Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10
* Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient.
c) Information and Promotion
Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include:
* Instructions for use;
* Indications that the product or therapy has been convincingly proven to treat;
* Contraindications, side effects and interactions with other medications;
* Should advise the consumer to inform their health care provider during any encounter that they are using this product.12
This information should be provided in such a way as to minimize the impact of vested commercial interests on its content.
In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims.
The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease.
The Role of Health Professionals
Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients.
Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically.
The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health.
1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004.
2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies.
5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies.
6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with "natural health" ingredients. Ottawa (ON): The Association; 2010. Available:
9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
Direct-to-Consumer Advertising (DTCA) Policy Statement
Canadians have a right to information about prescription drugs and other therapeutic interventions, to enable them to make informed decisions about their own health. This information must be evidence based and provide details about side effects and health risks as well as benefits.
Brand-specific direct-to-consumer advertisements, such as those permitted in the United States, do not provide optimal information on prescription drugs. We are concerned that DTCA:
* is not information but marketing, and sends the message that a prescription drug is a “consumer good” rather than a health care benefit.
* may not provide enough information to allow the consumer to make appropriate drug choices. For example, it generally does not provide information about other products or therapies that could be used to treat the same condition. In addition, it may stimulate demand by exaggerating the risks of a disease and generating unnecessary fear.
* may strain the relationship between patients and providers, for example if a patient’s request for an advertised prescription drug is refused.
* drives up the cost of health care, and undermines the efforts of physicians, pharmacists and others to promote optimal drug therapy.
Patient groups, health care providers, governments and pharmaceutical manufacturers should be supported in activities to develop objective, reliable plain-language information about prescription drugs to ensure that Canadians are able to make informed health care decisions.
* Support the provision of objective, evidence-based, reliable plain-language information for the public about prescription drugs.
* Oppose direct-to-consumer prescription drug advertising in Canada.
The harms associated with psychoactive prescription medicinesi including sedatives and tranquilizers1, stimulants2, and analgesics, particularly opioids3, such as oxycodone, hydromorphone and fentanyl, are a significant public health and patient safety issue.
Canada has one of the highest per capita consumption of prescription opioids in the world.4 Dispensing of medications has substantially increased in Canada, although patterns vary considerably between provinces.5 In 2011, while opioid consumption for medical purposes in morphine equivalence (ME)ii was 62mg per person globally, Canada's ME was 812mg per person.6 When comparing to other developed countries, Australia's ME was 427 and Denmark's 483. In North America, about 5% of the adult population, and substantially higher rates for teens and young adults, reported non-medical opioid use in the previous year. This rate is higher than all other illegal drugs, with the exception of marijuana.7
Psychoactive medications pose significant health and safety risks. The harms include overdoses, suicides, motor vehicle accidents, relationship and employment problems, workplace accidents and exposure to blood borne pathogens and other infections when used by injection, besides addiction.
Data are not collected systematically in Canada, making it difficult to assess the harms and track the trends and impact of the introduction of policy changes. However, practitioners have seen the significant impact of these prescription drugs on their patients and to public health. Studies in Ontario show that the number of people enrolled in methadone maintenance treatment rose from about 7,800 in 2001 to over 35,000 in 2011, where opioids have surpassed heroin as the drug used.8 Opioid-related deaths nearly tripled from 2002 to 2010, according to the Office of the Chief Coroner of Ontario.9 Another study showed that other non-opioid depressants (sedatives), such as benzodiazepines, were involved in 92% of the opioid-related deaths.10
The impact is felt particularly among vulnerable populations, such as youth, seniors, First Nations and those living in poverty. In 2013, opioids were reported as the third most common drug used by students in Ontario (after alcohol and marijuana).11 Opioid addiction rates anywhere from 43% to 85% have been reported in some Indigenous communities.12 13 While accurate data on the harms of prescription medication among seniors is lacking, it is well known that the prevalence of pain is higher among older adults and that they account for a significant proportion of prescriptions.
The "high" they produce also leads to these medications being sought after for recreational purposes and, as they are legal products, they are often more easily accessible than street drugs. Surveys with youth have shown that as much as 70% of opioids have been obtained from legitimate prescriptions to family and friends (55% were shared at no cost).14 As well, because opioids have high abuse liability and addiction potential, people have resorted to illegal behaviour to obtain them, such as doctor-shopping, forging prescribers' signatures, or buying from street dealers.
Of great concern, opioid dispensing levels are strongly correlated with increased mortality, morbidity and treatment admissions for substance use.15 16 Studies in Ontario and British Columbia have replicated similar findings in the US. Many patients were prescribed these medications and developed dependence.17
Psychoactive medications are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. Medications, such as opioids, have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.
Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.18 19 However, there is evidence for significant pain relief in the short term but a need for more evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.20 21 22
Important contributing factors for the increase in prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with the patient. In addition, there are new highly potent opioid drugs available.23 24
Canada's physicians are deeply concerned about the harms of opioids and other psychoactive prescription medications. As prescribers, they have a fundamental role in helping to ensure safe and effective use of these drugs, and the deterrence of abuse. 25 26 27 Physicians assess patients and consider whether a prescription is clinically indicated according to best practices, as well as consider whether the benefits outweigh the risks, while screening for risk factors for substance dependence and diversion. This area can be a source of tension with patients who might seek to obtain drugs through fraudulent means.28 It is also an area which causes concern to many physicians, and this could be affecting access to adequate pain management where it is needed.29
The challenge for physicians and public policymakers is how to mitigate the harms of psychoactive prescription drug use, while ensuring that patients have access to the appropriate treatment for their clinical conditions.
Comprehensive National Strategy
Canada's physicians believe that this challenge requires a complex and multifaceted solution; and to further such a solution, the CMA recommends that Canada have a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based, complementing existing strategies to address the harms associated with the two legal drugs - alcohol and tobacco. This comprehensive approach is necessary, as isolated measures can have unintended consequences, such as under-medicating people that require a medical treatment or constraining people to seek illegal drugs as an option when medications are made tamper-resistant.
The federal government has created the National Advisory Council on Prescription Drug Misuse, co-chaired by the Canadian Centre on Substance Abuse, the Coalition on Prescription Drug Misuse (Alberta) and the Nova Scotia Department of Health and Wellness, in partnership with Health Canada's First Nations and Inuit Health Branch's Prescription Drug Abuse Coordinating Committee. In its 2013 report First Do No Harm: Responding to Canada's Prescription Drug Crisis30, there are nearly 60 recommendations toward the development of a strategy to combat the harms associated with psychoactive prescription medications. However, there is much still to be done.
The CMA supports collaborative efforts by the federal and provincial/territorial governments, and by health professionals and other stakeholders, to develop and implement a comprehensive national strategy. Such a strategy should include the following:
1. Improvement of Drug Safety
Health Canada, as the agency that approves prescription drugs for use and monitors their safety once on the market, has several levers by which it can control Canadians' access to drugs. One of these is the Controlled Drugs and Substances Act (CDSA) and its regulations, which govern access to illegal products and recently has included psychoactive prescription drugs.
Because of their health and safety risks, it is important that Health Canada ensures that the CDSA subjects psychoactive substances to high levels of regulatory scrutiny during both the approval process and post-approval surveillance. The Act should require manufacturers to:
* Meet stringent pre-approval requirements. For example, Health Canada could require intensive review of pre-approval clinical trial results and of product monographs by an expert impartial review committee (including addiction, pain and public health expertise); or require that the manufacturer fulfill special conditions, such as formal post-market studies, as a condition of the drugs' approval; or even require larger sample sizes or longer study periods to assess harms;
* Adhere to restrictions on the marketing of controlled medications to health professionals and the general public. The adequacy of regulations needs to be assessed in this regard.
* Develop and cover tamper-resistant formulations of psychoactive drugs of concern. Although not a standalone solution, tamper-resistant formulations can reduce the potential for manipulation to be able to use through snorting, chewing or intravenously.
2. Enhancement of Optimal Prescribing through Evidence-Based Guidance, Education and Support for Prescribers
CMA recommends that appropriate prescribing of psychoactive medications should be addressed through evidence-based guidance and education. A strategy to support optimal therapy might include:
* Support for models of care that allow a physician to spend time with complex patients.
* Ongoing development and dissemination of clinical guidance. The Canadian Guideline for Use of Opioids to Treat Chronic Non-Cancer Pain was published in the CMAJ in 2010. CMA has co-sponsored an online CME module based on this guideline. There is interest in similar guidelines for sedatives and stimulants.
* Evaluative research to support the critical review of guidelines periodically. It is essential to review data on chronic conditions for which risks might outweigh benefits.
* Relevant, unbiased and easily accessible information for prescribers, which can readily be incorporated into everyday practice. This should include clinical decision-support tools for use at the point of care, inclusive of dosing guidelines and guidance on when to seek consultation with experts. Physicians also require tools, including those that facilitate: monitoring of effectiveness and tolerance by tracking pain and physical function; screening for past and current substance use; screening for depression; tapering of problematic or ineffective doses; among others.
* Educational programs in optimal prescribing, pain management and in the management of addictions, as part of the curriculum in medical school, and residency training as well as in continuing education. Particular support is needed for those in primary care.
* Guidance for prescribers about how to deal with conflict in their practice. This would include guidance for patient-centred educational discussions on safe opiate prescribing and use and management of addictions.
* Access to expert advice if required through such means as:
o Policies or standards of practice developed by provincial regulatory colleges of physicians, which can include limitations on prescription volume, treatment period and indications.
o Communities of practice, knowledge hubs and clinical support networks that link practitioners with experts in the field, facilitating triage and supporting front line generalists. Experts can not only provide clinical information, but can provide mentorship and personal advice about best practices.
o Feedback to practitioners about their prescribing practices, particularly if potentially concerning patterns are identified. This initiative should be facilitated by collaborative work between health care professionals and their respective provincial regulatory colleges.
o Academic detailing programs, which use personalized, one-on-one techniques to deliver impartial prescribing information to practitioners.
3. Enhancement of Optimal Prescribing through Physician Regulation and Prescription Monitoring Programs
Medicine is a regulated profession, and the provincial colleges of physicians have ultimate authority and responsibility for the oversight of physician practice. The colleges have taken a leading role in educating their members about appropriate prescribing, in monitoring prescribing practices to ensure their appropriateness and taking disciplinary action when required, and through collaborating with law enforcement agencies to detect and halt criminal diversion.
The CMA recommends that federal and provincial regulations regarding controlled substances recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and the purpose for which the data are collected. Standardization of monitoring systems across Canada according to best practices can contribute to addressing the harms associated with psychoactive prescription medication by:
* Allowing health care practitioners to identify previous or concomitant prescriptions of controlled medications with more than one practitioner at the time the prescription is requested or filled;
* Deterring interprovincial or jurisdictional fraud, by allowing health care practitioners to identify other prescriptions at the time the prescription is requested or filled; and
* Improving professional regulatory bodies' capacity for oversight and intervention by establishing a mechanism for real-time monitoring.
The CMA recommends that all levels of government work with one another and with health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring. As a first step, the CMA recommends the establishment of consistent national standards for prescription monitoring.
PMPs should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. PMPs should not deter physicians from using controlled medications when necessary.
CMA also recommends that Health Canada ensure that its legislative framework be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can help individual physicians or pharmacists identify potential diversion and double prescriptions, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, and could minimize the potential administrative burden.
PMPs should conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. The CMA strongly recommends that Health Canada undertake a privacy impact assessment of the regulatory framework for controlled prescription drugs, and share the results with stakeholders.
4. Increase in Access to Treatment for Pain
Chronic pain affects many aspects of a person's life including their ability to work, their emotional, mental and physical health, and their quality of life. Pain costs Canada an estimated $60 Billion dollars per year; more than the cost of heart disease, cancer and diabetes.31 CMA has endorsed a national strategy for pain, developed and proposed by the Canadian Pain Coalition and Canadian Pain Society,32 which addresses four target areas: awareness and education; access; research; and ongoing monitoring.
Experts believe that improved access to specialized pain treatment could reduce inappropriate use of pain medications. Current best practices in pain management include:
* Care by an interprofessional team that could include physiotherapists, occupational therapists, psychologists and other health professionals;
* Recommendation of non-pharmaceutical interventions such as therapy for trauma and social pain, social supports and coping strategies;
* Appropriate pharmaceutical prescription options, covered by provincial formularies; and
* A focus on patient participation and empowerment.
However, specialized pain treatment programs are in short supply. Wait times are greater than one year at more than one third of publicly funded inter-professional treatment programs.33 In many parts of Canada, particularly rural and remote areas, such programs are not available. In addition, while physician visits are covered by the public health care system, services provided by other health professionals are more likely to be either covered by private health benefits or paid out of pocket, and are therefore beyond the means of many Canadians. These factors may result in heavier reliance on prescription medication as treatment for chronic pain.
The CMA recommends that all partners work to improve and promote access to specialized treatment programs for pain management, and that investments be made in research about options for treatment.
5. Increase in Access to Treatment for Addiction
Access to addiction treatment is very limited and, when available, is primarily comprised of detox or the substitution treatments with methadone or Suboxone(r) (buprenorphine and naloxone). As addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry by definition, which manifests along biological, psychological, social and spiritual dimensions, treatment must address all those areas rather than just one or another.34
The CMA supports the enhancement of access to options for addiction treatment that address different needs. Treatment programs must be coordinated and patient-centred, and address physical, psychological, social and spiritual circumstances. For example, it is important that addiction programs be culturally relevant for Indigenous communities.
Treatment programs must also be integrated within the health care system and be adequately funded to meet evidence based, best-practice guidelines.
CMA also supports the development and dissemination of practice tools and guidelines to help physicians assess the addiction potential of a patient receiving psychoactive medications, and to assist in managing patients who have addiction and related problems and complications.
6. Increase in Information through Epidemiological Surveillance
One of the challenges in dealing with prescription drug abuse, which can reflect hazardous (episodic) use, harmful (regular) use or addiction, is the incompleteness of our knowledge of the extent of the problem. Countries, such as the US and France, are able to monitor psychoactive drug use, while in Canada we still rely on unsystematically collected or locally limited data. The creation of a national surveillance system that supports the collection of systematic, standardized information would:
* Permit the thorough assessment of the problem, with the development and monitoring of indicators;
* Support the early detection of diversion or inappropriate prescribing behaviour;
* Support the establishment of best practices to address crucial issues;
* Identify research priorities; and
* Evaluate the impact of the implementation of strategies.
Sources of information should include PMPs, coroner's investigations, emergency room admissions, and poison control data, among others.
7. Prevention of Deaths due to Overdose
Overdose deaths have increased 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. Opioid death and complications overdoses can be prevented with appropriate medication and prompt emergency response. The CMA recommends the:
* Creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. Training should be made available to health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.35
* Improvement of access to naloxone to reverse opioid overdoses. This should include the prescription of naloxone to high risk individuals and third parties who can assist a victim experiencing an opiate-related overdose.
* Enactment of Good Samaritan laws by all levels of government in order to protect callers from criminal charges if they call emergency services to report an overdose. 36 37
8. Provision of Information for Patients and the Public
Awareness programs that provide accurate information to patients and the general public are important, and could include:
* Information on the benefits and harms of psychoactive prescription medication use, and signs of dependence and overdose. This should include the risk of dependence and addiction associated with the use of opiates for the treatment of acute and chronic pain.
* Messages aimed at the prevention of problematic drug use among young people and other populations at risk.
* Information regarding safe medication storage and disposal, and reducing access to medications from family and friends. CMA supports national prescription drug "drop off" days, and recommends that patients be educated about the importance of routinely returning unused prescription drugs to the pharmacy.
The CMA recommends that Canada have a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based. This strategy should include:
* That Health Canada require that manufacturers meet stringent pre-approval requirements, adhere to restrictions on the marketing of controlled medications to health professionals and the general public, and develop formulations of psychoactive drugs of concern that are tamper-resistant.
* Support for optimal prescribing through evidence-based guidance, education and supports, such as clinical guidance, clinical decision-support tools, educational programs, expert advice, and supportive models of care.
* The enhancement of optimal prescribing through physician regulation and the development of a pan-Canadian system of real-time prescription monitoring programs, compatible with electronic medical and pharmacy record systems, based on national standards.
* Increased access to specialized pain management and treatment, according to best practices, with investments in research.
* The enhancement of access to options for addiction treatment that address different needs, and the support for the development and dissemination of practice tools and guidelines.
* The creation of a national surveillance system that supports the collection of systematic, standardized information to better inform and track policy changes.
* The creation and scaling up of community-based programs that
* Offer access to opioid overdose prevention tools and services, including the improvement of access to medication to reverse opioid overdoses (naloxone) and the enactment of Good Samaritan laws by all levels of government.
* The provision of accurate information to patients and the general public, including safe medication storage and disposal.
i Psychoactive drugs are substances that, when taken, have the ability to change an individual's consciousness, mood or thinking processes (WHO, 2004). Psychoactive prescription drugs include sedatives (such as benzodiazepines and barbiturates), stimulants (such as amphetamines), and opioids (such as oxycodone, hydromorphone, morphine and fentanyl). [World Health Organization (2004) Neuroscience of psychoactive substance use and dependence. Available at: http://www.who.int/substance_abuse/publications/en/Neuroscience.pdf]
ii Comprises six main opioids: fentanyl, hydromorphone, methadone, morphine, oxycodone and pethidine.
1 Canadian Centre on Substance Abuse. Prescription sedatives and tranquilizers. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Prescription-Sedatives-and-Tranquilizers-2013-en.pdf
2 Canadian Centre on Substance Abuse. Prescription stimulants. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Prescription-Stimulants-2013-en.pdf
3 Canadian Centre on Substance Abuse. Prescription opioids. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Canadian-Drug-Summary-Prescription-Opioids-2013-en.pdf
4 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013.
5 Fischer B, Jones W, Murray K, et al. Differences and over-time changes in levels of prescription opioid analgesic dispensing from retail pharmacies in Canada, 2005-2010. Pharmacoepidemiol Drug Saf. 2011;20:1269-77.
6 United Nations Office on Drugs and Crime. World drug report 2014. New York: The Office; 2014. Available: www.unodc.org/documents/wdr2014/World_Drug_Report_2014_web.pdf
7 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81.
8 Fischer B, Argento E. Prescription opioid related misuse, harms, diversion and interventions in Canada: a review. Pain Physician. 2012;15:ES191-ES203.
9 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013.
10 Dhalla IA, Mamdani MM, Sivilotti MLA, et al. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone CMAJ. 2009;181(12): 891-6.
11 Centre for Addiction and Mental Health. Drug use among Ontario students, 1977-2013: results of the Ontario Student Drug Use and Health Survey. Toronto: The Centre; 2013. Available: www.camh.ca/en/research/news_and_publications/ontario-student-drug-use-and-health-survey/Documents/2013%20OSDUHS%20Docs/2013OSDUHS_Highlights_DrugUseReport.pdf
12 Chiefs of Ontario. Prescription drug abuse strategy: 'Take a stand.' Final report. Toronto: Chiefs of Ontario; 2010. Available: www.chiefs-of-ontario.org/sites/default/files/files/Final%20Draft%20Prescription%20Drug%20Abuse%20Strategy.pdf
13 Health Canada. Honouring our strengths: a renewed framework to address substance use issues among First Nations people in Canada. Ottawa: Health Canada; 2011. Available: http://nnadaprenewal.ca/wp-content/uploads/2012/01/Honouring-Our-Strengths-2011_Eng1.pdf
14 US Department of Health and Human Services Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings. Rockville (MD): The Department; 2011. p. 25. Available: www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf
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21 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10:147-59.
22 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev. 2010;(1):CD006605.
23 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health. 2008;99(3): 182-4.
24 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81.
25 Silversides A. Opioid prescribing challenges doctors. CMAJ. 2009;181(8):E143-E144.
26 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011;343:d5142.
27 Kirschner N, Ginsburg J, Sulmasy LS. Prescription drug abuse: a policy position paper from the American College of Physicians. Ann Intern Med. 2014;160:198-213.
28 Saveland C, Hawker L, Miedema B, et al. Abuse of family physicians by patients seeking controlled substances. Can Fam Physician. 2014;60:e131-6.
29 Wenghofer EF, Wilson L, Kahan M, et al. Survey of Ontario primary care physicians' experiences with opioid prescribing. Can Fam Physician. 2011;57(3):324-32.
30 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013. Available: www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse-report-en.pdf
31 Canadian Pain Strategy Initiative. Rise up against pain: the Canadian Pain Strategy. Available: http://canadianpainstrategy.ca/en/home.aspx
32 Canadian Pain Coalition, Canadian Pain Society. Call to action: the need for a national pain strategy for Canada. 2011. Available: http://canadianpainstrategy.ca/media/11445/final%20nat%20pain%20strategy%20for%20can%20121511%20eng.pdf
33 Canadian Pain Coalition, Canadian Pain Society. Call to action: the need for a national pain strategy for Canada. 2011. Available: http://canadianpainstrategy.ca/media/11445/final%20nat%20pain%20strategy%20for%20can%20121511%20eng.pdf
34 American Society of Addiction Medicine. Public policy statement: definition of addiction. 2011. Available: www.asam.org/for-the-public/definition-of-addiction
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37 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/
S.C.C. File No.: 33556
IN THE SUPREME COURT OF CANADA
(APPEAL FROM THE BRITISH COLUMBIA COURT OF APPEAL)
ATTORNEY GENERAL OF CANADA AND
MINISTER OF HEALTH FOR CANADA
PHS COMMUNITY SERVICES SOCIETY, DEAN EDWARD WILSON and SHELLY
TOMIC, VANCOUVER AREA NETWORK OF DRUG USERS (VANDU)
ATTORNEY GENERAL OF BRITISH COLUMBIA
ATTORNEY GENERAL OF QUEBEC, DR. PETER AIDS FOUNDATION,
VANCOUVER COASTAL HEALTH AUTHORITY, CANADIAN CIVIL LIBERTIES
ASSOCIATION, CANADIAN HIV/AIDS LEGAL NETWORK, INTERNATIONAL
HARM REDUCTION ASSOCIATION AND CACTUS MONTREAL, CANADIAN
NURSES ASSOCIATION, REGISTERED NURSES' ASSOCIATION OF ONTARIO
AND ASSOCIATION OF REGISTERED NURSES OF BRITISH COLUMBIA,
CANADIAN PUBLIC HEALTH ASSOCIATION, CANADIAN MEDICAL
ASSOCIATION, BRITISH COLUMBIA CIVIL LIBERTIES ASSOCIATION, BRITISH
COLUMBIA NURSES'S UNION
FACTUM OF THE INTERVENER,
CANADIAN MEDICAL ASSOCIATION
BORDEN LADNER GERVAIS LLP
100 Queen Street — Suite 1100
Ottawa, ON KIP 1J9
Guy J. Pratte/Nadia Effendi
Tel: (613) 237-5160
Fax: (613) 230-8842
Counsel for the Intervener, Canadian Medical
Roger Bilodeau, Q.C.
SUPREME COURT OF CANADA
Robert J. Frater
Attorney General of Canada
Bank of Canada Building
234 Wellington Street, Room 1161
Telephone: (613) 957-4763
FAX: (613) 954-1920
Counsel for Appellant/Respondent on Cross-
Appeal, the Attorney General of Canada
Robert J. Frater
Attorney General of Canada
Bank of Canada Building
234 Wellington Street, Room 1161
Telephone: (613) 957-4763
FAX: (613) 954-1920
Counsel for Appellant/Respondent on Cross-
Appeal, the Minister of Health for Canada
Joseph H. Arvay, Q.C.
1350 - 355 Burrard Street
Vancouver, British Columbia
Telephone: (604) 689-4421
FAX: (604) 687-1941
Counsel for Respondent, PHS Community
Jeffrey W. Beedell
300 - 50 O'Connor Street
Telephone: (613) 232-7171
FAX: (613) 231-3191
Agent for Respondent, PHS Community
Joseph H. Arvay, Q.C.
1350 - 355 Burrard Street
Vancouver, British Columbia
Telephone: (604) 689-4421
FAX: (604) 687-1941
Counsel for Respondent, Dean Edward Wilson
and Shelly Tomic
John W. Conroy, Q.C.
Conroy & Company
2459 Pauline St
Abbotsford, British Columbia
Telephone: (604) 852-5110
FAX: (604) 859-3361
Counsel for Respondent/Appellant on Cross-
Appeal, Vancouver Area Network of Drug
Craig E. Jones
Attorney General of British Columbia
1001 Douglas Street, 6th floor
Victoria, British Columbia
Telephone: (250) 387-3129
FAX: (250) 356-9154
Counsel for Respondent, the Attorney General
of British Columbia
Procureur general du Quebec
1200 Route de l'Èglise, 2e etage
Telephone: (418) 643-1477
FAX: (418) 644-7030
Counsel for Intervener, Attorney General of
Jeffrey W. Beedell
300 - 50 O'Connor Street
Telephone: (613) 232-7171
FAX: (613) 231-3191
Agent for Respondent, Dean Edward Wilson
and Shelly Tomic
Henry S. Brown, Q.C.
Gowling Lafleur Henderson LLP
2600 - 160 Elgin St
P.O. Box 466, Stn "D"
Telephone: (613) 233-1781
FAX: (613) 788-3433
Agent for Respondent/Appellant on Cross-
Appeal, Vancouver Area Network of Drug
Robert E. Houston, Q.C.
70 Gloucester Street
Telephone: (613) 566-2058
FAX: (613) 235-4430
Agent for Respondent, the Attorney General
of British Columbia
Noel & Associes
111, rue Champlain
Telephone: (819) 771-7393
FAX: (819) 771-5397
Agent for Intervener, Attorney General of
Andrew I. Nathanson
Fasken Martineau DuMoulin LLP
2900 - 550 Burrard Street
Vancouver, British Columbia
Telephone: (604) 631-4908
FAX: (604) 631-3232
Counsel for Intervener, Dr. Peter AIDS
Ryan D. W. Dalziel
Bull, Housser & Tupper LLP
3000 - 1055 West Georgia Street
Vancouver, British Columbia
Telephone: (604) 641-4881
FAX: (604) 646-2671
Counsel for Intervener, British Columbia Civil
2800 Park Place
666 Burrard Street
Vancouver, British Columbia
Telephone: (604) 643-2980
FAX: (604) 605-3781
Counsel for Intervener, Vancouver Coastal
Paul F. Monahan
Fasken Martineau DuMoulin LLP
333 Bay Street, Suite 2400
Bay Adelaide Centre, Box 20
Telephone: (416) 366-8381
FAX: (416) 364-7813
Counsel for Intervener, Canadian Civil
Scott M. Prescott
Fasken Martineau DuMoulin LLP
1300 - 55 Metcalfe Street
Telephone: (613) 236-3882
FAX: (613) 230-6423
Agent for Intervener, Dr. Peter AIDS
Brian A. Crane, Q.C.
Gowling Lafleur Henderson LLP
2600 - 160 Elgin St
Telephone: (613) 233-1781
FAX: (613) 563-9869
Agent for Intervener, British Columbia Civil
300 - 50 O'Connor Street
Telephone: (613) 232-7171
FAX: (613) 231-3191
Agent for Intervener, Vancouver Coastal
Fasken Martineau DuMoulin LLP
55 Metcalfe Street
Telephone: (613) 236-3882
FAX: (613) 230-6423
Agent for Intervener, Canadian Civil Liberties
Michael A. Feder
McCarthy Tétrault LLP
Suite 1300, 777 Dunsmuir Street
Vancouver, British Columbia
V7Y 1 K2
Telephone: (604) 643-5983
FAX: (604) 622-5614
Counsel for Intervener, the Canadian
HIV/AIDS Legal Network, International
Harm Reduction Association and CACTUS
Rahool P. Agarwal
Ogilvy Renault LLP
3800 - 200 Bay Street
Toronto, Ontario M5J 2Z4
Telephone: (416) 216-3943
FAX: (416) 216-3930
Counsel for Intervener, Canadian Nurses
Association, Registered Nurses' Association
of Ontario and Association of Registered
Nurses of British Columbia
Owen M. Rees
77 King Street West
Suite 4130, P.O. Box 140
Telephone: (416) 593-7200
FAX: (416) 593-9345
Counsel for Intervener, Canadian Public
Brenda C. Swick
McCarthy Tétrault LLP
200 - 440 Laurier Avenue West
Telephone: (613) 238-2000
FAX: (613) 563-9386
Agent for Intervener, the Canadian HIV/AIDS
Legal Network, International Harm Reduction
Association and CACTUS Montréal
Sally A. Gomery
Ogilvy Renault LLP
1500 - 45, O'Connor Street
Ottawa, Ontario KIP lA4
Telephone: (613) 780-8661
FAX: (613) 230-5459
Agent for Intervener, Canadian Nurses
Association, Registered Nurses' Association
of Ontaro and Association of Registered
Nurses of British Columbia
Dougald E. Brown
Nelligan O'Brien Payne LLP
1500 - 50 O'Connor S1.
Telephone: (613) 231-8210
FAX: (613) 788-3661
Agent for Intervener, Canadian Public Health
Victory Square Law Office
100 West Pender Street
Vancouver, British Columbia
Telephone: (604) 684-8421
FAX: (604) 684-8427
Counsel for Intervener, British Columbia
Michael A. Chambers
50 O'Connor Street, Suite 1625
Telephone: (613) 233-1146
FAX: (613) 233-7190
Counsel for Intervener, Real Women Canada
Sack Goldblatt Mitchell LLP
500 - 30 Metcalfe St.
Telephone: (613) 235-5327
FAX: (613) 235-3041
Agent for Intervener, British Columbia
TABLE OF CONTENTS
Part I — Statement of Facts ........................................................................................................... .1
A. Overview ......................................................................................................................... 1
B. CMA's Interest in the Appeal ............................................................................................ 1
C. CMA's Position on the Facts ............................................................................................ 1
Part II — Statement of the Questions in Issue ................................................................................3
Part III — Statement of Argument .................................................................................................3
A. Charter Interpretation Must be Guided by Reality, Not Ideology ......................................... 3
B. The Impugned Provisions Infringe Section 7 of the Charter ................................................. 5
(1)Denying Access to Necessary Health care Infringes Section 7 of the Charter.................. 5
(2)The Rights to Life and Security of Patients Have Been Infringed ................................... 5
(3)Drug Addicts Have Not Waived Their Statutory and Constitutional Right to
Treatment .................................................................................................................. 6
(4)The Rights to Liberty of the Individual Respondents Have Been Infringed ..................... 8
(5)The Principles of Fundamental Justice Have Not Been Respected ................................. 8
a) The Impugned Provisions Are Arbitrary ..................................................................... 8
b) The Impugned Provisions Are Overbroad ................................................................... 9
C. If There is an Infringement of Section 7, the Law is Not Saved by Section 1 of the
Charter ................................................................................................................................ 9
D. Remedy ......................................................................................................................... 10
Part IV — Submissions as to Costs .............................................................................................. 10
Part V — Order Sought ................................................................................................................10
Part VI — Table of Authorities .................................................................................................... 11
Part VII — Statutes, Regulations, Rules ...................................................................................... 13
PART I — STATEMENT OF FACTS
1. Fair and equitable access to medically necessary, evidenced-based health care is of
fundamental importance to Canadian patients and physicians, as this Court recognized in
2. Where life and security of a person is at risk because of a medical condition, like drug
addiction, the Court's delineation of a government or legislature's constitutional obligations
should be guided by facts. Unfounded ideological assumptions about the character of patients
must not trump clinical judgment based on the best medical evidence available; otherwise, the
life, liberty and security of patients is put at risk arbitrarily, contrary to section 7 of the Charter.
3. The Appellants' position that those addicted to drugs have foregone any right to access
medical treatment is antithetical to the raison d'être of the Canadian health care system and
inconsistent with the federal government's obligations under section 7 of the Charter.
4. Neither the statutory law nor the Constitution allows the state to deny access to health
care because of "lifestyle" choices or presumed waiver of legal or constitutional rights.
B. CMA's Interest in the Appeal
5. The Canadian Medical Association ("CMA") is the national voice of Canadian
physicians with over 74,000 members across the country. Its mission is to serve and to 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 heath care.
6. Critical to CMA's role is the upholding of harm reduction as one pillar in a
comprehensive public health approach to disease prevention and health promotion. Further, the
CMA possesses a distinct expertise and broad-based knowledge of many aspects of policy and
law concerning harm reduction as a clinically mandated and ethical method of care and
C. CMA's Position on the Facts
7. By Order dated February 17, 2011, the CMA was granted leave to intervene in this
8. The CMA accepts the facts as stated by the Respondents.
9. This appeal flows from separate actions commenced by some of the Respondents seeking
relief that would obviate the need for exemptions granted by the Federal Minister of Health
under section 56 of the Controlled Drugs and Substances Act (the "Act"), S.C. 1996 c. 19. Thus,
when within the confines of the Vancouver Safe Injection Site ("Insite"), patient drug users were
not liable to prosecution for possession of a controlled substance contrary to section 4(1) of the
Act, or staff for trafficking contrary to section 5(1). The initial exemptions, based on "necessity
for a scientific purpose", were granted for a term of three years commencing September 12,
2003. They were thereafter extended to December 31, 2007, and then to June 30, 2008. Insite's
ability to operate was dependent upon the exemptions. However, no further extensions were
10. In their actions, the Respondents, in addition to the division of powers argument,
contended that sections 4(1) and 5(1) of the Act violated section 7 of the Charter, were
unconstitutional, and should be struck down. The Respondents were successful before the
Applications Judge and the Court of Appeal.
11. The Applications Judge found that sections 4(1) and 5(1) of the Act infringed section 7 of
the Charter and declared them to be of no force and effect.
12. On appeal by the Attorney General of Canada and cross-appeal by the Respondents, PHS,
Wilson and Tomic, the majority of the Court of Appeal found that sections 4(1) and 5(1) of the
Act were inapplicable to Insite by reason of the application of the doctrine of interjurisdictional
13. In concurring reasons, Rowles J.A. also found that sections 4(1) and 5(1) engaged section
7 of the Charter and that such application did not accord with the principles of fundamental
justice because of overbreadth.
14. The findings of the Applications Judge and Rowles J.A. under the Charter are, the CMA
submits, premised on the correct and supported fact that harm reduction is an evidenced-based
form of medical treatment for patient drug addicts suffering from the illness of addiction. It is
unconstitutional for governments to prevent access to treatment on pain of criminal penalty and
deprivations of life, liberty and security of the person on grounds informed by ideological
assumptions and not the evidence.
PART II - STATEMENT OF THE QUESTIONS IN ISSUE
15. The following constitutional questions, as stated by the Chief Justice on September 2,
2010, are to be determined in this appeal:
1. Are ss. 4(1) and 5(1) of the Controlled Drugs and Substances Act, S.c. 1996, c. 19, constitutionally
inapplicable to the activities of staff and users at Insite, a health care undertaking in the Province of
2. Does s. 4(1) of the Controlled Drugs and Substances Act, S.c. 1996, c. 19, infringe the rights
guaranteed by s. 7 of the Canadian Charter of Rights and Freedoms?
3. If so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free
and democratic society under s. 1 of the Canadian Charter of Rights and Freedoms?
4. Does s. 5(1) of the Controlled Drugs and Substances Act, S.C. 1996, c. 19, infringe the rights
guaranteed by s. 7 of the Canadian Charter of Rights and Freedoms?
5. If so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free
and democratic society under s. 1 of the Canadian Charter of Rights and Freedoms?
16. Questions two to five, which relate to the Charter, are of particular importance for the
CMA, and are addressed in more detail below. The CMA submits that sections 4(1) and 5(1) of
the Act infrnge the rights guaranteed by section 7 of the Charter and are not justified under
PART III - STATEMENT OF ARGUMENT
A. Charter Interpretation Must be Guided by Reality, Not Ideology
17. When determining whether or not impugned legislation infringes the Charter, courts
must not play host to political debates, but instead must rise above them by ensuring that public
policy passes constitutional muster.
Chaoull v. Québec (Attorney General), (2005) 1 S.c.R. 791, at para. 89 (CMA Authorities,
R. v. Morgentaler, (1988)1 S.C.R. 30 at 45-46 (CMA Authorities, Tab 13).
18. The Appellants' position is clearly premised on ideological preconceptions with regard to
individuals suffering from addictions. Yet, as the history of birth control legislation in Canada
shows, a legal framework informed by ideological assumptions about the morality of patients
seeking to control their reproduction can violate a person's most fundamental rights.
See R. v. Morgentaler, supra at 62 where the Court rejected arguments that it should assess
administrative structures in the abstract: "when denial of a right as basic as security of the
person is infringed by the procedure and administrative structures created by the law itself,
the courts are empowered to act" (CMA Authorities, Tab 13).
19. In order for the courts to meet their role in determining whether a particular piece of
legislation is constitutional, it must consider Parliament's enactments by relying on the available
evidence. In fact, it is well established that a deprivation of the rights to life, liberty or security of
the person must be proven by solid evidence.
Taylor, M. and Jamal, M., The Charter of Rights in Litigation, loose-leaf (Canada Law Book:
Aurora, 2010) at para. 17:15 [CMA Authorities, Tab 20].
20. The presentation of facts is not a mere technicality, but rather it is essential to a proper
consideration of Charter issues:
Charter cases will frequently be concerned with concepts and principles that are of fundamental
importance to Canadian society. For example, issues pertaining to freedom of religion, freedom of
expression and the right to life, liberty and the security of the individual will have to be considered by the
courts. Decisions on these issues must be carefully considered as they will profoundly affect the lives of
Canadians and all residents of Canada. In light of the importance and the impact that these decisions may
have in the future, the courts have every right to expect and indeed to insist upon the careful preparation
and presentation of a factual basis in most Charter cases. The relevant facts put forward may cover a
wide spectrum dealing with scientific, social, economic and political aspects. Often expert opinion as to
the future impact of the impugned legislation and the results of the possible decisions pertaining to it may
be of great assistance to the courts.
MacKay v. Manitoba,  2 S.C.R. 357 at 361 [CMA Authorities, Tab 5].
21. Specifically, with respect to section 7 of the Charter, this Court has confirmed that the
task of the courts is to evaluate the issue in "the light, not just of common sense or theory, but of
the evidence". The Court dispenses with unsubstantiated theoretical arguments, relying instead
on empirical and scientific evidence presented by the parties:
In support of this contention, the government called experts in health administration and policy. Their
conclusions were based on the "common sense" proposition that the improvement of health services
depends on exclusivity (R.R., at p. 591). They did not profess expertise in waiting times for treatment.
Nor did they present economic studies or rely on the experience of other countries. They simply
assumed, as a matter of apparent logic, that insurance would make private health services more
accessible and that this in turn would undermine the quality of services provided by the public health care
The appellants, relying on other health experts, disagreed and offered their own conflicting "common
sense" argument for the proposition that prohibiting private health insurance is neither necessary nor
related to maintaining high quality in the public health care system. Quality public care, they argue,
depends not on a monopoly, but on money and management. They testified that permitting people to buy
private insurance would make alternative medical care more accessible and reduce the burden on the
public system. The result, they assert, would be better care for all [...]
To this point, we are confronted with competing but unproven "common sense" arguments, amounting to
little more than assertions of belief. We are in the realm of theory. But as discussed above, a theoretically
defensible limitation may be arbitrary if in fact the limit lacks a connection to the goal.
This brings us to the evidence called by the appellants at trial on the experience of other developed
countries with public health care systems which permit access to private health care. The experience of
these countries suggests that there is no real connection in fact between prohibition of health insurance
and the goal of a quality public health system.
Chaoulli, supra at paras. 136-149 (see also paras. 115, 117, 136-149, 150, 152 where the Court
refers to Statistics Canada studies and evidence from other western democracies) [CMA
Authorities, Tab 2]. See also Rodriguez v. British Columbia (Attorney General),  3
S.C.R. 519 at 601-602 [CMA Authorities, Tab 16].
22. Drug addicts suffer from a medical condition that can be treated. Hence, Insite is
designed as a health treatment aimed at reducing the harmful consequences of drug use as well as
exposing its vulnerable patients to other health care options. In this context, the federal
legislation and government actions at issue amount to a denial of evidence-based medical
treatment whose effect is to put the life and security of patients at great risk.
23. Charter interpretation should generally be grounded on fact rather than speculation or
ideological assumptions, especially where life and security of the person (i.e., the patient) is at
risk because of a medical condition (such as addiction). In such cases, the Court's delineation of
the state's constitutional obligations should be guided by evidence-based medicine and
independent clinical judgment.
Chaoulli, supra at paras. 85, 107 [CMA Authorities, Tab 2]. See also Operation Dismantle
Inc. v. The Queen,  1 S.C.R. 441 at 452-454 [CMA Authorities, Tab 7]; Auton
(Guardian ad litem of) v. British Columbia (Attorney General),  3 S.C.R. 657, at para. 66
[CMA Authorities, Tab 1].
24. Accordingly, CMA submits that, at the very least, in the health care field where lives are
at risk, there must be sound evidentiary basis for legislative and government action that deny
B. The Impugned Provisions Infringe Section 7 of the Charter
(1) Denying Access to Necessary Health care Infringes Section 7 of the Charter
25. While the legislature is generally entitled to enact legislation prohibiting drug use or
trafficking, this legislation (however well-intended) cannot have the effect of putting the lives of
affected persons at risk. This Court has already found in Chaoulli that section 7 of the Charter
was infringed when governments impeded timely patient access to care.
(2) The Rights to Life and Security of Patients Have Been Infringed
26. Both the Applications Judge and the Court of Appeal found that the right to life and
security was engaged in the present case. The evidence on these issues was plentiful:
1. Addiction is an illness. One aspect of the illness is the continuing need or craving to consume the
substance to which the addiction relates;
2. Injection drug use leads to an increased incidence and prevalence of infectious diseases including
HIV/AIDS, Hepatitis A, B and C, and skin- and blood-borne infections; frequent drug overdoses
resulting in significant morbidity and mortality; increased hospital and emergency service utilization;
3. The risk of morbidity and mortality associated with addiction and injection is ameliorated by injection
in the presence of qualified health professionals at Insite;
4. User of Insite who are addicted to heroin, cocaine and other controlled substances are not engaged in
recreation. Their addiction is an illness frequently, if not invariably, accompanied by serious infections
and the real risk of overdose.
Reasons for Judgment of the Applications Judge, paras. 87, 89, 135-136, Appellants' Record,
Vol. I, pp. 24-25, 34. See also Reasons for Judgment of the B.C. Court of Appeal, para. 30,
Appellants' Record, Vol. I, p. 65.
(3) Drug Addicts Have Not Waived Their Statutory and Constitutional Right to
27. The Appellants did not really dispute the medical evidence to the effect that addiction to
drugs was a disease. They sought instead to justify their position by claiming that drug addicts
had "chosen" their lifestyle and were solely responsible for their medical condition. For the
following reasons, this "rationale" does not pass constitutional muster.
28. The Appellants assert that the section 7 rights are not engaged as they stem from an
alleged "choice made by the consumer", relying on the fact that 95% of the injections in the
downtown east side of Vancouver do not take place at Insite. The Appellants do not explain how
this assertion demonstrates why addicts are able to make a choice not to inject themselves, given
that it only addresses where they inject themselves. In any event, contrary to the Appellants'
choice theory, the evidence before the Applications Judge and his findings were to the contrary:
the reasons for the addiction and resulting need are based on a complicated combination of
personal, governmental and legal factors, some of which lend themselves to choice and others
that do not.' Further, the Applications Judge found that it is the illness of addiction, and the
failure to manage it, that has led to further illness and death.
Reasons for Judgment of the Applications Judge, paras. 65, 89, 142, Appellants' Record, Vol.
I, pp. 21, 24-25, 35. See also Reasons for Judgment of the B.C. Court of Appeal, para. 39,
Appellants' Record, Vol. I, p. 67.
Contra the facts in R. v. Malmo-Levine; R. v. Caine,  3 S.C.R. 571 [Malmo-Levine]
[CMA Authorities, Tab 12].
29. The Appellants' position amounts to a claim that the users of Insite have effectively
waived their constitutional rights under section 7. Notwithstanding that the jurisprudence is
In fact, the evidence is clear that in the case of the Respondent Tomic, her first experience with illegal drugs
was not a personal choice [Reasons for Judgment of the Applications Judge, para. 65, Appellants' Record,
Vol. I, p. 21].
unclear as to whether a right under section 7 can actually be waived, it is well established that a
waiver or a renunciation of any right under the Charter must be voluntary, freely expressed and
accompanied with a clear understanding of the purpose the right was meant to serve and the
consequences of declining its protection. There is no evidence whatsoever that the patients of
Insite who suffer from addiction, knowingly and unequivocally waived their rights under the
Charter, and more specifically their right to access medical treatment.
See e.g. Godbout v. Longueuil (City),  3 S.C.R. 844, at paras. 71-72; Syndicat Northcrest
v. Amselem,  2 S.C.R. 551, at paras. 96-102; R. v. Richard,  3 S.C.R. 525, at
paras. 22-26; R. v. L.T.H.,  2 S.C.R. 739, at paras. 41-42; R. v. Clarkson,  1 S.C.R.
383 at 394-396; Korponay v. Canada (Attorney General),  1 S.C.R. 41 at 49; Yorkton
Union Hospital v. S.U.N. (1993), 16 Admin. L.R. (2d) 272, at para. 44 (C.A.) [CMA
Authorities, Tabs 3, 17, 15, 11, 8, 4, 18 respectively].
30. Indeed, Canadians do not forego their right to health care or to protection from section 7
violations because of their "choice" of lifestyles. The Appellants' position that addicts must take
responsibility for the choice they make undermines the raison d'être of the Canadian health care
system, namely (as found by the Applications Judge and the Court of Appeal) the fundamental
right of Canadians to access medical treatment and the ethical and clinical responsibilities of
their health care providers.
31. The Appellants' position skirts the clinical question at issue for physicians and their
patients: 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. In Canada,
neither the ethical obligations of physicians to treat patients, nor the patients' legal right to
treatment, are subject to a moral assessment of a patient's lifestyle. Behaviours that might be
deemed "risky" do not deprive patients of their rights of access to clinically required medical
32. Section 31 of CMA's Code of Ethics (relied on by the Court in the past e) provides that all
physicians must "[r]ecognize the responsibility of physicians to promote fair access to health
care resources". The patients at Insite would be deprived of positive health outcomes if Insite
were to close or even continue to operate under the ongoing threat of closure.
33. Adopting the Appellants' approach to Charter interpretation would set an extremely
dangerous precedent. Thus, if one were to apply the rationale of "choice" to other medical
2 See e.g. R. v. Dersch,  3 S.C.R. 768 at 784-785, where the Court refers to CMA's Code of Ethics [CMA
Authorities, Tab 9].
contexts, such as chronic disease, patients suffering from diabetes because of contributing factors
such as poor nutrition and lack of exercise would, under the same logic, be denied medical care.
Indeed, many of the complex elements beyond individual choice such as socio-economic and
genetic factors found by the Applications Judge in the case at bar to shape addiction as an ilness
are prevalent in other diseases. This approach would be not only unethical and clinically
unsound, but unconstitutionaL.
(4) The Rights to Liberty of the Individual Respondents Have Been Infringed
34. The courts have recognized that the threat of criminal prosecution and possibility of
imprisonment for an offence is suffcient to trigger the liberty interest and scrutiny under
Malmo-Levine, supra at para. 84 ICMA Authorities, Tab 12).
R. v. Parker (2000),188 D.L.R. 4th 385, at para. 101 (Ont. C.A.) ICMA Authorities, Tab 14).
35. Vulnerable patients suffering from addiction and the health care providers who provide
treatment at Insite suffer violations of their constitutionally guaranteed rights (section 7 of the
Charter) because of the threat of prosecution under the Act. The uncertainty associated with a
ministerial exemption mechanism for Insite from certain provisions of the Act imposes a great
burden on those already labouring under the weight of addiction. Moreover, health care
providers are also put at risk in their ability to provide medically necessary and evidence-based
health care services in a timely manner to all citizens by the capricious exemption mechanism
contained in the Act.
(5) The Principles of Fundamental Justice Have Not Been Respected
36. It is well established that a law that is arbitrary or overbroad will constitute a breach of
the principles of fundamental justice. The CMA submits that the Applications Judge was correct
when he found that the impugned provisions were arbitrary, or if not arbitrary, grossly
disproportionate and overbroad. The Court of Appeal agreed that the provisions were overbroad.
P. Hogg, Constitutional Law of Canada, 5th ed., loose-leaf (Carswell: Toronto, 2007) at 47-52
to 47-60.1 ICMA Authorities, Tab 19).
R. v. Heywood, (1994) 3 S.c.R. 761 at 792-794 ICMA Authorities, Tab 10).
Chaoull, supra at para. 127 ICMA Authorities, Tab 2).
Rodriguez, supra at 590-591 ICMA Authorities, Tab 16).
a) The Impugned Provisions Are Arbitrary
37. A law is arbitrary when it bears no relation to, or is inconsistent with, the objective that
lies behind it. In order not to be arbitrary, a limit on the section 7 right requires not only a
theoretical connection between the limit and the legislative goal, but a real connection on the
Chaoulli, supra at paras. 130-131 [CMA Authorities, Tab 2].
38. In the present case, by prohibiting access to evidence-based, medically necessary care,
the government has contributed to the very harm it claims it seeks to prevent, i.e. drug possession
and addiction. The best available medical evidence suggests that clinics such as Insite not only
protect life, but offer positive health outcomes and care alternatives to vulnerable patients.
39. Moreover, the justification of any denial of access to necessary medical care based on
ideology rather than facts is arbitrary since, by definition, it bears no real connection to the facts.
b) The Impugned Provisions Are Overbroad
40. It is a well-established principle of fundamental justice that criminal legislation must not
be overbroad. If the government, in pursuing a legitimate objective, uses means which are
broader than is necessary to accomplish that objective, the principles of fundamental justice will
Heywood, supra at 792-793 [CMA Authorities, Tab 10].
See also Malmo-Levine, supra at paras. 130-131 [CMA Authorities, Tab 12].
41. A fortiori, that will be true when the state itself has a particular interest in acting to
protect vulnerable persons. In the present case, the evidence before the Applications Judge
demonstrated that harm reduction has been a component of Canada's drug strategy for many
years. In 2002, the House of Commons Special Committee on the Non-Medical Use of Drugs
rejected the dichotomy between harm reduction and an abstinence-based treatment model. It also
specifically considered the creation of a safe injection facility in the downtown east side of
Vancouver because it recognized that that community presented a "public health disaster".
42. Hence, while the government may be justified in preventing drug possession and
trafficking, it cannot cast a legislative prohibition so widely that it captures persons in need of
C. If There is an Infringement of Section 7, the Law is Not Saved by Section 1 of the
43. Should the Court find that sections 4(1) and 5(1) of the Act infringe the rights guaranteed
Guy Pratt /Nadia ffend
Borden L dner Gervais L
by section 7 of the Charter, the CMA submits that the provisions cannot be justified under
section 1 of the Charter as any law that offends the principles of fundamental justice cannot be
justified, and more specifically, meet the minimal impairment branch of the section 1 analysis.
See e.g. New Brunswick (Minister of Health and Community Services) v. G. (J.),  3
S.C.R. 46, at para. 99 [CMA Authorities, Tab 6]; Heywood, supra at 802-803 [CMA
Authorities, Tab 10].
44. Fundamental justice requires either permanent exemptions or a declaration that the
impugned law, as it applies to users of supervised injection sites, is invalid. The CMA submits
that this position is consistent with sound constitutional interpretation of section 7 of the Charter,
while protecting the most vulnerable patient populations in accordance with evidence-based
medicine and physicians' ethical obligations.
PART IV — SUBMISSIONS AS TO COSTS
45. The CMA seeks no costs and asks that none be awarded against it.
PART V — ORDER SOUGHT
46. The CMA submits that constitutional questions two and four should be answered
affirmatively. Should the Court answer these questions in the affirmative, however,
constitutional questions three and five should be answered negatively.
47. The CMA seeks leave of this Court, pursuant to rule 59(2) of the Rules of the Supreme
Court of Canada, to present oral argument at the hearing of this appeal.
Rules of the Supreme Court of Canada, SOR/83-74, as amended, Rule 59(2) [Part VII of
ALL OF WHICH IS RESPECTFULLY SUBMITTED THIS 13th DAY OF APRIL, 2011.
OTTO1 \ 4423086 \ 7
PART VI — TABLE OF AUTHORITIES
TAB SOURCES Paras. in factum
1. Auton (Guardian a litem of) v. British Columbia (Attorney
General),  3 S.C.R. 657
2. Chaoulli v. Quebec (Attorney General),  1 S.C.R. 791 17, 21, 23, 36, 37
3. Godbout v. Longueuil (City),  3 S.C.R. 844 29
4. Korponay v. Canada (Attorney General),  1 S.C.R. 41 29
5. MacKay v. Manitoba,  2 S.C.R. 357 20
6. New Brunswick (Minister of Health and Community Services) v.
G. (J.),  3 S.C.R. 46
7. Operation Dismantle Inc. v. The Queen,  1 S.C.R. 441 23
8. R. v. Clarkson,  1 S.C.R. 383 29
9. R. v. Dersch,  3 S.C.R. 768 32
10. R. v. Heywood,  3 S.C.R. 761 36, 40, 43
11. R. v. L.T.H.,  2 S.C.R. 739 29
12. R. v. Malmo-Levine; R. v. Caine,  3 S.C.R. 571 28, 34, 40
13. R. v. Morgentaler,  1 S.C.R. 30 17, 18
14. R. v. Parker (2000), 188 D.L.R. 4th 385 (Ont. C.A.) 34
15. R. v. Richard,  3 S.C.R. 525 29
16. Rodriguez v. British Columbia (Attorney General),  3
17. Syndicat Northcrest v. Amselem,  2 S.C.R. 551 29
18. Yorkton Union Hospital v. S. UN. (1993), 16 Admin. L.R. (2d)
272 (Sask. C.A.)
TAB SOURCES Paras.
19. Hogg, P., Constitutional Law of Canada, 5th ed., loose-leaf
(Carswell: Toronto, 2007) at 47-52 to 47-60.1.
20. Taylor, M. and Jamal, M., The Charter of Rights in Litigation,
loose-leaf (Canada Law Book: Aurora, 2010) at para. 17:15
PART VII — STATUTES, REGULATIONS, RULES
Canadian Charter of Rights and Freedom, sections 1 and 7
Controlled Drugs and Substances Act, S.C. 1996, c. 19, sections 4(1), 5(1), 56
Rules of Supreme Court of Canada, SOR/83-74, as amended, Rule 59
Canadian Charter of Rights and
PART I OF THE CONSTITUTION ACT,
Charte canadienne des droits et libertes
PARTIE I DE LA LOI
CONSTITUTIONNELLE DE 1982
Rights and freedoms in Canada
1. The Canadian Charter of Rights and
Freedoms guarantees the rights and
freedoms set out in it subject only to such
reasonable limits prescribed by law as can
be demonstrably justified in a free and
Life, liberty and security of person
7. Everyone has the right to life, liberty
and security of the person and the right not
to be deprived thereof except in
accordance with the principles of
Droits et libertes au Canada
1. La Charte canadienne des droits et
libertes garantit les droits et libertós qui y
sont enonces. Its ne peuvent etre restreints
que par une regle de droit, dans des limites
qui soient raisonnables et dont la
justification puisse se demontrer dans le
cadre d'une society libre et democratique.
Vie, liberte et securite
7. Chacun a droit a la vie, a la liberte et
a la securite de sa personne; it ne peut etre
porte atteinte a ce droit qu'en conformite
avec les principes de justice fondamentale.
Controlled Drugs and Substances Act
S.C. 1996, c. 19
Possession of substance
4. (1) Except as authorized under the
regulations, no person shall possess a
substance included in Schedule I, II or III.
Trafficking in substance
5. (1) No person shall traffic in a substance
included in Schedule I, II, III or IV or in any
substance represented or held out by that
person to be such a substance.
Exemption by Minister
56. The Minister may, on such terms and
conditions as the Minister deems necessary,
exempt any person or class of persons or any
controlled substance or precursor or any class
thereof from the application of all or any of the
provisions of this Act or the regulations if, in
the opinion of the Minister, the exemption is
necessary for a medical or scientific purpose or
is otherwise in the public interest.
Loi reglementant certaines drogues et autres
L.C. 1996, ch. 19
Possession de substances
4. (1) Sauf dans les cas autorises aux
termes des reglements, la possession de toute
substance inscrite aux annexes I, II ou III est
Trafic de substances
5. (1) Il est interdit de faire le trafic de
toute substance inscrite aux annexes I, II, III ou
IV ou de toute substance presentee ou tenue
pour telle par le trafiquant.
Exemption par le ministre
56. S'il estime que des raisons medicales,
scientifiques ou d'interet public le justifient, le
ministre peut, aux conditions qu'il fixe,
soustraire a l'application de tout ou partie de la
presente loi ou de ses reglements toute
personne ou categorie de personnes, ou toute
substance designee ou tout precurseur ou toute
categorie de ceux-ci.
Rules of the Supreme Court of Canada
(in force on October 13, 2006)
Regles de la Cour supreme du Canada.
(en vigueur le 13 octobre 2006)
59. (1) In an order granting an intervention, the
(a) make provisions as to additional
disbursements incurred by the appellant or
respondent as a result of the intervention; and
(b)impose any terms and conditions and grant
any rights and privileges that the judge may
determine, including whether the intervener is
entitled to adduce further evidence or
otherwise to supplement the record.
(2)In an order granting an intervention or after
the time for filing and serving all of the
memoranda of argument on an application for
leave to appeal or the facta on an appeal or
reference has expired, a judge may, in their
discretion, authorize the intervener to present
oral argument at the hearing of the application
for leave to appeal, if any, the appeal or the
reference, and determine the time to be allotted
for oral argument.
(3)An intervener is not permitted to raise new
issues unless otherwise ordered by a judge.
59. (1) Dans l'ordonnance octroyant
l'autorisation d'intervenir, le juge petit :
a) prevoir comment seront supportes les
&pens supplementaires de l'appelant ou de
l'intime resultant de l'intervention;
b) imposer des conditions et octroyer les droits
et privileges qu'il determine, notamment le
droit d'apporter d'autres elements de preuve ou
de completer autrement le dossier.
(2)Dans l'ordonnance octroyant l'autorisation
d'intervenir ou aprês l'expiration du Mai de
depOt et de signification des memoires de
demande d'autorisation d'appel, d'appel ou de
renvoi, le juge peut, a sa discretion, autoriser
l'intervenant a presenter une plaidoirie orale a
l'audition de la demande d'autorisation
d'appel, de l'appel ou du renvoi, selon le cas,
et determiner le temps alloue pour la plaidoirie
(3) Sauf ordonnance contraire d'un juge,
l'intervenant n'est pas autorise a soulever de
Older Canadians represent the fastest-growing segment of our population and are the largest users of prescription drugs. Seniors take more drugs than younger Canadians because, on average, they have a higher number of chronic conditions. According to the Canadian Institute for Health Information, in 2012, nearly two-thirds of seniors had claims for 5 or more drug classes, and more than one-quarter of seniors had claims for 10 or more drug classes. The number of drugs used by seniors increased with age.
The use of multiple medications, or polypharmacy, is of concern in the senior population. The risk of drug interactions and adverse drug reactions is several-fold higher for seniors than for younger people. This phenomenon is associated with pharmacokinetic and pharmacodynamics factors in seniors, including changes in renal and hepatic function, increased sensitivity to drugs and, potentially, multiple medical problems. In older persons, adverse drug reactions are often complex and may be the direct cause of hospital admissions for acute care. Cognitive and affective disorders, for example, may be due to adverse reactions to sedatives or hypnotic drugs. Chronic pain is a common issue, and it is important to carry out research into and education for health care providers concerning the unique challenges of managing pain in older adults.
The CMA supports the development of a coordinated national approach to reduce polypharmacy and prevent adverse drug reactions. Prescribers must be vigilant to optimize pharmacotherapy and in reconciling medications, taking into consideration physiological changes as a person ages. Deprescribing should be considered, reducing or stopping medications that may be harmful or no longer be of benefit, seeking to improve quality of life.
There has been considerable interest in determining which factors affect prescribing behavior and how best to influence these factors. Strategies that improve prescribing practices include evidence-based drug information provided through academic detailing; objective continuing medical education; accessible, user-friendly decision support tools available at point of care; and electronic prescribing systems that allow physicians access to their patient's treatment and medication profiles.
The following principles define the basic steps to appropriate prescribing for seniors.
Know the patient.
Know the diagnosis.
Know the drug history. Keep a medication list for each patient and review, update, reconcile and evaluate adherence at each visit. Instruct the patient to bring all prescription and over-the-counter medications, including medications prescribed by other physicians, and natural health products, to each appointment. In some provinces, pharmacists conduct medication use reviews for patients on public drug benefit programs.
Know the history of use of other substances such as alcohol, tobacco, cannabis, opioids and caffeine.
Consider non-pharmacologic therapy, including diet, exercise, psychotherapy or community resources. Continuing medical education in specific non-pharmacologic therapies is valuable. For example, evaluation and management of behavioural and psychological symptoms of dementia should be considered before anti-psychotic therapy. As well, Canadian standardized non-pharmacologic order sets should be developed for the treatment of delirium.
Know the drugs. Critically evaluate all sources of drug information and use multiple sources such as clinical practice guidelines, medical journals and databases, continuing medical education and regional drug information centres. Monitor patients continually for adverse drug reactions. Appropriate drug dosage depends on factors such as age, sex, body size, general health, concurrent illnesses and medications, and hepatic, renal and cognitive function (for example, older people are particularly sensitive to drugs that affect the central nervous system).
Keep drug regimens simple. Avoid mixed-frequency schedules when possible. Try to keep the number of drugs used for long-term therapy under five to minimize the chance of drug interactions and improve adherence.
Establish treatment goals. Determine how the achievement of goals will be assessed. Regularly re-evaluate goals, adequacy of response and justification for continuing therapy. Time to benefit of prescribed medications should be a key consideration when providing care to seniors at end of life.
Encourage patients to be responsible medication users. Verify that the patient and, if necessary, the caregiver, understands the methods and need for medication. Recommend the use of daily or weekly medication containers, calendars, diaries or other reminders, as appropriate, and monitor regularly for compliance. Encourage the use of one dispensary.
The Institute for Safe Medication Practices Canada has developed a program, Knowledge is the best medicine (https://www.knowledgeisthebestmedicine.org), that can be helpful to seniors and their healthcare team manage medicines safely and appropriately.
Approved by the Board on May 28, 2011
Update approved by the Board on March 02, 2019