Re: Future Mandate of the Health Care Innovation Working Group (the Council of the Federation)
On behalf of the Canadian Nurses Association (CNA) and the Canadian Medical Association (CMA), I am writing in advance of the meeting of the Council of the Federation later this month regarding the future mandate of the Health Care Innovation Working Group with respect to seniors care.
The CNA and CMA welcomed the Council of the Federation's prioritization of seniors care as an area of focus of the Health Care Innovation Working Group. Already, seniors and their families in communities across Canada face significant challenges accessing social supports and health services. These challenges will only intensify as the demographic shift progresses. Based on current trends and approaches, the proportion of provincial/territorial health spending associated with seniors care is forecast to grow by over 15% to almost 62% of health budgets by 2036.
Recognizing the significant pressure this will present for health care systems and provincial/territorial budgets moving forward, it is critical that the Council of the Federation maintain its prioritization of seniors care and meeting the needs of an aging population. As such, we respectfully encourage you in your capacity as Co-Chairs of the Health Care Innovation Working Group to ensure the future mandate of the working group on seniors care be included as part of the agenda at the January 30, 2015 meeting of the Council of the Federation.
The CNA and CMA are actively engaged on this issue and welcome the opportunity to meet with each of you to discuss how we may collaborate to ensure improved health outcomes for seniors, now and in the future.
Christopher S. Simpson, MD, FRCPC, FACC, FHRS
Karima Velji, RN, PhD, CHE
The Canadian Medical Association (CMA) is pleased to present its brief to the House of Commons Standing Committee on Health for consideration as part of its study of "Best Practices and Federal Barriers: Practice and Training of Health Professionals".
The subject under discussion is relevant to both parts of the CMA's mission. The CMA has undertaken considerable activity on the issue. For example, in 2012 and 2013 we participated, with the Canadian Nurses Association and the Health Action Lobby (HEAL) on the Council of the Federation's (CoF) working group on Team-based Care. For many years, the CMA has conducted the National Physician Survey, which develops comprehensive information on physician demographics and practice patterns.
In the past decade a number of health professions have expanded their scopes of practice. In most provinces, for example, pharmacists can now renew prescriptions or provide emergency prescription refills. Ontario has established nurse-practitioner-led primary health care clinics which collaborate with family physicians and others in the community. Nova Scotia has experimented with using paramedics as first-contact primary caregivers in rural or remote areas. Governments expand scopes of practice for a number of possible reasons: cost-effectiveness (i.e. replacing one health professional with a less expensive one); improving access, particularly in areas underserviced by physicians; increasing convenience for patients (for example, allowing a neighbourhood pharmacist to give a flu shot may save the patient from taking time off work for a doctor's appointment): or responding to lobbying by health provider groups.
The CMA believes that ideally, every health care provider should have a scope of practice that is consistent with his or her education and training, and that the health care system should enable them to practice to the fullest extent of this scope. More importantly, the scope of practice of every health professional should enable them to contribute optimally to providing high quality patient-centered care without compromising patient safety. Indeed, the primary reason for expanding the scope of practice of a health professional should be to improve Canadians' health and health care.
In the following pages we will discuss several specific topics related to the Scope of Practice issue, and make recommendations for a possible federal role in supporting best practices among health professionals.
1. A Canada-Wide Approach to Scopes of Practice
Scopes of practice are determined largely by provincial and territorial governments, and each jurisdiction has developed its own regulations regarding what health professional groups may do and under what circumstances. This has led to inconsistency across the country. For example, about half the jurisdictions in Canada allow pharmacists to order laboratory tests and prescribe for minor ailments; provinces vary in the degree to which they fund nurse
practitioner positions; and there is wide variation in how, and even if, physician assistants are regulated.
While recognizing that the authority to determine scopes of practice rests with provincial/territorial governments, CMA believes that it is desirable to work toward consistency in access to health services across Canada.
Recommendation 1: that the federal government work with provincial/territorial governments and with health professional associations to promote a consistent national approach to scope-of-practice expansions
2. Promoting and Facilitating Team-Based Care
The scopes-of-practice issue is closely related to the development of models for team-based care, a development that CMA supports. When Canadians seek health care today, it is mainly to help them maintain their health or to manage chronic diseases. This trend is expected to continue as the population ages and the rate of chronic disease rises correspondingly. For patients who have multiple chronic diseases or disabilities, care needs can be complex and a number of different health and social-services professionals may be providing care to the same person. A patient might, for example, be consulting a family physician for primary health care, several medical specialists for different conditions, a pharmacist to monitor a complex medication regime, a physiotherapist to help with mobility difficulties, health care aides to make sure the patient is eating properly or attending to personal hygiene, and a social worker to make sure his or her income is sufficient to cover health care and other needs.
The complexity of today's health care requires that the system move away from the traditional "silo" method of delivering care and encourage health professionals to work collaboratively to effectively meet patients' needs. The CMA believes that the following factors contribute to the success of inter-professional care:
Patient access to a primary care provider who is familiar with the patient's needs and preferences, and has responsibility for the overall care of the patient, co-ordinating the various providers involved in this care. For more than 30 million Canadians, that primary care provider is a family physician. The College of Family Physicians of Canada believes that family practices can serve as patient's "medical home," in which care is anchored and co-ordinated by a family physician, with access to other health care providers as required.
Mechanisms that encourage collaboration and communication among providers. These include:
o Interdisciplinary primary care practices, such as Family Health Networks in Ontario, which permit patients to access a variety of different health professionals and their expertise from one practice setting;
Widespread use of the electronic health record, which can facilitate information sharing and communication among providers.
A smooth, seamless process for referral from one provider to another.
Role clarity and mutual trust. Each health professional on a care team should have a clear understanding of their own roles and the roles of other team members.
The CoF's Team-Based Care Working Group investigated the critical factors for successful team based care, and identified models in certain provinces that it believed should be considered for rollout across Canada. This rollout could be enhanced if it were encouraged by all governments, including the Government of Canada. In the past, Health Canada has supported demonstration projects in health system reform through the National Primary Care Research Group. The CMA believes that the federal government could take a similar role in future, in supporting and disseminating promising models of inter-professional practice. The dissemination process should be accompanied by a process to rigorously evaluate the effect of such models on health outcomes, quality of patient care, and health care costs.
Recommendation 2: that the Government of Canada support research into and evaluation of innovative models of team-based care, and actively promote the dissemination of successful models nationwide.
Recommendation 3: that Canada Health Infoway work with provinces and territories to increase the adoption of electronic medical records at the point of care and build connectivity among points of care.
3. A Health-Care System That Supports Best Practices in Team-Based Care
We have already discussed the part that governments could play in identifying, disseminating and evaluating models of inter-professional practice. The health care system's planners, funders and managers can also foster team-based care in other ways, such as:
Promoting education in inter-professional care. As the Committee has heard, the Association of Faculties of Medicine of Canada's guiding principles for medical education include valuing inter-professionalism and incorporating it into residency learning and practice. CMA encourages the development of programs to help new physicians and other health professionals acquire the skills needed to function optimally an in inter-professional setting.
Improving access to health services not funded under the Canada Health Act. At present, patients who do not have private health care coverage must pay out of pocket for physiotherapy, dietitian services, mental health care and most social services. This works against the principles of inter-professional care by hindering access to necessary services; this could compromise patient health and safety.
Undertaking an open and meaningful consultation process when changes to scopes of practice are proposed. CMA's experience has been that physicians are more accepting of changes in other professions' scopes of practice if their medical associations have been involved in negotiation on these changes.
Ensuring that the supply of health professionals in Canada is sufficient to the needs of Canadian patients, by developing, implementing and monitoring human resource plans for all major health professions.
Recommendation 4: that the federal government work with provincial/territorial government and national health professional associations to develop and implement a health human resources plan that ensures Canadians' access to all appropriate health care providers.
In conclusion, the Canadian Medical Association recognizes that the great majority of decisions regarding scopes of practice are made at the provincial/territorial level. But we believe that in order to encourage a Canadian health-care system in which all providers work together, contributing their unique skills and expertise to providing patient-centered, seamless, cost-effective care, the support and encouragement of the federal government will be extremely beneficial.
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
Helping physicians care for patients
Aider les médecins à prendre soin des patients
Canada is a nation on the precipice of great change. This change will be driven primarily by the economic and social implications of the major demographic shift already underway. The added uncertainties of the global economy only emphasize the imperative for federal action and leadership.
In this brief, the Canadian Medical Association (CMA) is pleased to present four recommendations to the House of Commons Standing Committee on Finance for meaningful federal action in support of a national seniors strategy; these are essential measures to prepare for an aging population.
Canada's demographic and economic imperative
In 2011 the first of wave of the baby boomer generation turned 65 and Canada's seniors population stood at 5 million.1 By 2036, seniors will represent up to 25% of the population.2 The impacts of Canada's aging population on economic productivity are multi-faceted.
An obvious impact will be fewer workers and a smaller tax base. Finance Canada projects that the number of working-age Canadians for every senior will fall from about 5 today to 2.7 by 2030.3
The projected surge in demand for services for seniors that will coincide with slower economic growth and lower government revenue will add pressure to the budgets of provincial and territorial governments. Consider that while seniors account for about one-sixth of the population, they consume approximately half of public health spending.4 Based on current trends and approaches, seniors' care is forecast to consume almost 62% of provincial/territorial health budgets by 2036.5
The latest fiscal sustainability report of the Parliamentary Budget Officer explains that the demands of Canada's aging population will result in "steadily deteriorating finances" for the provinces and territories and they "cannot meet the challenges of population ageing under current policy."6
Theme 1: Productivity
A) New federal funding to provincial/territorial governments
Canada's provincial and territorial leaders are aware of the challenges ahead. This July, the premiers issued a statement calling for the federal government to increase the Canada Health Transfer to 25% of provincial and territorial health care costs to address the needs of an aging population.
To support the innovation and transformation needed to address these needs, the CMA recommends that the federal government deliver additional funding on an annual basis beginning in 2016-17 to the provinces and territories by means of a demographic-based top-up to the Canada Health Transfer (Table 1). For the fiscal year 2016-17, this top-up would require $1.6 billion in federal investment.
Table 1: Allocation of the federal demographic-based top-up, 2016-20 ($million)7
All of Canada
Newfoundland and Labrador
Prince Edward Island
B) Federal support for catastrophic drug coverage
A major gap in Canada's universal health care system is the lack of universal access to prescription medications, long recognized as the unfinished business of medicare. Canada stands out as the only country with universal health care without universal pharmaceutical coverage.8
According to the Angus Reid Institute, more than one in five Canadians (23%) report that they or someone in their household did not take medication as prescribed because of the cost during the past 12 months.9 Statistics Canada's Survey of Household Spending reveals that households headed by a senior spend $724 per year on prescription medications, the highest among all age groups and over 60% more than the average household.10 Another recent study found that 7% of Canadian seniors reported skipping medication or not filling a prescription because of the cost.11
In addition to the very real harms to individuals, lack of coverage contributes to the inefficient use of Canada's scarce health resources. While there are sparse economic data in Canada on this issue, earlier research indicated that this inefficiency, which includes preventable hospital visits and admissions, represents an added cost of between $1 billion and $9 billion annually.12
As an immediate measure to support the health of Canadians and the productivity of the health care sector, the CMA recommends that the federal government establish a new funding program for catastrophic coverage of prescription medication. The program would cover prescription medication costs above $1,500 or 3% of gross household income on an annual basis. Research commissioned by the CMA estimates this would cost $1.48 billion in 2016-17 (Table 2). This would be a positive step toward comprehensive, universal prescription drug coverage.
Table 2: Projected cost of federal contribution to cover catastrophic prescription medication costs, by age cohort, 2016-2020 ($ million)13
Share of total cost
Under 35 years
35 to 44 years
45 to 54 years
55 to 64 years
65 to 74 years
75 years +
Theme 2: Infrastructure and communities
All jurisdictions across Canada are facing shortages in the continuing care sector. Despite the increased availability of home care, research commissioned for the CMA indicates that demand for continuing care facilities will surge as the demographic shift progresses.14
In 2012, it was reported that wait times for access to a long-term care facility in Canada ranged from 27 to over 230 days. It is estimated that 85% of "alternate level of care" patients in hospitals (i.e., patients who do not require hospital-level care) are in these beds because of the lack of availability of long-term care. Due to the significant difference in the cost of hospital care (approximately $846 per day) versus long-term care ($126 per day), the CMA estimates that the shortages in the long-term care sector represent an increased cost of $2.3 billion.
Despite the recognized need for infrastructure investment in the continuing care sector, to date, this sector has been excluded from the Building Canada Plan. The CMA recommends that the federal government amend the criteria of the Building Canada Plan to include capital investment in continuing care infrastructure, including retrofit and renovation. Based on previous estimates, the CMA recommends that $540 million be allocated for 2016-17 (Table 3).
Table 3: Estimated cost to address forecasted shortage in long-term care beds, 2016-20 ($ million)15
Forecasted shortage in long-term care beds
Estimated cost to address shortage
Federal share to address shortage in long-term care beds (based on 1/3 contribution)
Theme 3: Jobs
As previously mentioned, Canada's aging population will produce significant changes in the labour force. There will be fewer Canadian workers, each with a greater likelihood of having caregiving responsibilities for family and friends.
According to the report of the federal Employer Panel for Caregivers, Canadian employers "were surprised and concerned that it already affects 35% of the Canadian workforce."16 This report highlights key findings of the 2012 General Social Survey: 1.6 million caregivers took leave from work; nearly 600,000 reduced their work hours; 160,000 turned down paid employment; and, 390,000 quit their jobs to provide care. It is estimated that informal caregiving represents $1.3 billion in lost workforce productivity. These costs will only increase as Canada's demographic shift progresses.
In parallel to the increasing informal caregiving demands on Canadian workers, Canada's aging population will also increase the demand for personal care workers and geriatric competencies across all health and social care professions.17
Theme 4: Taxation
The above section focused on the economic costs of caregiving on the workforce. The focus of this section will be on the economic value caregivers provide while they take on an increased economic burden.
Statistics Canada's latest research indicates that 8.1 million Canadians are informal caregivers, 39% of whom primarily care for a parent.18 The Conference Board of Canada reports that in 2007 informal caregivers contributed over 1.5 billion hours of home care - more than 10 times the number of paid hours in the same year.19 The economic contribution of informal caregivers was estimated to be about $25 billion in 2009.20 This same study estimated that informal caregivers incurred over $80 million in out-of-pocket expenses related to caregiving in 2009.
Despite their tremendous value and important role, only a small fraction of caregivers caring for a parent received any form of government support.21 Only 5% of caregivers providing care to parents reported receiving financial assistance while 28% reported needing more assistance than they received.22
As a first step to providing increased support for Canada's family caregivers, the CMA recommends that the federal government amend the Caregiver and Family Caregiver Tax Credits to make them refundable. This would provide an increased amount of financial support for family caregivers. It is estimated that this measure will cost $90.8 million in 2016-17.23
The CMA recognizes that in the face of ongoing economic uncertainty the federal government may face pressures to avoid new spending initiatives. The CMA strongly encourages the federal government to adopt the four recommendations outlined in this submission rather than further delay making a meaningful contribution to meeting the future care needs of Canada's aging population. The CMA would welcome the opportunity to provide further information and its rationale for each recommendation.
1 Statistics Canada. Generations in Canada. Cat. No. 98-311-X2011003. Ottawa: Statistics Canada; 2012. Available: www12.statcan.gc.ca/census-recensement/2011/as-sa/98-311-x/98-311-x2011003_2-eng.pdf
2 Statistics Canada. Canada year book 2012, seniors. Available: www.statcan.gc.ca/pub/11-402-x/2012000/chap/seniors-aines/seniors-aines-eng.htm
3 Finance Canada. Economic and fiscal implications of Canada's aging population. Ottawa: Finance Canada; 2012. Available: www.fin.gc.ca/pub/eficap-rebvpc/eficap-rebvpc-eng.pdf
4 Canadian Institute for Health Information. National health expenditure trends, 1975 to 2014. Ottawa: The Institute; 2014. Available: www.cihi.ca/web/resource/en/nhex_2014_report_en.pdf
5 Calculation by the Canadian Medical Association, based on Statistics Canada's M1 population projection and the Canadian Institute for Health Information age-sex profile of provincial-territorial health spending.
6 Office of the Parliamentary Budget Officer. Fiscal sustainability report 2015. Ottawa: The Office; 2015. Available: www.pbo-dpb.gc.ca/files/files/FSR_2015_EN.pdf
7 Conference Board of Canada. Research commissioned for the CMA, July 2015.
8 Morgan SG, Martin D, Gagnon MA, Mintzes B, Daw JR, Lexchin J. Pharmacare 2020: The future of drug coverage in Canada. Vancouver: Pharmaceutical Policy Research Collaboration, University of British Columbia; 2015. Available: http://pharmacare2020.ca/assets/pdf/The_Future_of_Drug_Coverage_in_Canada.pdf
9 Angus Reid Institute. Prescription drug access and affordability an issue for nearly a quarter of Canadian households. Available: http://angusreid.org/wp-content/uploads/2015/07/2015.07.09-Pharma.pdf
10 Statistics Canada. Survey of household spending. Ottawa: Statistics Canada; 2013.
11 Canadian Institute for Health Information. How Canada compares: results From The Commonwealth Fund 2014 International Health Policy Survey of Older Adults. Available: www.cihi.ca/en/health-system-performance/performance-reporting/international/commonwealth-survey-2014
12 British Columbia Pharmacy Association. Clinical service proposal: medication adherence services. Vancouver: The Association; 2013. Available: www.bcpharmacy.ca/uploads/Medication_Adherence.pdf
13 Supra at note 7.
14 Conference Board of Canada. Research commissioned for the CMA, January 2013.
16 Government of Canada. Report from the Employer Panel for Caregivers: when work and caregiving collide, how employers can support their employees who are caregivers. Available: www.esdc.gc.ca/eng/seniors/reports/cec.shtml
17 Stall S, Cummings G, Sullivan T. Caring for Canada's seniors will take our entire health care workforce. Available: http://healthydebate.ca/2013/09/topic/community-long-term-care/non-md-geriatrics
18 Statistics Canada. Family caregivers: What are the consequences? Available: www.statcan.gc.ca/pub/75-006-x/2013001/article/11858-eng.htm
19 Conference Board of Canada. Home and community care in Canada: an economic footprint. Ottawa: The Board; 2012. Available: http://www.conferenceboard.ca/cashc/research/2012/homecommunitycare.aspx
20 Hollander MJ, Liu G, Chappeel NL. Who cares and how much? The imputed economic contribution to the Canadian health care system of middle aged and older unpaid caregivers providing care to the elderly. Healthc Q. 2009;12(2):42-59.
21 Supra at note 16.
23 Supra at note 7.
The Canadian Medical Association (CMA) is pleased to provide the information below in
response to questions by the Canada Revenue Agency (CRA) for consideration as part of the
development of regulations following the enactment of the Disability Tax Credit Promoters
Restriction Act. This information is in follow up to CMA’s submission to the CRA dated
December 19, 2014, attached for reference.
As explained in the CMA’s submission attached, the CMA strongly encourages the CRA to
include an exemption for “a health care practitioner duly licensed under the applicable
regulatory authority who provides health care and treatment” from the reporting requirements
in the forthcoming regulations enabled by the Disability Tax Credit Promoters Restriction Act.
This exemption is necessary to ensure CRA does not impose duplicative regulatory oversight
of the medical profession, specific to the provision of this uninsured service. As fully explained
in the CMA’s brief, this exemption would not introduce a potential “loophole”.
Issue 1: Organizations Responsible for Physician Regulatory Oversight
The statutory authority for the regulatory oversight of physicians rests with the provincial and
territorial medical regulatory colleges. As explained on page 4 of the CMA’s submission,
medical regulatory colleges have statutory, comprehensive regulatory authority of physicians;
this authority captures: medical licensure, governing standards of practice, professional
oversight, and disciplinary proceedings. Included in this authority is broad regulatory
oversight for fees that physicians may charge for uninsured services, which would capture the
fee charged for the Disability Tax Credit form. The Federation of Medical Regulatory
Authorities of Canada (FMRAC) is the umbrella organization representing provincial and
territorial medical regulatory authorities in Canada and can address how best to contact
individual regulatory colleges.1
Issue 2: CMA’s Code of Ethics
In addition to policies, guidance and oversight by provincial and territorial regulatory
colleges, charging a fee associated with the delivery of an uninsured service, in this case a
fee associated with completing the form associated with the Disability Tax Credit, is captured
by Section 16 of the CMA’s Code of Ethics. Section 16 states: “In determining professional
fees to patients for non-insured services, consider both the nature of the service provided and
the ability of the patient to pay, and be prepared to discuss the fee with the patient.”2
Issue 3: Fee Structure for Uninsured Services
As the CRA does not provide remuneration to physicians for the completion of the Disability
Tax Credit form, the delivery of this service by physicians is an uninsured service. As an
uninsured service there is no set fee level. While provincial and territorial medical associations
Canadian Medical Association 3
May 15, 2015
may provide guidance to physicians within their jurisdiction on uninsured services, which may
be referenced in policies by regulatory colleges, this guidance does not constitute a set fee
schedule. As captured in the CMA’s Code of Ethics referenced above, physicians may
consider patient-specific and other factors in determining a fee for the delivery of an
uninsured service. The CMA encourages CRA to review relevant policies and guidance of
individual provincial and territorial regulatory colleges for a comprehensive understanding of
the oversight of uninsured services.
Once again, the CMA appreciates the opportunity to provide further information to support
the development of regulations to enable the new authorities of the Disability Tax Credit
Promoters Restriction Act and to ensure that CRA does not impose redundant and duplicative
regulatory oversight of the medical profession.
1 FMRAC’s Executive Director is Dr. Fleur-Ange Lefebvre and can be reached at firstname.lastname@example.org
2 CMA’s Code of Ethics may be accessed here: https://www.cma.ca/Assets/assetslibrary/