ACCESSIBILITY: THE SOLUTION
LIES IN COOPERATION
Joint Brief of
The Quebec Medical Association and the Canadian Medical Association
BILL no. 20:
An Act to enact the Act to promote access to family medicine and specialized medicine services and to amend various legislative provisions relating to assisted procreation
March 25, 2015
We would like to thank the members of the Committee on Health and Social Services for giving the Quebec Medical Association (QMA) and the Canadian Medical Association (CMA) the opportunity to express their preliminary views on Bill 20. We use the word "preliminary" deliberately because the bill in its current form sets out broad principles but is lacking in specifics. We would have liked to see more transparency on the government's part early in the process, whereas the regulatory guidelines were only made public on March 19. This shows a lack of respect or courtesy, or is a deliberate expression of the government's determination to ignore the opinion of the professionals concerned, that is to say, physicians.
We have chosen not to critique the bill clause by clause, so we will not go that route for the regulatory guidelines either. We will instead limit ourselves to a few general comments.
For example, how was it determined that an HIV-positive patient is "worth" two vulnerable patients, or that a patient receiving end-of-life care at home is worth 25? Why not 22, 26, or 30? Only ministry insiders know for sure, since neither of our organizations was consulted. And how many civil servants will it take to measure and monitor this new form of "mathematical" medical practice?
The QMA is the only Quebec association whose members include general practitioners, specialists, residents and medical students. It calls on its vast network of members to consider the issues the medical profession faces, propose solutions and innovate in order to rethink the role doctors play in society and continually improve medical practice.
The CMA is the largest national association of Canadian physicians and advocates on their behalf at the national level. The association's mission is to help physicians care for patients. The CMA is a leader in engaging and serving physicians and the national voice for the highest standards for health and health care.
This brief is a historic first for both organizations. This is the first time that the CMA has submitted a brief in Quebec's National Assembly as well as the first time that the QMA and CMA have submitted a joint brief.
This joint initiative says a lot about how concerned the country's physicians are about Bill 20. This attack on the professional autonomy of physicians is unprecedented in the history of Canadian organized medicine. Undoubtedly, the issues speak to the entire medical profession because of the consequences the bill could have on the profession itself.
Our input is intended to be realistic, constructive and reflective of our member's opinions and legitimate concerns.
Our two organizations-which, we note, are not negotiating bodies-have a profound understanding of the health community in Quebec, Canada and internationally.
In keeping with the tradition of our two organizations, we are constantly seeking ways to improve the health care system in order to bring about patient-centred care. That said, we are also well aware of the budget constraints Quebec is currently facing.
Our comments will mainly address the following points:
o Access to family physicians and specialists;
o The "productivity" of Quebec physicians;
o Examples elsewhere in Canada;
o Success factors.
Obviously, access to health care and services in Quebec is a problem, particularly with regard to family physicians.
Statistics Canada reported that, in 2013, an average 15.5% of Canadians did not have a regular medical doctor1. Quebec, with 25.1% of residents lacking a family physician, was well above the national average. All four of the Atlantic Provinces as well as Ontario provided better access than Quebec while Manitoba and British Columbia reported rates that were about the same as the national average.
Despite considerable investment in recent years, plainly many Quebecers still do not have access to a family physician and other specialists. We do not believe the status quo is an option. Something must be done.
Unlike as provided in Bill 20, however, we do not believe that imposing patient quotas on physicians is the solution. Quotas could have the adverse effect of leading physicians to choose quantity of care over quality, which could result in incomplete examinations, increased use of diagnostic tests and, ultimately, overdiagnosis.
This is the sort of practice that the QMA and CMA have been trying to eliminate for 18 months with their "Choosing Wisely Canada"2 awareness campaign, which advocates for better medicine and fewer tests and procedures of no added value. Overdiagnosis has significant impacts on cost, quality, effectiveness, efficacy and patient access to health care and, as a result, on the efficiency of the entire health care network. In short, doing more is not always better. The campaign has been embraced both by physicians and patients, but Bill 20 risks not only undermining considerable effort but also sending the public a contradictory message.
The "productivity" of Quebec physicians
The services provided by Quebec physicians have been the subject of much debate in recent months. The government's claim that Quebec physicians are less "productive" than their colleagues in other provinces is based on a false premise. The reality is that billing methods are different and cannot be meaningfully compared.
The national data shows that 8.5% of Canadian physicians are salaried, while 41.9% are paid a fee per service and 41.4% are paid lump sums or through capitation, or a combination of the two.
Longitudinal analysis of the 2014 National Physician Survey-a partnership between the College of Family Physicians of Canada, the Canadian Medical Association and the Royal College of Physicians and Surgeons of Canada-offers a way to relativize the "productivity" of Quebec physicians compared to that of their colleagues in other provinces. For more than a decade, the survey has been a point of reference for researchers, governments and stakeholders interested in analyzing and improving health care in Canada.
The Canadian database for this study clearly shows that the gap between the hours devoted per week to direct patient services by Quebec and other Canadian physicians is shrinking. Even though physicians in the rest of Canada still report working more than their Quebec colleagues, the difference decreased 44% between 2010 and 2014 to 1.37 hours per week. For family physicians, the gap decreased 23% to 2.41 hours in 2014. Plainly, we are far from the alarming situation that has been decried in recent weeks.
Furthermore, the results show that, on average, Quebec physicians perform more than 20% more research-related activities per week than their Canadian counterparts, confirming a trend over the past 10 years.
On-call work for health care establishments should also be considered in the productivity debate as family physicians who perform such work spend on average more than eight hours per week on related tasks compared to approximately six hours in the rest of Canada. Counting specialists, the figure rises to more than 11 hours per week, compared to a bit less than eight hours per week by family physicians and specialists in the rest of the country.
In 2014 Quebec family physicians reported having to spend 23% more time each week on administrative tasks than their Canadian colleagues (2.8 hours versus 2.27 hours). This trend has become more pronounced over the past 10 years.
In short, Quebec physicians work almost as much as their colleagues in the rest of Canada. Yet they appear to be less efficient. Why? Because of the shortcomings in the way our system is organized, physicians are busy doing administrative work, seeking out clinical information that should be at their fingertips, and performing tasks that could be left to other health care professionals.
These figures, which show that the number of hours worked by physicians in direct patient care declined an average of 10% in the other provinces between 2004 and 2014, raise a question. How is it that, despite this decrease in hours worked, there is better accessibility to health care services? Because in collaboration with physicians, Alberta, Ontario and British Columbia have each successfully introduced measures in recent years to improve their services, particularly on the front line. Quebec would do well to examine those initiatives.
Elsewhere in Canada
A GP for Me
A GP for Me is an initiative in British Columbia jointly funded by the provincial government and Doctors of BC to:
Enable patients who want a family doctor to find one;
Increase the capacity of the primary health care;
Confirm and strengthen the continuous doctor-patient relationship; including better support for the needs of vulnerable patients.
The mission of Doctors of BC3 is to make a meaningful difference in improving the health care for British Columbians by working to achieve quality patient care through engagement, collaboration and physician leadership. Its goal is to promote a social, economic and political climate in which members can provide the citizens of BC with the highest standard of health care, while achieving maximum professional satisfaction and fair economic reward.
Ontario chose to tackle the access problem by obtaining the support and cooperation of faculties of medicine, health organizations and the College of Physicians and Surgeons of Ontario. Two hundred family health teams (the equivalent of Quebec's family medicine groups) were created. The groups promote access to care by bringing different health care providers together under the same roof. Ontario also has more specialized nurse practitioners than Quebec does. The result of all these efforts is that two million more Ontarians can now call on a family physician.
The inspiring example of Taber, Alberta
The Taber Integrated Primary Healthcare Project4 is an initiative launched in the early 2000s in the town of Taber, in rural Alberta. The goal of the project was to improve health care services delivery through integration of the services provided by a physician group and the Chinook Health Region. In light of the project's success, it was expanded to the entire region five years later.
According to Dr. Robert Wedel, one of the people behind the project, four factors explain the initiative's success: a community assessment and shared planning; evidence-based, interdisciplinary care; an integrated electronic information system; and investment in processes and structures that support change.
Community evaluation and shared planning: First, successful integration of primary health care depends on gaining an understanding of individual, family and community health care needs. Health services providers and users must also have a shared vision of optimal health care delivery.
Evidence-based, interdisciplinary care: Second, the introduction of interdisciplinary teams (physicians, nurses, managers and other health professionals) facilitated the transition from a facility-based service delivery approach to a community-based wellness approach.
Electronic information system: Third, the introduction of an integrated information system aided interdisciplinary care and access to patient information in various points of service.
Alternative payment plan: Finally, processes and structures were put in place to support change over the long term. An alternative payment plan was implemented to clarify physician remuneration, define service and productivity expectations and protect organizational autonomy.
The plan was also designed to enable physicians to delegate tasks to other professionals on the team in order to spend additional time with patients with more complex needs. The physicians now receive a fixed salary for specific services (in-clinic ambulatory services, emergencies, minor operations, prenatal care, and so on). However, some services continue to be billed on a fee-for-service basis (births, major operations and anaesthesia). Salaries are reduced when a registered patient receives care outside the physician group. Furthermore, organizational change strategies were put in place to address resistance to the changes. Modifications were made so that a common, integrated care site could eventually be established.
All these changes had significant, positive consequences in Taber but also throughout the Chinook region. This approach enables better monitoring of chronic diseases and more prevention and education services for patients. Also noted was better accessibility to care, even for vulnerable and generally underserved patients. In the early 2000s, patients had to wait about 30 days before the first available appointment, but the wait has been completely eliminated since 2006. Physician services increased about 10% and those by other professionals, 50%. Patients visit their physicians less often (2.1 visits per year rather than 5.6 visits in other regions), and a marked decline in emergency room visits and laboratory tests has been observed.
Quebec could capitalize on the Taber initiative by adapting it to the situation in Quebec and encouraging physicians to participate fully like the committed partners they are of patients and the health system.
Improvements from the Taber project and other initiatives in Alberta, Ontario and British Columbia-all of which provide greater health care access than Quebec-share three common features that are available to Quebec as well:
o Electronic health records (EHRs)
Quebec lags behind other provinces in adopting EHRs. A mere 25% of Quebec physicians order diagnostic and laboratory tests electronically.
The 2014 National Physician Survey ranks Quebec almost last in health care system computerization. The Quebec Health Record Project promised for 2011 at a cost of $543 million has been, according the health minister himself, an abject failure. Recently he said that the Quebec government planned to deliver the project in 2021 at a cost of $1.6 billion before adding that he was not sure there would be money to pay for it. Physicians have nothing to do with this delay or the squandering of public funds. They're ready and waiting to make use of computerized records to improve health care access and communicate better with patients.
The confusion and delays in switching to EHRs in Quebec are a big part of the reason for Quebec's poor results on the survey. Some of the problems might indeed be caused by the older generation's reluctance to embrace information technology, but that's not the whole story. We need to have a system that is absolutely reliable and accessible.
Primary care organizations in Ontario are using electronic medical records to identify and support patient needs. All Ontario's primary care organizations mentioned using EHRs in descriptions they submitted on their quality improvement plans5-an example of how technology can be used to monitor patient needs and support improved delivery of care. Approximately 38% described using EHRs to identify specific diseases.
We cannot overlook the fact that EHRs have been the cornerstone of the productivity improvements elsewhere in Canada.
o Interdisciplinary work organization
Quebec also lags behind in providing environments conducive to greater interdisciplinary work and enlisting contributions from other health professionals (nurse practitioners [NPs], nurses, managers and other health professionals). Certain Canadian provinces are far ahead in this area. Team care allows the various professionals to do their regular tasks and delegate when the situation calls for it.
The solutions that have put most Canadian provinces on the road to solving the problem of frontline health care access have generally come through collaboration between the government and the medical profession. With effective information systems and the implementation of interdisciplinary approaches, in a spirit of cooperation and collaboration, such health care systems manage to provide the kind of accessible, high quality care patients and taxpayers are entitled to expect when they need it.
The bottom line is that interdisciplinary work allows physicians to do what they do best: diagnose and treat.
o Remuneration practices for population-based responsibility
Quebec seems to be the Canadian province where physician remuneration is closest to a fee-for-service model. Quebec Health Insurance Plan data from 2013 shows that close to 80% of Quebec physicians' total compensation is fee-for-service.6 Elsewhere in the country, mixed remuneration methods appear to make it easier to foster population-based responsibility, i.e., not just covering a territory, but also incorporating the determinants of population health and well-being, among which are access to high quality services and the full participation of all stakeholders.
In its 2011 support strategy for the practice of population-based responsibility7, MSSS spelled out the government's approach. However, that strategy was developed around local service networks managed through CSSSs, which were recently done away with by Bill 10, An Act to modify the organization and governance of the health and social services network, in particular by abolishing the regional agencies.
The authors of the strategy define population-based responsibility collectively, as follows:
* Using health and social services data to develop a shared picture of the reality on the ground;
* Deciding, in consultation with the public, partners in the health and social services network and other sectors, on a basket of integrated, quality services to meet the needs of the local population;
* Strengthening actions on health determinants in order to improve the health and well-being of the entire local population; and
* Tracking performance and seeking ongoing improvements, in the interests of greater accountability
Implementing population-based responsibility clearly requires a collective approach. Nothing in Bill 20 appears to indicate that the government might arrive at such an approach.
No discussion of population-based responsibility would be complete without considering the Kaiser Permanente model. Kaiser Permanente is a nonprofit organization whose mission is to provide high quality, affordable health care services and improve the health of its members and the communities it serves. Approximately 9.9 million people receive health care from Kaiser Permanente, which has 17,000 physicians and 174,000 employees (including 48,000 nurses) working in 38 hospitals and medical centres and more than 600 clinics.
The organization lists five keys to its model's success:8
1. Accountability for population
3. Use of electronic health records and the Internet
4. Team care
5. Moving care out of doctor's office
There are no provisions in Bill 20 for developing any of the above.
Clearly, the fee-for-service model does not encourage population-based responsibility. We have seen in the Taber example a broad basket of services covered in the clinic's overall budget, with other things remaining fee-for-service (births, major operations, anaesthesia etc.).
The way physicians are currently compensated stands in the way of any strategy whereby physician groups would receive fixed budgets to care for a given population. This is where Bill 20 goes off track-by individualizing patient targets instead of grouping them. Under group approaches, a physician who fails to meet commitments and does not see the required number of patients risks repercussions from colleagues and not the government, because the physician is responsible for contributing to the group's objectives. A physician in that same clinic who sees only complex cases will necessarily see fewer patients, but colleagues will be freed up to deal with more.
We sincerely believe that physicians are in favour of a population-based responsibility approach. Yet the inescapable conclusion is that Bill 20, with its fee-per-service and individualized appointment targets, is taking us in a different direction entirely.
We are convinced that physicians are overwhelmingly in favour of mixed compensation methods. The health and welfare commissioner launched a series of studies to assess the impact of remuneration on health system effectiveness and efficiency. As soon as RAMQ data becomes available, researchers will be able to complete their work and show how adjusting remuneration methods would contribute to improving health care access.
It is no coincidence that we have not attempted a clause-by-clause critique of Bill 20. The government's entire approach needs to be changed. It is high time the government understood that physicians are part of the solution to health service access problems, and that a coercive approach is counterproductive and demoralizing.
History is full of examples in which working together in a climate of mutual respect led to impressive results. Both the QMA and CMA fully support the idea and purpose of the bill-to improve access to health care-but we believe Bill 20 is not the answer. We think changes worked out in partnership get the best results. All real improvements to the health care system have always been achieved in an atmosphere of dialogue and collaboration.
To sum up, the QMA and CMA recommend first and foremost that the government work with the medical profession to improve access to health care, as well as the following measures:
* Speed up the process of switching to electronic health records-an indispensable tool in 2015.
* Reorganize tasks to accord a greater role to other health professionals (NPs, nurses, administrators and others) by forming care teams that can pool their knowledge and skills to better serve patients.
* Reconsider Quebec's near-exclusive reliance on fee-for-service and consider bringing in a form of mixed remuneration that leads towards a population-based responsibility model. Elsewhere in Canada, this approach has contributed significantly to improvements in health care access, particularly on the front line.
4 Wedel R, Kalischuk RG, Patterson E, et al. Turning Vision into Reality: Successful Integration of Primary Healthcare in Taber, Canada. Healthcare Policy 2007; 3(1): 81-95.
6 Régie de l'assurance maladie du Québec. Évolution du coût des services médicaux et du nombre de médecins selon le mode de rémunération. Services médicaux, Québec, 2009-2013.
8 Molly Porter. An Overview of Kaiser Permanente: Integration, Innovation, and Information Systems in Health Care. Presentation for the Canadian Medical Association, Kaiser Permanente International, March 2, 2015.
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