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
The Canadian Medical Association (CMA) is pleased to participate in the Government of Canada's consultation on ensuring the ongoing strength of Canada's retirement income system. Ensuring sufficient income in retirement is a concern for CMA's more than 72,000 physician members and the patients they serve. With the aging of the Canadian population and the decline in the number of Canadians participating in employer-sponsored pension plans, now is the time to explore strengthening the third pillar of Canada's government-supported retirement income system: tax-assisted savings opportunities. Two areas in need of government attention are tax-assisted savings vehicles for high-earning and self-employed Canadians, and vehicles available to help Canadians save to meet future continuing care needs.
Like the Canadian population at large, physicians represent an aging demographic - 38% of Canada's physicians are 55 or older - for whom retirement planning is an important concern. In addition, the vast majority of CMA members are self-employed physicians and, as such, they are unable to participate in workplace registered pension plans (RPPs). This makes physicians more reliant on Registered Retirement Savings Plans (RRSPs) relative to other retirement savings vehicles. As we saw during the recent economic downturn, the volatility of global financial markets can have an enormous impact on the value of RRSPs over the short- and medium-term. This variability is felt most acutely when RRSPs reach maturity during a time of declining market returns and RRSP holders are forced to 'sell low'.
The possibility that higher-earning Canadians, such as physicians, may not be saving enough for retirement was raised by Jack Mintz, Research Director for the Research Working Group on Retirement Income Adequacy of Federal-Provincial-Territorial Ministers of Finance. In his Summary Report on Retirement Income Adequacy Research, Mr. Mintz reported that income replacement rates in retirement fall below 60% of after-tax income for about 35% of Canadians in the top income quintile. This is due to the effect of the maximum RPP/RRSP dollar limits, which is why the government should consider raising these limits.
The CMA supports exploring ways to expand tax-assisted options available for retirement saving, particularly measures that would allow organizations to sponsor RPPs and Supplementary Employee Retirement Plans (SERPs) on behalf of the self-employed.
Such changes could allow the growing ranks of self-employed Canadians to benefit from the security and peace of mind already available to Canadians with workplace pensions. CMA members favour a voluntary approach, both for employers/plan sponsors in deciding whether to sponsor such plans and for potential plan participants in choosing whether or not to participate.
Just as the government should explore ways to modernize the rules governing registered pension plans to account for today's demographics and employment structures, so too should it explore ways to help Canadians save for their continuing care - including home care and long-term care - needs. When universal, first-dollar coverage of hospital and physician services-commonly known as 'medicare' - was implemented in Canada in the late-1950s and 1960s, health care within an institutional setting was the norm and life expectancy was almost a decade shorter than it is today. With Canadians living longer and continuing care falling outside the boundaries of Canada Health Act first-dollar coverage, there is a growing need to help Canadians save for their home care and long-term care needs.
The attached backgrounder highlights the pressing need for greater support for home and long-term care in Canada, as well as some principles and options for governments to help Canadians pay for these services. It should be noted that the introduction of Tax-free Savings Accounts (TFSAs) in the 2008 federal budget created a new savings vehicle to support Canadians' continuing care needs. The CMA was pleased to see its introduction.
Government action on these two related issues would benefit all Canadians. Expanding retirement-saving options for physicians would provide a strong incentive for physicians to stay in Canada. Similarly, by helping Canadians save for their own continuing care needs, governments could contribute to the health of elderly citizens and ease the demand on unpaid caregivers and government-funded continuing care.
Ensuring that Canadians have the tools at their disposal to save for their continuing care needs and that Canada's physicians have the right tools to save for retirement are important issues for the CMA. Canada's physicians have long been active on these issues and government action on these files would benefit all Canadians. We are pleased to take part in Finance Canada's consultations and would welcome any further opportunities to participate.
Anne Doig, MD, CCFP, FCFP