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
I am writing in response to your letter inviting comment on the discussion paper Strengthening the Pan-Canadian Public Health System distributed in February 2004. The Canadian Medical Association (CMA) welcomes the opportunity to participate in this consultation process on a national public health system. Our country’s experience combating SARS brought home to all of us the critical need for a strong and effective public health system to ensure that we are never again found unprepared to deal with the consequences of an emerging infectious disease. The commitments to establish a strong and effective public health system, a Canada Public Health Agency and a Chief Public Health Officer detailed in the February 2, 2004 Speech from the Throne have raised expectations across the land, and particularly within the public health community.
In June 2003 CMA detailed a Public Health Action Plan in its submission to the National Advisory Committee on SARS and Public Health (Naylor Committee). The CMA’s Plan was further elaborated in our October 2003 submission to the Standing Senate Committee on Social Affairs, Science and Technology (Kirby Committee) hearing on public health governance and infrastructure. The CMA is also a founding member and active supporter of the Canadian Coalition for Public Health in the 21st Century. Both of the CMA submissions and the Coalition stress the need for strong leadership, capacity building and appropriate funding to ensure that Canada’s public health system is able to deal with the challenges ahead.
In this submission I will first focus on the responsibility and actions the federal government can take now to create a strong and effective public health system and then comment on issues raised in the Strengthening the Pan-Canadian Public Health System discussion paper.
The CMA believes that the country today has a rare opportunity to build a public health system for Canada that can take the best elements from the past while embracing new
innovative approaches to the future. But to achieve the Speech from the Throne commitment to “establish a strong and responsive public health system” strong leadership is needed now. The federal government has a critical role to play. In both the United Kingdom and the United States, national leadership has been instrumental in clearly defining health goals for the population and stating the role of the public health system, its key infrastructure elements and the development of strategies to attain them.
The CMA is pleased with your commitment and that of your government to the establishment of a Canada Public Health Agency (CPHA) but we can not stress strongly enough the need for you and your cabinet colleagues to take the bold steps needed to ensure that a national public health agency is truly independent. A CPHA that is not adequately funded and independent of the government bureaucracy will only result in a shuffling of the deck chairs.
A credible Chief Public Health Officer (CPHO) must be appointed to lead the Agency, be the federal government’s chief medical officer of health (CMOH) and the country's chief spokesperson for all public health issues.
The CPHA and the Chief Public Health Officer should have a central role in providing public health services to those areas falling under federal jurisdiction where local and provincial Chief Medical Officers of Health do not have access or authority. Airports, railways, military bases, aboriginal peoples living on reserve, federal meat packing plants and national parks are examples of areas under federal jurisdiction. The delivery of public health in these jurisdictions has been especially compromised by the lack of comprehensive coordination between provincial and federal systems. The federal CMOH should have all the powers and responsibilities of a provincial /territorial CMOH with respect to public health in federal jurisdictions.
While there is an urgent need for the federal government to address problems with the delivery of public health services within its own backyard, it also must enhance co-ordination within the various federal departments and agencies that address public health concerns.
In its submission to the National Advisory Committee on SARS and Public Health the CMA also called for federal leadership in times of national health emergencies. The enactment of a Canada Emergency Health Measures Act would enhance the federal government’s “command and control” powers in a measured way during times of national health emergencies. The Act would give the federal government specific authority to act for a pre-determined, temporary period of time, during a declared extraordinary health emergency. It would also provide the authority for development of a graduated health alert system with corresponding public health interventions to enable a rapid co-ordinated response as a public health threat emerges.1 A systematic approach to health emergencies outlining roles, responsibilities and authority of jurisdictions would go a long way to avoiding the chaos and confusion that surrounded the country’s emergency response to SARS.
The public health infrastructure is the foundation that supports the planning, delivery and evaluation of public health activities. In 2001, a working group of the Federal, Provincial and Territorial (F/P/T) Advisory Committee on Population Health assessed the capacity of the public health system through a series of key informant interviews and literature reviews. The consistent finding was that public health had experienced a loss of resources and there was concern for the resiliency of the system infrastructure to respond consistently and proactively to the demands placed on it.
It is essential that the federal government work with the provinces/ territories and municipalities to stop the hemorrhaging in public health across the country. We must stabilize and shore up the core public health capacity at the municipal, and provincial/territorial levels. At the federal level, in the short term, we must sustain our current capacity to tackle critical public health issues. The recent focus on infectious disease must not lead us to take monies from chronic disease prevention and health promotion to bolster efforts to manage outbreaks of infectious disease. Robbing Peter to pay Paul will only compound and exacerbate the challenges facing the public health system. All of the essential functions of public health must be recognized and resourced within a coherent public health strategy.
This will require an investment of at least $1.5 billion over the next five years, beginning with an immediate commitment of $200 million in the upcoming budget. There is also a critical need for additional resources to reach the frontline public health workers in the many local agencies across Canada. In this regard, on March 12, 2004 the CMA, the Canadian Nurses Association, Canadian Pharmacists Association and the Canadian Healthcare Association wrote to the Prime Minister urging him to consider adding the recent one-time $2 billion transfer into the Canada Health Transfer (CHT) funding base and ear-mark 10% of this amount for public health action.
The infusion of $1.5 billion over the next five years would go a long way to provide federal, provincial/territorial and municipal governments with the tools needed to rebuild capacity in the public health system. An area needing immediate attention is human resource capacity. For the essential functions of the public health system to be realized, we need a public health workforce with appropriate and constantly updated skills. Unfortunately that workforce is extremely thin today. We need to invest in additional training capacity in all of the public health disciplines. CMA has proposed an investment of $50 million in 2004/05 to begin to strategically rebuild human resource capacity.
To provide additional surge capacity CMA has further proposed the establishment of a Canadian public health emergency response service or Canadian Health Corps. The service would be made up of a core group of highly trained and mobile public health professionals, employed by the federal government, to be directed by the Chief Public Health Officer. A complementary ‘reserve pool’ or volunteer relief network would be made up of acute health care and public health professionals willing to be deployed anywhere in Canada on short notice to provide services during health emergencies. A predetermined and pre-licensed pool of professionals that can respond to a call to action in times of crisis is a critical resource that must be established before we are faced with another emergency situation.
Canadians expect the federal government to assume its responsibility to provide national leadership in public health. Visionary leadership, investment and capacity building are essential components of a reinvigorated public health system. It is within this context that CMA has reviewed the Strengthening the pan-Canadian public health system discussion paper.
Strengthening the pan-Canadian public health system
The discussion paper Strengthening the Pan-Canadian Public Health System unfortunately positions the planning assumptions for a national public health strategy within the traditional F/P/T process. While we are encouraged with the commitment of the F/P/T Ministers of Health to work collaboratively on the creation of a Pan-Canadian Public Health Network, it is not what Canadians or CMA envisioned in terms of providing leadership on the development of a national public health strategy and a consistent and co-ordinated approach to health emergencies.
The discussion paper is proposing that a CPHA be the centralized responsibility centre or ‘co-ordinating node’ of a Pan-Canadian Public Health Network that would develop national public health strategies and co-ordinate responses to public health emergencies. While the Network is necessary to facilitate intergovernmental co-operation, CMA believes that it is now time to move beyond traditional processes that, in the past, have often hindered the country’s ability to respond rapidly to address pan-Canadian problems.
Therefore in its briefs to both the Naylor and Kirby Committees, the CMA proposed the creation of an independent CPHA to provide leadership and comprehensive public health expertise in the development of a strategic pan Canadian approach to public health planning and services. These CMA briefs speak to many of the issues pertaining to the CPHA and CPHO that are raised in the federal discussion paper. CMA proposals for a CPHA as outlined below address the questions of mission and mandate, accountability and transparency posed by the paper.
The CPHA, as described by CMA, would become the lead national agency on public health matters with a broad mandate to co-ordinate all aspects of planning for national public health emergencies, provide ongoing national health surveillance and work closely with provinces/territories to reinforce other essential public health functions. To effectively carry out its mandate the CPHA structure must respect five guiding principles. It must be:
* Independent – At arm’s length from government, insulated from day-to-day vagaries of political pressures while remaining accountable to Canadians.
* Science-based – Adherence to the highest standards of risk assessment and decision-making with a view to safeguarding the health of Canadians.
* Transparent – Open to public scrutiny and encouraging public participation in its activities.
* Responsive – Characterized by a nimble decision-making process and a capability of deploying resources and expertise quickly and efficiently to any part of the country.
* Collaborative – Partnership-oriented, fostering collaboration with other federal, provincial and non-governmental partners.
CMA has recommended that the CPHA be established as an arms length, adequately resourced agency within the purview of the federal government. Under this approach, the CPHA would be structured on a corporate model in which decision-making powers are vested in an expert advisory board. The board, in turn, would be accountable to Parliament and the public for the exercise of these powers. The CPHA would be created through new federal legislation but would remain under the health portfolio, with accountability to Parliament through the health minister. The chief public health officer would head the CPHA, oversee the day-to-day operation of the office, be the federal government’s chief medical officer of health, and act as the lead scientific voice for public health in Canada.
This structure would mark a departure from the status quo in that the level of professional autonomy would increase and the level of ministerial involvement in professional issues would be reduced. This would contribute to making the CPHA more credible as a science-based organization. The board governance structure would encourage participation from the broader public health community and could therefore be more effective in creating partnerships with other key players.
The CMA commends you and the federal and provincial/territorial governments for the evident commitment to address the public health challenges facing this nation. It is unfortunate that it took a public health tragedy to bring this commitment to the forefront but never the less the public health community in Canada stands ready to work with governments to achieve a strong and responsive public health system.
As part of that community the medical profession is ready and willing to support initiatives that will improve public health programs and services that ultimately make
Canada a safer and healthier place to live. We do not support a continuation of the status quo. We must seize this opportunity to create a public health system that that can take the best elements from the past while embracing new innovative approaches to the future.
Sunil V. Patel, MB, ChB
1 Answering the Wake-Up Call: Canada’s Public Health Action Plan, June 2003. Available: http://www.cma.ca/cma/menu/displayMenu.do?tab=422&skin=432&pMenuId=1&pSubMenuId=2&pageId=/staticContent/HTML/N0/l2/where_we_stand/political/index.htm