On behalf of the Canadian Medical Association (CMA) I would like to respond to Health Canada’s papers, released on October 7, 2005, “Developing a Drug Supply Network and an Export Restriction Scheme” and “Requiring a Patient-Practitioner Relationship as a Condition of Sale of Prescription Drugs in Canada,” which invite discussion on the Minister of Health’s June 29, 2005 proposals to control cross-border pharmacy and ensure that Canadians have a continued supply of prescription drugs.
The CMA agrees that Canadians must have a supply of drugs adequate to meet their needs. Currently the most serious threat to this supply appears to be the legislative proposals, currently before the United States Congress, that would allow Americans to purchase Canadian drugs in bulk. Proactive measures to protect our drug supplies are warranted to guard against this threat.
In summary, our response to the Minister’s three proposals is as follows:
* Supply monitoring network: We support supply monitoring as a necessary activity.
* Export restrictions: We believe that all Canadian drugs should be subject to export restriction, and the Government of Canada should grant itself the power to enact bans on export as needed.
* Requiring a patient-physician relationship: We do not believe this proposal can be enforced, or that it will contribute materially to securing an adequate drug supply for Canada. We recommend that Health Canada instead support the activities of medical and pharmacy regulatory authorities in ensuring that prescribing behaviour is appropriate.
Our detailed comments on the proposals are below.
1) Drug supply monitoring system
The CMA strongly supports the development of a comprehensive strategy and an adequately resourced system for monitoring domestic drug supply. Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. We recommend that more careful consideration be given to the most effective design and functioning for a supply-monitoring network. It is our understanding that manufacturers and distributors currently monitor supply of their own products. Ideally, a mechanism should be found to unite these individual activities into a robust and effective network without creating a costly parallel effort. Specific comments follow:
* 2.1 Gathering Drug Shortage Information: Voluntary reporting is a preferred approach. In designing a voluntary scheme, it should be taken into account that soliciting reports from a wide variety of players, including the public, may result in a flood of anecdotal, poorly documented reports that will require expert analysis to verify and put into context. Regardless of who is solicited for shortage reports, the reporting process should be made as clear, simple and user-friendly as possible, and all stakeholders who might be in a position to make reports should be made aware of its existence.
* 2.2 Assessment and Verification: We agree that a baseline of drug inventory data is required, as are benchmarks for what constitutes an appropriate drug supply for Canada. These should be established as a first step, before the implementation of a voluntary reporting scheme.
* 2.3 Communication of Information: While physicians may seldom be in a position to report drug shortages, it is essential that they be informed at once when a shortage exists, and how long it is expected to last. Guidance for physicians on measures they might take while the shortage lasts (for example, other drugs they might prescribe as substitutes) is highly desirable. Medical associations could help Health Canada communicate this information to their members.
The paper makes reference to Health Canada’s preference for collaboration in this endeavour “without assuming responsibility for becoming the primary source of information for Canadians on drug shortages or for resolving all reported drug shortages.” This is not appropriate. Leadership responsibilities and public expectations preclude the Minister from shirking responsibility for these functions. Accountability for such a complex network must be vested in one authority, i.e. Health Canada.
* 2.4 Response measures: Though the paper lists response capacity as an element of drug supply monitoring, it does not contain practical suggestions for responding in the event of a shortage. This is a crucial element and needs to be developed. There is no point in monitoring supply without a plan for managing shortages.
2) Export Restriction
CMA supports this proposal. The power to restrict export of drugs offers Canada its best chance of protection should the U.S. legalize bulk purchasing. This power should be strong and far-reaching. Serious consideration should be given to the June 2005 motion from the House Standing Committee on Health motion to ban all bulk exports of prescription drugs. Specific comments follow:
* 3.4.2 Drug products deemed necessary for human health: The discussion paper proposes to restrict export only under certain circumstances, e.g. if the drug is deemed necessary to human health, and to establish criteria to determine whether a drug meets this condition. All prescription drugs are necessary for human health; certainly those who are taking them consider them so. For equity’s sake - and also because establishing and abiding by criteria may prove impossible - we believe every prescription drug in Canada should be considered a candidate for export restriction.
* 3.4.3 Implications for patient care: We acknowledge that in many cases, other effective therapies can be substituted for drugs in short supply. Many physicians will make these substitutions as needed; but they must first be made aware of the shortages. Physicians must be advised of available alternatives if an unavoidable shortage exists; however, we caution that the existence of alternatives should not be used as justification for not taking action if a drug is in shortage. The final decision as to the most appropriate available therapy should remain a matter to be determined by the patient and physician and consultation.
3) Requiring a Patient-Practitioner Relationship
The Minister has expressed his desire to ensure that physicians maintain high ethical and professional prescribing standards. The CMA shares this desire. As discussed in the attached CMA Statement on Internet Prescribing (Appendix I), we hold that prescriptions should be written in the context of an appropriate patient-physician relationship. However, we do not accept that the proposed option of requiring an established patient-practitioner relationship for every prescription issued in Canada will have a meaningful effect on ensuring adequate drug supply, for the following reasons:
* The proposal does not target the real problem. Most current drug shortages are caused by raw material shortages, inventory management disruptions, unexpected spikes in demand, and other conditions that have nothing to do with the clinical encounter. More important, targeting the patient-practitioner relationship will not protect Canadians from the impact of U.S. bulk purchasing should legislation pass Congress.
* Prescribing outside the context of the patient-physician relationship is already subject to sanction by medical regulatory authorities. The vast majorities of Canada’s physicians conduct themselves ethically and only prescribe for patients in the context of a professional relationship. Those who do not, contravene both the CMA’s policy and the standards of practice for provincial/territorial regulatory Colleges of Physicians and Surgeons. These regulatory authorities, and the long and effective tradition of professional self-regulation they represent, should be respected and supported.
* The proposal is burdensome and will be difficult to enforce. The proposal places the onus for evaluating the patient-practitioner relationship on pharmacists. While pharmacists are required, as part of their professional responsibility, to ensure that a prescription has been written by a physician licensed to practice in that jurisdiction, they are not customarily familiar with the details of the interaction leading up to the prescription. Requiring them to formally screen for this will impose a heavy administrative burden, and will compromise patient confidentiality.
In addition, compliance monitoring by Health Canada will be complex, if feasible at all. For example, despite the Minister’s recent comment that prescriptions “can only be signed by a medical practitioner who actually sees and treats the patient in question”, it is generally accepted that perfectly legitimate prescribing can take place without a face-to-face encounter (e.g. through telemedicine) or an “ongoing” patient-physician relationship (e.g. in an emergency). While it is easy to detect flagrant infractions (such as a hundred prescriptions a day written for American patients by the same Canadian doctor) it will be much harder to precisely identify the boundary between what is legitimate prescribing behaviour and what is not. Many provincial regulatory authorities have already developed definitions of the patient-physician relationship, which Health Canada includes in the discussion document. It is unlikely that Health Canada will be able to improve on them.
* Determining an appropriate relationship may be more appropriately a provincial or territorial responsibility. The patient-physician interaction, like other scope-of-practice issues, is regulated at the provincial level. We do not believe the cross-border prescribing problem justifies Health Canada’s overarching federal-level intervention.
In conclusion, we support further exploration of the supply-monitoring and export-restriction options, and believe that existing medical and pharmaceutical regulatory authorities should be respected and supported in enforcing appropriate prescribing behaviour.
We appreciate the opportunity to comment on your proposals. We look forward to further opportunities for input during the development of legislation.
Briane Scharfstein, MD, CCFP, MBA
Associate Secretary General, Professional Affairs
cc: Ms. Meena Ballantyne, Director General, Health Care Strategies and Policy Directorate,
CMA Provincial/Territorial Divisional CEO’s
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