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Letter - CMA Submission to the Minister of Health

https://policybase.cma.ca/en/permalink/policy9286
Last Reviewed
2009-02-21
Date
2000-09-06
Topics
Health systems, system funding and performance
  1 document  
Policy Type
Response to consultation
Last Reviewed
2009-02-21
Date
2000-09-06
Topics
Health systems, system funding and performance
Text
The Canadian Medical Association (CMA) values the open, constructive and ongoing dialogue that has developed over the past year with you and your ministry in seeking solutions to the critical issues and challenges that face Canada's health system. As an open society, it is essential to the future of the health care system that every effort is made to work together to find lasting solutions to what is a series of complex and interdependent social policy issues. With many policy challenges placed squarely on the table, it is timely that we move beyond issue identification and strive to develop a comprehensive plan for health care that incorporates a set of solutions that are strategic, targeted, long-term, and sustainable. Given the evolving nature of the health care system, the plan must also be flexible, adaptive and innovative. To assist you as you enter into extensive policy discussions with your provincial and territorial colleagues, CMA believes it is crucial that there is a clear sense of where the medical profession stands on a number of issues. The purpose of the letter is to outline an action plan to revitalize Canada's health care system. The plan is a series of constructive proposals in which the sum is greater than the individual components. The proposals are grouped under the categories of sustainable and accountable federal funding, national health system innovation and physician resource strategy. This information will likely form the basis of the CMA's presentation to the House of Commons Standing Committee on Finance later this Fall. By their very nature, the proposals are strategically targeted and align policy solutions to a number of key policy challenges that face the health care system today, tomorrow and into the future. The proposals are designed to complement one another. They should be considered as a series of investments that address a spectrum of policy issues in the health care system. Our proposals are designed in such a manner that they are sufficiently flexible in meeting provincial and territorial health care priorities, while ensuring that the federal government is fully recognized for its essential investment. Furthermore, to promote a higher degree of accountability, transparency and legitimacy, each proposal sets out its own rationale and includes, where possible, an order-of-magnitude cost estimate. In specific terms, the total cost of the recommendations that the CMA is putting forward is a minimum of $10.15 billion. Each investment is accounted for as follows: * Health-specific Federal Cash Restoration $3.81 billion * National Health Technology Fund $1.74 billion * National Health Connectivity Investment $4.10 billion * National Physician Resource Strategy $0.50 billion Total $10.15 billion The attached documents summarize our recommendations and provide detailed information each proposal. The CMA has offered a powerful and strategic combination of policy initiatives designed to revitalize Canada's health care system. The proposals are realistic, practical and serve to focus on making the health care system one that is innovative, responsive and accessible by all Canadians. Finally, it must also be made clear that no one group can address all of the policy issues and challenges facing the health care system. Thus, the CMA's commitment to working with the federal government and others to ensure that our health care system will be there for all Canadians in need is once again offered. The CMA looks forward to discussing with you how these specific proposals can be implemented. Sincerely yours, Original signed by Peter Barrett Peter Barrett, MD, FRCSC President enclosures c.c. Prime Minister and Provincial and Territorial Premiers Provincial and Territorial Ministers of Health Federal Minister of Finance CMA Board of Directors CMA Provincial and Territorial Divisions and Affiliated Societies SUMMARY OF RECOMMENDATIONS September 6, 2000 In seeking to place the health care system on the road to long-term sustainability, the CMA is committed to working in close partnership with the federal government and others identifying, developing and implementing policy initiatives that serve to strengthen Canadians' access to quality health care. In the spirit of placing Canada's health care system on the road to recovery, the CMA offers the following recommendations: 1. That the federal government fund Canada's publicly financed health care system on a long-term, sustainable basis to ensure quality health care for all Canadians. 2. That the federal government, in consultation with the provinces and territories, and stakeholders, introduce a health-specific cash transfer mechanism to promote greater public accountability, transparency and linkage of sources to their respective uses. 3. That the federal government, at a minimum, increase federal cash for health care by an additional $3.8 billion, effective immediately. 4. That beginning April 1, 2001, the federal government introduce an escalator mechanism that will grow the real value of health-specific cash over time. 5. That the federal government must allocate new monies, over and above the $3.8 billion increase to the health-specific cash floor to facilitate the development of a comprehensive and seamless system of care. 6. That the federal government commit a minimum of $1.74 billion over three years to A National Health Technology Fund, to increase country-wide access to needed health technologies. 7. That the federal government make a minimum investment of $4.1 billion in National Health Connectivity 8. That the federal government immediately establish a Physician Education and Training Fund in the amount of $500 million to fund: (1) increased enrolment in undergraduate and postgraduate medical education; and (2) the expanded infrastructure (both human and physical resources) of Canada's 16 medical schools needed to accommodate the increased enrolment. 9. That the federal government increase funding targeted to institutes of postsecondary education to alleviate some of the pressures driving tuition fee increases. 10. That the federal government enhance financial support systems for medical students, provided that they are: (a) non-coercive; (b) developed concomitantly or in advance of any tuition increase; (c) in direct proportion to any tuition fee increase; and (d) provided at levels that meet the needs of the students. ON THE ROAD TO RECOVERY... AN ACTION PLAN FOR THE FEDERAL GOVERNMENT TO REVITALIZE CANADA'S HEALTH CARE SYSTEM September 2000 SUSTAINABLE AND ACCOUNTABLE FEDERAL FUNDING Since the introduction of the Canada Health and Social Transfer (CHST) on April 1, 1996, the CMA has taken the strong position that the federal government must restore the level of federal cash notionally allocated to health care that was in place in 1995. Since that time, the federal government has introduced a series of important first steps towards stabilizing Canada's health care system. Specifically, in 1999, the government announced a five-year fiscal framework that reinvested $11.5 billion, on a cumulative basis, in the health care system. In the budget papers, it was clear that this money was to be earmarked for the health care system only. In 2000, an additional one-time investment of $2.5 billion, unearmarked through the CHST over four years, was announced. While seen as a series of important first steps, the figures, however, must be placed in context. Specifically, it is important to note that the CHST monies that have been announced are a combination of increases to the CHST cash floor and "one-time" injections (i.e., "supplements"). Table 1 accounts for the increases via the CHST and its supplement. (NOTE Table content does not display correctly -- SEE PDF) TABLE 11 CANADA HEALTH AND SOCIAL TRANSFER BUDGET IMPACTS (1999 AND 2000) 1999/00 TO 2003/04 ($ BILLIONS) Year 1999/00 2000/01* 2001/02 2002/03 2003/04 5 Years Budget 2000 Increase CHST Supplement** -- 1.0 0.5 0.5 0.5 2.5 Budget 1999 Increase CHST Supplement*** CHST Cash Floor 2.0 -- 1.0 1.0 0.5 2.0 -- 2.5 -- 2.5 3.5 8.0 Budget 1998 Cash 12.5 12.5 12.5 12.5 12.5 62.5 Total CHST Cash 14.5 15.5 15.5 15.5 15.5 76.5 CHST Tax Transfers 14.9 15.3 15.8 16.5 17.2 79.7 Total CHST 29.4 30.8 31.3 32.0 32.7 156.2 * All figures for 2000/01 onward, with the exception of CHST cash, are projections. ** The $2.5 billion cash supplement will be paid to a third party trust and accounted for in 1999/00 by the federal government. Payments will be made in a manner that treats all jurisdictions equitably, regardless of when they draw down funds over four years. *** The $3.5 billion cash supplement was paid into a third party trust and accounted for by the federal government in 1998/99. In the latter case, these "CHST supplements," totaling $3.5 billion over three years in 1999 and $2.5 billion over four years in 2000 are specifically designed not to be included as part of the CHST cash floor. Nor is it intended to grow over time through an escalator. In fact the supplement, which is framed as a multi-year investment is charged to the preceding year's budget. Thus, once allocated and spent, the money is gone. While the CHST supplements were important first steps, the CMA views them as "tentative half-measures" and by no means a substitute for fostering short-, medium- and/or long-term planning of the health care system. A long-term commitment by the federal government is required to increase its health-specific cash allocation. Recognizing the limitations of the CHST supplement, on an annual basis, this means that CHST cash for health care increased by $2.0 billion in 1999/00; it will remain at the same level for 2000/01 and then increase by $500 million (to $2.5 billion) in 2001/02, and remain at that level for the 2002/03 and 2003/04. In other words, only in 2002/03 will the CHST cash floor return to its 1995 nominal spending levels, 7 years after the fact, with no adjustment for the increasing health care needs of Canadians, inflation or economic growth. The budget announcements by the federal government in 1998/99 and 1999/00 are presented in Table 2. Please note that the amounts applied to the CHST cash floor and the cash supplements have been separated. TABLE 2 TOTAL CHST CASH, HEALTH-SPECIFIC CHST CASH, CHST SUPPLEMENT 1995/96 TO 2003/04 ($ BILLION) Year Total CHST Cash CHST Cash for Health Care* CHST Supplement Total CHST Cash for Health Care 1995/96 18.5 7.59 N/A 7.59 1996/97 14.7 6.03 N/A 6.03 1997/98 12.5 5.13 N/A 5.13 1998/99 12.5 5.13 N/A 5.13 1999/00 12.5 + 2.0 = 14.5 5.13 3.5 8.63 2000/01 13.5 + 2.0 = 15.5 6.13 2.5 8.63** 2001/02 14.5 + 1.0 = 15.5 7.13 N/A 7.13 2002/03 15.0.+ 0.5 = 15.5 7.63 N/A 7.63 2003/04 15.0 + 0.5 = 15.5 7.63 N/A 7.63 * It is assumed that in 1995/96 the notional allocation to health care is 41% of CHST. Prior to the introduction of the CHST, Established Programs Financing (EPF) and the Canada Assistance Plan (CAP) were in place. In addition, federal cash that has been "earmarked" allocated for health care and added to the CHST base, as outlined in the past two federal budgets, are included ** Assumes that the $2.5 billion supplement was allocated to health care only. It is important to pay careful attention with regard to how the figures have been derived and on what basis. Close attention has been paid to the distinction between the increase to the CHST cash floor and the introduction of a "CHST supplement," which has been applied by the federal government over the last two years. In the latter case, the supplement has not been factored into the CHST cash floor analysis since it is a one time expenditure, charged to the previous fiscal year, that can never grow over time. Simply put, once allocated it is gone in perpetuity and does not have any further application in terms of facilitating future growth of the CHST cash floor. Based on Table 2, it is estimated that the CHST cash floor in support of health care currently stands at $6.13 billion in 2000/01. This is roughly $1.5 billion below the 1995/96 level without adjusting the cash floor in support of health care to reflect a number of factors including, a growing and aging population, the depreciation of the system's physical infrastructure, the cost of pharmaceuticals, or inflation, to name a few. At a minimum, the federal government must put back what it has taken out of the system. Specifically, the CMA believes that the federal government must re-establish the level of CHST cash allocated to health care at the 1995 level, adjusted to reflect the changing health care needs of Canadians in the coming year of 2001. The question then becomes on what basis can one arrive at a reasonable estimate? Based on a recent study prepared by the Provincial and Territorial Ministers of Health, the CMA believes that this is an important point of departure in considering orders of magnitude.2 Therefore, if one applies the growth factor that was recently calculated by the Provinces and Territories in its "cost driver" study (at 4.6% per annum), the health portion of CHST cash in 1995 at $7.59 billion is adjusted upwards to $9.94 billion in 2001 dollars (see Table 3). TABLE 3 ESTIMATED VALUE OF CHST HEALTH-SPECIFIC CASH FLOOR 1995/96 TO 2001/02 ($ BILLIONS) YEAR CURRENT CHST CASH FLOOR FOR HEALTH CARE ESCALATOR APPLIED TO BASE YEAR OF 1995/96 (% INCREASE) EXPECTED HEALTH-SPECIFIC CASH FLOOR 1995/96 7.59 4.6 1996/97 6.03 4.6 7.94 1997/98 5.13 4.6 8.30 1998/99 5.13 4.6 8.69 1999/00 5.13 4.6 9.09 2000/01 6.13 4.6 9.50 2001/02 7.13 4.6 9.94 Based on the recent combination of announcements by the federal government to increase the CHST cash floor and the supplements, it is estimated that the 2000/2001 health-specific cash floor stands at $6.13 billion. Therefore, to bring the health-specific cash that flows through the CHST in line with the changing health care needs of Canadians, it should, at a minimum, increase by $3.81 billion effective immediately. In reviewing the approach taken by the CMA, it is important to understand that the $3.81 billion figure is a health-specific cash calculation only. As the CHST is currently configured, it flows federal cash for health, post-secondary education and income support programs. Currently, the Provinces and Territories are adamant that the federal government return the CHST cash floor to its 1993-94 level of $18.7 billion by adding $4.2 billion immediately. However, the $4.2 billion that is being requested is in "1993/94 dollars"; it is not adjusted to account for the changing needs of Canadians between 1993/94 and 2000/2001 for health, post-secondary education or income support programs. While raising the health-specific cash floor will serve to stabilize the system, it is likely that there will be future debate about what is the appropriate share of federal cash. While there are those who factor in the value of the tax point transfer, it is only federal cash that can be used to sanction the provinces and territories that are in violation of the Canada Health Act.3 As the Minister of Health was recently quoted "For the Canadian government to continue to have the moral authority to influence reform, we have to be a more robust contributor."4 In this context, the adage "no cash, no clout applies" in its strictest sense. Therefore, while federal cash must be reinfused into the health care system, there must also be substantive policy discussion about what the federal government's contribution should be in the future, and through what mechanism. For example, should it be a fixed amount only; should it be tied to provincial/territorial public expenditures on health; and/or how should it grow over time? The Need for Financial Accountability In making a critical investment in the health care system, the CMA strongly supports the principle of financial accountability. This is consistent with the federal government's call for increased accountability in the health care system. After all, if the federal government is calling on provincial and territorial governments, and providers to be more accountable for what they do, then the federal government should be prepared to be measured by the very same principle when it comes to funding Canada's health care system. Therefore, every effort should be made to ensure that health-specific federal monies are visible and transparent. The CMA view is also consistent with the underpinnings of the recently negotiated Social Union Framework Agreement which calls for greater public accountability on all levels of government. These issues have been recently noted by the Auditor-General of Canada "Under the CHST, the federal government does not know its exact total contribution to provinces and territories for health care as distinct from social assistance and services and post-secondary education."5 The report goes on to recommend that the federal government explore options to improve information on its total contribution to health care, and work with the provinces and territories to develop requirements for information and reporting purposes with respect to CHST additional funds. The Canadian Institute for Health Information also observed that "following the introduction of the Canada Health and Social Transfer (CHST) in April 1996, total federal contributions to health care cannot be clearly defined."6 Furthermore a recent policy document released by Mr. Tom Kent, one of the policy architects of Medicare in the 1960s, refers to the CHST as "jelly...It can be varied as we choose, spent however each province chooses." 7 He also says "Ensure that the federal financial contribution to the medicare partnership is made continuingly clear. This transparency is required not only for the credit of the present government but, equally, to protect the provinces against any future federal government thinking that it could cut its funding with little political penalty...In short, the federal need for recognition of funding and the provincial need for security of funding are not in conflict."8 In many ways, the announcement of the $11.5 billion, cumulatively, in 1999 was a de facto recognition of the need for a health-specific allocation in support of health care. The recent calculations released by the Federal Department of Finance only serve to reinforce this point.9 At a time of increased societal awareness and demand for accountability, the CHST mechanism appears to be anachronistic by having one indivisible cash transfer that does not recognize explicitly the federal government's contribution to health in a post-Social Union Agreement world. Therefore, the CHST cash transfer mechanism should be restructured to ensure that there is a higher degree of transparency and explicit linkage between the sources of federal funding and their respective uses at the provincial and territorial level. This can be achieved such that the provinces and territories have the flexibility to allocate resources on the basis of agreed-upon priorities, while ensuring that the federal government is fully recognized for its investment. It would also underscore the relationship between financial "inputs" and health "outputs." A Mechanism to Grow the Real Value of Health-Specific Federal Cash Over Time In addition to increasing the federal cash floor in support of health care, there is also the need to ensure that the cash can grow over time to meet the future needs of Canadians. With this in mind, the CMA recommends the re-introduction of an escalator mechanism to grow the real value of health-specific federal cash. If left as is, federal cash will continue to erode over time with increasing demands from an ageing and growing population, epidemiological trends, new technologies, to name a few. In previous years, the CMA has proposed an escalator formula which recognizes that future health care costs are not always synchronized with economic growth. In fact, in times of economic hardship (e.g., unemployment, stress, and familial discord), a greater burden is placed on the health care system. The concept of an escalator is not new. In fact, at the time of Established Programs Financing, a three-year moving average of nominal Gross Domestic Product per capita was in place. This policy was regrettably tinkered with and then eliminated in the mid-1990s.10 Thus, the CMA believes that now is the time to reintroduce a policy measure that served federal-provincial/territorial fiscal relations well. Such a policy measure would be a clear signal to the provinces and territories that the federal government is prepared to be there over the long-term, and is prepared to move away from the annual finger-pointing that plagues federal/provincial/territorial collaboration when it comes to the future of the health care system. To illustrate the financial impact of an escalator, if the federal government's health-specific cash floor is $9.94 billion, assuming an escalator of 4.6% would yield an additional $457 million to the provinces and territories in year 1, and $547 million in year 5. This is not prohibitive when one considers the current revenues of the federal government, and its anticipated series of surpluses.11 It should also be noted that these recommendations are consistent with the direction set out by the National Liberal Caucus Task Force on Health Care Sustainability.12 Combined, the issues of the level of health-specific federal cash for health care and the need for an escalator mechanism speak not only to the fundamental principles of the necessity of stabilizing the health care system, but also in terms of the federal government taking the necessary concrete leadership steps to ensure that adequate and long-term funding is available to meet the health care needs of all Canadians. Their rationale is reasoned and strategic; they give the federal government full recognition for its investment and the provinces and territories flexibility in allocating monies to meet their respective priorities. It also serves to build on and strengthen the core foundation of Canada's health care system. If Canada's health care system is not only to survive, but thrive in the new millennium, we must give serious consideration to a range of possible solutions that place our system, and the federal role within that system, on a more secure and sustainable financial footing. The CMA therefore recommends: 1. That the federal government fund Canada's publicly financed health care system on a long-term, sustainable basis to ensure quality health care for all Canadians. 2. That the federal government, in consultation with the provinces and territories, and stakeholders, introduce a health-specific cash transfer mechanism to promote greater public accountability, transparency and linkage of sources to their respective uses. 3. That the federal government, at a minimum, increase federal cash for health care by an additional $3.8 billion, effective immediately. 4. That beginning April 1, 2001, the federal government introduce an escalator mechanism that will grow the real value of health-specific cash over time. Looking to the Future... While the federal government must make a series of investments to stabilize the health care system, it must also consider the broader spectrum of health care services needed to ensure that Canadians do not fall through the cracks. In the past, the CMA has proposed a Health System Renewal Fund. The purpose of the multi-year fund was to recognize the changing nature of our health care system and to facilitate the development of a more comprehensive and seamless system of care. The Fund proposed that as the system continues to evolve additional transitional funding is required to ensure that it remains accessible, and can do so with minimal interruption to Canadians. That being said, over the longer-term, the CMA recognizes that the federal government will have to move from transitional funding to investing significant new federal dollars that will not jeopardize access to quality acute care services. The CMA recommends: 5. That the federal government must allocate new monies, over and above the $3.8 billion increase to the health-specific cash floor to facilitate the development of a comprehensive and seamless system of care. HEALTH SYSTEM INNOVATION In reviewing the current state of Canada's health care system and the need to carefully consider its future, there are at least two fundamental issues that require our collective wisdom and action. First, there is the need for long-term sustainable funding. The second concerns the overall structure of the health care system, and the degree to which it must be revitalized. Often portrayed as a separate set of strategic policy issues, system funding and system structure are linked inextricably in a practical sense when it comes to ensuring timely access to quality health care. When it comes to structure, the CMA is of the view that renewal and innovation is essential if we, as a society, are to ensure that our health system remains sustainable and responsive over the short-, medium- and longer-term. While we must ensure that the health care system of tomorrow is structurally sound, it must also be sufficiently flexible, adaptive and focused on excellence. The CMA, therefore, proposes that the federal government invest in two areas that are strategically targeted, and serve to facilitate future innovation, adaptability and flexibility in the health care system. At the same time, they also give the provinces and territories full flexibility in determining their priorities within the mandate of the funds while giving the federal government full recognition for its investment. National Health Technology Fund As part of the CMA's submission to the 2000 House of Commons Standing Committee on Finance pre-budget consultations, it was recommended that the government establish a National Health Technology Fund. The purpose of the Fund is to address the significant concerns that have been raised about the lack of access to needed diagnostic and treatment technologies in Canada. Based on the most recent OECD information, Canada ranks poorly when it comes to the availability of technologies, ranking 12th (out of 15) for CT Scanners; 11th (out of 13) for MRIs; and 10th (out of 11) for Lithotripters. Canada ranks favorably only in the availability of radiation equipment 5th (out of 13) OECD countries. Given the very real concerns that have been raised with regard to waiting times across the country, Canadians deserve better when it comes to making available needed health technologies that can effectively diagnose and treat disease. Furthermore, it is clear that we must do more to facilitate the diffusion of new cost-effective health technologies that are properly evaluated and meet defined standards of quality. While physicians are trained to provide quality medical care to all Canadians, they must, at the same time, have "the tools" to do so. In the absence of ready access to current and emerging health technologies, Canadians face the prospect of continued and untreated progression of disease, increased anxiety over their health status, and possibly premature death, while the health care system and society bears the direct and indirect costs associated with delayed access. If Canada were to provide a level of access to these medical technologies that was comparable to other countries with similar standards of living, a minimum expenditure of $1.0 billion would be required for capital costs alone. Our proposal, however, recommends that targeted resources be provided to the provinces and territories to operate the equipment for a three-year period at an overall cost of $1.74 billion. This would give the provinces and territories the opportunity to factor in these additional resources into their respective health budgets. The CMA recommends: 6. That the federal government commit a minimum of $1.74 billion over three years to A National Health Technology Fund, to increase country-wide access to needed health technologies. For your information, a copy of the detailed proposal is enclosed. National Health Connectivity Investment In addition to a national health technologies fund there is a need for significant attention to be paid to ensure access to both hardware and software in order to develop a health information infrastructure that will create "connectivity" throughout the health care system. The health care system operates within an information intensive environment. However, to date, a substantial amount of the data being collected is gleaned as a derivative of administrative or billing/financial systems. Although this provides useful information for arriving at a "high level" view of the operation of the health care system, it is generally of limited value to health care providers at the interface with their patients. Much of the recent debate about the future of the health care system has focused on the need to improve its adaptability and overall integration. One critical ingredient in re-vitalizing the system has to with the necessary information technologies that physicians and other health care professionals must have at their disposal. Specifically, health care providers require access to a secure electronic health record (EHR) that provides details of all health services provided to the patient in front of them. An EHR that meets the clinical needs of health care providers when interacting with their patients will serve to benefit not only the health of Canadians, but the overall efficiency and effectiveness of the health care system. Introduction of new technology, such as an EHR, should be viewed as a "social investment" in the acquisition of knowledge. This benefits patients through the potential reduction in mortality/morbidity rates due to misdiagnosis and improper treatment as well as the reduction in medication errors through access to online drug reference databases and by largely eliminating handwritten prescriptions. Health promotion and disease prevention is enhanced through improved monitoring and patient education as well as improved decision-making by providers and patients. These benefits represent only a sub-set of the potential benefits to Canadians. There are many benefits to providers in having access to an EHR, ranging from administrative cost savings to decreased loss of medical records and improved privacy from physical intrusion of a medical record. The healthcare system as a whole benefits from increased efficiencies and effectiveness. In the United States, the Veterans Health Services and Research Administration (VHSRA) in a controlled prospective study found that a computerized patient record to support providers in outpatient geriatric clinics resulted in cost reductions and improvements in the quality and outcomes of patient care. With baby boomers some 10 - 15 years from retirement, cost reductions and improvements in the quality and outcomes of patient care are not an insignificant benefit of an EHR.13 With this as an introduction, the CMA recommends to the federal government that a national investment in health connectivity be established with the objective of improving the health of Canadians as well as improving the efficiency and effectiveness of the health care system by funding an information technology infrastructure for the health care system. The CMA has determined that a preliminary estimate of the total initial cost of such an investment in knowledge acquisition is a point order-of-magnitude estimate of $4.1 billion. This represents a capital of cost $1.6 billion with a five year implementation and operating costs of $2.5 billion, plus or minus 20%. The yearly operating costs after 5 years are estimated to be $830 million. Of course, substantial additional work is required to arrive at more precise cost estimates as well as the potential savings of such an endeavour. Such an investment would provide Canadians with a bold vision of the future of health care and the federal government's role in moving the health care system into the future. The CMA proposal for an investment in National Health Connectivity dovetails with the recent views of the First Ministers at their most recent meeting. The CMA concurs with the views of First Ministers that the broadened application of information and communications technologies to the health care sector will improve the quality, timeliness and integration of health care services. The CMA, as the representative of Canadian physicians, can play a pivotal partnership role in achieving the buy-in and cooperation of physicians and other health care providers, through a multi-stakeholder process that would encompass the health care team. Our involvement would be a critical success factor in helping the federal government in making a connected health care system a realizable goal in the years to come. The CMA therefore recommends: 7. That the federal government make a minimum investment of $4.1 billion in National Health Connectivity. NATIONAL PHYSICIAN RESOURCE STRATEGY As the federal government is aware, Canada is experiencing a physician shortage that will be significantly exacerbated in the next decade. In November 1999, when the Canadian Medical Forum (CMF) and Society of Rural Physicians of Canada met with the federal and provincial governments, a detailed report on physician supply, containing five specific recommendations, was submitted. The CMA and the other CMF organizations are encouraged to see that many of the jurisdictions across Canada agreed with the need to increase enrolment in undergraduate medical education programs, although we are still far from the 2,000 by 2000 proposed by the CMF. These increases in undergraduate enrolment in medicine require funding not only for the positions themselves, but also for the necessary infrastructure (human and physical resources) to ensure high quality training. The concomitant increases in postgraduate positions that will be required three to four years after entry into medical school must also be resourced appropriately. It is important to note that these positions are independent of the extra positions recommended in the November 1999 CMF report that are needed to increase: (a) flexibility in the postgraduate training system; (b) the capacity to provide training to international medical graduates; and (c) opportunities for reentry for physicians who have been in practice.) The federal government needs to demonstrate its commitment to the principle of self-sufficiency in the production of physicians to meet the medical needs of the Canadian population. The CMA recommends: 8. That the federal government immediately establish a Physician Education and Training Fund in the amount of $500 million to fund: (1) increased enrolment in undergraduate and postgraduate medical education; and (2) the expanded infrastructure (both human and physical resources) of Canada's 16 medical schools needed to accommodate the increased enrolment. Escalation and Deregulation of Tuition Fees The CMA remains very concerned about high, and rapidly escalating, medical school tuition fee increases across Canada. The CMA is particularly concerned about their subsequent impact on the physician workforce and the Canadian health care system. In addition to the significant impact of high tuition fees on current and potential medical students, the CMA believes that high tuition fees will have a number of consequences, including: (1) creating barriers to application to medical school and threaten the socioeconomic diversity of future health care providers serving the public; and (2) exacerbating the physician 'brain drain' to the United States so that new physicians can pay down their large and growing debts more quickly. The CMA decries tuition deregulation in Canadian medical schools and recommends: 9. That the federal government increase funding targeted to institutes of postsecondary education to alleviate some of the pressures driving tuition fee increases. 10. That the federal government enhance financial support systems for medical students, provided that they are: (a) non-coercive; (b) developed concomitantly or in advance of any tuition increase; (c) in direct proportion to any tuition fee increase; and (d) provided at levels that meet the needs of the students. Proposals for a National Health Technology Fund Currently, there is a crisis in confidence among Canadians that access to quality health care services will be there when they need it. In addition, there is a crisis of morale among health care providers who are concerned that they are not able to provide the quality care their patients need. One of the areas that your government could show strong and effective leadership is in the development of a national health technologies infrastructure program. In its 2000 pre-budget submission to the House of Commons Standing Committee on Finance the CMA made the following recommendation: "That the federal government establish a National Health Technology Fund to increase country-wide access to needed health technologies". The purpose of this recommendation recognizes that there are country-wide concerns with the availability of current health technologies in Canada and the speed with which the distribution of new technologies is taking place. In both instances, they have a direct impact on the ability of Canadians to access, within a reasonable time, needed health technologies. As a consequence, Canadians are facing ever-growing waiting lists for access to needed health technology services (including magnetic resonance imagers; computed tomography scanners; lithotripters; radiation therapy, dialysis) which are essential in the early detection of cancers (e.g., breast, prostate, lung), tumours, circulatory complications (e.g., stroke; hardening of the arteries) and treatment of disease. At the same time, physicians are either delayed or denied the ability to use proven state-of-the-art health technologies to assist them as clinicians. In the absence of ready access to current and emerging health technologies, Canadians face the prospect of continued and untreated progression of disease, increased anxiety over their health status, and possibly premature death, while the health care system and society bears the direct and indirect costs associated with delayed access. In considering this issue, the consensus view is that there is a lack of sustainable financial (i.e., capital) resources to purchase needed health technologies. As well, there also appears to be a lack of ongoing financial resources to ensure that the technology can be operated and maintained (i.e., operational) allowing for access on an ongoing basis. Notwithstanding the supply of health technologies, questions have also been raised about the adequate supply of health care professionals that are needed to operate the technology, and associated physical infrastructure to facilitate reasonable access to care. Currently Provincial and Territorial governments, and other groups have called on the federal government to continue its reinvestment in the health care system via the Canada Health and Social Transfer (CHST). However, one drawback of the transfer mechanism is that it is "blind" with no linkage or accountability between federal cash and its intended uses. Recognizing that there is an urgent need for additional funds to be invested and allocated for needed health technologies, the question from a policy perspective is how to design an accountable, targeted and visible program that will invest federal cash into a specific area of the health care system without intruding in the jurisdictional responsibilities of the Provinces and Territories. One approach is for the federal government to announce the creation of a National Health Technology Fund (NHTF). It is proposed that the NHTF would have the following features: 1) The NHTF would be a time-limited program with the singular focus of assisting the Provinces and Territories in the funding and acquisition of needed health technologies. 2) The NHTF would require that all Provinces and Territories apply to the federal government program for funding for needed health technologies. By so doing, it would give the Provinces and Territories full flexibility in determining their technological priorities, how many and what mix of technologies should be allocated in their jurisdiction. 3) The NHTF would provide full financing (i.e., capital) for the purchase of the technology, and defined resources to defray the operational costs associated with the health technologies across the country. Available monies to the Provinces and Territories could be allocated on a per capita basis and/or cost-sharing basis. 4) Once the program has been sun-setted, the Provinces and Territories would be responsible for the ongoing (operational) funding and maintenance for the technologies. The CMA believes that the form of the fund must be closely aligned with its function and would, therefore, make the following specific recommendations: 1. The NHTF would explicitly link the source of federal funding with its intended use at the Provincial and Territorial level - establishing a new level of federal accountability in financing strategic components of the health care system. 2. The federal government's investment in health care would be visible, with full recognition for the investment. 3. The federal government's investment would directly contribute to the increasing patient access to health technologies and reducing waiting lists across the country. 4. The NHTF would be targeted funding in an area of need. As designed, the NHTF would not be seen as intruding on the Provincial and Territorial decision-making process. The NHTF would give the Provinces and Territories full flexibility to apply for federal funding, as well as determining the number and mix of health technologies. Notwithstanding the immediacy and importance of the federal government making this critical investment in the health care system, there are a series of benefits to the federal government, Canadians and institutions/providers. The following are some of the benefits the CMA would ask you to consider: The Federal Government 1. The federal government begins the process of re-establishing its leadership role when it comes to preserving and enhancing Canadians' access to needed health technologies, and assisting in the stabilization of the acute care system. 2. The Fund avoids transferring non-earmarked money (such as via the CHST) to the Provinces and Territories, and ensures that it will be invested in a specific area of priority. 3. The NHTF is a visible and accountable Fund for which the federal government can take full credit. The Public 1. Canadians will benefit directly in terms of having increased access to needed health technologies. 2. Canadians will be fully aware of the federal government's investment into the acute care system. 3. Canadians will benefit in terms of quicker diagnosis and treatment of disease. 4. The public's confidence in its publicly financed health care system will improve. Improved access will reduce the direct (e.g., time off from work) and indirect costs (i.e., caring for family members) of illness, and accelerate Canadians' return to functional status. Health Care Institutions and Providers 1. The additional funding will give institutions increased flexibility in purchasing needed health technologies. 2. It will give institutions the ability to provide more readily accessible health care to Canadians. 3. Providers will have state-of-the-art diagnostic and treatment tools to provide quality health care to all Canadians. The CMA has assessed the cost implications of this national initiative and this information is attached. In addition to a national health technologies fund there is a need for significant attention to be paid to ensure access to both hardware and software in order to develop a health information infrastructure that will create "connectivity" throughout the health care system. The objective would be to foster the integration of the components of the system across the continuum of care supported by evidence-based decision-making by both clinicians and managers. The CMA would like to work with you and your colleague, the Minister of Industry, to explore opportunities to work in partnership with the profession and Canada's high technology industrial sector to develop this health information infrastructure. It is our hope that your government will give serious consideration to our recommendation for a national health technologies fund. The CMA believes that such a fund is clearly warranted. Cost Estimates: In support of the Canadian Medical Association's proposal for a National Health Technology Fund, the following cost estimates, based on the best available data, for the acquisition of medical technology has been compiled. The most recent data available on medical technology comparisons between countries is from the OECD (1997). Equipment costs, in terms of acquisition, siting and operating costs where provided by CMA Affiliates as noted in the cost estimates. If Canada were to provide a level of access to these medical technologies that was comparable to other countries with similar standards of living a minimum expenditure of $1 billion would be required for capital costs alone. Our program, however, in keeping with the spirit of the Canada Health Act, recommends that resources be provided to the provinces/territories to operate the equipment for a three year period at an overall cost (capital and three years of operating costs) of $1.74 billion. This would give the provinces/territories the opportunity to factor in these additional operating costs into their respective health budgets over the three year period. It should be noted that the CMA's estimates do not address the aging state of Canada's existing medical technologies. Unfortunately, information is not available to provide an estimate of the costs of updating such equipment. Medical Technology Acquisition Cost Estimates: Purpose: To estimate the costs of funding a National Health Technology Program. Data Sources: * OECD Health Data 99 - Number of units of technology equipment per million population for countries reporting data for 1997 (most recent year). * Costing information courtesy of: 1) Canadian Association of Radiologists; 2) Winnipeg Health Region Authority; and 3) Canadian Urology Association Data: * Capital cost includes, equipment acquisition cost and siting cost (building space, mechanical, technical, electrical, etc.). * Operating cost includes, yearly service contract and estimate for technical support staff. It does not include expenditures on medical services. Methodology: 1) Medical technologies included: - Computed Tomography scanners (CT scanners) - Magnetic Resonance Imaging units (MRI) - Radiation therapy equipment (linear accelerators, cobalt-60 units, caesium-137 telepathy units, low to orthovoltage x-ray units, high dose rate brachytherapy units, low dose rate brachytherapy units, conventional brachytherapy) - Lithotripters (extracorporeal shock wave lithotriptors) - Positron Emission Tomography (PET) 2) Technologies are expressed in units per million population and are compared only with countries included in the OECD database for 1997 that had a purchasing power parity PPP $ GDP per capita greater than $20,000. Canada's PPP GDP per capita in 1997 was $23,745 while the average for the comparator countries was $23,749. A GDP criteria for comparator inclusion was used to compare Canada with countries that have similar standards of living and potentially similar demands for access to their health care system and to medical technology. 3) The comparator countries are mainly from Europe which have a very high population density. The number of units per million population don't take into account the geographic diversity of Canada. 4) PET data were provided by the Canadian Association of Radiologists (CAR) who stated there were 200 PETs in the world in 1998. Europe and the USA each had a 40% share with Canada having a 3% share used mostly for research. CAR estimates that accounting for population size; and growth; and that PETs in Canada are mostly used for research, an additional 10 units are required. 5) The equipment highlighted are more readily identifiable given their high acquisition costs but other medical technologies in Canadian hospitals need replacement or upgrading as well. For example, gamma cameras are generally 10 to 15 years old and need to be replaced with gated imaging cameras at a cost of $650,000 each. Colour doppler ultrasound machines are also required at $200,000 each. As well brachytherapy equipment, which is used for cancer treatment, is becoming increasingly obsolete and has a replacement cost of $750,000 per unit. 6) An 85% factor has been used to estimate requirements for other medical technologies. That is, CAR estimates that radiological high technology medical equipment represents 85% of the overall cost of radiological medical technology. Therefore overall capital costs (equipment and siting) have been grossed up by a factor of (1/.85) or 17.65% to allow for the purchase of other medical technology equipment that cannot be accounted for with the information available. 7) Equipment acquisition cost estimates (excluding siting costs) are based on average estimated costs. Depending upon the sophistication of the equipment the ranges are: CT scanners: $0.50m - $1.50m Linear accelerators: MRIs: $1.25m - $2.50m Low energy: $1.50m Lithotripters: $1.25m - $1.50m High energy $1.80m 8) Operating costs have been calculated over a three-year period so that all provinces/territories would be able to make use of the program which is in keeping with the spirit if not the terms of the Canada Health Act. It would also give them the opportunity to factor these additional operating costs into their respective health budgets after the 3 years. Caveats: The cost estimates reflect the additional cost of bringing Canada up to a standard of access to medical technology of developed countries with similar $ PPP GDP per capita. The cost estimates do not take into account any replacement of existing medical technology equipment that may be required. The acquisition cost of medical technology equipment is only one factor. Associated with such equipment are the costs of a physical site, yearly service contracts and the yearly operating cost of materials and personnel. Findings The estimated overall capital cost is $1 billion. The overall cost of the program, which includes resources to operate the equipment for a three year period, is $1.74 billion. 1 Source: Backgrounder on Federal Support for Health in Canada. March 29, 2000. Department of Finance. 2 Understanding Canada's Health Care Costs - Interim Report. Provincial and Territorial Ministers of Health, June 2000. 3 One must keep in mind that once the tax point transfer occurred, they are part of the provinces own-source revenue structure. The tax points cannot be repatriated to the federal government. Furthermore, with the creation of the CHST cash floor, the relationship between the level of federal cash and tax points has been formally severed. 4 Iglehart J. Restoring the Status of An Icon: A Talk With Canada's Minister of Health. Health Affairs, Volume 19, Number 3, page 133. 5 Report of the Auditor-General of Canada. Chapter 29 Federal Support of Health Care Delivery, November, 1999. 6 Canadian Institute for Health Information. Health Care in Canada - A First Annual Report. 2000. 7 Kent T. What Should Be Done About Medicare. Caledon Institute of Social Policy, August 1, 2000. pp 3-4 8 Ibid, page 2. 9 Backgrounder on Federal Support for Health in Canada. Department of Finance, March 29, 2000. 10 Thomson A. Diminishing Expectations - Implications of the CHST. May, 1996. 11Beauchesne. Federal Surplus Soars. Ottawa Citizen, August 18, 2000. Through the first three months of the current fiscal year, the surplus stands at $8.2 billion - 42% higher than last year at the same time. Extrapolated over the full year, the surplus would be $32.8 billion. . McCarthy S. Ottawa May Have $74 Billion to Allocate. Globe and Mail, August 29, 2000. The article reports that the Ottawa should have a $44 billion surplus over the next five years even after allowing spending to rise by more than $3 billion a year to cover population growth and inflation and setting aside $3 billion annually for debt reduction. 12 Investing in New Approaches to Health Care. National Liberal Caucus Task Force on Health Care Sustainability. June 14, 2000. pp 3. 13Dammond KW, Prather RJ, Date VV, King CA. Computers in Biology and Medicine, Vol. 20, No. 4, pages 267-279, 1990, "A Provider-Interactive Medical Record Can Favorably Influence Costs and Quality of Medical Care."
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Tamper Resistance under the Controlled Drugs and Substances Act

https://policybase.cma.ca/en/permalink/policy11295
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada. The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential. The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse. A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure." Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing 1 Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription 2 Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E 3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably. 4 National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered. The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5 Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards. The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected. As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9. Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the 5 Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance. Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6 Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23. 7 Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol. 8:400-407. 8 Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9. 9 The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved from: http://www.conferenceboard.ca/Libraries/CONF_PDFS_PUBLIC/14-0131_SummaryReport_June6.sflb progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet. There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects. The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management. Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential. The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations. Recommendations The CMA recommends that: 1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders. 2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations. 3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages. 4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects. 5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. 6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.
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Regulatory framework for the mandatory reporting of adverse drug reactions and medical device incidents by provincial and territorial healthcare institutions.

https://policybase.cma.ca/en/permalink/policy11814
Date
2016-01-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-01-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s consultation document Questions related to Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare Institutions. Prescription medication has an important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient’s capacity to function productively in the community. In consideration of this important role, the CMA has developed a substantial body of policy on pharmaceutical issues which includes policy on Canada’s post-approval surveillance system for prescription medication. It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan. The CMA welcomes Health Canada’s consultation on the new legislative authority established by Vanessa’s Law to implement mandatory reporting of adverse drug reactions (ADR) and medical device incidents by provincial and territorial healthcare institutions. The CMA appreciates all opportunities to work with governments, health care professionals and the public in strengthening Canada’s post-approval surveillance system and ensuring that the prescription drugs Canadians receive are safe and effective. The CMA’s submission is organized in three main sections. In the first section, the CMA’s concerns with the current ADR reporting system are identified as critical context for this regulatory development process. The second section provides an overview of the CMA’s recommendations on necessary improvements to this system. Finally, the CMA’s responses to the questions outlined in Health Canada’s discussion document are presented in the third section. Part 1: Context of CMA’s Recommendevices with which they have a concern, and also for research purposes.
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Health Canada’s Consultation on “Plain and Standardized Packaging”

https://policybase.cma.ca/en/permalink/policy13817
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation, May 2016. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” Over the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The current Health Canada proposal will help realize that goal and the CMA supports the measures outlined in the consultation paper. There are two elements that the CMA recommend be addressed in this consultation. The CMA recommends that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. In a similar vein, the CMA recommends a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.” While the CMA supports these measures, they must be part of the overall goal of further reducing and eliminating smoking. These measures will be an essential element of a sustained, well-funded and comprehensive program to reduce tobacco use, combining policy interventions with educational and social-marketing interventions including mass media campaigns. These programs should reflect current best practices, and be evaluated regularly for effectiveness and impact. To that end, the CMA calls on the federal government to renew the Tobacco Strategy before it expires in March 2017. At the same time, the CMA also recommends that the government allocate adequate funding to ensure implementation of the strategy. Finally, the consultation paper closes with some potential challenges to the implementation of these proposals. With respect to the problem of counterfeit cigarettes, all levels of government should take the strongest possible measures to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. The problem of retailers having difficulty implementing the regulations, resulting in service delays to their customers, is not really an issue related to these proposals. It is very doubtful that the retailers will experience such problems for very long and will find ways of resolving such difficulties. As for the problem of the manufacturers continuing to innovate in order to circumvent these measures, there should be sufficient enforcement tools within the regulations that will enable Health Canada to deal with such infractions. The Canadian Medical Association remains committed to working with governments and stakeholders to address this issue. We reiterate our long-standing support for plain and standardized packaging for tobacco products. In summary, the CMA recommends that: 1) only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed; 2) a single allowable length of cigarette and that a minimum diameter or width be established; 3) the federal government renew the Tobacco Strategy before it expires in March 2017 and that that the government allocate adequate funding to ensure implementation of the strategy. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism
Vice-président, Professionnalisme médicale Canadian Medical Association
Association médicale canadienne
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Avoiding negative consequences to health care delivery from federal taxation policy

https://policybase.cma.ca/en/permalink/policy11957
Date
2016-08-31
Topics
Health human resources
Physician practice/ compensation/ forms
  1 document  
Policy Type
Response to consultation
Date
2016-08-31
Topics
Health human resources
Physician practice/ compensation/ forms
Text
The Canadian Medical Association (CMA) provides this submission in response to Finance Canada’s consultation on Legislative Proposals Relating to Income Tax, Sales Tax and Excise Duties (Draft Tax Legislative Proposals). The CMA is the national voice of Canadian physicians. On behalf of its more than 83,000 members and the Canadian public, the CMA’s mission is helping physicians care for patients. In fulfillment of this mission, the CMA’s role is focused on national, pan-Canadian health advocacy and policy priorities. As detailed in this brief, the CMA is gravely concerned that by capturing group medical structures in the application of Clause 13 of the Draft Tax Legislative Proposals, the federal government will inadvertently negatively affect medical research, medical training and education as well as access to care. To ensure that the unintended consequences of this federal tax policy change do not occur, the CMA is strongly recommending that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction in Clause 13 of the Draft Tax Legislative Proposals. Relevance of the Canadian Controlled Private Corporation Framework to Medical Practice Canada’s physicians are highly skilled professionals, providing an important public service and making a significant contribution to our country’s knowledge economy. Due to the design of Canada’s health care system, a large majority of physicians – more than 90% – are self-employed professionals and effectively small business owners. As self-employed small business owners, physicians typically do not have access to pensions or health benefits, although they are responsible for these benefits for their employees. Access to the Canadian-Controlled Private Corporation (CCPC) framework and the Small Business Deduction (SBD) are integral to managing a medical practice in Canada. It is imperative to recognize that physicians cannot pass on any increased costs, such as changes to CCPC framework and access to the SBD, onto patients, as other businesses would do with clients. In light of the unique business perspectives of medical practice, the CMA strongly welcomed the federal recognition in the 2016 budget of the value that health care professionals deliver to communities across Canada as small business operators. Contrary to this recognition, the 2016 budget also introduced a proposal to alter eligibility to the small business deduction that will impact physicians incorporated in group medical structures. What’s at risk: Contribution of group medical structures to health care delivery The CMA estimates that approximately 10,000 to 15,000 physicians will be affected by this federal taxation proposal. If implemented, this federal taxation measure will negatively affect group medical structures in communities across Canada. By capturing group medical structures, this proposal also introduces an inequity amongst incorporated physicians, and incentivizes solo practice, which counters provincial and territorial health delivery priorities. Group medical structures are prevalent within academic health science centres and amongst certain specialties, notably oncology, anaesthesiology, radiology, and cardiology. Specialist care has become increasingly sub-specialized. For many specialties, it is now standard practice for this care to be provided by teams composed of numerous specialists, sub-specialists and allied health care providers. Team-based care is essential for educating and training medical students and residents in teaching hospitals, and for conducting medical research. Put simply, group medical structures have not been formed for taxation or commercial purposes. Rather, group medical structures were formed to deliver provincial and territorial health priorities, primarily in the academic health setting, such as teaching, medical research as well as optimizing the delivery of patient care. Over many years, and even decades, provincial and territorial governments have been supporting and encouraging the delivery of care through team-based models. To be clear, group medical structures were formed to meet health sector priorities; they were not formed for business purposes. It is equally important to recognize that group medical structures differ in purpose and function from similar corporate or partnership structures seen in other professions. Unlike most other professionals, physicians do not form these structures for the purpose of enhancing their ability to earn profit. It is critical for Finance Canada to acknowledge that altering eligibility to the small business deduction will have more significant taxation implication than simply the 4.5% difference in the small business versus general rate at the federal level. It would be disingenuous for Finance Canada to attempt to argue that removing full access to the small business deduction for incorporated physicians in group medical structures will be a minor taxation increase. As taxation policy experts, Finance Canada is aware that this change will impact provincial/territorial taxation, as demonstrated below in Table 1. Table 1: Taxation impacts by province/territory, if the federal taxation proposal is implemented In Nova Scotia, for example, approximately 60% of specialist physicians practice in group medical structures. If the federal government applies this taxation proposal to group medical structures, these physicians will face an immediate 17.5% increase in taxation. In doing so, the federal government will establish a strong incentive for these physicians to move away from team-based practice to solo practice. If this comes to pass, the federal government may be responsible for triggering a reorganization of medical practice in Nova Scotia. Excerpts from physician communiques The CMA has received as well as been copied on a significant volume of correspondence from across our membership conveying deep concern with the federal taxation proposal. To provide an illustration of the risks of this proposal to health care, below are excerpts from some of these communiques:
“Our Partnership was formed in the 1970s…The mission of the Partnership is to achieve excellence in patient care, education and research activities….there would be a serious adverse effect on retention and recruitment if members do not have access to the full small business deduction…The changes will likely result in pressure to dissolve the partnership and revert to the era of departments services by independent contractors with competing individual financial interests.” Submitted to the CMA April 15, 2016 from a member of the Anesthesia Associates of the Ottawa Hospital General Campus
“The University of Ottawa Heart Institute is an academic health care institution dedicated to patient care, research and medical education…To support what we call our “academic mission,” cardiologists at the institute have formed an academic partnership…If these [taxation] changes go forward they will crippled the ability of groups such as ours to continue to function and will have a dramatic negative impact on medical education, innovative health care research, and the provision of high-quality patient care to our sickest patients.” Submitted to the CMA April 19, 2016 from a member of the Associates in Cardiology
“We are a general partnership consisting of 93 partners all of whom are academic anesthesiologists with appointments to the Faculty of the University of Toronto and with clinical appointments at the University Health Network, Sinai Health System or Women’s College Hospital…In contrast to traditional business partnerships, we glean no business advantage whatsoever from being in a partnership…the proposed legislation in Budget 2016 seems unfair in that it will add another financial hardship to our partners – in our view, this is a regressive tax on research, teaching and innovation.” Submitted to the CMA April 14, 2016 from members of the UHN-MSH Anesthesia Associates Recommendation The CMA recommends that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction, as proposed in Clause 13 of the Draft Tax Legislative Proposals. Below is a proposed legislative amendment to ensure group medical structures are exempted from Clause 13 of the Draft Tax Legislative Proposals: Section 125 of the Act is amended by adding the following after proposed subsection 125(9): 125(10) Interpretation of designated member – [group medical partnership] – For purposes of this section, in determining whether a Canadian-controlled private corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician is a designated member of a particular partnership in a taxation year, the term "particular partnership" shall not include any partnership that is a group medical partnership. 125(11) Interpretation of specified corporate income – [group medical corporation] – For purposes of this section, in determining the specified corporate income for a taxation year of a corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician, the term "private corporation" shall not include a group medical corporation. Subsection 125(7) of the Act is amended by adding the following in alphabetical order: "group medical partnership" means a partnership that: (a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and (b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice; "group medical corporation" means a corporation that: (a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and (b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice. "medical practice" means any practice and authorized acts of a physician as defined in provincial or territorial legislation or regulations and any activities in relation to, or incidental to, such practice and authorized acts; "physician" means a health care practitioner duly licensed with a provincial or territorial medical regulatory authority and actively engaged in practice;
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Front-of-package labelling consultation

https://policybase.cma.ca/en/permalink/policy13800
Date
2016-10-31
Topics
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-10-31
Topics
Health care and patient safety
Text
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices. In this regard, CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans fat and calorie content of processed foods and prepared meals; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels.1 We commend Health Canada on recent work on updating the nutrition facts table and the current revision of the Canada Food Guide and are very pleased to provide a response to the consumer questionnaire on the Health Canada proposal for front-of-package (FOP) nutrition labelling. FOP nutrition labelling approach and possible symbols Do you support Health Canada's proposal to use a symbol to identify foods that are high in sodium, sugars and/or saturated fat? Please explain. In 2011, appearing before the House of Commons Standing Committee on Health, the CMA supported a standard "at a glance" approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices.2 There is a growing body of evidence linking the consumption of diets high in saturated fats, sugars or sodium to cardiovascular and chronic disease (hypertension, dyslipidemia, diabetes mellitus, obesity, cancer, and heart disease and stroke) - leading preventable risk factors and causes of death and disability within Canada and worldwide. Therefore, the CMA does support the proposal to use a symbol for "high in" FOP labelling of foods high in sugar, sodium or saturated fats. FOP labelling on packaged foods may help Canadians make healthier food choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling. Which symbol would help you recognize foods high in sodium, sugars and/or saturated fat? Please explain. Of the proposed symbols, we believe that those that resemble a stop sign would send a strong and recognizable signal of a food to avoid. The triangle yield sign shape is too similar to the shape often used to indicate a hazard such as poison. We would recommend holding focus groups with Canadians to better understand how the proposed symbols will be understood by consumers. Foods that do not have nutrition labelling Do you think these foods should be exempt from FOP symbols even if they're high in sodium, sugars and/or saturated fat? Please explain. The CMA can support the exemption of FOP labelling for products in very small packages but we would like to see a provision to include information on "high in" sugar, salt or saturated fats on foods such as sausages, bakery products, prepared dishes from the deli produced and prepackaged by grocery stores/retailers as they are categories of foods often high in these nutrients. A "high in" sticker could be added to the retailer's packaging to be consistent with other packaged foods. Nutrient levels for a "high in" FOP label Do you think the proposed nutrient levels make sense to identify foods that are high in sodium, sugars and/or saturated fat? Please explain. The CMA supports the proposed nutrient levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring that the "high in" threshold and the 15% "a lot" daily value (DV) message are consistent delivers a clear message of concern. While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we suggest that the threshold for "high in" sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education. Updating nutrient content claims and other nutrition-related statements Do you support not allowing a "no added sugars" claim on foods high in sugars? Please explain. Allowing a food that qualifies for a "high in" sugar FOP symbol to also display a "no added sugars" claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing "no added sugar" claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion. Labelling of foods that have sweeteners Do you support that these sweeteners be declared in the list of ingredients only, rather than in the list of ingredients and the front of the package? Please explain. We do not support the elimination of the labelling requirement for artificial sweeteners on the principle display panel. For products that have high intensity sweeteners added and which bear claims such as "unsweetened" or "no sugar added," a declaration of "artificially sweetened" should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn't need to be on the principal display. For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government's Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism 1 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca. 2 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca --------------- ------------------------------------------------------------ --------------- ------------------------------------------------------------
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Regulation of Self-Care Products in Canada

https://policybase.cma.ca/en/permalink/policy13802
Date
2016-10-31
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-10-31
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) appreciates the opportunity to respond to the Health Canada consultations on the regulation of self-care products in Canada. The CMA is encouraged that Health Canada is proposing a framework for the regulation of self-care products that is reliant on scientific proof to support health claims. The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The CMA’s comments on the regulation of self-care products, particularly natural health products and non-prescription drugs is based on the CMA Policy on Complementary and Alternative Medicine attached as Appendix 1. Our position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Canadians deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end.1 CMA supports a regulatory approach to self-care products such as natural health products that is based on risk assessment and the development of standards. 2 1 Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf F:\E-sig\JB_Signature.jpg 2 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 3Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf 4 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 5 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. 6 Canadian Medical Association. Brief BR2014-09 - Bill C-17 An Act to amend the Food and Drugs Act. Ottawa: The Association; 2014. Risk Based Approach As noted above CMA has recommended a regulatory approach that is based on risk assessment. We are troubled that the consultation document does not provide enough information on Health Canada’s risk assessment process. We are concerned that the proposal for a risk based approach could place many natural health and homeopathic products in a lower risk category based on whether or not the product makes a health claim which would require no Health Canada review or licensing of these products. As noted in the consultation document all health products have some level of risk and Health Canada’s role is to ensure that the benefits of a product outweigh any know risks. CMA does not believe that a determination of risk can be made based on historical use of a product or on the basis of a philosophical system not supported by science. The CMA has a long standing position that the same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. 3 CMA would recommend that the initial risk assessment of a self-care product should be evidence informed and based on the same standards of proof and efficacy as those for conventional medicines and pharmaceuticals. As such, we are concerned that homeopathic and natural health products are given as examples of lower risk products that would not require Health Canada review or licensing. Health Claims The consultation document redefines a health claim to only those that pertain to diagnosis, treatment, prevention, cure or mitigation of disease or serious health condition. These claims will need to be supported by scientific evidence and only these health claims will be allowed and reviewed by Health Canada. The CMA has recommended that safety and efficacy claims for natural health products, and claims for the therapeutic value of these products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications currently regulated by Health Canada. 4 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.5 Therefore the CMA supports the proposal that two products making similar claims would have to provide the same level of scientific evidence and are held to the same standard. CMA would not be in support of the proposal that products can still make claims “based on traditional systems of medicine or alternate modalities” with only “adequate supporting information” to be maintained by the company without review or licensing by Health Canada. CMA would also recommend that even those products that do not make health claims are held to the same standard as those established for pharmaceutical products. Since our position is that all self-care products from lower risk to higher risk should be reviewed for safety and quality, all products should undergo review by Health Canada. Information It is certainly problematic that, as noted in the consultation document, fewer than 2 in 5 Canadians surveyed rated themselves knowledgeable about the effectiveness of self-care products. Canadians have the right to reliable, accurate information on self-care products to help ensure that choices they make are informed. It is very important that Canadians understand the level of scrutiny a product has undergone by Health Canada. CMA can support the proposal for an authorization number on those products that have been reviewed and approved by Health Canada. Equally, a disclaimer on the product label that indicates that the product has not been reviewed or approved by Health Canada for effectiveness is very important. We must guard against an assumption by the public that if Health Canada did not need to review a product there is no risk associated with the product. The Information provided on self-care products should be user friendly and easy to access and include a list of ingredients, instructions for use, indications that the product has been proven to treat, contraindications, side effects and interactions with other medications. In an era when product claims can be spread vie social media and the internet and cannot be easily monitored it is important to ensure consistent oversight of product marketing. Health claims can only be promoted if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Additional Powers In its submission on Bill C -17 An Act to amend the Food and drugs Act – Protecting Canadians from Unsafe drugs the CMA recommended that the ministerial authorities and measures to address patient safety risks should extend to natural health products.6 We would therefore suggest that Health Canada explore the need for additional powers and tools to require a company to change labels, or order a recall of an unsafe product and institute new penalties to address patient safety issues. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's regulatory framework for self-care products to ensure that the health related products Canadians receive are safe and effective. Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism Canadian Medical Association CMA POLICY COMPLEMENTARY AND ALTERNATIVE MEDICINE (Update 2015) This statement discusses the Canadian Medical Association’s (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA’s position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should “consider first the well-being of the patient.”1 The ethical principle of non-maleficence obliges physicians to reduce their patient’s risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM. 1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. 2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies. CAM in Canada CAM has been defined as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.”i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health. analysis, the CMA divides CAM into four general categories: . Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based. . Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products. . Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise. . Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada. Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the “holistic” concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM. Toward Evidence-Informed Health Care Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious. The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA’s Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below: a) Research: Building an Evidence Base To date, much of the public’s information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public. b) An Appropriate Regulatory Framework Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments. i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada. The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products’ safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include: 5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies. 6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. Available: 9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. 12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. * manufacturing processes that ensure the purity, safety and quality of the product; * labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6 The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm’s length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8 The Canadian Medical Association advocates that foods fortified with “natural health” ingredients should be regulated as food products and not as natural health products The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada’s MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada. ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge. Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients. Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to: . Resist any influence or interference that could undermine their professional integrity;9 . Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10 . Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient. c) Information and Promotion Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include: . Instructions for use; . Indications that the product or therapy has been convincingly proven to treat; . Contraindications, side effects and interactions with other medications; . Should advise the consumer to inform their health care provider during any encounter that they are using this product.12 This information should be provided in such a way as to minimize the impact of vested commercial interests on its content. In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims. The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease. The Role of Health Professionals Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients. Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically. The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
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Consultation on the renewal of Federal Tobacco Control Strategy

https://policybase.cma.ca/en/permalink/policy13804
Date
2017-04-05
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2017-04-05
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of the Canadian Medical Association (CMA), I am responding to your request for consultation on renewal of the Federal Tobacco Control Strategy (FTCS) and on the consultation document: “Seizing the Opportunity: The Future of Tobacco Control in Canada.” We are pleased that Health Canada is renewing the FTCS. The most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014. The decrease is welcome news but much more needs to be done to ensure the decline continues. We support the Endgame Summit’s goal of less than 5% tobacco use by 2035. It must be recognized that specific sub-populations, such as Indigenous populations, will require different targets along with prevalence reduction goals that recognize their unique circumstances and needs. Tobacco has ceremonial significance among Indigenous peoples; the harm associated with tobacco arises not from its ceremonial use but from its daily, repeated abuse. As the Summit suggests a renewed strategy must go beyond the traditional approaches of incremental stricter measures by focussing on the activities of the tobacco industry while offering more assistance to those affected by tobacco products. The whole-of-government approach recommended by the Summit and the framework it proposes are essential for the success of the strategy in the long-term. The CMA believes that despite the reduction in smoking rates, tobacco control remains a priority and should continue to be supported by a sustained, well-funded federal strategy and strong leadership and support from Health Canada, including a coordinated, comprehensive national cessation strategy. We recommend that the next version of the FTCS make the following initiatives a priority: . Pricing There is abundant evidence that high prices are crucial to discouraging tobacco use, especially among young people who are particularly sensitive to price increases. The Summit’s recommendation of a joint pricing strategy developed by Health Canada and Finance Canada that combines substantial excise tax increases and other measures will be key in that regard. As in reducing prevalence, pricing strategies that recognize the unique circumstances and needs of specific sub-populations will need to be developed. . Plain and Standardized Tobacco Packaging The CMA recommends only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA also supports a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.” . Retailing The CMA recommends tightening the licensing system to limit the number of outlets where tobacco products can be purchased. The more restricted is tobacco availability, the easier it is to regulate. . Age of sale The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco, preventing them from starting to use tobacco and encouraging them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. The CMA supports raising the minimum age of sale to 21 years. . Promotion Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to young people. The CMA supports educational and public relations initiatives aimed at countering these messages. For example, movie classification systems should restrict access by children and youth to films that portray tobacco use and tobacco product placement. The CMA also supports a total ban on promotion, including tobacco-branded tobacco accessories and non-tobacco products. . Industry interference The CMA supports the Endgame Summit’s recommendations with respect to preventing the tobacco industry’s interference with health policy (i.e., Article 5.3 Guidelines to the Framework Convention on Tobacco Control). It is the CMA’s position that the federal government has a vital role to play in smoking cessation. A fully funded and resourced tobacco control strategy that meets the challenges of the 21st century will help accomplish that goal. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism
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Consultation on proposed front-of-package labelling

https://policybase.cma.ca/en/permalink/policy13882
Date
2018-04-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-04-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Dear Mr. Rodrigue: The Canadian Medical Association is pleased to have this opportunity to participate in the consultation on the proposed front-of-packaging labelling (FOP) as posted in the Canada Gazette Part One on February 9, 2018.1 This new requirement will “provide clear and consistent front-of-package information and updated nutrient content claims to help protect Canadians from the risks of chronic diseases” related to the intake of foods high in sugar, sodium, saturated fats and trans fat.2 1 Canada Gazette Part One. Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) Department of Health Vol. 152, No. 6 — February 10, 2018 2 Ibid pg.1 3 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels. We also commend Health Canada for its current work on revising the Canada Food Guide. Front-of-Packaging Labelling The CMA has supported a standard “at a glance” approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices since 2011.3 FOP labelling on packaged foods will help Canadians make healthier food and beverage choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling. The CMA supports the placement of the proposed symbol on the upper and/or right hand side of the packaging, covering 25% of the principal display surface. The symbol must be clearly delineated from the product packaging so that it stands out and can be located with relative ease. It is important for the symbol to convey to the consumer that there is a certain degree of risk involved in consuming these foods, hence the colours used and the shape will be important. Of the four symbols proposed by Health Canada, our preference is for the one displayed here but with a more defined, thicker border, that includes a small outer buffer (in white). It will be essential for Health Canada to ensure that the symbol design has been tested thoroughly with consumers and is effective in conveying the intended “high in” message. As such, manufacturers will need clear guidance about the constraints on the use and placement of these symbols to ensure they cannot be misconstrued and to prevent the use of configurations that will diminish their effectiveness. Manufacturers must not be permitted to place voluntary nutrient content or health claims below or near the main symbol that would distort the message and create confusion. Foods to be exempted from front-of-package nutrition labelling There will be foods that are exempt from the labelling requirements and consumers will need clear explanations with respect to those that are exempt and why; some will be obvious, some will not. The CMA supports the proposed exemptions for eggs, fruits, vegetables and unsweetened, unsalted plain milk, and whole milk. However, we do not believe flavoured and/or seasoning salts and “sea salts” should be exempted from the requirement to have an FOP symbol on the package. Health Canada will need to undertake an education program to explain to consumers that these products are actually high in sodium. Nutrient thresholds for sodium, sugar & saturated fat CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans-fat and calorie content of processed foods and prepared meals.4 The nutrient levels chosen will therefore be critical in that regard. The CMA supports the proposed levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring consistency between the “high in” threshold and the 15% “a lot” daily value (DV) message delivers a clear message of concern. 4 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca. While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we recommend that the threshold for “high in” sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education. Nutrient content claims, in relation to Front-of-Packaging Labelling symbol Allowing a food that qualifies for a “high in” sugar FOP symbol to also display a “no added sugars” claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing “no added sugar” claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion. High-intensity sweetener labelling Canadians have come to rely on easy-to-recognize information that alerts them that food may contain artificial sweeteners. Therefore, we do not support the elimination of the labelling requirement for artificial sweeteners on the principal display panel. For products that have high intensity sweeteners added and which bear claims such as “unsweetened” or “no sugar added,” a declaration of “artificially sweetened” should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn’t need to be on the principal display. Further, while we recognize that harmonizing with USA labelling regulations is desirable, we recommend strongly against the use of the term “phenylketonurics.” The proper approach would be to use the phrase “people with phenylketonuria” for any warnings on products containing aspartame, which contains phenylalanine. Consumer education For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government’s Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism
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Health Canada consultation on tobacco products regulations (plain and standardized appearance)

https://policybase.cma.ca/en/permalink/policy13930
Date
2018-09-06
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-09-06
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s proposed regulations entitled Tobacco Products Regulations (Plain and Standardized Appearance) and an Order to amend Schedule 1 to the Tobacco and Vaping Products Act with respect to colouring agents, in Canada Gazette, Part 1. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use and for the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 in a resolution recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” We are pleased to support the proposed regulations and that they will apply to the packaging of all tobacco products and that brand colours, graphics and logos will be prohibited on packages. No exceptions, including for cigars and pipe tobacco, should be considered. These measures will assist in promoting harm reduction efforts and further the goal of reducing and eliminating smoking. In 2017, 16.2% of Canadians aged 12 and older smoked either daily or occasionally; this is down from 17.7% in 2015. These proposed regulations will be a significant step in the goal of further reducing the smoking rate. However, there are three areas that the CMA would like to see strengthened and are described below. Slide and Shell Packaging – Minimum package dimensions and warning surface area The CMA supports strongly the concept of tobacco products being sold in standardized packages. We recommended that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one type and allow for the largest possible surface area to be used to convey health warnings and other health-related information. With respect to the draft regulation (s.39) concerning the dimensions of the new packages when closed, the CMA recommends that the measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions.1 The Quebec requirement for a warning surface area of 46.5 sq. cm should be the minimum across Canada. To achieve that, we suggest that the new slide and shell package for regular size cigarettes have the following dimensions when it is closed: (a) its height must be no less than 74 mm and no more than 77 mm; (b) its width must be no less than 84 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes. A similar adjustment is recommended for the width of packages of king size cigarettes when closed: (a) its width must be no less than 83 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes. In both cases, this is over and above the dimensions in s.39 (1)(a) and (b) for regular size cigarettes and s.39(2)(b) for king size cigarettes. We also recommend that the number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. This would also prohibit manufacturers from adding one or two additional cigarettes as a “bonus” or “premium.” Brand names The appearance of brand names on the packages should be in a manner that is standard for all brands. Tobacco manufacturers should not be able to include terms such as “organic” or “natural” as part of a brand name. These descriptions would convey the perception that these products are somehow better or are healthier for the consumer. As well, they may be used to evoke a lifestyle or are fashionable. Such terms and phrases should be banned in the regulations; the European Union’s Directive 2014/40/EU of the European Parliament and of the Council could serve as the guide is this instance. Leaflets Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to their customers. The CMA has always supported educational and public health initiatives aimed at countering these messages. Permitting a leaflet inside packages “that warns consumers of the health hazards arising from the use of the tobacco product or that provides instructions for its use” (draft regulation s. 36.3) is a positive step but should not provide manufacturers with a potential loophole to exploit. The draft regulation should be amended to indicate that the only instance where any instructions are permitted on the leaflet are when the product has an electronic component. This would prevent manufacturers from using the leaflet as any sort of a promotional platform to minimize, for example, the impact of health warnings on the package exterior. Summary Canada's physicians have been working for decades toward the goal of a smoke-free Canada and we are pleased to support the proposed regulations. We recommend that the draft regulations be strengthened in the following manner: 1) The measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions. 2) The number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. 3) Use of terms and phrases such as “organic” and “natural” in brand names should be banned in the regulations. 4) The only instance where any instructions are permitted on the proposed leaflets are when the product has an electronic component. Tobacco and Vaping Products Act: Tobacco Products Regulations (Plain and Standardized Appearance) Canada Gazette, Part I, 2018 Jun 23 152(25). Available: http://gazette.gc.ca/rp-pr/p1/2018/2018-06-23/html/reg9-eng.html (accessed 2018 Aug 7). Statistics Canada. Smoking, 2017 Health Fact Sheets Cat. No. 82-625-X June 26, Ottawa, Ont.: Statistics Canada, 2018. Available: https://www150.statcan.gc.ca/n1/en/pub/82-625-x/2018001/article/54974-eng.pdf?st=7HkJdkUB (accessed 2018 Sep 5). Canadian Medical Association (CMA). Letter in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation. Ottawa: CMA; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Aug 29). The European Parliament and The Council of the European Union. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive. 2001/37/EC. Brussels: Official Journal of the European Union, 2014. Available: https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf (accessed 2018 Sep 4).
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