To Whom It May Concern:
The Canadian Medical Association (CMA) is pleased to provide its comments with respect to Health Canada’s Patented Medicines Regulations Consultations. The CMA is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations.
As the second-largest share of total health expenditures in Canada, forecast to be 16% in 2016, the cost of drugs is of significant concern to physicians.1 In 2014, 42.6% of prescribed drug spending ($12.5 billion) came from the public sector.2 Pharmaceuticals play an important role in overcoming disease and maintaining health but access to these drugs can be problematic outside of hospital care due to their cost. This is why the CMA has called for a pan-Canadian system of catastrophic coverage for prescription drugs.3 We viewed this as a step toward the development of comprehensive, universal coverage for prescription medicines in Canada.4
1 CIHI. National Health Expenditure Trends 1975-2016, December 15, 2016
3 Canadian Medical Association (CMA). A New Vision for Health Care in Canada: Addressing the Needs of an Aging Population. 2016 Pre-budget Submission to the Minister of Finance. Ottawa: The Association; 2016 Feb 12
In its brief to the Commission of Inquiry on the Pharmaceutical Industry in August, 1984, the CMA stated that we “fully support the objective of providing prescription drugs to patients at the lowest possible cost that is consistent with wise health care delivery.”5 This remains our objective. This submission will address the proposed improvements to the regulations raised in the consultation document from a broad perspective.
5 Canadian Medical Association (CMA). Brief to the Commission of Inquiry on the Pharmaceutical Industry August 15, 1984
6 Gray C. Patented drugs: Is the price right? CMAJ 1998 158:1645
7 Silversides A. Monitoring the price of new drugs CMAJ 2006 174(11):1548-1549
8 The Commission of Inquiry on the Pharmaceutical Industry. The Report of the Commission of Inquiry on the Pharmaceutical Industry H.C. Eastman, Commissioner. Ottawa Minister of Supply and Services 1985 p. 347
9 Industry Canada. Pharmaceutical industry profile. https://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html (Accessed 2017 June 20)
10 Morgan SG, Leopold C, Wagner AK. Drivers of expenditures on primary care prescription drugs in 10 high-income countries with universal health coverage. CMAJ 2017;189:E794-9
The ability of the PMPRB to monitor drug prices has long been the subject of review and concern.6,7 The CMA is pleased that the Government of Canada is undertaking this review to provide the Patented Medicines Prices review Board (PMPRB) with a new regulatory framework to protect Canadians from excessive prices and improving the regulatory process. The board needs to use every economic measure and tool at its disposal to ensure Canadians pay fair and equitable prescription drug prices.
As the Eastman Commission pointed out in its 1985 report, “Canadian consumption is a small proportion of world consumption so that Canadian patent policy has little effect on the world-wide profitability of the pharmaceutical industry.”8 Indeed, Canadian pharmaceutical sales represent 2% of the global market which makes us the tenth largest world market.9 Yet our small size with respect to the global market has not shielded us from high prices. For example, a recent study found that although the volume of therapies purchased in Canada across six classes of “primary care medicines” was similar, we paid an estimated $2.3 billion more for them in 2015 than if these treatments had the “same average cost per day in Canada as in the nine comparator countries combined.”10
Prescription medication spending is an issue for many Canadians, especially when it has an impact on compliance with prescription regimes, an unintended consequence of the manner in which the board’s regulatory framework has been applied. On the
Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.11 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.12
11 Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15.
12 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23.
13 Vebeeten D, Astiles P, Prada, G. Understanding Health and Social Services for seniors in Canada. Ottawa: The Conference Board of Canada, 2015.
16 Morgan SG, Lee A. Cost-related non-adherence to prescribed medicines among older adults: a cross-sectional analysis of a survey in 11 developed countries BMJ Open 2017;7: e014287. doi:10.1136/bmjopen-2016-014287 (access 2017 Jun 16)
17 Zhang R., Martin D., Naylor CD., Regulator or regulatory shield? The case for reforming Canada’s Patented Medicines Prices review Board. CMAJ 2017 April 10;189:E515-6. doi: 10.1503/cmaj.161355
The CMA is especially worried about the impact high drug costs have on seniors in the absence of universal drug coverage. They have access to some level of drug coverage in all provinces and territories but it is not even.13 Eight provinces have an income-test that determines the deductibles they will pay while in two they pay a small portion of the cost with the province or a third-party insurer covering the rest.14 All three territories have plans for those who qualify but the provisions may be limited.15 A recent study found that older Canadian adults (55 and older) had the second-highest prevalence (8.3%) of cost-related non-adherence (CRNA) for prescribed medications.16 CRNA was higher among those with lower incomes and lower among those over 65.
Finally, the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures the government undertakes to strengthen and improve the PMPRB do not exacerbate drug shortages.
The PMPRB’s current benchmark “that Canadian prices for patented drugs should be less than the median of prices in selected comparison countries” places us at a distinct disadvantage.17 As the authors note, “it puts Canada well above the OECD average by
aligning Canada with countries that spend more from the outset.”18 The PMBRB should expand its range of comparator countries beyond those identified originally (France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States) to include those OECD countries with middle to low patent drug pricing.19
Furthermore, to ensure that the process is clear and transparent for Canadians, the PMPRB should “set prices closer to what comparator countries actually pay for their drugs as opposed to the “sticker” prices that most commonly represent the starting point for confidential negotiations.”20 Canadians deserve that much after years of paying such high prices for their patented medicines.
The CMA is very concerned about the cost of medications. In the absence of universal drug coverage and, at a minimum, a pan-Canadian system of catastrophic coverage of prescription drug costs, a strengthened and robust regulatory framework for the pricing of patented medicines in Canada is crucial. The CMA calls on the federal government to revise the PMPRB regulations such that it provides Canadians with transparency and clarity around the setting of patented medicines prices while achieving the lowest costs possible and ensuring we continue to have access to a wide array of pharmaceutical products.
Granger R. Avery, MB BS, FRRMS
Submission to the Health Canada consultation on the potential risks, benefits and impacts of changes to the regulations to the Controlled Drugs and Substances Act that would require all products containing codeine to be sold by prescription only
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's notice as published in the Canada Gazette, Part I1 for interested stakeholders to provide comments on the potential risks, benefits, and impacts of changes to the regulations to the Controlled Drugs and Substances Act that would require all products containing codeine to be sold by prescription only.
Codeine is a widely used narcotic analgesic in Canada - low dose formulations are currently sold without a prescription, when in combination with at least two other medications. It is not available for self-selection, but kept behind the counter in pharmacies.
However, serious concerns have been raised about the safety of this practice in recent years.2,3,4 A literature review examining over the counter medicine abuse in several countries found that "there is a recognized problem internationally involving a range of medicines and potential harms," including codeine-based medicines.5
Doctors support patients in the management of acute and chronic pain, as well as addictions, and as such we have long been concerned about the harms associated with opioid use, including codeine. Codeine is considered to be "a poor analgesic in its own right," for which there are more suitable alternatives.6 In addition, genetic factors can substantially affect the metabolism of codeine into morphine, resulting in concentrations that vary from person to person. This can lead to potentially serious consequences, even at conventional doses, particularly in children.2
Codeine has the potential for dependence. Studies show an increase in non-therapeutic use of codeine, including over the counter formulations, leading to increases in morbidity and mortality as well as social costs. 7,8,9 An Australian study noted that "codeine-related deaths (with and without other drug toxicity) are increasing as the consumption of codeine-based products increases."10 Ontario data shows that over 500 people began methadone treatment for non-prescription codeine, between 2011 and 2014.3
In addition, over the counter codeine is often combined with acetaminophen or ASA, which also present concerns in terms of toxicity, particularly in higher doses.
A review of the process examining the problems related to codeine-based over the counter formulations in Australia, New Zealand, and the United Kingdom found that each of their respective committees had decided, based on the existing evidence, "to minimize harm by using regulatory levers to restrict availability."11 Many European countries have also implemented a prescription-only status for products containing codeine, as well as some U.S. States. Some Canadian hospitals have removed codeine from their formularies, and Manitoba ended the over the counter sales last year12.
Given this reality and, as part of the CMA's advocacy to reduce the harms related to opioid use, the CMA supports the requirement that all products containing codeine be sold by prescription only, as this is both a public health and a patient safety issue.
Moving codeine to prescription-only will enable limiting its use and closer monitoring of patients with the view of preventing harms.10 A challenge for policy makers and prescribers is to ensure patients still have access to treatments that are appropriate for their clinical conditions.13
At the same time, we recognize that there could be unintended consequences when moving low-dose codeine to prescription-only status, particularly for those who have come to depend on its availability over-the-counter. Some may choose to seek out illicit markets for these products or purchase other, more powerful, narcotics as a substitute. Authorities must develop educational tools to inform people about less-harmful pain-relief options. As well, a reasonable timeframe for implementation of this measure should be given to allow for patients to find appropriate alternatives.
The CMA continues to urge governments to increase access to services and treatment options for addiction and pain management, as well as harm reduction.14
1 Controlled Drugs and Substances Act: Notice to interested parties - Non-prescription availability of low-dose codeine products. Canada Gazette Part I. 2017 Sep 09, 151(36). Available: http://www.gazette.gc.ca/rp-pr/p1/2017/2017-09-09/html/notice-avis-eng.php#ne3 (accessed 2017 Nov 07).
2 MacDonald N, MacLeod SM. Has the time come to phase out codeine? Can Med Assoc J 2010;182(17):1825. Available: https://doi.org/10.1503/cmaj.101411 (accessed 2017 Nov 07).
3 Yang J, Zlomislic D. Star investigation: Canada's invisible codeine problem. The Toronto Star. Jan. 17, 2015. Available: https://www.thestar.com/news/canada/2015/01/17/star-investigation-canadas-invisible-codeine-problem.html (accessed: 2017 Nov 7).
4 MacKinnon, JIJ. Tighter regulations needed for over-the-counter codeine in Canada. Can Pharm J Rev Pharm Can, 2016;149(6):322-4. Available: http://www.cmaj.ca/content/182/17/1825 (accessed 2017 Nov 07).
5 Cooper RJ. Over-the-counter medicine abuse - a review of the literature. J Subst Use, 2013 Apr;18(2):82-107. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3603170/pdf/JSU-18-82.pdf (accessed: 2017 Oct 23).
6 Vagg M. Four reasons why codeine should not be sold without a prescription. The Conversation. Apr. 30, 2015. Available: http://theconversation.com/four-reasons-why-codeine-should-not-be-sold-without-prescription-41025 (accessed: 2017 Oct 23).
7 Nielsen S, Cameron J, Pahoki S . Over the counter codeine dependence final report 2010. Victoria: Turning Point, 2010. Available: http://atdc.org.au/wp-content/uploads/2011/02/OTC_CODEINE_REPORT.pdf (accessed 2017 Nov 07).
8 Fischer B, Ialomiteanu A, Boak A, et al. Prevalence and key covariates of non-medical prescription opioid use among the general secondary student and adult populations in Ontario, Canada. Drug Alcohol Rev 2013;32(3):276-87.
9 Compton WM, Volkow ND. Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend 2006 Feb 01;81(2):103-7.
10Roxburgh A. et. al. Trends and characteristics of accidental and intentional codeine overdose deaths in Australia. Med J Aust 2015; 203(7): 299
11 Tobin CL, Dobbin M, McAvoy B. Regulatory responses to over-the-counter codeine analgesic misuse in Australia, New Zealand and the United Kingdom. N Z J Public Health 2013 Oct. 37(5): 483-488. Available: http://onlinelibrary.wiley.com/doi/10.1111/1753-6405.12099/abstract (accessed: 2017 Nov 7).
12 Zlomislic, D. & Yang, J. The Toronto Star. Jan 12, 2016. Available: https://www.thestar.com/life/health_wellness/2016/01/13/manitoba-sets-new-rule-limiting-codeine.html (accessed: 2017 Nov 7).
13 Canadian Medical Association. Opening Statement addressing the opioid crisis to the House of Commons Standing Committee on Health. Ottawa: The Association; 2016 Oct. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/hesa-opioid-study-opening-remarks-oct-18-2016-e.pdf (accessed: 2017 Nov 7).
14 Canadian Medical Association. Harms Associated with Opioids and Other Psychoactive Prescription Drugs. CMA Policy, 2015. Ottawa: The Association; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed: 2017 Nov 7).
The Canadian Medical Association (CMA) is pleased to provide its comments with respect to the Government of Canada's consultation on the Proposed Excise Duty Framework for Cannabis Products published November 10.1
In the move towards the legalization and regulation of cannabis, there are many economic interests at play; private corporations and different levels of government stand to benefit greatly with sales and considerable tax revenue.2 It is essential that the federal and provincial/territorial governments be held accountable to the public health and safety objectives set out for the new regime for legal access to cannabis, particularly that of protecting children and youth.3 It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls.
Final pricing must be such as to discourage the illegal production and trafficking of cannabis. However, a balance must be found with the use of taxation and pricing levers to discourage use. Revenues need to be clearly earmarked to cover the health and social costs of legalization. In some U.S. jurisdictions, for example, some of the revenue is directed to recovering the costs of regulatory programs as well as in substance use treatment programs, and for social programs.
Most of the future tax revenues should be redistributed to the provinces and territories. This is because they have jurisdiction over services that will likely feel the impact with legalization, such as health care, education, social and other services, as well as enforcement of legislation and regulations. A public health approach to legalization will emphasize prevention, education and treatment initiatives which require adequate and reliable funding. It will also require strong surveillance and monitoring activities to adjust measures should unintended harms be detected. Resources need to be promptly available to address potential negative impacts.
CMA recommends that the revenue resulting from the taxation of cannabis production and sales be earmarked to address health and social harms of cannabis use and its commercialization, in line with a public health approach to the legalization of cannabis.
The proposal states that "Any cannabis products sold under the proposed Cannabis Act for medical purposes will be subject to the duty rates and conditions of the excise duty framework, which will become applicable as per the transitional rules (...) Cannabis products that are produced by an individual (or a designated person) for the individual's own medical purposes in accordance with the proposed Cannabis Act will not be subject to the excise duty. Seeds and seedlings used in this production will be subject to duty."1
The CMA is supportive of similar taxation treatment of cannabis products, regardless of whether they are used for medical or non-medical purposes.
The CMA has long called for more research to better understand potential therapeutic indications of cannabis, as well as its risks.4 5 Physicians recognize that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with cannabis used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency, interactions with medications and adverse effects. Health Canada does not approve of cannabis as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical. It is important that there be support for cannabis research in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol(r)), nabilone (Cesamet(r)) and THC/CBD (Sativex(r)).
The experience of legalization for non-medical use in Colorado and Washington has shown that two separate regimes with distinct regulations can be very difficult to enforce given the different standards.6 A lower tax rate on cannabis for medical use could potentially provide an incentive for people to seek a medical authorization, and that was observed initially in Colorado.7
The CMA recommends that the same tax rates be applied to the production and sales of both the medical and the non-medical use of cannabis products.
The move towards the legalization and regulation of cannabis will require a balanced approach to discourage the illegal production and trafficking of cannabis while also using taxation and pricing levers to discourage use. Much of the revenues raised should be redistributed to the provinces and territories to enable them to cover the health and social costs of legalization.
A public health approach to legalization will emphasize prevention, education, treatment and surveillance initiatives which requires adequate and reliable funding.
1 Department of Finance Canada. Proposed excise duty framework for cannabis products. Ottawa: Department of Finance Canada; 2017. Available: http://www.fin.gc.ca/n17/data/17-114_1-eng.asp (accessed 2017 Dec 05).
2 Sen A, Wyonch R. Don't (over) tax that joint, my friend. Intelligence MEMOS. Ottawa: CD Howe Institute; 2017 Jul 19. Available: https://www.cdhowe.org/sites/default/files/blog_Anindya%20and%20Rosalie_0719.pdf (accessed 2017 Dec 06).
3 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed 2017 Dec 05).
4 Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/cannabis.pdf (accessed 2017 Dec 05).
5 Canadian Medical Association (CMA). Medical Marijuana. CMA Policy. Ottawa: CMA; 2011. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD11-02-e.pdf (accessed 2017 Dec 05).
6 Canadian Centre on Substance Use and Addiction (CCSA). Cannabis regulation: Lessons learned in Colorado and Washington State. Ottawa: CCSA; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2017 Dec 05).
7 Office of the Parliamentary Budget Officer. Legalized cannabis: Fiscal considerations. Ottawa: Office of the Parliamentary Budget Officer; 2016. Available: http://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2016/Legalized%20Cannabis/Legalized%20Canabis%20Fiscal%20Considerations_EN.pdf (accessed 2017 Dec 05).
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.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism
The Canadian Medical Association (CMA) is pleased to provide its response to Health Canada's public consultation on the Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall), in reference to the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which came into force on November 6, 2014.
The CMA supports a robust legislative framework toward an unbiased, evidence-based system for the oversight of pharmaceutical products, which spans both the pre- and post-approval of these products, with the ultimate goal of patient safety. Prescription medication plays a critical role as part of a high-quality, patient-centred and cost-effective health care system. It is a priority to physicians that all Canadians have access to affordable, safe and effective prescription medications.
Stemming from this perspective, the CMA strongly welcomed the new ministerial authorities established by Vanessa's Law as an important contribution to patient safety and the effectiveness of Health Canada's oversight of prescription pharmaceuticals. With these new authorities now in effect, it is critical that implementation is comprehensive, effective and transparent. As such, CMA's response to this public consultation on the new Guide will focus on the need for:
* increased clarity on the thresholds that underpin the use of these new authorities,
* guidance on the notification of public, physicians and other health care practitioners, and
* a commitment to ongoing oversight and revision process of this guidance.
ISSUE 1: PROVIDE INCREASED CLARITY ON THE THRESHOLDS
In CMA's brief1 to the House of Commons Standing Committee on Health as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, key recommendations included clarification of both ministerial authority and responsibility in support of patient safety. The CMA supported the intent of the expansion of these powers, but expressed concern with the lack of clarity on the threshold required to be met to enable the use of these new authorities.
In order to ensure the consistent and effective implementation of these new ministerial authorities, the CMA considers it essential that the Guide provide more clarity on the threshold that enables the use of the new authorities, including the determination of serious risk.
To determine this threshold, Health Canada relies on experts to analyze scientific information and make a recommendation to the Minister.
The CMA recommends that guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
As the definition of "serious risk of injury to human health" is not provided in Vanessa's Law, it is critical that it be addressed in the Guide. Annex A of the Guide states that "the determination of whether a therapeutic product presents a serious risk is complex and is conducted on a case-by-case basis when new information becomes available", and puts forward a "non-exhaustive" list of elements to be considered. It also states that different weights would be attributed to different elements and suggests further contextual elements. The CMA is concerned that without a clear process for the determination of what constitutes a serious risk that subjectivity may have an undue role in this determination and there is the potential for a lack of consistency from case to case. Further, a detailed process is required to ensure that this threshold does not constrain ministerial authority when action is needed.
The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
ISSUE 2: INCLUDE GUIDANCE NOTIFICATION TO PUBLIC, PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS
The CMA is supportive of the guiding principles that should govern all decisions made by Health Canada acting as a regulatory decision-maker, i.e., that power is exercised in a process that is free from bias, based on evidence and in a transparent manner.
In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies2 and by Health Canada, when these new authorities are exercised.
Access to accurate, unbiased information is essential for people to make decisions about their own health.. A clear elaboration and articulation of the process and timelines for how and when public notification is issued in relation to the exercise of the new ministerial authorities is critical to ensure their comprehensive, effective and transparent implementation.
Also, when new information is discovered about a prescription medication, it is important that health professionals be informed as quickly and efficiently as possible.
As part of Health Canada's commitment to transparency, the CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
The U.S. Food and Drug Administration (U.S. FDA), for example, provides guidance and instructions on their public notification expectations in a situation where a product may pose a significant health hazard.3 In addition, there are different mechanisms of public notification, including 'mobile web' and alerts.
Finally, also consistent with the guidance of the U.S. FDA, the CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
ISSUE 3: SPECIFY THE OVERSIGHT AND REVISION OF THE GUIDANCE
As part of its public consultation outreach with stakeholders on this new guidance, Health Canada officials have described the Guide as an evergreen document that will be continually updated. The CMA is supportive of Health Canada's efforts to engage stakeholders and the public in the development and revision of this guidance.
To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
The CMA welcomed this opportunity to submit recommendations on how Health Canada may improve the Guide to New Authorities, which is critical to the comprehensive, effective and transparent implementation of the new authorities established by Vanessa's Law. The CMA looks forward to continued and ongoing collaboration with Health Canada on its implementation of these important new powers.
Overview of Recommendations
1. The CMA recommends that the guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
2. The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
3. In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies and by Health Canada when these new authorities are exercised.
4. The CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
5. The CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
6. To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
1 Canadian Medical Association (2014) Bill C-17 An Act to amend the Food and Drugs Act - Protecting Canadians from Unsafe Drugs. Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2014-09.pdf
2 Note: Throughout this submission, "companies" refers to whom the new ministerial powers apply outside of the regulator - as explained in the consultation document, in the case of s. 21.1 it is a "person" (can include an individual, a research institution, a corporation or an authorization holder), in the case of 21.2 it is the therapeutic product authorization holder, and in the case of s.21.3 it is a "person".
3 U.S. Food and Drug Administration (2015) Guidance for Industry: Product Recalls, Including Removals and Corrections. Retrieved from: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm