The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “New Health-Related Labelling for Tobacco Products - Document for Consultation, October 2018”.
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. Our response will follow the questions posed in the consultation document.
Labelling on Individual Cigarettes
Displaying a warning on individual cigarettes provides another means of conveying important health warnings about the hazards of smoking. The warnings should be like those that will be displayed on the leaflets included in the cigarette packages as well as the packages themselves. They should be of sufficient size, font and colour that will draw the attention of the smoker to the message. They should also be placed as close to the filter end of the cigarette as possible to remain visible for as long as possible.
Health Information Messages
The CMA has always supported educational and public health initiatives aimed at countering tobacco manufacturers messages that would render smoking attractive and glamorous to their customers. The health information messages and any leaflets included in the package must be of sufficient size, colour and font to 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.
The CMA supports strongly the concept of tobacco products being sold in standardized packages and we have recommended that only the “slide-and-shell” style of package be authorized and that the “flip-top”
package be removed. This would allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA has recommended 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.
Toxic Statements (Includes Toxic Emissions Statements and Toxic Constituents Statements)
The size, colour and design of new Toxic Statements proposed in the consultation document should be sufficient to be read and easily understood. The Statements should be rotated periodically to include new and updated information related to emissions and toxic constituents.
Connecting Labelling Elements/ Quitline Information
Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous, especially to young people. The CMA supports packages displaying prominent, simple and powerful health warnings, such as the graphic pictorial warnings, as well as quit tips and information on product content and health risks.2 Connecting the themes should help to reinforce the messages being conveyed with these labels. The size, colour, and placement of the proposed quitline and website information should be sufficient to maximize the noticeability of the information on various types of tobacco product packaging.
Percentage of Coverage/Minimum Size of Health Warnings on Tobacco Products Other than Cigarettes and Little Cigars
The amount of space given to the warnings should be sufficient to convey the maximum amount of information while remaining clear, visible, and legible. The warnings should be in proportion to the packaging available, like that of a regular cigarette package.
Labelling for All Tobacco Products that Do Not Currently Require Labels
The CMA supports mandatory health warnings being applied equally to all tobacco products. If package size allows, Health Warnings, Health Information Messages, and Toxic Statements should all be included. The messages should be relevant to the types of tobacco products they are covering.
The rotation timeframe suggested in the consultation document of 12 to 18 months is a reasonable period.
Government of Canada. New Health-Related Labelling for Tobacco Products. Document for Consultation Ottawa: Health Canada; 2018. Available: https://www.canada.ca/en/health-canada/programs/consultation-tobacco-labelling.html (accessed 2018 Oct 29).
Canadian Medical Association (CMA) Tobacco Control (Update 2008). Ottawa: The Association; 2008. Available: http:// policybase.cma.ca /dbtw-wpd/Policypdf/PD08-08.pdf (accessed 2018 Dec 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: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Nov 19).
Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: The Association; 2018. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2019-01.pdf (accessed 2018 Nov 19).
Canadian Medical Association (CMA). Policy Resolution BD88-03-64 - Smokeless tobacco. Ottawa: The Association; 1987. Available: https://tinyurl.com/y7eynl5q (accessed 2018 Dec 5).
The Canadian Medical Association (CMA) is pleased to provide this submission to Health Canada in response to the publication of the Notice of Intent to restrict the marketing and advertising of opioids.1 The CMA is very concerned with the high rates of overdose deaths due to opioids2 and supports a comprehensive, multi-pronged approach to address this public health crisis.3
As part of the Government of Canada's strategy, the Minister of Health's 2017 mandate letter committed to "consult with provinces, territories, and professional regulatory bodies to introduce appropriate prescribing guidelines to curb opioid misuse, ensure prescriptions are appropriately tracked in a consistent and patient-centred way, and increase transparency in the marketing and promotion of therapies."4 Health Canada is proposing to further restrict drug manufacturers' advertising of opioids and is consulting on the scope and intent of the restrictions. The Food and Drugs Act defines advertisement as "any representation by any means for the purpose of promoting, directly or indirectly, the sale of any drug or device".5
Opioids are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. These medications have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.3 Any measures to address advertising must not restrict appropriate access. Limiting access without appropriate alternatives and careful tapering can lead to undue suffering and seeking of drugs, potentially tainted, on the illegal market.
However, of great concern, opioid dispensing levels have been shown to be strongly correlated with increased mortality, morbidity and treatment admissions for substance use.6,7 Many patients were prescribed these medications and developed dependence.8
Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.9,10 However, there is evidence for pain relief in the short term but insufficient evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.11,12,13 There was also a concerted effort by industry to minimize the risk of addiction in the use of opioids for the treatment of chronic non-cancer pain. While stating that the risk of addiction was less than one percent, many studies have shown that the risk varies from 0 to 50% depending on the criteria used and sub population studied.14 Marketing significantly influences the type and amount of opioids consumed.15 Substantial tension exists between the competitive pressures that manufacturers face to expand product sales and support for limited, evidence-based use of most cost-effective available alternatives.16
Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage.17 Important contributing factors for the increase in opioid prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with patients. Prescriptions also increased due to the availability of new, highly potent opioid drugs.18,19 Addressing advertising is only one component of the issue, and significant efforts need to be made to address issues such as access to alternatives for pain management and treatment of addiction.
Presently, advertising of opioids is prohibited to the public, and only permitted to health care professionals if the claims are consistent with the terms of market authorization by Health Canada. Pharmaceutical industry's marketing practices to health care practitioners "can take many forms of direct and indirect activities and incentives, including, for example, manufacturer-sponsored presentations at conferences, continuing education programs, advertisements in medical journals, and personal visits from sales representatives. It can also include use of promotional brochures, fees for research, consulting or speaking, reimbursement for travel and hospitality expenses to attend industry-sponsored events, and gifts of meals, equipment, and medical journals and texts."1 As well, industry has sponsored advocacy organizations dedicated to the treatment of pain and key opinion leaders.15,20 Studies have shown that marketing influences prescribing patterns.21
Initiatives to regulate advertising and the promotion of prescription drugs have come from industry, nongovernmental organizations and government. The pharmaceutical industry itself is voluntarily self-regulated in Canada through the Pharmaceutical Advertising Advisory Board (PAAB), pre-clearing marketing initiatives based on a Code of Advertising.22 The CMA recommends that marketing initiatives could be vetted for accuracy and truthfulness through a pre-clearance mechanism such as PAAB.
Faced with multiple legal challenges in the U.S., some opioid manufacturers have limited marketing, however, such measures had not been taken in Canada. The federal government has a complaints-based system and hasn't been proactive in the regulation and monitoring of advertising and marketing of opioids.
In recently published regulations amending the Food and Drug Regulations,23 the Minister of Health can require companies to develop and implement risk management plans, which include the preclearance of opioid-related materials to be provided to health care professionals. Product information prepared by manufacturers, summarizing scientific evidence on effects and setting out conditions for use, as well as promotional activities are subject to regulatory approval. The authority conferred to the Minister has the objective of allowing Health Canada to "appropriately monitor, quantify, characterize, and mitigate the risks associated with post-market use" of opioids. CMA supports such actions. As Van Zee has noted in the case of the United States, "modifications of the promotion and marketing of controlled drugs by the pharmaceutical industry and an enhanced capacity of the Food and Drug Administration to regulate and monitor such promotion can have a positive impact on public health".14 This approach would confer a similar benefit for Canada in that, if effective, could contribute to unbiased, evidence-based prescribing.
There are important guidelines and standards in place, developed by physicians, to guide relationships with the pharmaceutical industry. CMA's "Guidelines for Physicians in Interactions with Industry"24 were developed as a resource tool both for physicians, medical students and residents, as well as medical organizations, to support decisions as to appropriate relationships with industry, in conjunction with CMA's Code of Ethics.25 In summary, physicians have a responsibility to ensure that their interaction with the pharmaceutical industry is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible, appropriately managing these situations when necessary.
These guidelines include principles for continuing medical education and continuing professional development (CME/CPD) and are the basis for the National Standard for Support of Accredited CPD Activities, developed by the Royal College of Physicians and Surgeons of Canada (RCPSC), the College of Family Physicians of Canada (CFPC) and the Collège des médecins du Québec. According to the Standard, "the interests of organizations that provide financial and in-kind support for the development of accredited CPD activities cannot be assumed to always be congruent with the goal of addressing the educational needs of the medical profession. Therefore, it is essential that the medical profession define and assume their responsibility for setting standards that will guide the development, delivery, and evaluation of accredited CPD activities."26 Physicians must complete CPD credits to maintain their professional license, and the accreditation bodies (such as CFPC, RCPSC) have processes in place to assure that these courses are evidence-based and free from industry bias.
In recognition of the importance of opioid prescribing, and the key role that physicians play in this field, the CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids. This funding could include unconditional contribution from the opioid manufacturers, to ensure independence. The CMA appreciates the role that Health Canada has had in funding evidence-based guidelines.27 This has been a key initiative, which sought to provide physicians with unbiased information. Ongoing funding to maintain their currency would be warranted.
The CMA supports long overdue actions related to the restriction of the marketing of opioids and looks forward to collaboration between Health Canada and the physician community.
The CMA supports Health Canada's efforts to place significant restrictions on the ability of drug manufacturers to advertise opioids to health care practitioners. Marketing initiatives should be vetted for accuracy and truthfulness through a pre-clearance mechanism.
The CMA recommends that the measures chosen to constrain advertising do not unduly restrict access to opioids for appropriate use.
The CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids, and consider unconditional funding from opioid manufacturers.
The CMA recommends that the government support keeping the 2017 Opioid Prescribing Guidelines current through ongoing funding.
The CMA recognizes that restricting advertising is only one, overdue, measure to address the opioid crisis, and recommends that issues such as access to alternatives for pain management and addiction treatment urgently be addressed.
1 Government of Canada. Notice of intent to restrict the marketing and advertising of opioids. Ottawa: Government of Canada; 2018. Available: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/restrict-advertising-opioids.html (accessed 2018 Jul 17).
2 Public Health Agency of Canada. National report: apparent opioid-related deaths in Canada (released June 2018). Ottawa: Public Health Agency of Canada; 2018. Available: https://www.canada.ca/en/public-health/services/publications/healthy-living/national-report-apparent-opioid-related-deaths-released-june-2018.html (accessed 2018 Jul 17).
3 Canadian Medical Association. Harms associated with opioids and other psychoactive prescription drugs. Ottawa: Canadian Medical Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Jul 17).
4 Trudeau J. Minister of Health mandate letter. Ottawa: Office of the Prime Minister; 2017 Oct 4. Available: https://pm.gc.ca/eng/minister-health-mandate-letter (accessed 2018 Jul 17).
5 Government of Canada. Food and Drugs Act. Ottawa: Government of Canada; 1985. Available: http://lois-laws.justice.gc.ca/eng/acts/F-27/index.html (accessed 2018 Jul 17).
6 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf 2013;22(4):438-42.
7 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q 2011;14(1):22-4.
8 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend 2004;73(2):199-207.
9 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician 2014;17(1):E1-10.
10 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ 2011;343:d5142 DOI: 10.1136/bmj.d5142.
11 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology 2014;83:1277-84.
12 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: Findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain 2009;10:147-59.
13 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010;(1):CD006605.
14 Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-27.
15 Hamunen K, Paakkari P, Kalso E. Trends in opioid consumption in the Nordic countries 2002-2006. Eur J Pain 2009;13:954-962.
16 Alves TL, Lexchin J, Mintzes B. Medicines information and the regulation of the promotion of pharmaceuticals. Sci Eng Ethics 2018:1-26.
17 Canadian Medical Association. Optimal prescribing. Ottawa: Canadian Medical Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf (accessed 2018 Jul 17).
18 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health 2008;99(3):182-4.
19 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction 2013;109:177-81.
20 Dyer O. OxyContin maker stops marketing opioids, as report details payments to advocacy groups. BMJ 2018;360:k791.
21 Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioethics 2003;3(3):39-46.
22 Pharmaceutical Advertising Advisory Board. PAAB Code. Ottawa: PAAB; 2018. Available: http://code.paab.ca/ (accessed 2018 Jul 17).
23 Regulations Amending the Food and Drug Regulations (Opioids), SOR/2018-77. Canada Gazette, Part II 2018 May 2;152(9). Available: http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html (accessed 2018 Jul 17).
24 Canadian Medical Association. Guidelines for physicians in interactions with industry. Ottawa: Canadian Medical Association; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf (accessed 2018 Jul 17).
25 Canadian Medical Association. CMA Code of Ethics (Update 2004). Ottawa: Canadian Medical Association; 2004. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_Code_of_ethics_of_the_Canadian_Medical_Association_Update_2004_PD04-06-e.pdf (accessed 2018 Jul 17).
26 Royal College of Physicians and Surgeons of Canada. National standard for support of accredited CPD activities. Ottawa: Royal College of Physicians and Surgeons of Canada; 2017. Available: http://www.royalcollege.ca/rcsite/cpd/providers/tools-resources-accredited-cpd-providers/national-standard-accredited-cpd-activities-e (accessed 2018 Jul 17).
27 Busse JW, Craigie S, Juurlink DN, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ 2017;189:E659-66.