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Health Canada consultation on edible cannabis, extracts & topicals

https://policybase.cma.ca/en/permalink/policy14020
Date
2019-02-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-02-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association appreciates this opportunity to respond to Health Canada’s consultation on the proposed regulations for edible cannabis, cannabis extracts, and cannabis topicals. The CMA’s approach to cannabis is grounded in public health policy. It includes promotion of health and prevention of problematic use; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation, recommendations regarding Bill C-45. As well, we submitted comments to Health Canada with respect to the consultation on the proposed regulatory approach for the Cannabis Act, Bill C-45. Canada’s physicians have a longstanding concern about the health risks associated with consuming cannabis. , Consumers use these products for both recreational and medical purposes, compelling the need for accuracy in the labeling as well as quality control in the manufacturing process.10 Cannabis Edibles, Extracts and Topicals Cannabis will have a different effect on the user, depending on whether it is smoked or ingested, as in an edible. It has been found that “smoking marijuana results in clinical effects within 10 minutes, peak blood concentrations occur between 30 and 90 minutes, and clearance is complete within 4 hours of inhalation. Oral THC does not reach significant blood concentration until at least 30 minutes, with a peak at approximately 3 hours, and clearance approximately 12 hours after ingestion.” Because of the delay in absorption when ingested, people might consume more to feel the psychoactive effects faster. This might lead to the consumption of very high doses and result in toxic effects, such as anxiety, paranoia and in rare cases, a psychotic reaction with delusions, hallucinations, incoherent speech and agitation. Rates of use of edibles are not well known. A recent study in California high schools found that “polyuse via multiple administration methods was a predominant pattern of cannabis use and report the first evidence, to our knowledge, of triple product polyuse of combustible, edible, and vaporized cannabis among youths.” We are limiting our response to Health Canada’s consultation questions that pertain to the CMA’s position with respect to cannabis and relate to our expertise and knowledge base. Proposed THC limits for the new classes of cannabis products Standardization within all classes of cannabis products in a legal regime is essential. Tetrahydrocannabinol (THC) levels in black market products can vary widely so one can never be assured of the strength being purchased, creating the potential for significant harm. , Experience in jurisdictions where cannabis has been legalized has shown that restrictions on the potency of products (i.e., THC limits) are necessary, given the higher risks of harm associated with higher potencies.2 Prohibition of high potency products is important.3 THC limits should be based on the best available evidence of safety for consumers. The increased potency of cannabis over the years raises concerns about its use in edibles, extracts and topicals, offering a significant challenge with respect to regulating their use. This becomes particularly worrisome with respect to preadolescents and adolescents who should avoid using cannabis due to concerns with the impact on the developing brain.2 Use has been associated with a “significant increased risk of developing depression or suicidality in young adulthood.” More research is needed with respect to the effects of cannabis on all age groups, especially children, adolescents and seniors. Saunders et al describe the case of an elderly patient with a history of coronary artery disease suffering what appears to have been a myocardial infarction after ingesting most of a marijuana lollipop that contained 90 mg of THC. Such cases demonstrate how crucial it is to establish appropriate levels of THC. This is an especially important consideration because “consuming cannabis-infused edibles may inadvertently result in toxicity because absorption can take hours, compared with minutes when smoking. An individual who does not yet feel an effect may over-consume.” Small children and people with cognitive impairment will not be able to read labels, so preventive measures are very important, as with any pharmaceutical. Since legalizing cannabis, Colorado’s Rocky Mountain Poison & Drug Center has reported an increase in calls related to edible exposures. Children can accidentally eat products that contain cannabis, making them ill enough to seek medical assistance. The CMA maintains that the proposed draft regulations of 10 mg per discrete unit and package is too high and should be established at a maximum of 5 mg per dose, given the higher risks of overconsumption with edibles, the risks of accidents in children and the experience in other jurisdictions. Colorado’s limit was set at 10 mg per unit, and health authorities recognize that a lower limit would have been warranted to prevent more accidents. Other preventive measures, such as child proof packaging, are considered in other sections of this brief. The amount of THC must be displayed clearly and prominently on the package to help prevent accidental or overconsumption of the product. Rules addressing the types of ingredients and additives that could be used in edible cannabis, cannabis extracts, and cannabis topicals appropriately address public health and safety risks while enabling sufficient product diversity The CMA concurs with the proposed regulations. Experience in areas such as caffeinated, high-sugar alcoholic beverages provides ample evidence to proceed with restraint concerning the types of ingredients and additives that may be permitted in edible cannabis, cannabis extracts, and cannabis topicals. Proposed new rules for the packaging and labelling of the new classes of cannabis products The CMA reiterates its position with respect to the packaging and labelling of cannabis products as presented in its submission on the proposed approach to the regulation of cannabis.5 This includes:
a requirement for plain and standard packaging
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause an overdose. Plain and standardized packaging is necessary with respect to edibles as their wider availability raises several public health issues, not the least of which is ingestion by young children. It is imperative that the packages and labels of edibles not resemble popular confectionaries, for example. As the Canadian Paediatric Society has noted, “the unintended consumption of edibles manufactured to look like sweets by younger children is particularly concerning.”15 Also, by “restricting the extent to which marijuana edibles can look and taste like familiar sweets, (it) could also keep the psychological barriers to marijuana initiation among children and adolescents from being lowered.” The CMA has adopted similar positions with respect to tobacco and vaping products. , , It is recognized that these regulations are targeted at products meant for the adult market, but the entry of these new classes also creates challenges beyond that audience. Teens are attracted to vaping cannabis rather than smoking it because “smoke is not combusted and also may allow for more covert use given the reduction in odor.” , As well, as “edibles have no odor, they are largely undetectable to parents.”23 The CMA views this as an opportunity to educate Canadians about the health, social and economic harms of cannabis especially in young people. Package inserts must outline and reinforce the health risks involved; they must also be designed by governments and health professionals, not cannabis producers or distributors. Inserts should include:5
information on securing the product in the home to prevent access by youth and children,
recommendations not to drive or to work with hazardous chemicals or operate equipment while using the contents of the package,
information on the health and social consequences (including legal penalties) of providing cannabis to those under a designated minimum age for purchasing, and
contact information for hotlines for poison control and for crisis support. Cannabis topicals, as outlined in the proposed regulations, would fall under the category of health products and be found in non-prescription drugs, natural health products, and cosmetics. The CMA believes that all health claims need to be substantiated with sufficient evidence that meets standards for efficacy, besides safety and quality, to protect Canadians from misleading claims.5 This is important because the level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence for effectiveness is needed for a DIN but not for an NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product.5 Requirements for tamper-resistant and child-proof containers need to be in place to enhance consumer safety. More research is required to address the environmental concerns with extra packaging, which would result from single dose packaging. It is critical to put in place measures that make it difficult to ingest large doses of THC. Simply adding grooves to chocolate bars or baked goods, for example, separating different doses, is insufficient to prevent people, particularly children, from ingesting more than a dose (which in of itself is designed for an adult). As well, there is no guarantee that the THC is spread out uniformly throughout the product. More research is needed with respect to “determining risks and benefits through proper clinical trials;” that includes determining the safest level of THC for extracts and topicals to reassure consumers will not be harmed by these products.18 With regards to cannabidiol (CBD), it would seem that “published data from around the world has taught us that misleading labels as well as harmful contaminants are real and actual problems for CBD products.”18 Health claims need to be substantiated via a strong evidentiary process. There will be a need for careful monitoring of the health products released in the market and the health claims made.5 Experience has shown that regulations can and will be circumvented, and these activities will have to be addressed. Edible cannabis and the requirement for all products to be labelled with a cannabis-specific nutrition facts table Yes. The CMA supports the use of a cannabis-specific nutrition facts table (NFT) as described in the proposed regulations.1 These products should have the same standards and regulations applied to them as traditional food products do under the Food and Drugs Regulations. As such, a cannabis-specific nutrition facts table will help consumers differentiate them from standard food products. The proposal for the labelling of small containers and the option to display certain information on a peel-back or accordion panel The size of the container should not be an impediment to supplying consumers with the necessary information to make informed choices. Manufacturers should be required to use whatever method (peel-back or accordion panel) is most efficient and conveys all the necessary information. As the CMA noted in a recent brief with respect to tobacco labeling 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.”20 Adding warnings on individual cigarettes, as we recommended, illustrates that it is feasible to apply important information to even the smallest surfaces.20 It is important to note that key information should be visible on the external part of the container, including the standardized cannabis symbol, ingredients and warnings. Proposal that the standardized cannabis symbol would be required on vaping devices, vaping cartridges, and wrappers Yes. As noted earlier, the CMA called for strict packaging requirements around both tobacco and vaping products.22 The requirement for the standardized cannabis symbol is an extension of that policy and to the labelling of cannabis products in general.5 Proposed new good production practices, such as the requirement to have a Preventive Control Plan, appropriately address the risks associated with the production of cannabis, including the risk of product contamination and cross-contamination Yes. The CMA concurs with this requirement. The requirement that the production of edible cannabis could not occur in a building where conventional food is produced Yes. The CMA concurs with this requirement. Separate facilities are necessary to prevent cross-contamination for the protection of consumer health and safety. Conclusion The CMA supports the federal government’s commitment to a three-year legislative review as it affords the opportunity to evaluate the regulations’ impact and adjust them as needed. It continues to be important to have good surveillance and monitoring systems, as well as to continue to learn from other jurisdictions where cannabis is legal for recreational purposes. Public education and awareness must accompany the introduction of new forms of cannabis, emphasizing the risks of accidental ingestion and overconsumption. It should also emphasize the need for safe storage of cannabis products, as well as personal possession limits. Much more research is needed into the impact of these new classes across all age groups, and into public health strategies that discourage use and increase harm reduction practices. It is fundamental that profit driven commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls, in a manner that is consistent with a public health approach. Government of Canada. Canada Gazette, Part I, Volume 152, Number 51: Regulations Amending the Cannabis Regulations (New Classes of Cannabis) Ottawa: Health Canada; 2018. Available: http://www.gazette.gc.ca/rp-pr/p1/2018/2018-12-22/html/reg4-eng.html (accessed 2018 Dec 22). Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH. 2017 Aug;107(8):e1-e12. Available: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed& (accessed 2019 Feb 01). Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on cannabis, legalization and regulation. Ottawa: CMA; 2016 Aug 29. Available: https://policybase.cma.ca/en/permalink/policy11954 (accessed 2019 Feb 01). Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: CMA; 2017 Aug 18. Available: https://policybase.cma.ca/en/permalink/policy13723 (accessed 2019 Feb 01). Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis. Ottawa: CMA; 2018 Jan 19. Available: https://policybase.cma.ca/en/permalink/policy13838 (accessed 2019 Feb 04). Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana. CMA Submission to the House of Commons Standing Committee on Health. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11138 (accessed 2019 Feb 14). 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://policybase.cma.ca/en/permalink/policy1968 (accessed 2019 Feb 14). Monte A, Zane R, Heard K. The Implications of Marijuana Legalization in Colorado JAMA. 2015 January 20; 313(3): 241–242 Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/ (accessed 2019 Feb 15). Peters E, Bae D, Barrington-Trimis J, et al. Prevalence and Sociodemographic Correlates of Adolescent Use and Polyuse of Combustible, Vaporized, and Edible Cannabis Products JAMA Network Open. 2018;1(5): e182765. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2703946 (accessed 2019 Feb 15). Wyonch R. Regulation of Edible and Concentrated Marijuana Products Intelligence Memos. Toronto: CD Howe Institute: 2018 Oct 2. Available: https://www.cdhowe.org/sites/default/files/blog_Rosalie_1002.pdf (accessed 2019 Feb 01). Vandrey R, Raber JC, Raber ME, et al. Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products. Research Letter JAMA 2015 Jun 23-30;313(24):2491-3. Available: https://jamanetwork.com/journals/jama/fullarticle/2338239 (accessed 2019 Feb 06). Cascini F, Aiello C, Di Tanna G. Increasing Delta-9-Tetrahydrocannabinol ( -9-THC) Content in Herbal Cannabis Over Time: Systematic Review and Meta-Analysis. Curr Drug Abuse Rev. 2012 Mar;5(1):32-40. Available: https://www.datia.org/datia/resources/IncreasingDelta9.pdf (accessed 2019 Feb 14). Gobbi G, Atkin T, Zytynski T, et al. Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood. A Systematic Review and Meta-analysis JAMA Psychiatry. 2019 Feb 13. doi: 10.1001/jamapsychiatry.2018.4500. Available: https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2723657 (accessed 2019 Feb 15). Saunders A, Stevenson RS. Marijuana Lollipop-Induced Myocardial Infarction. Can J Cardiol. 2019 Feb;35(2):229. Available: https://www.onlinecjc.ca/article/S0828-282X(18)31324-2/fulltext (accessed: 2019 Feb 11). Grant CN, Bélanger RE.Cannabis and Canada’s children and youth. Paediatr Child Health. 2017 May;22(2):98-102. Available: https://www.cps.ca/en/documents/position/cannabis-children-and-youth (accessed 2019 Feb 06). Denver Public Heath. Substance Use Exposure Dashboard. Denver: Denver Public Health; 2018. Available: http://www.denverpublichealth.org/community-health-promotion/substance-misuse/substance-use-exposure-dashboard (accessed 2019 Feb 06). Neuwirth, J. (Colorado Department of Public Health and Environment). Personal interview. (2019 Jan 30). Paradis C, April N, Cyr C, et al. The Canadian alcopop tragedy should trigger evidence-informed revisions of federal alcohol regulations. Drug Alcohol Rev. 2019 Feb 4. Available: https://onlinelibrary.wiley.com/doi/epdf/10.1111/dar.12896 (accessed 2019 Feb 14). MacCoun, RJ, Mello MM, Half-Baked — The Retail Promotion of Marijuana Edibles. N Engl J Med 2015; 372:989-991. Available: https://www.nejm.org/doi/full/10.1056/NEJMp1416014 (accessed 2019 Feb 5). Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Feb 05). Canadian Medical Association (CMA). Health Canada’s Consultation on New Health-related Labelling for Tobacco Products Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13939 (accessed 2019 Feb 05). Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 Feb 05). Johnson RM, Brooks-Russell A, Ma M, et al. Usual Modes of Marijuana Consumption Among High School Students in Colorado. J Stud Alcohol Drugs. 2016;77(4):580-8. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987070/pdf/jsad.2016.77.580.pdf (accessed 2019 Feb 06). Friese B, Slater MD, Annechino R, et al. Teen Use of Marijuana Edibles: A Focus Group Study of an Emerging Issue. J Prim Prev. 2016 June 37(3):303–309. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4864086/pdf/nihms-766186.pdf (accessed 2019 Feb 06).
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Health Canada consultation on potential market for cannabis health products that would not require practitioner oversight

https://policybase.cma.ca/en/permalink/policy14125
Date
2019-09-03
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-09-03
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on potential markets for cannabis health products that would not require practitioner oversight.1 The CMA’s approach to cannabis is grounded in public health policy. It includes promotion of health and prevention of problematic use; access to assessment, counseling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines2 and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation,3 and recommendations regarding Bill C-45.4 As well, we submitted comments to Health Canada with respect to the consultation on the proposed regulatory approach for the Cannabis Act, Bill C-45.5 We also responded to Health Canada’s recent Consultation on Edible Cannabis, Extracts & Topicals.6 Overview The CMA first expressed its concerns about the sale of natural health products containing cannabis in our response to the proposed regulatory approach to the Cannabis Act, Bill C-45.5 We recognize that, in general, health products include prescription health products, non-prescription drugs, natural health products, cosmetics and medical devices. Although all these products are regulated by Health Canada, they are subject to different levels of scrutiny for safety, efficacy and quality, and in some cases, industry does not need to provide scientific evidence to support the claims made on the label. Health Claims As with all health products, the CMA supports an approach in which higher risk products, that is, those for which health claims are made, must be subject to a more meticulous standard of review. Rigorous scientific evidence is needed to support claims of health benefits and to identify potential risks and adverse reactions. We support Health Canada’s proposal that authorized health claims for cannabis health products (CHP) would be permitted for treatment of minor ailments, on the strict condition they are substantiated via a strong evidentiary process. It is the view of the CMA that all such products making a health claim must be reviewed thoroughly for efficacy, as well as safety and quality, for the protection of Canadians.5 Recent experience in the United States supports this approach. A warning letter was sent to Curaleaf Inc. of Wakefield, Massachusetts, by the US Food and Drug Administration (FDA) “for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.”7 This is not the first time it was necessary for the FDA to take such action. The agency had sent letters on previous occasions to other businesses over claims “to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.”7 The CMA shares the FDA’s concerns that such claims “can put patients and consumers at risk by leading them to put off important medical care.”7 A study conducted by Dalhousie University found that only 35.8% of respondents were familiar with the biochemical properties of CBD when asked what cannabinoid they thought was potentially a pain killer.8 Systematic reviews and guidelines have highlighted the state of the science and the limited indications for which there is evidence.9,10,11 Both cannabis and CBD specifically have been approved for use in a few conditions, but more research is needed in this rapidly growing field. For example, medical cannabinoids have been approved in several jurisdictions for the treatment of multiple sclerosis but the evidence of how well it works is limited. As the Canadian authors note, “carefully conducted, high-quality studies with thought given to the biologic activity of different cannabis components are still required to inform on the benefits of cannabinoids for patients with MS.”12 Consumers need to be reassured that health claims are being assessed thoroughly so they can make informed decisions.13 4 Packaging and Labelling Requirements The CMA has laid out its position with respect to packaging and labelling with respect to cannabis products.5,6 Strict packaging requirements are necessary as their wider availability raises several public health issues, not the least of which is ingestion by young children. Requirements for tamper-resistant and child-proof containers need to be in place to enhance consumer safety. To reiterate:
a requirement for plain and standard packaging
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause a poisoning Prescription Drugs Containing Cannabis The CMA addressed prescription drugs containing cannabis in a previous brief.5 The level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence to support claims of efficacy is needed for a DIN but not for an NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product. As a result, consumers presently do not have enough information to choose appropriate products. Prescription drugs are subject to Health Canada’s pharmaceutical regulatory approval process, based on each drug’s specific indication, dose, route of administration and target population. Health claims need to be substantiated via a strong evidentiary process. All potential prescription medications containing cannabis must meet a high standard of review for safety, efficacy and quality, equivalent to that of the approval of prescription drugs (e.g., Marinol® and Sativex®), to protect Canadians from further misleading claims. The CMA urges caution especially around exemptions for paediatric formulations that would allow for traits that would “appeal to youth.” The CMA understands that these products, used under strict health professional supervision, should be child friendly, for example, regarding palatability, but we do not support marketing strategies that would suggest their use is recreational (e.g., producing them in candy or animal formats). Recommendations 1. The CMA recommends that all cannabis health products, including those with CBD, making a health claim must be reviewed thoroughly for efficacy, as well as safety and quality, for the protection of Canadians. 2. The CMA recommends that strict packaging requirements be put in place with respect cannabis health products as their wider availability raises several public health issues, not the least of which is ingestion by young children. 3. The CMA recommends tamper-resistant and child-proof containers need to be in place to enhance consumer safety. 4. The CMA recommends that all potential prescription medications containing cannabis must meet a high standard of review for safety, efficacy and quality, equivalent to that of the approval of prescription drugs to protect Canadians from further misleading claims. 5 1Health Canada. Document: Consultation on Potential Market for Cannabis Health Products that would not Require Practitioner Oversight. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-potential-market-cannabis/document.html (accessed 2019 Aug 8). 2 Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH. 2017 Aug;107(8):e1-e12. Available: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed&. (accessed 2019 Aug 8). 3 Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on cannabis, legalization and regulation. Ottawa: CMA; 2016 Aug 29. Available: https://policybase.cma.ca/en/permalink/policy11954 (accessed 2019 Aug 8). 4 Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: CMA; 2017 Aug 18. Available: https://policybase.cma.ca/en/permalink/policy13723 (accessed 2019 Aug 8). 5 Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis. Ottawa: CMA; 2018 Jan 19. Available: https://policybase.cma.ca/en/permalink/policy13838 (accessed 2019 Aug 8). 6 Canadian Medical Association (CMA). Health Canada Consultation on Edible Cannabis, Extracts & Topicals Ottawa: CMA; Available: https://policybase.cma.ca/en/permalink/policy14020 (accessed 2019 Aug 8). 7 Food and Drug Administration (FDA). FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety. Media Release. Silver Spring, MD: FDA; 2019 Jul 23. Available: https://www.fda.gov/news-events/press-announcements/fda-warns-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-cancer (accessed 2019 Aug 15). 8 Charlebois S., Music J., Sterling B. Somogyi S. Edibles and Canadian consumers’ willingness to consider recreational cannabis in food or beverage products: A second assessment. Faculty of Management: Dalhousie University; May, 2019 Available: https://cdn.dal.ca/content/dam/dalhousie/pdf/management/News/News%20%26%20Events/Edibles%20and%20Canadian%20Consumers%20English_.pdf (accessed 2019 Aug 20). 9 Allan GM. Et al. Simplified guideline for prescribing medical cannabinoids in primary care. Canadian Family Physician. Feb 2018;64(2):111. Available: https://www.cfp.ca/content/cfp/64/2/111.full.pdf (accessed 2019 Aug 29). 10 Health Canada. Information for Health Care Professionals. Cannabis (marihuana, marijuana) and the cannabinoids) Dried or fresh plant and oil administration by ingestion or other means Psychoactive agent. Ottawa: Health Canada; October 2018. Available: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-medication/cannabis/information-medical-practitioners/information-health-care-professionals-cannabis-cannabinoids-eng.pdf (accessed 2019 Aug 29). 11 National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: Current state of evidence and recommendations for research. Washington, DC: The National Academies Press; 2017. Available: http://www.nationalacademies.org/hmd/reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx (accessed 2019 Aug 29). 12 Slaven M., Levine O. Cannabinoids for Symptoms of Multiple Sclerosis JAMA Network Open. 2018;1(6):e183484. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706491 (accessed 2019 Aug 26). 13 Food and Drug Administration (FDA). What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD Consumer Updates. Silver Spring, MD: FDA; 2019 July 17. Available: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis (accessed 2019 Aug 29).
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Health Canada consultation on reducing youth access and appeal of vaping products

https://policybase.cma.ca/en/permalink/policy14078
Date
2019-05-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-05-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures.1 Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, 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 always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes (e-cigarettes). Our approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. The CMA has stated its position to the federal government on electronic cigarettes and vaping clearly in recent years.2,3 In our April 2017 submission on Bill S-5 to the Senate Standing Committee on Social Affairs, Science and Technology we recommended that the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.2 We also argued that the government should take the same approach to plain and standardized packaging regulations for e-cigarettes as has now been implemented for tobacco products.2 In our most recent brief we addressed the two main issues outlined in the government’s Notice of Intent with respect to the advertising of vaping products: the placement of that advertising and the use of health warnings.3,4 We expressed concerns that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. Further, we reiterated our position that health warnings for vaping should be like those being considered for tobacco packages. This brief will address the issues of greatest concern to the CMA with respect to vaping and youth. This includes marketing, flavours, nicotine levels, and reducing vaping and e-cigarette use among youths. Introduction The Council of Chief Medical Officers of Health have expressed alarm at the rising number of Canadian youths who are vaping, finding this trend “very troubling.”5 The Canadian Medical Association concurs with this assessment and appeals to the federal government to move urgently on this important public health issue. As our knowledge about the risks of using e-cigarettes increases, there is an even greater imperative to dissuade youth from taking up the habit. This is important because those youth “who believe that e-cigarettes are not harmful or are less harmful than cigarettes are more likely to use e-cigarettes than youth with more negative views of e-cigarettes.”6 Marketing The e-cigarette marketplace is evolving quickly as new products emerge. The industry has made clever use of social media channels to promote their wares by taking advantage of the belief that they are a safer alternative to cigarettes.7 They have also promoted “innovative flavoring and highlighted the public performance of vaping.”7 It is no surprise that the United States Food and Drug Administration (FDA) has referred to youth vaping as an “epidemic,” calling it “one of the biggest public health challenges currently facing the FDA.”8 As the US National Academies of Sciences, Engineering, and Medicine has noted “young people who begin with e-cigarettes are more likely to transition to combustible cigarette use and become smokers who are at risk to suffer the known health burdens of combustible tobacco cigarettes.”9 However, some of the efforts employed to convince youth to take up vaping are especially troublesome. As the 4 US Centers for Disease Control and Prevention (CDC) reported, “one in 5 (US) high school students and 1 in 20 middle school students reported using e-cigarettes in the past 30 days in 2018,” a significant rise in the number of high school students between 2011 and 2018.10 The use of social media campaigns employing “influencers” to capture more of the youth and young adult market or influence their choices shows the need to be especially vigilant.11 In an attempt to counter this influence, a group of over 100 public health and anti-tobacco organizations from 48 countries “are calling on Facebook, Instagram, Twitter and Snap to take “swift action” to curb advertising of tobacco products on their platforms.”12 As much as the industry is making major efforts to attract or sway customers through advertising, youth themselves may hold the key to countering that pressure. A recent US study found that “adolescents generally had somewhat negative opinions of other adolescents who use e-cigarettes. Building on adolescents’ negativity toward adolescent e-cigarette users may be a productive direction for prevention efforts, and clinicians can play an important role by keeping apprised of the products their adolescent patients are using and providing information on health effects to support negative opinions or dissuade formation of more positive ones.”13 Health Canada can play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers.14 We reiterate the concerns we expressed in our recent brief on the potential measures to reduce advertising of vaping products and to help diminish their appeal to youth. The CMA noted that the sections most problematic to the Association were those encompassing public places, broadcast media, and the publications areas.3 Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.3 These areas need to be addressed on an urgent basis. Flavours As of 2013, over 7,000 flavours had been marketed in the US.15 The data indicated that “about 85% of youth who used e-cigarettes in the past 30 days adopted non-tobacco flavors such as fruit, candy, and dessert.”15 Flavours are helpful in attracting youth, especially when coupled with assertions of lower harm.13 And they have been successful in doing so, as evidenced by the rise in the rates of vaping among youth.8, 16 The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.16,17,18 The concern is that e-cigarettes “may further entice youth to experiment with e-cigarettes and boost e-cigarettes’ influence on increased cigarette smoking susceptibility among youth.”15 More worrisome, flavoured e-cigarettes “are recruiting females and those with low smoking-risk profile to experiment with conventional cigarettes.”19 Limiting the availability of “child-friendly flavors” should be considered to reduce the attraction of vaping to youth.19 In a recent announcement, the US FDA has proposed to tighten e-cigarette sales and “remove from the market many of the fruity flavors …blamed on fueling “epidemic” levels of teen use.”20 As we have noted in previous submissions, the CMA would prefer to see flavours banned to reduce the attractiveness of vaping to youth as much as possible, a sentiment shared by other expert groups. 2,3,21 Nicotine Levels One of the most popular devices to vape with is JUUL™, entering the US market in 2015.22 JUUL’s™ nicotine pods contain 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods.17 Some of JUUL’s™ competition have pods containing even higher levels (6% and 7%).17 The CMA is very concerned about the rising levels of nicotine available through the vaping process, especially by the newer delivery systems. They supply “high levels of nicotine with few of the deterrents that are inherent in other tobacco products. Traditional e-cigarette products use solutions with free-base nicotine formulations in which stronger nicotine concentrations can cause aversive user experiences.”23 Nicotine, among other issues, “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment.15,24 In addition to flavours, and to ease delivery and to make the taste more pleasant, nicotine salts are added to make the e-liquid “less harsh and less bitter” and “more 5 palatable despite higher nicotine levels.”17 Addressing the Rise in Youth Vaping There are many factors that lead youth to experiment with vaping and e-cigarettes. For some it is simple curiosity, for others it is the availability of different flavours while still others perceive vaping as “cool,” especially when they can use the vapour to perform “smoke tricks.”25 The pod devices themselves (e.g., JUUL™) help enhance the allure because of the “unique aesthetic appeal of pod devices, ability to deliver nicotine at high concentrations and the convenience of using them quickly and discreetly.”26 As vaping continues to grow in popularity, it will not be easy to curb youths’ enthusiasm for it. However, it is too important of a public health issue to not intervene More research is needed into how youth perceive vaping and e-cigarettes as they do not hold a universally positive view of the habit.7,13 As well, there is evidence to suggest that many are coming to see vaping as being “uncool” and that there are potential health consequences to continued use.25 In view of the still-evolving evidence of the safety of vaping and e-cigarettes, “strategic and effective health communication campaigns that demystify the product and counteract misconceptions regarding e-cigarette use are needed.”25 Further, “to reduce youth appeal, regulation efforts can include restricting the availability of e-cigarette flavors as well as visible vapors.”25 Another approach to consider is the state of Colorado’s recent creation of “a health advisory recommending that health care providers screen all youth specifically for vaping, in addition to tobacco use, because young people may not necessarily associate tobacco with vaping.”27 Recommendations 1. The CMA calls for all vaping advertising to be strictly limited. The restrictions on the marketing and promotion of vaping products and devices should be the same as those for tobacco products. 2. The CMA recommends the limitation of number of flavours available to reduce the attractiveness of vaping to youth. 3. Health Canada should work to restrict the level of nicotine available for vaping products to avoid youth becoming addicted. 4. Health Canada must play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers. 5. Health Canada must develop communication campaigns directed at youth, parents and health care providers to demystify vaping and e-cigarettes and that create a link between tobacco and vaping. 1 Government of Canada. Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-reducing-youth-access-appeal-vaping-products-potential-regulatory-measures.html (accessed 2019 Apr 11). 2 Canadian Medical Association (CMA). CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Nonsmokers’ Health Act and to make consequential amendments to other Acts. Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 May 13). 3 Canadian Medical Association (CMA). Health Canada consultation on the impact of vaping products advertising on youth and non-users of tobacco products. Ottawa: CMA; 2019 Mar 22. Available: https://policybase.cma.ca/en/permalink/policy14022 (accessed 2019 May 13). 4 Government of Canada. Notice to Interested Parties – Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-measures-reduce-impact-vaping-products-advertising-youthnon-users-tobacco-products.html (accessed 2019 Feb 27). 5 Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health on the increasing rates of youth vaping in Canada. Health Canada; 2019. Available: https://www.newswire.ca/news-releases/statement-from-the-council-of-chief-medical-officers-of-health-on-the-increasing-rates-of-youth-vaping-in-canada-812817220.html (accessed 2019 May 14). 6 6 Glantz SA. The Evidence of Electronic Cigarette Risks Is Catching Up with Public Perception. JAMA Network Open 2019;2(3):e191032. doi:10.1001/jamanetworkopen.2019.1032. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2729460 (accessed 2019 May 14). 7 McCausland K., et al. The Messages Presented in Electronic Cigarette–Related Social Media Promotions and Discussion: Scoping Review. J Med Internet Res 2019;21(2):e11953). Available: https://www.jmir.org/2019/2/e11953/ (accessed 2019 May 14). 8 Food and Drug Administration (FDA). Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use. Silver Spring, MD: FDA; February 11, 2019. Available: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-data-demonstrating-rising-youth-use-tobacco (accessed 2019 May 17). 9 National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press; 2018. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 May 17). 10 Kuehn B. Youth e-Cigarette Use. JAMA. 2019;321(2):138. Available: https://jamanetwork.com/journals/jama/fullarticle/2720740 (accessed 2019 May 14). 11 Kirkum C. Philip Morris suspends social media campaign after Reuters exposes young 'influencers'. New York: Reuters; May 10, 2019. Available: https://www.reuters.com/article/us-philipmorris-ecigs-instagram-exclusiv/exclusive-philip-morris-suspends-social-media-campaign-after-reuters-exposes-young-influencers-idUSKCN1SH02K (accessed 2019 May 13). 12 Kirkham C. Citing Reuters report, health groups push tech firms to police tobacco marketing. New York: Reuters; May 22, 2109. Available: https://www.reuters.com/article/us-philipmorris-ecigs-socialmedia/citing-reuters-report-health-groups-push-tech-firms-to-police-tobacco-marketing-idUSKCN1SS1FX (accessed 2019 May 22). 13 McKelvey K, Popova L, Pepper JK, Brewer NT, Halpern-Felsher. Adolescents have unfavorable opinions of adolescents who use e-cigarettes. PLoS ONE 2018;13(11): e0206352. Available: https://doi.org/10.1371/journal.pone.0206352 (accessed 2019 May 14). 14 Calioa D. Vaping an 'epidemic,' Ottawa high school student says. Ottawa: CBC News; November 27, 2018. Available: https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 May 14). 15 Chen-Sankey JC, Kong G, Choi K. Perceived ease of flavored e-cigarette use and ecigarette use progression among youth never tobacco users. PLoS ONE 2019;14(2): e0212353. Available: https://doi.org/10.1371/journal.pone.0212353 (accessed 2019 May 17). 16 Drazen JM, Morrissey S, Campion EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019; 380:679-680. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMe1900484?articleTools=true (accessed 2019 May 17). 17 Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 May 20). 18 Reichardt EM., Guichon J. Vaping is an urgent threat to public health. Toronto: The Conversation; March 13, 2019. Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 May 20). 19 Chen JC. et al. Flavored E-cigarette Use and Cigarette Smoking Susceptibility among Youth. Tob Regul Sci. 2017 January ; 3(1): 68–80. Available: https://www.ncbi.nlm.nih.gov/pubmed/30713989 (accessed 2019 May 20). 20 LaVito A. FDA outlines e-cigarette rules, tightens restrictions on fruity flavors to try to curb teen vaping. New Jersey: CNBC; March 13, 2019 Available: https://www.cnbc.com/2019/03/13/fda-tightens-restrictions-on-flavored-e-cigarettes-to-curb-teen-vaping.html (accessed 2019 Mar 20). 21 Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there. Toronto: CBC News; November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 May 20). 22 Huang J, Duan Z, Kwok J, et al. Vaping versus JUULing: how the extraordinary growth and marketing of JUUL transformed the US retail e-cigarette market. Tobacco Control 2019;28:146-151. Available: https://tobaccocontrol.bmj.com/content/tobaccocontrol/28/2/146.full.pdf (accessed 2019 May 21). 23 Barrington-Trimis JL, Leventhal AM. Adolescents’ Use of “Pod Mod” E-Cigarettes — Urgent Concerns. N Engl J Med 2018; 379:1099-1102. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1805758?articleTools=true (accessed 2019 May 20). 24 U.S. Department of Health and Human Services. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2016. Available: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf (accessed 2019 May 20). 25 Kong G. et al. Reasons for Electronic Cigarette Experimentation and Discontinuation Among Adolescents and Young Adults. Nicotine & Tobacco Research, 2015 Jul;17(7):847-54. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674436/pdf/ntu257.pdf (accessed 2019 May 21). 26 Keamy-Minor E, McQuoid J, Ling PM. Young adult perceptions of JUUL and other pod electronic cigarette devices in California: a qualitative study. BMJ Open. 2019;9:e026306. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500190/pdf/bmjopen-2018-026306.pdf (accessed 2019 May 21). 27 Ghosh TS, Et al. Youth Vaping and Associated Risk Behaviors — A Snapshot of Colorado. N Engl J Med 2019; 380:689-690.Available: https://www.nejm.org/doi/full/10.1056/NEJMc1900830 (accessed 2019 May 21).
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Health Canada consultation on the impact of vaping products advertising on youth and non-users of tobacco products

https://policybase.cma.ca/en/permalink/policy14022
Date
2019-03-22
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-03-22
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products under the authority of the Tobacco and Vaping Products Act (TVPA). Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, 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 always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes. This brief will address the two main issues outlined in the Notice of Intent: the placement of advertising and health warnings. Placement of Advertising The CMA’s approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. In our April 2017 submission on Bill S-5 to the Senate Standing Committee on Social Affairs, Science and Technology we recommended that the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. This would include the same approach to plain and standardized packaging regulations under consideration for tobacco products.2, The CMA is concerned that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. It is from a public health perspective that the CMA is calling for all vaping advertising to be strictly limited. The CMA supports the provisions proposed for point-of-sale information. The material offered will need to have the health warnings included in this Notice of Intent. However, the sections of the proposed regulations most problematic to the CMA are those encompassing public places, broadcast media, and the publications areas. Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.2 The advertisements permitted currently seem to have managed to find their way to youth, even if they are not directed at them, as claimed. A report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.” Social media provides an easy means of promoting vaping products and techniques, especially to youth.21 A US study found that the landscape is “being dominated by pro-vaping messages disseminated by the vaping industry and vaping proponents, whereas the uncertainty surrounding e-cigarette regulation expressed within the public health field appears not to be reflected in ongoing social media dialogues.” The authors recommended that “real-time monitoring and surveillance of how these devices are discussed, promoted, and used on social media is necessary in conjunction with evidence published in academic journals.”6 The need to address the issue of advertising around vaping is growing more urgent. Vaping is becoming more popular and more attractive to Canadian youth, especially with the arrival of more high-tech versions of electronic cigarettes such as the pod-based JUUL™. , A similar trend has been observed in the United States where a recent study indicated that “use by adolescents and young adults of newer types of e-cigarettes such as pod-based systems is increasing rapidly.” JUUL™ entered the US market in 2015 “with a novel chemistry (nicotine salts) enabling higher concentrations in a limited aerosol plume.” JUUL’s™ nicotine levels contained 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods. Some of JUUL’s™ competition have pods containing even higher levels (6% and 7%).10 The nicotine salts are “less harsh and less bitter, making e-liquids more palatable despite higher nicotine levels.”10 It has been noted by researchers that “among adolescents and young adults who use them, pod-based e-cigarettes are synonymous with the brand-name JUUL™ and use is termed “juuling,” whereas “vaping” has typically been used by youths to refer to using all other types of e-cigarettes.”9 The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.10, The purpose in doing so is because “smoking is not a natural behavior, like eating or drinking, the manufacturers of these devices commonly add flavoring to the liquid from which the nicotine aerosol is generated, to make the initial exposures more pleasurable. The flavoring enhances the appeal to first-time users — especially teenagers.” The CMA and other expert groups would prefer to see flavours banned to reduce the attractiveness of vaping as much as possible.2, It is very important that the pod-based systems are cited specifically to ensure they are included under the new advertising regulations for all vaping products. Youth vaping has reached the point where the US Food and Drug Administration referred to it as an “epidemic,” calling it “one of the biggest public health challenges currently facing the FDA.” Durham Region Health Department, using data from the Ontario Student Drug Use and Health Survey conducted by CAMH and administered by the Institute for Social Research, York University, noted that 17% of high school students in that region had used an electronic cigarette in the past year (2016-17), numbers that are similar for the rest of Ontario. In the United States, a survey indicated that, among high school students, “current e-cigarette use increased from 1.5% (220,000 students) in 2011 to 20.8% (3.05 million students) in 2018;” between 2017 and 2018 alone it rose 78% (from 11.7% to 20.8%). Concern is growing across Canada among educators seeing a rise in the number of youths turning to vaping. , , The problem has reached the point where a school official resorted to removing the doors from the washrooms to “crack down” on vaping in the school. Youth themselves are aware of the increasing problem; many are turning to YouTube to learn “vape tricks” such as making smoke rings. Some refer to the practice of vaping as “the nic;” as a University of Ottawa student noted “They call it getting light-headed. Sometimes it's cool.” As the Canadian Paediatric Society noted in 2015, efforts to “denormalize tobacco smoking in society and historic reductions in tobacco consumption may be undermined by this new ‘gateway’ product to nicotine dependency.” , Decades of effort to reduce the incidence of smoking are in danger of being reversed. A growing body of evidence indicates that vaping can be considered the prime suspect. A Canadian study provides “strong evidence” that use of electronic cigarettes among youth is leading them to the consumption of combustible tobacco products. In a similar vein, a “large nationally representative study of US youths supports the view that e-cigarettes represent a catalyst for cigarette initiation among youths.” Granting vaping manufacturers scope to advertise will likely exacerbate this problem. Health Warnings The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages.2,3 We support the proposed warning labels being placed on all vaping products. The need for such warnings is important as there is still much that is not known about the effects vaping can have on the human body. Substances that have been identified in e-cigarette liquids and aerosols include “nicotine, solvent carriers (PG and glycerol), tobacco-specific nitrosamines (TSNAs), aldehydes, metals, volatile organic compounds (VOCs), phenolic compounds, polycyclic aromatic hydrocarbons (PAHs), flavorings, tobacco alkaloids, and drugs.” Researchers have noted that there is a “striking diversity of the flavorings in e-cigarette liquids, (and that) the effects on health of the aerosol constituents produced by these flavorings are unknown.” A US study found “evidence that using combusted tobacco cigarettes alone or in combination with e-cigarettes is associated with higher concentrations of potentially harmful tobacco constituents in comparison with using e-cigarettes alone.” Some researchers have found that there is “significant potential for serious lung toxicity from e-cig(arette) use.” , Another recent US study indicates that “adults who report puffing e-cigarettes, or vaping, are significantly more likely to have a heart attack, coronary artery disease and depression compared with those who don’t use them or any tobacco products.” Further, it was found that “compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke.”32 The need for parents to be educated on the impact of vaping on children is also very important. A study examining how smoke-free and vape-free home and car policies vary for parents who are dual users of cigarettes and e-cigarettes, who only smoke cigarettes, or who only use e-cigarettes demonstrated that these parents may perceive e-cigarette aerosol as safe for children. It noted that “dual users were less likely than cigarette-only smokers to report various child-protective measures inside homes and cars.”33 Recommendations 1. The CMA calls for all vaping advertising to be strictly limited. The restrictions on the marketing and promotion of vaping products and devices should be the same as those for tobacco products. 2. The CMA recommends that vaping advertisements should not be permitted in any public places, broadcast media, and in publications of any type, with no exceptions. 3. The CMA supports the provisions proposed in this Notice of Intent for point-of-sale information. This should include health warnings. 4. The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages. We support the proposed warning labels being placed on all vaping products. 5. The CMA recommends more research into the health effects of vaping as well as on the components of the vaping liquids. Government of Canada. Notice to Interested Parties – Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products Ottawa: Health Canada; 2019 Available: https://www.canada.ca/en/health-canada/programs/consultation-measures-reduce-impact-vaping-products-advertising-youth-non-users-tobacco-products.html (accessed 2019 Feb 27) Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts Ottawa: CMA; 2017 Apr 7. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-06.pdf (accessed 2019 Mar 1). Canadian Medical Association. Health Canada consultation on tobacco products regulations (plain and standardized appearance) Ottawa: CMA; 2018 Sep 6 Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2019-01.pdf (accessed 2019 Mar 5) Gagnon E. IMPERIAL TOBACCO: Kids shouldn’t be vaping; our marketing is aimed at adults. Halifax Chronicle Herald March 5, 2019 Available: https://www.thechronicleherald.ca/opinion/imperial-tobacco-kids-shouldnt-be-vaping-our-marketing-is-aimed-at-adults-289673/ (accessed 2019 Mar 8) U.S. National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA-8029A. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016. Available https://cancercontrol.cancer.gov/brp/tcrb/monographs/21/docs/m21_complete.pdf (accessed 2019 Mar 8) McCausland K, Maycock B, Leaver T, Jancey J. The Messages Presented in Electronic Cigarette–Related Social Media Promotions and Discussion: Scoping Review J Med Internet Res 2019;21(2):e11953 Available: https://www.jmir.org/2019/2/e11953/ (accessed 2019 Mar 14) Glauser W. New vaping products with techy allure exploding in popularity among youth. CMAJ 2019 February 11;191:E172-3. doi: 10.1503/cmaj.109-5710 Available: http://www.cmaj.ca/content/191/6/E172 (accessed 2019 Mar 1) Crowe K. Canada's 'wicked' debate over vaping CBC News February 2, 2019 Available https://www.cbc.ca/news/health/vaping-juul-vype-health-canada-cigarette-smoking-nicotine-addiction-1.5003164 (accessed 2019 Mar 8) McKelvey K et al. Adolescents’ and Young Adults’ Use and Perceptions of Pod-Based Electronic Cigarettes. JAMA Network Open. 2018;1(6):e183535. doi:10.1001/jamanetworkopen.2018.3535 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2707425 (accessed 2019 Mar 1) Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. doi:10.1136/tobaccocontrol-2018-054796 Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 Mar 12) Reichardt EM., Guichon J. Vaping is an urgent threat to public health The Conversation March 13, 2019 Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 Mar 14) Drazen JM., Morrissey S., Campion, EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019; 380:679-680 Available: https://www.nejm.org/doi/full/10.1056/NEJMe1900484 (accessed 2019 Mar 13) Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there CBC News November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 Mar 13) Food and Drug Administration Statement. Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use Media Release February 11, 2019 Available: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631112.htm (accessed 2019 Mar 11) Durham Region Health Department Students’ use of e-cigarettes in the past year, 2016-2017 Quick Facts December 2018 Available https://www.durham.ca/en/health-and-wellness/resources/Documents/HealthInformationServices/HealthStatisticsReports/E-cigaretteAlternativeSmokingDeviceStudents-QF.pdf (accessed 2019 Mar 11) Cullen KA et al. Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students — United States, 2011–2018 Morbidity and Mortality Weekly Report November 16, 2018 Vol. 67 No. 45 Available: https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm (accessed 2019 Mar 13) Munro N. Vaping on the rise in Nova Scotia high schools Halifax Chronicle Herald March 5, 2019 Available: https://www.thechronicleherald.ca/news/local/vaping-on-the-rise-in-nova-scotia-high-schools-289761/ (accessed 2019 Mar 11) Soloducha A. Is your child vaping? Regina Catholic Schools educating parents as trend continues to rise CBC News March 1, 2019 Available https://www.cbc.ca/news/canada/saskatchewan/regins-catholic-schools-vaping-education-1.5039717 (accessed 2019 Mar 11) Emde W. Growth of vaping labelled ‘crisis’ in Vernon. Kelowna Daily Courier Available http://www.kelownadailycourier.ca/life/article_253d6404-4168-11e9-934f-7b6df68fb0fd.html (accessed 2019 Mar 11) Lathem C. Ottawa principal's solution to student vaping: Remove the washroom doors. CTV News January 9, 2019 Available https://www.ctvnews.ca/canada/ottawa-principal-s-solution-to-student-vaping-remove-the-washroom-doors-1.4246317 (accessed 2019 Mar 11)) Calioa D. Vaping an 'epidemic,' Ottawa high school student says CBC News November 27, 2018 Available https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 Mar 11) Schnurr J. New data is showing a worrisome trend about vaping and smoking among teens CTV News January 18, 2019 Available https://ottawa.ctvnews.ca/new-data-is-showing-a-worrisome-trend-about-vaping-and-smoking-among-teens-1.4260008 (accessed 2019 Mar 11) Stanwick R. E-cigarettes: Are we renormalizing public smoking? Reversing five decades of tobacco control and revitalizing nicotine dependency in children and youth in Canada Policy Statement Canadian Paediatric Society March 6, 2015 (Reaffirmed February 28, 2018) Available: https://www.cps.ca/en/documents/position/e-cigarettes (accessed 2019 Mar 12) Fairchild AL., Bayer R., Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med 370:4 January 23, 2014 Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1313940 (accessed 2019 Mar 12) Hammond d. et al. Electronic cigarette use and smoking initiation among youth: a longitudinal cohort study. CMAJ October 30, 2017 189 (43) E1328-E1336; Available: http://www.cmaj.ca/content/189/43/E1328 (accessed 2019 Mar 1) Berry KM et al. Association of Electronic Cigarette Use With Subsequent Initiation of Tobacco Cigarettes in US Youths JAMA Network Open. 2019;2(2):e187794. doi:10.1001/jamanetworkopen.2018.7794 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723425?resultClick=3 (accessed 2019 Mar 12) National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24952. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 Mar 13) Dinakar, C., O’Connor GT. The Health Effects of Electronic Cigarettes. N Engl J Med 2016;375:1372-81 Available: https://www.nejm.org/doi/full/10.1056/NEJMra1502466 (accessed 2019 Mar 13) Goniewicz ML. et al. Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes JAMA Network Open. 2018;1(8):e185937 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2718096 (accessed 2019 Mar 13) Chan LF. Et al. Pulmonary toxicity of e-cigarettes Am J Physiol Lung Cell Mol Physiol 313: L193–L206, 2017 Available: https://www.physiology.org/doi/full/10.1152/ajplung.00071.2017?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed (accessed 2019 Mar 13) Li D, Sundar IK, McIntosh S, et al. Association of smoking and electronic cigarette use with wheezing and related respiratory symptoms in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. Tob Control. 0:1-8, 2019. American College of Cardiology. E-Cigarettes Linked to Heart Attacks, Coronary Artery Disease and Depression. Media Release March 7, 2019 Available: https://www.acc.org/about-acc/press-releases/2019/03/07/10/03/ecigarettes-linked-to-heart-attacks-coronary-artery-disease-and-depression (accessed 2019 Mar 13) Drehmer JE, Nabi-Burza E, Hipple Walters B, et al. Parental Smoking and E-cigarette Use in Homes and Cars. Pediatrics. 2019;143(4):e20183249 Available: https://pediatrics.aappublications.org/content/early/2019/03/07/peds.2018-3249 (accessed 2019 Mar 13)
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Health Canada consultation on vaping products labelling and packaging regulations

https://policybase.cma.ca/en/permalink/policy14124
Date
2019-09-05
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-09-05
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to the notice as published in the Canada Gazette, Part 1 for interested stakeholders to provide comments on Health Canada’s intent to establish a single set of regulations under the authorities of the Tobacco and Vaping Products Act (TVPA) and the Canada Consumer Product Safety Act (CCPSA) with respect to the labelling and packaging of vaping products.1 Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, 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 always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes (e-cigarettes). Our approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. Introduction In our most recent brief, the CMA expressed its concerns regarding vaping and youth. This included marketing, flavours, nicotine levels, and reducing vaping and e-cigarette use among youths.2 In April 2019, the Council of Chief Medical Officers of Health expressed alarm at the rising number of Canadian youths who are vaping, having found this trend “very troubling.”3 The CMA concurred with this assessment and supports Health Canada’s intention to further tighten the regulations.2 Identifying Vaping Substances The findings of a recent Canadian study indicate an increase in vaping among adolescents in Canada and the United States.4 The growing acceptance of this practice is of concern to the CMA because of the rapidly emerging popularity of vaping products such as JUUL® and similar devices.4 It will be very important to identify clearly on the packaging all the vaping substances contained therein, along with a list of ingredients, as not enough is known about the long-term effects users may face.5,6 Users need to know what they are consuming so they can make informed choices about the contents. Studies have found substances in e-cigarette liquids and aerosols such as “nicotine, solvent carriers (PG and glycerol), tobacco-specific nitrosamines (TSNAs), aldehydes, metals, volatile organic compounds (VOCs), phenolic compounds, polycyclic aromatic hydrocarbons (PAHs), flavorings, tobacco alkaloids, and drugs.”7 Nicotine Content As Hammond et al noted in their recent study, “JUUL® uses benzoic acid and nicotine salt technology to deliver higher concentrations of nicotine than conventional e-cigarettes; indeed, the nicotine concentration in the standard version of JUUL® is more than 50 mg/mL, compared with typical levels of 3-24 mg/mL for other e-cigarettes.”4 The salts and flavours available to be used with these devices reduce the harshness and bitterness of the taste of the e-liquids. Some of its competition deliver even higher levels of nicotine.8 The CMA has expressed its concerns about the rising levels of nicotine available through the vaping process.2 They supply “high levels of nicotine with few of the deterrents that are inherent in other tobacco products. Traditional e-cigarette products use solutions with free-base nicotine formulations in which stronger nicotine concentrations can cause aversive user experiences.”9 The higher levels of nicotine in vaping devices is also of concern because it “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment.”10,11 The CMA has called on Health Canada to restrict the level of nicotine in vaping products to avoid youth (and adults) from developing a dependence.2 4 Health Warnings The CMA reiterates, again, its position that health warnings for vaping should be similar to those for tobacco packages.12,13 We support placing warning labels on all vaping products, regardless of the size of the package. The “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.”13 The need for such cautions is important as there is still much that is not known about the effects vaping can have on the human body. A US study found “evidence that using combusted tobacco cigarettes alone or in combination with e-cigarettes is associated with higher concentrations of potentially harmful tobacco constituents in comparison with using e-cigarettes alone.”14 Some researchers have found that there is “significant potential for serious lung toxicity from e-cig(arette) use.”15,16 Another recent US study indicates that “adults who report puffing e-cigarettes, or vaping, are significantly more likely to have a heart attack, coronary artery disease and depression compared with those who don’t use them or any tobacco products.”17 Further, it was found that “compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke.17 A worrisome development has emerged in the United States. The Centers for Disease Control and Prevention is working in consultation with the states of Wisconsin, Illinois, California, Indiana, and Minnesota regarding a “cluster of pulmonary illnesses linked to e-cigarette product use, or “vaping,” primarily among adolescents and young adults.”18 Additional possible cases have been identified in other states and are being investigated. Child-Resistant Containers The CMA supports the need for child-resistant containers in order to enhance consumer safety; we have adopted a similar position with respect to cannabis in all forms.19,20 The need to include warning labels should reinforce the need for packaging these vaping products such that they will be inaccessible to small children. Recommendations 1. The CMA recommends more research into the health effects of vaping as well as on the components of the vaping liquids. 2. Health Canada should work to restrict the level of nicotine available for vaping products to avoid youth and adults from developing a dependence. 3. The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages. We support the proposed warning labels being placed on all vaping products. 4. The CMA recommends that all the vaping substances be identified clearly on the packaging, along with a list of ingredients. 5. The CMA supports the need for child-resistant containers. 5 1 Government of Canada. Canada Gazette, Part I, Volume 153, Number 25: Vaping Products Labelling and Packaging Regulations. Ottawa: Government of Canada; 2019. Available: http://gazette.gc.ca/rp-pr/p1/2019/2019-06-22/html/reg4-eng.html (accessed 2019 Jul 10). 2 Canadian Medical Association (CMA). Health Canada Consultation on Reducing Youth Access and Appeal of Vaping Products. Ottawa: CMA; 2019 May 24. Available: https://policybase.cma.ca/en/permalink/policy14078 (accessed 2019 Jul 10). 3 Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health on the increasing rates of youth vaping in Canada. Ottawa: Health Canada; 2019. Available: https://www.newswire.ca/news-releases/statement-from-the-council-of-chief-medical-officers-of-health-on-the-increasing-rates-of-youth-vaping-in-canada-812817220.html (accessed 2019 Jul 24). 4 Hammond David, Reid Jessica L, Rynard Vicki L, et al. Prevalence of vaping and smoking among adolescents in Canada, England, and the United States: repeat national cross sectional surveys BMJ. 2019; 365:2219. Available: https://www.bmj.com/content/bmj/365/bmj.l2219.full.pdf (accessed 2019 Jul 24). 5 WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization; 2019. Available: https://apps.who.int/iris/bitstream/handle/10665/326043/9789241516204-eng.pdf?ua=1 (accessed 2019 Jul 30). 6 Dinakar, C., O’Connor GT. The Health Effects of Electronic Cigarettes. N Engl J Med. 2016;375:1372-81. Available: https://www.nejm.org/doi/full/10.1056/NEJMra1502466 (accessed 2019 Jul 30). 7 National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press; 2018. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 Jul 29). 8 Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. 9 Barrington-Trimis JL, Leventhal AM. Adolescents’ Use of “Pod Mod” E-Cigarettes —Urgent Concerns. N Engl J Med 2018; 379:1099-1102. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1805758?articleTools=true (accessed 2019 Jul 30). 10 Chen-Sankey JC, Kong G, Choi K. Perceived ease of flavored e-cigarette use and ecigarette use progression among youth never tobacco users. PLoS ONE 2019;14(2): e0212353. Available: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212353 (accessed 2019 Jul 30). 11 U.S. Department of Health and Human Services. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2016. Available: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf (accessed 2019 Jul 30). 12 Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts. Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 Jul 30). 13 Canadian Medical Association. Health Canada consultation on tobacco products regulations (plain and standardized appearance) Ottawa: CMA; 2018 Sep 6. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Jul 30). 14 Goniewicz ML. et al. Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes JAMA Network Open. 2018;1(8):e185937. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2718096 (accessed 2019 Jul 30). 15 Chan LF. Et al. Pulmonary toxicity of e-cigarettes Am J Physiol Lung Cell Mol Physiol. 313: L193–L206, 2017 Available: https://www.physiology.org/doi/pdf/10.1152/ajplung.00071.2017 (accessed 2019 Jul 30). 16 Li D, Sundar IK, McIntosh S, et al. Association of smoking and electronic cigarette use with wheezing and related respiratory symptoms in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. Tob Control. 0:1-8, 2019. 17 American College of Cardiology. E-Cigarettes Linked to Heart Attacks, Coronary Artery Disease and Depression. Media Release March 7, 2019 Available: https://www.acc.org/about-acc/press-releases/2019/03/07/10/03/ecigarettes-linked-to-heart-attacks-coronary-artery-disease-and-depression (accessed 2019 Jul 30). 18 Centers for Disease Control and Prevention. CDC, states investigating severe pulmonary disease among people who use e-cigarettes. Media Statement 2019 Aug 17. Available: https://www.cdc.gov/media/releases/2019/s0817-pulmonary-disease-ecigarettes.html (accessed 2019 Aug 20). 19 Canadian Medical Association (CMA). Health Canada Consultation on Edible Cannabis, Extracts & Topicals Ottawa: CMA; 2019 Feb 20. Available: https://policybase.cma.ca/en/permalink/policy14020 (accessed 2019 Aug 6). 20 Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis Submission to Health Canada. 2018 Jan 19 Available: https://policybase.cma.ca/en/permalink/policy13838. (accessed 2019 Aug 6).
Documents
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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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