The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada.
The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential.
The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse.
A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure."
Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing
Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA
Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription
Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the
consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E
3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper
resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably.
National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa:
Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf
prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered.
The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5
Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards.
The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected.
As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9.
Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the
Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance.
Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6
Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23.
Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol.
Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9.
The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved
progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet.
There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects.
The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management.
Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential.
The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations.
The CMA recommends that:
1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders.
2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations.
3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages.
4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects.
5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths.
6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s consultation document Questions related to Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare Institutions.
Prescription medication has an important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient’s capacity to function productively in the community. In consideration of this important role, the CMA has developed a substantial body of policy on pharmaceutical issues which includes policy on Canada’s post-approval surveillance system for prescription medication.
It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan.
The CMA welcomes Health Canada’s consultation on the new legislative authority established by Vanessa’s Law to implement mandatory reporting of adverse drug reactions (ADR) and medical device incidents by provincial and territorial healthcare institutions. The CMA appreciates all opportunities to work with governments, health care professionals
and the public in strengthening Canada’s post-approval surveillance system and ensuring that the prescription drugs Canadians receive are safe and effective.
The CMA’s submission is organized in three main sections. In the first section, the CMA’s concerns with the current ADR reporting system are identified as critical context for this regulatory development process. The second section provides an overview of the CMA’s recommendations on necessary improvements to this system. Finally, the CMA’s responses to the questions outlined in Health Canada’s discussion document are presented in the third section.
Part 1: Context of CMA’s Recommendevices with which they have a concern, and also for research purposes.
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation, May 2016.
Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use.
The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.”
Over the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The current Health Canada proposal will help realize that goal and the CMA supports the measures outlined in the consultation paper.
There are two elements that the CMA recommend be addressed in this consultation. The CMA recommends that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information.
In a similar vein, the CMA recommends a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.”
While the CMA supports these measures, they must be part of the overall goal of further reducing and eliminating smoking. These measures will be an essential element of a sustained, well-funded and comprehensive program to reduce tobacco use, combining policy interventions with educational and social-marketing interventions including mass media campaigns. These programs should reflect current best practices, and be evaluated regularly for effectiveness and impact.
To that end, the CMA calls on the federal government to renew the Tobacco Strategy before it expires in March 2017. At the same time, the CMA also recommends that the government allocate adequate funding to ensure implementation of the strategy.
Finally, the consultation paper closes with some potential challenges to the implementation of these proposals. With respect to the problem of counterfeit cigarettes, all levels of government should take the strongest possible measures to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions.
The problem of retailers having difficulty implementing the regulations, resulting in service delays to their customers, is not really an issue related to these proposals. It is very doubtful that the retailers will experience such problems for very long and will find ways of resolving such difficulties.
As for the problem of the manufacturers continuing to innovate in order to circumvent these measures, there should be sufficient enforcement tools within the regulations that will enable Health Canada to deal with such infractions.
The Canadian Medical Association remains committed to working with governments and stakeholders to address this issue. We reiterate our long-standing support for plain and standardized packaging for tobacco products.
In summary, the CMA recommends that:
1) only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed;
2) a single allowable length of cigarette and that a minimum diameter or width be established;
3) the federal government renew the Tobacco Strategy before it expires in March 2017 and that that the government allocate adequate funding to ensure implementation of the strategy.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-President, Medical Professionalism
Vice-président, Professionnalisme médicale
Canadian Medical Association
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices. In this regard, CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans fat and calorie content of processed foods and prepared meals; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels.1 We commend Health Canada on recent work on updating the nutrition facts table and the current revision of the Canada Food Guide and are very pleased to provide a response to the consumer questionnaire on the Health Canada proposal for front-of-package (FOP) nutrition labelling.
FOP nutrition labelling approach and possible symbols
Do you support Health Canada's proposal to use a symbol to identify foods that are high in sodium, sugars and/or saturated fat? Please explain.
In 2011, appearing before the House of Commons Standing Committee on Health, the CMA supported a standard "at a glance" approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices.2
There is a growing body of evidence linking the consumption of diets high in saturated fats, sugars or sodium to cardiovascular and chronic disease (hypertension, dyslipidemia, diabetes mellitus, obesity, cancer, and heart disease and stroke) - leading preventable risk factors and causes of death and disability within Canada and worldwide. Therefore, the CMA does support the proposal to use a symbol for "high in" FOP labelling of foods high in sugar, sodium or saturated fats. FOP labelling on packaged foods may help Canadians make healthier food choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling.
Which symbol would help you recognize foods high in sodium, sugars and/or saturated fat? Please explain.
Of the proposed symbols, we believe that those that resemble a stop sign would send a strong and recognizable signal of a food to avoid. The triangle yield sign shape is too similar to the shape often used to indicate a hazard such as poison. We would recommend holding focus groups with Canadians to better understand how the proposed symbols will be understood by consumers.
Foods that do not have nutrition labelling
Do you think these foods should be exempt from FOP symbols even if they're high in sodium, sugars and/or saturated fat? Please explain.
The CMA can support the exemption of FOP labelling for products in very small packages but we would like to see a provision to include information on "high in" sugar, salt or saturated fats on foods such as sausages, bakery products, prepared dishes from the deli produced and prepackaged by grocery stores/retailers as they are categories of foods often high in these nutrients. A "high in" sticker could be added to the retailer's packaging to be consistent with other packaged foods.
Nutrient levels for a "high in" FOP label
Do you think the proposed nutrient levels make sense to identify foods that are high in sodium, sugars and/or saturated fat? Please explain.
The CMA supports the proposed nutrient levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring that the "high in" threshold and the 15% "a lot" daily value (DV) message are consistent delivers a clear message of concern.
While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we suggest that the threshold for "high in" sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education.
Updating nutrient content claims and other nutrition-related statements
Do you support not allowing a "no added sugars" claim on foods high in sugars? Please explain.
Allowing a food that qualifies for a "high in" sugar FOP symbol to also display a "no added sugars" claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing "no added sugar" claims on these foods.
The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion.
Labelling of foods that have sweeteners
Do you support that these sweeteners be declared in the list of ingredients only, rather than in the list of ingredients and the front of the package? Please explain.
We do not support the elimination of the labelling requirement for artificial sweeteners on the principle display panel. For products that have high intensity sweeteners added and which bear claims such as "unsweetened" or "no sugar added," a declaration of "artificially sweetened" should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn't need to be on the principal display.
For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government's Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism
1 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca.
2 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca
The Canadian Medical Association (CMA) appreciates the opportunity to respond to the Health Canada consultations on the regulation of self-care products in Canada. The CMA is encouraged that Health Canada is proposing a framework for the regulation of self-care products that is reliant on scientific proof to support health claims.
The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care.
The CMA’s comments on the regulation of self-care products, particularly natural health products and non-prescription drugs is based on the CMA Policy on Complementary and Alternative Medicine attached as Appendix 1. Our position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Canadians deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end.1 CMA supports a regulatory approach to self-care products such as natural health products that is based on risk assessment and the development of standards. 2
1 Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf
2 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
3Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf
4 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
5 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010.
6 Canadian Medical Association. Brief BR2014-09 - Bill C-17 An Act to amend the Food and Drugs Act. Ottawa: The Association; 2014.
Risk Based Approach
As noted above CMA has recommended a regulatory approach that is based on risk assessment. We are troubled that the consultation document does not provide enough information on Health Canada’s risk assessment process. We are concerned that the proposal for a risk based approach could place many natural health and homeopathic products in a lower risk category based on whether or not the product makes a health claim which would require no Health Canada review or licensing of these products. As noted in the consultation document all health products have some level of risk and Health Canada’s role is to ensure that the benefits of a product outweigh any know risks. CMA does not believe that a determination of risk can be made based on historical use of a product or on the basis of a philosophical system not supported by science.
The CMA has a long standing position that the same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. 3
CMA would recommend that the initial risk assessment of a self-care product should be evidence informed and based on the same standards of proof and efficacy as those for conventional medicines and pharmaceuticals. As such, we are concerned that homeopathic and natural health products are given as examples of lower risk products that would not require Health Canada review or licensing.
The consultation document redefines a health claim to only those that pertain to diagnosis, treatment, prevention, cure or mitigation of disease or serious health condition. These claims will need to be supported by scientific evidence and only these health claims will be allowed and reviewed by Health Canada.
The CMA has recommended that safety and efficacy claims for natural health products, and claims for the therapeutic value of these products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications currently regulated by Health Canada. 4 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.5 Therefore the CMA supports the proposal that two products making similar claims would have to provide the same level of scientific evidence and are held to the same standard. CMA would not be in support of the proposal that products can still make claims “based on traditional systems of medicine or alternate modalities” with only “adequate supporting information” to be maintained by the company without review or licensing by Health Canada.
CMA would also recommend that even those products that do not make health claims are held to the same standard as those established for pharmaceutical products. Since our position is that all self-care products from lower risk to higher risk should be reviewed for safety and quality, all products should undergo review by Health Canada.
It is certainly problematic that, as noted in the consultation document, fewer than 2 in 5 Canadians surveyed rated themselves knowledgeable about the effectiveness of self-care products. Canadians have the right to reliable, accurate information on self-care products to help ensure that choices they make are informed. It is very important that Canadians understand the level of scrutiny a product has undergone by Health Canada. CMA can support the proposal for an authorization number on those products that have been reviewed and approved by Health Canada. Equally, a disclaimer on the product label that indicates that the product has not been reviewed or approved by Health Canada for effectiveness is very important. We must guard against an assumption by the public that if Health Canada did not need to review a product there is no risk associated with the product.
The Information provided on self-care products should be user friendly and easy to access and include a list of ingredients, instructions for use, indications that the product has been proven to treat, contraindications, side effects and interactions with other medications.
In an era when product claims can be spread vie social media and the internet and cannot be easily monitored it is important to ensure consistent oversight of product marketing. Health claims can only be promoted if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages.
In its submission on Bill C -17 An Act to amend the Food and drugs Act – Protecting Canadians from Unsafe drugs the CMA recommended that the ministerial authorities and measures to address patient safety risks should extend to natural health products.6 We would therefore suggest that Health Canada explore the need for additional powers and tools to require a company to change labels, or order a recall of an unsafe product and institute new penalties to address patient safety issues.
Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's regulatory framework for self-care products to ensure that the health related products Canadians receive are safe and effective.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-President, Medical Professionalism
Canadian Medical Association
COMPLEMENTARY AND ALTERNATIVE MEDICINE
This statement discusses the Canadian Medical Association’s (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA’s position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should “consider first the well-being of the patient.”1 The ethical principle of non-maleficence obliges physicians to reduce their patient’s risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM.
1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004.
2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies.
CAM in Canada
CAM has been defined as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.”i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this
i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health.
analysis, the CMA divides CAM into four general categories:
. Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based.
. Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products.
. Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise.
. Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada.
Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the “holistic” concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM.
Toward Evidence-Informed Health Care
Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious.
The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA’s Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below:
a) Research: Building an Evidence Base
To date, much of the public’s information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained
should be widely disseminated to health professionals and the public.
b) An Appropriate Regulatory Framework
Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments.
i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada.
The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products’ safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include:
5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies.
6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. Available:
9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
* manufacturing processes that ensure the purity, safety and quality of the product;
* labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6
The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm’s length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8
The Canadian Medical Association advocates that foods fortified with “natural health” ingredients should be regulated as food products and not as natural health products
The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada’s MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada.
ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge.
Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients.
Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to:
. Resist any influence or interference that could undermine their professional integrity;9
. Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10
. Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient.
c) Information and Promotion
Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include:
. Instructions for use;
. Indications that the product or therapy has been convincingly proven to treat;
. Contraindications, side effects and interactions with other medications;
. Should advise the consumer to inform their health care provider during any encounter that they are using this product.12
This information should be provided in such a way as to minimize the impact of vested commercial interests on its content.
In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims.
The CMA recommends that product labels include approved health claims, cautions
and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease.
The Role of Health Professionals
Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients.
Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically.
The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
On behalf of the Canadian Medical Association (CMA), I am responding to your request for consultation on renewal of the Federal Tobacco Control Strategy (FTCS) and on the consultation document: “Seizing the Opportunity: The Future of Tobacco Control in Canada.” We are pleased that Health Canada is renewing the FTCS.
The most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014. The decrease is welcome news but much more needs to be done to ensure the decline continues.
We support the Endgame Summit’s goal of less than 5% tobacco use by 2035. It must be recognized that specific sub-populations, such as Indigenous populations, will require different targets along with prevalence reduction goals that recognize their unique circumstances and needs. Tobacco has ceremonial significance among Indigenous peoples; the harm associated with tobacco arises not from its ceremonial use but from its daily, repeated abuse.
As the Summit suggests a renewed strategy must go beyond the traditional approaches of incremental stricter measures by focussing on the activities of the tobacco industry while offering more assistance to those affected by tobacco products. The whole-of-government approach recommended by the Summit and the framework it proposes are essential for the success of the strategy in the long-term.
The CMA believes that despite the reduction in smoking rates, tobacco control remains a priority and should continue to be supported by a sustained, well-funded federal strategy and strong leadership and support from Health Canada, including a coordinated, comprehensive
national cessation strategy. We recommend that the next version of the FTCS make the following initiatives a priority:
. Pricing There is abundant evidence that high prices are crucial to discouraging tobacco use, especially among young people who are particularly sensitive to price increases. The Summit’s recommendation of a joint pricing strategy developed by Health Canada and Finance Canada that combines substantial excise tax increases and other measures will be key in that regard. As in reducing prevalence, pricing strategies that recognize the unique circumstances and needs of specific sub-populations will need to be developed.
. Plain and Standardized Tobacco Packaging The CMA recommends only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA also supports a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.”
. Retailing The CMA recommends tightening the licensing system to limit the number of outlets where tobacco products can be purchased. The more restricted is tobacco availability, the easier it is to regulate.
. Age of sale The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco, preventing them from starting to use tobacco and encouraging them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. The CMA supports raising the minimum age of sale to 21 years.
. Promotion Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to young people. The CMA supports educational and public relations initiatives aimed at countering these messages. For example, movie classification systems should restrict access by children and youth to films that portray tobacco use and tobacco product placement. The CMA also supports a total ban on promotion, including tobacco-branded tobacco accessories and non-tobacco products.
. Industry interference The CMA supports the Endgame Summit’s recommendations with respect to preventing the tobacco industry’s interference with health policy (i.e., Article 5.3 Guidelines to the Framework Convention on Tobacco Control).
It is the CMA’s position that the federal government has a vital role to play in smoking cessation. A fully funded and resourced tobacco control strategy that meets the challenges of the 21st century will help accomplish that goal.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism
1. Protection and disclosure of the information
This is a foundational component of any regulatory framework for both practitioners and patients/requestors. The CMA recommends placing greater emphasis on the protection of privacy by
a. conducting a privacy impact assessment, with input from the Federal Privacy Commissioner (if that hasn't already been done).
b. requiring, as part of the regulations, privacy/data sharing agreements in instances when
o data is shared to meet the objectives outlined (p. 2); and
o information collected under the framework will be made available to designated provincial and territorial government bodies for their use (p. 3). This is particularly important given that this involves the collection of identifiable (private) information about practitioners and patients/requestors.
c. using aggregate data where applicable.
d. providing greater detail on how the "Rigorous protection of all personal information (patient and practitioner) will be a paramount feature of the monitoring regime" - such detail is essential even in the preliminary stages of developing a monitoring and reporting system.
2. Further specification of what constitutes a request
As is currently stated, what constitutes a request is not sufficiently defined, i.e., what constitutes a "written request"? Is any written request a request? What about for those who can't (or who can no longer) write? Further specifying what constitutes a request is especially important since the practitioner has to document the circumstances of the request in every instance, including where follow-up is required and a report has to be filed as part of a follow-up.
A timeframe of 10 days to file a report is alarmingly short. It is commonly known that physicians already feel burdened by paperwork and it is highly likely that they would find it nearly impossible to meet this requirement. This could conceivably deter physicians from choosing to provide assistance in dying or participate in an assessment under threat of criminal sanction, potentially significantly impacting patient access.
Information required for this category includes "results of the eligibility assessment". It should be required to explicitly include reasons why the patient/requestor was deemed ineligible.
5. MAiD self-administered
a. The application of safeguards should be a specific category requiring reporting (and not simply used an example).
b. To assess (in)consistency of emerging practices and the variability of provincial legislative or regulatory requirements, it would be worthwhile to require stating whether the practitioner was present during the self-administration.
6. Coroners and medical examiners
When the monitoring regime (periodically) requests information from Chief Coroners or Medical Examiners:
To assess (in)consistency of emerging practices and the variability of provincial legislative or regulatory requirements, it would be worthwhile to gather data on who completes the death certificate and the information included on the death certificate.
The Canadian Medical Association (CMA) is pleased to provide input on the proposed regulations of the federal monitoring of Medical Assistance in Dying in Canada.
The CMA fully supports the proposed intent of the regulations, in particular, public accountability and transparency and safeguards for vulnerable patient populations. Tracking trends and carrying out research is very important to monitor the implementation and implications of medical assistance in dying.
The CMA further supports the intent to provide electronic reporting and guidance documents, and to leverage any synergies between the federal and provincial/territorial governments, especially to prevent duplication and to promote consistency in reporting across the country.
The CMA would like to raise the following critical areas for your consideration:
1. Definitions/parameters of terms
There continues to be a need to more clearly define several terms to ensure consistency of reporting. For example:
a. Who constitutes a “practitioner”? One can argue that there is a broad scope of who is “a medical practitioner or nurse practitioner”. Is it the practitioner who provides MAiD? Or he practitioner who first reads a patient’s request for MAiD? Or is the first practitioner? Or second practitioner who assesses the patient?
b. What constitutes a therapeutic relationship (as one of the eight proposed items to be collected about the practitioner)? A therapeutic relationship is not required to access MAiD. This criterion should be removed and if not, given the differences in opinion in the health professions as to what constitutes a therapeutic relationship includes, it should be clearly defined.
c. What constitutes a request, a written request, the receipt of a request? If reporting obligations are “triggered” by a patient’s “written request”, at what point is that request actually triggered? The very first practitioner who receives the patient’s written request? Or the practitioner who conducts the eligibility assessment upon receipt of the written request? Or the practitioner who provides the prescription or carries out the procedure?
d. On a related point, without clear definitions, any future comparative analysis of research or trends will be difficult as there will be no common starting point.
e. There continues to be confusion on how to count or when to start counting the required 10 clear days. There are many reasons why this requires more clarity.
2. Collection and protection of data
We applaud Health Canada for further reducing and revising data requirements. We submit, however, that further reductions are required for several reasons, including adherence to privacy best practices that require the collection of the least amount of data necessary to achieve reasonable purposes. In particular:
a. In view of the quantity and highly personal and sensitive data that will be collected about patients and practitioners, data sharing agreements should be required; for example, agreements between the federal government and provincial/territorial governments or between researchers and others requesting use of the data to facilitate the appropriate sharing of data.
b. Collection of personal information should be limited to what is relevant to the purpose of monitoring medical assistance in dying. Personal information, such as the patient’s full postal code, marital status, or principal occupation is beyond the scope of the eligibility criteria outlined in the legislation and thus beyond the scope of the purpose of monitoring the impact of the legislation.
c. Any “characteristics” of the patient should refer only to the eligibility criteria. If other data will be collected beyond that scope, the justification for doing so, and the characteristics themselves, should be clearly outlined.
d. The scope of the information collected about the practitioner could be narrowed. As is, it is very broad – a list of eight items – while the Quebec regulations, as a comparator, have only three-four items that must be collected in relation to the physician who administers MAiD.
3. Additional requirements
Schedule 4 [section 2(i)] of the proposed regulations requires that the practitioner opine as to whether the patient met, or did not meet, all of the eligibility criteria outlined in the legislation – with two significantly expanded requirements; the requirements that the practitioner: 1) provide an estimate as to the amount of time MAiD shortened the patient’s life; and 2) indicate the anticipated likely cause of natural death of the patient.
These additional requirements are beyond the letter and spirit of the legislation and, in many ways, are in direct contradiction to the legislation. The Legislature was not unaware when it drafted the Act that it did not follow other jurisdictions’ criteria requiring either a terminal illness or a prognosis of time within which the practitioner believed the patient would die, e.g., “within the next 6 months”.
It is specifically the lack of a timeframe that makes the legislation unique and provides flexibility for both patients and practitioners. By adding these two additional criteria for reporting, in effect, they become additional criteria for eligibility which is, as stated above, beyond the scope, and in contradiction to, the legislation.
4. Lack of clarity of reasons for ineligibility
There is a potential for misunderstanding as to whether reasons are required when the patient does not meet the criteria under Schedule 4, section 2(a) – (h). The introduction to section 2 speaks to the practitioner giving an indication as to (a) whether the patient met or (b) did not meet the criteria. However, in the itemized criteria [2(a)-(h)] it only speaks to the practitioner having to provide reasons when the patient meets the criteria (and not when the patient has not met the criteria). It would be helpful to specify that reasons should be required when the patient does and does not meet the criteria. This is also crucial for the publication of the Minister of Health’s annual report requiring that the reasons, and which eligibility criteria were not met, be addressed.
The CMA recognizes the importance of regulations to capture the provision, collection, use, and disposal of information for the purpose of monitoring MAiD. The CMA cautions against introducing reporting requirements that are beyond the scope of the legislation.
As noted in the legislation, practitioners who fail to provide information under the regulations may be found guilty under the Criminal Code and subject to possible imprisonment. It is thus imperative that the federal government drafts clear regulations that respect the legislation, privacy, research ethics, and a de minimus approach.
Dear Mr. Rodrigue:
The Canadian Medical Association is pleased to have this opportunity to participate in the consultation on the proposed front-of-packaging labelling (FOP) as posted in the Canada Gazette Part One on February 9, 2018.1 This new requirement will “provide clear and consistent front-of-package information and updated nutrient content claims to help protect Canadians from the risks of chronic diseases” related to the intake of foods high in sugar, sodium, saturated fats and trans fat.2
1 Canada Gazette Part One. Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) Department of Health Vol. 152, No. 6 — February 10, 2018
2 Ibid pg.1
3 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels. We also commend Health Canada for its current work on revising the Canada Food Guide.
The CMA has supported a standard “at a glance” approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices since 2011.3 FOP labelling on packaged foods will help Canadians make healthier food and beverage choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling.
The CMA supports the placement of the proposed symbol on the upper and/or right hand side of the packaging, covering 25% of the principal display surface. The symbol
must be clearly delineated from the product packaging so that it stands out and can be located with relative ease. It is important for the symbol to convey to the consumer that there is a certain degree of risk involved in consuming these foods, hence the colours used and the shape will be important.
Of the four symbols proposed by Health Canada, our preference is for the one displayed here but with a more defined, thicker border, that includes a small outer buffer (in white). It will be essential for Health Canada to ensure that the symbol design has been tested thoroughly with consumers and is effective in conveying the intended “high in” message.
As such, manufacturers will need clear guidance about the constraints on the use and placement of these symbols to ensure they cannot be misconstrued and to prevent the use of configurations that will diminish their effectiveness. Manufacturers must not be permitted to place voluntary nutrient content or health claims below or near the main symbol that would distort the message and create confusion.
Foods to be exempted from front-of-package nutrition labelling
There will be foods that are exempt from the labelling requirements and consumers will need clear explanations with respect to those that are exempt and why; some will be obvious, some will not. The CMA supports the proposed exemptions for eggs, fruits, vegetables and unsweetened, unsalted plain milk, and whole milk. However, we do not believe flavoured and/or seasoning salts and “sea salts” should be exempted from the requirement to have an FOP symbol on the package. Health Canada will need to undertake an education program to explain to consumers that these products are actually high in sodium.
Nutrient thresholds for sodium, sugar & saturated fat
CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans-fat and calorie content of processed foods and prepared meals.4 The nutrient levels chosen will therefore be critical in that regard. The CMA supports the proposed levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring consistency between the “high in” threshold and the 15% “a lot” daily value (DV) message delivers a clear message of concern.
4 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca.
While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we recommend that the threshold for “high in”
sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education.
Nutrient content claims, in relation to Front-of-Packaging Labelling symbol
Allowing a food that qualifies for a “high in” sugar FOP symbol to also display a “no added sugars” claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing “no added sugar” claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion.
High-intensity sweetener labelling
Canadians have come to rely on easy-to-recognize information that alerts them that food may contain artificial sweeteners. Therefore, we do not support the elimination of the labelling requirement for artificial sweeteners on the principal display panel. For products that have high intensity sweeteners added and which bear claims such as “unsweetened” or “no sugar added,” a declaration of “artificially sweetened” should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn’t need to be on the principal display.
Further, while we recognize that harmonizing with USA labelling regulations is desirable, we recommend strongly against the use of the term “phenylketonurics.” The proper approach would be to use the phrase “people with phenylketonuria” for any warnings on products containing aspartame, which contains phenylalanine.
For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government’s Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s proposed regulations entitled Tobacco Products Regulations (Plain and Standardized Appearance) and an Order to amend Schedule 1 to the Tobacco and Vaping Products Act with respect to colouring agents, in Canada Gazette, Part 1.
Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use and for the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements.
The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 in a resolution recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.”
We are pleased to support the proposed regulations and that they will apply to the packaging of all tobacco products and that brand colours, graphics and logos will be prohibited on packages. No exceptions, including for cigars and pipe tobacco, should be considered. These measures will assist in promoting harm reduction efforts and further the goal of reducing and eliminating smoking.
In 2017, 16.2% of Canadians aged 12 and older smoked either daily or occasionally; this is down from 17.7% in 2015. These proposed regulations will be a significant step in the goal of further reducing the smoking rate. However, there are three areas that the CMA would like to see strengthened and are described below.
Slide and Shell Packaging – Minimum package dimensions and warning surface area
The CMA supports strongly the concept of tobacco products being sold in standardized packages. We recommended that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one type and allow for the largest possible surface area to be used to convey health warnings and other health-related information.
With respect to the draft regulation (s.39) concerning the dimensions of the new packages when closed, the CMA recommends that the measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions.1 The Quebec requirement for a warning surface area of 46.5 sq. cm should be the minimum across Canada.
To achieve that, we suggest that the new slide and shell package for regular size cigarettes have the following dimensions when it is closed:
(a) its height must be no less than 74 mm and no more than 77 mm;
(b) its width must be no less than 84 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes.
A similar adjustment is recommended for the width of packages of king size cigarettes when closed:
(a) its width must be no less than 83 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes.
In both cases, this is over and above the dimensions in s.39 (1)(a) and (b) for regular size cigarettes and s.39(2)(b) for king size cigarettes. We also recommend that the number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. This would also prohibit manufacturers from adding one or two additional cigarettes as a “bonus” or “premium.”
The appearance of brand names on the packages should be in a manner that is standard for all brands. Tobacco manufacturers should not be able to include terms such as “organic” or “natural” as part of a brand name. These descriptions would convey the perception that these products are somehow better or are healthier for the consumer. As well, they may be used to evoke a lifestyle or are fashionable. Such terms and phrases should be banned in the regulations; the European Union’s Directive 2014/40/EU of the European Parliament and of the Council could serve as the guide is this instance.
Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to their customers. The CMA has always supported educational and public health initiatives aimed at countering these messages. Permitting a leaflet inside packages “that warns consumers of the health hazards arising from the use of the tobacco product or that provides instructions for its use” (draft regulation s. 36.3) is a positive step but should not provide manufacturers with a potential loophole to exploit. The draft regulation should be amended to indicate that the only instance where any instructions are permitted on the leaflet are when the product has an electronic component. This would prevent manufacturers from using the leaflet as any sort of a promotional platform to minimize, for example, the impact of health warnings on the package exterior.
Canada's physicians have been working for decades toward the goal of a smoke-free Canada and we are pleased to support the proposed regulations. We recommend that the draft regulations be strengthened in the following manner:
1) The measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions.
2) The number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market.
3) Use of terms and phrases such as “organic” and “natural” in brand names should be banned in the regulations.
4) The only instance where any instructions are permitted on the proposed leaflets are when the product has an electronic component.
Tobacco and Vaping Products Act: Tobacco Products Regulations (Plain and Standardized Appearance) Canada Gazette, Part I, 2018 Jun 23 152(25). Available: http://gazette.gc.ca/rp-pr/p1/2018/2018-06-23/html/reg9-eng.html (accessed 2018 Aug 7).
Statistics Canada. Smoking, 2017 Health Fact Sheets Cat. No. 82-625-X June 26, Ottawa, Ont.: Statistics Canada, 2018. Available: https://www150.statcan.gc.ca/n1/en/pub/82-625-x/2018001/article/54974-eng.pdf?st=7HkJdkUB (accessed 2018 Sep 5).
Canadian Medical Association (CMA). Letter in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation. Ottawa: CMA; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Aug 29).
The European Parliament and The Council of the European Union. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive. 2001/37/EC. Brussels: Official Journal of the European Union, 2014. Available:
https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf (accessed 2018 Sep 4).
The Canadian Medical Association (CMA) welcomes this opportunity to provide input to the Advisory Council on the Implementation of National Pharmacare (Advisory Council) on the issues set out in its discussion paper.1 The striking of the Advisory Council by the federal government is long overdue. We will focus on the questions set out in the discussion paper and draw attention to more specific issues that the Advisory Council should consider as it develops its final report.
At the outset, Canada’s physicians are very concerned about their patients’ access to prescription medicines. A June 2018 survey of the CMA member e-panel found the following:
71% reported that they always/often ask their patients if they have prescription drug coveragebefore writing a prescription;
60% reported that greater than 20% of their patients are either uncovered or inadequatelycovered for prescription drugs; and
79% reported that copayments pose affordability challenges among their patients with drugcoverage and that they resort to a variety of strategies to help them.
Indeed, when asked to pick one of three options for a national prescription program, the results were as follows:
57% - a single, national, public pharmacare plan operated by the federal government and fundedby taxes collected by the federal government;
34% - a mix of private prescription drug plans operated by private insurance companies andpublic drug plans run by the provinces and territories, supplemented by a prescription drug planprovided by the federal government for persons with high out-of-pocket drug costs; and
9% - separate regional, public pharmacare plans in each province and territory, funded by taxescollected by both the federal government and the provincial governments.
Who should be covered under national pharmacare? / How should national pharmacare be delivered?
The CMA’s position is that all Canadians should have access to medically necessary drugs regardless of their ability to pay. The challenge is how to resolve the issue of the most expedient and affordable means of achieving this in a manner that is acceptable to the provincial/territorial governments.
At the present time there are two main options that are being discussed. The first is the approach recommended by the Standing Committee on Health (HESA) that calls for the development of a common national prescription drug formulary and the amendment of the Canada Health Act to include out-of-hospital prescription drugs in the definition of insured health services; essentially a universal, single public payer program.2 The second is the “closing the gap” or “catastrophic coverage” approach recommended previously by the Kirby and Romanow commissions, and which was one of the unfulfilled commitments that First Ministers made in the 2003 Health Accord.
There is a large difference in the cost of these two approaches. Regarding the first, the federal Parliamentary Budget Office (PBO) has estimated the net cost to the federal government of assuming the cost of a pharmacare program modelled on the Quebec drug formulary at $19.3 billion in 2015-16, increasing to $22.6 billion in 2020-21.3 Regarding the second approach, in 2002 the Kirby commission suggested that a catastrophic drug program with a cap of 3% of family income would cost $500 million per year.4 A 2015 study by the Conference Board estimated that a program with a cap of 3% of household income or $1,500 would cost the federal government $1.6 billion in 2016, increasing to $1.8 billion in 2020.5
There are parallels between the present situation with insurance coverage for prescription drugs and the insurance coverage for medical services that existed at the time of the Hall Commission (1961-1964).
In 1961 there were 9.6 million Canadians with some form of medical insurance or prepayment coverage, representing 53% of the population.6 Almost one-half of this number (4.5 million) were covered by the physician-sponsored not-for-profit Trans-Canada Medical Plans.7 In its 1962 brief to the Hall Commission the CMA projected that this percentage would increase to 67% by 1970 and it recommended a “closing the gap” approach for the uninsured and under-insured:
That, for the 1,520,000 persons, or approximately 8% of Canada’s population who may adjudged to be medically indigent, tax funds be used to provide comprehensive medical insurance on services…for persons in economic circumstances just superior to the identifiable indigent we recommend the application of tax funds on proof of need to permit the partial assistance which they require.8
After Hall reported in 1964 with the recommendation of first dollar public Medicare, as they say, the rest is history. More than 50 years after the initial passage of the Medical Care Act in 1966, virtually nobody would suggest that Canada got it wrong.
In the case of pharmacare today, the circumstances are somewhat different. First the prevalence of prescription drug insurance is much higher today than medical insurance was back in the early 1960s. A 2017 report from the Conference Board estimates that just 5.2% of Canadians are uninsured for prescription drugs.9 Other survey estimates indicate that roughly one in 10 Canadians report financial difficulty in filling prescriptions10, although some surveys have yielded higher results, such as a September, 2018 Abacus Data poll that found that 23% of Canadians reported that the medicines they need are unaffordable.11 Second, the role of the provincial/territorial (PT) governments paying for prescription drugs today is much greater than their role in paying for medical services prior to Medicare. In 1961 it was estimated that all public sources accounted for 12.4% of medical care expenditures.12 In 2017, PT governments accounted for an estimated 37% of prescription drug spending.13
It is also instructive to consider how Medicare ramped up from its initial spending under the Hospital Insurance and Diagnostic Services Act in 1958-59 through to the first payments under the Medical Care Act a decade later, shown in Table 1. The table shows clearly that Medicare payments increased gradually over the two stages. Medicare as a share of total federal program spending increased from 1% in 1958-59 to a high of 11% in 1971-72. Interestingly, federal spending on Medicare never reached the 50/50 cost-sharing that was offered, reaching 36% in 1976-77, the year prior to the Established Programs Financing Act coming into effect. As an aside, according to the 2017 Fall Economic statement the Canada Health Transfer, valued at $37.1 billion in 2017-18 represents 12.2% of program spending.14
This history highlights the need to consider how the federal government might phase in the program recommended by HESA given the cost estimated by the PBO at $19.3 billion. This appears a daunting challenge in light of the recent increases in federal health funding, which amount to annual increases in the Canada Health Transfer of just over $1 billion plus the $11 billion allocated in the 2017 federal budget over a 10-year period for home care and mental health.15
There is no disagreement that at the present time the fiscal prospects are better for the federal than the PT governments. In its 2018 Fiscal Sustainability Report, the PBO reported that over the 2018-92 projection period the federal government could either increase annual spending or reduce taxes by 1.4% of Gross Domestic Product ($29 billion) and maintain its net debt at the current (2017) level.16 However, the government has many other spending priorities. Conversely, sub-national governments would be required to either increase taxes or reduce spending by 0.8% of GDP or ($18 billion) to maintain net debt at the current level.
The CMA has previously recommended that the federal government pursue a “close the gap” approach in partnership with the PT governments and the private insurance industry. This approach could be scaled up toward a full national public pharmacare by either or both of lowering the household income threshold or raising the level of federal contribution.17 However this has never developed any serious momentum. While the first Ministers committed in their 2003 Accord to take measures, by the end of 2005/06 to ensure that Canadians, wherever they live, have reasonable access to catastrophic coverage,18 this ran aground with the first and only progress report of the National Pharmaceuticals Strategy in 2006.19 It was
evident in the report that much of the current public funding had been shifted into the catastrophic category, ranging from $6.6 billion to $10.3 billion across the four scenarios presented. The only further public PT government pronouncement on a catastrophic drug plan was a three-point proposal set out in a backgrounder for the PT health Ministers meeting in 2008 calling for a funding formula that would: protect the autonomy of the PTs in program design; set a ceiling of 5% of income; and recognize the federal government’s role as an equal partner with 50/50 cost sharing of a total estimate cost of $5.03 billion (2006).20 The amount of $5.03 billion would have represented 62% of PT spending on prescription drugs in 2006.
More recently, an “essential medicines” approach to universal pharmacare has been put forward by Morgan and colleagues, modelled on 2015 data. Essential medicines are defined by the World Health Organization (WHO) as those that satisfy the priority health care needs of the population.21 WHO maintains a model list of essential medicines, and the 2017 version contains some 430 medications.22 Using a multi-step review process, Taglione and colleagues adapted the 2013 version of the WHO list to produce a shorter list of 125 medications that they assessed against the prescription audits of two Toronto-based family health teams comprising 4,777 and 35,554 patients in 2014. They reported 90.8% and 92.6% coverage with the preliminary list of 125 medications in the two sites respectively.23 The list is now called the CLEAN Meds list (http://cleanmeds.ca/).
Morgan and colleagues used 117 items from the CLEAN Meds list to model the impact of adding universal public coverage of an essential medicines list to the existing public drug plans in Canada, based on 2015 data. They reported the following base case results:
Total public expenditure would increase by $1.229 billion to $11.99 billion;
Total private expenditure would decrease by $4.272 billion to $11.172 billion; and
Public expenditure on essential medicines would be $6.14 billion, representing 51% of the total$12 billion in total public expenditure.24
In further research conducted for the Patented Medicine Prices Review Board (PMPRB), Morgan examined the listing of the CLEAN Meds list across the public formularies in Canada for 2015 and found that the public plans listed 93% on average of the 125 medicines, and that this increased to 98% when weighted by drug plan costs.25 The Institute of Fiscal Studies and Democracy at the University of Ottawa has done a similar analysis of 128 medications on the CLEAN Meds list and coverage ranged across provinces from Manitoba at the bottom (with 88 covered completely and 8 requiring special authorization) to Quebec at the top with coverage of 121 items.26
This would suggest that one approach would be for the federal government to offer to cover universal coverage for essential medicines, which would cost at least $6 billion. There would be coordination issues with both public and private plans, as was the case when Ontario introduced OHIP + in early 2018 to extend coverage to persons under 25.27 This could be subsequently scaled up by adding coverage for additional medications.
In terms of how pharmacare should be delivered, that will depend on how far the federal government wants to go. Could the federal government administer a national pharmacare program? It already controls levers including drug approval by Health Canada and price-setting through the PMPRB, and it provides the majority (70%) of funding to the Canadian Agency for Drugs and Technologies and Health which oversees the Common Drug Review.28 In May, 2015 Canadian Blood Services (CBS) CEO Dr. Graham Sher proposed that CBS could be considered as a model for national pharmacare, given its history of running a national (except Quebec) formulary of plasma protein drugs at no cost to patients.29 In his subsequent testimony to the HESA pharmacare study Sher described CBS’ success in negotiating price reductions through public tendering and bulk purchasing’ although he did also note that their formulary includes 45 brands and classes of plasma protein products, far fewer than the thousands of items in PT formularies.30 More recently Flood et al. have suggested that one option for pharmacare could involve the PT governments delegating authority to an arm’s-length agency similar to CBS that would purchase drugs and administer drug benefits.31
However, in the comuniqué following their June 2018 meeting the PT health Ministers emphasized that provinces and territories must retain responsibility for the design and delivery of public drug coverage…Quebec will maintain its own program and will receive comparable compensation if the federal government puts a pan-Canadian program in place.32 This was repeated by the Premiers in their communiqué three weeks later, which would suggest that a national agency approach is a non-starter. Moreover, none of the PT drug plans testified to the HESA pharmacare study. One issue that has received scant attention in all of the discussions about pharmacare since 2015 is the future role of private supplementary health insurance. When Medicare came in in the late 1960s, while the expenditures increased steadily, enrolment in non-profit medical insurance plans disappeared virtually overnight, dropping from 8.3 million enrollees in 1968 to 1.1 million in 1970 and none thereafter.33 This appears unlikely to happen to private insurance in the foreseeable future. For example, in the essential medicines modeling done by Morgan et al. the essential medicines would represent just 27% of total prescription drug expenditures and all public drug expenditures would account for 52% of the total.24 If the federal and PT governments were able to collectively “wave a magic wand” and come up with the PBO’s $19.3 billion and a purchasing and distribution strategy it seems likely that this would raise questions about the continued viability of the health insurance benefits industry. In their testimony to HESA, the Canadian Life and Health Insurance Association did allude to an impact on the industry should prescription drugs become a public program but was not specific.34 We have been unable to locate any international comparative literature on the structure of the health benefits industry. In 2017 CLHIA’s members paid out $11.3 billion in drug benefits, representing 44% of the $25.5 billion total. Dental benefits accounted for $8.1 billion, or 32% of the total.35 Dental benefits paid by CLHIA members accounted for two-thirds (65%) of the estimated total expenditures on dental benefits in Canada in 2017; just 6% were publicly funded.13 Socio-economic inequalities in access to dental care are well-documented36, but this issue is nowhere on the public policy agenda. In addition, any transition from private to public coverage will require some administrative coordination. As noted above, Morgan et al. estimated that an essential medicines approach would reduce private spending by $4.2 billion, a large proportion of which would be currently paid for by private insurance.24 Which drugs should be covered/how much variability across jurisdictions should there be? In terms of which drugs should be covered, the CMA believes that optimal prescribing is the prescription of a drug that is:
The most clinically appropriate for the patient’s condition;
Safe and effective;
Part of a comprehensive treatment plan; and
The most cost-effective drug available to meet the patient’s needs.37
There is no dispute that private insurance companies offer wider formularies than the public drug programs. In their 2017 study the Conference Board compiled information on the number of drugs dispensed in 2015 through: both public and private plans, public plans only; and private plans only. This was presented for nine provinces, excluding PEI. Across the nine provinces, the following averages were observed:
4,878 drugs were dispensed from both public and private plans;
336 drugs were dispensed from public plans only;
1,938 drugs were dispensed from private plans only.9
On the 2018 CMA member e-panel survey, physicians were much more likely to report formulary coverage issues with their patients who with public coverage than they were for their patients with Private coverage. More than five in 10 (54%) physicians reported that they always/often have formulary coverage
issues with their publicly insured patients versus just over one in 10 (13%) for their privately insured patients.
If the federal government plans to pursue national pharmacare Canadians should be well-informed about the range of prescription drugs that will be available to them.
In terms of the variability of coverage, if pharmacare or some portion of it becomes a publicly insured service it should be offered to all Canadians under uniform terms and conditions, as specified in the CHA.
In practical terms, Morgan and colleagues have previously demonstrated that there is a high degree of commonality in the formularies across the public drug programs. Based on a review of 2006 formulary listings of 796 drugs across all provincial formularies except PEI, they found that coverage ranged from 55% to 73%, but when weighted by national retail sales the measure of formulary coverage exceeded 86% in all 9 provinces.38 More recently, in the 2017 PMPRB study of formulary coverage Morgan studied 729 drugs across all provinces and the Non-Insured Health Benefits Plan for 2015. The public plans listed an average of 79% of the 729 drugs, and this increased to 95% when drug costs were factored in.25 These findings would lend further support to the case for an essential medicines approach to national pharmacare.
Should patients pay a portion of the cost of drugs/should employers continue to play a role?
If the federal government intends to define out-of-hospital prescription drugs as an insured service under the CHA it will be necessary to address the feasibility of first dollar coverage in light of the accessibility criterion that prohibits user charges. The CMA addressed this issue in our 2016 brief to the HESA pharmacare study with reference to Scotland, which eliminated prescription charges in April, 2011.39 There are now more recent data. In the four years leading up to the elimination of prescription charges the volume of prescriptions dispensed increased by 3.6% annually. In the seven years since the charges were eliminated, the annual increase has been 1.8%; indeed between 2016/17 and 2017/18 there was a decrease of 0.06%.40 It should be added however that dispensing charges only accounted for 3% of prescription costs in 2008/09. Wales and Northern Ireland have also eliminated prescription charges for their citizens. The experiences of these countries should be examined more closely.
There has been very little research on how employers would react to the implementation of a full or partial public pharmacare plan. Ipsos conducted research among the employer community in 2012. Just under one in two (47) of respondents indicated that they would support a public program for supplementary benefits introduced by the federal government that was funded by increased taxes, but nearly nine in ten agreed that even if the government implemented a program I would recommend that our company/organization still offer a supplementary health benefits program (over and above the government offer) because it would give us an advantage in recruiting/retaining employees.41
If some form of a public pharmacare program is implemented, this will reduce the amount of drug benefits that private insurance companies are required to pay out, which should result in lower premiums for those employers who provide supplementary benefits. The implications of this in terms of how a pharmacare program might be funded have not received much scrutiny to date. However, regardless of the notionally ear-marked health taxes or premiums that are levied against businesses or individuals, Medicare has been paid for out of general tax revenues.
In conclusion, the initial modeling study published by Morgan et al. in 201542 has resulted in welcome attention to the longstanding issue of access to prescription drugs for Canadians who are either uninsured or under-insured. However the discussions have been light on how we could transition to a situation where Canadians can access prescription drugs on the same basis as they access medical and hospital services. This would require concerted discussion between the federal and PT governments and
the health insurance benefits industry and this has not yet occurred. The discussions since 2015 have mainly ignored the issue of highly expensive drugs for rare diseases and very expensive drugs for more common diseases, such as biologic drugs for rheumatoid arthritis. The CMA is pleased to see that HESA is launching a study on the barriers to access to treatment and drugs for Canadians with rare diseases and disorders.43
The Canadian Medical Association recommends that the Advisory Committee on the Implementation of National Pharmacare:
1.Engage with the federal and provincial/territorial governments and the health insuranceindustry on the feasibility of a universal federally funded “essential medicines”prescription drug plan as a scalable approach to the implementation of a nationalpharmacare plan.
2.Engage the business community and the health insurance industry on the question of thecontinued viability of the provision of supplementary health benefits (e.g. dental care)should a national pharmacare plan be implemented.
3.Study the international experience of Scotland and other countries with respect to theprovision of first dollar coverage of prescription drugs.
Table 1. The Evolution of Medicare ($ million) Year HIDS Medical Care Act Total program spend Medicare as a % of total program Total hospital spend Total physician spend Medicare as a % of total H&P 1958-59 54.7 0 4716 1% 640.608 301.337 6%
14% 1960-61 189.4 0 5160.5 4% 834.932 355.014 16%
22% 1962-63 336.7 0 5652.5 6% 1031.749 406.075 23%
24% 1964-65 433.9 0 6167 7% 1273.38 495.657 25%
16% 1966-67 397.4 0 7589.2 5% 1637.647 605.2 18%
18% 1968-69 561.9 33 9258 6% 2179.906 788.089 20%
24% 1970-71 734.3 400.5 11262 10% 2775.391 1031.555 30%
33% 1972-73 960.5 630.8 16324 10% 3384.801 1375.127 33%
33% 1974-75 1307.6 762.7 26037 8% 4579.041 1647.025 33%
34% 1976-77 2030.5 1003.6 34209 9% 6357.3 2071 36%
Hospital Insurance and Diagnostic Services (HIDs) and Medical Care Act – Public Accounts of Canada Issues 1958-59 – 1976-77. Spending by National Health and Welfare.
Total program spend – Public Accounts of Canada Issues 1958-59-1976-77. Budgetary Expenditures Classified by Function – Total spend less public debt charges.
Total hospital and physician spend – calendar year data 1958 – 1975 in Statistics Canada, Historical Statistics of Canada. Series B504-513 Health expenditures, Canada, 1926 to 1975. 1976 – Canadian Institute for Health Information. National Health Expenditures Data Tables Table A.3.1.1.
1 Government of Canada. Towards implementation of national pharmacare. Discussion paper. https://www.canada.ca/content/dam/hc-sc/documents/corporate/publications/council_on_pharmacare_EN.PDF. Accessed 10/02/18.
2 House of Commons Standing Committee on Health. Pharmacare now: prescription medicine coverage for all Canadians. http://www.ourcommons.ca/Content/Committee/421/HESA/Reports/RP9762464/hesarp14/hesarp14-e.pdf. Accessed 10/02/18.
3 Office of the Parliamentary Budget Officer. Federal cost of a national pharmacare program. https://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2017/Pharmacare/Pharmacare_EN_2017_11_07.pdf. Accessed10/02/18.
4 Standing Senate Committee on Social Affairs, Science and Technology. The health of Canadians – the federal role. Volume six: recommendations for reform. https://sencanada.ca/content/sen/committee/372/soci/rep/repoct02vol6-e.pdf. Accessed 10/-2/18.5 Conference Board of Canada. Federal policy action to support the health care needs of Canada’s aging population. https://www.cma.ca/Assets/assets-library/document/en/advocacy/conference-board-rep-sept-2015-embargo-en.pdf. Accessed 10/02/18.6 Berry C. Voluntary medical insurance and prepayment. Ottawa: Queen’s Printer, 1965.7 Clarkson G. The role of Trans-Canada Medical plans in Canadian medical insurance. News & Views on the Economics of Medicine 1966, Number 136.8 Canadian Medical Association. Submission of the Canadian Medical Association to the Royal Commission on Health Services. Toronto, 1962.9 Conference Board of Canada. Understanding the gap: a pan-Canadian analysis of prescription drug insurance coverage. https://www.conferenceboard.ca/temp/7bef4501-6ba6-4527-8b99-8b788c461d14/9326_Understanding-the-Gap__RPT.pdf. Accessed 10/02/18.10 Canadian Institute for Health Information. How Canada compares: Results from the Commonwealth Fund’s 2016 International Health Policy Survey of Adults in 11 Countries.https://www.cihi.ca/sites/default/files/document/commonwealth-fund-2016-chartbook-en-web-rev.pptx. Accessed10/02/18.11 Abacus Data. Canadian perspectives on pharmacare. http://abacusdata.ca/canadian-perspectives-on-pharmacare/. Accessed 10/02/18.12 Royal Commission on Health Services. 1964—Report Volume 1. Ottawa: Queen’s Printer, 1964.13 Canadian Institute for Health Information. National health expenditure trends 1975 to 2017: data tables.https://www.cihi.ca/sites/default/files/document/series_b-nhex2017-en.xlsx. Accessed 10/02/18.14 Department of Finance Canada. Progress for the middle class. Fall economic statement 2017.https://www.budget.gc.ca/fes-eea/2017/docs/statement-enonce/fes-eea-2017-eng.pdf. Accessed 10/02/18.15 Department of Finance Canada. Building a strong middle class. Budget plan 2017. https://www.budget.gc.ca/2017/docs/plan/budget-2017-en.pdf. Accessed 10/02/18. 16 Office of the Parliamentary Budget Officer. Fiscal sustainability report 2018. https://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2018/FSR%20Sept%202018/FSR_2018_25SEP2018_EN_2.pdf. Accessed 10/02/18. 17 Canadian Medical Association. Funding the continuum of care. https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD10-02-e.pdf. Accessed 1-/-2/18. 18 Canadian Intergovernmental Conference Secretariat. 2003 First Ministers’ Accord on Health Care Renewal. http://www.scics.ca/wp-content/uploads/CMFiles/800039004_e1GTC-352011-6102.pdf. Accessed 10/02/18. 19 National Pharmaceuticals Strategy. National Pharmaceuticals Strategy progress report. June 2006. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 10/02/18. 20 Canadian Intergovernmental Conference Secretariat. Annual conference of provincial-territorial Ministers of health. Backgrounder: National pharmaceutical strategy decision points. http://www.scics.ca/en/product-produit/backgrounder-national-pharmaceutical-strategy-decision-points/. Accessed 10/02/18. 21World Health Organization. Essential medicines and health products. http://www.who.int/medicines/services/essmedicines_def/en/. Accessed 10/02/18. 22World Health Organization. WHO model list of essential medicines. 20th list (Amended August 2017). http://www.who.int/medicines/publications/essentialmedicines/20th_EML2017.pdf?ua=1. Accessed 10/02/18. 23 Taglione M, Ahmad H, Slater M, Aliarzadeh B, Glazier R, Laupacis A, Persaud N. Development of a preliminary essential medicines list for Canada. CMAJ Open 2017, 5(1):E137-43. 24 Morgan S, Li W, Yau B, Persaud N. Estimated effects of adding universal public coverage of an essential medicines list to existing public drug plans in Canada. CMAJ 2017;189(8):E295-302. 25 Patented Medicine Prices Review Board. Alignment among public formularies in Canada. Part 1: General overview. http://www.pmprb-cepmb.gc.ca/CMFiles/NPDUIS/NPDUIS_formulary_report_part_1_en.pdf. Accessed 10/02/18. 26 Institute for Fiscal Studies and Democracy. National pharmacare in Canada: Choosing a path forward. http://www.ifsd.ca/web/default/files/Presentations/Reports/18006%20-%20National%20Pharmacare%20in%20Canada-%20Choosing%20a%20Path%20Forward%20-%2016%20July%202018%20-%20Final.pdf. Accessed 10/02/18. 27 CTV News. Ottawa dad raising red flag about OHIP+. https://ottawa.ctvnews.ca/ottawa-dad-raising-red-flag-about-ohip-1.3759115. Accessed 10/02/18. 28 Canadian Agency for Drugs and Technologies in Health. Financial statements March 31, 2018. https://www.cadth.ca/sites/default/files/corporate/planning_documents/CADTH-FS-FY17-18-e.pdf. Accessed 10/02/18. 29 Sher G. Canadian Blood Services as a model for national pharmacare. National Post, April 15, 2015. https://blood.ca/en/media/graham-sher-canadian-blood-services-as-a-model-for-national-pharmacare. Accessed 10/02/18.
30 House of Commons Standing Committee on Health. Evidence. Monday, May 2, 2016. https://www.ourcommons.ca/Content/Committee/421/HESA/Evidence/EV8226056/HESAEV09-E.PDF. Accessed 10/02/18. 31 Flood C, Thomas B, Moten A, Fafard P. Universal pharmacare and federalism: policy options for Canada. http://irpp.org/wp-content/uploads/2018/09/Universal-Pharmacare-and-Federalism-Policy-Options-for-Canada.pdf. Accessed 10/02/18. 32 Canadian Intergovernmental Conference Centre. Conference of provincial and territorial Ministers of health. Provincial/territorial health Ministers meeting communiqué. June 28, 2018. http://www.scics.ca/en/product-produit/news-release-provincial-territorial-health-ministers-meeting-communique/. Accessed 10/02/18. 33 Statistics Canada. Historical Statistics of Canada. Series 8514-516. Estimated enrolment in non-profit medical insurance plans, Canada, at 31 December, 1937 to 1975. https://www150.statcan.gc.ca/n1/en/pub/11-516-x/pdf/5500093-eng.pdf?st=W5ksoTqs. Accessed 10/02/18. 34 House of Commons Standing Committee on Health. Evidence. Monday, May 9, 2016. https://www.ourcommons.ca/Content/Committee/421/HESA/Evidence/EV8251913/HESAEV10-E.PDF. Accessed 10/02/18. 35 Canadian Life and Health Insurance Association. Canadian life and health insurance facts 2018 edition. https://www.clhia.ca/web/clhia_lp4w_lnd_webstation.nsf/resources/Factbook_2/$file/2018+FB+EN.pdf. Accessed 10/02/18. 36 Farmer J, Phillips R, Singhal S, Quinonez C. Inequalities in oral health: understanding the contributions of education and income. Canadian Journal of Public Health 2017;108(3):3240-5. 37 Canadian Medical Association. A prescription for optimal prescribing. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf. Accessed 10/02/18. 38 Morgan S, Hanley G, Raymond C, Blais R. Breadth, depth and agreement among provincial formularies in Canada. Healthcare Policy 2009;4(4):e162-84. 39 Canadian Medical Association. National pharmacare in Canada: getting there from here. https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/national-pharmacare-canada-e.pdf. Accessed 10/02/18. 40 ISD Scotland. Data Tables Prescribing and Medicines. Volume and cost (NHSScotland) (Financial years 2008-09-2017/18). http://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Publications/data-tables2017.asp?id=2204#2204. Accessed 10/02/18. 41 Ipsos Reid. Two in ten (18%) Canadians have no supplementary health coverage. https://www.ipsos.com/sites/default/files/publication/2012-08/5714.pdf. Accessed 10/02/18. 42 Morgan S, Law M, Daw J, Abraham L, Martin D. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ 2015;187(7):491-7. 43 House of Commons Standing Committee on Health Minutes of Proceedings, Meeting No. 100 April 18, 2018. http://www.ourcommons.ca/DocumentViewer/en/42-1/HESA/meeting-100/minutes. Accessed 10/02/18.
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “New Health-Related Labelling for Tobacco Products - Document for Consultation, October 2018”.
Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA
issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate
for the strongest possible measures to control its use and for the past 30 years we have reiterated our
long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. Our response will follow the questions posed in the consultation document.
Labelling on Individual Cigarettes
Displaying a warning on individual cigarettes provides another means of conveying important health warnings about the hazards of smoking. The warnings should be like those that will be displayed on the leaflets included in the cigarette packages as well as the packages themselves. They should be of sufficient size, font and colour that will draw the attention of the smoker to the message. They should also be placed as close to the filter end of the cigarette as possible to remain visible for as long as possible.
Health Information Messages
The CMA has always supported educational and public health initiatives aimed at countering tobacco manufacturers messages that would render smoking attractive and glamorous to their customers. The health information messages and any leaflets included in the package must be of sufficient size, colour and font to prevent manufacturers from using the leaflet as any sort of a promotional platform to minimize, for example, the impact of health warnings on the package exterior.
The CMA supports strongly the concept of tobacco products being sold in standardized packages and we have recommended that only the “slide-and-shell” style of package be authorized and that the “flip-top”
package be removed. This would allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA has recommended that the measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions.
Toxic Statements (Includes Toxic Emissions Statements and Toxic Constituents Statements)
The size, colour and design of new Toxic Statements proposed in the consultation document should be sufficient to be read and easily understood. The Statements should be rotated periodically to include new and updated information related to emissions and toxic constituents.
Connecting Labelling Elements/ Quitline Information
Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous, especially to young people. The CMA supports packages displaying prominent, simple and powerful health warnings, such as the graphic pictorial warnings, as well as quit tips and information on product content and health risks.2 Connecting the themes should help to reinforce the messages being conveyed with these labels. The size, colour, and placement of the proposed quitline and website information should be sufficient to maximize the noticeability of the information on various types of tobacco product packaging.
Percentage of Coverage/Minimum Size of Health Warnings on Tobacco Products Other than Cigarettes and Little Cigars
The amount of space given to the warnings should be sufficient to convey the maximum amount of information while remaining clear, visible, and legible. The warnings should be in proportion to the packaging available, like that of a regular cigarette package.
Labelling for All Tobacco Products that Do Not Currently Require Labels
The CMA supports mandatory health warnings being applied equally to all tobacco products. If package size allows, Health Warnings, Health Information Messages, and Toxic Statements should all be included. The messages should be relevant to the types of tobacco products they are covering.
The rotation timeframe suggested in the consultation document of 12 to 18 months is a reasonable period.
Government of Canada. New Health-Related Labelling for Tobacco Products. Document for Consultation Ottawa: Health Canada; 2018. Available: https://www.canada.ca/en/health-canada/programs/consultation-tobacco-labelling.html (accessed 2018 Oct 29).
Canadian Medical Association (CMA) Tobacco Control (Update 2008). Ottawa: The Association; 2008. Available: http:// policybase.cma.ca /dbtw-wpd/Policypdf/PD08-08.pdf (accessed 2018 Dec 5).
Canadian Medical Association (CMA). Letter in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Nov 19).
Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: The Association; 2018. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2019-01.pdf (accessed 2018 Nov 19).
Canadian Medical Association (CMA). Policy Resolution BD88-03-64 - Smokeless tobacco. Ottawa: The Association; 1987. Available: https://tinyurl.com/y7eynl5q (accessed 2018 Dec 5).
The Canadian Medical Association (CMA) 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.
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
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)
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
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.
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
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).
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.
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).
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.
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
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
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.
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.
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.
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).
Since 1867, the Canadian Medical Association has been the national voice of Canada’s medical profession. We work with physicians, residents and medical students on issues that matter to the profession and the health of Canadians. We advocate for policy and programs that drive meaningful change for physicians and their patients
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 proposed Vaping Products Promotion Regulations “that would (1) prohibit the promotion of vaping products and vaping product-related brand elements by means of advertising that is done in a manner that can be seen or heard by young persons, including the display of vaping products at points of sale where they can be seen by young persons; and (2) require that all vaping advertising convey a health warning about the health hazards of vaping product use.”
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, and will continue to support, strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government. 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 governments in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence.
It is imperative that the regulations concerning the promotion of vaping products be tightened sooner rather than later. While the CMA views Health Canada’s proposed regulations as a step in the right direction, they should only be considered as the start of extensive regulatory, policy and public health work required to effectively address the harms associated with vaping.
Vaping is not without risks. Evidence continues to grow about the hazards associated with the use of e-cigarettes, especially for youth and young adults. The emergence of e-cigarette, or vaping, product use-associated lung injury (EVALI) in the United States and to a lesser extent in Canada, illustrates the danger these products can pose. The Centers for Disease Control and Prevention (CDC) reported that as of January 7, 2020 that there were 2,602 cases of hospitalized EVALI or deaths (57 so far) reported by all 50 states, the District of Columbia, and 2 U.S. territories (Puerto Rico, and the U.S. Virgin Islands). In an update published in the CDC’s Morbidity and Mortality Weekly Report, “younger age was significantly associated with acquiring THC-containing and nicotine-containing products through informal sources.” The report concludes with this warning: “Irrespective of the ongoing investigation, e-cigarette, or
vaping, products should never be used by youths, young adults, or pregnant women.”3 In Canada, as of January 7, 2020, 15 cases of severe pulmonary illness associated with vaping have been reported to the Public Health Agency of Canada.
A recent public opinion survey conducted by the Angus Reid Institute (ARI) indicates that Canadians are growing more concerned about the safety of vaping as more information on the potential harms becomes available. The survey found that the number of people saying that vaping does more harm than good rose from 35% in 2018 to 62% in 2019.5 Further, 17% of parents with children under 19 said their child either vaped or had tried it; 92% of those parents considered vaping harmful.5 Significant to this discussion is the fact that 90% of respondents support “banning advertisements of vaping products in areas frequented by young people. This includes areas such as bus shelters or parks, and digital spaces like social media.”5 As public unease continues to rise, the need for further tightening of regulations becomes vital.
Unfortunately, the federal government is still behind the curve when it comes to the proliferation of vaping and the vaping industry. Health Canada will have to step up surveillance and enforcement if tightening of the regulations is to be effective.
This brief will address the planned regulations as well as discuss important issues not covered such as nicotine levels and flavours. We have expressed concerns about these topics in previous consultations and will be reiterating them here.
Promotion of Vaping Products
The CMA appreciates Health Canada’s intent to tighten the regulations but this proposal is not sufficient, and we must reiterate our long-held position that the restrictions on the promotion of all vaping products and devices be the same as those for tobacco products. , The proposed regulations provides the vaping industry with too much latitude in their promotion activities to ensure youth are protected. As we noted in our response to Health Canada’s consultation on The Impact of Vaping Products Advertising on Youth and Nonusers of Tobacco Products, the advertisements that have been permitted to this point seem to have managed to find their way to youth, even if they are not directed at them, as has been asserted.7, We recommended vaping advertisements should not be permitted in any public places, broadcast media, and in publications of any type, with no exceptions. The CMA stands by that recommendation.7
The methods used by the vaping industry in the past succeeded in attracting more and more youth and young adults and it will no doubt continue efforts to find novel approaches for promoting their products, including the use of popular social media channels. , , , Indeed, “JUUL’s™ advertising imagery in its first 6 months on the market was patently youth oriented. For the next 2 ½ years it was more muted, but the company’s advertising was widely distributed on social media channels frequented by youth, was amplified by hashtag extensions, and catalyzed by compensated influencers and affiliates.”10
The vaping industry’s efforts to circumvent marketing restrictions in other jurisdictions are evident in view of some recent developments. A US study outlines an e-cigarette marketing technique that involves the promotion of scholarships for students. The study found 21 entities (manufacturers, e-cigarette review websites, distributors) offering 40 scholarships, ranging in value from $300 to $5000 (US).13 Most of the scholarships required “an essay submission, with most listing prompts related to e-cigarettes or eliciting information about the benefits of vaping.”13 The authors suggest “that prohibitions on e-cigarette scholarships to youth are also needed, as many of these scholarships require youth under the age of 18 years (for whom use of e-cigarettes are illegal) to write positive essays about vaping.”13
The CMA reiterates, yet again, its position that all health warnings for vaping products and devices should be similar to those presently required for tobacco packages in Canada.6, The need for such cautions is important in that we still do not understand fully the effects vaping can have on the human body.
More research is needed into the potential harms of using electronic cigarettes to understand the long-term effects users may face. , , The proposed health warnings are not strong enough in light of the research and knowledge that has emerged to date about the harms caused by e-cigarettes. For example, a recent US study highlighted the potential link between e-cigarette use and depression. It found “a significant cross-sectional association between e-cigarette use and depression, which highlights the need for prospective studies analyzing the longitudinal risk of depression with e-cigarette use.”18 As the authors note, “the potential mental health consequences may have regulatory implications for novel tobacco products.”18
Further, with respect to respiratory issues, a US study found that “use of e-cigarettes appears to be an independent risk factor for respiratory disease in addition to all combustible tobacco smoking.” The authors also don’t recommend the use of e-cigarettes as a smoking cessation tool because “for most smokers, using an e-cigarette is associated with lower odds of successfully quitting smoking.”19
Nicotine levels and flavours are not addressed in this consultation. However, the CMA considers these issues to be vital in the effort to protect youth and young adults from the harms associated with e-cigarettes and will therefore provide comment in effort to speed movement toward resolving these problems.
The CMA remains very concerned about the rising levels of nicotine available through the vaping process. 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.”
Hammond et al noted in their 2019 study that “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.”9 The salts and flavours available to be used with these devices reduce the harshness and bitterness of the taste of the e-liquids with some of the competition delivering even higher levels of nicotine.
The CMA called on Health Canada to restrict the level of nicotine in vaping products to avoid youth (and adults) from developing a dependence.20 Health Canada set the maximum level at 66 mg/ml while a European Union (EU) directive of 2014 indicates the level should not exceed 20 mg/ml. , Nicotine, among other issues, “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment. , Utilizing the EU level as an interim measure until more scientific research is available to determine an optimal level is acceptable.
On December 5, 2019, the Government of Nova Scotia became the first province or territory to announce it would institute a ban on sale of flavoured e-cigarettes and juices, as of April 1, 2020. The CMA recommends that flavours banned to reduce the attractiveness of vaping to youth as much as possible; others share this sentiment.6,7, Flavours are strong factors in attracting youth, especially when coupled with assertions of lower harm. Their success in doing so is evidenced by the rise in the rates of vaping among youth.9, A recent US study found that “perceiving flavored e-cigarettes as easier to use than unflavored e-cigarettes may lead to e-cigarette use progression among youth never tobacco users. Determining the factors (including e-cigarette marketing and specific e-cigarette flavors) that lead to perceived ease of using flavored e-cigarettes would inform efforts to prevent and curb youth e-cigarette use.” The CMA recommends that flavours be banned to reduce the attractiveness of vaping to youth as much as possible.
1. 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.
2. The CMA reiterates its position that all health warnings for vaping products and devices should be similar to those for tobacco packages.
3. The CMA believes that the European Union 2014 directive indicating the nicotine concentration not exceed 20 mg/ml should be adopted as an interim measure until more scientific research is available to determine an optimum level.
4. CMA recommends flavours be banned to reduce the attractiveness of vaping to youth as much as possible.