Antibiotics for agricultural use

https://policybase.cma.ca/en/permalink/policy10916
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-99
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
Policy Type
Policy resolution
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-99
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
Text
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
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Antibiotics for use in food animals

https://policybase.cma.ca/en/permalink/policy10913
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-97
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
Policy Type
Policy resolution
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-97
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
Text
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
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Bill C-45: The Cannabis Act

https://policybase.cma.ca/en/permalink/policy13861
Date
2018-04-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2018-04-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The CMA is pleased to provide this submission to the Senate Standing Committee, Social Affairs, Science &Technology on Bill C-45, the Cannabis Act. The CMA has long-standing concerns about the health risks associated with consuming cannabis,i particularly in its smoked form.1,2 Children and youth are especially at risk for cannabis-related harms, given their brains are undergoing rapid and extensive development. The CMA's approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA believes that harm reduction encompasses policies, goals, strategies and programs directed at decreasing adverse health, social and economic consequences of drug use for the individual, the community and the society while allowing the user to continue to use drugs, not precluding abstinence.3,4 Specifically, the CMA recommends a multi-faceted cannabis public health strategy that prioritizes impactful and realistic goals before, and certainly no later than, any legalization of cannabis.5 We propose that the first goal should be to develop educational interventions for children, teenagers and young adults. Other goals relate to data collection; monitoring and surveillance; ensuring a proportionate balance between enforcement harms and the direct and indirect harms caused by cannabis use; and research. There is an ongoing need for research into the medicinal and harmful effects of cannabis use. As noted by the Lower-Risk Cannabis Use Guidelines, 6 there is limited evidence on such subjects as synthetic cannabinoids; practices like "deep inhalation" to increase the psychoactive effects of cannabis; and the combination of risky behaviours, like early-onset and frequent use, associated with experiencing acute or chronic health problems.6 Since 2002, the CMA has taken a public health perspective regarding cannabis and other illegal drugs. More recently, the CMA endorsed the Lower-Risk Cannabis Use Guidelines, and we submitted 22 recommendations to the Task Force on Cannabis Legalization and Regulation ("the Task Force").7 Overview According to the recent Canadian Tobacco, Alcohol and Drugs Survey, cannabis is the most used illicit drug in Canada.8 In particular, 25%-30% of adolescents or youth report past-year cannabis use.9 This concerns the CMA. The increasing rate of high usage, despite the fact that non-medical use of cannabis is illegal, coupled with cannabis' increased potency (from 2% in 1980 to 20% in 2015 in the United States),10 the complexity and versatility of the cannabis plant,ii the variable quality of the end product, and variations in the frequency, age of initiation and method of use make it difficult to study the full health impacts and produce replicable, reliable scientific results. The CMA submits, therefore, that any legalization of cannabis for non-medical use must be guided by a comprehensive cannabis public health strategy and include a strong legal-regulatory framework emphasizing harm reduction principles. Given that the Task Force employed a minimizing of harms approach11 and given how the proposed legislation aligns with the Task Force's recommendations,12 the bill addresses several aspects of a legal-regulatory framework "to provide legal access to cannabis and to control and regulate its production, distribution and sale."13 This work provides the starting point for creating a national cannabis public health strategy. The CMA has long called for a comprehensive drug strategy that addresses addiction, prevention, treatment, enforcement and harm reduction.3 There are, however, key public health initiatives that the Canadian government has not adequately addressed and should be implemented before, or no later than, the implementation of legislation. One such initiative is education. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. Supporting a Legal-Regulatory Framework that Advances Public Health and Protection of Children and Youth From a health perspective, allowing any use of cannabis by people under 25 years of age, and certainly those under 21 years of age, is challenging for physicians given the effects on the developing brain.1,3,14 The neurotoxic effect of cannabis, especially with persistent use, on the adolescent brain is more severe than on the adult brain.15,16 Further, neurological studies have shown that adolescent-onset cannabis use produces greater deficits in executive functioning and verbal IQ and greater impairment of learning and memory than adult-onset use.17,18 This underscores the importance of protecting the brain during development. Since current scientific evidence indicates that brain development is not completed until about 25 years of age,19 this would be the ideal minimum age for legal cannabis use. Youth and young adults are among the highest users of cannabis in Canada. Despite non-medical use of cannabis being illegal in Canada since 1923, usage has increased over the past few decades. The CMA recognizes that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach.3 Harm reduction is not one of polarities rather it is about ensuring the quality and integrity of human life and acknowledging where the individual is at within his/her community and society at large.5 The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug's physiological harm. The Canadian government has recognized this disproportionality for over 15 years. Since 2001, there have been two parliamentary committee reportsiii and two billsiv introduced to decriminalize possession of small amounts of cannabis (30 g). It was recommended that small amounts of cannabis possession be a "ticketable" offence rather than a criminal one. Given all of the above, the CMA recommends that the age of legalization should be 21 years of age and that the quantities and the potency of cannabis be more restricted to those under age 25. Supporting a Comprehensive Cannabis Public Health Strategy with a Strong, Effective Education Component The CMA recognizes that Bill C-45 repeals the prohibition against simple possession while increasing penalties against the distribution and sale of cannabis to young people, but this is not enough to support a harm reduction approach. We note that the Federal Tobacco Control Strategy, with its $38 million budget, is intended to help reduce smoking rates and change Canadians' perceptions toward tobacco.20 Similarly, there are extensive education programs concerning the dangers of alcohol, particularly for young people.v The government of Canada has proposed a modest commitment of $9.6 million to a public awareness campaign to inform Canadians, especially youth, of the risks of cannabis consumption, and to surveillance activities.21 A harm reduction strategy should include a hierarchy of goals with an immediate focus on groups with pressing needs. The CMA submits that young people should be targeted first with education. The lifetime risk of dependence to cannabis is estimated at 9%, increasing to almost 17% in those who initiate use in adolescence.22 In 2012, about 1.3% of people aged 15 years and over met the criteria for cannabis abuse or dependence - double the rate for any other drug - because of the high prevalence of cannabis use.23 The strategy should include the development of educational interventions, including skills-based training programs, social marketing interventions and mass media campaigns. Education should focus not only on cannabis' general risks but also on its special risks for the young and its harmful effects on them. This is critical given that for many, the perception is that (i) legalization of possession for both adults and young people translates into normalization of use and (ii) government control over the source of cannabis for sale translates into safety of use. Complicating this has been the fear-mongering messaging associated with illegal drugs. The evidence shows that fewer adolescents today believe that cannabis use has any serious health risks24 and that enforcement policies have not been a deterrent.25 Having an appropriate education strategy rolled out before legalization of possession would reduce the numbers of uninformed young recreational users. It would also provide time to engage in meaningful research on the impact of the drug on youth. Such strategies have been successful in the past; for example, the long-termvi Federal Tobacco Control Strategy has been credited with helping reduce smoking rates to an all-time low in Canada.26 The Lower-Risk Cannabis Use Guidelines were developed as a "science-based information tool for cannabis users to modify their use toward reducing at least some of the health risks."6 The CMA urges the government to support the widespread dissemination of this tool and incorporation of its messages into educational efforts. Other strategies must include plain packaging and labelling with health information and health warnings. Supporting a One-System Approach. Alternatively, a Review of Legislation in Five Years The CMA believes that once the act is in force, there will be little need for two systems (i.e., one for medical and one for non-medical cannabis use). Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization (some people may self-medicate with cannabis to alleviate symptoms but may be reluctant to raise the issue with their family physician for fear of being stigmatized), and for those who wish to use it for other purposes. The medical profession does not need to continue to be involved as a gatekeeper once cannabis is legal for all, especially given that cannabis has not undergone Health Canada's usual pharmaceutical regulatory approval process. The Task Force's discussion reflects the tension it heard between those who advocated for one system and those who did not. One concern raised by patients was about the stigma attached to entering retail outlets selling non-medical cannabis. The CMA submits that this concern would be alleviated if the federal government continued the online purchase and mail order system that is currently in place. Given that there is a lack of consensus and insufficient data to calculate how much of the demand for cannabis will be associated with medical authorization, the Task Force recommended that two systems be established, with an obligation to review - specifically, a program evaluation of the medical access framework in five years.11 If there are two systems, then in the alternative, the CMA recommends a review of the legislation within five years. This would allow time to ensure that the provisions of the act are meeting their intended purposes, as determined by research on the efficacy of educational efforts and other research. Five-year legislative reviews have been previously employed, especially where legislation must balance individual choice with protecting public health and public safety.vii For example, like Bill C-45, the purpose of the Controlled Drugs and Substances Act is to protect public health and public safety.27 Its review within five years is viewed as allowing for a thorough, evidence-based analysis to ensure that the provisions and operations of the act are meeting their intended purpose(s).viii Furthermore, a harm reduction approach lends itself to systematic evaluation of the approach's short- and long-term impact on the reduction of harms.5 The CMA, therefore, submits that if a two-system approach is implemented when the legislation is enacted, the legislation should be amended to include the requirement for evaluation within five years of enactment. Criteria for evaluation may include the number of users in the medical system and the number of physicians authorizing medical cannabis use. The CMA would expect to be involved in the determination of such criteria and evaluation process. Conclusion Support has risen steadily in Canada and internationally for the removal of criminal sanctions for simple cannabis possession, as well as for the legalization and regulation of cannabis' production, distribution and sale. The CMA has long-standing concerns about the health risks associated with consuming cannabis, especially by children and youth in its smoked form. Weighing societal trends against the health effects of cannabis, the CMA supports a broad legal-regulatory framework as part of a comprehensive and properly sequenced public health approach of harm reduction. Recommendations 1. The CMA recommends that the legalization age be amended to 21 years of age, to better protect the most vulnerable population, youth, from the developmental neurological harms associated with cannabis use. 2. The CMA recommends that a comprehensive cannabis public health strategy with a strong, effective health education component be implemented before, and no later than, the enactment of any legislation legalizing cannabis. 3a. The CMA recommends that there be only one regime for medical and non-medical use of cannabis, with provisions for the medical needs of those who would not be able to acquire cannabis in a legal manner (e.g., those below the minimum age). 3b. Alternatively, the CMA recommends that the legislation be amended to include a clause to review the legislation, including a review of having two regimes, within five years. i The term cannabis is used as in Bill C-45: that is, referring to the cannabis plant or any substance or mixture that contains any part of the plant. ii The plant contains at least 750 chemicals, of which there are over 100 different cannabinoids. Madras BK. Update of cannabis and its medical use. Agenda item 6.2. 37th Meeting of the Expert Committee on Drug Dependence, Department of Essential Medicines and Health Products, World Health Organization; 2015. Available: www.who.int/medicines/access/controlled-substances/6_2_cannabis_update.pdf (accessed 2017 Jul 27). iii House of Commons Special Committee on the Non-Medical Use of Drugs (2001) and the Senate Special Committee on Illegal Drugs (2002). iv An Act to amend the Contraventions Act and the Controlled Drugs and Substances Act (Bill C-38), which later was reintroduced as Bill C-10 in 2003. v For example, the Substance Use and Addictions Program (SUAP), a federal contributions program, is delivered by Health Canada to strengthen responses to drug and substance use issues in Canada. See Government of Canada. Substance Use and Addictions Program. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/services/health/campaigns/canadian-drugs-substances-strategy/funding/substance-abuse-addictions-program.html (accessed 2017 Jul 27). vi The Federal Tobacco Control Strategy was initiated in 2001 for 10 years and renewed in 2012 for another five years. vii Several federal acts contain review provisions. Some examples include the Controlled Drugs and Substances Act, SC b1996, c 19, s 9 (five-year review); the Preclearance Act, SC 1999, c 20, s 39 (five-year review); the National Defence Act, RSC 1985, c N-5, s 273.601(1) (seven-year review); the Public Servants Disclosure Protection Act, SC 2005, c 46, s 54 (five-year review); and the Red Tape Reduction Act, SC 2015, c 12 (five-year review). viii The 2012 amendments to the Controlled Drugs and Substances Act were adopted from Bill S-10, which died on order papers in March 2011. The Senate Standing Committee on Legal and Constitutional Affairs reviewed Bill S-10 and recommended that the review period should be extended from two to five years as two years is not sufficient to allow for a comprehensive review. See Debates of the Senate, 40th Parliament, 3rd Session, No 147:66 (2010 Nov 17) at 1550; see also Senate Standing Committee on Legal and Constitutional Affairs, Eleventh Report: Bill S-10, An Act to Amend the Controlled Drugs and Substances Act and to Make Related and Consequential Amendments to Other Acts, with Amendments (2010 Nov 4). 1 Canadian Medical Association. Health risks and harms associated with the use of marijuana. CMA submission to the House of Commons Standing Committee on Health. Ottawa: The Association; 27 May 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2017 Jul 27). 2 Canadian Medical Association. A public health perspective on cannabis and other illegal drugs. CMA submission to the Special Senate Committee on Illegal Drugs. Ottawa: The Association; 11 Mar 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2017 Jul 27). 3 Canadian Medical Association. Bill C-2 An Act to Amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the House of Commons Standing Committee on Public Safety and National Security. Ottawa: The Association; 28 Oct 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/CMA_Brief_C-2_Respect%C3%A9-for_Communities_Act-English.pdf (accessed 2017 Jul 27). 4 Harm Reduction International. What is harm reduction? A position statement from Harm Reduction International. London, UK: Harm Reduction International; 2017. Available: www.hri.global/what-is-harm-reduction (accessed 2017 Jul 27). 5 Riley D, O'Hare P. Harm reduction: history, definition and practice. In: Inciardi JA, Harrison LD, editors. Harm reduction: national and international perspectives. Thousand Oaks, CA: Sage Publications; 2000. 6 Fischer B, Russel C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health 2017;107(8):e1-e12. 7 Canadian Medical Association. Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada - Task Force on Cannabis Legalization and Regulation. Ottawa: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27). 8 Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): 2015 summary. Ottawa: Government of Canada; 2017. Available: www.canada.ca/en/health-canada/services/canadian-tobacco-alcohol-drugs-survey/2015-summary.html (accessed 2017 Jul 27). 9 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS): summary of results for 2012. Ottawa: Health Canada; 2014. Available: www.canada.ca/en/health-canada/services/health-concerns/drug-prevention-treatment/drug-alcohol-use-statistics/canadian-alcohol-drug-use-monitoring-survey-summary-results-2012.html (accessed 2017 Jul 27). 10 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: http://apps.who.int/iris/bitstream/10665/251056/1/9789241510240-eng.pdf?ua=1 (accessed 2017 Jul 27). 11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016. 12 Government of Canada. Legislative background: an Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). Ottawa: Government of Canada; 2017. 13 An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, Bill C-45, First Reading 2017 Apr 13. 14 Crean RD, Crane NA, Mason BJ. An evidence based review of acute and long-term effects of cannabis use on executive cognitive functions. J Addict Med 2011;5(1):1-8. 15 Meier MH, Caspi A, Ambler A, et al. Persistent cannabis users show neuropsychological decline from childhood to midlife. Proc Natl Acad Sci USA 2012;109(40):E2657-64 16 Crépault JF, Rehm J, Fischer B. The cannabis policy framework by the Centre for Addiction and Mental Health: a proposal for a public health approach to cannabis policy in Canada. Int J Drug Policy 2016;34:1-4. 17 Pope HG Jr, Gruber AJ, Hudson JI, et al. Early-onset cannabis use and cognitive deficits: What is the nature of the association? Drug Alcohol Depend 2003;69(3):303-310. 18 Gruber SA, Sagar KA, Dahlgren MK, et al. Age of onset of marijuana use and executive function. Psychol Addict Behav 2011;26(3):496-506. 19 National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington (DC): The National Academies Press; 2017. 20 Canadian Cancer Society. 2017 federal pre-budget submission. Canadian Cancer Society submission to the Standing Committee on Finance. 2014 Aug. Available: www.ourcommons.ca/Content/Committee/421/FINA/Brief/BR8398102/br-external/CanadianCancerSociety-e.pdf (accessed 2017 Jul 27). 21 Health Canada. Backgrounder: legalizing and strictly regulating cannabis: the facts. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/health-canada/news/2017/04/backgrounder_legalizingandstrictlyregulatingcannabisthefacts.html (accessed 2017 Jul 27) 22 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet 2009;374(9698):1383-91. 23 Statistics Canada. Canadian Community Health Survey: Mental Health, 2012. The Daily. 2013 Sep 18. Statistics Canada cat. No. 11-001-X. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2017 Jul 27). 24 Miech RA, Johnston LD, O'Malley PM, Bachman JG, Schulenberg, JE. Monitoring the future national survey results on drug use, 1975-2010. Vol 1: Secondary students. Ann Arbor: Institute for Social Research, University of Michigan; 2011. 25 Spithoff S, Kahan M. Cannabis and Canadian youth: evidence, not ideology. Can Fam Physician 2014;60(9):785-7. 26 Health Canada. Strong foundation, renewed focus: an overview of Canada's Federal Tobacco Control Strategy 2012-2017. Ottawa: Health Canada; 2012. Available: www.canada.ca/content/dam/canada/health-canada/migration/healthy-canadians/publications/healthy-living-vie-saine/tobacco-strategy-2012-2017-strategie-tabagisme/alt/tobacco-strategy-2012-2017-strategie-tabagisme-eng.pdf (accessed 2017 Jul 27). 27 Controlled Drugs and Substances Act, SC 1996, c 19, s 9.
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CMA Response: Health Canada's Medical Marijuana Regulatory Proposal

https://policybase.cma.ca/en/permalink/policy10702
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association welcomes the opportunity to comment on proposed changes to Health Canada's Marihuana for Medical Purposes Regulations, published in the Canada Gazette, Part I on December 15, 2012. CMA provided comments on the proposed changes when Health Canada first announced them in June 2011. Our position on these changes, and indeed on the entire Medical Marihuana Access Program (MMAP), has been consistent since the program was initiated. We remain deeply concerned that, though the program has made a physician's authorization the key to a patient's access to medical marijuana, physicians and other health professionals have little to no evidence-based information about its use as medical therapy. As our President, Dr. Anna Reid, noted in December, the regulatory proposals are "equivalent to asking doctors to prescribe while blindfolded." Health Canada gives two reasons for its regulatory proposal: first, to address concerns about the safety of home grow-ops; and secondly, to reduce the cost of administering a program that has proven more popular than anticipated. Neither of these reasons is related to improving patient care or advancing our clinical knowledge of marijuana as a medical treatment. CMA understands that many Canadians suffer constant pain from chronic or terminal illnesses and are searching for anything that will provide relief. We know that some patients find that use of marijuana relieves their symptoms and that some health professionals also believe it has therapeutic value. However, we are concerned that these claims remain inadequately supported by scientific research. Controlled studies of medical marijuana have been published recently and some have shown benefits. However, these studies are few in number, of short duration and with small samples, and knowledgeable clinicians say that more research is required. In addition, some say that marijuana has become more potent since it became a popular recreational drug in the 1960s, though others disagree,1 and growers say they can develop strains tailored to the needs of individual medical users.2 Though these claims are part of the popular understanding of medical marijuana, there is no scientifically valid evidence that supports them. What Physicians Have Told Us In May 2012, CMA surveyed members of its "e-panel" of physicians to obtain more information about their attitudes and needs regarding medical marijuana. The survey received just over 600 responses out of more than 2,200, for a 27 per cent response rate. Among the findings: * About 70 per cent of respondents had been asked by patients to approve medical marijuana, though only four per cent said they were asked to do so "often." Of those who were asked, one-third reported that they "never" supported such requests, while 18 per cent "usually" did so. * 64 per cent of respondents were concerned that patients who request medical marijuana may actually be using it for recreational purposes; * A large majority of respondents said they would find more information on the appropriate use of marijuana for medicinal purposes, and on its therapeutic benefits and risks, useful or very useful. * About two-thirds agreed or strongly agreed that they would feel more comfortable if: o Physicians wishing to use medical marijuana in their practices were required to undergo special training and licensing; and, o Health Canada offered them protection from liability. * In open-ended questions, some respondents expressed favourable views on marijuana's medical benefits. However, a larger number expressed concern over its harmful effects, such as: psychotic symptoms, especially in younger people; potential for addiction and dependency; and the risks to lung health from smoking it or any other substance. Marijuana is Not Like Other Therapeutic Products Theoretically, marijuana, when used for medicinal purposes, is regulated under the Food and Drugs Act. However, because of its unique legal position, Health Canada has exempted it from the applications of the Act and its regulations, and it has not undergone the scrutiny of benefits and risks required of other therapeutic products approved for use in Canada, be they prescription-only or over-the-counter. According to the Food and Drugs Act (FDA), all drugs requiring a health professional's authorization must be approved for use by Health Canada, based on evidence of effectiveness obtained from controlled clinical trials, which remain the best currently available means of validating knowledge. In addition, Health Canada has a system of post-market surveillance to keep track of problems that arise with prescription drugs in real-world use. Though the CMA has been critical of some aspects of this system,3 we acknowledge that it has added to our body of knowledge on drug safety risks. If marijuana were not an illegal product, it might have been assessed through some form of pre-approval and post-approval surveillance. By exempting marijuana from the FDA's pre-approval and post-approval requirements, Health Canada has lost an opportunity to improve our knowledge of the drug's therapeutic uses. The Views of Canadians A recent online survey conducted by Ipsos-Reid on behalf of the CMA provides insight into the views of Canadians on Health Canada's regulatory proposal.4 The survey found: * 92 per cent of Canadians think it is very or somewhat important that Health Canada not remove itself from its oversight role until guidelines are put in place for physicians; * 90 per cent believe that research on the effectiveness, safety and risks of medical marijuana is needed before Health Canada removes itself from the authorization process; * 85 per cent of Canadians believe medical marijuana should be subject to the same rigorous testing and approval standards as other medicines; * 79 per cent agree that Health Canada has a responsibility to maintain its role in the authorization process.; The Role of the Physician The CMA cannot with certainty predict the consequences of these regulatory changes for the practising physician (and, if the regulations are approved, for the nurse practitioner as well). However, we have several causes for concern: * The gatekeeper role of health professionals: The most significant change, from our point of view, is that Health Canada is removing itself from the approval process, making it a transaction between the patient, the practitioner and the licensed producer. In addition, Section 125 of the regulatory proposal would reduce the content of the authorization form, from its current two-page format to a brief document requiring little more information than is required for a standard medical prescription. We are concerned that these changes will put an even greater onus on physicians than do the current regulations. The CMA agrees with the Federation of Medical Regulatory Authorities that the lack of evidence to support the use of marijuana for medicinal purposes signifies that it is not a medical intervention. In our opinion, putting physicians in the role of gatekeeper for access to marijuana is inappropriate and may be an abdication of responsibility on Health Canada's part.5 Such a move could increase physicians' liability risk and put them at odds with their medical regulatory authorities, which have no choice but to continue to advise physicians to exercise extreme caution. The CMA believes, as does the Canadian Medical Protective Association, that a drug's approval under the Food and Drugs Act does not impose a legal obligation on physicians or nurse practitioners to authorize its use if, in their judgment, it is clinically inappropriate. The Ontario Court of Appeal reached a similar decision recently in the case of R. v. Mernagh. * Protection of Physician Privacy. Under the proposed regulations, health information and physician data - such as the patient's name and date of birth, or the provider's licence number - will be collected by licensed producers who may not be subject to the same regulatory and privacy constraints as the health care sector. The draft regulations also indicate that the licensed producer is expected to confirm that the data on the "medical document" is correct and complete - in other words, health providers who authorize medical marijuana use will receive correspondence from the producer. We are very concerned about the risks this would pose to the privacy of patient and health care provider information. We believe Health Canada should conduct a privacy impact assessment of its proposed regulations or, if it has done so, to share the results. * Physicians as Dispensers. Section 124 of the proposed regulations would allow authorized health care practitioners to "sell, provide or administer dried marijuana." This is contrary to Article 46 of the CMA Guidelines for Physicians in Interactions with Industry, which states that "Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party."6 * Other possible consequences. We are also concerned about other potential consequences of the regulatory changes. Will more people go to health professionals requesting an authorization, on the assumption that the new regulations will make it easier to get? Will entrepreneurs seize the opportunity to establish "dispensaries" whose intended clientele are not those in legitimate medical need, as recent news stories have suggested?7 Will medical marijuana advocates put increased pressure on physicians to authorize its use? Meeting the Information Needs of Physicians In one respect, Health Canada has listened to physicians' concerns regarding the lack of evidence about medical marijuana, and acknowledged the need to remedy this problem. Though it is not addressed in the draft regulations, Health Canada has established an Expert Advisory Committee (EAC) to help provide comprehensive information to health professionals. The CMA has attended meetings of this committee in an observer capacity, suggested the names of practising physicians to serve as members, and made a presentation to the committee at its meeting in November 2012. If the EAC follows the CMA's suggestions, it will consider actively supporting the following activities: * Funding of scientific research on the clinical risks and benefits of marijuana; * Knowledge translation activities to convert this research into accessible, user-friendly tools for education and practice; * Development of best practice guidelines in the therapeutic use of marijuana. Though this guideline would of necessity be based on "C" level evidence, it would be an improvement on what now exists; and * Support for a compulsory training and licensing program for physicians wanting to authorize marijuana for medicinal purposes. The CMA believes that the EAC should be given the mandate and resources to undertake these activities. Conclusion Health Canada's stated mission is to help the people of Canada maintain and improve their health. The CMA believes that if Health Canada wants its Medical Marihuana Access Program to serve this mission, it should not withdraw from administering the program, leaving it to health professionals working within a large knowledge gap. Rather, it should support solid research into the use of marijuana as medication and make a commitment to share this knowledge with the health professional community and to support best clinical practices. 1 Bonsor K: "How marijuana works". Accessed at http://science.howstuffworks.com/marijuana5.htm 2 http://medicalmarijuana.ca/learning-center/marijuana-strains 3 CMA Submission to the House of Commons Standing Committee on Health: Post-Market Surveillance of Prescription Drugs (February 28, 2008). Accessed at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf 4 Online survey of 1,000 Canadians the week of Feb. 24, 2013 conducted by Ipsos-Reid. Summary report of the poll can be accessed at www.cma.ca/advocacy/cma-media-centre. 5 Letter to Health Canada from Yves Robert, MD, President of the Federation of Medical Regulatory Authorities of Canada, November 4, 2011. 6 CMA. 2004. Guidelines for Physicians in Interactions with Industry. Guideline can be accessed online: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf 7 Lee J. "Ross Rebagliati to Open medical marijuana franchise." Vancouver Sun. January 23, 2013. Accessed at http://www.vancouversun.com/health/Ross+Rebagliati+open+medical+marijuana+franchise/7860946/story.html
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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

https://policybase.cma.ca/en/permalink/policy13918
Date
2018-02-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Date
2018-02-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Standing Committee on Health for its study of Bill S-5, An Act to amend the Tobacco Act and the Non-Smokers Health Act and to make consequential amendments to other Acts. We support the government’s effort to implement a new legislative and regulatory framework to address vaping products and related matters. Vaping products, such as electronic cigarettes (or e-cigarettes) replicate the act and taste of smoking but do not contain tobacco. We also recognize that the federal government is attempting to find a balance between regulating vaping devices and making them available to adults. 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. Our most recent efforts centred on our participation in the 2016 Endgame Summit, held late last year in Kingston, Ontario. This brief will focus on three areas: supporting population health; the importance of protecting youth; and, the promotion of vaping products. Overview Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Smoking has been on the decline in Canada 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 2014.1 Many strong laws and regulations have already been enacted but some areas remain to be addressed and strengthened especially as the 1 Statistics Canada. Smoking, 2015. Health Fact Sheets. Statistics Canada Cat. 82-625-X. Ottawa: Statistics Canada; 2016. Available: http://www.statcan.gc.ca/pub/82-625-x/2017001/article/14770-eng.htm (accessed 2018 Feb 1). 2 Czoli CD, Hammond D, White CM. Electronic cigarettes in Canada: Prevalence of use and perceptions among youth and young adults. Can J Public Health. 2014;105(2):e97-e102. 3 Filippos FT, Laverty AA, Gerovasili V, et al. Two-year trends and predictors of e-cigarette use in 27 European Union member states. Tob Control. 2017;26:98-104. 4 Malas M, van der Tempel J, Schwartz R, Minichiello A, Lightfoot C, Noormohamed A, et al. Electronic cigarettes for smoking cessation: A systematic review. Nicotine Tob Res. 2016;18(10):1926–36. 5 O’Leary R, MacDonald M, Stockwell T, Reist D. Clearing the air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. Victoria, BC: Centre for Addictions Research of BC; 2017. Available: http://ectaofcanada.com/clearing-the-air-a-systematic-review-on-the-harms-and-benefits-of-e-cigarettes-and-vapour-devices/ (accessed 2018 Feb 1). 6 El Dib R, Suzumura EA, Akl EA, Gomaa H, Agarwal A, Chang Y, et al. Electronic nicotine delivery systems and/or electronic non-nicotine delivery systems for tobacco smoking cessation or reduction: a systematic review and meta-analysis. BMJ Open. 2017 23;7:e012680. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5337697/pdf/bmjopen-2016-012680.pdf (accessed 2018 Feb 1). 7 Shahab L, Goniewicz M, Blount B, et al. Nicotine, carcinogen, and toxin exposure in long-term e- cigarette and nicotine replacement therapy users: A cross sectional study. Annals of Internal Medicine. 2017;166(6):390-400. 8 Collier R. E-cigs have lower levels of harmful toxins. CMAJ. 2017 Feb 27;189:E331. 9 Sleiman M, Logue J, Montesinos VN, et al. Emissions from electronic cigarettes: Key parameters affecting the release of harmful chemicals. Environmental Science and Technology. 2016 Jul 27;50(17):9644-9651. 10 England LJ, Bunnell RE, Pechacek TF, Tong VT, McAfee TA. Nicotine and the developing human: A neglected element in the electronic cigarette debate. Am J Prev Med. 2015 Aug;49(2):286-93. 11 Foulds J. Use of Electronic Cigarettes by Adolescents. J Adolesc Health. 2015 Dec;57(6):569-70. 12 Khoury M, Manlhiot C, Fan CP, Gibson D, Stearne K, Chahal N, et al. Reported electronic cigarette use among adolescents in the Niagara region of Ontario. CMAJ. 2016 Aug 9;188(11):794-800. 13 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. 14 Miech R, Patrick ME, O’Malley PM, Johnston LD. E-cigarette use as a predictor of cigarette smoking: results from a 1-year follow-up of a national sample of 12th grade students. Tob Control. 2017 Dec;26(e2):e106–11. 15 Primack BA, Soneji S, Stoolmiller M, Fine MJ, Sargent JD. Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr. 2015 Nov;169(11):1018–23. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800740/pdf/nihms768746.pdf (accessed 2018 Feb 1). 16 Hoe J, Thrul J, Ling P. Qualitative analysis of young adult ENDS users’ expectations and experiences. BMJ Open. 2017;7:e014990. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353280/pdf/bmjopen-2016-014990.pdf (accessed 2018 Feb 1). 17 Fairchild AL, Bayer R, Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med. 2014 Jan 23;370:4 Available: http://www.nejm.org/doi/pdf/10.1056/NEJMp1313940 (accessed 2018 Feb 1). 18 Choi K, Grana R, Bernat D. Electronic nicotine delivery systems and acceptability of adult cigarette smoking among Florida youth: Renormalization of smoking? J Adolesc Health. 2017 May;60(5):592–8. tobacco industry continues to evolve. Electronic cigarettes and vaping represents the next step in that evolution. While Canada is to be congratulated on its success to date, it needs to maintain an environment that encourages Canadians to remain tobacco-free if smoking prevalence is to be reduced further in Canada. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Supporting Population Health The arrival of vaping products in Canada placed them in a “grey zone” with respect to legislation and regulation. Clarification of their status is crucial from a public health perspective because of their growing popularity, particularly among youth.2 E-cigarettes have both defenders and opponents. Proponents say they are safer than tobacco cigarettes since they do not contain the tar and other toxic ingredients that are the cause of tobacco related disease. Indeed, some believe they serve a useful purpose as a harm reduction tool or cessation aid (though it is forbidden to market them as such since that claim has never been approved by Health Canada). Opponents are concerned that the nicotine delivered via e-cigarettes is addictive and that the cigarettes may contain other toxic ingredients such as nitrosamines. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to the use of tobacco by people who might otherwise have remained smoke-free. This issue will be addressed later in this brief. This difference of opinion certainly highlights the need for more research into the harms and benefits of vaping products and the factors that cause people to use them.3 Encouraging smokers to move from combustible tobacco products to a less harmful form of nicotine may be a positive step. However the current available evidence is not yet sufficient to establish them as a reliable cessation method. A systematic review published by M. Malas et al. (2016) concluded that while “a majority of studies demonstrate a positive relationship between e-cigarette use and smoking cessation, the evidence remains inconclusive due to the low quality of the research published to date.”4 Indeed, some are helped by these devices to quit smoking but “more carefully designed and scientifically sound studies are urgently needed to establish unequivocally the long-term cessation effects of e-cigarettes and to better understand how and when e-cigarettes may be helpful.”4 The authors found that the evidence examining e-cigarettes as an aid to quitting smoking was determined to be “very low to low.”4 A similar result was found for their use in reducing smoking; the quality of the evidence was revealed as being “very low to moderate.”4 This conclusion is supported by another review conducted by the University of Victoria (2017). It too indicates that there are not enough studies available to fully determine the efficacy of vaping devices as a tobacco cessation device.5 This review also noted that there is “encouraging evidence that vapour devices can be at least as effective as other nicotine replacements.”5 Another review by R. El Dib et al. (2017) reinforces these findings. Limited evidence was also found with respect to the impact of electronic devices to aide cessation. They also noted that the data available from randomized control trials are of “low certainty” and the “observational studies are of very low certainty.”6 The wide range of devices available makes it very difficult to test which are the most effective in helping cessation efforts. Many of the studies are on older devices so it is possible that as second-generation technology becomes available they will prove to be more successful. In view of this uncertainty, the CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. Physicians need to be confident that if they recommend such therapy to their patients it will have the desired outcome. To that end, we are pleased that Health Canada will continue to require manufacturers to apply for authorization under the Food and Drugs Act to sell products containing nicotine and make therapeutic claims. Risk and Safety In addition to the discussion concerning the usefulness of vaping devices as cessation devices, concerns from a public health standpoint involve the aerosol or vapour produced by heating the liquids used in these devices, and the nicotine some may contain. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine and/or flavourings that are intended to boost their appeal to young people. The CMA is concerned that not enough is known about the safety of the ingredients in the liquids being used in vaping devices. While it is the case that because e-cigarettes heat rather than burn the key constituent, they produce less harmful toxins and are much safer than conventional cigarettes. Research in the UK suggested that “long-term Nicotine Replacement Therapy (NRT)-only and e-cigarette-only use, but not dual-use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.”7 However, this study has been criticized because “it only looked at a few toxins and didn’t test for any toxins that could be produced by e- cigarettes.”8 The variety of flavourings and delivery systems available make it imperative that the risks associated with these products be fully understood. As one study noted “analysis of e-liquids and vapours emitted by e-cigarettes led to the identification of several compounds of concern due to their potentially harmful effects on users and passively exposed non-users.”9 The study found that the emissions were associated with both cancer and non-cancer health impacts and required further study.9 There is another aspect of the public health question surrounding vaping devices. There is data to support the idea that “nicotine exposure during periods of developmental vulnerability (e.g., fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development.”10 Therefore it is imperative that pregnant women and youth be protected. There is not enough known about the effects of long-term exposure to the nicotine inhaled through vaping devices at this time.11 Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. Protecting Youth The CMA is encouraged by the government’s desire to protect youth from developing nicotine addiction and inducements to use tobacco products. Young people are particularly vulnerable to peer pressure, and to tobacco industry marketing tactics. The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco and have been drawn to vaping devices, discouraging them from starting to use them and persuading them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. These programs should be available continuously in schools and should begin in the earliest grades. The “cool/fun/new” factor that seems to have developed around vaping devices among youth make such programs all the more imperative.12 The CMA recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. We are pleased to see that Bill S-5 aims to restrict access to youth, including prohibiting the sale of both tobacco and vaping products in vending machines as well as prohibiting sales of quantities that do not comply with the regulations. In fact, the CMA recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. The more restricted is availability, the easier it is to regulate. The CMA considers prohibiting the promotion of flavours in vaping products that may appeal to youth, such as soft drinks and cannabis, to be a positive step. A recent 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.”13 We are therefore pleased that sales of vaping products via the internet will be restricted through prohibiting the sending and delivering of such products to someone under the age of 18. This will be critical to limiting the tobacco industry’s reach with respect to youth. There have also been arguments around whether vaping products will serve as gateways to the use of combusted tobacco products. The University of Victoria (2017) paper suggests this isn’t the case; it notes that “there is no evidence of any gateway effect whereby youth who experiment with vapour devices are, as a result, more likely to take up tobacco use.”5) They base this on the decline in youth smoking while rates of the use of vaping devices rise.Error! Bookmark not defined. Others contend that vaping is indeed a gateway, saying it acts as a “one-way bridge to cigarette smoking among youth. Vaping as a risk factor for future smoking is a strong, scientifically-based rationale for restricting access to e-cigarettes.”14 Further, in a “national sample of US adolescents and young adults, use of e-cigarettes at baseline was associated with progression to traditional cigarette smoking. These findings support regulations to limit sales and decrease the appeal of e- cigarettes to adolescents and young adults.”15 However, there may be a role for vaping products in relation to young users. A New Zealand study conducted among young adults that examined how electronic nicotine delivery systems (ENDS) were used to recreate or replace smoking habits. It found that study participants “used ENDS to construct rituals that recreated or replaced smoking attributes, and that varied in the emphasis given to device appearance.”16 Further, it was suggested that ascertaining how “ENDS users create new rituals and the components they privilege within these could help promote full transition from smoking to ENDS and identify those at greatest risk of dual use or relapse to cigarette smoking.”16 The CMA believes that further research is needed on the question of the use of vaping products as a gateway for youth into combustible tobacco products. Recommendations: 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. Promotion of Vaping Products 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.” The CMA would like to see the proposed plain packing provisions for tobacco be extended to vaping products as well. The inclusion of the health warning messages on vaping products is a good first step but efforts should be made to ensure that they are of similar size and type as those on tobacco as soon as possible. The restrictions being applied to the promotion of vaping products is a positive step, especially those that could be aimed at youth, but they do not go far enough. The CMA believes the restrictions on promotion should be the same as those for tobacco products. As the WHO/U.S. National Cancer Institute has already demonstrated, e- cigarette retailers are very good at using social media to promote their products, relying on appeals to lifestyle changes to encourage the use of their products. The CMA is also concerned that e-cigarette advertising could appear in locations and on mediums popular with children and youth if they are not prohibited explicitly in the regulations. This would include television and radio advertisements during times and programs popular with children and youth, billboards near schools, hockey arenas, and on promotional products such as t-shirts and ball caps. As efforts continue to reduce the use of combustible tobacco products there is growing concern that the rising popularity of vaping products will lead to a “renormalization” of smoking. In fact, worry has been expressed that the manner they have been promoted “threaten(s) to reverse the successful, decades-long public health campaign to de- normalize smoking.”17 A recent US study indicated that students that use vaping products themselves, exposure to advertising of these devices, and living with other users of vaping products is “associated with acceptability of cigarette smoking, particularly among never smokers.”18 Further research is needed to explore these findings. Recommendations: 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. Conclusion Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Our members see the devastating effects of tobacco use every day in their practices and to that end the CMA has been working for decades toward the goal of a smoke-free Canada. The tobacco industry continues to evolve and vaping represents the next step in that evolution. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Bill S-5 is another step in that journey. Researchers have identified potential benefits as well as harms associated with these products that require much more scrutiny. The association of the tobacco industry with these products means that strong regulations, enforcement, and oversight are needed. Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.
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Consultation on proposed front-of-package labelling

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

https://policybase.cma.ca/en/permalink/policy14017
Date
2018-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2018-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s consultation on new and innovative ideas on how to further strengthen the federal government’s health-focussed approach to substance use issues through the Canadian Drugs and Substances Strategy (CDSS) Question 1 What sorts of circumstances do you see within your networks, communities or in society that you think contribute to problematic substance use? There are multiple factors that contribute to problematic substance use. It is a serious, chronic and relapsing medical condition for which there are effective treatments. However, using the social determinants as a framework, most health promotion and prevention efforts will take place outside of the traditional health and medical care services. . Many Canadians face barriers in their physical, social and economic environments which can contribute to problematic substance use, and certain populations are at higher risk given these circumstances. For example, early childhood is a critical time in the social, emotional, cognitive and physical development of a person. Experiences in early life can ‘get under the skin’, changing the ways that genes are expressed. Negative experiences such as poverty or family or parental violence can have significant impacts on this important period of development. What is necessary is a coordinated effort across government sectors to ensure that all policy decisions serve to increase opportunities for health. Improving population health and reducing inequities should be an overall objective for all governments in Canada. Question 2 Have you seen or experienced programs, practices or models at the local or regional level that could be expanded, or implemented more broadly, to improve circumstances or social determinants of health that influence substance use? Income is critical to individual health and is closely linked to many of the other social determinants of health. These include but are not limited to: education, employment, early childhood development, housing, social exclusion, and physical environment. Adequate consideration must be given to the social and economic determinants of health, factors such as income and housing that have a major impact on health outcomes. Minimizing poverty should be a top priority. In 2015, the CMA passed a resolution endorsing the concept of a basic income guarantee, which is a cash transfer from government to citizens not tied to labour market participation. It ensures sufficient income to meet basic needs and live with dignity, regardless of employment status. A basic income guarantee has the potential to alleviate or even eliminate poverty. It has the potential to reduce the substantial, long-term social consequences of poverty, including higher crime rates and fewer students achieving success in the educational system. Drug use must not be treated with a criminal justice approach, which does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. More investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system. Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential. Question 3 What needs to change to make sure that opioid medications are being provided and used appropriately, based on the needs of each patient? Policy makers must recognize that prescription opioids are an essential tool in the alleviation of pain and suffering, particularly in palliative and cancer care. Doctors support patients in the management of acute and chronic pain, as well as problematic substance use, and as such have long been concerned about the harms associated with opioid use. Treatment options and services for both problematic substance use as well as pain management are woefully under-resourced in Canada. Experts believe that improved access to specialized pain treatment could reduce inappropriate use of pain medications. Current best practices in pain management include care by an interprofessional team that could include physiotherapists, occupational therapists, psychologists and other health professionals; non-pharmaceutical interventions such as therapy for trauma and social pain, social supports and coping strategies; appropriate pharmaceutical prescription options, covered by provincial formularies; and a focus on patient participation and empowerment.12 Availability and access of these critical resources varies by jurisdiction and region. The federal government should prioritize the expansion of these services. It is also important to support clinicians in their practice. The 2017 Opioid Prescribing Guidelines need to be kept current through ongoing funding. Physicians require tools, including those that facilitate monitoring of effectiveness and tolerance by tracking pain and physical function; screening for past and current substance use; screening for depression; and, tapering of problematic or ineffective doses. Question 4 How can we make sure that those who require prescription opioids to manage their pain have access to them, without judgement or discrimination? Governments need to incorporate the identification and elimination of stigma as a quality of care indicator in the ongoing monitoring of health system performance at all levels. They also need to implement and evaluate national public awareness and education strategies to counteract the stigma associated with substance use issues as well as enforcing legislation and regulations to guard against discrimination against people with mental and substance use issues. Health professionals need to have access to education on pain management and treatment of problematic substance use, recognizing both issues as serious medical conditions for which there are effective treatments. Question 5 Which kinds of messages would work best to help Canadians understand the serious harms that can result from stigma around substance use? A recent report from the Canadian Centre on Substance Use and Addiction (CCSA) and Public Safety Canada cited stigma as “an enormous barrier to individuals seeking and maintaining treatment.” Even though there is broad recognition that we are in a public health crisis, until very recently the focus of the federal National Anti-Drug Strategy was heavily skewed towards a criminal justice approach rather than a public health approach with an emphasis on enforcement, as opposed to prevention, treatment and harm reduction.8 This has serious implications in how society views people who use drugs. As noted in the CCSA-Public Safety report, “Language matters. Speak about people first, with compassion and respect.”13 A stigma reduction strategy must be core to the activities of the federal government. Stigma involves thoughts, emotions and behaviours; thus, a comprehensive approach includes interventions to target each of these dimensions at both the individual and population level. The strategy should include aspects of: * Public awareness and education to facilitate understanding about the importance of early diagnosis, treatment, recovery and prevention; * Enhanced provider/student education and support; * Policy analysis and modification of discriminatory legislation; * Support for a strong voluntary sector to voice the concerns of patients and their families; * Exposure to positive spokespeople (e.g. prominent Canadians) who have mental illness and/or addiction in order to highlight success stories; * Researching stigma. Question 6 How can we best act to reduce stigma across the country? Engagement with people who use drugs to help them share their stories and experiences with stigma with the public Question 7 What would you recommend to improve substance use treatment services in Canada? This challenge requires a complex and multifaceted solution; and to further this aim, Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based, complementing existing strategies to address the harms associated with the other two legal drugs - alcohol and tobacco. This comprehensive approach is necessary, as isolated measures can have unintended consequences, such as under-medicating people that require a medical treatment or constraining people to seek illegal drugs as an option when medications are made tamper-resistant. One of the fundamental principles of health care is that it be patient centred.11 CMA defines patient-centred care as “seamless access to the continuum of care in a timely manner … that takes into consideration the individual needs and preferences of the patient and his/her family and treats the patient with respect and dignity.” It is essential that patients be core members of the health care team, working with health care providers to address their individual needs, preferences and aspirations and to seek their personal paths to well-being. Physicians and other health professionals can help patients make choices about their treatment and can provide information and support to patients and their families as they seek to cope with the effects of problematic use and live functional lives. The health care provider community needs tools to assist in the reduction of stigma, access to resources and supportive environments. Question 8 What obstacles or barriers do people face when they want to access treatment in Canada? Obstacles to treatment include the lack of publicly-funded treatment centres, access to locations for remote areas, limited number of beds available, the cost of private treatment (lack of insurance), and stigma. The CMA supports the enhancement of access to options for treatment that address different needs.12 Treatment programs must be coordinated and patient-centred, and address physical, psychological, social and spiritual circumstances. For example, it is important that treatment programs be culturally relevant for Indigenous communities. Question 10 In addition to current harm reduction initiatives – such as supervised consumption sites, needle exchange programs – what other harm reduction services should governments consider implementing in Canada? There is a dire need to address harm reduction in prisons. Even back in 2005, the CMA recommended to the Correctional Service of Canada that it develop, implement and evaluate a pilot needle exchange program in prison(s) under its jurisdiction. These services are not widespread and accessible to prison populations. In Canada, people in prison face far greater risk of HIV and hepatitis C infection because they are denied access to sterile injection equipment as a harm reduction strategy. Hospitals need to incorporate harm reduction strategies as well, allowing people who use drugs to access much needed health services. Question 12 How can we better bring public health and law enforcement together to explore ways to reduce the cycle of involvement for people who use substances with the criminal justice system? Training for police and other frontline criminal justice and corrections workers in how to interact with people with substance use issues is essential. The CMA believes that the government must take a broad public health policy approach. Changes to the criminal law affecting cannabis must not promote normalization of its use and must be tied to a national drug strategy that promotes awareness and prevention and provides for comprehensive treatment.13 The CMA recognized that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach. The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug's physiological harm. Question 13 What further steps can the federal government take to better address current regulation and enforcement priorities, such as addressing organized drug crime and the dangerous illegal drugs like fentanyl being brought into Canada? The federal government must continue to work closely with the RCMP, local and provincial law enforcement agencies, Canada Post, the Canadian Border Services Agency, Crown attorneys, the Canadian military, and international health officials and law enforcement agencies to address this issue. This topic was covered in the recent CCSA/Public Safety Canada report.10 Question 14 Recognizing Indigenous rights and self-determination, how can all governments work together to address the high rates of problematic substance use faced by some Indigenous communities? Difficulties in access are particularly acute for Canada's Indigenous peoples. Many live in communities with limited access to health care services, sometimes having to travel hundreds of miles to access care. Additionally, there are jurisdictional challenges; many fall through the cracks between the provincial and federal health systems. While geography is a significant barrier for Indigenous peoples, it is not the only one. Indigenous peoples living in Canada's urban centres also face difficulties. Poverty, social exclusion and discrimination can be barriers to needed health care. Of all federal spending on indigenous programs and services only 10% is allocated to urban Aboriginals. This means that Aboriginals living in urban areas are unable to access programs such as Aboriginal head start, or alcohol and drug services, which would be available if they were living on reserve. Further, even when care is available it may not be culturally appropriate. Canada's indigenous peoples tend to be over-represented in populations most at risk and with the greatest need for care, making the lack of access a much greater issue for their health status. It is important that problematic substance use programs be culturally relevant for Indigenous communities. It is clear that the First Nations and Inuit peoples of Canada experience mental illness, problematic substance use and poor mental health at rates exceeding that of other Canadians.11 Individual, community and population level factors contribute to this including socioeconomic status, social environment, child development, nutrition, maternal health, culture and access to health services. The urgent need to work with these communities and identify the structures and interventions to reduce the burden of mental illness and substance use is critical to the health and wellness and future of First Nations and Inuit peoples. Enhanced federal capacity should be created through First Nations and Inuit Health that will provide increased funding and support for First Nations and Inuit community health strategies. The establishment of a working groups comprised of First Nations and Inuit health experts and accountable to First Nations and Inuit leadership is essential for the success of this initiative. Both expert and resource supports are integral elements to facilitate and encourage culturally appropriate strategies and programming in these communities. Question 15 What can we learn from Indigenous approaches to problematic substance use, such as using holistic approaches, that may help inform activities under the CDSS? The federal government must consult First Nations, Inuit, and Métis representatives to develop programs that are culturally relevant and appropriate for Indigenous communities. Question 16 How can governments, and the health, social, and law enforcement sectors design more effective substance use policies and programs for at-risk populations? The government must identify and consult those communities and populations most at risk. This includes First Nations, Inuit, and Métis representatives, community advocates, municipalities, and provincial and local public health officers. Data that describes rates of use and issues specific to each at risk group is important to be able to better understand and address needs. Question 17 What are effective policies and programs to help improve access to prevention, treatment, and harm reduction services for at-risk populations? There are innovative approaches to address the needs of high-volume users as well as at-risk populations. As many of these involve greater integration between health and the community sector and attention to issues not traditionally funded through health care payment systems, there is a need to provide access to funds to enable these innovations to continue and be spread across the country. A targeted, integrated approach to identify communities in need is required and this must be based on reliable community data (i.e., meaningful use of patient data) which can be used to integrate resources to improve health status. For example, the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) is Canada's first multi-disease electronic medical records (EMR) surveillance and research system that allows family physicians, epidemiologists and researchers from across the country to better understand and manage chronic care conditions for their patients. Health information is collected from EMRs in the offices of participating primary care providers (e.g. family physicians) for the purposes of improving the quality of care for Canadians suffering from chronic and mental health conditions and three neurologic conditions including Alzheimer's and related dementias. CPCSSN makes it possible to securely collect and report on vital information from Canadians' health records to improve the way these chronic diseases and neurologic conditions are managed (http://cpcssn.ca/). Question 18 What urgent gaps related to substance use (in terms of data, surveillance, and/or research) need to be addressed in Canada? Improvements are being made in the collection of data in Canada. This is crucial to be able to assess the harms and track the trends and impact of the introduction of policy changes.12 As well, the government must continue to improve the ability of the Public Health Agency of Canada, the Canadian Institute of Health Information, the chief coroners of Canada and related agencies to collect, analyze and report data. One such program is the surveillance system in the United States called RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance system) that is “a surveillance system that collects product-and geographically-specific data on abuse, misuse, and diversion of prescription drugs.” It surveys data involving opioids including poison control centres, treatment programs, on the “illicit acquisition or distribution of prescription opioids, stimulants, and other prescription drugs of interest from entities investigating drug diversion cases,” among other opioid-related issues. The CMA has recommended that all levels of government work with one another and with health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring. As a first step, the CMA recommends the establishment of consistent national standards for prescription monitoring. Prescription Monitoring Programs (PMP) should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. PMPs should not deter physicians from using controlled medications when necessary. Further, PMPs are a valuable component in addressing the gaps related to substance use. Question 19 How can we use research tools to better identify emerging substance use issues as early as possible? See above response to question 18 - “RADARS” Government of Canada. Consultation on strengthening Canada’s approach to substance use issues. Ottawa: Health Canada; 2018. Available: https://www.canada.ca/en/health-canada/programs/consultation-strengthening-canada-approach-substance-use-issues.html (accessed 2018 Sep 5). Canadian Medical Association (CMA). Health in all policies. Ottawa: The Association; 2015 Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-10.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Early childhood development. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-03.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Canadian Medical Association Submission on Motion 315 (Income Inequality). Ottawa: The Association; 2013. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2013-07.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). CMA’s recommendations for effective poverty reduction strategies. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-04.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Bill C-2 An Act to amend the Controlled Drugs and Substances Act. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-11.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-15.pdf (accessed: 2018 Nov 26). Canadian Medical Association (CMA). Non-prescription availability of low-dose codeine products. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2018-04.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Health Canada consultation on restriction of marketing and advertising of opioids. Ottawa: The Association; 2018. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2018-13.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Joint Canadian Medical Association & Canadian Psychiatric Association Policy - Access to mental health care. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-15.pdf (accessed 2018 Nov 26). Public Safety Canada, Canadian Centre on Substance Use and Addiction. 2018 Law Enforcement Roundtable on the Opioid Crisis. Meeting Summary. Ottawa; 2018. Available: https://www.publicsafety.gc.ca/cnt/rsrcs/pblctns/lw-nfrcmnt-rndtbl-pd-crss-2018/index-en.aspx?utm_source=stakeholders&utm_medium=email&utm_campaign=opioidcrisis (accessed 2018 Nov 29). Canadian Medical Association (CMA). Study on Mental Health, Mental Illness and Addiction in Canada: Supplementary Submission to the Senate Standing Committee on Social Affairs, Science and Technology. Ottawa: The Association; 2006. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2006-01.pdf (accessed 2018 Nov 29). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Nov 2018). Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-09.pdf (accessed 2018 Nov 28). Canadian Medical Association (CMA). Ensuring equitable access to health care: Strategies for governments, health system planners, and the medical profession. Ottawa: The Association; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD14-04.pdf (accessed 2018 23 Nov). Canadian Medical Association (CMA). Submission to Advisory Panel on Healthcare Innovation. Ottawa: The Association; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-06.pdf (accessed 2018 Nov 29). Radars System. 2018. Available: https://www.radars.org/. (accessed: 2018 Nov 29). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015 Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Dec 4). Sproule B. Prescription Monitoring Programs in Canada: Best Practice and Program Review. Ottawa, ON, 2015 Canadian Centre on Substance Abuse. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Prescription-Monitoring-Programs-in-Canada-Report-2015-en.pdf (accessed 2018 Dec 4).
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Health Canada consultation on regulatory amendments regarding tramadol

https://policybase.cma.ca/en/permalink/policy13927
Date
2018-08-14
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-08-14
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's notice as published in the Canada Gazette, Part 1 for interested stakeholders to provide comments on Health Canada's intent to amend Schedule 1 to the Controlled Drugs and Substances Act (CDSA) and the Schedule to the Narcotic Control Regulations (NCR) to include tramadol, its salts, isomers and derivatives and the salts and isomers of its derivatives.1 Tramadol has been marketed in Canada since 2005 and is available only by prescription.1 The CMA is concerned that, despite tramadol being judged low-risk in terms of addiction, it is nevertheless an opioid and should be placed in the Controlled Drugs and Substances Act, under Schedule 1.2 The Canadian Institute for Health Information reports that tramadol is one of six opioids accounting for 96% of all opioid prescriptions between 2012 and 2016.3 The report noted that there was a significant increase in tramadol prescriptions and Defined Daily Doses (DDDs) in that same 2012 to 2016 timeframe that may have been due in part to a decrease in prescriptions and DDDs for codeine. Tramadol is considered a weak opioid and is used to treat "moderate pain that has not responded to first-line treatments."4 It is regarded as having a lower rate of overdose, misuse and addiction than more powerful opioids.4 However, it is not without risks. The addition of tramadol to the CDSA, Schedule 1, is important because, as with any opioid, dependence on tramadol can occur with use over prolonged periods. According to the World Health Organization "dependence to tramadol may occur when used within the recommended dose range of tramadol but especially when used at supra-therapeutic doses."5 Physical dependence is "distinct from addiction, which includes behavioural elements and harm despite continued drug use." Maintenance of patients on opioids sometimes is only to avoid withdrawal symptoms, caused by physical dependence, as opposed to being used to treat pain.6 Tramadol must be tapered under supervision from a health professional. In addition, tramadol's analgesic effect can be unpredictable depending on a person's genetic capacity to metabolize the drug. Success or failure will be predicated "on it being converted by CYP2D6 to an active metabolite, O-desmethyltramadol."7 If there is a CYP2D6 inhibitor present or if the person's genetic make-up is such that they do not metabolize the enzyme very well, "conversion can be blocked so that little or none of the metabolite is produced and little analgesic effect is achieved."7 These tramadol pathways may also be blocked which could lead to the drug being "present at higher concentrations for longer periods."7 As one expert has noted "when a doctor prescribes tramadol, he or she rolls the dice, not knowing whether the patient will get a bit of opioid, a lot of opioid or none at all."6 The risks associated with tramadol with respect to children are such that the United States Food and Drug Administration (FDA) recently recommended that tramadol (and codeine) should not be given to children under 12.8 Their concern stems from the potential for tramadol (and codeine) to "cause life-threatening breathing problems in children."9 The FDA also recommended that breast-feeding women not be given tramadol because of the potential harm to the child. As well, teens 12 to 18 should not be given the drug "if there is a history of obesity, obstructive sleep apnea, or severe lung disease."9 Further, it warned that it should not "be given to children or adolescents as a pain medication after surgery to remove the tonsils or adenoids."9 It is very important for the health and safety of Canadians that tramadol be placed on CDSA's Schedule 1. As described in the Notice of Intent for this consultation, this change will "prevent diversion of tramadol and protect Canadians from the health risks associated with unauthorized use."1 Further, pharmacists will not be able to follow verbal prescriptions and or provide refills of tramadol, and other controls outlined in the Narcotic Control Regulations within the Controlled Drugs and Substances Act.10 In conclusion, the CMA is concerned that, despite tramadol being judged low-risk in terms of addiction, it is nevertheless an opioid and carries dangers similar to its stronger counterparts. Doctors support patients in the management of acute and chronic pain, as well as addictions, and as such we have long been concerned about the harms associated with opioid use. Therefore, as part of our advocacy, the CMA supports Health Canada's intent to amend Schedule 1 to the Controlled Drugs and Substances Act (CDSA) and the Schedule to the Narcotic Control Regulations (NCR) to include tramadol, its salts, isomers and derivatives and the salts and isomers of its derivatives. By doing so it will "help dispel the perception that it's somehow safer than other opioids."6 The CMA continues to urge governments to increase access to services and treatment options for addiction and pain management, as well as harm reduction.11 1 Controlled Drugs and Substances Act: Notice to interested parties - Proposal to add tramadol to Schedule I to the Controlled Drugs and Substances Act and the Schedule to the Narcotic Control Regulations Canada Gazette, Part I, 2018 Jun 16 152(24) Available: http://www.gazette.gc.ca/rp-pr/p1/2018/2018-06-16/html/notice-avis-eng.html#ne2 (accessed 2018 Jun 25) 2 Young JWS, Juurlink DN. Five things to know about Tramadol. CMAJ May 2013 185(5) Available: http://www.cmaj.ca/content/cmaj/185/8/E352.full.pdf (accessed 2018 Jul 31) 3 Canadian Institute for Health Information. Pan-Canadian Trends in the Prescribing of Opioids, 2012 to 2016. Ottawa, ON: CIHI; 2017. 4 Kahan M, Mailis-Gagnon A, Wilson L, et al. Canadian guideline for safe and effective use of opioids for chronic noncancer pain; clinical summary for family physician. Part 1: general population. Can Fam Physician November 2011 011;57:1257-66. Available: http://www.cfp.ca/content/cfp/57/11/1257.full.pdf (accessed 2018 Jul 30) 5 World Health Organization. Tramadol Update Review Report Expert Committee on Drug Dependence. Thirty-sixth Meeting Geneva, 16-20 June 2014 Available: http://www.who.int/medicines/areas/quality_safety/6_1_Update.pdf (accessed: 2018 Aug 1) 6 Juurlink DN. Why Health Canada must reclassify tramadol as an opioid. The Globe and Mail November 27, 2017 7 Flint, A., Merali, Z., and Vaccarino, F. (Eds.). (2018). Substance use in Canada: improving quality of life: substance use and aging. Ottawa, Ont: Canadian Centre on Substance Use and Addiction. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Substance-Use-and-Aging-Report-2018-en.pdf#search=all%28aging%29 (accessed 2018 Aug 1) 8 Jin J. Risks of Codeine and Tramadol in Children. JAMA 2017;318(15):1514. doi:10.1001/jama.2017.13534 Available: https://jamanetwork.com/journals/jama/fullarticle/2657378 (accessed: 2018 Aug 2) 9 United States Food and Drug Administration. Codeine and Tramadol Can Cause Breathing Problems for Children. Consumer Update April 20, 2017 Available: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm315497.htm (accessed: 2018 Aug 14) 10 Minister of Justice. Narcotic Control Regulations C.R.C., c. 1041. Current to July 5, 2018. Last amended on May 20, 2018 Available: http://laws-lois.justice.gc.ca/PDF/C.R.C.,_c._1041.pdf (accessed: 2018 Aug 14) 11 Canadian Medical Association. Harms Associated with Opioids and Other Psychoactive Prescription Drugs. CMA Policy, 2015. Ottawa: The Association; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed: 2018 Aug 2).
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Health Canada consultation on restriction of marketing and advertising of opioids

https://policybase.cma.ca/en/permalink/policy13921
Date
2018-07-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-07-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to Health Canada in response to the publication of the Notice of Intent to restrict the marketing and advertising of opioids.1 The CMA is very concerned with the high rates of overdose deaths due to opioids2 and supports a comprehensive, multi-pronged approach to address this public health crisis.3 As part of the Government of Canada's strategy, the Minister of Health's 2017 mandate letter committed to "consult with provinces, territories, and professional regulatory bodies to introduce appropriate prescribing guidelines to curb opioid misuse, ensure prescriptions are appropriately tracked in a consistent and patient-centred way, and increase transparency in the marketing and promotion of therapies."4 Health Canada is proposing to further restrict drug manufacturers' advertising of opioids and is consulting on the scope and intent of the restrictions. The Food and Drugs Act defines advertisement as "any representation by any means for the purpose of promoting, directly or indirectly, the sale of any drug or device".5 Opioids are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. These medications have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.3 Any measures to address advertising must not restrict appropriate access. Limiting access without appropriate alternatives and careful tapering can lead to undue suffering and seeking of drugs, potentially tainted, on the illegal market. However, of great concern, opioid dispensing levels have been shown to be strongly correlated with increased mortality, morbidity and treatment admissions for substance use.6,7 Many patients were prescribed these medications and developed dependence.8 Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.9,10 However, there is evidence for pain relief in the short term but insufficient evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.11,12,13 There was also a concerted effort by industry to minimize the risk of addiction in the use of opioids for the treatment of chronic non-cancer pain. While stating that the risk of addiction was less than one percent, many studies have shown that the risk varies from 0 to 50% depending on the criteria used and sub population studied.14 Marketing significantly influences the type and amount of opioids consumed.15 Substantial tension exists between the competitive pressures that manufacturers face to expand product sales and support for limited, evidence-based use of most cost-effective available alternatives.16 Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage.17 Important contributing factors for the increase in opioid prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with patients. Prescriptions also increased due to the availability of new, highly potent opioid drugs.18,19 Addressing advertising is only one component of the issue, and significant efforts need to be made to address issues such as access to alternatives for pain management and treatment of addiction. Presently, advertising of opioids is prohibited to the public, and only permitted to health care professionals if the claims are consistent with the terms of market authorization by Health Canada. Pharmaceutical industry's marketing practices to health care practitioners "can take many forms of direct and indirect activities and incentives, including, for example, manufacturer-sponsored presentations at conferences, continuing education programs, advertisements in medical journals, and personal visits from sales representatives. It can also include use of promotional brochures, fees for research, consulting or speaking, reimbursement for travel and hospitality expenses to attend industry-sponsored events, and gifts of meals, equipment, and medical journals and texts."1 As well, industry has sponsored advocacy organizations dedicated to the treatment of pain and key opinion leaders.15,20 Studies have shown that marketing influences prescribing patterns.21 Initiatives to regulate advertising and the promotion of prescription drugs have come from industry, nongovernmental organizations and government. The pharmaceutical industry itself is voluntarily self-regulated in Canada through the Pharmaceutical Advertising Advisory Board (PAAB), pre-clearing marketing initiatives based on a Code of Advertising.22 The CMA recommends that marketing initiatives could be vetted for accuracy and truthfulness through a pre-clearance mechanism such as PAAB. Faced with multiple legal challenges in the U.S., some opioid manufacturers have limited marketing, however, such measures had not been taken in Canada. The federal government has a complaints-based system and hasn't been proactive in the regulation and monitoring of advertising and marketing of opioids. In recently published regulations amending the Food and Drug Regulations,23 the Minister of Health can require companies to develop and implement risk management plans, which include the preclearance of opioid-related materials to be provided to health care professionals. Product information prepared by manufacturers, summarizing scientific evidence on effects and setting out conditions for use, as well as promotional activities are subject to regulatory approval. The authority conferred to the Minister has the objective of allowing Health Canada to "appropriately monitor, quantify, characterize, and mitigate the risks associated with post-market use" of opioids. CMA supports such actions. As Van Zee has noted in the case of the United States, "modifications of the promotion and marketing of controlled drugs by the pharmaceutical industry and an enhanced capacity of the Food and Drug Administration to regulate and monitor such promotion can have a positive impact on public health".14 This approach would confer a similar benefit for Canada in that, if effective, could contribute to unbiased, evidence-based prescribing. There are important guidelines and standards in place, developed by physicians, to guide relationships with the pharmaceutical industry. CMA's "Guidelines for Physicians in Interactions with Industry"24 were developed as a resource tool both for physicians, medical students and residents, as well as medical organizations, to support decisions as to appropriate relationships with industry, in conjunction with CMA's Code of Ethics.25 In summary, physicians have a responsibility to ensure that their interaction with the pharmaceutical industry is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible, appropriately managing these situations when necessary. These guidelines include principles for continuing medical education and continuing professional development (CME/CPD) and are the basis for the National Standard for Support of Accredited CPD Activities, developed by the Royal College of Physicians and Surgeons of Canada (RCPSC), the College of Family Physicians of Canada (CFPC) and the Collège des médecins du Québec. According to the Standard, "the interests of organizations that provide financial and in-kind support for the development of accredited CPD activities cannot be assumed to always be congruent with the goal of addressing the educational needs of the medical profession. Therefore, it is essential that the medical profession define and assume their responsibility for setting standards that will guide the development, delivery, and evaluation of accredited CPD activities."26 Physicians must complete CPD credits to maintain their professional license, and the accreditation bodies (such as CFPC, RCPSC) have processes in place to assure that these courses are evidence-based and free from industry bias. In recognition of the importance of opioid prescribing, and the key role that physicians play in this field, the CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids. This funding could include unconditional contribution from the opioid manufacturers, to ensure independence. The CMA appreciates the role that Health Canada has had in funding evidence-based guidelines.27 This has been a key initiative, which sought to provide physicians with unbiased information. Ongoing funding to maintain their currency would be warranted. The CMA supports long overdue actions related to the restriction of the marketing of opioids and looks forward to collaboration between Health Canada and the physician community. Recommendations The CMA supports Health Canada's efforts to place significant restrictions on the ability of drug manufacturers to advertise opioids to health care practitioners. Marketing initiatives should be vetted for accuracy and truthfulness through a pre-clearance mechanism. The CMA recommends that the measures chosen to constrain advertising do not unduly restrict access to opioids for appropriate use. The CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids, and consider unconditional funding from opioid manufacturers. The CMA recommends that the government support keeping the 2017 Opioid Prescribing Guidelines current through ongoing funding. The CMA recognizes that restricting advertising is only one, overdue, measure to address the opioid crisis, and recommends that issues such as access to alternatives for pain management and addiction treatment urgently be addressed. 1 Government of Canada. Notice of intent to restrict the marketing and advertising of opioids. Ottawa: Government of Canada; 2018. Available: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/restrict-advertising-opioids.html (accessed 2018 Jul 17). 2 Public Health Agency of Canada. National report: apparent opioid-related deaths in Canada (released June 2018). Ottawa: Public Health Agency of Canada; 2018. Available: https://www.canada.ca/en/public-health/services/publications/healthy-living/national-report-apparent-opioid-related-deaths-released-june-2018.html (accessed 2018 Jul 17). 3 Canadian Medical Association. Harms associated with opioids and other psychoactive prescription drugs. Ottawa: Canadian Medical Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Jul 17). 4 Trudeau J. Minister of Health mandate letter. Ottawa: Office of the Prime Minister; 2017 Oct 4. Available: https://pm.gc.ca/eng/minister-health-mandate-letter (accessed 2018 Jul 17). 5 Government of Canada. Food and Drugs Act. Ottawa: Government of Canada; 1985. Available: http://lois-laws.justice.gc.ca/eng/acts/F-27/index.html (accessed 2018 Jul 17). 6 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf 2013;22(4):438-42. 7 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q 2011;14(1):22-4. 8 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend 2004;73(2):199-207. 9 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician 2014;17(1):E1-10. 10 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ 2011;343:d5142 DOI: 10.1136/bmj.d5142. 11 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology 2014;83:1277-84. 12 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: Findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain 2009;10:147-59. 13 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010;(1):CD006605. 14 Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-27. 15 Hamunen K, Paakkari P, Kalso E. Trends in opioid consumption in the Nordic countries 2002-2006. Eur J Pain 2009;13:954-962. 16 Alves TL, Lexchin J, Mintzes B. Medicines information and the regulation of the promotion of pharmaceuticals. Sci Eng Ethics 2018:1-26. 17 Canadian Medical Association. Optimal prescribing. Ottawa: Canadian Medical Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf (accessed 2018 Jul 17). 18 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health 2008;99(3):182-4. 19 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction 2013;109:177-81. 20 Dyer O. OxyContin maker stops marketing opioids, as report details payments to advocacy groups. BMJ 2018;360:k791. 21 Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioethics 2003;3(3):39-46. 22 Pharmaceutical Advertising Advisory Board. PAAB Code. Ottawa: PAAB; 2018. Available: http://code.paab.ca/ (accessed 2018 Jul 17). 23 Regulations Amending the Food and Drug Regulations (Opioids), SOR/2018-77. Canada Gazette, Part II 2018 May 2;152(9). Available: http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html (accessed 2018 Jul 17). 24 Canadian Medical Association. Guidelines for physicians in interactions with industry. Ottawa: Canadian Medical Association; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf (accessed 2018 Jul 17). 25 Canadian Medical Association. CMA Code of Ethics (Update 2004). Ottawa: Canadian Medical Association; 2004. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_Code_of_ethics_of_the_Canadian_Medical_Association_Update_2004_PD04-06-e.pdf (accessed 2018 Jul 17). 26 Royal College of Physicians and Surgeons of Canada. National standard for support of accredited CPD activities. Ottawa: Royal College of Physicians and Surgeons of Canada; 2017. Available: http://www.royalcollege.ca/rcsite/cpd/providers/tools-resources-accredited-cpd-providers/national-standard-accredited-cpd-activities-e (accessed 2018 Jul 17). 27 Busse JW, Craigie S, Juurlink DN, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ 2017;189:E659-66.
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Health Canada consultation on tobacco products regulations (plain and standardized appearance)

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