The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's Notice of proposed order to amend the schedule to the Tobacco Act1, from October 14, 2014, on the restriction of the use of additives.
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.
Flavoured tobacco products include candy or fruit flavoured products including cigarillos, water pipe tobacco, smokeless tobacco and blunt wraps. They come in flavours that are appealing to youth such as chocolate, mint, cherry, peach, or strawberry. Flavouring makes the tobacco products more palatable to youth and young adult smokers because they have a lower tolerance for irritation and an underdeveloped taste for tobacco smoke.2 Menthol is a long standing and common flavour used in cigarettes and is used to reduce the harshness of cigarette smoke. It is the most popular flavour among youth. Almost three out of 10 Canadian youth who smoked cigarettes in the last 30 days (29 per cent) reported smoking menthol cigarettes.3
Tobacco Use and Youth
While tobacco use has declined in Canada we must remain vigilant in our efforts to reduce smoking rates. Today 16 per cent of Canadians continue to smoke on a regular basis and physicians are particularly concerned about the smoking prevalence among young adults and youth with 20 per cent of those aged 20-24, and 11 per cent of youth aged 15-19 currently smoking on a regular basis. 4
Flavoured tobacco products, with their appeal to young Canadians are a major threat to the health and well-being of our youth. A recent report, Flavoured Tobacco Use: Evidence from Canadian Youth based on the 2012/13 Youth Smoking Survey, shows that young people are using flavoured tobacco products at high levels. Results show that 50 per cent of high school students in Canada who used tobacco products in the previous 30 days used flavoured tobacco products.5
Previous Amendments Regarding Flavouring Agents
The CMA supported efforts of the federal government in 2009 to limit the addition of flavouring agents to tobacco products through the 2010 Act to Amend the Tobacco Act. But the Act did not cover all tobacco products and it excluded menthol as a flavouring agent. Manufacturers have been able to modify the weight and packaging of their products to technically comply with the Act while they continue to market flavoured products.
It is the CMA's position that the federal government has an important role in smoking cessation and prevention among youth. The CMA supports the proposed extension of the prohibitions on the use of certain flavouring additives in relation to the manufacture and sale of little cigars to cigars weighing more than 1.4 g but less than 6 g.
The CMA remains very concerned that these amendments do not ban menthol flavouring in tobacco products. To that end, the CMA recommends that Health Canada extend its prohibition on flavouring additives to include a ban on the addition of menthol in all tobacco products.
1 Health Canada. Notice of proposed order to amend the schedule to the Tobacco Act. October 14, 2014. Accessed at: http://www.hc-sc.gc.ca/hc-ps/consult/_2014/tobacco-act-loi-tabac/index-eng.php
2 Carpenter CM, Wayne GF, Pauly JL, Koh HK, Connolly GN. New cigarette brands with flavors that appeal to youth: Tobacco marketing strategies: Tobacco industry documents reveal a deliberate strategy to add flavors known to appeal to younger people. Health Affairs 2005;24(6):1601-1610.
3 Manske SR, Rynard VL, Minaker LM. 2014 (September). Flavoured Tobacco Use among Canadian Youth: Evidence from Canada's 2012/2013 Youth Smoking Survey. Waterloo: Propel Centre for Population Health Impact, 1-18. cstads.ca/reports.
4 Canadian Tobacco Use Monitoring Survey 2012 , accessed at http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/research-recherche/stat/ctums-esutc_2012-eng.php.
5 Manske SR, Rynard VL, Minaker LM. 2014 (September). Flavoured Tobacco Use among Canadian Youth: Evidence from Canada's 2012/2013 Youth Smoking Survey. Waterloo: Propel Centre for Population Health Impact, 1-18. cstads.ca/reports.
Minaker L, Manske S, Rynard VL, Reid JL & Hammond D. Tobacco Use in Canada: Patterns and Trends, 2014 Edition - Special Supplement: Flavoured Tobacco Use. Waterloo, ON: Propel Centre for Population Health Impact, University of Waterloo.
Canadian Medical Association 2
November 10, 2014
On behalf of its more than 82,000 members and the Canadian public, CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery.
The CMA is a voluntary professional organization representing the majority of Canada's physicians and comprising 12 provincial and territorial divisions and 51 national medical organizations.
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Health Committee for its study on e-cigarettes.
Electronic cigarettes, or e-cigarettes, which replicate the act and taste of smoking, but do not contain tobacco, are growing rapidly in popularity. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid, mainly propylene glycol. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine. Flavourings are also added with the intention of boosting their appeal to young people. Issues have been identified with labelling of e-cigarettes, where upon inspection, there have been contaminants, and nicotine has been detected in products labeled without nicotine.1 Users are generally able to modify the contents of e-cigarettes, with the addition of other substances, including marijuana.
Originally most e-cigarette manufacturers were small entrepreneurial companies; now, however, all major transnational tobacco companies are also producing e-cigarettes and competing for a share in the market.
There are little data on Canadian use. In the U.S., one in five adult smokers has tried them, according to the Centers for Disease Control and Prevention2.
Current Regulatory Status
Health Canada issued a warning in 20093 about the potential dangers and the fact that e-cigarettes had not been fully evaluated for safety, quality and efficacy. The sale of e-cigarettes containing nicotine is currently illegal in Canada under the Food and Drugs Act regulations4 though they can still be purchased in the US or over the Internet. However, those that do not make any health claim and do not contain nicotine may legally be sold in Canada under the same regulation. Health Canada is considering additional regulatory measures but none have yet been introduced. Some municipal jurisdictions are also considering regulation changes.
Internationally, regulation of e-cigarettes is just beginning, and approaches vary. A few countries - such as Brazil, Norway and Singapore - have banned them outright. France plans to regulate e-cigarettes in the same way as tobacco products, and the US Food and Drug Administration is considering a similar approach. On the other hand, Britain will regulate e-cigarettes as non-prescription drugs starting in 2016.5
Current evidence is insufficient to estimate the health effects of e-cigarettes. There are both defenders and opponents, though their arguments are based largely on opinion since e-cigarettes are only beginning to undergo rigorous clinical testing.6
Proponents, including some health officials and groups, 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.7 Some believe they serve a useful purpose as a harm reduction tool or cessation aid, although marketing them as such is not permitted 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 e-cigarettes may contain other toxic ingredients such as nitrosamines, a carcinogen. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to use of tobacco by people who might otherwise have remained smoke-free.8 The use of flavouring agents and attractive packaging could entice children and youth, and survey data in some countries has shown that teens are increasingly experimenting with e-cigarettes.
There has also been a dramatic increase in cases of nicotine overdose by ingestion or through dermal contact, particularly in children.9 The number of these incidents seems to be rising in countries that monitor poisonings.
The World Health Organization recently released a report on the health impacts of electronic nicotine delivery systems (ENDS) use which incorporates the 2013 deliberations and scientific recommendations by the WHO Study Group on Tobacco Product Regulation. It concludes that "ENDS use poses serious threats to adolescents and fetuses. In addition, it increases exposure of non-smokers and bystanders to nicotine and a number of toxicants." The report says that it is possibly less toxic for the smoker than conventional cigarettes but it is unknown by how much.10 This report suggests that governments should have the following regulatory objectives:
* impede the promotion and uptake of e-cigarettes with nicotine by non-smokers, pregnant women and youth;
* minimize potential health risks to e-cigarette users and non-users;
* prohibit unproven health claims from being made about e-cigarettes; and
* protect existing tobacco-control efforts from commercial and other vested interests of the tobacco industry.11
Given the absence of solid evidence of harms or benefits, CMA recommends that:
1. E-cigarettes containing nicotine should not be authorized for sale in Canada.
2. The sale of all e-cigarettes should be prohibited to Canadians younger than the minimum age for tobacco consumption in their province or territory.
3. Smoke-free policies should be expanded to include a ban on the use of e-cigarettes in areas where smoking is prohibited.
4. Research on the potential harms and benefits of electronic cigarette use should be supported.
1 Institut national de santé publique du Québec (INSPQ). (Mai 2013). La cigarette électronique: état de situation. Available : http://www.inspq.qc.ca/pdf/publications/1691_CigarElectro_EtatSituation.pdf
2 Centers for Disease Control and Prevention. About one in five U.S. adult cigarette smokers have tried an electronic cigarette. Centers for Disease Control and Prevention Press Release. February 28, 2013 Available: http://www.cdc.gov/media/releases/2013/p0228_electronic_cigarettes.html (accessed October 31, 2014)
3 Health Canada. Health Canada Advises Canadians Not to Use Electronic Cigarettes (archived). Available: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2009/13373a-eng.php (accessed October 31, 2014)
4 Health Canada. Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada. Available: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/notice_avis_e-cig-eng.php (accessed October 31, 2014)
5 Kelland, K. & Hirschler, B. Insight - No smoke, plenty of fire fuels e-cigarettes. Reuters. June 13, 2013. http://uk.reuters.com/article/2013/06/13/uk-ecigarettes-insight-idUKBRE95C0F720130613 (accessed October 31, 2014)
6 Non-Smokers Rights Association. Product Regulation: The Buzz on E-Cigarettes. Available: http://www.nsra-adnf.ca/cms/page1385.cfm (accessed October 31, 2014)
7 Weeks, C. Could e-cigarettes save smokers' lives? Some health advocates think so. The Globe and Mail April 29, 2013. Retrieved from http://www.theglobeandmail.com/life/health-and-fitness/health/could-e-cigarettes-save-smokers-lives-some-health-advocates-think-so/article11583353/?cmpid=rss1
8 Toronto Public Health. E-cigarettes in Toronto. Staff report to the Toronto Board of Health. August 1, 2014. Available: http://www.toronto.ca/legdocs/mmis/2014/hl/bgrd/backgroundfile-72510.pdf (accessed October 31, 2014).
9 Centers for Disease Control and Prevention. Notes from the Field: Calls to Poison Centers for Exposures to Electronic Cigarettes - United States, September 2010-February 2014. Morbidity and Mortality Weekly Report, 63(13): 292-293. April 4, 2014. Available: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6313a4.htm?s_cid=mm6313a4_w (accessed October 31, 2014).
10 World Health Organization. Electronic nicotine delivery systems. Conference of the Parties to the WHO Framework Convention on Tobacco Control. Sixth session Moscow, Russian Federation, 13-18 October 2014. Provisional agenda item 4.4.2. Available: http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf?ua=1
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study of Bill C-31 the Budget Implementation Bill, in particular the section concerned with tobacco taxation.
Tobacco use is still the number one cause of preventable disease and death in Canada, claiming 37,000 or more Canadians' lives every year. It is a major risk factor for the chronic diseases that burden Canadians and their health care system, and it costs the country over $17 billion per year for medical treatment, social assistance, lost productivity and reduced quality of life. While progress has been made in lowering smoking rates and changing attitudes towards smoking much work remains - nearly 4.6 million Canadians still smoke.
Physicians have been warning of the dangers of smoking for over 50 years. Canada's doctors treat the harmful effects of tobacco use every day in their offices, and see first-hand the devastation it causes to patients and their families. The CMA has consistently recommended tough legislative and regulatory measures to control tobacco use. Comprehensive tobacco control efforts must include legislation, regulation, together with public education and smoking cessation programs.
Impact of Price on Smoking
Research has shown that an increase in cigarette prices has an impact on reducing both the number of cigarettes smoked and smoking prevalence rates. Permanent, inflation-adjusted increases in cigarette prices, which could be achieved by increasing cigarette taxes, will contribute to reducing cigarette smoking rates in Canada. Youth are up to three times more sensitive to price than adults, with a 10 per cent price increase estimated to reduce youth smoking prevalence by 5 per cent or more and also to reduce cigarette consumption among continuing young smokersi
With the current smoking rate of 20 per cent among Canadian young adults, higher than the smoking rate for the rest of Canada which is 16 per cent, additional initiatives to reduce smoking in this population are urgently required.
Research has also shown that persons of low socioeconomic status are more responsive to price than the general population but it is less clear on the impact on long-term heavy smokers and aboriginal smokersii
Estimates imply that the long-run effect of a permanent price increase is approximately double the short-run impact. Thus, a 10 per cent increase in cigarette price is expected to reduce the prevalence of cigarette smoking by approximately 8 per cent in the long run.iii
Excise Tax Adjustments
The current proposal to adjust the domestic rate of excise duty on tobacco products to account for inflation and eliminate the preferential excise duty treatment of tobacco products available through duty free markets will increase the cost of cigarettes and other tobacco products like fine-cut tobacco for use in roll-your-own cigarettes, chewing tobacco and cigars. For example, the government has stated that the excise "duty free" rate for cigarettes will increase from $15.00 to $21.03 per carton of 200 cigarettes. The commitment to make an automatic inflation adjustment every 5 years is a means to ensure that tobacco tax rates retain their real value in the future.
The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. This proposal represents a positive step toward the development of a federal integrated tobacco tax strategy for both domestic and imported products, and speaks to the importance of the relationship between health policy and tax policy.
There is a risk that a rise in tobacco taxes with the resultant rise in the cost of smoking will lead to an increase in the smuggling of lower-cost cigarettes. To avoid potential unintended consequences, such as smuggling, the CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders. In addition, all levels of government should take the most stringent measures possible to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions.
Investing Tobacco Taxes in Health Promotion
The Minister of Finance has estimated that increasing tobacco taxes, including excise taxes on tobacco products, will increase federal tax revenues by $96 million in 2013-14, 685 million in 2014-15 and $660 million in 2015-16.
The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy.
The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The federal government should place a high priority for funding tobacco prevention and evidence-based cessation programs for young Canadians as early as primary school age. For these, substantial and sustainable funding is required.
A portion of these tobacco taxes should also be used to defray the costs of tobacco interventions, including physician-based clinical tobacco intervention services and up to 12 weeks stop-smoking medication annually per smoker. We encourage the government to focus their efforts on "high-risk" and "hard-to-reach" populations.
For Canada's Tobacco Control strategy to continue to reduce smoking rates in Canada we must continue to assess evolving best practices in smoking cessation programs, and conduct research on the impact of policies on high risk populations.
The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. This evidence comes from surveying Canadians on smoking behavior, conducting research and evaluation, and keeping track of trends and emerging issues.
The CMA supports increasing the excise duty on tobacco products. An increase in the excise duty tax on tobacco products is long overdue and a welcome contribution to efforts already underway to further reduce smoking rates in Canada.
Summary of Recommendations
The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products.
The CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders to avoid potential unintended consequences, such as smuggling.
The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy.
The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use.
The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use.
i The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14
Frank J. Chaloupka, Rosalie Liccardo Pacula
ii Effects of Tobacco Taxation and Pricing on Smoking Behavior in High Risk Populations: A Knowledge Synthesis
Pearl Bader, David Boisclair, Roberta Ferrence
Int J Environ Res Public Health. 2011 November; 8(11): 4118-4139. Published online 2011 October 26. doi: 10.3390/ijerph8114118
iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14
Frank J. Chaloupka, Rosalie Liccardo Pacula
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada.
The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential.
The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse.
A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure."
Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing
Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA
Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription
Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the
consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E
3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper
resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably.
National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa:
Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf
prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered.
The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5
Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards.
The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected.
As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9.
Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the
Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance.
Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6
Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23.
Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol.
Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9.
The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved
progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet.
There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects.
The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management.
Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential.
The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations.
The CMA recommends that:
1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders.
2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations.
3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages.
4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects.
5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths.
6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.