The Canadian Medical Association (CMA) is pleased to provide its comments with respect to the Government of Canada's consultation on the Proposed Excise Duty Framework for Cannabis Products published November 10.1
In the move towards the legalization and regulation of cannabis, there are many economic interests at play; private corporations and different levels of government stand to benefit greatly with sales and considerable tax revenue.2 It is essential that the federal and provincial/territorial governments be held accountable to the public health and safety objectives set out for the new regime for legal access to cannabis, particularly that of protecting children and youth.3 It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls.
Final pricing must be such as to discourage the illegal production and trafficking of cannabis. However, a balance must be found with the use of taxation and pricing levers to discourage use. Revenues need to be clearly earmarked to cover the health and social costs of legalization. In some U.S. jurisdictions, for example, some of the revenue is directed to recovering the costs of regulatory programs as well as in substance use treatment programs, and for social programs.
Most of the future tax revenues should be redistributed to the provinces and territories. This is because they have jurisdiction over services that will likely feel the impact with legalization, such as health care, education, social and other services, as well as enforcement of legislation and regulations. A public health approach to legalization will emphasize prevention, education and treatment initiatives which require adequate and reliable funding. It will also require strong surveillance and monitoring activities to adjust measures should unintended harms be detected. Resources need to be promptly available to address potential negative impacts.
CMA recommends that the revenue resulting from the taxation of cannabis production and sales be earmarked to address health and social harms of cannabis use and its commercialization, in line with a public health approach to the legalization of cannabis.
The proposal states that "Any cannabis products sold under the proposed Cannabis Act for medical purposes will be subject to the duty rates and conditions of the excise duty framework, which will become applicable as per the transitional rules (...) Cannabis products that are produced by an individual (or a designated person) for the individual's own medical purposes in accordance with the proposed Cannabis Act will not be subject to the excise duty. Seeds and seedlings used in this production will be subject to duty."1
The CMA is supportive of similar taxation treatment of cannabis products, regardless of whether they are used for medical or non-medical purposes.
The CMA has long called for more research to better understand potential therapeutic indications of cannabis, as well as its risks.4 5 Physicians recognize that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with cannabis used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency, interactions with medications and adverse effects. Health Canada does not approve of cannabis as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical. It is important that there be support for cannabis research in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol(r)), nabilone (Cesamet(r)) and THC/CBD (Sativex(r)).
The experience of legalization for non-medical use in Colorado and Washington has shown that two separate regimes with distinct regulations can be very difficult to enforce given the different standards.6 A lower tax rate on cannabis for medical use could potentially provide an incentive for people to seek a medical authorization, and that was observed initially in Colorado.7
The CMA recommends that the same tax rates be applied to the production and sales of both the medical and the non-medical use of cannabis products.
The move towards the legalization and regulation of cannabis will require a balanced approach to discourage the illegal production and trafficking of cannabis while also using taxation and pricing levers to discourage use. Much of the revenues raised should be redistributed to the provinces and territories to enable them to cover the health and social costs of legalization.
A public health approach to legalization will emphasize prevention, education, treatment and surveillance initiatives which requires adequate and reliable funding.
1 Department of Finance Canada. Proposed excise duty framework for cannabis products. Ottawa: Department of Finance Canada; 2017. Available: http://www.fin.gc.ca/n17/data/17-114_1-eng.asp (accessed 2017 Dec 05).
2 Sen A, Wyonch R. Don't (over) tax that joint, my friend. Intelligence MEMOS. Ottawa: CD Howe Institute; 2017 Jul 19. Available: https://www.cdhowe.org/sites/default/files/blog_Anindya%20and%20Rosalie_0719.pdf (accessed 2017 Dec 06).
3 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed 2017 Dec 05).
4 Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/cannabis.pdf (accessed 2017 Dec 05).
5 Canadian Medical Association (CMA). Medical Marijuana. CMA Policy. Ottawa: CMA; 2011. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD11-02-e.pdf (accessed 2017 Dec 05).
6 Canadian Centre on Substance Use and Addiction (CCSA). Cannabis regulation: Lessons learned in Colorado and Washington State. Ottawa: CCSA; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2017 Dec 05).
7 Office of the Parliamentary Budget Officer. Legalized cannabis: Fiscal considerations. Ottawa: Office of the Parliamentary Budget Officer; 2016. Available: http://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2016/Legalized%20Cannabis/Legalized%20Canabis%20Fiscal%20Considerations_EN.pdf (accessed 2017 Dec 05).
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).
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The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products under the authority of the Tobacco and Vaping Products Act (TVPA).
Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes.
This brief will address the two main issues outlined in the Notice of Intent: the placement of advertising and health warnings.
Placement of Advertising
The CMA’s approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence.
In our April 2017 submission on Bill S-5 to the Senate Standing Committee on Social Affairs, Science and Technology we recommended that the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. This would include the same approach to plain and standardized packaging regulations under consideration for tobacco products.2,
The CMA is concerned that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. It is from a public health perspective that the CMA is calling for all vaping advertising to be strictly limited. The CMA supports the provisions proposed for point-of-sale information. The material offered will need to have the health warnings included in this Notice of Intent.
However, the sections of the proposed regulations most problematic to the CMA are those encompassing public places, broadcast media, and the publications areas. Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.2 The advertisements permitted currently seem to have managed to find their way to youth, even if they are not directed at them, as claimed. A report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.” Social media provides an easy means of promoting vaping products and techniques, especially to youth.21 A US study found that the landscape is “being dominated by pro-vaping messages disseminated by the vaping industry and vaping proponents, whereas the uncertainty surrounding e-cigarette regulation expressed within the public health field appears not to be reflected in ongoing social media dialogues.” The authors recommended that “real-time monitoring and surveillance of how these devices are discussed, promoted, and used on social media is necessary in conjunction with evidence published in academic journals.”6
The need to address the issue of advertising around vaping is growing more urgent. Vaping is becoming more popular and more attractive to Canadian youth, especially with the arrival of more high-tech versions of electronic cigarettes such as the pod-based JUUL™. , A similar trend has been observed in the United States where a recent study indicated that “use by adolescents and young adults of newer types of e-cigarettes such as pod-based systems is increasing rapidly.”
JUUL™ entered the US market in 2015 “with a novel chemistry (nicotine salts) enabling higher concentrations in a limited aerosol plume.” JUUL’s™ nicotine levels contained 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods. Some of JUUL’s™ competition have pods containing even higher levels (6% and 7%).10 The nicotine salts are “less harsh and less bitter, making e-liquids more palatable despite higher nicotine levels.”10 It has been noted by researchers that “among adolescents and young adults who use them, pod-based e-cigarettes are synonymous with the brand-name JUUL™ and use is termed “juuling,” whereas “vaping” has typically been used by youths to refer to using all other types of e-cigarettes.”9
The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.10, The purpose in doing so is because “smoking is not a natural behavior, like eating or drinking, the manufacturers of these devices commonly add flavoring to the liquid from which the nicotine aerosol is generated, to make the initial exposures more pleasurable. The flavoring enhances the appeal to first-time users — especially teenagers.” The CMA and other expert groups would prefer to see flavours banned to reduce the attractiveness of vaping as much as possible.2, It is very important that the pod-based systems are cited specifically to ensure they are included under the new advertising regulations for all vaping products.
Youth vaping has reached the point where the US Food and Drug Administration referred to it as an “epidemic,” calling it “one of the biggest public health challenges currently facing the FDA.” Durham Region Health Department, using data from the Ontario Student Drug Use and Health Survey conducted by CAMH and administered by the Institute for Social Research, York University, noted that 17% of high school students in that region had used an electronic cigarette in the past year (2016-17), numbers that are similar for the rest of Ontario. In the United States, a survey indicated that, among high school students, “current e-cigarette use increased from 1.5% (220,000 students) in 2011 to 20.8% (3.05 million students) in 2018;” between 2017 and 2018 alone it rose 78% (from 11.7% to 20.8%).
Concern is growing across Canada among educators seeing a rise in the number of youths turning to vaping. , , The problem has reached the point where a school official resorted to removing the doors from the washrooms to “crack down” on vaping in the school. Youth themselves are aware of the increasing problem; many are turning to YouTube to learn “vape tricks” such as making smoke rings. Some refer to the practice of vaping as “the nic;” as a University of Ottawa student noted “They call it getting light-headed. Sometimes it's cool.”
As the Canadian Paediatric Society noted in 2015, efforts to “denormalize tobacco smoking in society and historic reductions in tobacco consumption may be undermined by this new ‘gateway’ product to nicotine dependency.” , Decades of effort to reduce the incidence of smoking are in danger of being reversed. A growing body of evidence indicates that vaping can be considered the prime suspect. A Canadian study provides “strong evidence” that use of electronic cigarettes among youth is leading them to the consumption of combustible tobacco products. In a similar vein, a “large nationally representative study of US youths supports the view that e-cigarettes represent a catalyst for cigarette initiation among youths.” Granting vaping manufacturers scope to advertise will likely exacerbate this problem.
Health Warnings
The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages.2,3 We support the proposed warning labels being placed on all vaping products. The need for such warnings is important as there is still much that is not known about the effects vaping can have on the human body.
Substances that have been identified in e-cigarette liquids and aerosols include “nicotine, solvent carriers (PG and glycerol), tobacco-specific nitrosamines (TSNAs), aldehydes, metals, volatile organic compounds (VOCs), phenolic compounds, polycyclic aromatic hydrocarbons (PAHs), flavorings, tobacco alkaloids, and drugs.” Researchers have noted that there is a “striking diversity of the flavorings in e-cigarette liquids, (and that) the effects on health of the aerosol constituents produced by these flavorings are unknown.”
A US study found “evidence that using combusted tobacco cigarettes alone or in combination with e-cigarettes is associated with higher concentrations of potentially harmful tobacco constituents in comparison with using e-cigarettes alone.” Some researchers have found that there is “significant potential for serious lung toxicity from e-cig(arette) use.” ,
Another recent US study indicates that “adults who report puffing e-cigarettes, or vaping, are significantly more likely to have a heart attack, coronary artery disease and depression compared with those who don’t use them or any tobacco products.” Further, it was found that “compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke.”32
The need for parents to be educated on the impact of vaping on children is also very important. A study examining how smoke-free and vape-free home and car policies vary for parents who are dual users of cigarettes and e-cigarettes, who only smoke cigarettes, or who only use e-cigarettes demonstrated that these parents may perceive e-cigarette aerosol as safe for children. It noted that “dual users were less likely than cigarette-only smokers to report various child-protective measures inside homes and cars.”33
Recommendations
1. The CMA calls for all vaping advertising to be strictly limited. The restrictions on the marketing and promotion of vaping products and devices should be the same as those for tobacco products.
2. The CMA recommends that vaping advertisements should not be permitted in any public places, broadcast media, and in publications of any type, with no exceptions.
3. The CMA supports the provisions proposed in this Notice of Intent for point-of-sale information. This should include health warnings.
4. The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages. We support the proposed warning labels being placed on all vaping products.
5. The CMA recommends more research into the health effects of vaping as well as on the components of the vaping liquids.
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McCausland K, Maycock B, Leaver T, Jancey J. The Messages Presented in Electronic Cigarette–Related Social Media Promotions and Discussion: Scoping Review J Med Internet Res 2019;21(2):e11953 Available: https://www.jmir.org/2019/2/e11953/ (accessed 2019 Mar 14)
Glauser W. New vaping products with techy allure exploding in popularity among youth. CMAJ 2019 February 11;191:E172-3. doi: 10.1503/cmaj.109-5710 Available: http://www.cmaj.ca/content/191/6/E172 (accessed 2019 Mar 1)
Crowe K. Canada's 'wicked' debate over vaping CBC News February 2, 2019 Available https://www.cbc.ca/news/health/vaping-juul-vype-health-canada-cigarette-smoking-nicotine-addiction-1.5003164 (accessed 2019 Mar 8)
McKelvey K et al. Adolescents’ and Young Adults’ Use and Perceptions of Pod-Based Electronic Cigarettes. JAMA Network Open. 2018;1(6):e183535. doi:10.1001/jamanetworkopen.2018.3535 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2707425 (accessed 2019 Mar 1)
Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. doi:10.1136/tobaccocontrol-2018-054796 Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 Mar 12)
Reichardt EM., Guichon J. Vaping is an urgent threat to public health The Conversation March 13, 2019 Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 Mar 14)
Drazen JM., Morrissey S., Campion, EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019; 380:679-680 Available: https://www.nejm.org/doi/full/10.1056/NEJMe1900484 (accessed 2019 Mar 13)
Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there CBC News November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 Mar 13)
Food and Drug Administration Statement. Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use Media Release February 11, 2019 Available: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631112.htm (accessed 2019 Mar 11)
Durham Region Health Department Students’ use of e-cigarettes in the past year, 2016-2017 Quick Facts December 2018 Available https://www.durham.ca/en/health-and-wellness/resources/Documents/HealthInformationServices/HealthStatisticsReports/E-cigaretteAlternativeSmokingDeviceStudents-QF.pdf (accessed 2019 Mar 11)
Cullen KA et al. Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students — United States, 2011–2018 Morbidity and Mortality Weekly Report November 16, 2018 Vol. 67 No. 45 Available: https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm (accessed 2019 Mar 13)
Munro N. Vaping on the rise in Nova Scotia high schools Halifax Chronicle Herald March 5, 2019 Available: https://www.thechronicleherald.ca/news/local/vaping-on-the-rise-in-nova-scotia-high-schools-289761/ (accessed 2019 Mar 11)
Soloducha A. Is your child vaping? Regina Catholic Schools educating parents as trend continues to rise CBC News March 1, 2019 Available https://www.cbc.ca/news/canada/saskatchewan/regins-catholic-schools-vaping-education-1.5039717 (accessed 2019 Mar 11)
Emde W. Growth of vaping labelled ‘crisis’ in Vernon. Kelowna Daily Courier Available http://www.kelownadailycourier.ca/life/article_253d6404-4168-11e9-934f-7b6df68fb0fd.html (accessed 2019 Mar 11)
Lathem C. Ottawa principal's solution to student vaping: Remove the washroom doors. CTV News January 9, 2019 Available https://www.ctvnews.ca/canada/ottawa-principal-s-solution-to-student-vaping-remove-the-washroom-doors-1.4246317 (accessed 2019 Mar 11))
Calioa D. Vaping an 'epidemic,' Ottawa high school student says CBC News November 27, 2018 Available https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 Mar 11)
Schnurr J. New data is showing a worrisome trend about vaping and smoking among teens CTV News January 18, 2019 Available https://ottawa.ctvnews.ca/new-data-is-showing-a-worrisome-trend-about-vaping-and-smoking-among-teens-1.4260008 (accessed 2019 Mar 11)
Stanwick R. E-cigarettes: Are we renormalizing public smoking? Reversing five decades of tobacco control and revitalizing nicotine dependency in children and youth in Canada Policy Statement Canadian Paediatric Society March 6, 2015 (Reaffirmed February 28, 2018) Available: https://www.cps.ca/en/documents/position/e-cigarettes (accessed 2019 Mar 12)
Fairchild AL., Bayer R., Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco
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Hammond d. et al. Electronic cigarette use and smoking initiation among youth: a longitudinal cohort study. CMAJ October 30, 2017 189 (43) E1328-E1336; Available: http://www.cmaj.ca/content/189/43/E1328 (accessed 2019 Mar 1)
Berry KM et al. Association of Electronic Cigarette Use With Subsequent Initiation of Tobacco Cigarettes in US Youths JAMA Network Open. 2019;2(2):e187794. doi:10.1001/jamanetworkopen.2018.7794 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723425?resultClick=3 (accessed 2019 Mar 12)
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Dinakar, C., O’Connor GT. The Health Effects of Electronic Cigarettes. N Engl J Med 2016;375:1372-81 Available: https://www.nejm.org/doi/full/10.1056/NEJMra1502466 (accessed 2019 Mar 13)
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American College of Cardiology. E-Cigarettes Linked to Heart Attacks, Coronary Artery Disease and Depression. Media Release March 7, 2019 Available: https://www.acc.org/about-acc/press-releases/2019/03/07/10/03/ecigarettes-linked-to-heart-attacks-coronary-artery-disease-and-depression (accessed 2019 Mar 13)
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The Canadian Medical Association (CMA) is pleased to make this submission in response to the consultation led by the federal Task Force on Marijuana Legalization and Regulation, which has the objective of providing advice to the government on the design of a new framework for marijuana for non-medical, or recreational, purposes.
On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury 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 has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care.
The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations.
The Government of Canada has made a commitment to legalize, strictly regulate and restrict access to marijuana in response to the high rates of marijuana use among Canadians, particularly youtha 1 2, despite its current illegal status. The existing approach to drugs has resulted in high rates of criminal records for non-violent drug offences each yearb 3, affecting disadvantaged groups disproportionately. Organized crime is supported by these high levels of use. This situation has resulted in considerable harm to society.
a Marijuana is the most commonly used illegal substance in Canada. 43% of Canadians claim to have used marijuana at some point in their life, despite almost a century of prohibition. Canadian youth has the highest rate of marijuana use among 29 developed countries. Almost a quarter of the population aged 15 to 24 years reported past-year use.
b According to a Stats Canada report, there were 73 thousand marijuana-related criminal offences (67% of all police-reported drug offences) in 2013.
1 Rotermann M, Langlois, K. Prevalence and correlates of marijuana use in Canada, 2012. Health Reports. 2015 Apr;26(4):10-5. Statistics Canada Catalogue no. 82-003-X. Available: http://www.statcan.gc.ca/pub/82-003-x/2015004/article/14158-eng.pdf (accessed August 12, 2016).
2 UNICEF Office of Research. Child Well-being in Rich Countries: A Comparative overview. Innocenti Report Card 11. Florence: UNICEF Office of Research; 2013. Available: https://www.unicef-irc.org/publications/pdf/rc11_eng.pdf (accessed August 12, 2016).
3 Cotter A, Greenland J, Karam M. Drug-Related Offences in Canada, 2013. Juristat. 2015 Jun 25;1-38. Catalogue no. 85-002-X. Available: http://www.statcan.gc.ca/pub/85-002-x/2015001/article/14201-eng.pdf (accessed 2016 Aug 11).
4 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed July 25, 2016).
5 Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana. CMA Submission to the House of Commons Standing Committee on Health. Ottawa: Canadian Medical Association; 2014. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2016 Aug 12).
Public opinion in Canada and internationally has risen steadily in support of the removal of criminal sanctions for simple marijuana possession, as well as for the legalization and regulation of marijuana.
The federal Task Force has developed a discussion paper, Toward the Legalization, Regulation and Restriction of Access to Marijuana4, which includes the following objectives for the new regime for legal access to marijuana:
Protect young Canadians by keeping marijuana out of the hands of children and youth;
Keep profits out of the hands of criminals, particularly organized crime;
Reduce the burdens on police and the justice system associated with simple possession of marijuana offences;
Prevent Canadians from entering the criminal justice system and receiving criminal records for simple marijuana possession offences;
Protect public health and safety by strengthening, where appropriate, laws and enforcement measures that deter and punish more serious marijuana offences, particularly selling and distributing to children and youth, selling outside of the regulatory framework, and operating a motor vehicle while under the influence of marijuana;
Ensure Canadians are well-informed through sustained and appropriate public health campaigns, and, for youth in particular, ensure that risks are understood;
Establish and enforce a system of strict production, distribution and sales, taking a public health approach, with regulation of quality and safety (e.g., child-proof packaging, warning labels), restriction of access, and application of taxes, with programmatic support for addiction treatment, mental health support and education programs;
Continue to provide access to quality-controlled marijuana for medical purposes consistent with federal policy and Court decisions; and
Conduct ongoing data collection, including gathering baseline data, to monitor the impact of the new framework.
Context
The CMA has longstanding concerns about the health risks associated with consuming marijuana, particularly in its smoked form.5 6 Children and youth are especially at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development.
6 Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: Canadian Medical Association; 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2016 Aug 16).
7 Volkow ND, Baler RD, Compton WM, Weiss SR. Adverse health effects of marijuana use. N Engl J Med. 2014 Jun 5;370(23):2219–2227. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4827335/pdf/nihms762992.pdf (accessed 2016 Aug 15).
8 Wilkinson ST, Yarnell S, Radhakrishnan R, Ball SA, D'Souza DC. Marijuana Legalization: Impact on Physicians and Public Health. Annu Rev Med. 2016 Jan 14;67:453-466. doi: http://dx.doi.org/10.1146/annurev-med-050214-013454. (accessed 2016 Aug 12).
9 World Health Organization (WHO). Management of substance abuse: Cannabis. Geneva: World Health Organization; 2016. Available: http://www.who.int/substance_abuse/facts/cannabis/en/ (accessed 2016 Aug 16).
10 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. The Lancet, 2009 Oct 23;374(9698):1383-91. doi: http://dx.doi.org/10.1016/S0140-6736(09)61037-0. (accessed 2016 Aug 12).
11 Statistics Canada. Canadian Community Health Survey – Mental Health, 2012. The Daily. Ottawa: Statistics Canada; 2013 Sep 18. Component of Statistics Canada catalogue no. 11-001-X. p. 1-2. Available: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2016 Aug 12).
12 Shenfeld A. Growing Their Own Revenue: The Fiscal Impacts of Cannabis Legalization. Economic Insights. Toronto: CIBC World Markets Inc.; 2016 Jan 28. p. 7-8. Available: http://research.cibcwm.com/economic_public/download/eijan16.pdf (accessed 2016 Aug 11).
13 Canadian Centre on Substance Abuse (CCSA). Cannabis Regulation: Lessons Learned In Colorado and Washington State. Ottawa: Canadian Centre on Substance Abuse, 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2016 Aug 15).
14 Canadian Centre on Substance Abuse (CCSA). Marijuana for Non-Therapeutic Purposes: Policy Considerations. Ottawa: Canadian Centre on Substance Abuse, 2014. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Non-Therapeutic-Marijuana-Policy-Brief-2014-en.pdf (accessed 2016 Aug 15).
15 Retail Marijuana Public Health Advisory Committee. Monitoring Health Concerns Related to Marijuana in Colorado: 2014. Denver (CO): Colorado Department of Public Health and Environment; 2015. Available: http://www2.cde.state.co.us/artemis/hemonos/he1282m332015internet/he1282m332015internet01.pdf (accessed 2016 Aug 16).
16 Blue Ribbon Commission on Marijuana Policy. Pathways Report: Policy Options for Regulating Marijuana in California. Denver (CO): Blue Ribbon Commission on Marijuana Policy; 2015. Available: https://www.safeandsmartpolicy.org/wp-content/uploads/2015/07/BRCPathwaysReport.pdf (accessed 2016 Aug 15).
17 Walsh J, Ramsey G. Uruguay’s Drug Policy: Major Innovations, Major Challenges. Washington (DC): Brookings Institution, Washington Office on Latin America; 2015. Available: https://www.brookings.edu/wp-content/uploads/2016/07/Walsh-Uruguay-final.pdf (accessed 2016 Aug 15).
18 Centre for Addiction and Mental Health (CAMH). Cannabis Policy Framework. Toronto: Centre for Addiction and Mental Health; 2014. Available: http://www.camh.ca/en/hospital/about_camh/influencing_public_policy/documents/camhcannabispolicyframework.pdf (accessed 2016 Aug 10).
Our understanding of the health effects of marijuana continues to evolve. c 7 8 9 Marijuana use is linked to several adverse health outcomes, including addiction, cardiovascular and pulmonary effects (e.g., chronic bronchitis), mental illness, and other problems, including cognitive impairment and reduced educational attainment. There seems to be an increased risk of chronic psychosis disorders, including schizophrenia, in persons with a predisposition to such disorders. The use of high potency products, higher frequency of use and early initiation are predictors of worse health outcomes.
c Unlike pharmaceuticals, marijuana is a complex combination of more than 100 different chemicals. The main psychoactive component is delta-9-tetrahydrocannabinol (THC), but other components, such as cannabidiol (CBD), also act on the central nervous system and may modify the effects of THC. The concentration of these compounds can vary substantially, making it difficult to characterize the specific positive or negative health effects of marijuana, especially in uncontrolled and epidemiological studies. As well, the average content of THC in marijuana has increased substantially in the last 30 years. For these and other reasons, research and attribution of harm and benefit are challenging.
d Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine.
e Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs.
f Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs.
The lifetime risk of dependence to marijuana is estimated at about 9%d, increasing to almost 17% in those who initiate use in adolescence.10 In 2012, about 1.3% of people aged 15 and over met the criteria for marijuana abusee or dependencef – double that of any other drugs – due to the high prevalence of marijuana use. 11
Another area of great concern is that of impairment and the operation of vehicles, as well as the performing of work in an unsafe manner. There is an increased risk of motor vehicle collisions up to 6 hours after use, depending on method of use, dose and tolerance. As well, experience in the U.S. and even in Canada has shown that there can be an increased risk of unintentional overdoses in children due to marijuana edibles.
The CMA’s overarching recommendation to the federal government is that the government must take a broad public health policy approach to address the legalization and regulation of marijuana for non-medical use. A public health approach would place an increased focus on: preventing drug abuse and dependence; the availability of assessment, counselling and treatment services for those who wish to stop using; and harm reduction to increase the safety for those who are using.
This approach seeks to ensure that the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation. Monitoring, surveillance and research of marijuana use are essential to better understand the short and long term harms as well as to develop policy options to address prevention, treatment, harm reduction and enforcement.
There are huge economic pressures at play that need to be considered in a new regime and it is essential that public health objectives be central to the process of legalization and regulation. A recent report12
estimates that it could create a $10 billion a year industry in Canada, including production and distribution. As well, legalizing marijuana will bring in considerable tax revenue, and governments could collect as much as 50% or more of that if the rate of taxation is high, as in the ‘sin’ tax on the sale of alcohol and tobacco. As well, legalization could also lead to substantial savings in enforcement and incarceration. Given these pressures by private corporations, governments and other lobby groups, it is essential that the federal and provincial/territorial governments be held accountable to public health objectives of decreasing harms of marijuana use, particularly in children and youth.
The CMA’s submission does not address the question of whether marijuana should be legal; the current federal government has already made it clear that this is their intent. Instead, this submission focuses on specific recommendations from physicians as they apply to the regulatory framework, with the objective of protecting individual and public health. It is based on input from CMA’s members, discussions with key stakeholders and experts from specialty societies, a review of reports on the experience in jurisdictions that have legalized marijuana for non-medical use, such as Colorado, Washington and Uruguay13 14 15 16 17, as well as expert literature18 19.
19 George T, Vaccarino F. (eds.). Substance abuse in Canada: The effects of cannabis use during adolescence. Ottawa: Canadian Centre on Substance Abuse; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Effects-of-Cannabis-Use-during-Adolescence-Report-2015-en.pdf (accessed 2016 Aug 16).
20 Centers for Disease Control and Prevention (CDC). Behavioral Risk Factor Surveillance System (BRFSS) Survey. Atlanta (GA): Centers for Disease Control and Prevention; 2016. Available: http://www.cdc.gov/brfss/ (accessed 2016 Aug 10).
21 Rocky Mountain High Intensity Drug Trafficking Area (RMHIDTA). Legalization of Marijuana in Colorado. The Impact. 2014 Aug;2:1-166. Available: http://www.rmhidta.org/html/august%202014%20legalization%20of%20mj%20in%20colorado%20the%20impact.pdf (accessed 2016 Aug 15).
22 Monte AA, Zane RD, Heard KJ. The implications of marijuana legalization in Colorado. JAMA. 2015;313(3):241-42. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/pdf/nihms679104.pdf (accessed 2016 Aug 15).
23 Retail Marijuana Public Health Advisory Committee. Monitoring Health Concerns Related to Marijuana in Colorado: 2014. Denver (CO): Colorado Department of Public Health and Environment; 2015. Available: http://www2.cde.state.co.us/artemis/hemonos/he1282m332015internet/he1282m332015internet01.pdf (accessed 2016 Aug 16).
24 Cunningham JA, Blomqvist J, Koski-Jannes A, Raitasalo K. Societal Images of Cannabis use: Comparing Three Countries. Harm Reduct J. 2012 Jun 18;9:21. Available: http://www.biomedcentral.com/content/pdf/1477-7517-9 -21.pdf (accessed 2016 Aug 15).
25 Porath-Waller A, Brown J, Frigon A, Clark H. What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse; 2013. Available: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf (accessed 2016 Aug 12).
26 Health Canada. Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Health Canada; 2006. Available: http://publications.gc.ca/site/eng/349980/publication.html (accessed 2016 Aug 15).
27 Fischer B, Jeffries V, Hall W, Room R, Goldner E, Rehm J. Lower Risk Cannabis Use Guidelines for Canada (LRCUG): A Narrative Review of Evidence and Recommendations. Can J Public Health. 2011 Sep-Oct;102(5):324-27. Available: http://journal.cpha.ca/index.php/cjph/article/view/2758 (accessed 2016 Aug 16).
28 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Ottawa: Health Canada; 2013. Available: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php (accessed 2016 Aug 12).
29 Young MM, Student Drug Use Surveys Working Group (SDUS). Cross-Canada report on student alcohol and drug use: Technical report. Ottawa: Canadian Centre on Substance Abuse; 2011. Available:
http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf (accessed 2016 Aug 16).
30 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Available: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf (accessed 2016 Aug 16).
The Task Force’s discussion paper presents the potential elements of a new system, which were grouped into five themes: 1) minimizing harms of use; 2) establishing a safe and responsible production system; 3) designing an appropriate distribution system; 4) enforcing public safety and protection; and 5) accessing marijuana for medical purposes. Each theme includes questions on specific concerns for which the Task Force is seeking input. Presented below are the CMA’s recommendations to the federal government for each section of the discussion paper. A summary of all recommendations is listed at the end of the brief.
RECOMMENDATION:
The CMA recommends that the federal government take a broad public health policy approach in legalizing marijuana for non-medical purposes, and that it be held accountable to these public health objectives.
1. MINIMIZING HARMS OF USE
1.1. Do you believe that these measures are appropriate to achieve the overarching objectives to minimize harms, and in particular to protect children and youth? Are there other actions which the government should consider enacting alongside these measures?
Legalization and strict regulation of marijuana for recreational use seeks to reduce health and social harms, particularly in higher risk groups; however, with the increased access, there could be an inverse effect, with the potential that harms could be intensified. There is also the considerable risk that the degree of “normalization” of use that already exists could increase.
Colorado has seen an increase in marijuana-related traffic deaths and an increase in the use of health care due to intoxication, burns and cyclic vomiting syndrome, as well as overdoses in children due to marijuana in edibles.20 21 22
Many of the regulatory interventions used in reducing tobacco normalization and rates, as well as controlling the harms of alcohol at a population level, are proposed in the Task Force’s discussion paper as part of a framework for marijuana legalization and regulation. These include:
1) Minimum age for legal purchase with the objective of protecting children and youth, particularly since the risks of marijuana use are higher in ages where the brain is still in development.
2) Advertising and marketing restrictions to minimize the profile and attractiveness of products, seeking to prevent or at least reduce the “normalization” of use in society, particularly among children and youth.
3) Taxation and pricing to discourage use and provide the government with revenues to offset related costs (such as substance abuse services, law enforcement and regulatory oversight).
4) Restrictions on marijuana products, particularly with regards to the THC component, given higher concentration products have added risks and unknown long term impacts, with most impact on children and youth. Restrictions would include maximum THC limits and prohibition of high-potency products.
5) Restrictions on types of marijuana products, particularly edibles, to prevent accidental or unintentional ingestion, particularly by children. Limits would be placed on dosing and potency.
6) Limitations on quantities for personal possession, with the objective of helping to reduce demand and to minimize opportunities for resale of legally purchased marijuana on the illicit market (particularly to children and youth).
7) Limitation on where marijuana can be sold in order to minimize harms.
Despite the merit of each of the proposed measures, collectively these may not adequately protect children and youth. A pathway to better implementation would require:
. Taking the time to adequately prepare for the implementation, including developing the capacity to meet demand, administer the system, enforce regulations and deal with adverse effects. A phased-in approach or pilots in certain jurisdictions should be considered before going nationwide.
. Learning from the lessons gained in jurisdictions that have made changes in drug policy, including the U.S. states of Colorado and Washington, Uruguay, the Netherlands and Portugal.
. Learning from successes and failures in the regulation of tobacco and alcohol, with respect to the objectives of reducing or eliminating use for all Canadians (tobacco) and promoting responsible use among adults, while prohibiting use in youth (alcohol).
. Developing the capacity to carry out a rigorous national-level evaluation of the impact of legalization of marijuana on the health and safety of Canadians. Data collection and analysis cannot be conducted if national surveillance systems do not exist. Important data to be monitored include marijuana-related emergency room visits and hospitalizations, rates of drug-impaired driving, recreational injuries, unintentional poisonings, product contamination, overconsumption and food-borne illness from edible products.23
. Support for a research agenda to better understand harms of marijuana, particularly among vulnerable groups such as children and youth, pregnant women, people with mental illness and chronic diseases. Research should also support policy interventions, including those to address second hand smoke, harm reduction measures, treatments and effective education strategies.
The CMA is supportive of the regulatory interventions proposed by the government to reduce the harms, regarding:
Marketing and advertising: The CMA recommends that the marketing and advertising of marijuana be prohibited, as is currently the case for tobacco and cigarettes. Measures such as plain packaging, prohibition of appealing flavours and shapes, adequate content and potency labelling, as well as health warnings, should be incorporated to discourage experimentation. A package insert should outline health risks and supporting references, the need for securing the product in the home, preventing access by youth and children, and recommendations not to drive or work with hazardous chemicals or equipment. The insert should include information detailing the health and social consequences, including legal penalties for providing marijuana to those under a designated minimum age for purchasing.
Taxation and pricing: Taxation and pricing levers should be used to discourage use, with revenues clearly earmarked for covering the health and social costs of legalization. In Colorado, for example, revenue is used in substance abuse programs, regulation of marijuana and for public school construction. However, as with tobacco, final pricing must be such as to discourage the illegal production and trafficking of marijuana. Most of future tax revenues should be redistributed to the provinces and territories. This is because they will feel the impact of legalization directly as they have jurisdiction over health care, education, social and other services, as well as responsibility for enforcement.
Restrictions on the potency of marijuana products: Experience in jurisdictions where marijuana has been legalized has shown that restrictions on the potency of products (i.e., THC limits) are necessary, given the higher risks of harm associated with higher potencies. Prohibition of high potency products is important. However, there is a risk that the prohibition could lead to an illicit market of more potent marijuana preparations.
Restrictions on types of marijuana products: It is essential that restrictions be placed on the dosing of products, particularly of edibles, given the incidence of accidental overdoses of children. Content in a package should not be sufficient to cause an overdose. Because of these incidents, child proof packaging should also be required.
Limitations on quantities for personal possession: Placing maximum limits on quantities that can be purchased would help to reduce the opportunities for illegal distribution and sale, especially to those below the established minimum age limit.
The proposed measures related to minimum age for legal purchase and limitation on where marijuana can be sold are discussed in Sections 1.2 and 3, respectively, below.
In addition to the regulatory interventions proposed in the “Minimizing Harms of Use” section of the discussion paper, others are equally fundamental, including:
A clear process for identifying, testing and charging individuals who are driving under the influence of marijuana should be in place prior to legalization (see further discussion under Section 4).
Public education: The use of public education tools to inform youth and families of the risks and harms of marijuana use is necessary. Awareness of Canadians of the harms of marijuana is generally low.24 25 26 Youth tend to emphasize the drug’s ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There are also many dangerous myths, such as
that marijuana can counter the harmful effects of smoking tobacco by preventing cancer or that marijuana makes people better drivers. There is also a perception amongst some that marijuana is not an addictive substance because it is “natural”.
However, traditional public campaigns and educational programs for youth have been shown to be minimally effective. There is a need for more effective programs, including those that incorporate skills-based training that teaches youth how to handle situations that involve drugs and/or alcohol.
Harm reduction measures, such as those outlined in the Lower Risk Cannabis Use Guidelines for Canadag 27 should be discussed, particularly with teens, in an effort to minimize harm, even if they choose to continue to use.
g These include delaying use until early adulthood; avoiding frequent use; preferring smokeless delivery systems; using less potent products; not driving after use; and abstaining from use when at higher risk of cannabis-related problems (people with a personal or family history of psychosis, cardiovascular problems and pregnant women).
It is important that these education programs be designed by governments and health professionals, and not marijuana producers or distributers. However, costs of such programs could come from the profits of such industries.
Expanded access and immediate availability of substance use, mental health and social stabilization services is another very important measure to minimize harm. These services are currently difficult to access in the community and have long wait times; in many parts of Canada they are simply unavailable. A plan to expand training programs in addiction medicine and access to treatment should be in place prior to legalization.
Enforcement of regulations: Licensed producers and retail outlets should be held accountable in their compliance with policies, guidance and good practices to prevent contaminants that may cause additional health issues if consumed, particularly by minors (See also Section 3).
1.2. What are your views on the minimum age for purchasing and possessing marijuana? Should the minimum age be consistent across Canada, or is it acceptable that there be variation amongst provinces and territories?
In order to achieve the first objective of legalization, i.e., to protect young Canadians by keeping marijuana out of the hands of children and youth, a minimum age for its purchase and possession must be adopted. This has been an important measure in tobacco and alcohol regulations. Existing evidence on marijuana points to the importance of protecting the brain during its development. Since that development is only finalized by about 25 years of age, this would be an ideal minimum age based on currently accepted scientific evidence, although knowledge on brain development is still evolving.
However, marijuana use among youth (ages 15 to 24) is still double that of the general population, at 20%, even though there has been a slight decrease in use in recent years.28 A 2011 report on student alcohol and drug use in Canada showed that of those youth who had used marijuana in the past 3 months, 25% had used it daily. The average age of initiation was 16.1 years. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.29
A minimum age lower than 25 years should be considered in order to deter youth from seeking marijuana from organized crime groups, where they are exposed to other more dangerous drugs, sometimes even laced into marijuana.
In jurisdictions where marijuana has been legalized, the minimum age has been set at the same minimum age for purchase of alcohol, i.e., 21 years. In Canada, the age limits for acquiring alcohol and tobacco are either 18 or 19 years of age, depending on the province or territory. In a survey carried out with a sample of the CMA membership, 25.4% recommended age 21, 20.3% age 25, 19.7% age 18, and 14.2% age 19.
The CMA recommends that the minimum age should be set at 21, and that quantities and the potency of marijuana be more restricted to those under age 25 to discourage use and sharing with underage friends. The CMA recommends that the minimum age be established at the national level, and federally regulated, to avoid differences at the provincial/territorial level. This would reduce problems with enforcement in areas near provincial/territorial borders.
SECTION 1 RECOMMENDATIONS:
The CMA recommends that the federal government incorporate the following measures to support improved implementation of the legalization of marijuana:
a) Ensure sufficient time to adequately prepare for the implementation of the legalized regime, including a phased-in approach and piloting legalization in smaller regions prior to national roll-out;
b) Assess international experience with legalization and incorporate lessons-learned from other jurisdictions into Canada’s approach;
c) Assess the domestic experience in the regulation of tobacco and alcohol against meeting the national objectives for each substance and incorporate lessons-learned from those experiences; and,
d) Develop capacity for national surveillance to ensure rigorous national-level monitoring and evaluation.
e) Support for a research agenda.
The CMA recommends that the federal government prohibit the marketing and advertising of marijuana and that packaging requirements include plain packaging, potency labelling and health warnings. The CMA further recommends that the federal government prohibit flavouring and shapes.
The CMA recommends that the federal government employ taxation and pricing levers to discourage consumption and that the revenues of this taxation be allocated to the provinces and territories and clearly allocated for health and social services.
The CMA recommends that the federal government establish potency restrictions to reduce the harms associated with higher potencies.
The CMA recommends that the federal government establish dosing restrictions on marijuana products, notably edibles.
The CMA recommends that the federal government establish maximum limits on quantities of marijuana that can be purchased.
The CMA recommends that the federal government employ effective public education tools, including skills-based training, to inform youth and families of the risks and harms of marijuana usage.
The CMA recommends that the federal government expand access and availability of substance use, mental health and social stabilization services simultaneously to the legalization of marijuana.
As part of this initiative, the CMA recommends that the federal government implement a plan to expand training programs in addiction medicine.
The CMA recommends that the federal government set the minimum age of purchase and consumption at 21 and that quantities and potency be restricted for those under the age of 25.
The CMA recommends that the federal government establish the minimum age at the national level to ensure consistency across all jurisdictions.
2. ESTABLISHING A SAFE AND RESPONSIBLE PRODUCTION SYSTEM
2.1. What are your views on the most appropriate production model? Which production model would best meet consumer demand while ensuring that public health and safety objectives are achievable? What level and type of regulation is needed for producers?
There will be no perfect production model, with each one having its risks and benefits. The CMA would support a tightly regulated competitive model. A set number of licenses should be granted to producers, who are part of a competitive system, and there should be a reasonable cost associated to offset regulatory expenses. Producers would have to comply with policies and guidelines set by Health Canada, and be subject to inspections.
It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls.
2.2. To what extent, if any, should home cultivation be allowed in a legalized system? What, if any, government oversight should be put in place?
The CMA does not recommend home cultivation in a legalized system for non-medical purposes, as it presents many challenges to municipal, enforcement and public health authorities, particularly given the potentially high number of homes that could seek to cultivate marijuana.
There are many health and safety hazards in cultivation, such as high humidity and temperatures, risk of fire, as well as the use of hazardous chemicals, including pesticides used for the control of fungi, bacteria and insects. There is little quality control regarding contamination and potency of the product. As well, home cultivation has an enhanced risk of abuse, if individuals use the production for sale rather than exclusively for personal use. Access to marijuana by children and youth is also a serious concern with home cultivation.
In the present marijuana for medical purposes system, where some users have been allowed to continue to grow for personal use, there is great difficulty in monitoring and inspecting these properties. However,
this has been allowed given the Allard v Canada court decision, to not hinder access for medical purposes.
Washington has not permitted home cultivation, but Colorado has allowed the growth of a small number of plants for personal use (up to 6 plants, with a maximum 3 mature ones, in an enclosed, locked space).
2.3. Should a system of licensing or other fees be introduced?
Should limited home cultivation for non-medical purposes be an option, a system of registration and licensing would have to be set up to allow for tracking and inspections of home production. It would also allow penalties for non-registered producers as well as larger scale operations. This would be a system that would require intense government regulation, oversight and tremendous resources to be effective.
2.4. The MMPR set out rigorous requirements over the production, packaging, storage and distribution of marijuana. Are these types of requirements appropriate for the new system? Are there features that you would add or remove?
The requirements for production, packaging, storage and distribution of marijuana set out by the MMPR are appropriate for the new system. However, a rigorous review of the MMPR should be conducted to determine if there are weaknesses that need to be corrected before expanding to a non-medical market. Ongoing evaluation will be warranted as well. Distribution would have to expand beyond the mail service.
2.5. What role, if any, should existing licensed producers under the MMPR have in the new system (either in the interim or the long-term)?
The CMA’s policy position does not extend to whether the existing licensed producers should be suppliers to the recreational market. The experience in Colorado, however, showed that having the industry set up for medical purposes first allowed a smoother transition, in contrast with Washington, which did not have an industry.
SECTION 2 RECOMMENDATIONS:
The CMA supports a tightly regulated competitive model wherein production and distribution is heavily regulated and includes strict oversight.
The CMA recommends that the federal government prohibit home cultivation in the legalized system for non-medical use.
The CMA recommends that the federal government evaluate the requirements established by the MMPR system for production, packaging, storage and distribution to introduce improvements for implementation in the new legalized system for non-medical use.
3. DESIGNING AN APPROPRIATE DISTRIBUTION SYSTEM
3.1. Which distribution model makes the most sense and why?
There is the need to continue mail availability for patients accessing marijuana for medical purposes to ensure nationwide access, however, a distribution system based exclusively on mail service would probably not meet the objectives of a recreational system.
When a sample of our membership was asked about distribution models, first preference was given to existing non-health care structures, such as liquor stores. In some provinces, they would have the additional benefit of having a tightly regulated government monopoly by control board entities with a social responsibility mandate. Restrictions could be placed to limit the acquisition of both alcohol and marijuana. As stated earlier, marketing should be prohibited. Staff in these stores receives training and hours can be limited.
A close second preference was given to legal storefronts, similar to the independent dispensaries. Several municipalities have been in varied degrees of discussion on the regulation of the presently illegal dispensaries, and those regulations could be looked at as models in a legalized environment.
When asked about health care settings, such as pharmacies, respondents to the survey did not support this model. Almost 60% disagreed or strongly disagreed. A reason for this lack of support could be that placing marijuana in pharmacies could lend it credibility as a pharmaceutical medication, whereas placing it in liquor stores would send the message that it needs strict and formal controls.
As per previous discussion, the creation of private industries for production and distribution would have to be very tightly controlled to avoid commercialization. As we have learned from the alcohol and tobacco industries, private companies have an interest in recruiting customers and encouraging high levels of ongoing consumption. It is important that the regulatory framework be protected from these commercial and fiscal interests.
Regardless of the actual point of sale, storefront densities should be federally set and restrictive. There is good evidence from the regulation of alcohol that the less restrictive retail outlet density is, the more harms associated with alcohol use occur. Restrictions would also be placed on distances from schools, parks, playgrounds, colleges and universities, as well as on hours of sale. Regulations would lay out standards, including for the control of product sources, proof of minimum age required for purchase and restrictions on quantities sold.
3.2. To what extent is variation across provinces and territories in terms of distribution models acceptable?
In the CMA’s survey of our members, there was not a consensus among respondents as to whether provincial and territorial governments should decide on their own distribution mechanisms. Many comments stated that a federal standard is warranted due to the need for initial close oversight and the ability to make effective changes more quickly. The CMA position is that there is an important role for the federal government to play in ensuring consistency across the country and avoiding provincial/territorial variation.
3.3. Are there other models worthy of consideration?
The CMA recommends a phased in approach to the roll out of the system of distribution. Several pilot locations could be considered before going nationwide. Given the novelty and impact of this new legislation, particular caution is absolutely necessary from a regulatory and public health perspective.
SECTION 3 RECOMMENDATIONS:
The CMA recommends that the distribution model should occur outside health care structures, for example, in liquor stores, and that storefront densities should be federally set and restrictive.
The CMA recommends that the distribution model should be established at the federal level and be consistent across jurisdictions.
The CMA recommends a phased implementation approach prior to national availability.
4. ENFORCING PUBLIC SAFETY AND PROTECTION
4.1. How should governments approach designing laws that will reduce, eliminate and punish those who operate outside the boundaries of the new legal system for marijuana?
The severity of punishment for simple possession and personal use of marijuana should be eliminated with the removal of criminal sanctions. The CMA recommends that resources currently devoted to combating simple marijuana possession through the criminal law be diverted to public health and education strategies, particularly for youth. Having a criminal record limits employment prospects, and the impact on health status is profound, disproportionately among marginalized populations. Laws should include such things as the facilitation of access by individuals to services to address substance use, mental health and social stabilization. Laws should be drafted in a clear fashion to minimize ambiguity and provide as much guidance and direction to users, health care providers, enforcement authorities, producers, distributors and others.
4.2. What specific tools, training and guidelines will be most effective in supporting enforcement measures to protect public health and safety, particularly for impaired driving?
The use of marijuana is associated with an increased risk of impairment, and is incompatible with the operation of vehicles and work in safety sensitive positions due to risk of injury to oneself, coworkers or the general public.
Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Report on Student Alcohol and Drug Use30 states that 14–21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug. Often, marijuana is associated with alcohol use, having an additive effect.
A clear and reliable process for identifying, testing and imposing consequences on individuals who use marijuana and drive absolutely needs to be in place nationally prior to legalization. This will be complicated by the fact that a roadside test for marijuana use is not in widespread use; blood and urine testing also pose challenges. Another issue is the fact that recent use does not necessarily equate to impairment and no scientific standard for impairment exists in the literature.
All individuals charged with impaired driving should have a specialist assessment to determine whether a substance use disorder is present. Individuals with substance use disorders should have immediate access to addiction treatment, mental health services and social stabilization.
There is also a need for the development of guidelines for employers for the assessment and management of risk.
4.3. Should consumption of marijuana be allowed in any publicly-accessible spaces outside the home? Under what conditions and circumstances?
No public smoking should be permitted, due to the risk of second hand smoke. Second hand marijuana smoke contains many of the same toxins, including carcinogens, found in directly inhaled marijuana smoke, in similar amounts, if not more. There is special concern for harmful health effects, especially among children. The CMA does not recommend the exposure of children to second hand smoke in public areas or in the home. The success in the reduction of tobacco use rates is significantly related to banning of smoking in public places.
In the CMA’s survey of a sample of its members, 51.7% disagreed with consumption in designated public places, such as the Dutch model of coffee shops.
SECTION 4 RECOMMENDATIONS:
The CMA recommends that the federal government reallocate resources currently dedicated to the enforcement of marijuana infractions, to public health, education and treatment programs.
The CMA recommends that the federal government ensure that a clear and reliable process for identifying, testing and imposing consequences on individuals who operate a motor vehicle under the influence of marijuana be in place nationally prior to the legalization of marijuana.
The CMA recommends that the federal government prohibit smoking of marijuana for non-medical purposes in public places.
5. ACCESSING MARIJUANA FOR MEDICAL PURPOSES
5.1. What factors should the government consider in determining if appropriate access to medically authorized persons is provided once a system for legal access to marijuana is in place?
The CMA recognizes that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with marijuana used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency (levels of THC, CBD), interactions with medications and adverse effects. Health Canada does not approve of marijuana as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical.
The present system poses a serious challenge for physicians in providing the best care to patients. The CMA has long called for more research to better understand potential therapeutic indications, as well as its risks. It is important that there be support for research of marijuana in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol®), nabilone (Cesamet®) and THC/CBD (Sativex®).
The present marijuana for medical purposes regime operates as an exception to a criminal prohibition for production, possession and trafficking of marijuana. It was developed in reaction to court challenges regarding the right to legal access of individuals to marijuana for medical purposes.
With the new legal system for marijuana for non-medical use, the requirement to maintain a separate regulatory framework would not be necessary, given court-mandated access will be provided. As well, the experience of legalization for non-medical use in Colorado and Washington has shown that two separate
regimes with distinct regulations can be very difficult to enforce given the dual standards (including different minimum ages, purchase quantities and taxation).
Provisions would have to exist within the new system to attend to legitimate medical needs of individuals who are under the minimum age for purchase of marijuana, or for those with a requirement for a more potent product than that which is legally available. Consideration might also be given to affordable access for those with low incomes.
As stated previously, the option of distribution through mail would have to continue, to facilitate access in remote areas. As well, patients or their families would be able to access marijuana through the distributors of marijuana for non-medical purposes, such as storefronts or liquor store-like entities, which would have employees trained to support patients and their needs.
The use of marijuana products for medical indications, through this system, should preferably be done under research protocols. This framework would contribute to the provision of more robust scientific data.
SECTION 5 RECOMMENDATION:
The CMA recommends that there be only one regime for marijuana, following legalization of non-medical marijuana, with provisions for the medical needs of those who would not be able to acquire marijuana in a legal manner, e.g., those below the minimum age or those with a requirement for a more potent product than legally available.
6. Summary of Recommendations
The CMA appreciates the opportunity to provide feedback on this important matter to physicians and the public. Legalization of marijuana for non-medical purposes is a fundamental shift in the approach to drugs. The CMA’s position is that it is essential that the government consult with experts, key stakeholders and the general public not only at this phase in preparation for legislation on this matter, but throughout the process of the development of regulations and implementation.
Recommendations:
1) The CMA recommends that the federal government take a broad public health policy approach in legalizing marijuana for non-medical purposes, and that it be held accountable to these public health objectives.
Section 1
2) The CMA recommends that the federal government incorporate the following measures to support improved implementation of the legalization of marijuana:
a) Ensure sufficient time to adequately prepare for the implementation of the legalized regime, including a phased-in approach and piloting legalization in smaller regions prior to national roll-out;
b) Assess international experience with legalization and incorporate lessons-learned from other jurisdictions into Canada’s approach;
c) Assess the domestic experience in the regulation of tobacco and alcohol against meeting the national objectives for each substance and incorporate lessons-learned from those experiences; and,
d) Develop capacity for national surveillance to ensure rigorous national-level monitoring and evaluation.
e) Support for a research agenda.
3) The CMA recommends that the federal government prohibit the marketing and advertising of marijuana and that packaging requirements include plain packaging, potency labelling and health warnings. The CMA further recommends that the federal government prohibit flavouring and shapes.
4) The CMA recommends that the federal government employ taxation and pricing levers to discourage consumption and that the revenues of this taxation be allocated to the provinces and territories and clearly allocated for health and social services.
5) The CMA recommends that the federal government establish potency restrictions to reduce the harms associated with higher potencies.
6) The CMA recommends that the federal government establish dosing restrictions on marijuana products, notably edibles.
7) The CMA recommends that the federal government establish maximum limits on quantities of marijuana that can be purchased.
8) The CMA recommends that the federal government employ effective public education tools, including skills-based training, to inform youth and families of the risks and harms of marijuana usage.
9) The CMA recommends that the federal government expand access and availability of substance use, mental health and social stabilization services simultaneously to the legalization of marijuana.
10) As part of this initiative, the CMA recommends that the federal government implement a plan to expand training programs in addiction medicine.
11) The CMA recommends that the federal government set the minimum age of purchase and consumption at 21 and that quantities and potency be restricted for those under the age of 25.
12) The CMA recommends that the federal government establish the minimum age at the national level to ensure consistency across all jurisdictions.
Section 2
13) The CMA supports a tightly regulated competitive model wherein production and distribution is heavily regulated and includes strict oversight.
14) The CMA recommends that the federal government prohibit home cultivation in the legalized system for non-medical use.
15) The CMA recommends that the federal government evaluate the requirements established by the MMPR system for production, packaging, storage and distribution to introduce improvements for implementation in the new legalized system for non-medical use.
Section 3
16) The CMA recommends that the distribution model should occur outside health care structures, for example, in liquor stores, and that storefront densities should be federally set and restrictive.
17) The CMA recommends that the distribution model should be established at the federal level and be consistent across jurisdictions.
18) The CMA recommends a phased implementation approach prior to national availability.
Section 4
19) The CMA recommends that the federal government reallocate resources to the enforcement of marijuana infractions to public health, education and treatment programs.
20) The CMA recommends that the federal government ensure that a clear and reliable process for identifying, testing and imposing consequences on individuals who operate a motor vehicle under the influence of marijuana be in place nationally prior to the legalization of marijuana.
21) The CMA recommends that the federal government prohibit smoking of marijuana for non-medical purposes in public places.
Section 5
22) The CMA recommends that there be only one regime for marijuana, following legalization of non-medical marijuana, with provisions for the medical needs of those who would not be able to acquire marijuana in a legal manner, e.g., those below the minimum age or those with a requirement for a more potent product than legally available.
CMA Statement - Legalization of Marijuana
Ottawa, September 9, 2016 - The CMA's submission to the Task Force on Marijuana Legalization and Regulation is framed by the fundamental position that the legalization of marijuana is a societal prerogative; the CMA is not weighing in on this decision as it has already been made.
Keeping with our mandate as the national voice for the highest standards of health and health care, the CMA is squarely focused on minimizing the negative impact on individuals and public health.
The CMA has longstanding concerns about the health risks associated with consuming marijuana, particularly in smoked form.
Children and youth are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development.
As such, the CMA's submission is framed by the overarching recommendation that the government must take a broad public health policy approach in developing the legalization framework. Focusing on the legalization issue alone is inadequate to deal with the complexity of the situation.
The CMA recommendations build on Canada's experience regulating alcohol and tobacco.
The legalization framework must include:
Marketing and packaging restrictions
Restrictions on the types of products and their potency
Prohibiting home cultivation
Expanding access to support services such as mental health and substance use services
Expanding access to training programs in addiction medicine, and
Making extensive educational resources on the risks of harm to the user and others available
We must recognize that the legalization of marijuana is a complex matter. Overall the CMA has submitted to the Task Force 22 evidence-based recommendations for a broad public health approach.
For interviews: mediainquiries@cma.ca 613-806-1865
The Canadian Medical Association appreciates this opportunity to respond to Health Canada's public consultation on the proposed regulatory approach for the proposed Cannabis Act, Bill C-45.
Our 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 endorsed the Lower-Risk Cannabis Use Guidelines1 and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation,2 recommendations regarding Bill C-453 and submission on the cannabis excise duty framework.4
Therefore, we are limiting our response to those consultation questions that pertain to that approach and relate to our expertise and knowledge base. We are providing responses to questions 9, 10 and 11.
Consultation questions
Packaging and labelling
9. What do you think about the proposed rules for the packaging and labelling of cannabis products? Do you think additional information should be provided on the label?
The CMA concurs with the proposed regulations. Packaging and labelling of cannabis products should include measures such as:
a requirement for plain and standard packaging,5 6
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause an overdose.
Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. In that regard, the regulations with respect to packaging and labelling should be viewed as an opportunity to maximize educational opportunities. Package inserts must outline and reinforce the health risks involved; they must also be designed by governments and health professionals, not cannabis producers or distributors.
Package inserts should include:
information on securing the product in the home to prevent access by youth and children,
recommendations not to drive or to work with hazardous chemicals or operate equipment while using the contents of the package,
information on the health and social consequences (including legal penalties) of providing cannabis to those under a designated minimum age for purchasing, and
contact information for hotlines for poison control and for crisis support.
In addition, the regulations for the marketing and advertising of cannabis should use an approach similar to those in place for tobacco and cigarettes.7 8 9
Cannabis for medicinal purposes
10. What do you think about the proposed approach to providing cannabis for medical purposes? Do you think there should be any specific additional changes?
CMA maintains its position that there should be one system with one set of regulations for medical and recreational cannabis.
The CMA believes that once the Act and regulations are in force, there will be no need for two systems. Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization, and for those who wish to use it for other purposes. The medical profession does not need to authorize use once cannabis is legalized, especially given that cannabis has not undergone Health Canada's usual pharmaceutical regulatory approval process, and its anticipated removal as a controlled substance from the Controlled Drugs and Substances Act.
Those who have experienced a two-system approach in Washington and Colorado have remarked on the challenges of having dual standards and regulations (e.g., purchase and possession quantities, taxation levelsa 4) and the contribution to the grey market.b 11
Consistent with the advice it received from the Task Force on Legalization and Regulation of Cannabis,12 the government intends on pursuing both a medicinal and retail cannabis system at this time. In this instance the CMA supports regulations for each system being as similar as possible. Furthermore, the CMA strongly supports the need for appropriate and relevant data collection (e.g., interaction of individuals between the medicinal and retail systems) to provide the necessary evidence for the future legislative review, anticipated in three years' time. The CMA would expect to be involved and looks forward to participating in the criteria development, evaluation and performance review of the systems.
Sale of health products containing cannabis
11. What do you think about the proposed restrictions on the sale of health products containing cannabis authorized by Health Canada? Do they strike an appropriate balance between facilitating access to safe, effective and high quality health products, and deterring illegal activities and youth access?
Health products include prescription health products, non-prescription drugs, natural health products, cosmetics and medical devices. Although all these products are regulated by Health Canada, they undergo different levels of scrutiny for safety, efficacy and quality, and in some cases industry does not need to provide scientific evidence to support the claims made on the label. The level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence is needed for a DIN but not for a NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product. As a result, consumers presently do not have sufficient information to choose appropriate products.
Health Canada launched a consultation in 201613 on the approval process of the categories of non-prescription drugs, natural health products and cosmetics ("self-care products") with the intent of modernizing the present regulations. The CMA fully supports this work and hopes it will be brought to a timely conclusion.14
With respect to all health products, the CMA supports a risk-based approach in which higher risk products, for example, those for which health claims are made, must meet a higher standard of review. Rigorous scientific evidence is needed to support claims of health benefits and to identify potential risks and adverse reactions.
All health products containing cannabis must meet a high standard of review for safety, efficacy and quality, equivalent to that of the approval of prescription drugs (e.g., Marinol(r) and Sativex(r)), to protect Canadians from further misleading claims. Prescription drugs are subject to Health Canada's pharmaceutical regulatory approval process, based on each drug's specific indication, dose, route of administration and target population. Health claims need to be substantiated via a strong evidentiary process.
With respect to the sale of cannabis products to youth, the CMA recommends the adoption of strict controls as outlined in the proposed regulations; as per the proposal, "All health products would be subject to provisions that control against practices that may appeal to youth, or the use of testimonials, real or fictional characters or animals, or lifestyle branding. Tamper-evident and child-resistant packaging requirements would also apply."15 We also support the additional precautions around medical devices, especially those sold to young persons.
The CMA urges caution around the exemption for paediatric formulations that would allow for traits that would "appeal to youth." The CMA understands that these products, used under strict health professional supervision, should be child friendly, for example, regarding palatability, but we do not support marketing strategies that would suggest their use is recreational (e.g., producing them in candy or animal formats).
There will be a need for careful monitoring of the health products released in the market and the health claims made. Experience has shown that regulations can and will be circumvented, and these activities will have to be addressed. Various examples have been reported in the media highlighting the need to be vigilant, as illustrated in Switzerland regarding health and other products with cannabis and high cannabidiol content.16 17
a The CMA supports similar taxation treatment of cannabis products for medical and non-medical purposes.
b Grey market refers to products produced or distributed in ways that are unauthorized or unregulated, but not strictly illegal.
1 Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH 2017 Aug;107(8):e1-e12. Available: http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed& (accessed 2017 Jul 27).
2 Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada - Task Force on cannabis, legalization and regulation. Ottawa: 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).
3 Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: The Association; 2017 Aug 18. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2017-09.pdf (accessed 2018 Jan 17).
4 Canadian Medical Association (CMA). Excise duty framework for cannabis products. Submission to the Government of Canada consultation on the proposed excise duty framework for cannabis products. Ottawa: The Association; 2017 Dec 7. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2018-06.pdf (accessed 2018 Jan 17).
5 Vardavas C, Filippidis F, Ward B, et al. Plain packaging of tobacco products in the European Union: an EU success story? European Respiratory Journal 2017;50:1701232 Available: http://erj.ersjournals.com/content/erj/50/5/1701232.full.pdf (accessed 2018 Jan 17).
6 Torjesen I. Standardised packs cut adult smoking as well as discouraging young people, evidence indicates BMJ 2015;350:h935. Available: http://www.bmj.com/content/350/bmj.h935 (accessed 2018 Jan 17).
7 Hughes N, Arora M, Grills N. Perceptions and impact of plain packaging of tobacco products in low and middle income countries, middle to upper income countries and low-income settings in high-income countries: a systematic review of the literature. BMJ Open 2016;6:e010391. doi:10.1136/bmjopen-2015-010391. Available: http://bmjopen.bmj.com/content/bmjopen/6/3/e010391.full.pdf (accessed 2018 Jan 17).
8 White V, Williams T, Wakefield M. Has the introduction of plain packaging with larger graphic health warnings changed adolescents' perceptions of cigarette packs and brands? Tob Control 2015;24:ii42-ii49. Available: http://tobaccocontrol.bmj.com/content/tobaccocontrol/24/Suppl_2/ii42.full.pdf (accessed 2018 Jan 17).
9 Smith C, Kraemer J, Johnson A, Mays D. Plain packaging of cigarettes: do we have sufficient evidence? Risk Management and Healthcare Policy 2015;8:21-30. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396458/pdf/rmhp-8-021.pdf (accessed 2018 Jan 17).
10 Canadian Centre on Substance Use and Addiction (CCSA). Cannabis regulation: Lessons learned in Colorado and Washington State. Ottawa: CCSA; 2015 Nov. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2018 Jan 18).
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. Available: https://www.canada.ca/content/dam/hc-sc/healthy-canadians/migration/task-force-marijuana-groupe-etude/framework-cadre/alt/framework-cadre-eng.pdf (accessed 2018 Jan 18).
12 Government of Canada. Consultation on the regulation of self-care products. Ottawa: Government of Canada; n/d. Available: https://www.canada.ca/en/health-canada/programs/consultation-regulation-self-care-products.html (accessed 2018 Jan 17).
13 Canadian Medical Association (CMA). Regulation of self-care products in Canada. Ottawa: The Association; 2016. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2017-11.pdf (accessed 2018 Jan 17).
14 Health Canada. Proposed approach to the regulation of cannabis [consultation]). Ottawa: Health Canada; 2017 Nov. Available: https://www.canada.ca/content/dam/hc-sc/documents/programs/consultation-proposed-approach-regulation-cannabis/proposed-approach-regulation-cannabis.pdf (accessed 2018 Jan 17).
15 Knodt M. In Switzerland, high-CBD cannabis being sold legally as 'Tobacco Substitute'. Seattle: Leafly; 2018. Available: https://www.leafly.com/news/politics/switzerland-high-cbd-cannabis-sold-legally-tobacco-substitute (accessed 2018 Jan 17).
16 Wiley C. Could a legal quirk bring cannabis tourism to Switzerland? The Telegraph 2017 Jul 28;Travel Section. Available: http://www.telegraph.co.uk/travel/destinations/europe/switzerland/articles/cannabis-tourism-has-arrived-in-switzerland/ (accessed 2018 Jan 17).
Review of Controlled Drugs and Substances Act: Canadian Medical Association submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements."
The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety.
The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds.
Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety
As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety.
In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy.
In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy.
A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach.
It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration.
In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach.
A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse
The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States.
The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination.
Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers.
Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested.
The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways:
i) Improving the approval, labelling and safety monitoring of controlled substances
The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require:
* More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies);
* Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals.
* Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse.
* Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions.
ii) Establishing consistent requirements for prescription monitoring
In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse.
While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by:
* Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled.
* Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled.
* Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring.
* Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues.
Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden.
The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should:
* Enable inter-jurisdictional accessibility and operability;
* Ensure that practitioners have real-time access to the monitoring system;
* Enable electronically-based prescription monitoring; and;
* Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2).
B) Supporting harm reduction as a component of a drug strategy
The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition.
Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive.
In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites.
C) Developing clinical knowledge base about the medical use of marijuana
The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians.
Part 2: Ensuring protection of patient privacy
In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework.
As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information.
The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions.
Part 3: Enabling e-prescribing
As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers.
For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D).
Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section.
Part 4: Establishing a mechanism for changes to scope of practice
The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us.
Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety.
To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change:
* Demonstration that it will improve public health and patient safety;
* Meaningful consultation with professional organizations and regulatory authorities; and,
* Support of provincial and territorial ministers of health.
Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require:
* That new classes of prescribers have conflict of interest policies;
* That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and
* That a mandatory five-year review be established for new classes of prescribers.
Part 5: Recognizing the authority of physician regulatory colleges
As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes.
Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action.
In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
Conclusion
The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety.
In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail.
List of Appendices:
* Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada
* Appendix B: CMA Policy Statement - Medical Marijuana
* Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information
* Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association
* Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012)
Overview of recommendations
The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety.
The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule.
The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication.
The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring.
To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body".
The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians.
The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework.
The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions.
The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations.
The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change:
* Demonstration of public health and patient safety improvement;
* Meaningful consultation with professional organizations and regulatory authorities; and,
* Support of provincial and territorial ministers of health.
The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require:
* That new classes of prescribers have conflict of interest policies;
* That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and
* That a mandatory five-year review be established for new classes of prescribers.
The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
