BPF Submission to Heath Canada on MMAR Changes
SUBMISSION OF THE BEYOND PROHIBITION FOUNDATION IN RESPONSE TO PROPOSED IMPROVEMENTS TO HEALTH CANADA’S MARIHUANA MEDICAL ACCESS PROGRAM
The Beyond Prohibition Foundation was established in 2010 to advocate for the repeal of cannabis prohibition and its replacement with a system of regulated production and distribution. It operates the website www.whyprohibition.ca, Canada's largest dedicated drug policy reform website and host to more than 30,000 members. The Foundation's mission includes advocacy on behalf of safe access to medicinal cannabis and cannabis byproducts for those obtaining therapeutic and medicinal benefit.
This submission responds to Health Canada's consultation document titled "Proposed Improvements to Health Canada's Marihuana Medical Access Program" (the "Consultation Document"). In the Consultation Document, Health Canada foreshadows significant changes to Canada's medical cannabis policies. The Foundation welcomes Health Canada's tacit acknowledgement that the current Marihuana Medical Access Regulation (MMAR) system is deeply flawed and in need of significant reform. That reform is necessary in two primary areas: (1) the need to improve access to the legal protections afforded by the legislative and regulatory scheme; and (2) the need to provide consumers with safe access to an effective supply of medicinal cannabis and cannabis byproducts. This submission lays out the Foundation's view of the proposed changes and offers suggestions for making necessary improvements to the federal program.
BROAD POLICY CONSIDERATIONS
Canada's medical cannabis policy, currently embodied in the MMAR, does not exist in a legislative or regulatory vacuum. The impact of existing legislation, principally the Controlled Drugs and Substances Act, and regulations, including the Narcotic Control Regulation and Natural Health Product Regulation, cannot be overstated. As an initial policy matter, the Foundation submits that the scope of the intended review is far too narrow given the context in which access to medicinal cannabis in Canada takes place. A litany of difficulties with the existing situation exist and come from a wide variety of stakeholders including - most importantly - consumers but also producers, distributors, municipalities, law enforcement authorities, health care practitioners and members of the general public. The primary concerns are addressed below. Nevertheless, it is critical to note at the outset that the vast majority of concerns - real or purported - simply cannot be adequately addressed by merely altering the medicinal cannabis access regime. A broad-based review and reformulation of Canada's cannabis policy is of critical importance.
The Foundation acknowledges that the Consultation Document is clear that ending cannabis prohibition is not being contemplated at this time. In the strongest possible terms, the Foundation submits that this apparent willful blindness to the broader policy context does a deep disservice to all stakeholders and, indeed, all Canadians. We urge Health Canada to undertake a thorough consultation and review of the prohibition on cannabis contained in the Controlled Drugs and Substances Act in order to adequately understand and ameliorate the negative effects of that prohibition on medicinal cannabis consumers and on Canadians and Canadian society generally. Until broad policy changes are implemented, altering the medical cannabis access regime is nothing more than a band-aid solution to a crisis requiring major reconstructive surgery. Virtually all of the concerns expressed by stakeholders can be addressed by ending prohibition and implementing a non-criminal regulatory regime.
THE COURTS AND THE CHARTER OF RIGHTS AND FREEDOMS
The Consultation Document indicates that improvements are being contemplated but fails to acknowledge that a motivation for major change is the leading judicial decisions in this area including R. v. Parker (2000), 188 D.L.R. (4th) 385 (Ont. C.A.), Hitzig et. al. v. Canada (2003), 177 C.C.C. (3d) 449 (Ont. C.A.), Canada (Attorney General) v. Sfetkopoulos 2008 FCA 328, R. v. Beren 2009 BCSC 429 and R v. Mernagh, 2011 ONSC 2121. Because these decisions identify deficiencies in the existing regime that have not been addressed to date, and in large part do not appear to be addressed in the proposed changes, this submission will deal with those cases in addition to the stated reasons for contemplating improvements to the system.
On July 31, 2000, the Ontario Court of Appeal confirmed the existence of a constitutional right to choose cannabis as medicine. The government chose not to appeal this decision and the Parker case became the seminal case on the constitutional requirement that the government provide a means by which medical cannabis users can be exempted from the operation of the criminal law. Subsequent cases, up to and including the recent decision in Mernagh, have confirmed that the right to access medical cannabis is protected by the Charter.
This Charter-based right encompasses two general categories; access to the legal protections of a program (the "Access Issue") and access to a safe and effective supply of the medicine (the "Supply Issue"). Parker dealt with both issues, ultimately concluding that Parker's right to produce and possess cannabis for his personal medical use was worth of Charter protection. Hitzig also dealt with both issues and, while the physician-as-gatekeeper requirement was not, at that time, found to infringe the Charter, the Court ordered changes to both the Access and Supply sides of the MMAR. Sfetkopolous addressed further continuing Supply Issues and, again, found features of the MMAR to violate the Charter. Beren addressed both Access and Supply Issues, ultimately concluding on the facts presented that certain portions of the MMAR were invalid due to arbitrary restrictions on supply. Finally, Mernagh principally addressed the Access Issue resulting in the declaration that the MMAR and sections 4 (prohibiting possession) and 7 (prohibiting production) of the CDSA were invalid because the physician-as-gatekeeper requirement acted as a barrier to accessing the legal protections of the regulatory scheme.
Several more items of litigation are pending in the Courts related to, without limitation, endemic delays associated with processing MMAR applications, the continued arbitrariness of the Supply side regulations and the MMAR's failure to allow for the lawful production, distribution and possession of cannabis byproducts such as edible, topical and oral modes of ingestion. All told, Canadian taxpayers have subsidized the federal government's unwillingness to conform its medical cannabis scheme to the dictates of the Charter to the tune of millions of dollars. If the proposals set out in the Consultation Document are implemented as proposed, there will undoubtedly be further litigation and medical consumers and caregivers will continue to suffer needlessly.
A PATIENT/CONSUMER ORIENTED APPROACH
Patient consumers are the most important stakeholder in this process. Unfortunately, for far too long the concerns and needs of Canada's patient population have been subordinated to concerns - some real, some false or exaggerated, of other stakeholder groups such as law enforcement and a vocal minority of municipalities. If Health Canada is truly interested in improving the regulatory scheme, it must put the concerns of patients in the foreground and craft a response that adequately addresses those concerns. Failing to do so, particularly at this juncture in the development of the program and in light of the litany of judicial decisions finding fault with both the regulations as written and the policy directives underlying the regulatory choices, would lead reasonable persons to conclude that the government's goal is not improvement but, rather, continued recalcitrance and opposition to actual reform.
Cannabis is a medicinal plant containing a multiplicity of active therapeutic compounds in proportions that vary significantly based upon the genetic profile of the particular plant. It comes in a number of cultivars, also called strains, each with differing features and medicinal effect. The Consultation Document implicitly recognizes this and suggests that private producers will be permitted to provide an unlimited number of strains to authorized persons. This is a welcome change but it raises certain questions, principally how the private producers will obtain known genetic lines. While many cannabis seed breeders and distributors exist, both within and outside Canada, it will require a regulatory exemption to allow producers to lawfully obtain breeding stock.
Additionally, many existing authorized producers are already in possession of strains that have been developed for particular patient use. These genetic lines must be preserved. Finally, there exists (paraphrasing the Hitzig Court), a network of unlicensed producers that have been supplying Canada's compassion clubs for more than a decade. These producers have devoted countless hours to breeding and experimenting with various cultivars in order to meet patient need. The knowledge base of these heretofore unlawful producers is extensive and any regulatory reform must include provision for maintaining and expanding this know-how and the existing genetics.
Because there is currently no Canada-wide system for reimbursement of the cost of medicinal cannabis, cost is a major factor limiting access. The proposal to phase out personal and caregiver designated production will exacerbate this problem by taking away two of the most cost-effective means of accessing medicinal cannabis. In addition, patients and producers that have invested significant funds developing production facilities in reliance upon the existing regulatory framework will lose the value of those investments. Because of these facts, the Foundation urges Health Canada to retain personal and caregiver designated production. Ideally the new system will increase the number of existing producers from the relatively minute number licensed under the existing MMAR.
Cannabis is ingested in a variety of formats. It can be smoked, vaporized, eaten, applied topically and incorporated into virtually any fat or alcohol-based medium. The dried plant matter can be processed resulting in the collection of resin which contains the active ingredients without any plant material. Unfortunately, the existing MMAR allows only possess of dried cannabis, removing patient options for other, potentially more efficacious and safer forms of using the medicine. The Foundation submits that any improvements to the scheme must include provision for the lawful production, distribution and possession of cannabis resin and byproducts.
4. Stigmatization/Marginalization and Interaction with Law Enforcement
Cannabis use, even for medical purposes, takes place in a highly stigmatized environment. Misinformation about the plant, its consumers, distributors and producers is legion. There remains unfounded skepticism about the many medicinal benefits of cannabis and a tremendous level of fear-mongering about its purported harms. The dangers of production are grossly overstated, principally by groups with vested interests in maintaining the existing criminal prohibition and preventing normalization of the consumption, distribution and production of cannabis. This climate of fear has a dramatic negative impact on patients and caregivers. Even persons authorized to possess cannabis, with valid identification issued pursuant to the MMAR, report harassment by law enforcement authorities, municipalities, landlords and public housing administrators.
Unfortunately, even the announcement of this consultation process and language in the Consultation Document itself contributes to the stigma and marginalization by suggesting that the current MMAR require "improvement" not in order to address the serious patient-oriented deficiencies well-known to Health Canada and found to exist repeatedly by the Courts but, rather, "[t]o reduce the risk of abuse and exploitation by criminal elements and keep our children and communities safe." This language crystallizes much of what is wrong with the government's approach to the issue of medicinal cannabis. There is little evidence that the current MMAR are being abused and exploited by criminal elements (indeed, the very small number of lawful producers in the face of an unlawful cannabis industry that currently employs hundreds of thousands of Canadians suggests that any such exploitation is minimal at worst) and no credible evidence that medicinal cannabis consumption and production by authorized persons poses any risk to "children and communities." Using this politically charged language, reminiscent of the prohibitionist "war on drugs" rhetoric that accompanies discussion of the issue of cannabis generally, is unhelpful at best. Worse, the Consultation Document explicitly rejects the only policy approach that would minimize the harms associated with criminal involvement in cannabis production and distribution: ending prohibition entirely and implementing a system of reasonable non-criminal regulation.
Health Canada should assist in ameliorating, rather than enhancing, stigma by adopting a strict evidence-based approach to evaluating and regurgitating claims of harm. In addition, any changes in the scheme must include a standardized means by which authorized persons can identify themselves as such to law enforcement and a comprehensive outreach program designed to educate all stakeholders about cannabis consumption, distribution and production.
THE CONCERNS IDENTIFIED IN THE CONSULTATION DOCUMENT
The Consultation Document identifies certain concerns raised by stakeholders. The Foundation reproduces these below, with comment.
1. The potential for diversion of marihuana produced for medical purposes to the illicit market.
This concern may exist but its actual relevance is minimal. Any prohibition on a desired product will create a black market - indeed, the diversion of prescription narcotics (which are much easier to access and much more dangerous than cannabis) is a significant and growing problem. The concern in terms of cannabis exists only because of the policy decision to prohibit cannabis generally. Moreover, the actual impact of diversion by authorized medical consumers or producers is minimal. The black market in cannabis in Canada is immense, with reports placing the economic impact of the trade in the billions of dollars annually. Millions of Canadians consume cannabis regularly despite the prohibition and basic supply and demand principles dictate that others will produce and sell it to this huge consumer base. The production of cannabis in British Columbia alone is reported to employ more than one hundred thousand persons. As of the date of this submission, ten years into the MMAR program, only a few thousand people can possess and produce it lawfully. Even if every single person was diverting to the black market (a proposition with no evidentiary support), it would represent at worst a minute fraction of the overall black market. Restricting the rights of patients to produce for themselves or to have a caregiver produce for them because of the possibility that an insignificant number will divert to the black market is shortsighted and arbitrary.
2. The risk of home invasion due to the presence of large quantities of dried marihuana or marihuana plants.
This concern is overstated and has little evidentiary support. Home invasions related to cannabis are exceedingly rare and much less common than home invasions related to the theft of jewelry, electronic appliances and other consumer goods. Cannabis, due to its bulk and difficulties associated with selling it after theft, is in fact a much less appealing target for thieves than many common household goods.
3. Public safety risks, including electrical and fire hazards, stemming from the cultivation of marihuana in homes.
These risks, while undeniably possible, have largely been overstated and are all easily ameliorated with reasonable regulation. It appears the evidence base for these concerns is primarily a deeply flawed and biased study produced at the behest of law enforcement. Even that study, read properly, demonstrates that cannabis production poses less of a fire risk than many common household activities including cooking and smoking cigarettes. Moreover, the risks simply do not exist with outdoor production.
4. Public health risks due to the presence of excess mould and poor air quality associated with the cultivation of marihuana plants in homes.
These risks, again, are overstated. Cannabis is a plant. It does not cause poor air quality and, indeed, quite the contrary. Like all plants, cannabis utilizes carbon dioxide and produces oxygen. Mould is only created if the production facility is improperly ventilated. Unfortunately, improper construction of cannabis production facilities is a facet of prohibition and the marginalization felt by cannabis consumers and producers.
5. The complexity and length of the application process for individuals who wish to obtain an authorization to possess and/or a licence to produce marihuana.
This is a real and valid concern that must be addressed in any improvements to the scheme. Other jurisdictions with medicinal cannabis access programs, such as several US states, have dramatically simplified application processes. This concern could be address by revisiting the declarations required in the MMAR, simplifying and condensing the information sought in the application forms and ending the arbitrary distinction between Category 1 and Category 2 applicants.
6. The impact of increasing participation in the Program on the efficiency and timeliness of the application and review process.
This concern is real and one that negatively impacts many Canadians. Bona fide medical consumers are at risk of violating the criminal law and facing severe deprivations of liberty because of inefficiencies and delays in processing applications and renewals. Between 400,000 and 1,000,000 Canadians use cannabis for medical purposes yet less than 10,000 are current participants in the program. It is unclear what factors led to the inefficiencies and delays but they must be addressed. Increased funding for staff combined with simplification of the application process are two areas of improvement that can be implemented immediately.
7. The fact that Health Canada only supplies one strain of dried marihuana.
This is a valid concern that has been addressed in part above. Any new scheme must include genetic differentiation including preservation of existing genetic lines and the knowledge built by the network of currently unlicensed producers serving medical consumers directly and through community-based dispensaries and compassion clubs.
8. The need for more current medical information pertaining to the risks and benefits associated with the use of marihuana for medical purposes, as a means of supporting discussions between physicians and their patients as to whether such treatment is appropriate.
This is a valid concern. Unfortunately Health Canada appears to no longer be supporting the research component contemplated when the medical cannabis access program was initiated. Facilitating research must be a feature of any improvements to the scheme. This can be accomplished in part by increased funding for research and loosening of the existing requirements for obtaining research licensing. In addition, Health Canada must revisit its publications in this area including its Information for Health Care Practitioners, a document which is both woefully out of date and ideologically biased. Finally, as described above, Health Canada must recommit to evidence-based policy making and education in the area of cannabis and medicinal cannabis. The climate of fear, stigma and marginalization must be reversed and supplemented with compassion, reason and evidence.
THE PROPOSED CHANGES
Health Canada proposes changes in two areas: physician patient interaction and dried cannabis production and distribution. The specific proposals, along with the Foundation's comment and suggestions, appear below.
A. Physician-Patient Interaction
Health Canada proposes the following changes:
1. Health Canada maintains that the determination as to whether the use of marihuana for medical purposes is appropriate for a particular individual is best made through a discussion with their physician. In this regard, Health Canada is proposing to eliminate the categories of conditions or symptoms for which an individual may possess marihuana for medical purposes under the MMAR.
2. Individuals would continue to be required to consult a physician to obtain access to marihuana for medical purposes. Since categories would be eliminated, there would no longer be a requirement for some individuals to obtain the support of a specialist in addition to their primary care physician in order to access marihuana for medical purposes.
The Foundation agrees that eliminating the categories of conditions or symptoms is a necessary improvement, as is removal of any requirement that a specialist be consulted. Both changes are improvements and would be consistent with working toward remedying the issues raised by the Court's findings in Mernagh. It is clear, however, that these changes do not go far enough. Physicians have essentially boycotted the current MMAR scheme and continuing to require that they be the sole gatekeepers to legal protection and lawful access to cannabis will result in continued serious violations of the Charter rights of patients. The categories of health care professionals able to permit lawful access to cannabis must be expanded to, at minimum, to any practitioner currently regulated by a provincial Act including, for example, Naturopathic Physicians, Doctors of Traditional Chinese Medicine and Nurse Practitioners. These practitioners, in many provinces, have the ability to provide lawful access to medicines with significantly greater risk profiles than cannabis. In addition, Naturopathic Physician and Doctors of Traditional Chinese Medicine have the benefit of familiarity with whole plant medicines generally and cannabis specifically. Expanding the gatekeeper role is consistent with evidence-based policy making and the requirements of the Charter.
3. The existing medical declaration would be replaced by a new document provided by the physician to the individual. Health Canada will consult the medical community on the form this document will take.
4. Individuals would no longer be required to submit information to Health Canada to be authorized to possess dried marihuana. Instead, they would submit their physician's document directly to a licensed commercial producer.
The Foundation agrees that the current declarations create a barrier to access and are in need of improvement. In addition, the Foundation welcomes the move toward a system of access to cannabis that closely mirrors that used by existing, and currently unlawful, dispensaries and compassion clubs. These community-based organizations have distributed cannabis to medical consumers for more than a decade by, essentially, requiring only that consumers provide applications forms from their health care practitioner. The Foundation is, however, dismayed that the proposed improvements do not contemplate licensing the very organizations that already comport with the procedure being proposed as the future of the government's program. This concern is more fully discussed in the production and distribution section below.
5. Health Canada will establish an Expert Advisory Committee to improve physician access to comprehensive, accurate and up-to-date information on the use of marihuana for medical purposes, thereby facilitating informed decision-making with respect to the use of marihuana for medical purposes.
6. Health Canada would work with the medical community, their provincial/territorial licensing authorities and their associations on the proposed improvements to the program.
The Foundation agrees that Health Canada must work toward proving physicians with accurate information about the use of medicinal cannabis. There must be a commitment to accuracy and rigor in evaluating the information being provided, a challenge that will be particularly onerous given the highly politically charged climate surrounding cannabis policy generally. The Foundation is deeply concerned that the language chosen to provide the social context for Health Canada's proposals (keeping "children and families" safe) does not foreshadow a commitment to sound evidence-based policy making.
B. Dried Marihuana Production and Distribution
1. Under the proposed redesigned program, Health Canada would no longer enter into a contract with a commercial entity to supply and distribute dried marihuana and marihuana seeds.
2. The only legal source of dried marihuana would be commercial producers, who would be licensed by Health Canada to produce and distribute dried marihuana. Individuals would purchase their supply of dried marihuana from one of these licensed commercial producers.
3. Personal and designated production would be phased out.
4. In order to be licensed by Health Canada, licensed commercial producers would have to demonstrate compliance with requirements related to, for example, product quality, personnel, record-keeping, safety and security, disposal and reporting, as set out in new proposed regulations. These controls would aim to ensure the quality of the product being purchased by program participants, as well as the security of production sites.
5. Health Canada would establish a comprehensive compliance and enforcement regime for licensed commercial producers, centered on regular audits and inspections.
6. Licensed commercial producers would be required to comply with specific product labelling and packaging requirements. The label and/or the package itself could be one way by which a program participant could demonstrate that their supply of marihuana is legal.
7. Licensed commercial producers would only be permitted to produce marihuana indoors.
8. Licensed commercial producers would be able to produce any strain(s) of marihuana, thus giving individuals greater choice as to which strain(s) they wish to use.
9. Licensed commercial producers would set the price for marihuana for medical purpose.
10. Licensed commercial producers would only be able to send the dried marihuana they cultivate to individuals by registered mail or bonded courier.
The Foundation believes that the proposed future production and distribution system would work well as an adjunct to the existing regime of personal and designated production. It is critical, however, that personal and caregiver designated production be preserved. Patients and producers have spent years, and significant funds, developing genetic lines to treat their specific ailments. In addition, personal and caregiver production is often the most cost effective, and for some the only economically viable, means of accessing cannabis. Removal of this right is likely to be found to violate the Charter and, more importantly, will certainly limit rather than improve access to a safe and effective supply of medicinal cannabis. It is of paramount importance that personal and caregiver production be retained in any future iteration of the medicinal cannabis access program.
The Foundation is also concerned that the proposals fail to address the use of cannabis in a variety of modes of ingestion including by way of resin, edibles, tinctures, salves, balms and other means of obtaining therapeutic benefit. As noted above, the recognition that patients require a variety of strains is welcome but it remains unclear how licensed producers will obtain those genetics. Moreover, the proposal fails to recognize the need to capitalize upon the knowledge and experience of the existing network of unlicensed suppliers represented by dispensaries and their current producers.
The proposal also contemplates only the delivery of cannabis by courier or mail. Many persons, particularly those living on disability or social assistance, have no fixed address and are unable to receive mail or delivery by courier. Many prefer to have the ability to view and smell the dried cannabis before purchasing it. And, most importantly, many patients appreciate the social capital gained by obtaining cannabis at a community-based dispensary. At minimum, Health Canada must include an option for regulating community-based dispensaries that can, and do, provide patients with more than just a supply of medicine. The existing network of unlicensed suppliers represented by dispensaries and compassion clubs provide members with significant social capital including supportive environments, knowledge about the medicine and particular strain/symptom pairings and the proper use of cannabis and cannabis byproducts.
The proposal is also vague about the standards to which producers will be held. The Foundation urges Health Canada to implement evidence-based requirements rather than overly onerous rules that will prevent most producers from obtaining licenses. There is, for example, no evidentiary basis for requiring only indoor production. Outdoor production can be cost-effective and produce an end product with compositions of therapeutic compounds that are not present in strictly indoor production.
As the Courts have held in relation to the Supply Issue, a system of arbitrary rules that creates barriers to access will be found to violate the Charter. The Foundation urges Health Canada to rethink its proposals. It is concerned that the proposed access scheme will continue to fail to meet the needs of critically and chronically ill Canadians.
The Foundation welcomes Health Canada's recognition that the current scheme is inadequate and in need of improvement. Unfortunately, the proposals set out in the Consultation Document will fail to address the deficiencies long identified by patients and by the Courts. The language used to identify the context for the proposed improvement is troublesome and contributes to the marginalization and stigmatization currently plaguing this important health issue. The refusals to consider the broader policy context created by the failed and harmful criminal prohibition of cannabis generally bespeaks a willful blindness to key social contexts informing this issue. The specific proposals set out in the Consultation Document are insufficient to protect patient access to a safe and effective supply of cannabis and cannabis byproducts.
Health Canada should consider licensing the current network of compassion clubs and dispensaries to provide cannabis directly to patients. The patient's right to produce for him or herself, or to have a caregiver assist in producing medicine, must be preserved. Additional producers and distributors should also be licensed on reasonable terms that do not present undue barriers to participating in the regulatory scheme. Finally, Health Canada should provide additional research funding and facilitate licensing of researchers in conjunction with a commitment to evidence-based education and policy making.
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