28 February 2013
The Canadian Consortium for the Investigation of Cannabinoids (CCIC) is a federally registered nonprofit organization whose mandate is the promotion of research and education on cannabinoids in health and disease. The CCIC and its members (including over 200 scientists, physicians and other healthcare professionals) has been involved at various levels with the MMAR program since its inception as a section 56 exemption program in 1999. We have been involved in doing some of the critical research on cannabis and cannabinoids at the bench and bedside, and into wider society, and in the last three years we have embarked on an extensive medical education campaign on cannabinoids that is receiving international recognition and attention.
The CCIC was part of earlier consultations with HC on the proposed MMAR changes, we have consulted with our members, and we are pleased to comment on the new Marihuana Medical Purposes Regulations (MMPR) released in the Canada Gazette Part 1 on 16 December 2012.
The CCIC recognizes that regulating medical cannabis is a complex, global, multi-stakeholder issue. Cannabis, as a raw herbal product, does not fit any standard regulatory framework, and, in the absence of large-scale trials and major industry sponsorship, is unlikely to ever follow standard pharmaceutical drug development paradigms. The status of herbal cannabis as a controlled substance restricts it from being handled as a natural health product. Therefore, we recognize that any regulatory framework is likely to be regarded as flawed from the perspective of one or more stakeholders. However, we recognize that cannabis and its active ingredients have therapeutic potential for a wide range of symptoms and diseases, and can be administered in a wide variety of means. This inherent variability presents unique challenges, and opportunities, for clinical practice and research.
The focus of the CCIC, as clinicians, scientists, and educators, is on the impact of these regulations on our patients, our health professionals, our community and our research. Our comments are based around these themes.
The new MMPR proposes the elimination of personal production and designated production licenses and the establishment of licensed producers. Patients will only be able to access cannabis for medical purposes from these licensed producers. The major concern expressed by CCIC members around this aspect is one of access. We understand the need to bring designated licenses under tighter regulatory control in the interests of public safety, but we are concerned that the inability for patients to cultivate cannabis for personal use may have a severe impact on those patients in vulnerable conditions who will be unable to afford access to cannabis through licensed producers. The only way out of this dilemma is to ensure that mechanisms exist for patients in dire and proven economic need to be able to continue to access cannabis affordably. If these mechanisms are not in place, such patients will continue to cultivate cannabis illegally, and with new mandatory minimum sentences in place for the possession of cannabis,these patients are actually at increased risk under the MMPR. This situation will likely not be acceptable in the courts, and we recommend proactive consideration of these concerns.
The solution to the problem of access will likely be a combination of industry initiatives (e.g. sliding scale pricing models), tax breaks (e.g. medical cannabis expenses allowed as deductions for medical expenses) and efforts to establish appropriate cost coverage under provincial formularies. The latter will only be possible if it can be demonstrated that covering the costs of medical cannabis results in substantial economic savings elsewhere. This can only be investigated if appropriate monitoring programs are established (see below). The MMPR should be structured to allow such approaches to address potential shortfalls in access to the most vulnerable patients.
On the positive side, the CCIC recognizes that increases in licensed production will increase choice for patients, and this choice may meet currently unmet medical needs. Producers will need to ensure that they recognize and respond to patients’ needs in terms of cannabis phenotyping and patient profiling. It is unfortunate that the MMPR is silent on the issue of oral cannabis-based products such as infusions and tinctures which may have a role in reducing use of smoked products.
The MMPR does not appear to allow any role for community-based distribution facilities without the involvement of pharmacists. While we welcome a role for pharmacists and pharmacy-type distribution, there is considerable experience and expertise currently based in community dispensaries, particularly in terms of patient education and alternative delivery systems, and it is unfortunate that this wisdom is not recognized in the regulations. The CCIC hopes that provincial health delivery policy makers and pharmacists will find creative ways to harness such community-based approaches in ways that are legitimate, compassionate and collaborative in order to improve patients’ understanding of the complexities of medical cannabis use.
The move to eliminate the centralized authorization procedure and move toward a prescription approach appears to handle cannabis more like a prescription medication (albeit without the formal approval typically required for pharmaceuticals). The ability for nurse practitioners to prescribe cannabis, in jurisdictions where this is within their scope of practice, is seen as a positive step and deserves serious consideration.
The major issue that the CCIC sees with this process will be the need for clinician education. Education will need to be based on the product (mechanism of action, safety and efficacy, dosing, guidelines for monitoring etc.) and the policy (legal implications, how to interpret the regulations, relationship with licensing bodies etc.). The CCIC is encouraged by Health Canada’s efforts to develop information for health care professionals, and serious and dedicated efforts to get this knowledge out in a meaningful way to the end knowledge users must be forthcoming.
The issue of serious adverse event (SAE) reporting needs to be addressed. In the existing MMPR it is the stated responsibility of the licensed producers to report SAEs:
57. (1) A licensed producer who sells or provides dried marihuana must provide the Minister with a case report for each serious adverse reaction to the dried marihuana, within 15 days after the day on which the producer becomes aware of the reaction.
(2) A licensed producer who sells or provides dried marihuana must annually prepare and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the dried marihuana that have occurred during the previous 12 months.
This approach fails to recognize that the major source of SAE reports will be the patients, reporting to or detected by either the clinician prescribing the cannabis or the dispensing pharmacist. SAEs have a specific regulatory definition (i.e. an AE that results in death, cancer, disability, prolonged hospitalization, congenital abnormality). For a licensed producer to collect the SAE directly from the patient would require the prescribing clinician to be advised, and this opens the door to serious privacy concerns (already an issue that the CCIC recognizes). The MMPR must be amended to reflect the role of health care professionals in monitoring for and reporting AEs (including SAEs) (Part 4).
The CCIC does not believe that health care practitioners (HCP) should be able to sell cannabis (Part 4 section 124(a)). This would appear to be contrary to ethical medical practice and should be removed, along with all sections where the HCP is stated to be able to sell cannabis.
The MMPR continues to contain no provision for supporting or promoting research on cannabis for medical purposes. Given that the evidence base for the safety and efficacy of the therapeutic use of herbal cannabis is known to be limited, that the Canadian Government is proposing to allow commercial production of an unapproved drug for therapeutic purposes, that there will be tax revenues generated through this program, and that Canada has considerable scientific capacity, and the will, to study the effects of cannabis on human health, the CCIC feels that there is a moral imperative to engage the research community in setting up monitoring programs independently of commercial production, funded through the revenues from the sale of cannabis under the MMPR. Research priorities should be set by basic, clinical and health policy researchers to respond to the needs of patients and health care professionals. Not to support research would represent a lost opportunity to inform the entire global community of the health effects of cannabis.
The CCIC assumes that the savings from eliminating the central authorization process will not be offset by increased costs to regulate licensed producers. Program review should be ongoing rather than waiting five years as currently stated in the MMPR.
Overall, the CCIC sees the proposed changes as an improvement over the MMAR. The keys to the success of the MMPR will be adequate clinical and public education, independent monitoring of health and economic outcomes, and solutions to access issues for financially challenged patients.