CCIC comments to Health Canada s consultation document July

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1 July 28 th, 2011 Marihuana Consultations Controlled Substances and Tobacco Directorate Health Canada Mail Room, Federal Records Centre Bldg 18 1 st floor, 161 Goldenrod Driveway, Tunney s Pasture Ottawa, ON, K1A 0K9 Fax: Consultations-marihuana@hc-sc.gc.ca CCIC comments to Health Canada s consultation document July Preamble We would like to start by commending Health Canada (HC) for taking concrete steps towards improving the Marihuana Medical Access Regulations (MMAR). We are aware that this process has been ongoing for the last two years, with a detailed program review and focal consultations leading to the proposed changes, and we commend Health Canada for embarking on wide consultation at this stage. The Canadian Consortium for the Investigation of Cannabinoids (CCIC) is a federally registered non-profit organization whose mandate is the promotion of research and education on cannabinoids in health and disease. The CCIC and its members (including over 150 scientists, physicians and other healthcare professionals) have been involved with the MMAR program since its inception as a section 56 exemption program in 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 two years we have embarked on an extensive medical education campaign on cannabinoids that is receiving international recognition and attention. Overall, we see the proposed changes as a positive step, recognizing in particular the public safety issues that have arisen around lack of regulation on designated growers, and the lack of access to physicians who are willing to sign MMAR authorization forms. We accept the concerns laid out in the document as valid, but we feel it is important to point out that the concerns do not, at this time, stem from concerns around the safety of the use of the drug by patients. We are also pleased that the intent of the program remains true, and wish to highlight the fact that the intent is to provide seriously ill Canadians with reasonable access to a legal source of marihuana for medical purposes. The proposed changes include the following steps: - 1 -

2 A. Physician-patient interaction 1. Eliminate HCs role in reviewing applications 2. New supply and distribution system 3. Emphasis on physicians to authorize access 4. No more categories of conditions or symptoms 5. Set up an Expert Advisory Committee to improve physician access to information 6. Work with medical community and licensing authorities B. Marihuana production and distribution 1. No contracted supplier 2. Establish licensed commercial producers 3. Phase out personal and designated production 4. Regulate and monitor commercial producers 5. Allow commercial producers to grow more than one strain, set prices and sell direct to consumer via mail or courier The devil, as they say, is in the details. It is there that the proposed changes will face true challenges of design and implementation and will require innovative solutions and compromise to achieve a balanced regulatory approach that is acceptable to all stakeholders. We will provide comment and suggestions under each item. A. Physician-patient interaction 1. Eliminate HCs role in reviewing MMAR applications This is appropriate. HCs role should be in regulating the program, not deciding who is or is not eligible. 2. New supply and distribution system This is also reasonable, provided that access and choice is improved (see below). 3. Emphasis on physicians to authorize access This is where a major issue is going to be faced with this process. There are two issues. The first relates to the need for further education. Most physicians are not familiar with the extensive science regarding the endocannabinoid system and the role of cannabinoids as therapeutic agents. The CMA has been very clear that physicians who think they do not have the appropriate knowledge base should not be involved in the MMAR program. This perspective has not changed and the majority of physicians have chosen not to be involved. Several CCIC members have stated their discomfort with the gatekeeper role for physicians, and have indicated that this has led to additional burden on physicians and clinics who have taken the time to review the literature and elected to become involved. The second issue relates to the fact that physicians who are educated about the endocannabinoid science and who elect to become involved with the MMAR are only in a - 2 -

3 position to identify if cannabis is a reasonable treatment for the specific medical condition of their patient. Physicians will not have access to reliable information as to whether the patient has been arrested for trafficking or diversion in relation to drugs in the past. Thus it will be important to include a mechanism to review this type of issue known only to law enforcement. The proposed changes to the MMAR place the physician squarely in the role of gatekeeper. The issue of physician education will have to be examined, and concrete, accessible and effective programs will need to be put into place and evaluated. Physicians will need simple guidelines and access to support, and the task of the Expert Advisory Committee (EAC) will be paramount in this process. Included in this will be the need to make the new forms simple, clear, effective and legally and ethically acceptable. 4. No more categories of conditions or symptoms We support this. Cannabis (in its herbal form) is not an approved drug, so it is misleading to have approved indications. MDs will need access to such data as does exist on cannabis and cannabinoids for the more common presenting disorders (see below). 5. Set up an Expert Advisory Committee to improve physician access to information This is a critical step, and the first test of how serious (and successful) this process is will be who chairs and sits on this committee. The CCIC suggests that representation from the CMA, CMPA, CCIC, addiction medicine, pain management, psychiatry, neuroscience, sociology, pharmacy, nursing and patient representation should be strongly considered. The committee should be adequately briefed by law enforcement, compassion clubs, existing licensed producers, policymakers, lawyers and other stakeholders. 6. Work with medical community and licensing authorities Developing a knowledge transfer mechanism (likely by the EAC) will be critical to inform and engage provincial colleges in the process. Other important stakeholders at the provincial level include insurance companies (e.g. workman s compensation, automobile insurance etc) and medical schools. B. Marihuana production and distribution Here the CCIC has no experience, but we suggest that the key to success of this part of the program will be in finalizing the level of regulation required to act as a commercial producer. The screening and approval process will need to be balanced between regulatory rigor and fairness for competition. 1. No contracted supplier We agree. Health Canada should not be in the business of growing and selling cannabis

4 2. Establish licensed commercial producers See above 3. Phase out personal and designated production We anticipate that HC will face a strong response from the medical cannabis community in this regard, and we suggest that some form of compromise will have to be sought with this item. If the regulations for commercial producers are so stringent that few companies step up to provide this service, and if their ability to offer choice of cannabis strains to patients is limited, then HC can expect this issue to be challenged legally. The CCIC recognizes that there has been abuse of the designated production license, and that this should be phased out, but we believe that personal production should remain, provided it, too, is closely monitored and regulated. There are several reasons for this position. One is that for many patients it will be easier and cheaper to grow their own supply of cannabis than to purchase from a commercial producer. Another is that for many patients the act of growing their own medicine is actually therapeutic in its own right, and gives them a sense of control and ownership of their health and treatments. This intangible effect is purely based on compassion, not evidence. We believe that a regulatory mechanism can be set up for personal growers. They must be prepared to submit site and product for inspection, provide appropriate conditions, and be able to submit samples to centralized labs for testing at reasonable cost. Penalties for abusing the personal production license (PPL) should be firm but fair. Commercial producers would be able to sell seed to personal production license holders; costs of equipment, materials and hydro etc would remain the responsibility of the PPL holder. If the commercial producers are good and accessible, we suspect that the PPL option will be exercised by few individuals, but its presence does allow for a supply option to the patient and this will be an important point in negotiations with stakeholders. 4. Regulate and monitor commercial producers We agree. 5. Allow commercial producers to grow more than one strain, set prices and sell direct to consumer via mail or courier We agree. Such producers should be encouraged to engage in research to evaluate what the phenotypic differences in these strains are (e.g. cannabinoid content, delta-9- tetrahydrocannabinol and cannabidiol, terpenoid content etc) and how these relate to differences in patient outcomes. Rural access and shipping costs need to be addressed, and we propose that a pharmacy distribution model should be seriously explored to allow access to remote areas and to avoid patients taking on the burden of ship costs which may become prohibitive and thereby limit access

5 CONCLUDING COMMENTS The main concern from the CCIC at this point is the lack of any attempt to stimulate research on the endocannabinoid system and the medical use of cannabis and other cannabinoids. One of the main barriers to the entire process has always been a lack of data, and it is only through research that we can provide up-to-date information to health care providers, patients and the public. To resolve this, the CCIC proposes that any and all commercial producers who are licensed under the new regulations must contribute a percentage of their revenue to a centrallymanaged independent Cannabis Research and Education (CARE) fund. This levy will be tax-deductible, uniformly applied, and fair given that the companies are profiting from selling an unapproved drug. The funds will be managed by an appropriate committee and could, for example, be used to support a research group to conduct a voluntary patient monitoring program (patients must provide informed consent to participate) for adverse events, or to provide guidelines to participating clinicians on follow-up to monitor patient outcomes and safety issues. These data will also feed into the education programs (see above). Such an approach will be of very low cost to HC, allow independent arms-length monitoring of the health of Canadians participating in the MMAR by experts in the field, and will reassure international bodies that Canada is not only allowing compassionate access to cannabis for medical purposes, but by doing so, is also committed to adding to the body of knowledge on the subject to the international scientific and clinical community. Sincerely, Dr. Mark A. Ware President and Executive Director Canadian Consortium for the Investigation of Cannabinoids Westwood Dr. Pointe-Claire QC H9S 4Y5 tel : fax : mware@ccic.net