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Letter from Health Canada to Ted Smith
By Hempology | June 12, 2008
If you would like to see the earlier letters between me and Health Canada see the Cannabis Digest issues #5, 7, 8, 9, 10, 11, 12 and 16.
June 3, 2008
Dear Mr. Smith
Thank you for your letter dated December 4, 2007 sent to Honourable Tony Clement, regarding the research program and your request for an exemption under section 56 of the Controlled Drugs and Substances Act (CDSA) and the attachments as Health Canada did not receive your letter dated Jan 3, 2007. I have been asked to respond to you directly and apologize for the delay.
Health Canada appreciates stakeholders’ views and input and notes your comments regarding the need for a community based advisory committee to oversee the program. I would ask you that Health Canada considers, on an ongoing basis, comments received with the aim of improving the program’s efficiency. Furthermore, when required, committees may be established. As noted in your letter, in the case of marijuana for medical access program, a committee was established some years ago for specific discussions around amendments of the regulations. It has since been discontinued as its’ mandate was fulfilled.
I would like to take this opportunity to clarify the previous letter sent to you regarding the issue of marijuana resin and provide information to you. Activities such as producing marijuana resin or tetrahydrocannabinol (THC) by extraction, with chemicals or other substances, are outside the scope of the Medical Marijuana Access Regulations (MMAR). Unless authorized under the regulations to the Controlled Drugs and Substances Act (CDSA), these activities are illegal. According to subsection 7(1) except as authorized under the regulations, no person shall produce a substance included in Schedule I, II, III, or IV of the CDSA. Cannabis resin is included in subsection 17(1) of the Schedule to the Narcotic Control Regulations (NCR).
When an Authorization to Possess or a Licence to Produce dried marijuana for medical purposes is granted, each authorized person routinely receives a fact sheet that explains what an authorization to possess dried marijuana will allow them to do as well as the requirements of the regulations and other general information including the mention that this authorization or licence does not apply to any derivatives of marijuana such as marijuana resin, hash oil, etc.
The Government of Canada believes that clinical research regarding the use of marijuana for therapeutic purposes and the development of marijuana based products is best undertaken and funded by the pharmaceutical industry; however, there are mechanisms available to those who want to participate in research under certain conditions.
Also, I would like to point out that clinical trials for drugs are regulated by the Food and Drugs Regulations and managed by the Therapeutic Products Directorate of Health Canada. For more information on the requirements and how to apply to conduct clinical research, you can consult the following link:
http:www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_intro_e.html.
With regards to your request for an exemption under section 56 of the CDSA, to conduct research, more information would be required to clarify the nature of your request. You may be interested to know that avenues, other that a section 56 exemption, may be available to you. Section 67 of the NCR provides the Minister of Health with discretionary powers to issue a licence to any person who, in the opinion of the Minister, is qualified thereof, to cultivate, gather or produce marijuana for scientific purposes on such terms and conditions as the Minister deems necessary. For more information on the application process, please consult the “Interim Guidance Document- Cultivation of Cannabis for Scientific Purposes” available at the following link: http://hc-sc.gc.ca/dhp-mps/pubs/precurs/cannabis_scientific/index_e.html.
Moreover, an exemption under section 56 of the CDSA is not a mechanism to circumvent other available avenues for access. By its very nature, the exemption under section 56 of the CDSA, may be granted only in exceptional circumstances when, for example, all other avenues are not possible. As previously mentioned, other mechanisms may be available to meet your needs for distribution of marijuana in a clinical trial.
I also want to take this opportunity to acknowledge the research reference submitted for our consideration and would like to point out that Health Canada monitors peer reviewed journals for new clinical data on the risks and benefits of marijuana for medical purposes so it stays current as the science of marijuana evolves.
Please note that legal access to marijuana for medical purposes can only be obtained through Health Canada under the authority of the Medical Marijuana Access Regulations (MMAR). Once approved under the MMAR, individuals have three legal options for obtaining a supply of dried marijuana: they can apply under the MMAR to access Health Canada’s supply of dried marijuana; they can apply for a personal use production licence, or designate someone to cultivate on their behalf with a designated-person production licence. Therefore, compassion clubs are unregulated and have always operated outside Canadians laws. These clubs have no legal authority to provide access or to produce and distribute marijuana.
If you have any questions regarding this letter or the Regulation, please visit the Health Canada website at www.healthcanada.gc.ca/mma or you can contact the Marijuana Medical Access Division toll-free at 1-866-337-7705.
Yours sincerely,
Ronald Denault
Manager
Marijuana Medical Access Division
Drug Strategy and Controlled Substances Programme
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