Canadian Med-Pot Regulations change

MMAR Still Unconstitutional After Latest Amendments

Since its inception in 2001, Health Canada’s medical marijuana program has failed to fulfill its mandate from the Ontario Supreme Court Parker case to ensure that those who use cannabis as a medicine do not have to choose between their liberty and their health.1 Only 821 medical cannabis users in Canada, out of an estimated 500,000, are doing so legally. For many of those 821 people, the process of obtaining their license has been a bureaucratic nightmare.
In October of 2004, Health Canada’s Office of Cannabis Medical Access (OCMA) released proposed amendments to the Marijuana Medical Access Regulations (MMAR).2 The amendments were based on consultations with their Stakeholders Advisory Committee, made up in large part by law enforcement, medical and pharmaceutical interests, and a very small representation of medical cannabis users.

Several patient groups, including the Canadian Aids Society, the BC Compassion Club Society, and Medusers, submitted responses to the proposed amendments to the OCMA. In a display of cooperation, patience and optimism, these groups provided feedback outlining their concerns and recommendations.3 All groups felt the amended regulations fell well short of patient needs, and did little to render the programme accessible, effective, compassionate, or constitutional.

Last week, the amendments were approved and a new set of application forms was released.4 Feedback from cannabis users and advocates was not incorporated. Nor were the measures ordered by the Ontario Court of Appeal to remedy the programme’s unconstitutionality.5 Thus while some of the changes are being applauded, most medical users and advocates are disheartened, and remain skeptical of the programme and of Health Canada’s plans for its future direction.

The New Categories of Applicants

The major changes on the application forms are related to the categories of applicants and their respective requirements for physician support.

Whereas there used to be three categories of applicants, there are now two. In addition to those being treated within the context of compassionate end-of-life care, Category 1 now includes applicants with Multiple Sclerosis, Spinal Cord Injury, Spinal Cord Disease, Cancer, AIDS/HIV, Severe Arthritis, and Epilepsy. Conspicuously missing from this list is Hepatitis C. Category 1 applicants only require the support of one physician (specialist or general practitioner), potentially greatly improving the odds for these additional illness groups to access the programme.

The new Category 2, which includes everything else, now only requires the signature of one physician instead of an additional one or two specialist signatures, which were previously required for category 2 and 3 respectively. Specialist involvement is still required, however, and the physician must declare that they have consulted with a relevant specialist who has assessed the applicant’s case, concurs that conventional treatments are ineffective or medically inappropriate for the treatment of the applicant, and is aware that cannabis is being considered as an alternative treatment.

By requiring varying levels of physician support, these two categories arbitrarily discriminate between legitimate medical cannabis users, equally deserving relief from their symptoms.

Medical Practitioners

The forms are the front end of the regulations, and represent the biggest hurdle to accessing the programme: getting them filled out by a physician.

The new forms shift some of responsibility from the physician to the patient in that the applicants are now required to acknowledge and declare their acceptance of the risks associated with the use of cannabis in their declaration and the physicians are no longer required to state that the benefits of cannabis use outweigh the risks.

Physicians are also no longer required to list conventional therapies that have been tried or considered, or to provide their reasons for finding those therapies to be ineffective or inappropriate. However, they still have to declare that conventional therapies have been tried or considered and have been found ineffective or medically inappropriate.

Despite the fact that the Regulatory Impact Assessment document, which accompanied the proposed amendments to the forms, suggested that the requirement for physicians to make recommendations about daily dosage would be removed, it remains.

It is unclear if these changes are enough of a shift to increase physicians’ comfort level with their previously rejected role of gatekeeper to the programme.6 Without a concerted educational effort on the part of the OCMA and the professional medical associations, the latter which have previously encouraged physicians not to sign the forms, it is unlikely.7

As for Specialists, it is uncertain if this lessened involvement on their part is sufficient to encourage their support. What is certain is that the continued requirement for specialist involvement ignores the Ontario Court of Appeal’s 2003 Hitzig ruling that, as a remedy to the programme’s unconsitutionality, struck down the requirement for a second physician to endorse a patient’s application to receive medical marijuana.

“This requirement is at best redundant,” the court said. “It adds no value to the application and does little or nothing to advance the state objective. In particular, it does nothing to promote public health and safety.”

Patients and doctors alike have proposed that the medical declaration should be limited to confirmation of diagnosis only, which would respect physicians’ professional and liability concerns. It would also respect patients’ right to an informed and autonomous choice of treatment.

Natural Health Care Practitioners

The amendments continue to reject natural health care practitioners, such as Doctors of Traditional Chinese Medicine and Naturopaths, who have much more experience with herbal health care than physicians. Their reasoning, that “with few exceptions controlled substances can be sold or provided to a patient only by, or under the direction of a physician, dentist or veterinarian,” is rather circular. Cannabis is a great candidate for an exception given its relative harmlessness compared to other controlled substances, and even uncontrolled ones.

Natural Health Product

Health Canada is still in denial about cannabis being a natural health product. Cannabis is a traditional medicine that, according to these regulations, is available for sale pursuant to a confirmation of diagnosis from a physician and ministerial approval. The fact that it does not require a prescription makes cannabis a perfect fit with the Natural Health Products (NHP) regulations.8 Inconsistent with its assertion, the OCMA is using NHP cultivation standards to assess the quality of its contracted cannabis product.

Attempting to regulate and administer this herb as if it were a pharmaceutical product creates unnecessary obstacles for patients, doctors and the governing bodies of the medical community.

Supply Source

If the amendments help people jump through the first hoop of getting a license, they are then faced with inadequate options for a legal supply. On the forms applicants must check off that they 1) plan to grow their own cannabis, 2) plan to designate someone to grow it for them, or 3) plan to purchase it from Health Canada.

Current stats show that as of April of this year, 594 applicants ticked off the first two choices and got licenses to grow accordingly. It is unknown how many are actually following through on their plans, though it is known that only 54 have applied for seeds from Health Canada. On the new forms it appears that those applying for a personal or designated person production license will be required to apply for, and purchase, seeds.

The only directive, of four, from the Hitzig case that has been incorporated into the amendments is the removal of a restriction that prevents designated, licensed growers from receiving compensation for supplying marijuana to sick people eligible to receive it.

As for the third choice, Health Canada currently only allows for one licensed dealer, which at this time is Prairie Plant Systems (PPS). Considering Health Canada’s plans to phase out personal production and designated person licenses, this could be the only remaining legal source. PPS currently provides only one strain of cannabis, at one THC level. It is not grown organically, it uses controversial gamma irradiation, and is of questionable quality. Although the potency of this cannabis has increased to about 12%, this is still lower than ideal for medical cannabis users who prefer higher potency so that they can use less.

The PPS cannabis costs $5 a gram and there is no refund if returned, which may explain the drop in return rate from 30% last year to 2%. 128 license holders are accessing PPS cannabis.

The need for a standardized and quality controlled source of cannabis is not a justification for a monopoly on production. Rather, licensing of laboratories to conduct appropriate tests, and establishing licensing and inspection protocols for small-scale producers will fulfill the need of medical cannabis users for lower cost, higher quality, and increased strain variety.

However, these latest amendments continue to ignore the final two Hitzig directives to remove: A provision that prevents licensed growers from raising marijuana for more than one person.

A prohibition against licensed growers’ producing marijuana in common with more than two other growers.

These directives were meant to address the need of medical cannabis users to have more that an “illusion to access” that the current options provide, by clearing the way for the licensing of compassion clubs and growing cooperatives.

In court, Health Canada stated that compassion clubs “historically provided a safe source of marihuana to those with the medical need’ and that “the ‘unlicensed suppliers’ should continue to serve as the source of supply for those with a medical exemption”.

Unfortunately, there is still no box for applicants to choose compassion clubs as their source of supply, although it is estimated that these organization supply at least half of the license holders.

Across Canada, the network of mostly non-profit compassion clubs serves about 10,000 medical cannabis users, providing access to a variety of stains of clean, high quality cannabis. The BC Compassion Club and other well-established clubs, such as the Vancouver Island Compassion Society and the Toronto Compassion Centre, also provide education, monitoring, ongoing advice and support, and access to other forms of natural health care. Over the last 8 years, they have proven themselves to be an effective, affordable and sensible way not only to distribute medical cannabis, but also to provide suffering Canadians with services no other model can deliver.

Under the current regulations, Compassion Club operators and staff will continue to risk arrest and criminal prosecution in their effort to attend to the needs of Canada’s critically and chronically ill.

Law enforcement and Safety

Another significant change to the regulations is that the amendments provide explicit authority for Health Canada to communicate limited information concerning authorizations to possess and licenses to produce marihuana to police in response to a request made in the context of an investigation under the Controlled Drugs and Substances Act (CDSA) or the MMAR.

License holders have been informed that previous requests not to disclose information are no longer valid. Health Canada states on their forms that this provision is meant to reduce the possibility of police intervention when license holders engage in activities allowed under their authorization or license.

While this measure may go a long way in reducing the harassment license holders are now experiencing at the hands of law enforcement, serious concerns were expressed by medical cannabis users and advocates at an OCMA Stakeholder’s Advisory meeting about how the police will use the information disclosed to them. It is not explicit how limited the information police can access is, i.e. if police can access personal information about illness and about medical practitioners though this provision or through an access to information request. The amendments do not address these concerns, nor take any measures to protect license holder from the potential abuse of this provision.

Mandatory disclosure of information to police is a violation of privacy rights. There is no reason to discriminate against those who might benefit from the therapeutic use of cannabis by forcing them to disclose personal information at the request of police organizations. For many potential and current participants in the MMAR program, this requirement is reason enough to avoid federal registration for therapeutic cannabis use. As a result, police and courts will continue to be in the position of using their discretion in relation to legitimate medicinal users who chose not to participate in the MMAR because of forced disclosure.

Privacy

As a testament to common sense, the new authorization to possess cards will no longer display the licensee’s medical information. It seems that with the provision authorizing Canadian police to obtain relevant information from Health Canada, the address of license holder and the cannabis production, as well as quantity allowable, could also be omitted. Such indiscreet information poses a great security risk should the license be lost or stolen.

Renewals

Apparently a new renewal form has been included that is shorter than the main application form. Another improvement is the requirement that new photo ID be submitted every 5 years instead of every 2 years.

To the dismay of many, renewals are still required every year. This is probably one of the most distressing elements of the programme, considering how difficult it is to get physician support in the first place. Requiring patients to go through major stress every year seems rather unreasonable and inhumane, especially for those with chronic illnesses.

Cost Coverage

Cost coverage, one of most vital of all primary stakeholder concerns, was once again not addressed in this third version of the regulations.

This year, Revenue Canada has allowed cannabis purchased from PPS to be deducted as medical expenses under the Income Tax Act. Given how few people are using this source of supply, this is an inadequate, though appreciated, gesture.

Other cost coverage measures are necessary to ensure medical cannabis users are not forced into poverty. Tax deductions, private insurance, and provincial health care insurance, must address all costs of medicine including personal cultivation and cannabis purchased from compassion clubs.

Additionally, home owners or renters that are authorized to possess and/or licenced to produce cannabis for therapeutic purposes must also be able to access insurance coverage for loss of equipment, crops, or harvested cannabis in the event of a fire or theft. They must be assured they will not have their house insurance withdrawn, nor be evicted from their home.

Humour is the Best Medicine

Providing some comic relief, the OCMA has replaced a grammatically awkward programme name with a more aptly descriptive one. The Marihuana Medical Access Regulations (MMAR) is now called the Marihuana Medical Access Division (MMAD). There has been no comment on this as of yet from Mothers Against Drunk Driving (MADD).

In another suspension of reality, the regulations require applicants to consent to using marihuana only for the treatment of the symptom stated in the medical declaration. Those who find cannabis elevates their mood, helps them sleep, or reduces their stress, need not apply.

While on the one hand Canada must be applauded for being one of three countries with a medical marijuana programme, it is doubtful if the latest amendments will open up access to the programme. And it is doubtful whether they are indeed intended to, when the blatant disregard of the needs and rights of people living in Canada to relieve their suffering without risking their liberty continues year after year.

Considering Health Canada’s lack of commitment to research, it seems it is treating the programme as a stop-gap measure as they move towards their vision of a more “traditional” pharmaceutical model. If this is the case, they acting in bad-faith at the expense of tax-payer dollars and Canadians lives.

Most disturbingly, the programme creates a false impression that those with licenses are the only legitimate medical cannabis users. This makes it easier to persecute those without licenses. And when those without the licenses account for an overwhelming majority, we have to decide whether we should continue try to improve this programme, or abandon it completely.

The Parker decision gave the government the opportunity to ensure the rights of medical cannabis users in order to uphold the cannabis prohibition laws. It appears, with these latest amendments, they have failed once again. Perhaps the next court that finds the programme unconstitutional – and noncompliant with court-ordered remedies – will strike it down.

“Some of these people are terminally ill. To suspend our remedy if they may die in the meantime is, in our view, inconsistent with fundamental Charter values.”

1 www.johnconroy.com/parker2.html

2 canadagazette.gc.ca/partI/2004/20041023/html/regle2-e.html

3 www.cdnaids.ca/web/backgrnd.nsf/cl/cas-gen-0089
thecompassionclub.org/pdf/BCCCSMMAR- Revised.pdf
thecompassionclub.org/pgrouphstat.htm

4 the revised regulations are not yet on the OCMA webiste, however the forms are available at www.hc-sc.gc.ca/hecs-sesc/marihuana/how-comment/applicant-demandeur/index_e.html

5 www.johnconroy.com/Hitzig03-10-07.pdf

6 www.cmpa-acpm.ca/portal/pub_index.cfm?LANG=E&URL=cmpa_docs/english/resource_files/admin_docs/common/com_letter_to_rock_2002_11-e.html

7 www.cmaj.ca/cgi/content/full/166/1/83…

8 www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/nhp_regs_e.html

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