Chapter 13 - Regulating Therapeutic Use of Cannabis

Compassionate access?

 

One of the objectives of the MMAR was to provide a compassionate framework for medical access to marijuana. In addition, one of the criteria used in choosing the current regulatory approach was that it “must not unduly restrict the availability of marihuana to patients who may receive health benefits from its use.”[1][27]

While a process that authorizes the possession and production of marijuana has been established in Canada, this has not ensured that cannabis is suitably available to those in need. After careful review of the MMAR and thorough consideration of the evidence submitted to us, it is apparent that the MMAR have become a barrier to access. Rather than providing a compassionate framework, the regulations are unduly restricting the availability of cannabis to those who may receive health benefits from its use.

The following was stated in the Regulatory Impact Analysis Statement that accompanied the publication of the MMAR.

 

Due to anticipated increased visibility and efficiency of the new regulatory scheme and increased awareness of the potential uses or medical benefits of marihuana, it can reasonably be expected that the numbers of applicants will increase significantly. (emphasis added)

 

As reported to us by Health Canada, as of 3 May 2002, 658 exemptions had been granted under the authority of section 56, and 501 were still active. In terms of the MMAR, 498 applications were received and 255 had been authorized as of the same date. In addition, 164 personal production licences and 11 designated personal licences have been issued. The rest of the files are open and are incomplete, awaiting more information or undergoing review.[2][28]

Thus, almost one year after the MMAR came into force, only 255 people have been authorized to possess marijuana for therapeutic purposes and only 498 applications have been received. These numbers are significantly lower than the number of exemptions that were granted under section 56 of the CDSA. Although 501 exemptions under section 56 are still active, it is clear that the number of applicants has not increased significantly as could “reasonably be expected” under the MMAR. In fact, the stated efficiency of the new regulatory scheme should be viewed with much scepticism. The low participation rate, in itself, should raise serious concerns among those sincerely aiming to provide compassionate access to cannabis for therapeutic purposes. In addition, the following sections will set out some of the specific problems that must be addressed if the regulatory scheme is to be truly efficient and compassionate.

Eligibility

The current framework requires an applicant to obtain a declaration from a medical practitioner (or one or two specialists) indicating that the recommended use of marijuana would mitigate the applicant’s symptom and that the benefits from the applicant’s recommended use of marijuana would outweigh any risks associated with that use. The medical practitioner must also determine the applicant’s recommended daily dosage and period of use. A medical practitioner is defined as someone who is authorized under the laws of a province to practise medicine.

It is clear to everyone that requiring medical practitioners to act as “gatekeepers” in the use of marijuana for therapeutic purposes has created a major impediment to access, or, as Health Canada states, “there is a conundrum”. The Canadian Medical Association and many other professional medical organizations have refused to support the new federal application process because of issues of patient safety, dosages, and the legal liability of physicians prescribing cannabis.

This reluctance should not have come as a surprise to Health Canada. During the consultation process with regard to the proposed regulations, two medical associations and two provincial licensing authorities opposed the use of smoked marijuana for medical purposes. Their reasons included:  

··               The lack of scientific evidence supporting its use;

··               The fact that marijuana is not an approved drug product;

··               The view that the use of smoked marijuana is not an acceptable form of drug administration; and

··               The view that the responsibility placed on doctors to support the use of marijuana for medical purposes may place them in conflict with professional conduct rules relating to the use of unapproved or “alternative” medicines.[3][29]

 

The position taken by the Canadian Medical Protective Association (CMPA) is fairly reflective of the positions taken by other individuals and organizations in the medical community. The CMPA is a medical mutual defence organization with 60,000 members–about 95 per cent of the physicians practising in Canada. It has warned its members that they could expose themselves to liability or professional misconduct complaints if they prescribe marijuana without “detailed knowledge” of the drug’s risks and benefits and the appropriate dosage. The following was stated in an information sheet sent to members:

 

Section 69 of the regulations allows a medical licensing authority to request from the federal health minister information regarding a specific medical practitioner, which may be provided if the minister has reasonable grounds to believe the medical practitioner has made a false statement under the regulations. This is a significant concern, as physicians may unknowingly make a false statement because they are being asked to attest to matters that may go beyond the scope of their expertise. As a result, the risk that physicians could be reported to their College is increased.  

 

The fact that marijuana is not an approved drug product may lead some to conclude marijuana is an alternative medicine. This raises the important point as to whether the Colleges would consider physicians’ involvement in the application for a licence to possess marijuana as requiring them to comply with the policy of that College concerning alternative or complementary medicines. The CMPA advises physicians to ascertain from their regulatory authority what their position is in this regard.  

 

Given the consequences that may befall physicians with respect to their licensing body, or potential medico-legal liability, physicians will want to be very careful when determining whether to assist a patient in making an application under these regulations. [4][30]  

 

The CMPA has also stated that the information about the effectiveness of medical marijuana in each patient’s case, the relative risks and benefits of the drug and what dosage would be appropriate is “simply is not available,” making it nearly impossible for the vast majority of doctors to comply with requirements of the MMAR. It views the MMAR as placing “an unacceptable burden on member physicians” and states that, since “many physicians would not have the necessary knowledge about the effectiveness, risks or benefits of marijuana, we believe it is unreasonable to make physicians gatekeepers in this process.”[5][31]  The CMPA advised its members as follows:  

 

As you will see from the attached Information Sheet, now in the hands of our members, we have advised those physicians who are not or do not feel qualified to make those assessments to refrain from signing a declaration for a patient. We also advised our members to explain to their patients why they do not have the knowledge about marijuana, and to refer the patient to another physician, if known, with more experience in the medical use of marijuana.

 

Finally, recognizing that some physicians, out of compassion for their patients, may believe in good faith that their medical condition would benefit from marijuana, we have advised them to complete only Parts 1 and 2 of the form and to NOT complete Parts 3, 4 and 5, leaving Health Canada to decide whether to process an incomplete application. [6][32]

 

Clearly, under these circumstances, patients will have difficulty finding a medical practitioner willing to complete the required declaration forms, and even more difficulty accessing the appropriate specialists. This situation has created an unacceptable barrier to access and one must conclude that physicians should not be the “gatekeepers” under the MMAR, a responsibility that they themselves do not desire. Even Health Canada recognizes that there is a problem.

 

Without that scientific evidence, the doctors are in a legitimate quandary. For other therapeutic products, doctors rely on information that Health Canada either develops or analyzes through the drug review process. That is the basis for doctors’ understanding of the particular products. They do not have that analysis in this particular situation.  

 

Through the marijuana medical access regulations, we have eliminated the criminality of possessing and growing for your own purposes. That is the regulatory regime that is in place. We are working with Prairie Plant Systems, as Ms Lynch has said, to develop a research source for this product that will be made available through legitimate clinical trials for patients.

 

Until such time as we can begin to get the results of the research and until the medical community can determine whether it will prescribe this in legitimate circumstances, there is a conundrum. [7][33]

 

The involvement of physicians in the process is not questioned–what must be determined is their proper role with respect to use of cannabis for therapeutic purposes. Physicians are trained to provide a diagnosis of a person’s medical conditions and symptoms and to determine how to treat these conditions and symptoms medically. Most do not have, however, adequate knowledge of the therapeutic benefits of cannabis and are reluctant to associate themselves with this product for a variety of reasons, including its illegality. In our view, and as we have explained in detail in Chapter 9, a distinction must be made between an approved medicine per se and a substance that has, at the very least, potential therapeutic applications–although these may not have been “scientifically” confirmed to date. Chapter 9 enumerates the conditions and symptoms for which cannabis has potential therapeutic applications.  Let us be clear: we do not view cannabis as a “miracle” substance that will treat or cure numerous medical conditions or symptoms. It is a substance, however, that is known to provide effective relief of certain medical conditions and symptoms, thus improving the quality of life of many individuals.

In these circumstances, the proper role of the physician should be to make a diagnosis of the patient’s medical conditions or symptoms. If the condition or symptom is one where cannabis has potential therapeutic applications, the patient would be authorized to use the therapeutic product of his or her choice, including cannabis. This would also mean eliminating the current requirement that all other “conventional treatments” have been tried or considered before the use of cannabis is authorized. There is no justification for making cannabis an option of “last resort.”

The requirement for specialist involvement in the current scheme clearly can lead to long delays. To make matters worse, the stated positions of medical organizations would make it very difficult to get two specialists to make the required declarations.  This creates another unwarranted barrier.

 

The requirement to involve a medical specialist in the authorization of possession of medicinal cannabis is unjustified, unfounded, unrealistic and punitive. It negates timely access, and places au unjustified burden on both the patient and the Health Care system. Many patients already wait from nine months to a year to see a specialist. This means that those waiting for authorization to access medicinal cannabis may be on hold for upwards of a year. This is an inhumane wait to force upon those in dire medical need. In addition, it will unnecessarily exacerbate already extensive waiting lists for specialists, meaning those in genuine need of the specialists will unduly suffer. [8][34]

  

The conditions and symptoms for which cannabis use would be authorized are set out in Chapter 9. New conditions or symptoms would be added based on ongoing research.  

We are aware that the 1961 Single Convention on Narcotic Drugs would seem to require medical prescriptions for the supply or dispensation of drugs to individuals.[9][35] We make two comments:

·               International conventions are generally subject to a country’s constitutional provisions. As previously discussed, courts in Canada have found that depriving an individual of the ability to choose marijuana as medication to alleviate the effects of a serious illness does violate the rights protected under the Canadian Charter of Rights and Freedoms unless there is a statutory exemption scheme authorizing such use. The courts have indicated that, where a statutory exemption scheme turns out to be “illusory,” a constitutional exemption will be granted. The stated positions of Canadian medical organizations may make the current MMAR exemption scheme turn out to be “illusory.”

··               It is better to look to the spirit rather than the letter of the Convention.  While cannabis may not be an approved medicine per se, there is no doubting its potential therapeutic applications. Thus, the Government of Canada should advise the international community that we will not strictly adhere to this requirement and that we will be requesting appropriate amendments to the international conventions.