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Drugs and Health Products

Medical Marihuana Regulatory Reform 2011 Consultations Results

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In recent years, a wide range of stakeholders including police and law enforcement, fire officials, physicians, municipalities, and program participants and groups representing their interests, have identified concerns with the current Marihuana Medical Access Program (MMAP).

To address these concerns, an online and in-person consultation process was launched between June - November 2011, to gather comments from interested parties on the proposed improvements to the Program. Input from these consultations will be considered in the development of new regulations.

Here's what they said:

Introduction

The Results

  1. Physician - patient interaction
  2. Patient access
  3. Proof of legal possession
  4. Licensed production

Conclusion

Introduction

Background

On June 17, 2011, in response to concerns heard from Canadians, the Minister of Health announced that she is considering improvements to Health Canada's Marihuana Medical Access Program (the Program). The proposed improvements would reduce the risk of abuse and exploitation by criminal elements and keep our children and communities safe, while significantly improving the way program participants access marihuana for medical purposes.

Health Canada also launched public consultations on the proposed improvements.  A consultation document was posted on the Health Canada website which outlines the proposed improvements. 

This report serves as a summary of the key themes heard during that consultation process.

The improvements under consideration

See more information on the proposed improvements to the Program.

Who was consulted?

Between June and November 2011, Health Canada consulted with key stakeholders to get their views on the proposed changes and to gain information and knowledge to inform the development of new regulations. Stakeholder groups included:

  • authorized and licensed individuals under the current Program;
  • compassion clubs and cannabis dispensaries;
  • provincial and territorial ministries of health and of public safety;
  • physicians, including medical associations and colleges of physicians and surgeons;
  • municipalities;
  • law enforcement officials;
  • fire officials;
  • pharmacists; and
  • Canadians with an interest in the Program.

The Results

1. Physician - patient interaction

Health Canada's proposal maintains that individuals would still be required to consult a physician to obtain access to marihuana for medical purposes.  However, categories of conditions and symptoms would be eliminated. Therefore, there would no longer be a requirement for some individuals to obtain a specialist assessment in addition to their primary care physician in order to access marihuana for medical purposes.  The existing medical declaration would be replaced by a simpler document provided by the physician to the individual.

In response to physicians' request for more information about the use of marihuana to support their patients, Health Canada is consulting with experts in the medical and scientific communities on ways to improve physicians' access in obtaining comprehensive, accurate, and up-to-date information on the use of marihuana for medical purposes.

The role of physicians

All stakeholders welcomed efforts to improve physicians' access to information on the use of marihuana for medical purposes.  Program participants, physicians and medical associations indicated that improving access to such information may be helpful in ensuring that physicians are better informed when discussing the use of marihuana for medical purposes as a treatment option.

Clinical guidelines on the use of marihuana for medical purposes, information on potential therapeutic indications and information on the evaluation of potential risks and benefits of marihuana for medical purposes were all identified as principal areas where physicians would like more information.

Categories of conditions and symptoms

The removal of categories of conditions and symptoms is considered a positive step toward improving the application process for program participants, particularly those who have stated that the requirement to get a specialist assessment can take a significant amount of time. Medical associations indicated that, in the absence of regulated categories of conditions and symptoms, they would like to continue to work with Health Canada to develop guidelines that could assist physicians in making informed decisions with respect to the use of marihuana to treat particular symptoms and/or conditions.  

The potential role of other healthcare practitioners

Some stakeholders suggested that the list of health care providers who can support an individual's request to use marihuana for medical purposes should be expanded. Suggestions included nurse practitioners, pharmacists, naturopaths, herbalists, practitioners of traditional Chinese medicine and chiropractors.

2. Patient access

Under the proposed redesigned program, individuals would no longer be required to apply to Health Canada to obtain an authorization to possess marihuana for medical purposes. Nor would Health Canada continue to issue personal-use production licenses (PUPLs) or designated person production licenses (DPPLs) to individuals. These forms of production would be phased out.  The only legal source of dried marihuana would be licensed producers, which would be licensed by Health Canada to produce and distribute dried marihuana by registered mail or bonded courier.

Application process

All stakeholders welcomed the streamlined process in which Health Canada no longer receives applications or collects personal medical information from program participants. 

The establishment of licensed producers and the phasing out of personal and designated production

Federal and provincial public safety officials, municipalities, law enforcement, and fire officials have, in the past, cited a number of serious public health and safety concerns with personal and designated production, including:

  • the potential for diversion of marihuana produced for medical purposes to the illicit market;
  • the risk of home invasion due to the presence of large quantities of dried marihuana or marihuana plants;
  • public safety risks, including electrical and fire hazards, stemming from the cultivation of marihuana in homes;
  • public health risks due to the presence of excess mould and poor air quality associated with the cultivation of marihuana plants in homes.

These stakeholder groups indicated that the proposed phase-out of personal and designated production would address their concerns regarding public safety, security and public health risks.  Law enforcement representatives indicated that the proposed changes would greatly reduce the potential for diversion of marihuana for medical purposes to the illicit market. 

All stakeholders agreed that the public health, safety, and security of residential neighbourhoods and the mitigation of risks associated with personal and designated production are important objectives. However, many current program participants suggested that Health Canada consider strengthening inspection processes for those individuals who hold a PUPL or a DPPL, rather than eliminating personal and designated production. Many stakeholders also agreed that licensed operations would allow for greater regulation and control of production through zoning and by-laws.

Distribution

All stakeholders agreed that it is necessary to ensure a secure means of distributing dried marihuana to individuals who use it for medical purposes. Many stakeholders groups requested that Health Canada consider distribution through pharmacies, as pharmacists have extensive knowledge and experience in dispensing therapeutic products. Absent the potential for pharmacy distribution, the majority of stakeholders agreed that distribution of dried marihuana directly to individuals by mail is a secure option as it reduces the potential number of points for diversion. Some stakeholders, particularly law enforcement and representatives of local governments, noted that some citizens may express discomfort with the idea of establishing store-front entities specific to the distribution of marihuana in their communities.

Compassion clubs and cannabis dispensaries asked that Health Canada consider inclusion within the regulatory framework of an option for store-front, community-based dispensaries. They believe that such entities could play an important role in providing education and outreach to individuals who use marihuana for medical purposes. 

Dried marihuana only

As in the current program, dried marihuana would be the only product permitted for production, sale and distribution under the proposed new regulations. Due to the unknown health risks associated with products such as cannabis oils, extracts, creams, and edibles, many stakeholders supported the status quo of dried marihuana to other products.  On the other hand, compassion clubs and cannabis dispensaries, as well as most program participants, asked that Health Canada consider allowing other forms of products, most notably edibles and extracts. 

3. Proof of legal possession

Under Health Canada's proposed improvements, program participants would no longer be required to submit information to Health Canada in order to be authorized to possess dried marihuana. Individuals would no longer receive an authorization to possess or an identification card from Health Canada.

Identification cards

Individuals who use marihuana for medical purposes and law enforcement see the value of an identification card as a convenient means by which to demonstrate that an individual is in lawful possession of marihuana. These stakeholder groups are in agreement that as long as another method to prove lawful possession is determined through this process, the card itself would not be necessary. However, these stakeholders noted the importance of Health Canada advising law enforcement agencies about the mechanism by which patients will be able to demonstrate proof of possession.

4. Licensed production

In order to be licensed by Health Canada, licensed producers would have to demonstrate compliance with requirements related to, for example, product quality, personnel, record-keeping, safety and security, disposal and reporting, as set out in new proposed regulations.  These controls would aim to ensure the quality of the product being purchased by program participants, as well as the security of production sites.

Licensed producers would be permitted to produce marihuana indoors and would be able to produce any strain(s) of marihuana.

Cost and choice for patients

Program participants considered the availability of multiple strains a significant improvement to the program. However, they are concerned that the transition to licensed production will render the price of marihuana more costly, given that licensed producers will have to take their overhead costs and profit margins into account when pricing their products.  Some individuals also expressed concerns that marihuana may not be covered under provincial and private drug plans. To address these issues, some stakeholders suggested that Health Canada explore means to regulate the price of dried marihuana for medical purposes

Regulatory requirements for licensed producers

All stakeholders welcomed clear regulations that outlined requirements for licensed producers; however, some parties interested in becoming licensed to produce commercially highlighted that requirements should not be so complex that only large businesses could become licensed.

Complying with municipal zoning bylaws and building codes was viewed by all stakeholders as a necessary step to securing a commercial production licence. Municipalities emphasized that it would be important for interested parties to obtain applicable municipal authorization to operate before applying to Health Canada for a commercial production licence.  Municipalities, fire officials, law enforcement and potential licensed producers agreed that production sites should not be publicly disclosed, but should be known by municipalities and first responders for inspections and public health and safety reasons.

Conclusion

Overall, the proposal to create a regulated industry is well received, though some program participants have asked that Health Canada consider allowing them to maintain their personal and/or designated production licenses.  All stakeholders are supportive of elements of the proposal that would improve and simplify the application process for participants. Finally, there is widespread support for measures that Health Canada could undertake to increase outreach and information for physicians.

Next steps

Input from these consultations is being considered in the development of new regulations, on which Canadians will again have an opportunity to comment when the proposed regulations appear in Canada Gazette, Part I, in 2012.