Harper Government Announces Proposed New Marihuana for Medical Purposes Regulations

Changes improve public safety, maintain patient access

VANCOUVER, BC, Dec. 16, 2012 /CNW/ - The Honourable Leona Aglukkaq, Minister of Health, announced today that after a broad consultation process, the Government of Canada intends to make changes to the way Canadians access marihuana for medical purposes.

"Current medical marihuana regulations have left the system open to abuse," said Minister Aglukkaq.  "We have heard real concerns from law enforcement, fire officials, and municipalities about how people are hiding behind these rules to conduct illegal activity, and putting health and safety of Canadians at risk.  These changes will make it far more difficult for people to game the system."

In the past decade, Health Canada's Marihuana Medical Access Program has grown exponentially, from under 500 authorized persons in 2002 to over 26,000 today.

This rapid increase has had unintended consequences for public health, safety and security as a result of allowing individuals to produce marihuana in their homes.

The proposed new regulations will protect the health, safety and security of Canadians and their communities by eliminating the production of marihuana in homes.

The Government will no longer produce and distribute marihuana for medical purposes, opening up the market to companies which meet strict security requirements.  Production will no longer take place in homes and municipal zoning laws will need to be respected, which will further enhance public safety.

The current Marihuana Medical Access Program costs Canadian taxpayers millions of dollars each year.  The $5/gram Health Canada charges to program participants who choose to purchase from the department is heavily subsidized.

"An average of one in 22 grow operations (legal and illegal) catch fire, which is 24 times higher than the average home," said Stephen Gamble, President of the Canadians Association of Fire Chiefs.  "We applaud the Government of Canada for strengthening Health Canada's regulations for marihuana for medical purposes to enhance the safety of Canada's firefighters and the communities they protect."

"Changes are necessary to reduce the risk of abuse and exploitation by criminal elements," said Chief Constable Jim Chu.  "We very much appreciate the collaborative relationship the Canadian Association of Chiefs of Police enjoys with Health Canada and how they are responding to the unintended public safety impact through the proposed changes to the Marihuana Medical Access Program."

In response to concerns from patients, the proposed new Marihuana for Medical Purposes Regulations aim to treat marihuana as much as possible like any other narcotic used for medical purposes.  Health care practitioners will be able to sign a medical document similar to a prescription, and then patients can purchase the appropriate amount from an authorized vendor.  The new system would cut red tape for individuals and ensure that they have access to marihuana for medical purposes produced under quality controls while streamlining the process for applicants and health care practitioners.

"These changes strike the right balance between patient access and public safety," said Minister Aglukkaq.

It is the Government's intention to fully implement this new system by March 31, 2014. On this date, all authorizations to possess and licences to produce issued under the current program would expire, and all individuals requiring marihuana for medical purposes would have to purchase it from licensed producers.

Details of the proposed new regulations are posted on our website. There will be a 75-day comment period and the Department will be receiving comments until February 28, 2013.  Health Canada will keep all stakeholders informed as we continue to move through the regulatory process.

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Backgrounder - Proposed Marihuana for Medical Purposes Regulations - Transitioning to a New System

The Minister of Health has announced proposed regulations that would change the way Canadians access marihuana for medical purposes.  These proposed changes will not be finalized until the proposed Marihuana for Medical Purposes Regulations (MMPR) come into force (expected in spring 2013).  Until that time, individuals will continue to obtain authorization under the current Marihuana Medical Access Program.

Here are some key dates in the transition to the new system:

Winter 2012

• Health Canada, through Public Works and Government Services Canada, will keep its contract with Prairie Plant Systems for the production and distribution of marihuana for medical purposes. This contract will run until March 31, 2014, and will make sure that program participants who choose to purchase dried marihuana from Health Canada will continue to have access to a legal supply of marihuana for medical purposes during the transition period.
• Health Canada will inform interested parties that they may apply to become authorized to conduct certain research and development activities with marihuana now, including testing plant materials and growing conditions. These activities could help potential licensed producers to be ready to apply for a licence as soon as the proposed regulations come into force.

Spring 2013

• The Marihuana for Medical Purposes Regulations (MMPR) are expected to come into force.
• In order to facilitate the transition from the Marihuana Medical Access Program (MMAP) to the MMPR, both would operate concurrently from the time the new regulations come into force until March 31, 2014.  During that time, individuals could choose to continue to access marihuana for medical purposes under the MMAP or order directly from a licensed producer (as soon as they are approved by Health Canada).
• Individuals would be allowed to use their Health Canada-issued authorization to possess or the medical declaration signed by their physician, for up to one year, to register with a licensed producer and place an order for dried marihuana from a licensed producer.  This would help make sure that patients can access dried marihuana and it would not be interrupted when the current program comes to an end.
• Once the first established licensed producers have set a price for dried marihuana, Health Canada will align the price of its own supply.

October 1, 2013

• For authorized users under the Marihuana Medical Access Program (MMAP), this system would begin to wind down.  Health Canada would no longer accept new applications under the MMAP for production licences or applications to change the location of a production site. This is because the time required to obtain seeds and produce a viable crop of marihuana for medical purposes is approximately six months and all production under the current program must end on March 31, 2014.
• Health Canada would continue to renew personal use and designated production licences under the current MMAP.
• Health Canada's supply would be available until March 31, 2014.  Supply provided by approved licensed producers, will also be available after the coming into force of the MMPR and will be the only source of supply after March 31, 2014.
• For new applicants, after October 1, 2013, individuals requiring access to marihuana for medical purposes who do not already hold a valid production licence for a given site would either have to obtain dried marihuana from Health Canada (until March 31, 2014 only), or go directly to an approved licensed producer.

April 1, 2014

• The new system is expected to be fully implemented and the MMAP would end.
• All authorizations to possess and licences to produce issued under the current program would expire. Holders of personal use and designated person production licences would no longer be allowed to grow their own crop.
• Health Canada would no longer produce or sell marihuana for medical purposes.
• All individuals requiring access to marihuana for medical purposes would have to obtain it from a licensed producer. This competitive industry would set its own prices, choose to sell a variety of strains, and be subject to security requirements, inspections, and good manufacturing practices.

Backgrounder - Proposed Marihuana for Medical Purposes Regulations

Based on consultations with a broad range of stakeholders, the Government of Canada is concerned that the current Marihuana Medical Access Program is far too open to abuse.

While courts have ordered that there must be reasonable access to marihuana for medical purposes for patients that are seriously ill, this must be done in a controlled fashion in order to protect public safety.

The proposed Marihuana for Medical Purposes Regulations balance the needs of patients with public health, security and safety concerns.  These changes will strengthen the safety of Canadian communities, while making sure patients can access what they need to treat serious illnesses.

The new regulations' objective is to treat marihuana as much as possible like other narcotics used for medical purposes by:

• Eliminating risky production of marihuana by individuals in their homes;
• Ending Health Canada's role in authorizing individuals to possess and produce marihuana and in supplying and distributing marihuana; and
• Creating conditions for the establishment of a regulated commercial market of licensed producers responsible for the production and distribution of marihuana for medical purposes.  These regulated licensed producers would have to meet extensive security and quality control requirements.
• Patients would obtain a medical document, similar to a prescription, and purchase marihuana directly from a licensed producer.
• Individuals would be able to obtain a medical document from a licensed medical practitioner, or, if permitted by provincial or territorial governments, from a nurse practitioner. If permitted by provinces and territories, pharmacists could also dispense marihuana directly to individuals.

The regulations would also streamline the process to obtain access to marihuana for medical purposes for individuals and improve the quality of this product by:

• No longer requiring individuals to apply to Health Canada - and submit their personal medical information to the government - for authorization to access marihuana for medical purposes;
• No longer requiring individuals to consult a specialist in addition to their health care practitioner;
• Simplifying the process for health care practitioners to support access by removing the requirement to sign a medical declaration and fill out Health Canada forms;
• Providing access to quality-controlled marihuana for medical purposes by requiring licensed producers to be subject to inspections and good production practices.

Backgrounder - Safety and Security Requirements for Licensed Producers

The Government of Canada is concerned that the current Marihuana Medical Access Program is vulnerable to abuse.  While the courts have said that there must be reasonable access to marihuana for medical purposes, the Government believes that this must be done in a controlled fashion in order to protect public safety.

The proposed Marihuana for Medical Purposes Regulations (MMPR) create the conditions for the establishment of a regulated commercial market of licensed producers responsible for the production and distribution of marihuana for medical purposes.  These regulated licensed producers would have to meet extensive security and quality control requirements. For example, when potential licensed producers apply to Health Canada for a license, they must demonstrate that:

• They employ a quality assurance person with appropriate training, experience and technical knowledge to approve the quality of their dried marihuana;
• Their production site is indoors, and not in a private dwelling.  This would reduce the risk of diversion posted by outdoor production and would reduce health and safety risks associated with producing marihuana in a private dwelling;
• The production site includes restricted-access areas, which would include all areas where a licensed activity is conducted with marihuana and cannabis other than marihuana (i.e. lab, production room, etc);
• Access to the production site is controlled at all times and includes 24/7 visual monitoring systems and an intrusion detection system to detect unauthorized access;
• Key personnel hold a valid security clearance, issued by the Minister of Health; and,
• They have provided a written notification of their application, providing details regarding the location of the production site, to the local police force, local fire authority and local government.

It will not be possible to apply to become a licensed producer until the proposed Marihuana for Medical Purposes Regulations come into effect.

However, interested parties may immediately apply to become authorized to conduct certain research and development activities with marihuana, including testing marihuana plant materials and growing conditions.  Beginning these research and development activities now may help potential licensed producers to be ready to apply for a licence when the regulations come into force.  However, authorisation to conduct research and development is not a guarantee that a producer will receive a licence under the proposed regulations. They would still have to demonstrate compliance with all of the regulatory requirements.

Interested parties can visit the Health Canada website for further information.

Image with caption: "Minister of Health, Leona Aglukkaq announces proposed new Marihuana for Medical Purposes Regulations in Maple Ridge, BC. (CNW Group/Health Canada)". Image available at: http://photos.newswire.ca/images/download/20121216_C9470_PHOTO_EN_21997.jpg

SOURCE: Health Canada