Mr. Speaker, the Marihuana for Medical Purposes Regulations, MMPR, allow for the licensing of qualified applicants, or “licensed producers”, responsible for the production and distribution of marijuana for Canadians who have been authorized by a physician. The regulations are comprehensive and include rigorous criteria to protect the public health, safety and security of Canadians, including preventing cannabis from being diverted to an illicit market or use. Applicants seeking to obtain a licence must meet all criteria stipulated in the regulations.
With regard to (a) (i) and (ii), Health Canada has put in a place a rigorous licensing program. The first two stages of the process include a detailed screening of the application, focused on verifying its completeness, an examination of the proposed site, the proposed security measures and a review of the qualifications of the quality assurance person. The key personnel are then subject to a security clearance stage, coordinated by the RCMP. This can involve a comprehensive analysis of police records, fieldwork and coordination with other law enforcement agencies to identify whether an applicant poses a risk to the integrity of the control of the production and distribution of cannabis. The application is then reviewed in detail to confirm appropriate good production practices, record keeping, and physical security plans and procedures. The department may then choose to provide a “Ready to Build” letter, should one be requested. Applicants are notified that this letter is not a guarantee that a licence will be issued. The department will conduct a pre-licence inspection. Once all the terms of the regulations have been satisfied, a licence will then be issued.
Since the introduction of the MMPR, Health Canada has received 1224 licensed producer applications. Most applications to date have been processed and decisions rendered. To date, 881 applications have been assessed and refused or withdrawn; 320 aplications are in process, including security clearance, review and/or pre-licensing inpection phases; and 23 licenses have been issued.
With regard to (iii) and (iv), all applications undergo a strict and rigorous review process. The quality and completeness of the application can significantly affect the length of the review period. The department may request additional information, as required, to support its review of an application. A licence is only issued once the department has solid evidence that the applicant is fully compliant with the MMPR and would not pose a risk to public health and safety. The duration of the review process is highly variable, and can take more than a year.
With regard to (v), (vi) and (vii), Health Canada has assigned 32 full-time equivalent employees to respond to the current activity levels for licensing and compliance and enforcement activities under the MMPR. The activities are conducted by a multi-disciplinary team including scientists, engineers, project managers and program administrators.
With regard to (viii), Health Canada is responsible for ensuring compliance with the MMPR. Applicants must ensure that they are compliant with all federal, provincial, municipal and environmental legislation, including zoning as well as building and fire codes. It is the responsibility of the municipality to conduct the relevant inspections for compliance with bylaws. Licensed producers are also required to communicate with local authorities whenever there is a change in the status of their licence.
With regard to (ix), Health Canada is aware of media reports about applicants. The department works closely with the RCMP and other organizations, and takes into consideration any information provided by them that is relevant to the review of an application. Licences are only issued once the department has a solid basis of evidence that demonstrates there is no risk to public health, safety and security.
With regard to (x) and (xi), there are no fees associated with applying to become a licensed producer. It is difficult to determine the cost of processing individual applications, however, the forecasted expenditures of licensing, compliance and enforcement activities under the MMPR for 2014-15 are estimated to be $3.7 million.
With regard to (b), (c) and (d), as of January 2015, there are 23 licensed producers under the terms of the MMPR that are producing and/or distributing marijuana for medical purposes in Canada, with over 15,500 clients registered. These licensed producers, with an overall approved production capacity of 25,000 kg per year, have sufficient supply to meet current demand in accordance with the quality control measures and appropriate safety standards of the MMPR.
