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Drugs and Health Products

Annual Compliance and Enforcement Report 2014-2015

Table of Contents

What We Do

The Office of Medical Cannabis (OMC) is responsible for developing and implementing legislation, regulations, policies and operational programs that support the control of marijuana for medical purposes.

Background

In 2001, the Marihuana Medical Access Regulations (MMAR) were introduced in response to a Court decision requiring Health Canada to provide reasonable access to Canadians with a medical need. The rapid expansion under the MMAR had significant, unintended consequences. The high value of marijuana on the illicit market increased the risks of home invasion and diversion. The production operations also presented fire and toxic mould hazards. These risks were not only felt by the home producers, but also by their neighbours and the community.

The Government of Canada implemented the Marihuana for Medical Purposes Regulations (MMPR) in June 2013 to address the concerns Health Canada heard from law enforcement officials, fire departments, and municipal officials across the country. On April 1, 2014, the MMPR became the only regulation authorizing access to marijuana for medical purposes.

Following the introduction of the MMPR, Health Canada has developed a comprehensive compliance and enforcement program to monitor the activities, products and sites of prospective and existing licenced producers. The program regularly conducts inspections to assess compliance to the MMPR, Controlled Drugs and Substances Act (CDSA) regulations and the Food and Drugs Act (FDA), with the goal of minimizing the risk to diversion and protecting the health and safety of Canadians. Health Canada can inspect the operations of a licenced producer at any reasonable time to confirm that the applicable legislative and regulatory requirements are being met.

As of March 31, 2015, there were 25 licenced producers across Canada under the MMPR. Health Canada is committed to providing licenced producers with information and guidance to assist them in meeting the requirements of the MMPR and to ensure that marijuana for medical purposes remains in legal distribution channels.

Through continuous monitoring and active enforcement, the public health and safety risks associated with marijuana have been reduced and Canadians with a medical need have access to a quality controlled product.

Compliance and Enforcement Activities

Overview:

Health Canada's compliance and enforcement activities include an inspection program that has been successful at protecting client safety and reducing the risk of diversion by identifying deficiencies and implementing corrective measures.

Health Canada continuously monitors all licenced producers to ensure they meet the good production practices, security directives and other requirements of the MMPR. Regional inspectors inspect applicants' and licenced producers' sites to educate prospective or existing licenced producers on their regulatory requirements with respect to the MMPR. Inspectors have been crucial in assessing licenced producers' security measures and good production practices in order to minimize the risk of diversion to the illicit market and to provide quality products to clients. Overall compliance under the MMPR is ensured through inspections, compliance promotion and enforcement.

Inspection Types:

Health Canada conducts four types of inspections to assess and monitor compliance with the MMPR, as well as other CDSA and FDA regulations as they apply to marijuana for medical purposes.

  • Pre-licence inspection is conducted to verify that the information submitted to Health Canada in a licence application is accurate prior to licence approval.
  • Initial Inspection is conducted when marijuana is ready for sale and testing is completed to verify that their facilities, activities, and products are in compliance with the good production practices and record keeping requirements.
  • Targeted Inspection is conducted to verify compliance with particular areas of the MMPR.
  • Regular Inspection is conducted to monitor and verify compliance with all the requirements MMPR and CDSA prior to licence renewal.

Inspections:

For 2014-2015, 240 inspections were conducted at licenced producers' sites. Figure 1 displays a breakdown by month of the inspection types conducted in 2014-2015.

Table 1 provides the breakdown of the inspections and their compliance rates. Of all these inspections, the average compliance rate was 95%. The inspection findings have resulted in licenced producers initiating five voluntary recalls of marijuana for medical purposes that did not meet the requirements of the MMPR. More information on recall process can be found in the section below.

Table 1. Number of inspection conducted and compliance rate, by type for 2014-2015
Inspection Type Number of Inspections Compliance Rate

Table 1 footnotes

Table 1 footnote *

Pre-licence inspections do not have a compliance rate as they are conducted to verify that the information submitted to Health Canada in a licence application is accurate prior to licence approval. For prospective licenced producers who were not approved for a licence, it is possible to have subsequent pre-licence inspections.

Return to table 1 footnote * referrer

Pre-licence 22 Not applicableTable 1 footnote *
Initial 27 92%
Targeted 171 93%
Regular 20 100%
 

Observations:

The MMPR are relatively new regulations and further direction to the industry is often imperative to facilitate full compliance with the MMPR. As noted in Figure 2, the highest number of observations was noted during the first quarter. This is attributed to the emerging licenced producers and the increased need for compliance promotion. The number of observations was reduced in the second and third quarter, in part due to continued inspections and the promotion of education and compliance. In the fourth quarter there was an increase in the number of observations. This is primarily due to the increase in the number of regular inspections conducted in the fourth quarter.

During an inspection, the inspector notes all deviations cited against the MMPR as observations. An inspection report is issued to the licenced producer and corrective measures are required for each observation. The most common inspection observations during 2014-2015 were related to the following:

  • Improper storage of dried marijuana;
  • Unsupervised access by employees to restricted areas within a site where cannabis is present;
  • Inability of licenced producer to explain fluctuations in inventory and failure to define triggers to report unusual waste or disappearance of cannabis;
  • Inadequate visual monitoring in areas within a site where cannabis is present; and
  • Lacking approval of standard operation procedures (for production, labelling and storage of dried marijuana) by a quality assurance person.

Recalls:

The inspection findings have resulted in several recalls of marijuana for medical purposes. Through the concerted efforts of Health Canada and licenced producers, clients have been effectively and efficiently informed of these recalls.

Licenced producers initiated five voluntary recalls of marijuana for medical purposes that did not meet the requirements of the MMPR. The reasons for conducting the recalls are listed below:

  • Product did not meet requirements of good production practices
  • Presence of mold in the product
  • Delta-9-tetrahydrocannabinol (THC) content of the product was higher than labelled

In all cases, the licenced producer instructed its clients to immediately discontinue the use of the recalled product and to return the product to the producer or destroy the product using Health Canada's recommended method of destruction. No reports of adverse reactions associated with the use of the recalled marijuana products have been reported to the licenced producers, healthcare practitioners, or Health Canada.

Advertising:

Health Canada successfully conducted a compliance and enforcement action related to advertising by licenced producers. In November 2014, Health Canada issued warning letters to 20 licenced producers regarding their advertising practices. These warning letters were in follow-up to an advertising bulletin sent to all licenced producers in June 2014, which outlined the general prohibitions against the advertising of cannabis. Health Canada clarified that all information provided by licenced producers to the public should be limited to basic information such as the brand name, proper or common name of the strain, the price per gram, the cannabinoid content, and the company's contact information. These licenced producers were given until January 12, 2015, to take corrective actions. By that date, all 20 licenced producers achieved compliance with the advertising provisions, and Health Canada continues to monitor the advertising practices of all licenced producers.

Health Canada continues to actively monitor and provide guidance to advertising and associated actions related to medical marijuana. The Department recognizes that the dissemination of advertising content within the guidelines of the Narcotic Control Regulations, FDA and CDSA is critical to providing Canadians with accurate information.

Conclusion

Forward planning:

Health Canada, through the Office of Medical Cannabis continues to streamline the management of the MMPR in the effort to protect the health and safety of Canadians and minimize the risk of diversion. In the coming year, the Office will develop and update policies and conduct operational activities to improve communication with licenced producers and enhance education and compliance on the requirements of the regulation.

Consistent with Health Canada's commitment to openness and transparency, the Department has launched a series of information products to provide detailed guidance clarifying regulations, communicating where improvements need to be made, and informing Canadians about the current state of the marijuana for medical purposes industry. MMPR aims to treat marijuana like other narcotics used for medical purposes by creating conditions for an industry that is responsible for its production and distribution.

Compliance is achieved through a cooperative approach between the regulated party and Health Canada. While it is expected that licenced producers take timely and appropriate corrective actions when any deficiency or deviation with the MMPR is brought to their attention, immediate action will be taken by Health Canada if a risk to health and safety is identified. If the regulated party fails to correct situations of non-compliance, a number of actions may be taken by Health Canada in order to achieve compliance and remedy regulatory violations. These include, but are not limited to, issuing warning letters, recalling products, seizing products and revoking licences. Health Canada recognizes that health, safety and quality standards can only be achieved through the involvement of the government, industry, health care practitioners and clients.