In my earlier article Bill C-17: modernizing the Food and Drugs Act but at what cost?1, I described the potential implications of the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa’s Law). Initially introduced to Parliament in December 2013, Vanessa’s Law sought to improve the safety of drugs and medical devices by broadening Health Canada’s pre- and post-market authority over industry stakeholders and dramatically changing the consequences for violating the Food and Drugs Act2(the “Act”) and its regulations.
Vanessa’s Law became law on November 6, 2014. However, only some of Health Canada’s broad authorities under the legislation came into force immediately.3 These powers included the Minister’s ability to: (i) require a person to provide information, (ii) disclose confidential business information in certain circumstances, (iii) order a label change/package modification, and (iv) order a recall. Other authorities provided to Health Canada under Vanessa’s Law were slated to come into force once their supporting regulations were established.
On June 18, 2016, the Federal Department of Health published a Notice of Intent advising of its intention to develop and propose amendments to the Food and Drug Regulations and the Medical Devices Regulations as part of the implementation of Vanessa’s Law. In particular, the amendments are geared toward the development of the supporting regulations necessary to enable Health Canada to exercise some of its authorities under Vanessa’s Law.
The Notice of Intent indicates the proposed regulations will be developed in phases. It describes an initial phase that includes two regulatory proposals intended in part to improve the effectiveness of recalls in Canada and to strengthen voluntary recall requirements.
The first regulatory proposal includes amendments to the Food and Drug Regulations
- prescribing the conditions under which the Minister may make an order under sections 21.31 (assessments) and 21.32 (tests, studies and other activities) of the Act;
- authorizing the Minister to impose or amend terms and conditions on any therapeutic product authorization respecting a drug under section 21.7 of the Act;
- requiring holders of a therapeutic product authorization respecting a prescription drug or a non-prescription drug administered under the supervision of a health care practitioner to report information including: (i) risks communicated, (ii) labeling changes, (iii) recalls, (iv) reassessments, and (v) suspensions or revocations of authorizations made out of Canada; and
- requiring all DIN holders to report to the Minister when a labelling change or packaging modification has been made in order to mitigate the risk of injury to human health.
The second regulatory proposal includes amendments to the Food and Drug Regulations and the Medical Devices Regulations
- requiring notification of a voluntary recall and provision of a risk evaluation within twenty-four hours following the recall decision;
- requiring a written report within 72 hours of the initial recall notification; and
- clarifying that the exemption in section 44(2)(b) of the Medical Device Regulations regarding the holding of an establishment license applies only to a health care facility in respect of the medical device that is distributed for use within a facility or hospital.
It is expected that the proposed regulations will be pre-published in the fall of 2016. At that time, interested stakeholders may provide comments on the proposed regulations. Health Canada has advised it will engage certain industry stakeholders on the development of these regulatory proposals in the interim.
Implications of the Regulatory Proposals
The two regulatory proposals identified in the Notice of Intent are likely to have significant implications for manufactures of drugs and medical devices if implemented. These implications could include:
- Expanded Reporting Requirements: The expansion of reporting requirements to include activities and events outside of Canada will require drug manufacturers to devise an internal system that ensures the provision of relevant information from a manufacturer’s foreign affiliates regarding drugs marketed in Canada.
- Amendment to Recall Protocols: The amendments will likely necessitate the bolstering of a manufacturer’s current recall protocol to comply with the mandatory recall reporting timelines and requirements identified in the regulatory proposals.
Both of these implications will undoubtedly increase the cost of compliance for manufacturers.
In light of the phased approach to the implementation of Vanessa’s Law, it is important for the manufacturers of drugs and medical devices to be aware of the latest developments in Health Canada’s powers and its obligations under the Act. Manufacturers should be attentive to the pending amendments and their potential implications to allow them to take pro-active steps not only to avoid the risk of non-compliance but also to manage the cost of continuing to do business in Canada.