On March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information) (collectively, the “Regulations”) came into force. The Regulations had been pre-published for comment (in substantially the same form) on December 9, 2017 (see article here).
The objective of the Regulations is to provide public access to clinical information submitted to Health Canada for drugs for human use and medical device applications. Following a final regulatory decision, clinical trial information will cease to be confidential business information, and release of this information will not require notice to the affected party.
As a result of the release of the final Regulations, Health Canada published the following:
- Guidance Document: Health Canada published the Public Release of Clinical Information: guidance document to help explain aspects of the new Regulations such as procedures to prepare information for release; the categories of information that continue to be subject to the definition of confidential business information and that may be eligible for redaction; and protection of personal information. The draft guidance had previously been published in April 2018 (see article here). The final guidance further outlines the procedure for sponsors to initiate a one-on-one process initiation meeting, to consult with Health Canada on the clinical documents within the scope of release and to provide an opportunity to clarify Health Canada's requirements and process, as outlined in section 4.1.
- Clinical Information Portal: Clinical information about drugs and medical devices can be accessed on Health Canada’s Clinical Information Portal.
According to the guidance document, Health Canada intends to proactively publish clinical information for submissions that receive a final regulatory decision after the Regulations came into force. Proactive publication will be phased in over four years, according to the schedule in section 3.3 of the guidance document. Drug submissions and medical device applications that received a final regulatory decision before the Regulations came into force will be released upon request.
In addition, Health Canada will protect the following information from public release, with valid justification from the manufacturer: (1) clinical information that was not used by the manufacturer in the drug submission or supplement, or medical device application to support the proposed conditions of use or the purpose for which the drug or medical device is recommended, or (2) clinical information that describes tests, methods or assays used exclusively by the manufacturer.
These regulations are one of the measures under Vanessa’s Law intended to increase transparency. Our previously published chart has been updated.