Release of Draft Guidance Document: Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act

March 10, 2016
Our reference number: 16-102694-289

Health Canada is pleased to announce the release of the Draft Guidance Document – “Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act for a 75-day stakeholder consultation.

This draft guidance document is part of Health Canada's Regulatory Transparency and Openness Framework. Through the Framework, Health Canada has committed to providing Canadians with information on important health and safety issues to help inform decisions affecting their health and the health of their families. To this end, more and more information is being published on the Department’s regulatory activities for therapeutic products including Summary Basis of Decision (SBD), Regulatory Decision Summaries (RDS), the Submissions Under Review (SUR) List, Summary Safety Reviews (SSR), the List of Advertising Complaints and the List of New Safety Reviews.

As part of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) (Bill C-17), which received royal assent on November 6, 2016, the Government amended the Food and Drugs Act to give the Minister of Health the discretionary authority to disclose confidential business information (CBI) to eligible persons for the purpose of protecting or promoting human health or the safety of the public.

The draft guidance document describes Health Canada’s implementation of the discretionary authority under paragraph 21.1(3)(c) by providing the broad principles, considerations and processes that Health Canada will use when deciding whether or not to disclose confidential business information (CBI).

This draft document applies to therapeutic products, including prescription and non-prescription drugs, vaccines, blood and blood products, radiopharmaceuticals, donor semen for assisted conception, gene and cell therapies, tissues and organs, and medical devices. It does not apply to CBI related to natural health products.

Comments on the draft guidance should be provided to Health Canada within 75 days from the date of this notice, preferably in electronic format using the attached template. The comments provided during the stakeholder consultation period may be made available upon request.

Should you have any questions or comments regarding the content of this guidance, please contact:

Resource Management and Operations Directorate
Health Canada
5th Floor, Room 545
Address Locator 20051
Graham Spry Building
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9

In order to seek clarification of users' comments, we ask that you include your name, telephone number, full mailing or email address.

Comments submitted by: <full name>, <company/association name (if applicable)>
Telephone number: <telephone number>
Address: <full mailing address>
Email: <email address>
Date: <date of comment submission>

Comment Number Section Comment and Rationale Proposed Revised Text (if applicable)
1 e.g. “Section 3.1 Principles, Principle iv”
Etc.
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