Confidential Business Information Disclosure Update
Posted: Monday April 17th, 2017
The Health Minister can disclose confidential business information (CBI) to protect or promote health or safety. A draft guidance document on the disclosure of CBI was published on Mar 10, 2016 and Health Canada underwent a consultation period. Comments received by May 24, 2016 have been incorporated into the revised guidance. A summary of comments received is available on request by email to firstname.lastname@example.org. This document is intended for health researchers and professionals, patient groups, and pharma and medical device industries. The document includes information on the following.
- paragraph 21.1(3)(c) of the Food and Drugs Act
- principals and considerations for Health Canada's exercise of the authority under paragraph 21.1(3)(c) of the Food and Drugs Act
- protection of personal information and respecting participant's informed consent
- protection against commercial use
- maintaining confidentiality of disclosed information
- process to review requests for disclosure
- requirements for persons requesting disclosure of confidential business information under paragraph 21.1(3)(c)
- findings generated from disclosed information
- forms and additional information:
- review process flow chart
- tools for finding regulatory information
Completed CBI disclosure requests under s21.1(3)(c) of the Food and Drugs Act can be found here.