Confidential Business Information Disclosure Update

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 A draft guidance document on the disclosure of CBI was published on Mar 10, 2016 and Health Canada underwent a consultation period.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 rmod_stakeholders-intervenants_dgro@hc-sc.gc.ca. 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.