Confidential Business Information Disclosure Update



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 A draft guidance document on the disclosure of CBI was published on Mar 10, 2016 and Health Canada underwent a consultation period.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 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.