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

December 7, 2018

This notice applies to all requests made under paragraph 21.1(3)(c) of the Food and Drugs Act and the guidance document “Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act.”

Under paragraph 21.1(3)(c) of the Food and Drugs Act, the Minister of Health has discretionary authority to disclose confidential business information about a therapeutic product (drug or device) to a person (individual or organization) who carries out functions relating to the protection or promotion of human health or the safety of the public for the purpose of protecting or promoting human health or the safety of the public. This discretionary authority was added to the Food and Drugs Act by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) and came into force in November 2014.

As noted in the Guidance document, all personal information contained in the records considered for disclosure will be protected from release according to the Privacy Act. When personal information is requested for research purposes and the de-identification of personal information is not feasible, the personal information may be separated from other records and referred for assessment under section 8(2)(j) of the Privacy Act.

Examples of personal information include individual patient records containing medical information on each trial subject including medical history (e.g. clinical case reports), individual efficacy response data, and laboratory measurements such as tabular patient data listings.  

The guidance document “Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act” is being revised and will be published shortly.   

Questions related to this Notice should be directed to hc.rmod_stakeholders-intervenants_dgro@hc-sc.gc.ca.

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