As previously reported, Bill C-17, An Act to amend the Food and Drugs Act, was passed by Canada’s House of Commons on June 16, 2014 and has proceeded to the Senate, where it awaits Second Reading. In this post, we focus on certain amendments to the Bill that were introduced at the committee stage and which, if ultimately proclaimed in force, will have a significant effect on confidential business information in the health products sector.
Specifically, the Bill – also known as “Vanessa’s Law” – proposes to amend the Food and Drugs Act (FDA) to empower the federal Minister of Health, in specified circumstances, to disclose confidential business information without notifying or obtaining consent from the person to whose business or affairs the information relates. In some cases, the scope of this disclosure is restricted to a government or specific persons, but in other cases the scope of disclosure is without limitation as to who will receive the information, and this could entail public disclosure. The distinction between the two situations is as follows:
- The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to (a) a government; (b) a person from whom the Minister seeks advice; or (c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public.
- The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk of injury to human health.
The definition of “confidential business information” proposed in the Bill is consistent with how that term is defined in the Canada Consumer Product Safety Act and with how it is commonly understood in regulatory settings. But there is a significant caveat: under the proposed amendments, the federal Cabinet (Governor in Council) would be empowered to make regulations specifying that certain information (i.e., information that is obtained under the Act in relation to authorizations) is not confidential, or the circumstances in which that information would cease to be confidential.
Bill C-17 is scheduled to proceed through Second Reading when the Senate resumes sitting on September 16, 2014. It will then be referred to the appropriate Senate committee – likely the Senate Standing Committee on Social Affairs, Science and Technology – for further study. Interested persons may make a request to the Clerk of the Committee to appear as a witness at Committee meetings or submit written submissions regarding the proposed amendments for distribution to Committee members.