Memorandum Re: Health Canada's 'Draft Guidance' on Section 21.1(3)(C) of the Food and Drugs Act

Abstract

In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “FDii. Enter into a confidentiality agreement;iii. Agree not to disclose the information to any third parties; and,iv. Demonstrate prior efforts to obtain the information from alternative sources;is contrary to the express wording of section 21.1(3)(c), constitutes an ultra vires exercise of statutory authority, substantially undermines the purpose of the provision, viz. to better protect Canadians from harm, and is fundamentally at odds with the scheme and object of the F&D Act as well as the intention of Parliament in enacting Vanessa’s Law. Further, these limitations potentially violate the Charter of Rights and Freedoms. We therefore call upon Health Canada to immediately alter its approach as stated in the Draft Guidance. In this brief we show that Health Canada’s Draft Guidance improperly “reads in” four requirements into section 21.1(3)(c), which run counter to the express wording and spirit of Vanessa’s Law. We begin by explaining why Health Canada’s practice of treating safety and effectiveness data as CBI is mistaken and misguided, fails to recognize an internationally recognized need for a new approach to drug safety, and fails to live up to Vanessa’s Law’s recognition of the need for new transparency measures. Then, we describe the legislative background and purpose of Vanessa’s Law, and detail the fundamental flaws in Health Canada’s Draft Guidance.