Memorandum Re: Health Canada's 'Draft Guidance' on Section 21.1(3)(C) of the Food and Drugs Act
29 Pages Posted: 28 May 2016
Date Written: May 24, 2016
In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend the Food and Drugs Act, 2d Sess., 41st Parl., 2014, c. 24, Preamble.)
On March 10, 2016, Health Canada published the “Draft Guidance – Document: Disclosure of Confidential Business Information Under Paragraph 21.1(3)(c) of the Food and Drugs Act” [hereinafter “Draft Guidance”]. We submit that this Draft Guidance runs counter to both the express wording and spirit of Vanessa’s Law. Specifically, Health Canada’s position that s. 21.1(3)(c) requires those who request information pursuant to this provision to,
i. Demonstrate qualifications as a health professional and research expertise; ii. 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 We therefore call upon Health Canada to immediately alter its approach as stated in the Draft Guidance.
In this brief we show that Health Canada’s Draft Guidance improperly “reads in” four requirements into section 21.1(3)(c), which run counter to the express wording and spirit of Vanessa’s Law.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.
Keywords: Drug Safety, Pharmaceutical Policy, Regulation, Transparency, Intellectual Property
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