Memorandum Re: Health Canada's 'Draft Guidance' on Section 21.1(3)(C) of the Food and Drugs Act

Document Type

Working Paper

Publication Date

5-28-2016

Abstract

In 2014 Parliament enacted a number of amendments to the Food and Drugs Act RSC 1985 c F27 hereinafter the "FD 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 postmarket 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 C17 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Act to Amend the Food and Drugs Act 2d Sess 41st Parl 2014 c 24 Preamble On March 10 2016 Health Canada published the "Draft Guidance Document Disclosure of Confidential Business Information Under Paragraph 2113c of the Food and Drugs Act" hereinafter "Draft Guidance" We submit that this Draft Guidance runs counter to both the express wording and spirit of Vanessa's Law Specifically Health Canada's position that s 2113c requires those who request information pursuant to this provision toi Demonstrate qualifications as a health professional and research expertiseii Enter into a confidentiality agreementiii Agree not to disclose the information to any third parties andiv Demonstrate prior efforts to obtain the information from alternative sourcesis contrary to the express wording of section 2113c 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 FD 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Charter of Rights and Freedoms We therefore call upon Health Canada to immediately alter its approach as stated in the Draft Guidance In this brief we show that Health Canada's Draft Guidance improperly "reads in" four requirements into section 2113c which run counter to the express wording and spirit of Vanessa's Law We begin by explaining why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

Comments

Research Papers, Working Papers, Conference Papers

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