Vanessa’s Law – Taking a First Look

Author: Karen Zhou

Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act), first enacted in 2014, added section 21.1(3) to Canada’s Food and Drugs Act to permit the Minister of Health to disclose confidential business information about a therapeutic product in certain circumstances. For the first time since the 2014 amendment, a court was called upon to interpret and apply Vanessa’s Law.  Doshi v. Canada represents the first such judicial consideration.

According to section 21.1(3), 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 applicant, Peter Doshi, filed requests with Health Canada to obtain clinical trial information regarding a number of drugs, in accordance with section 21.1(3). Doshi proposed to use the information for academic research. While Health Canada agreed that he is a person who carries out functions relating to the protection or promotion of human health or the safety of the public as per section 21.1(3)(c), the agency would only disclose the clinical data if Doshi agreed to sign a confidentiality agreement. Doshi disagreed, and his requests to Health Canada were denied. He then sought judicial review of this decision.

The Court disagreed with Doshi’s argument that Health Canada can never impose a confidentiality requirement when disclosing data under section 21.1(3).  After analyzing the text, context and scheme of the legislation and its legislative history, the Court noted that Vanessa’s Law provides a two-track approach to “confidential business information”. Under section 21.1(3), certain categories of information would be considered “confidential business information” that closely parallels that of trade secrets.  Under the second track, the regulation-making powers of section 30(1.2) allows the government to define what is “confidential business information”.  Although the government has released proposed regulations providing for the publication of clinical information when a decision is made on a new drug submission, these regulations have not been finalized, and until then, section 21.1(3) applies.

The Court held that Health Canada’s decision is unreasonable. First, it is inconsistent with the purpose Vanessa’s Law, which is to improve clinical trial transparency.  Second, the decision amounts to a fettering of discretion by Health Canada as its blanket confidentiality policy is inconsistent with section 21.1(3) where the legislature has chosen not to stipulate that information pursuant to this section must be confidential.  Third, the requirement to sign the confidentiality agreement infringed Doshi’s right to freedom of expression under section 2(b) of Canadian Charter of Rights and Freedoms.  Health Canada also failed to justify this restriction given the statutory purpose.

The Court ordered Health Canada to disclose all requested information.

 References:

https://decisions.fct-cf.gc.ca/fc-cf/decisions/en/item/315985/index.do

http://www.mondaq.com/canada/x/724046/Life+Sciences+Biotechnology/First+Judicial+Consideration+Of+Vanessas+Law+Health+Canada+Must+Disclose+Requested+Clinical+Trial+Data