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05 September 2018
In the first case calling upon a court to interpret and apply the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), the Federal Court ordered Health Canada to release requested complete copies of all sections of all clinical study reports and electronic datasets from the clinical trials, including participant level datasets, for Gardasil, Gardasil 9, Cervaris, Tamiflu and Relenza.(1)
Vanessa's Law was enacted in 2014 to amend the Food and Drugs Act, including by adding Section 21.1(3) (for further details please see "Update on Vanessa's Law"). This provision permits the minister of health to disclose confidential business information about a therapeutic product in certain circumstances.
The applicant, Peter Doshi, filed requests with Health Canada to obtain information pursuant to Section 21.1(3) of the Food and Drugs Act. Doshi proposed to use the information for his academic research.
Health Canada accepted that:
Nevertheless, Health Canada required Doshi to sign a confidentiality agreement. Doshi refused and Health Canada denied his request on this basis. Doshi sought judicial review.
As an initial matter, the Federal Court judge, Justice Grammond, disagreed with Doshi that Health Canada can never impose a confidentiality requirement when disclosing clinical data under Section 21.1(3). Upon analysing 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". The first track is provided for in Section 21.1(3) and suggests that the government may validly impose a confidentiality requirement with respect to specific categories of information (eg, trade secrets). Under the second track, the regulation-making powers of Section 30(1.2), the government has released proposed regulations providing for the publication of clinical information when a decision is made on a new drug submission. Until such regulations are made, Section 21.1(3) applies (for further details please see "Release of information contained in drug submissions and medical device applications").
The judge held that Health Canada's decision was unreasonable. First, the judge found that Health Canada's decision disregarded one of the main purposes of Vanessa's Law – namely, to improve clinical trial transparency.
Second, the judge found that Health Canada had fettered its discretion by adopting a blanket confidentiality policy, despite the fact that Parliament had declined to stipulate that information disclosed pursuant to Section 21.1(3) must remain confidential. The proposed regulations recognising the value of clinical trial transparency made Health Canada's position more untenable.
Third, the judge found that in preventing Doshi from quoting from the clinical trial reports, the confidentiality requirement would breach his freedom of expression under Section 2(b) of the Canadian Charter of Rights and Freedoms. This restriction was unjustified given the statutory purpose of improving clinical trial transparency.
The attorney general may appeal, as of right.
For further information on this topic please contact Lynn Ing at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) Doshi v Canada (Attorney General), 2018 FC 710.
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