The Federal Court of Canada has addressed how the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) should be applied in its decision in Peter Doshi v. Attorney General of Canada released on July 9.
What You Need To Know
- Federal Court of Canada held that section 21.1(3) of the Food and Drugs Act, enacted as part of Vanessa's Law, allows a scientific researcher to obtain from Health Canada clinical trial information contained in regulatory submissions after the submission has been reviewed and a drug product has been granted marketing authorization, or if the submission is rejected or withdrawn.
- The Court found that Heath Canada's current blanket policy of maintaining clinical data as confidential business information was inconsistent with the purpose of Vanessa's Law, which is to improve transparency of clinical trials, and contravenes the right to freedom of expression under section 2(b) of the Charter.
- The Court specifically contemplated that the Minister of Health could enact regulations permitted under Vanessa's Law to change this outcome. However, none have been enacted at this time. Health Canada has instead put out draft regulations1 that would expressly allow for publication of clinical trial data once a drug has been approved for marketing, or subject to a final rejection. So it is unlikely any restriction on disclosure under Vanessa's Law will be enacted.
- If this decision is not reversed on appeal, drug manufacturers will not have any assurances their clinical trial information will remain confidential indefinitely.
Background on Vanessa's Law
Vanessa's Law permits Health Canada to provide confidential business information, which could include unpublished clinical trial data submitted by a drug manufacturer in a regulatory submission, to scientific researchers who carry out "functions relating to the protection or promotion of human health or safety of the public."
Vanessa's Law was enacted after 15 year-old Vanessa Young died of a heart attack after taking certain prescription medication. Her father, Terence Young, was elected to Parliament and was the driving force behind Vanessa's Law—an amendment to the Food and Drugs Act—which was intended to make regulatory information about pharmaceuticals (including clinical trial information) more accessible to scientists. As a result, section 21.1(3) permits the Minister of Health to disclose confidential business information about a therapeutic product without notifying the sponsor of the product if the disclosure is intended to promote or protect human health and safety, and is directed to particular individuals, including a person who carries out functions relating to the protection or promotion of human health, or the safety of the public.
Dr. Doshi and the Application of Vanessa's Law
Dr. Peter Doshi, an Assistant Professor at the University of Maryland, asked Health Canada under Vanessa's Law for particular scientific information regarding a number of different and approved drugs. He was seeking the information to conduct a Cochrane review—a complex meta-analysis—of all available clinical information regarding two particular classes of medicines (HPV vaccines and anti-viral medications).
Health Canada was willing to provide Dr. Doshi with the requested information but, consistent with its current practice, required him to sign a confidentiality agreement. He refused to do so and in the process brought an application for judicial review asking the Federal Court to require Health Canada to provide the information by an order for mandamus.
Justice Grammond of the Federal Court allowed the application for judicial review and issued an order requiring Health Canada to provide Dr. Doshi with the requested information. He found that Health Canada's decision to simply follow their pre-Vanessa's Law practice of always requiring a confidentiality agreement was inconsistent with a key statutory purpose of Vanessa's Law, which was to improve transparency of clinical trials. In addition, by imposing a blanket policy of confidentiality, without any real consideration of the facts of this case, Health Canada improperly fettered its discretion. Justice Grammond also found that a requirement of confidentiality unduly burdened Dr. Doshi's constitutional right to freedom of expression.
While the typical remedy for an improper exercise of discretion is to quash the decision and send it back to the decision-maker for reconsideration, Justice Grammond held that the case was sufficiently exceptional that he should simply order Health Canada to release the materials to Dr. Doshi. While it is not clear whether the information has yet been released, absent a reversal on appeal, its release appears inevitable.
The Future for Pharmaceutical Companies
This case raises some significant questions for pharmaceutical companies. While companies have long taken the confidentiality of clinical trials for granted, unless the Minister introduces new regulations, it appears as if Vanessa's Law may well result in their disclosure to scientists and other researchers without any obligations of confidentiality. Moreover, it appears that the courts will not hesitate to apply s. 2(b) of the Charter to attempts by Health Canada to insist on confidentiality.
As a practical matter, Health Canada intends to begin releasing clinical trial data submitted with a drug submission once the drug has been approved or subject to a final rejection during review. This approach is consistent with the current process in the U.S. and EU. Draft regulations have been published and are expected to come into force later this year. Nevertheless, the industry should encourage to ensure a balance is struck between protecting confidential business information and protecting the public, so implementation of these new regulations as well as future disclosures under Vanessa's Law, do not compromise manufacturer's proprietary information.
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