In the recent decision of Doshi v Attorney General Canada the Federal Court ruled that Health Canada cannot withhold clinical trial results from a researcher who refused to sign a confidentiality agreement.
In particular, the court found that under section 21.1(3)(c) of the Food and Drugs Act enacted pursuant to the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) (the “Act”), Health Canada’s refusal of Dr. Peter Doshi’s request for the disclosure of clinical trial results, justified by a blanket confidentiality policy over clinical trial results, was unreasonable and “entirely disregards one of the main purposes of the Act, namely to improve clinical trial transparency”.
The Federal Court ordered that once Health Canada receives a Declaration of Conflict of Interest form from Dr. Doshi, the Minister of Health (“Minister”) must disclose copies of all sections of all clinical study reports and all electronic datasets from these same trials, including participant level datasets with respect to Gardasil, Gardasil 9, Cervarix, Tamiflu and Relenza.
Put more broadly, Health Canada may be required to disclose clinical trial results upon request from any researcher who qualifies as a “person who carries out functions related to the protection or promotion of human health or the safety of the public” without significant a confidentiality agreement.
The case concerned section 21.1(3)(c) of the Food and Drugs Act which provides that the Minister can disclose confidential business information (“CBI”) to persons who carry out functions relating to the protection or promotion of human health or safety of the public – and this, without notifying the person to whose business or affairs the information relates or obtaining their consent:
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
(c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public.
In this context, Dr. Peter Doshi, an assistant professor at the University of Maryland applied to Health Canada to obtain unpublished information, which included clinical trial reports, related to Gardasil, Gardasil 9, and Cervarix in one application and Tamiflu and Relenza in another.
Health Canada replied that in order to release this information to Dr. Doshi, he would be required to sign a confidentiality agreement, and a declaration of conflict of interest. Dr. Doshi refused to sign the confidentiality agreement. Consequently, his request for the clinical trial reports was rejected. Health Canada stated in its reasons for rejecting the application that it is Health Canada’s policy to treat all regulatory data as confidential business information (CBI).
The principal issue at hand was whether Health Canada’s decision to deny Dr. Doshi’s request, based on a policy that denied access to all clinical trial results without the signing of a confidentiality agreement, was reasonable.
The Purpose and Practice of the Act
In order to make such a determination, the Federal Court conducted a review of the legislative history of Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). The Court determined that section 21.1(3) was enacted for the purposes of improved clinical trial transparency.
Despite the foregoing, the Court recognized that transparency is not absolute. In particular, the Court reviewed the disclosure frameworks present in NAFTA and TRIPS to interpret the nature and purpose of disclosure under section 21.1(3).
The Federal Court outlined two routes through which confidential business information or other information pertaining to therapeutic products may be made available. The first route is outlined in 21.1(3) of the Food and Drugs Act, where confidential business information is kept confidential with exceptions being made on a case-by-case basis at the discretion of the Minister to a government, a person from whom the Minister seeks advice, or a person who carries out functions relating to the protection or promotion of human health or the safety of the public. The second route is derived from article 30(1.2) of the Food and Drugs Act and states that it is within the Minister’s power to define what is and is not and what ceases to be confidential business information.
Continuing to draw on NAFTA and TRIPS, the Federal Court draws a distinction between “undisclosed information”, “trades secrets” and “confidential business information” on one hand, and “data submitted to governments” (which would include clinical trials results) on the other. Although not explicitly stated, the potential implication is that clinical trial results would no longer be considered confidential under the umbrella of CBI.
The Federal Court also looked to the recent proposal published in the Canadian Gazette, which places clinical trial results under the umbrella of CBI until a Notice of Compliance is issued or a New Drug Submission is withdrawn or refused, at which point information regarding clinical trial would no longer be afforded protection as CBI (with some exceptions).
Based on the foregoing, the Court concludes: “Thus according to the logic of the legislation, the information sought by Dr. Doshi remains “confidential business information” that may be disclosed under section 21.1(3), because regulations that would take it out of that category are not yet in place”.
However, the Court also found that according to the wording of the Act, Parliament chose to have the confidentiality of each disclosure evaluated on a case-by-case basis insofar as it did not impose a blanket confidentiality requirement in the Act.
Accordingly, the Federal Court concluded that Health Canada should have used its discretionary power under section 21.1(3) and not compelled the signing of a confidentiality agreement.
Freedom of Expression
Dr. Doshi claimed his right to freedom of expression to protest the requirement of a confidentiality agreement, and argued that without the ability to disclose the data he requested to the public, any subsequent results would be of little value to the public.
When a Charter right is at issue it is the responsibility of the decision maker to perform a Doré analysis. The Doré analysis has at its core the proportionality exercise, and requires the decision-maker (in this case Health Canada) to balance the severity of the interference of the Charter protection (Dr. Doshi’s right to share his research findings) with the statutory objectives (those of the Act).
However, according to the Federal Court such an analysis was absent from Health Canada’s refusal, and as a result the impact of the confidentiality agreement on Dr. Doshi’s right to freedom of expression was never determined to be justifiable. According to the court, Health Canada did not identify any countervailing considerations, but instead simply made reference to its policy; whose purpose was found to be unstated and unclear. The Federal Court thus determined that in line with the purposes of the Act , which highly favored disclosure, and in the absence of countervailing considerations, it was unreasonable for Health Canada to impose a confidentiality requirement as a condition of the disclosure of data requested by Dr. Doshi.
Going forward, unless Health Canada finds substantial reasons to begin legitimately barring the disclosure of clinical trial information, or to maintaining its confidentiality once disclosed to individuals covered under article 21.1(3)(c), requested clinical information that meets the criteria outlined in section 21.1(3)(c) may likely continue to be disclosed without confidentiality requirements.
It remains to be seen whether Health Canada (or any other interested party) will appeal the decision and whether this case represents a pre-emptive judicial installation of the new regulations proposed by the Federal Government.
From another perspective, one could argue that insofar as the Act only provides for three specific and particular situations as to whom CBI can be disclosed, the effect of not requiring a confidentiality agreement could appear in practice to ultimately be equivalent to disclosure to the general public.
This article was also written by Michael Gardiner.