Precedent pushing practice: Canadian court orders release of unpublished clinical trial data

Canada’s Federal Court has just rendered a milestone decision for clinical trial transparency. In the case of Peter Doshi v. Attorney General of Canada (yes, that’s one of us), Justice Sébastian Grammond ordered Canada’s pharmaceutical regulator, Health Canada, to disclose “complete 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.”

Provided the government does not appeal, the decision should spur additional data transparency measures in Canada while immediately improving access to unpublished pharmaceutical data for scrutiny by independent researchers around the world.

We see Doshi v. Canada as part of a larger, global effort for increased transparency in pharmaceutical research and regulation. In Canada, that advocacy crystallized in 2014 with the passing of “Vanessa’s Law,” which amended Canada’s Food and Drugs Act to improve drug safety. (See the timeline below)

But so far, the regulator has not lived up to either the spirit or letter of the law. In 2015, researcher Nav Persaud asked for unpublished data for the morning sickness drug diclectin. Health Canada provided him with a clinical study report—but only after requiring he sign a confidentiality agreement.

Confidentiality agreements can stifle open science. So one of us (Herder) drafted a template letter to facilitate future researchers’ requests to Health Canada without any condition of confidentiality. In early 2016, Doshi used the template and filed a request for data on three HPV vaccines and two anti-influenza drugs.

Vanessa’s Law allows disclosing data to (1) a person who “carries out functions relating to the protection or promotion of human health or the safety of the public” if (2) the “purpose of the disclosure is related to the protection or promotion of human health or the safety of the public.” After months of frustrating back-and-forth (see here for details), Health Canada ultimately agreed that Doshi met these two conditions. But it still imposed a confidentiality agreement. When Doshi refused to sign, his requests were denied.

We decided to challenge that decision in Court—and, with support from a law firm (Caza Saikaley) who took on the case pro bono—filed for judicial review.

In Federal Court, the Attorney General argued that Health Canada’s approach of requiring a confidentiality agreement flowed from both the purpose of the law, which was not limited to protecting patients from potential harms, but also encouraging the development of new medicines, as well as Canada’s international obligations to protect data against unfair commercial use.

Justice Grammond disagreed, instead emphasizing the public health purpose of Vanessa’s law. He ruled that the regulator’s decision to impose a confidentiality agreement upon Doshi was “unreasonable” and effectively reversed a “choice made by Parliament.” In addition, the Court found that the confidentiality agreement undermined Doshi’s ability to “meaningfully communicate the results of his research” and thus interfered with his freedom of expression. 

Justice Grammond’s decision was critical and sent some clear messages about how to implement Vanessa’s Law.  He admonished Health Canada for continuing its past practices in the wake of Vanessa’s Law, calling the imposition of a confidentiality agreement “a carry-over from the pre-Vanessa’s Law period, when Health Canada took the position that all information submitted by pharmaceutical companies was confidential.” Justice Grammond dryly remarked: the “mere fact that the policy is aligned with the preferences of the pharmaceutical industry” is insufficient to justify the regulator’s position.

The Court did not, however, close the door entirely on the use of confidentiality agreements. Justice Grammond noted that there will be “situations where Health Canada may validly impose a confidentiality requirement with respect to specific categories of information, but that decision must be made on a case-by-case basis.” But the reasoning behind Doshi v. Canada makes it hard to imagine how Health Canada could impose confidentiality agreements on others.

Here’s why: in March 2017, Health Canada announced its intention to follow the European Medicines Agency’s lead and start treating unpublished drug data—once a drug has been approved or rejected for sale—as public information not subject to commercial confidentiality. Regulations to do so are now pending in Canada’s Parliament. In his decision, Justice Grammond referenced those regulations repeatedly, emphasizing that the government had, by virtue of introducing them, acknowledged that there was “no legitimate interest in keeping the results of clinical trials private.” It therefore seems unlikely that Health Canada could impose a confidentiality agreement with respect to the types of clinical trial data Doshi requested. That would be tantamount to the regulator undoing with one hand, what it—and the government—has proposed, by way of regulations, to do with the other, i.e. publicly disclosing clinical data following a regulatory decision.

The court ordered the release of the data to Doshi. But the landmark ruling sets a precedent  that should push Health Canada to become the world’s leader when it comes to data transparency.  Compared to the European Medicines Agency, which began in 1995, Health Canada is an old regulator, and its holdings are likely vast.  We hope Health Canada embraces this opportunity to lead the world in open science.

Matthew Herder, associate professor & director, Health Law Institute, Department of Pharmacology, Faculties of Medicine and Law, Dalhousie University, Canada.

Competing interests: Matthew Herder worked closely on the case in an unpaid capacity. He is also the Principal Investigator for two research grants awarded by the Canadian Institutes of Health Research (CIHR EOG 123678, CIHR PJT 156256) and was recently appointed to serve on Canada’s Patented Medicine Prices Review Board.

Peter Doshi, assistant professor, University of Maryland School of Pharmacy.

Competing interests: This article is about my case against the Attorney General of Canada.  In addition PD is a recipient of a grant from the Laura and John Arnold Foundation to run a RIAT Support Center and was co-recipient of a UK National Institute for Health Research grant (HTA – 10/80/01 Update and amalgamation of 2 Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children— /hta/108001#/. He is also in receipt of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. PD received €1500 from the European Respiratory Society in support of his travel to the society’s September 2012 annual congress in Vienna, where he gave an invited talk on oseltamivir. He has received funding support ($11,000) from the American Association of Colleges of Pharmacy for a study to analyse written medical information regarding the possible harms of statins. PD is also an associate editor of the BMJ and an unpaid member of the IMEDS steering committee at the Reagan- Udall Foundation for the FDA, which focuses on drug safety research.

Trudo Lemmens, Professor and Scholl Chair in Health Law and Policy at the University of Toronto Faculty of Law.

Competing interests: Trudo Lemmens worked closely on the case in an unpaid capacity. He is also a co-investigator on CIHR PJT 156256, and has received funding from the Office of the Privacy Commissioner of Canada for a project on clinical trials transparency and privacy.

Timeline of Canadian Policy Developments, 2013-2018

December 6, 2013 1st Reading of Bill C-17, Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) Amendments to the Food and Drugs Act, in Parliament
March 10, 2014 Publication of “Regulating Drugs for patient safety: Does Bill C-17 go far enough?” in CMAJ, calling for addition of provisions to improve transparency to Bill C-17
May 10, 2014 2nd Reading of Bill C-17 in Parliament, referred to House of Commons’ Standing Committee on Health (HESA)
June 5, 2014 HESA Committee Hearings re: Bill C-17 commence
June 12, 2014 HESA Committee Hearings re: Bill C-17 conclude; Bill C-17 amended to include several transparency related provisions, including s. 21.1(3)(c), which gives the Minister of Health the discretion to share unpublished pharmaceutical data
June 16, 2014 3rd Reading of Bill C-17; passed by the House of Commons; 1st Reading of Bill C-17 in Senate
September 18, 2014 2nd Reading of Bill C-17 in Senate, referred to the Standing Senate Committee on Social Affairs, Science, and Technology (SOCI)
September 24, 2014 SOCI Committee Hearings re: Bill C-17 commence
October 9, 2014 SOCI Committee Hearings re: Bill C-17 conclude, and Committee Report presented without amendments
October 23, 2014 3rd Reading of Bill C-17; passed by Senate without amendment
November 6, 2014 Bill C-17 given Royal Assent
October 1, 2015 Request for information sent by Peter Doshi to Health Canada (HC) re: power to disclose clinical trial data under Vanessa’s Law
October 14, 2015 News coverage of Nav Persaud required by HC to sign confidentiality agreement to obtain information pursuant to s. 21.1(3)(c) of Food & Drugs Act
December 22, 2015 Publication of “Reinstitutionalizing transparency at Health Canada” in CMAJ; AllTrials, other NGOs post template letter to request data under s. 21.1(3)(c)
January 16, 2016 Submission of requests by Peter Doshi to HC for unpublished information re: neuraminidase inhibitors and HPV vaccines pursuant to s. 21.1(3)(c). Correspondence between Doshi and Health Canada is available here.
March 10, 2016 Publication of Draft Guidance for disclosure of information under s. 21.1(3)(c) by HC
May 22, 2016 Submission of letters (95 total signatures) from (i) clinicians/researchers, (ii) civil society orgs, and (iii) legal scholars calling on HC to change approach to s. 21.1(3)(c)
March 7, 2017 Applications for judicial review of Minister’s decision *not* to disclose information to Peter Doshi pursuant to s. 21.1(3)(c) absent a signed confidentiality agreement
March 10, 2017 Publication of Final Guidance for disclosure of information under s. 21.1(3)(c) by HC, with no change to requirement of confidentiality to access pharmaceutical data
December 9, 2017 Regulations amending the Food and Drug Regulations (Public Release of Clinical Information) introduced in Parliament
April 10, 2018 Publication of Draft Guidance Document – Public Release of Clinical Information by HC, interpreting the proposed PCRI Regulations
June 12, 2018 Doshi v. Attorney-General of Canada heard in Federal Court, Ottawa
July 9, 2018 Appeal allowed by Federal Court, Health Canada ordered to provide information encompassed by Doshi’s two requests pursuant to s. 21.1(3)(c)