{"id":42646,"date":"2018-07-19T15:59:24","date_gmt":"2018-07-19T14:59:24","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=42646"},"modified":"2018-07-24T16:25:34","modified_gmt":"2018-07-24T15:25:34","slug":"precedent-pushing-practice-canadian-court-orders-release-of-unpublished-clinical-trial-data","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2018\/07\/19\/precedent-pushing-practice-canadian-court-orders-release-of-unpublished-clinical-trial-data\/","title":{"rendered":"Precedent pushing practice: Canadian court orders release of unpublished clinical trial data"},"content":{"rendered":"

Canada\u2019s Federal Court has just rendered a <\/span>milestone decision<\/span><\/a> for clinical trial transparency. In the case of <\/span>Peter Doshi v. Attorney General of Canada<\/span><\/i><\/a> (yes, that\u2019s one of us), Justice S\u00e9bastian Grammond ordered Canada\u2019s pharmaceutical regulator, Health Canada, to disclose \u201ccomplete 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.\u201d<\/span><\/p>\n

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appeal, the decision should spur additional data transparency measures in Canada while immediately improving access to unpublished pharmaceutical data for scrutiny by independent researchers around the world.<\/span><\/p>\n

We see <\/span>Doshi v. Canada<\/span><\/i> 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 \u201cVanessa\u2019s Law,\u201d which amended Canada\u2019s Food and Drugs Act to improve drug safety. (<\/span>See the timeline below)<\/span><\/p>\n

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 In 2015, researcher Nav Persaud asked for unpublished data for the morning sickness drug diclectin.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\u2014but only after requiring he sign a confidentiality agreement.<\/span><\/p>\n

Confidentiality agreements can stifle open science. So one of us (Herder) drafted a <\/span>template letter<\/span><\/a> to facilitate future researchers\u2019 requests to Health Canada without any condition of confidentiality. In early 2016, <\/span>Doshi used the template and filed a request<\/span><\/a> for data on three HPV vaccines and two anti-influenza drugs.<\/span><\/p>\n

Vanessa\u2019s Law allows disclosing data to (1) a person who \u201ccarries out functions relating to the protection or promotion of human health or the safety of the public\u201d if (2) the \u201cpurpose of the disclosure is related to the protection or promotion of human health or the safety of the public.\u201d After months of frustrating back-and-forth (<\/span>see here for details<\/span><\/a>)<\/span>, 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.<\/span><\/p>\n

We decided to challenge that decision in Court\u2014and, with support from a law firm (<\/span>Caza Saikaley<\/span><\/a>) who took on the case <\/span>pro bono\u2014<\/span><\/i>filed for judicial review.<\/span><\/p>\n

In Federal Court, the Attorney General argued that Health Canada\u2019s 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\u2019s international obligations to protect data against unfair commercial use.<\/span><\/p>\n

Justice Grammond disagreed, instead emphasizing the public health purpose of Vanessa\u2019s law. He ruled that the regulator\u2019s decision to impose a confidentiality agreement upon Doshi was \u201cunreasonable\u201d and effectively reversed a \u201cchoice made by Parliament.\u201d In addition, the Court found that the confidentiality agreement undermined Doshi\u2019s ability to \u201cmeaningfully communicate the results of his research\u201d and thus interfered with his freedom of expression.<\/span>\u00a0<\/span><\/p>\n

Justice Grammond\u2019s decision was critical and sent some clear messages about how to implement Vanessa\u2019s Law. \u00a0He admonished Health Canada for continuing its past practices in the wake of Vanessa\u2019s Law, calling the imposition of a confidentiality agreement \u201ca carry-over from the pre-Vanessa\u2019s Law period, when Health Canada took the position that all information submitted by pharmaceutical companies was confidential.\u201d Justice Grammond dryly remarked: the \u201cmere fact that the policy is aligned with the preferences of the pharmaceutical industry\u201d is insufficient to justify the regulator\u2019s position.<\/span><\/p>\n

The Court did not, however, close the door entirely on the use of confidentiality agreements. Justice Grammond noted that there will be \u201csituations 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.\u201d But the reasoning behind <\/span>Doshi v. Canada<\/span><\/i> makes it hard to imagine how Health Canada could impose confidentiality agreements on others.<\/span><\/p>\n

Here\u2019s why: in March 2017, Health Canada announced its intention to follow the European Medicines Agency\u2019s lead and start treating unpublished drug data\u2014once a drug has been approved or rejected for sale\u2014as public information not subject to commercial confidentiality. <\/span>Regulations<\/span><\/a> to do so are now pending in Canada\u2019s Parliament. In his decision, Justice Grammond referenced those regulations repeatedly, emphasizing that the government had, by virtue of introducing them, acknowledged that there was \u201cno legitimate interest in keeping the results of clinical trials private.\u201d 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\u2014and the government\u2014has proposed, by way of regulations, to do with the other, i.e. publicly disclosing clinical data following a regulatory decision.<\/span><\/p>\n

The court ordered the release of the data to Doshi. But the landmark ruling sets a precedent \u00a0that should push Health Canada to become the world\u2019s leader when it comes to data transparency. \u00a0Compared to the European Medicines Agency, which began in 1995, Health Canada is an old regulator, and its holdings are likely vast. \u00a0We hope Health Canada embraces this opportunity to lead the world in open science.<\/span><\/p>\n

Matthew Herder<\/strong>, associate professor & director, Health Law Institute, Department of Pharmacology, Faculties of Medicine and Law, Dalhousie University, Canada.<\/em><\/p>\n

Competing interests<\/strong>: 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\u2019s Patented Medicine Prices Review Board.<\/span><\/em><\/p>\n

Peter Doshi<\/strong>, assistant professor, University of Maryland School of Pharmacy.<\/em><\/p>\n

Competing interests<\/strong>: This article is about my case against the Attorney General of Canada. \u00a0In 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 \u2013 10\/80\/01 Update and amalgamation of 2 Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children\u2014 https:\/\/www.journalslibrary.nihr.ac.uk\/programmes \/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 \u20ac1500 from the European Respiratory Society in support of his travel to the society\u2019s 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.<\/span><\/em><\/p>\n

Trudo Lemmens<\/strong>, Professor and Scholl Chair in Health Law and Policy at the University of Toronto Faculty of Law.<\/em><\/p>\n

Competing interests<\/strong>: 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.<\/span><\/em><\/p>\n

Timeline of Canadian Policy Developments, 2013-2018<\/b><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
December 6, 2013<\/td>\n1st Reading of Bill C-17, Protecting Canadians from Unsafe Drugs Act (<\/span>Vanessa\u2019s Law<\/span><\/a>) Amendments to the Food and Drugs Act, in Parliament<\/span><\/td>\n<\/tr>\n
March 10, 2014<\/td>\nPublication of <\/span>\u201cRegulating Drugs for patient safety: Does Bill C-17 go far enough?\u201d<\/span><\/a> in CMAJ, calling for addition of provisions to improve transparency to Bill C-17<\/span><\/td>\n<\/tr>\n
May 10, 2014<\/td>\n2nd Reading of Bill C-17 in Parliament, referred to House of Commons\u2019 Standing Committee on Health (HESA)<\/span><\/td>\n<\/tr>\n
June 5, 2014<\/td>\nHESA Committee Hearings re: Bill C-17 commence<\/span><\/td>\n<\/tr>\n
June 12, 2014<\/td>\nHESA Committee Hearings re: Bill C-17 conclude; Bill C-17 amended to include <\/span>several transparency related provisions<\/span><\/a>, including s. 21.1(3)(c), which gives the Minister of Health the discretion to share unpublished pharmaceutical data<\/span><\/td>\n<\/tr>\n
June 16, 2014<\/td>\n3rd Reading of Bill C-17; passed by the House of Commons; 1st Reading of Bill C-17 in Senate<\/span><\/td>\n<\/tr>\n
September 18, 2014<\/td>\n2nd Reading of Bill C-17 in Senate, referred to the Standing Senate Committee on Social Affairs, Science, and Technology (SOCI)<\/span><\/td>\n<\/tr>\n
September 24, 2014<\/td>\nSOCI Committee Hearings re: Bill C-17 commence<\/span><\/td>\n<\/tr>\n
October 9, 2014<\/td>\nSOCI Committee Hearings re: Bill C-17 conclude, and Committee Report presented without amendments<\/span><\/td>\n<\/tr>\n
October 23, 2014<\/td>\n3rd Reading of Bill C-17; passed by Senate without amendment<\/span><\/td>\n<\/tr>\n
November 6, 2014<\/td>\nBill C-17 given Royal Assent<\/span><\/td>\n<\/tr>\n
October 1, 2015<\/td>\nRequest for information sent by Peter Doshi to Health Canada (HC) re: power to disclose clinical trial data under Vanessa\u2019s Law<\/span><\/td>\n<\/tr>\n
October 14, 2015<\/td>\nNews coverage<\/span><\/a> of Nav Persaud required by HC to sign confidentiality agreement to obtain information pursuant to s. 21.1(3)(c) of Food & Drugs Act<\/span><\/td>\n<\/tr>\n
December 22, 2015<\/td>\nPublication of \u201c<\/span>Reinstitutionalizing transparency at Health Canada<\/span><\/a>\u201d in CMAJ; <\/span>AllTrials<\/span><\/a>, other NGOs post template letter to request data under s. 21.1(3)(c)<\/span><\/td>\n<\/tr>\n
January 16, 2016<\/td>\nSubmission 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 <\/span>here<\/span><\/a>.<\/span><\/td>\n<\/tr>\n
March 10, 2016<\/td>\nPublication of <\/span>Draft Guidance<\/span><\/a> for disclosure of information under s. 21.1(3)(c) by HC<\/span><\/td>\n<\/tr>\n
May 22, 2016<\/td>\nSubmission of letters (<\/span>95 total signatures<\/span><\/a>) from (i) <\/span>clinicians\/researchers<\/span><\/a>, (ii) <\/span>civil society orgs<\/span><\/a>, and (iii) <\/span>legal scholars<\/span><\/a> calling on HC to change approach to s. 21.1(3)(c)<\/span><\/td>\n<\/tr>\n
March 7, 2017<\/td>\nApplications for judicial review of Minister\u2019s decision *not* to disclose information to Peter Doshi pursuant to s. 21.1(3)(c) absent a signed confidentiality agreement<\/span><\/td>\n<\/tr>\n
March 10, 2017<\/td>\nPublication of <\/span>Final Guidance<\/span><\/a> for disclosure of information under s. 21.1(3)(c) by HC, with no change to requirement of confidentiality to access pharmaceutical data<\/span><\/td>\n<\/tr>\n
December 9, 2017<\/td>\nRegulations amending the Food and Drug Regulations (<\/span>Public Release of Clinical Information<\/span><\/a>) introduced in Parliament<\/span><\/td>\n<\/tr>\n
April 10, 2018<\/td>\nPublication of <\/span>Draft Guidance Document<\/span><\/a> \u2013 Public Release of Clinical Information by HC, interpreting the proposed PCRI Regulations<\/span><\/td>\n<\/tr>\n
June 12, 2018<\/td>\nDoshi v. Attorney-General of Canada heard in Federal Court, Ottawa<\/span><\/td>\n<\/tr>\n
July 9, 2018<\/td>\nAppeal allowed by Federal Court, Health Canada ordered to provide information encompassed by Doshi\u2019s two requests pursuant to s. 21.1(3)(c) <\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Canada\u2019s 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\u2019s one of us), Justice […]<\/p>\n

More…<\/a><\/p>\n","protected":false},"author":1,"featured_media":42648,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5744],"tags":[],"class_list":["post-42646","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-open-data"],"yoast_head":"\nPrecedent pushing practice: Canadian court orders release of unpublished clinical trial data - The BMJ<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/bmj\/2018\/07\/19\/precedent-pushing-practice-canadian-court-orders-release-of-unpublished-clinical-trial-data\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Precedent pushing practice: Canadian court orders release of unpublished clinical trial data - The BMJ\" \/>\n<meta property=\"og:description\" content=\"Canada\u2019s Federal Court has just rendered a milestone decision for clinical trial transparency. 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