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Page 10 OctOber 15, 2018 • Law times www.lawtimesnews.com Data release ordered BY MICHAEL MCKIERNAN For Law Times C anada can remain at the forefront of clini- cal trial transparency after the Federal Court ordered the release of data to a public health researcher, ac- cording to the university profes- sor's lawyer. In Doshi v. Canada (At- torney General), Federal Court Justice Sébastien Grammond delivered the first judicial word on Vanessa's Law, the drug safe- ty legislation named in memory of 15-year-old Vanessa Young, who died from a heart attack in 2000 after taking prescription medication. In his July 9 decision, Gram- mond ruled that Peter Doshi, an assistant professor at the Univer- sity of Maryland, should receive complete copies of clinical study reports and raw datasets related to f lu vaccines Tamif lu and Re- lenza, as well as Cervarix, Gar- dasil and Gardasil 9, which are used to vaccinate against HPV, the cancer-causing human pap- illomavirus. The judge found that the re- strictive conditions Health Can- ada initially wanted attached to the data release, including a confidentiality agreement that would prevent Doshi from pub- lishing or disseminating his findings, "contradicts the pur- pose of Vanessa's Law, which is to improve clinical trial trans- parency." "Health Canada also fettered its discretion by adopting a rigid policy requiring a confidential- ity undertaking before disclos- ing information," Grammond added. "Lastly, I find that Health Canada failed to assess the ef- fects of its decision on Dr. Doshi's freedom of expression, guaranteed by section 2 (b) of the Canadian Charter of Rights and Freedoms." "We're obviously very happy, because it's the result we were hoping for," says Alyssa Tom- kins, an intellectual property litigator with Ottawa firm Caza Saikaley, who acted for Doshi. "It's an important precedent in favour of data disclosure, gener- ally speaking, and really offers an opportunity for Canada to take the lead on transparency of clinical trial data." Doshi launched his applica- tion within months of the new law coming into force. Bill C-17, the Protecting Ca- nadians from Unsafe Drugs Act (Vanessa's Law), received royal assent in late 2014, amending s. 21.1 of the federal Food and Drugs Act. The new provisions allow Health Canada to disclose con- fidential business information about a therapeutic product under certain circumstances, such as when there is reason to believe it may pose a risk to hu- man health. In addition, the law autho- rizes disclosures to government, ministerial advisers or a person carrying out "functions relating to the protection or promotion of human health or the safety of the public," a definition Doshi claimed covered his work at the University of Maryland's faculty of pharmacy in Baltimore. Clinical trial data for drugs in development have tradition- ally remained secret, but Gram- mond's decision explains that they have recently been exposed to a greater level of scrutiny due to fears about biased testing or selective publication of positive results. According to the decision, Doshi requested clinical study reports and data for the HPV and f lu vaccines in order to conduct a recognized form of systematic review for random- ized controlled trials, as well as a project he said would aim to improve "the methodology of evidence synthesis and appraisal of regulatory documents." Despite accepting that Doshi's position fell under the public health promotion defi- nition in Vanessa's Law, Health Canada insisted that the profes- sor sign a confidentiality agree- ment, and it denied his request when he refused. In a review of the text and context of the legislation, Gram- mond noted that clinical trial transparency was not men- tioned at all during the bill's first reading in 2013. That absence was viewed as a deficiency, both by MPs in the Commons and by experts who spoke during the Parliamentary committee process, resulting in a number of fresh amendments that found their way into the fi- nal text. While Doshi argued that Health Canada could never force a confidentiality agree- ment on a person receiving data under s. 21.1, the judge said there may be situations where one could be imposed to satisfy le- gitimate privacy interests. "But that decision must be made on a case-by-case basis," he added. FOCUS Alyssa Tomkins says a recent Federal Court ruling 'really offers an opportunity for Canada to take the lead on transparency of clinical trial data.' 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