|Posted on July 14, 2018 at 12:30 AM|
Trudeau government slapped down by federal court on clinical data secrecy
July 13, 2018, OAKVILLE - In its first test in court Vanessa’s Law: The Protecting Canadians from Unsafe Drugs Act passed with flying colours on July 9th.
Yet it was not a big pharma company in federal court arguing against the transparency provisions in a law all parties supported without dissent in both houses of parliament, but our own federal government.
Dr. Peter Doshi, an Assistant Professor at Maryland University applied under Vanessa’s Law to obtain unpublished clinical trial data held by Health Canada in order to investigate the safety and efficacy of certain drugs including Tamiflu and Relenza, drugs sold to treat or help prevent the flu.
Health Canada, operating under their discretionary powers outlined in a Guidance Document, refused to accede to his request unless he signed a “confidentiality agreement that would prevent him from disseminating or publishing the information disclosed,” which he refused to do, and sought judicial review in federal court.
Mr. Justice Grammond rejected the government’s arguments and allowed his application, saying “Health Canada exercised its discretionary power set forth in section 21.1 (3) in a manner that contradicts the purpose of Vanessa’s Law, which is to improve clinical transparency.”
The court also decided that Health Canada fettered its own discretion, and failed to assess “the effects of its decision on Mr. Doshi’s freedom of expression” in sec 2(b) of The Canadian Charter of Rights and Freedoms.
“This is wonderful for Canadian patients, but a major embarrassment for the Liberal government and the people who are supposed to enforce the law – Health Canada officials,” says Terence Young Chair of Drug Safety Canada, father of Vanessa, who as MP conceived the law and carried it through parliament.
“It is very revealing, and disturbing that the Liberals would vote for Vanessa’s Law in both houses without dissent in 2014, yet refuse to pass key regulations for over 3 ½ years, and take the industry position against transparency today in federal court. This while 10,000 Canadians die yearly due to adverse drug reactions. This confirms we need an independent drug agency for Canada immune from political interference.”
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