A federal court judge ruled this week that Health Canada cannot withhold clinical-trial data from a researcher who refused to sign a confidentiality agreement, a decision that could pave the way for greater transparency at the department.
The case centred on provisions in Vanessa’s Law, legislation designed to protect Canadians from unsafe drugs and passed in 2014. The law says the federal health minister can disclose confidential business information, such as clinical-trial data, to people who work in public health or safety.
Many researchers have long advocated for greater clinical trial transparency from Health Canada as a way of ensuring the safety of drugs. For instance, researchers who have access to drug-company trials may come to different conclusions about their efficacy or safety.
Peter Doshi, an assistant professor at the University of Maryland school of pharmacy, asked Health Canada in 2016 to release clinical-trial information pertaining to two types of drugs: vaccines for human papillomavirus, as well as Tamiflu and Relenza, antiviral medications used to treat influenza. Drug companies must submit clinical trials to Health Canada to have their products approved and Dr. Doshi wanted to analyze the information provided on those drugs as part of research he was conducting.
In both cases, Health Canada said it would not release the information unless Dr. Doshi signed a confidentiality agreement, so he took the matter to court.
In a July 9 ruling, Justice Sébastien Grammond said Health Canada’s decision is “unreasonable” and “entirely disregards one of the main purposes of Vanessa’s Law, namely to improve clinical-trial transparency.”
In a written statement, Dr. Doshi said he hopes the case will set a precedent and allow for greater transparency going forward.
“Regulators should see public access to data as … fundamental to fulfilling their mission to public health agencies,” he wrote. “In my opinion, the public’s interest in the unbiased assessments of medicines outweighs claims of commercial confidentiality.”
In a written statement, Health Canada spokeswoman Rebecca Purdy said the department is “committed to providing Canadians greater access to credible, timely, useful information” and that increasing access to data “can have widespread benefits throughout the health-care system.”
Nav Persaud, a staff physician at Toronto’s St. Michael’s Hospital and scientist at the Li Ka Shing Knowledge Institute, said the decision sends “a clear message” to the government.
“Health Canada’s blanket use of these confidentiality agreements wasn’t consistent with the law,” Dr. Persaud said. “Hopefully, it will change Health Canada’s general approach to openness and transparency.”
The Attorney-General, who argued the government’s case, argued that the law must balance increased public scrutiny of the pharmaceutical industry with the need to support the development of new drugs.
Justice Grammond rejected this argument, writing in his ruling that the stated purpose of the law is, first and foremost, to ensure drug safety and help protect the public.
He also noted that Health Canada has already published draft regulations that would give the government greater freedom to share drug company clinical trial results with interested parties.
But those regulations have not yet come into force, which is one reason why the federal court ruling is important, said Matthew Herder, director of the Health Law Institute at Dalhousie University who has been working with Dr. Doshi throughout the court case. Mr. Herder said the wording of the draft regulations appears to give Health Canada a lot of leeway for rejecting requests for access to clinical trials and it remains to be seen whether this week’s case will have a real impact on transparency.
Ms. Purdy said the regulations are expected to come into effect later this year and would help ensure Canadians have greater access to the information from clinical trials.