Intended for healthcare professionals

News

Canadian government ordered to release unpublished Tamiflu data in landmark ruling

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3112 (Published 13 July 2018) Cite this as: BMJ 2018;362:k3112

Opinion

Canadian court orders release of unpublished clinical trial data

  1. Gareth Iacobucci
  1. The BMJ

The Canadian government has been instructed to release unpublished clinical trial data relating to Tamiflu, Relenza, and three human papillomavirus vaccines immediately, in a landmark ruling hailed as a “major victory” for transparency.

The case was brought by Peter Doshi, assistant professor at the University of Maryland and associate editor of The BMJ, after Health Canada refused his request to obtain unpublished information relating to Tamiflu, Relenza, Gardasil, Gardasil 9, and Cervarix because he would not sign a confidentiality agreement that would have prevented him from disseminating or publishing anything on it.

A federal court judge said it was “unreasonable” for Health Canada to impose a confidentiality requirement as a condition for the disclosure of data, and ordered the agency to release it without any further reconsideration.

The case is the first time that the Canadian courts have been required to interpret and apply new legislation introduced in 2014 which empowered the government to disclose information concerning drugs to certain persons. The legislation is known as Vanessa’s Law, after 15 year old Vanessa Young, who died of a heart attack in 2000 after taking the prescription drug Prepulsid.

In his summing up, the judge Mr Justice Grammond said, “Health Canada’s decision in this case is unreasonable, because it entirely disregards one of the main purposes of Vanessa’s Law, namely to improve clinical trial transparency, it amounts to a fettering of discretion and it does not result in a proportionate balance between Dr Doshi’s freedom of expression and Health Canada’s purposes.

“Health Canada cannot ignore that parliament intended to make clinical trial data public and adopt a policy that is in direct contradiction with that purpose.”

The judge also noted that the Canadian government had already made moves towards greater transparency by tabling new regulations in December 2017 that will make clinical information from drug submissions and medical device applications publicly available once the regulatory review process for a drug or medical device was complete. The regulations are expected to come into effect by the end of 2018.

“Dr Doshi seeks clinical trial reports and data. This information will become public when the regulations are adopted. There is no principled basis to keep them private now,” the judge said.

In response to the verdict, Doshi said, “I am of course very pleased that the judge has rejected Health Canada’s demand that I sign a confidentiality agreement, and I commend him for linking this matter to one of freedom of expression—confidential data is incompatible with true freedom of speech. I’m looking forward to receiving the data for these major public health interventions. For me this case has always been about something larger than my specific request. It is about the principle of transparency. If my case sets a precedent and Health Canada begins making clinical trial data available to others—promptly, and without imposing confidentiality agreements—that will be the real victory.”

Matthew Herder, associate professor and director of the Health Law Institute at Dalhousie University, who assisted Doshi in trying to obtain the data, told The BMJ that the court had made a “significant ruling” for researchers that should lead to greater protection for patients. “It’s a really important victory for transparency,” he said.

A spokeswoman for Health Canada said, “Health Canada is reviewing the court’s decision and will continue to move ahead with its plan to make clinical information on drugs publicly available in order to better protect the health and safety of Canadians.”

View Abstract

Log in

Log in through your institution

Subscribe

* For online subscription