A Federal Court judge has ordered Health Canada to release reams of pharmaceutical clinical trial data on five medications to an American researcher, undercutting the federal government’s attempts to keep the information confidential.
The July 9 ruling stems from a request by Maryland-based researcher Peter Doshi for access to clinical trial data submitted to Health Canada by the manufacturers of the HPV vaccines Gardasil, Gardasil 9 and Cervarix, and the anti-viral medications Tamiflu and Relenza.
He wanted to conduct a “systematic review” of the findings, but Health Canada said it was confidential business information and it would only hand it over if he signed a confidentiality agreement.
Doshi refused and took the federal government to court.
“I hope my case sets a precedent and allows researchers, clinicians, and the public easy access to clinical trial data,” he said in an email to CBC News.
“Regulators shouldn’t have a monopoly on judging the risks and benefits of medicines or hinder others from doing the same via confidentiality agreements,” said Doshi, assistant professor at the University of Maryland School of Pharmacy and an associate editor at the BMJ (formerly known as the British Medical Journal).
Some types of HPV can lead to cervical and other cancers, and vaccines are offered to girls and many boys in Canadian schools. Health Canada says the vaccines are a safe and highly effective way of preventing the types of HPV infections that could lead to cancer.
Tamiflu and Relenza are used to treat influenza.
The court decision earlier this week is the first to interpret and apply Vanessa’s Law. The legislation came in the wake of the 2000 death of an Ontario teenager, to allow Canada’s minister of health to disclose drug information to certain people, such as those who protect or promote public health.
On Thursday, Health Canada said in a statement it is working on regulations that would publicly