A Halifax professor is trying to shed new light on the safety and effectiveness of prescription drugs by kick-starting an international letter-writing campaign asking Health Canada to release data it now keeps confidential.
Matthew Herder, an associate professor at Dalhousie University’s faculties of law and medicine, is out to change what he describes as Health Canada’s “culture of secrecy,” and is enlisting researchers, physicians, journalists and concerned individuals to help him do that, offering a fill-in-the-blanks template for information requests.
The move follows changes made last year to the Food and Drugs Act with the passage of Bill C-17, sometimes called “Vanessa’s Law.” Prof. Herder appeared alongside others at parliamentary hearings on the bill, asking that drug-safety data be made public as part of the changes.
They failed to get that, but the new bill was amended to allow the release of what it calls “confidential business information” to any “person who carries out functions relating to the protection or promotion of human health or the safety of the public” as long as they use the information for that purpose.
After fighting to win this concession, Prof. Herder says he worries theirs will be a Pyrrhic victory unless the new rules are tested.
“We have these new tools. They are not perfect, but we can try to take advantage of them,” he said in an interview. “The more the better.”
Prof. Herder issued his call to action in an article this week in the Canadian Medical Association Journal and the template for the letter to Health Minister Jane Philpott is available online through links on websites including Canadian Doctors for Medicare.
There is no requirement that those making the request be Canadians, and Prof. Herder is working with non-governmental organizations to encourage foreign researchers to make use of the new rules. He expects there could be push back from industry and a court challenge.
The one doctor, from Toronto, who tried using the new rules to access data, Nav Persaud, was required to sign an extensive non-disclosure agreement that prohibited him from sharing the data. For that reason, Prof. Herder, who consulted with Dr. Persaud and others in drafting the letter, has included in his template a list of terms and conditions he hopes will prevent the prohibitions imposed on the Toronto physician from becoming the standard.
“Vanessa’s Law says nothing about the exact terms under which data can be shared,” he said. “It simply sets a threshold: are you a person who protects and promotes human health and are you going to use it for that purpose.”
Health Canada confirmed it has only received one request under the new disclosure provisions and said in an e-mail it is “committed to making available information Canadians need on drug safety risks.”Report Typo/Error