Health Canada has been talking about improving the transparency of information around pharmaceutical drugs for years. The drug regulator has failed to back up that talk with genuine commitment and action.
Meanwhile, the lack of transparency around pharmaceutical drugs continues to undermine patient safety and public health. Unless a drug’s full safety and effectiveness profile is transparent, physicians and patients alike are at best misinformed. At worst, patients could suffer significant harm, even death, after taking a government-approved, physician-prescribed drug.
The lack of transparency around pharmaceutical drugs continues to undermine patient safety and public health.
The problem stems from the fact that lots of evidence about a drug’s safety and effectiveness is never published, sometimes because journals don’t accept it for publication, other times because the researchers and company sponsors choose not to disclose it, especially if the outcome of the study would be perceived to negatively affect sales. In other cases, it is published in a manner that does not accurately reflect what actually happened.
Government regulators do evaluate both published and non-published evidence, but only in confidence with drug manufacturers—a model that has proven deeply flawed. Whether it was evidence of heart attack risks with the pain relief drug rofecoxib (Vioxx) of the late 1990s and early 2000s or studies of children and teenagers’ use of the antidepressant paroxetine (Paxil), time and again, patients have been exposed to serious risks while regulators have been slow to act, were being misled by the companies involved, or simply missed gaps in the evidence—all behind closed doors.
Greater transparency is needed so researchers can independently assess a drug’s safety and effectiveness and doctors can examine the data to ensure the appropriateness of their prescribing, while investigative journalists and civil society at large put public pressure on regulators and industry to improve their practices.
Several countries (including the United States), regulators (such as the European Medicines Agency), and international institutions (World Health Organisation) have made important transparency commitments, followed by concrete action. Transparency remains a work in progress, but laws have been put into place and are beginning to be enforced.
Health Canada has offered up several supposed transparency initiatives, but each has failed to deliver meaningful change.
In contrast, until recently, Canada has done little more than talk. Following numerous Parliamentary Committees, Auditor General reports, journalist investigations, and calls by academic researchers for greater transparency, Health Canada has offered up several supposed transparency initiatives. But each has failed to deliver meaningful change.
In late 2014, Parliament finally made a commitment to improving transparency around pharmaceutical interventions by enacting “Vanessa’s Law.” Inspired by the death of former MP Terence Young’s teenage daughter, Vanessa, because of use of the prescription drug cisapride, the law gives the Minister of Health and in turn Health Canada several new and important powers in the name of patient safety. This law has great promise to finally turn things around and open up the black box of medicines’ safety in Canada.
One provision in Vanessa’s Law, section 21.1(3)(c), gives the Minister of Health the power to disclose information that companies and Health Canada have kept confidential to any person “who carries out functions relating to the protection or promotion of human health or the safety of the public” provided that “the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public.”
Section 21.1(3)(c) is discretionary: the Minister may disclose such information. It also treats—in our view wrongly—clinical data as “confidential business information,” thereby confirming secrecy as the norm. However, the provision is otherwise worded very broadly. It has the potential to open up reams of information that companies and the regulator have—again, wrongly—treated as private property for decades. Unless and until Parliament explicitly excludes unpublished drug studies as confidential business information, section 21.1(3)(c) has a critical part to play in fostering greater transparency.
Once again, Health Canada is threatening to undo the commitment to transparency in Vanessa’s Law.
Once again, though, Health Canada is threatening to undo the commitment to transparency in Vanessa’s Law. In March it published its Draft Guidance about how it intends to interpret section 21.1(3)(c), cementing an approach that has already stymied access to safety and effectiveness drug information.
Contrary to the provision’s broad wording and the purpose of Vanessa’s Law, Health Canada’s Draft Guidance narrows who is eligible to ask for drug information while requiring the few that the regulator deems eligible to make a request to sign a strictly worded confidentiality agreement, and demonstrate efforts to obtain the information from “all other possible sources” before receiving the information.
In response to Health Canada’s call for public commentary on its Draft Guidance, we wrote and coordinated a series of submissions, signed by 95 clinicians and researchers, representatives of civil society, and legal scholars, calling on Health Canada to remove these limitations and exclude drug safety and effectiveness from the category of confidential business information. We also argued in one of our submissions that the Draft Guidance is, in legal terms, deeply flawed and may violate the Charter of Rights and Freedoms.
Unless Health Canada responds to these points, Vanessa’s Law will become just the latest example of transparency talk rather than concrete commitment and action. At that point continuing to talk transparency will itself become harmful, obscuring the absence of real change.
This month, Health Canada announced its plans to develop regulations in order to implement Vanessa’s Law “in phases…beginning in fall 2016.” Yet the first phase will not include any of the key transparency provisions in Vanessa’s Law. This means Health Canada is putting off deciding what’s in and what’s out of confidential business information under section 21.1(3)(c), not to mention specifying what information drug companies must publicly disclose under section 21.71. While we await some future phase of consultation about proposed regulations, the transparency provisions of Vanessa’s Law will remain utterly opaque.
We are tired of all this transparency talk. Canadians have a right to know how safe and effective — or unsafe and ineffective — their medicines are. Anything less will come at a great cost to patient safety and public health.
Photo: Kaesler Media / Shutterstock.com
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