A guest blog from Matthew Herder, Assistant Professor, Dalhousie University
Canada’s recent record on pharmaceutical drug transparency is poor. Despite numerous articles and expert testimony calling for policy reform and growing attention to the issue in the popular press (examples of which can be found here, here, here and here), there remains no law requiring those who conduct or sponsor clinical trials (or other investigational studies) to register or report study results.
Canadian research ethics guidelines stipulate clinical trial registration but extend only to researchers and institutions in receipt of public funds. Moreover, whether the research ethics boards charged with monitoring compliance with the guidelines are actually doing so is open to serious question. Meanwhile, Canada’s drug safety regulator, Health Canada, has consistently under-delivered in terms of its transparency. For example, Health Canada’s “Summary Basis of Decision” (SBD) project is supposed to explain the reasoning behind (some of) its drug approvals. However, according to a recent analysis published by PLOS One SBDs provide “little to aid clinicians in their decision-making.”
Amidst efforts to increase transparency in other jurisdictions, Canada appears content to stay in the dark. In December 2013, a bill to amend Canada’s Food and Drugs Act was introduced into Parliament. To its credit, the bill contains a number of important patient safety measures, including the power to recall drugs from the market without having to first negotiate with drug manufacturers. (Listen to a discussion about the bill here) Yet, not a single provision in the bill promises greater transparency regarding the evidence base behind, or regulatory decisions about, biopharmaceutical drugs.
Without a meaningful commitment to transparency in Bill C-17, the government will be hard pressed to deliver on its promise of patient safety. A meaningful commitment means mandatory registration of all investigational studies (both clinical trials and observational studies), mandatory study results reporting and mandatory access to anonymised patient-level data—each backed by enforceable penalties—as well as greater openness in regulatory decision-making. Building upon laws that facilitate drug transparency in other jurisdictions and learning from AllTrials’ past successes, our efforts to bring about reform can only help.
The AllTrials campaign has been talking with Matthew Herder and others about the issues in Canada. We will be working hard to make sure clinical trial transparency is on the agenda and will need your help in the coming weeks and months. Make sure to share this campaign (www.alltrials.net) with your friends, family and any organisations you are involved in.
Matthew Herder LLM JSM is Assistant Professor in the Faculties of Medicine and Law, Health Law Institute at Dalhousie University, Nova Scotia, Canada.