Decreasing the Data Deficit: Improving Canada’s Drug Regulatory System: Paper by Trudo Lemmens & Shannon Gibson now publicly available on SSRN.
Last month, and in the wake of several media reports exposing the serious limitations of our current regulatory system for pharmaceutical products, the Canadian Standing Senate Committee on Social Affairs, Science and Technology tabled a significant Final Report on Prescription Pharmaceuticals in Canada. The Standing Committee calls for Health Canada to take a more active role in ensuring that the safety and effectiveness of the drug regulatory system. Research conducted at the Faculty of Law with funding from Genome Canada has indirectly contributed to the work of the Standing Senate Committee. We (Research Associate Shannon Gibson & Professor Trudo Lemmens) prepared a number of memoranda for the Committee, which provided background information in support of the Committee’s work, and one of us (TL) participated also in two expert hearings over the course of the Committee’s inquiry. An expanded and elaborated version of one of our memoranda (all memoranda are available on TL's SSRN webpage), Decreasing the Data Deficit: Improving Post-Market Surveillance in Pharmaceutical Regulation, which was published in the McGill Law Journal in 2014, has just become freely available for downloading at SSRN). This paper is part of a series of papers related to pharmaceutical regulation which have been published or are coming out in the near future.
In this McGill Law Journal paper, we first discuss how historically grown drug regulations have contributed to the development of industry control over the conduct, analysis, interpretation and public presentation of clinical trials. We explore some problematic aspects related to the fixation of the drug approval system on pre-market activities, including the lack of good “real-world” evidence on drug safety; the lack of comparative evidence of patient benefit beteween different drugs; the lack of evidence of the safety and efficacy of off-label prescribed drugs; and the inadequate reporting of adverse drug reactions (ADRs). We argue that a more rigorous and intense post-market surveillance system could counterbalance, at least in part, the distorted situation created by the regulatory reliance on premarket, industry-produced clinical trials data. In particular, we advocate for improvements to the current ADR reporting system, more explicit requirements for both comparative effectiveness studies and post-market clinical research in real-world settings, the promotion of transparency of pharmaceutical data, and insulating clinical research from industry control.
The Standing Senate Committee’s report does not go as far as we do in our critique of the regulatory structure, but it highlights the need for a more transparent drug regulatory system, it calls on Health Canada to publicly disclose all relevant information about drug products, and it strongly urges for improvements to the monitoring of drugs during the post-market phase. It emphasizes in particular the need to build a more effective system for reporting adverse drug reactions (ADR).
Several of the Senate Committee’s recommendations have already been addressed, at least in part, by the passage in November 2014 of new drug safety legislation, Vanessa’s Law, which amended some crucial components of the Food and Drug Act. Vanessa’s Law was named in honour of and to commemorate the daughter of Oakville MP Terence Young, who died because of an adverse reaction to Prepulsid, a heartburn medication which has since been pulled from the market. MP Terence Young has been one of the key promoters of stronger regulatory control over pharmaceutical products. The new legislation includes a number of important amendments including an expansion of Health Canada’s oversight power in the post-market phase, very significant increases in the available penalties for contravention of the Food and Drugs Act and its associated regulations, and the basis for further transparency requirements. Health Canada is currently holding consultations on the information needs of patients, the public, health care professionals and other stakeholders in relation to expanding the transparency of the drug regulatory system. It is also providing detailed information on its website with respect to further initiatives to promote transparency in the context of drug regulation. Time will tell whether Health Canada’s measures will go far enough to ensure that the public health interests associated with data transparency are not inappropriately restricted by industry interests in data secrecy.
Trudo Lemmens & Shannon Gibson
