Deploying the Precautionary Principle to Protect Vulnerable Populations in Canadian Post-Market Drug Surveillance
Drug regulatory bodies aim to ensure that patients have access to safe and effective drugs; however, no matter the quality of pre-licensure studies, uncertainty will remain regarding the safety and effectiveness of newly approved drugs until a large and diverse population uses those drugs. Recent analyses of Canada’s post-market drug surveillance (PMDS) system have found that Canada is not keeping pace with international requirements for PMDS, and have noted that efforts must be improved to monitor and address the safety and effectiveness of approved drugs among vulnerable populations. Given the uncertainty that exists when drugs enter the market, some have suggested that the precautionary principle is relevant to guiding decision-making in this context. This paper responds to recommendations that the Canadian PMDS system should be responsive to the health needs of vulnerable populations by assessing the utility of deploying the precautionary principle to guide a post-market strategy for vulnerable populations.
Copyright (c) 2020 Maxwell Smith, Ana Komparic, Alison Thompson
This work is licensed under a Creative Commons Attribution 4.0 International License.
The Canadian Journal of Bioethics applies the Creative Commons Attribution 4.0 International License to all its publications. Authors therefore retain copyright of their publication, e.g., they can reuse their publication, link to it on their home page or institutional website, deposit a PDF in a public repository. However, the authors allow anyone to download, reuse, reprint, modify, distribute, and/or copy their publication, so long as the original authors and source are cited.