The importance of and challenges with adopting life-cycle regulation and reimbursement in Canada
Document Type
Article
Department
Office of the Provost
Abstract
Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval and/or positive reimbursement decisions based on an undertaking to conduct post-market clinical trials that address evidentiary uncertainties, relying on the collection and analysis of post-market data. In practice, however, both conditional regulatory and reimbursement decisions have proven problematic. Here we discuss some of the regulatory implications and unsettled ethical and pragmatic issues, taking lessons from the recent experiences of Israel in rapidly approving the Pfizer-BioNTech COVID-19 vaccine.
Publication (Name of Journal)
Healthcare Policy
DOI
10.12927/hcpol.2022.26726
Recommended Citation
McPhail, M.,
McCabe, C.,
Regier, D. A.,
Bubela, T. M.
(2022). The importance of and challenges with adopting life-cycle regulation and reimbursement in Canada. Healthcare Policy, 17(3), 81-90.
Available at:
https://ecommons.aku.edu/provost_office/723
Comments
This work was published before Tania joined Aga Khan University.