The Importance of and Challenges with Adopting Life‑Cycle Regulation and Reimbursement in Canada

Melanie McPhail, Christopher McCabe, Dean A. Regier, Tania Bubela

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)81-90
Number of pages10
JournalHealthcare Policy
Volume17
Issue number3
DOIs
Publication statusPublished - Feb 2022
Externally publishedYes

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