The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada.
Healthc Policy
; 17(3): 81-90, 2022 02.
Article
in En
| MEDLINE
| ID: mdl-35319446
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Drug Approval
/
Insurance, Health
Type of study:
Prognostic_studies
Aspects:
Ethics
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Healthc Policy
Year:
2022
Document type:
Article