In June and July 2020, the PMPRB presented public research webinars on topics regarding drug pricing, market size, drug launches, investment, and shortages.
The PMPRB’s research is framed to support its proposed Guidelines policy approach. It also aims to refute findings by other sources concluding that the PMPRB proposals have already had, or will have, a negative impact on clinical trials and access to new medicines in Canada. Specifically, the PMPRB has criticized the data and methods used by these studies.
However, there are several limitations with the PMPRB’s methods which raise concerns regarding objectivity and rigor.
A comprehensive review of the existing body of research demonstrates that there is greater evidence of a decline in clinical trials and access to new medicines than there is evidence which supports the conclusion of “no impact,” as advanced by the PMPRB’s research. Numerous studies in the literature demonstrate the correlation between R&D/clinical trials and new drug access with drug prices/sales. Additionally, two recent analyses (IQVIA-LSO and IMC/LSO-Conference Board of Canada) suggest there are already signs of potential impacts in the time period coinciding with PMPRB regulatory amendments that were announced in August 2019.
The following is a summary of statements made by the PMPRB, with counterpoints, supporting rationale and data sources.