Clinical Trials in Canada Decrease: A Sign of Uncertainty Regarding Changes to the PMPRB?

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Summary

Nigel SB Rawson, PhD

Canadian Health Policy, April 2020. ISSN 2562-9492

Abstract

The Canadian federal government is introducing changes in the price review guidelines of the Patented Medicine Prices Review Board (PMPRB), the tribunal whose role is to set ceiling prices for patented medicines sold in Canada, which are due to come into effect in July 2020. The changes will lead to severe price reductions being required for new medicines and are causing much concern and uncertainty in patients, health care providers and pharmaceutical companies. The guidelines for the PMPRB’s working practices were released in November 2019. This allowed for an investigation as to whether the number of new trials posted in Health Canada’s clinical trials database between November 1, 2019 and March 15, 2020 differed from the numbers posted in the same time period in previous years. ClinicalTrials.gov was also used to identify Canadian and American trials in the same periods. Both databases demonstrated a decrease in trials in Canada in the study period of more than 52% compared with a reduction of only 21% in US trials. When pharmaceutical companies perform fewer clinical trials in Canada, this reduces investment in research and causes a loss of employment opportunities. It can also be a sign that manufacturers do not intend to bring new medicines here. The Canadian federal government is embarking on a novel and risky experiment in public policy that will severely regulate the prices of new therapeutics and negatively impact the level of clinical research in Canada. The large rate of decline in the number of clinical trials in Canada is concerning and likely a sign of things to come. Canadians should be made aware of the potential consequences of the government’s changes in the PMPRB guidelines at a time when they need new, innovative medicines more than ever to treat cancer, rare disorders and life-threatening infections.

References

1. Canadian Organization for Rare Disorders (2020). CORD’s response to Patented Medicine Prices Review Board. Toronto: CORD. http://www.raredisorders.ca/content/uploads/CORD-draft-PMPRB-Guidelines-Submission-Feb-14_2020Combined.pdf 

2. Health Canada (2016). Health Canada’s Clinical Trials Database. Ottawa: Government of Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database.html

3. Innovative Medicines Canada (2020). IMC response to PMPRB draft guidelines. Ottawa: IMC. http://www.pdci.ca/wp-content/uploads/2020/03/20200214_Innovative_Medicines_Canada_Guidelines_Response_FINALc.pdf

4. Life Sciences Ontario (2020). Impact of PMPRB pricing changes: final research report. Toronto: LSO. https://lifesciencesontario.ca/wp-content/uploads/2020/02/Research-Etc.-PMPRB-Survey-02-03-20.pdf

5. PMPRB (2018). Mandate and jurisdiction. Ottawa: Government of Canada. http://pmprb-cepmb.gc.ca/about-us/mandate-and-jurisdiction

6. US National Library of Medicine (2020). ClinicalTrials.gov. Bethesda, MD: National Library of Medicine. https://clinicaltrials.gov/ct2/home

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