The Hill Times,
Letter to the Editor

Posted on July 2, 2020

The Hill Times
Letter to the Editor
Published on July 1, 2020

Re: Second PMPRB consultation on new drug pricing rules will tackle drug access

Recent data from a range of sources confirms what Canada’s innovative medicines industry has been saying for more than three years now: Health Canada’s recent changes to the Patented Medicine Prices Review Board’s (PMPRB) Patented Medicines Regulations will have a negative impact on patients’ access to medicines, on investment in our life-sciences sector, and on the launch of new medicines and vaccines in Canada.

Since the amended PMPRB regulations were published last August, Innovative Medicines Canada members have reported several drug-launch delays or suspensions, including for rare disease and oncology medicines. IMC’s analysis of the Conference Board of Canada data (CBoC) confirms that between August 2019 and March 2020 there were 30-40 per cent fewer new drug submissions made within 12 months of the drug being submitted for approval elsewhere in the globe, compared to the  previous 3 years (24%), and twice as many drugs (42%) with Health Canada approval were delaying launch by more than 6 months, compared to the 3 previous years. IMC’s analysis of the CBoC data also showed that in the eleven months since the new regulations were published, Canada is already starting to see a decrease in the share of global industry-funded drug clinical trials. A separate recent analysis of new drug launches in Canada conducted by IQVIA – one of the world’s leading healthcare, biopharmaceutical and clinical trials data companies – reached a similar conclusion: 2019 saw a significant drop in Canada in both the number of new drug launches and in the share of global launches – to less than half the figures seen in recent years.

Similarly, a new peer-reviewed study by the Canadian Health Policy Institute published this week does not support PMPRB’s assertions that there is no evidence linking drug access and R&D investments with drug prices. Health economist Yanick Labrie conducted a detailed literature review and found that there is in fact a large body of evidence directly linking prices and price regulations to R&D investment and new drug access. Out of 49 studies that reviewed this specific issue, 44 found there was a significant negative relationship between drug price controls with each or both of R&D investment and drug access, or a significant positive relationship between drug price levels with each or both of R&D and drug access.

This and other research confirm that the threats of negative impact of the PMPRB changes are real and significant, not only for the life sciences sector in Canada, but more importantly for millions of Canadian patients that depend on new medicines and vaccines. Fortunately, it is not too late to find a solution that will avert this outcome. Industry is prepared to come forward, as we have been over the last three years, with alternative approaches that will prevent the negative consequences of the amended regulations, while still allowing Health Canada to meet its public policy objectives. We hope that government will be a willing partner.

Pamela Fralick, President, Innovative Medicines Canada 

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