In its 2016 Annual Report, the Patented Medicine Prices Review Board (PMPRB) provides a detailed summary and analysis of its findings concerning the 1,435 patented drug products under its jurisdiction. These products represent $15.5 billion in sales and account for 60.8% of all drug sales in Canada.
The 2016 Annual Report reflects the current climate of change at the PMPRB. This includes new strategic objectives and the PMPRB’s Rethinking the Guidelines consultation (reported here), which was put on hold following the close of the stakeholder-feedback process while Health Canada conducts its own consultation on changes to the Patented Medicines Regulations (reported here). The 2016 Annual Report indicates that these amendments are expected to be pre-published in Canada Gazette, Part I, this fall.
The 2016 Annual Report includes the following highlights:
- Price trends. Prices of existing patented drug products were stable versus 2015, while the consumer price index rose by 1.4%. Overall, Canada’s prices are fourth of the PMPRB7 countries (lower than the United States, Switzerland, and Germany).
- Failure to report, failure to file. There were six failure-to-report incidents and two board orders for failure to file. A judicial review of the PMPRB’s failure-to-file panel decision against Galderma Canada Inc. (reported here) is ongoing. The PMPRB’s failure-to-file proceeding against Baxalta Canada Corporation was discontinued on consent. One failure-to-file matter remains before the PMPRB involving Apotex Inc.
- New patented drug products. 128 new patented drugs were reported, more than in any other year in the PMPRB’s history.
- Existing patented drug products. Of the 1,307 existing patented drug products, 89 were the subject of investigations, 39 were identified as patented generic drugs, and 60 were subject to voluntary compliance undertakings (VCUs).
- The PMPRB received no complaints regarding over-the-counter or veterinary products. As we reported, the PMPRB switched to a complaints-based process for generics in February 2017.
- During 2016 (up to May 31, 2017), the PMPRB accepted 13 VCUs.
- Sales growth. Sales of patented drug products grew by 2.6% over 2015, the lowest rate since 2012. Growth was driven primarily by increases in the quantity of new drugs being sold and strong sales for new drugs.
- Price change by country. Drug prices fell by 0.5% in Canada. According to the report, however, Canadian prices exceed those in all of the additional countries being considered for inclusion in the proposed new list of comparator countries (Australia, Belgium, Japan, Netherlands, Norway, South Korea and Spain).
- R&D. The R&D-to-sales ratio for 2016 was 4.4%/4.9%.
- The PMPRB’s 2016 Annual Report can be found here.