The Patented Medicine Prices Review Board (PMPRB), in accordance with sections 89 and 100 of the Patent Act, has released the Annual Report for the year ended December 31, 2014. This year, the format has been updated, adopting a more user-friendly design highlighting the PMPRB activities and emphasizing important trends.
Below are the Statistical Highlights of 2014:
Regulatory Mandate
In terms of its regulatory mandate, 1,363 patented drug products for human use were reported to the PMPRB, including 103 new drug products. The PMPRB entered into Voluntary Compliance Undertakings (VCUs) following investigations into the pricing of five patented medicines, resulting in $2.79 million in excess revenues being paid to the Government of Canada by pharmaceutical patentees. In 2014, the PMPRB also commenced a hearing into the price of the patented medicine Soliris, the first such proceeding since 2012.
Reporting Mandate
Sales Trends:
- There were $13.7 billion in sales of patented drug products in Canada in 2014, an increase of 3.1% from 2013.
- 6% of the total drug sales in Canada were for patented drug products, a decrease from 60.7% in 2013.
Price Trends:
- Prices of patented drug products were stable, while the Consumer Price Index rose by 2.0%.
- Canadian prices were 3rd highest among the seven PMPRB comparator countries, lower than prices in Germany and the US.
Research and Development (R&D)
- $739.2 million in total R&D expenditures were reported by patentees, a decrease of 1.8% over 2013.
- $658.7 million in R&D expenditures were reported by Rx&D members, an increase of 1.0% over 2013.
R&D-to-Sales Ratios Decreased in 2014:
- 4% for all patentees, down from in 4.5% in 2013.
- 0% for Rx&D members, down from 5.4% in 2013.
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