Patented Medicine Prices Review Board
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ANNUAL REPORT 2011Statistical Highlights 2011Regulatory Mandate
Compliance
- 109 new patented drug products for human use reported to the PMPRB
- 86 were within Guidelines
- In total, 1,282 patented drug products for human use were under the PMPRB´s jurisdiction
Enforcement
Up to May 31, 2012:
- 15 Voluntary Compliance Undertakings accepted
- Three hearings completed: ratiopharm Inc.; ratio-Salbutamol HFA; and Copaxone Redetermination
- Decisions pending in two hearings: Sandoz Canada Inc.; and, Pentacel and Quadracel
- Two matters remain before the Board: Apotex Inc. and Apo-Salvent CFC Free
Reporting Mandate
Sales Trends
- Sales of patented drug products increased by 1.7% to $13.1B
- The share of patented drug products as a percentage of total sales rose slightly from 58.0% in 2010 to 59.1% in 2011
- Antineoplastics and immunomodulating agents made the largest positive contribution to sales growth while products related to the cardiovascular system had the largest decline
Patented Drug Price Trends
- Prices of patented drug products sold by patentees, as measured by the Patented Medicines Price Index, remained on average unchanged while the Consumer Price Index rose by 2.9%
- Canadian prices were the fourth highest among the seven comparator countries, lower than prices in Switzerland, Germany and the US.
Research and Development
- Patentees reported total R&D expenditures of $991.7 million, a decline of 15.8% over 2010
- Rx&D members reported $901.2 million in R&D expenditures, a 9.9% decline over 2010
- R&D-to-sales ratios declined in 2011:
- all patentees, from 6.9% in 2010 to 5.6%
- Rx&D members, from 8.2% to 6.7%
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