Monitoring and Evaluation Plan for the Major Changes in the Guidelines
The Patented Medicine Prices Review Board (PMPRB) has developed a Monitoring and Evaluation Plan (Plan) to assess, on an ongoing basis, the application and impact of the major changes made to its Compendium of Policies, Guidelines and Procedures(Guidelines). To ensure that the Guidelines remain relevant, while addressing the expectations of stakeholders, the Plan describes and provides information on the purpose of the major changes made to the Guidelines implemented in January 2010. It also presents information on the indicators (both qualitative and quantitative) which have been developed to measure the impact of each change, as well as results on some of the indicators.
On June 9, 2009, the PMPRB released the revised Guidelines, which were implemented on January 1, 2010. The Guidelines provide guidance to patentees and Board Staff on the factors set out in the Patent Act and on the Patented Medicines Regulations. The PMRPB applies factors set out in the Act to determine if the price of a patented drug product sold in Canada is excessive. The Guidelines are meant to provide assistance in the application of these factors.
The PMPRB is committed to making the price review process more open and transparent to all its stakeholders. In March 2005, the PMPRB initiated a review process to ensure that the Guidelines remained relevant, appropriate and effective in the modern pharmaceutical environment. This process included the publication of numerous discussion papers and an extensive series of consultations with all interested stakeholders, including representatives of the pharmaceutical industry, federal, provincial, and territorial governments, consumer groups and third-party payers.
The Board's Guidelines are issued pursuant to section 96 of the Patent Act; they are not considered a rigid set of decision-making rules and are neither binding on the Board nor patentees.
Monitoring and Evaluation Plan
While acknowledging the challenges in measuring the combined effect of changes to the Guidelines, the following measures are meant to provide useful information on the Board's overall approach to regulating patented medicines:
1. Trends in Prices of Patented Medicines
Capturing price trend information will assist the PMPRB in determining the effectiveness of the revised Guidelines and their degree of impact on patented drug product prices. Price trend information to be collected and analyzed as part of the Plan includes:
- Patented Medicines Price Index (PMPI) pre- and post-implementation
- Average foreign to Canadian price ratios pre- and post-implementation
- Average ratio of Median International Price (MIP) to Canadian prices pre- and post-implementation
- The ratio of total Canadian prices at introduction to Median International Prices, weighted by sales of drug products sold in Canada in a calendar year
2. Trends in Investigations
The Plan will enable the PMPRB to analyze the impact of the changes made to the Guidelines on the number of investigations. Information on investigation trends will be captured on an annual basis and will include:
- Number of investigations opened as a result of introductory pricing
- Number of investigations opened on the basis of year-over-year prices
- Number of investigations opened as a result of complaints
- Number of investigations closed
3. Stakeholder Feedback
Concerns and issues raised by the PMPRB's three stakeholder groups (patentees, consumers, and federal/provincial/territorial governments) in applying the Guidelines will be captured under the Plan.
Monitoring and Evaluation Plan