ARCHIVED - Patented Medicine Prices Review Board Canada

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Section II — Analysis of Program Activities by Strategic Outcome

Strategic Outcome

The Patented Medicine Prices Review Board (PMPRB) has one strategic outcome: Canadians and their health care system are protected from excessive prices for patented drug products sold in Canada and are informed on pharmaceutical trends.

The performance indicator for the strategic outcome is: Canada's prices on average are in line with the seven comparator countries listed in the Regulations.

The target for the strategic outcome is: Canada's prices on average are at or below the median of international prices.

The strategic outcome is supported by three Program Activities.

Program Activities

Program Activity 1: Compliance and enforcement of non-excessive prices for patented drug products

Human Resources (FTEs) and Planned Spending ($ thousands)
2010-2011		2011-2012		2012-2013
FTEs	Planned Spending	FTEs	Planned Spending	FTEs	Planned Spending
44	$7,648.8	44	$7,654.3	44	$7,654.3

Expected Results	Performance Indicators	Targets
Prices charged by patentees for patented drug products in Canada are not excessive according to the factors of the Patent Act.	Percentage of patented drug products that are within the Guidelines	95% of patented drug products are within Guidelines.

Summary of Program Activity

The PMPRB is responsible for regulating the prices that patentees charge for patented drug products sold in Canada for human and veterinary use. Through this program activity, the PMPRB reviews the prices that patentees charge for patented drug products, based on the price review factors in the Patent Act, to ensure that these prices are not excessive. In the event that the Board finds, following a public hearing, that a price is excessive in any market, it may order the patentee to reduce the price and take measures to offset any excess revenues it may have received as a result of excessive prices.

Planning Highlights

The PMPRB is responsible for ensuring that the prices that patentees charge, the "factory-gate" price, for patented drug products sold in Canada for human or veterinary use, are not excessive. The PMPRB relies on voluntary compliance whenever possible since it is less time consuming and less costly to all parties. Voluntary compliance by patentees is facilitated by published Excessive Price Guidelines (Guidelines), which are intended to assist patentees in setting prices that are not excessive by providing transparent and predictable information on how the price review will be carried out.

In order to ensure the Guidelines remain appropriate and effective in the modern pharmaceutical environment and that they also uphold the principles of fairness, transparency, openness and predictability, the Board initiated a process in 2005 to review its Guidelines, including consulting with key stakeholders as required by the Patent Act (Act). Revised Guidelines were released in June 2009 for implementation starting January 1, 2010.

The key priorities for the Compliance and Enforcement program over the planning period are:

• Implement and monitor the revised Excessive Price Guidelines (Guidelines), policies and procedures.
• Redevelop the Compliance Database.
• Ensure hearing processes are transparent and more efficient.
• Develop and implement IM plans and policies that will enhance capabilities to meet operational and reporting needs for information.

Benefits for Canadians

This program activity contributes to the Government of Canada outcome of Healthy Canadians by ensuring that prices of patented drug products are not excessive. Price reviews, investigations and, when necessary, hearings must be conducted in a transparent, effective and timely fashion so as to protect the interests of consumers and the Canadian health care system.

Policy and economic analysis ensures that the PMPRB's regulatory activities remain relevant, appropriate and effective in the context of the evolving pharmaceutical environment.

Program Activity 2: Pharmaceutical trends reporting

Human Resources (FTEs) and Planned Spending ($ thousands)
2010-2011		2011-2012		2012-2013
FTEs	Planned Spending	FTEs	Planned Spending	FTEs	Planned Spending
13	$1,624.8	13	$1,626.6	13	$1,626.6

Expected Results	Performance Indicators	Targets
Stakeholders are more aware of pharmaceutical trends and cost drivers.	Number of requests for PMPRB publications Number of presentations by PMPRB at external meetings	5% increase in requests over previous year 10 events per year

Summary of Program Activity

Through this program activity, the PMPRB provides analysis of pharmaceutical price trends and research and development spending by pharmaceutical patentees. It also provides critical analyses of price, utilization and cost trends for prescription drugs, and information on non-patented prescription drug prices. The PMPRB reports on these analytical studies and its price review and enforcement activities as they relate to excessive pricing for patented drug products, annually to Parliament through the Minister of Health.

Planning Highlights

The key priority for the Pharmaceutical Trends Reporting program over the planning period is:

• Enhance the profile and uptake of the research and analysis conducted by the PMPRB.

Benefits for Canadians

This program activity contributes to the Government of Canada outcome of Healthy Canadians by:

• reporting on pharmaceutical trends and on R&D spending by patentees to inform drug policy decision-making; and
• providing critical analyses of price, utilization and cost trends so that Canada's health system has more comprehensive and accurate information on how prescription drugs are being used and on sources of cost pressures.

Program Activity 3: Internal services

Human Resources (FTEs) and Planned Spending ($ thousands)
2010-2011		2011-2012		2012-2013
FTEs	Planned Spending	FTEs	Planned Spending	FTEs	Planned Spending
19	$2,908.0	19	$2,535.3	19	$2,535.3

Program Activity Summary

Internal Services are groups of related activities and resources that are administered to support the needs of programs and other corporate obligations of an organization. These groups are: Management and Oversight Services; Communications Services; Legal Services; Human Resources Management Services; Financial Management Services; Information Management Services; Information Technology Services; Real Property Services; Materiel Services; Acquisition Services; and Travel and Other Administrative Services. Internal Services include only those activities and resources that apply across an organization and not to those provided specifically to a program.

Planning Highlights

This program activity will continue to be devoted largely to ongoing activities designed to support program areas in the provision of their programs.

The key priorities for the Internal Services program over the planning period are:

• Redevelop the Compliance Database.
• Strengthen internal capacity of Board Staff and the Board by staffing vacant positions.
• Develop and implement IM plans and policies that will enhance capabilities to meet operational and reporting needs for information.
• Prepare for evaluation of Compliance and Enforcement Program in 2011-2012.

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