ARCHIVED - Patented Medicine Prices Review Board - Report

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Section II : Analysis of Program Activities by Strategic Outcome

Performance Status Legend

Exceeded: More than 100 per cent of the expected level of performance (as evidenced by the indicator and target or planned activities and outputs) for the expected result identified in the corresponding RPP was achieved during the fiscal year.

Met All: 100 per cent of the expected level of performance (as evidenced by the indicator and target or planned activities and expected outputs) for the expected result identified in the corresponding RPP was achieved during the fiscal year.

Mostly Met: 80 to 99 per cent of the expected level of performance (as evidenced by the indicator and target or planned activities and expected outputs) for the expected result identified in the corresponding RPP was achieved during the fiscal year.

Somewhat Met: 60 to 79 per cent of the expected level of performance (as evidenced by the indicator and target or planned activities and outputs) for the expected result identified in the corresponding RPP was achieved during the fiscal year.

Not Met: Less than 60 per cent of the expected level of performance (as evidenced by the indicator and target or planned activities and outputs) for the expected result identified in the corresponding RPP was achieved during the fiscal year.

Strategic Outcome

Canadians and their health care system are protected from excessive pricing for patented drug products sold in Canada and are informed on pharmaceutical trends.

Program Activity 1:

Compliance and enforcement of non-excessive prices for patented drug products

Program Activity 1 Description:

The Patented Medicine Prices Review Board (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.

2010-11 Financial Resources ($ 000's)

Planned Spending	Total Authorities16	Actual Spending
$7,648.8	$7,041.7	$4,232.0

2010-11 Human Resources (FTEs)

Planned	Actual	Difference
44	37.0	7.0

Expected Results	Performance Indicators	Targets	Performance Status
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 the Guidelines.	Mostly met

Performance Summary and Analysis of Program Activity 1

The Compliance and Enforcement Policy provided for the Board to establish criteria for identifying cases for investigation.  The criteria balance the need for pricing flexibility on the part of patentees with the PMPRB’s mandate of protecting consumers by ensuring that the prices of patented drug products are not excessive.  In accordance with Schedule 5 of the old Compendium – Criteria for Commencing an Investigation¹⁷, a price was considered to be within the Guidelines unless it met the criteria for commencing an investigation.

With the introduction of the revised Guidelines, the Policy for When a Price May be Considered Excessive was incorporated.  In summary, the policy states that if the patentees price exceeds the Maximum Average Potential Price or National Non-Excessive Average Price, but does not trigger the criteria for commencing an investigation¹⁸, the price of the patented drug product will be reported on the PMPRB website as “Does Not Trigger Investigation”  not “Within the Guidelines” as in the past.

As a result of this change reporting on this performance indicator presents a challenge.  Under the revised Guidelines only 79.8% of the prices of new and existing patented drug products are within the Guidelines. However, under the old Guidelines 91% of the prices of new and existing patented drug products in 2010 would be considered to be within the Guidelines as compared to 89.5% compliance in 2009.

In conclusion, both calculations result in a performance status of “Mostly Met”.

Lessons Learned

While both calculations result in a performance status of “Mostly Met”, the difference in the rate of compliance is significant. As a result the PMPRB will need to review its target for this indicator in 2011-2012.

Program Activity 2:

Pharmaceutical trends reporting

Program Activity 2 Description:

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.

2010-11 Financial Resources ($000's)

Planned Spending	Total Authorities19	Actual Spending
$1,624.8	$1,307.9	$890.4

2010-11 Human Resources (FTEs)

Planned	Actual	Difference
13.0	7.4	5.6

Expected Results	Performance Indicators	Targets	Performance Status
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	See Lessons Learned – page 20 Exceeded

Performance Summary and Analysis of Program Activity 2

All PMPRB publications, including studies, Board decisions and reference documents, are available on the PMPRB’s website. The PMPRB has focussed its efforts on increasing the visibility of its website through a comprehensive review and update of the site architecture and its content. The review introduced a monitoring system that measures access to Web pages, with a view to enabling a more focussed approach to the changes being made. The new architecture will be presented to management for approval early in 2011-2012, enhancements are proceeding and the launch of the enhanced site is scheduled for September 2011. A more user-friendly website, in conjunction with the implementation of the Board’s new Stakeholder Engagement Strategy, will enhance all PMPRB external communication activities, increasing general awareness of its role and overall activities, including pharmaceutical trends and information on pharmaceutical cost drivers.

In addition, the PMPRB has stepped up publication of its reports and studies under the National Prescription Drug Utilization Information System (NPDUIS). On December 15, 2010, the PMPRB released four new analytical reports:

• Use of the World Health Organization Defined Daily Dose in Canadian Drug Utilization and Cost Analyses (PDF)
• Baby-Boomer Effect on Prescription Expenditures and Claims (PDF)
• Generic Drugs in Canada: Market Structure — Trends and Impacts (PDF)
• Generic Drugs in Canada: Price Trends and International Price Comparisons, 2007(PDF)

These reports and future reports will contribute to informed decision-making in the pharmaceutical area.

In 2010-2011, the PMPRB participated in 20 external events and addressed a variety of audiences, including the PMPRB’s main stakeholders: patentees, provinces, third party payers and patient advocacy groups. The PMPRB also explored new mediums, including videoconference and webinar, to reach a greater number of stakeholders.

Lessons Learned

Stakeholders rely on the PMPRB website to access information with, on average, 13,000 visitors per month. It is likely that requests for printed publications will continue to decrease due to the enhanced accessibility of the website. As a result this indicator will need to be reviewed in the near future.

Program Activity 3:

Internal Services

Program Activity 3 Description:

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.

2010-11 Financial Resources ($000s)

Planned Spending	Total Authorities20	Actual Spending
$2,908.0	$4,198.3	$4,348.3

2010-11 Human Resources (FTEs)

Planned	Actual	Difference
19.0	22.3	(3.3)

Performance Summary and Analysis of Program Activity 3

This program activity continued to be devoted largely to ongoing activities designed to support program areas in the provision of their programs. Highlights of the Internal Services program activity over the planning period include:

• the continued re-development of the Compliance Database containing drug product pricing information in support of the compliance and enforcement functions of the PMPRB;
• the appointment by the Governor in Council of Board members to fill the positions of Chairperson and Vice-Chairperson;
• completing a review of the Government of Canada information management policies, training staff in information management, and selecting two new software systems to assist with the management of corporate records; and
• the finalization and approval of a Performance Measurement Strategy Framework both of the PMPRB’s program activities, including a Program Evaluation Framework for the Pharmaceutical Trends Analysis Program.

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