ARCHIVED - Patented Medicine Prices Review Board - Report

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Section III : Supplementary Information

Financial Highlights

Condensed Statement of Financial Position
As at March 31, 2011 ($ thousands)

	% Change	2010–11	2009–10
Total Assets	(284.7%)	$884.3	$3,402.0
Total Liabilities	(95.9%)	$2,359.9	$4,622.3
Equity of Canada	17.3%	($1,475.5)	($1,220.2)
	(284.7%)	$884.3	$3,402.0

Condensed Statement of Operations
For the year ended March 31, 2011 ($ thousands)

	% Change	2010–11	2009–10
Total Expenses	6.4%	$10,900.8	$10,205.8
Total Revenues	(4.0%)	$23,272.6	$24,204.6
Net Cost of Operations	(12.4%)	($12,371.8)	($13,908.8)

The Patented Medicine Prices Review Board (PMPRB) entered the 2010-2011 year with stable funding commensurate with its projected workload pressures.

Primary attention was given to critical activities such as the conduct of more complex and numerous price reviews, investigations and hearings and the implementation and monitoring, on an ongoing basis of the application and impact of the major changes made to the Guidelines.

Effort was dedicated to the re-development of the mission-critical database.  The new database is now being rigorously tested and employees have been trained.

The financial highlights presented within this Department Performance Report are intended to serve as a general overview of the PMPRB’s financial position and operations.

Financial Statements

The Board’s financial statements can be found on the Board’s Web site at http://www.pmprb-cepmb.gc.ca/english/View.asp?x=118.

List of Supplementary Information Tables

All electronic supplementary information tables listed in the 2010-11 Departmental Performance Report can be found on the Treasury Board of Canada Secretariat’s website at: http://www.tbs-sct.gc.ca/dpr-rmr/2010-2011/index-eng.asp.

• Sources of Respendable and Non-Respendable Revenue
• Green Procurement
• Upcoming Evaluations Over the Next Three Fiscal Years

Section IV : Other Items of Interest

Organizational Contact Information

The Patented Medicine Prices Review Board
Box L40
Standard Life Centre
333 Laurier Avenue West
Suite 1400
Ottawa, Ontario K1P 1C1
Telephone: (613) 952-7360
Toll-free no.: 1-877-861-2350
Facsimilie: (613) 952-7626
TTY: (613) 957-4373

Email: pmprb@pmprb-cepmb.gc.ca
Website: www.pmprb-cepmb.gc.ca

Additional Information (if applicable)

PMPRB Annual Report 2010 (http://www.pmprb-cepmb.gc.ca/english/view.asp?x=91)

Quarterly NEWSletter (http://www.pmprb-cepmb.gc.ca/english/View.asp?x=287&mp=68)

Patentee’s Guide to Reporting (http://www.pmprb-cepmb.gc.ca/english/view.asp?x=146)

Compendium of Guidelines, Policies and Procedures, June 2009 (implementation January 1, 2010) http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1206&mp=808
(http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1034)

Compendium of Policies, Guidelines and Procedures, March 2008 (http://www.pmprb-cepmb.gc.ca/english/view.asp?x=1034)

Patent Act (http://laws.justice.gc.ca/en/P-4/index.html)

Patented Medicines Regulations (http://laws.justice.gc.ca/en/P-4/SOR-94-688/index.html)

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¹Type is defined as follows: Previously committed to—committed to in the first or second fiscal year before the subject year of the report; Ongoing—committed to at least three fiscal years before the subject year of the report; and New—newly committed to in the reporting year of the DPR.

²April 2010 – International Therapeutic Class Comparison Test;

October 2010 – Direction of the Board on the Application of the Policy on Use of Patented and Non-Patented Drug Products in the Price Tests; under, The Guidelines - Update

October 2010 – Clarification of the Offset of Excess Revenues; under, The Guidelines – Update, and

January 2011 – Existing Patented Drug Products Subsequently Sold by Another Patentee.

³ Outreach sessions were held in Montreal and Toronto in March 2011; a total of 72 patentees/consultants attended.

⁴ More detailed information on the Guidelines concerning the DIP Methodology and “Any Market”Price Reviews can be found in Schedule 10 and 12 of the Compendium of Policies, Guidelines and Procedures respectively.

⁵ The PMPRB hosted a Webinar in April 2011 to present the recommendations of the DIP Methodology Working Group to interested stakeholders.

⁶ With the adoption of the 1987 amendments to the Act, Canada’s Research Based Pharmaceutical Companies (Rx&D) made a public commitment to increase their annual R&D expenditure to 10% if sales revenue by 1996 - as published in the Regulatory Impact Assessment Statement (RIAS) of the Patented Medicines Regulations, 1988, published in the Canada Gazette, Part II, Vol. 122, No. 20 – SOR/DORS/88-474

⁷ The NPDUIS Steering Committee is comprised of representatives of participating public drug plans (all jurisdictions except Quebec) and Health Canada.

⁸ Non-industry stakeholders include: consumer groups, patient advocacy groups, disease groups/associations, health care groups/associations, health care professionals and associations, provincial/territorial ministers of health, public drug plans, private payers, and academics.

⁹ The final report of the working group was presented to the Board at its quarterly meeting on March 4, 2011 and is available on the PMPRB Web site: www.pmprb-cepmb.gc.ca, under Consultations, DIP Methodology Technical Working Group.

¹⁰ More detailed information on the Guidelines concerning the DIP Methodology can be found in Schedule 10 of the Compendium of Policies, Guidelines and Procedures.  The Compendium is available on the PMPRB Web site: www.pmprb-cepmb.gc.ca, under Legislation, Regulations and Guidelines

¹¹ For more information on the Hearings and the Board Decisions refer to the Voluntary Compliance Undertakings and Hearings section of the PMPRB’s 2010 Annual Report which is available on the PMPRB’s Web site: www.pmprb-cepmb.gc.ca

¹² The Supreme Court of Canada Decision – Celgene Corporation v. Attorney General of Canada    http://www.scc-csc.gc.ca/case-dossier/cms- sgd/sum-som-eng.aspx?cas=33579

¹³ This is based on a sales-weighted arithmetic average of individual median-international-to-Canadian price ratios.

¹⁴ The variance between Planned Spending and Total Authorities is due to the fact that all EBP expenses were included in the Total Authorities for Internal Services.

¹⁵ The Total Authorities for Internal Services include the EBP expensed for the Compliance and enforcement of non-excessive prices for patented drug products of $606.9K and the Pharmaceutical trends reporting programs of $316.9K and the carry-forward amount of $393.4 K.

¹⁶ The variance between Planned Spending and Total Authorities is due to the fact that all EBP expenses were included in the Total Authorities for Internal Services.

¹⁷ For more in depth information on the Criteria for Commencing an Investigation prior to January 1, 2010, refer to the Compendium of Guideline, Policies and Procedures “up to 2009”, Schedule 5

¹⁸ For additional information on the Policy for When a Price May be Considered Excessive, refer to the Compendium of Guideline, Policies and Procedures, - June 2009, Part B – Policies, Para. B.5

¹⁹ The variance between Planned Spending and Total Authorities is due to the fact that all EBP expenses were included in the Total Authorities for Internal Services.

²⁰ The Total Authorities for Internal Services include the EBP expensed for the Compliance and enforcement of non-excessive prices for patented drug products of $606.9K and the Pharmaceutical trends reporting programs of $316.9K and the carry-forward amount of $393.4 K.

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