Quarterly Financial Report for the Quarter Ended June 30, 2016

Management Statement for the Quarter Ended June 30, 2016

1. Introduction

This quarterly report has been prepared by management as required by section 65.1 of the Financial Administration Act and in the form and manner prescribed by the Treasury Board Accounting Standard (TBAS) 1.3. This quarterly report should be read in conjunction with the Main Estimates and Supplementary Estimates.

1.1 Authority, Mandate and Program Activities

The Patented Medicine Prices Review Board (PMPRB) is an independent, quasi-judicial body created by Parliament as a result of revisions to the Patent Act (Act) in 1987 (Bill C-22). The Act was further amended in 1993 (Bill C-91). The revisions were intended to balance the stronger patent protection for pharmaceutical patentees, with the need to protect consumers from possible excessive patented drug prices.

The PMPRB is composed of Board Staff, who are public servants responsible for carrying out the organization’s day to day work, and Board members, Governor-in-Council appointees who serve as hearing panel members in the event of a dispute between Board Staff and a patentee over the price of a patented medicine.

If Staff determines that the price of a patented medicine appears to be excessive the patentee may agree to a Voluntary Compliance Undertaking (VCU) to resolve the matter. If a consensual resolution of the issue cannot be reached with the patentee, the Chairperson may hold a hearing on the matter if he/she is of the view that it is in the public interest.

At a hearing, a panel composed of Board Members acts as a neutral arbiter between Board Staff and the patentee. The Chairperson decides the composition of a panel. Provincial and territorial ministers of health have a statutory right to appear before the panel as parties, and other interested parties or groups may seek leave to participate as interveners.

In the event that a panel finds, after a public hearing, that the price of a patented medicine is or was in fact excessive, it can order a reduction of the price to a non-excessive level. It can also order a patentee to make a monetary payment to the Government of Canada in the amount of the excess revenue earned and, in cases where the panel determines there has been a policy of excessive pricing, it can double the amount of the monetary payment.

The PMPRB has a dual role:

Regulatory: To ensure that prices charged by patentees for patented medicines sold in Canada are not excessive.

Reporting: To report on pharmaceutical trends of all medicines, and on research and development (R&D) spending by pharmaceutical patentees.

Further details on the PMPRB’s authority, mandate and program activities may be found in the Report on Plans and Priorities and the Main Estimates.

1.2 Basis of Presentation

This quarterly report has been prepared by management using an expenditure basis of accounting. The accompanying Statement of Authorities includes the PMPRB’s spending authorities granted by Parliament and those used by the organization, consistent with the Main Estimates and Supplementary Estimates for the 2016-17 fiscal year. This quarterly report has been prepared using a special purpose financial reporting framework designed to meet financial information needs with respect to the use of spending authorities.

The authority of Parliament is required before moneys can be spent by the Government. Approvals are given in the form of annually approved limits through appropriation acts or through legislation in the form of statutory spending authority for specific purposes.

When Parliament is dissolved for the purposes of a general election, section 30 of the Financial Administration Act authorizes the Governor General, under certain conditions, to issue a special warrant authorizing the Government to withdraw funds from the Consolidated Revenue Fund (CRF). A special warrant is deemed to be an appropriation for the fiscal year in which it is issued.

As part of the departmental performance reporting process, the PMPRB prepares its annual departmental financial statements on a full accrual basis in accordance with Treasury Board accounting policies, which are based on Canadian Generally Accepted Accounting Principles for the public sector. However, the spending authorities voted by Parliament remain on an expenditure basis.

The quarterly report has not been subject to an external audit or review.

2. Highlights of Fiscal Quarter and Fiscal Year to Date (YTD) Results

This quarterly financial report reflects the results of the current fiscal period in relation to the Main Estimates. The PMPRB’s spending for Q1 of 2016-17 has increased by $108 thousand (6%) over spending for the same quarter in 2015-16.

The money reported in the PMPRB’s Annual Financial Statements as non-respendable revenue is a result of payments to the Government of Canada made by patentees through Voluntary Compliance Undertakings (VCUs)¹ or Board Orders to offset excess revenues. The Minister of Health may enter into agreements with any province respecting the distribution to that province of amounts received by the Receiver General, less any costs incurred in relation to the collection and distribution of those amounts.

The amount reported as non-respendable revenue is a function of the VCUs accepted by the Chairperson or a hearing panel, as the case may be, and the Board Orders issued as a result of public hearings into the price of a patented medicine. In Q1 of 2016-17 the PMPRB deposited 5 VCUs accepted by the Chairperson totalling $713 thousand in repayment of excess revenues, as compared to 1 VCU in repayment of excess revenues totalling $59 thousand in Q1 of 2015-16.

Revenues that are non-respendable are not available to discharge the PMPRB’s liabilities. While the Chairperson is expected to maintain accounting control, he/she has no authority regarding the disposition of non-respendable revenues. As a result, non-respendable revenues are considered to be earned on behalf of the Government of Canada and are not therefore presented as a reduction to the entity's total gross budgetary expenditures.

2.1 Significant Changes to Authority

As shown in the Statement of Authorities of this document, there were no significant changes to the total authorities available for the year when compared to Q1 of 2015-16.

2.2 Significant Changes to Budgetary Expenditures by Standard Object

This section elaborates on variances in expenditures, Statutory items and Vote 1 by standard object to explain changes in spending trends from the same quarter of the previous year.

Overall, Q1 spending has increased by $108 thousand (6%).

For “Personnel”, Q1 spending has increased by $73 thousand. The increase is mainly due to the completion of planned staffing actions of vacant positions. The increase is partially offset by a decrease in the amount of uncontrollable personnel costs paid in 2015-16.

For “Professional and special services”, Q1 spending has increased by $37 thousand. The variance is mostly attributable to an increase in spending on litigation-related legal services. The increase is partially offset by a decrease in the amount of drug information research services required for the scientific review of new patented drugs submitted by patentees to the PMPRB’s Human Drug Advisory Panel as compared to Q1 of last year.

For “Rentals”, Q1 spending has increased by $15 thousand. The variance is mainly due to the timing of invoicing for software license renewals. Small increases are also due to an increase in the cost of software licenses, and a change in license requirements.

For “Other subsidies and payments”, Q1 decreased by $10 thousand. The variance is mostly due to credits received due to exchange rate adjustments.

There were no significant variances to report in the other standard objects.

3. Risks and Uncertainties

The PMPRB is funded through annual appropriations. As a result, its operations are impacted by any changes in funding approved through Parliament. The PMPRB has no authority to spend revenues received during the year as a result of payments made by patentees to the Government of Canada through VCU’s or Board Orders to offset excess revenues. The Minister of Health may enter into agreements with any province respecting the distribution to that province of amounts received by the Receiver General, less any costs incurred in relation to the collection and distribution of those amounts.

The PMPRB’s funding includes a Special Purpose Allotment (SPA) to conduct Public Hearings, in Vote 1 (Program expenditures) of $2,470 thousand. The SPA can only be used to cover the costs of public hearings, such as external legal counsel and expert witnesses, etc. Any unspent amount is returned to the Consolidated Revenue Fund (CRF). The PMPRB’s expenditures are influenced by the number and complexity of investigations into the prices of patented medicines, the number of investigations that result in hearings and the number of hearing decisions that form the basis of judicial review applications, all of which are inherently unpredictable.

The PMPRB’s most significant expenditure is “Personnel”, representing 64% of its annual planned expenditures. Given the highly specialized nature of its consumer protection mandate, the PMPRB must continue to attract and retain subject matter experts. More than 35% of its employees are over 50 years of age and at least 12 of them are eligible to retire over the next 5 years. Given the organization’s small size, the departure or hiring of a handful of employees in one quarter can have a significant impact on the quarter’s expenditures.

4. Significant changes in relation to operations, personnel and programs

Changes to Key Senior Personnel

The five-year term of the Vice-Chairperson, Dr. Mitchell Levine expired March 3, 2016.

Mr. Richard Bogoroch resigned as a Member of the Board on May 30, 2016.

The Chairperson, Mary Catherine Lindberg completed her second and final term on June 26, 2016.

There are processes underway to fill vacancies in the Members of the Board. To date, there have been no new appointments to the Board.

Changes to Programs

There have been no significant changes in relation to programs over the last year.

Approval by Senior Officials

Approved by:

(Original signed by)

Douglas Clark
Chief Financial Officer

Ottawa, Canada
August 12, 2016

Footnotes

¹ VCUs are approved by the Chairperson or, if the VCU is submitted after the issuance of a Notice of Hearing, the Board Hearing Panel.

Statement of Authorities (unaudited)

¹ Includes only Authorities available for use and granted by Parliament at quarter end

(S) Statutory vote

Table 1: Departmental budgetary expenditures by Standard Object

¹ Includes only Authorities available for use and granted by Parliament at quarter end