Sources of Federal Government and Employee Information
Patented Medicine Prices Review Board
General Information
Introduction to Info Source
Info Source: Sources of Federal Government and Employee Information provides information about the functions, programs, activities and related information holdings of government institutions subject to the Access to Information Act and the Privacy Act. It provides individuals and employees of the government (current and former) with relevant information to access personal information about themselves held by government institutions subject to the Privacy Act and to exercise their rights under the Privacy Act.
The Introduction and an index of institutions subject to the Access to Information Act and the Privacy Act are available centrally.
The Access to Information Act and the Privacy Act assign overall responsibility to the President of Treasury Board (as the designated Minister) for the government-wide administration of the legislation.
Background
The Patented Medicine Prices Review Board (PMPRB) is an independent quasi-judicial body created as a result of revisions to the Patent Act (Bill C-22) and came into force on December 7, 1987. Subsequent revisions to the Patent Act in 1993 (Bill C-91) shifted ministerial responsibility to the Minister of Health and increased the Board’s remedial powers. The Minister of Health is responsible for the pharmaceutical provisions of the Patent Act as set out in sections 79 to 103. Although part of the Health Portfolio, the PMPRB carries out its mandate at arm’s length from the Minister of Health. It also operates independently of other bodies such as Health Canada, which approves drugs for safety and efficacy; federal, provincial, and territorial public drug plans, which are responsible for approving the listing of drugs on their respective formularies and determining price levels for the purpose of reimbursement; and the Common Drug Review, which provides listing recommendations based on cost-effectiveness to participating public drug plans.
Responsibilities
The PMPRB was given a mandate to carry out two functions:
Regulatory: To ensure that prices charged by patentees for patented medicines sold in Canada are not excessive. The PMPRB’s mandate extends to all patented drugs, including prescription and non-prescription medicines sold in Canada for human and veterinary use.
Reporting: To report on pharmaceutical trends and on research and development (R&D) spending by pharmaceutical patentees. The PMPRB reports annually to Parliament through the Minister of Health.
The Patent Act provides that the Board is to consist of no more than five members, appointed, on a part-time basis, by the Governor in Council, including a Chairperson and Vice-Chairperson. The Board’s Chairperson is designated under the legislation as the Chief Executive Officer of the Board and is granted authority and responsibility to supervise and direct the work of the Board, including the management of its internal affairs and the work of its staff.
The Executive Director manages the work of the staff. Senior staff consists of the Director of Regulatory Affairs and Outreach, the Director of Policy and Economic Analysis, the Director of Corporate Services, the Director of the Board Secretariat, Communications and Strategic Planning, and General Counsel.
The staff provides an information and education program; data collection, storage and dissemination; economic and scientific analysis; case preparation and related services for the registry; and administrative assistance to the Board. It also provides for hearings prior to the making of remedial orders by the Board.
The PMPRB has one strategic outcome and three program activities to support its regulatory and reporting roles. The PMPRB’s strategic outcome is to ensure that Canadians are protected from excessive prices for patented medicines sold in Canada and stakeholders are informed on pharmaceutical trends.
To support its strategic outcome and mandate, the PMPRB develops and implements policies and programs in three specifics areas: Patented Medicine Price Regulation, Pharmaceutical Trends and Internal Services.
Institutional Functions, Programs and Activities
Patented Medicine Price Regulation
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. Prices of patented medicines sold in Canada are under the PMPRB’s jurisdiction until the patent(s) expires.
The price regulation program includes the scientific review and price review processes in accordance with the requirements of the Patent Act and the Patented Medicines Regulations, to ensure that prices of patented medicines sold in Canada for human and veterinary use are not excessive.
Activities include collecting and analyzing information filed by pharmaceutical patentees in accordance with their statutory obligations under the Patent Act and the Patented Medicines Regulations, regarding the patentee’s intention to sell a patented medicine in Canada; the identification of the patented drug product offered for sale (Form 1 – Medicine Identification Sheet) and product monograph; the price at which the patentee sells a patented medicine in Canada, including date of first sale in Canada, quantity sold in final dosage form, and average price per package or net revenues from the sales of each dosage form, strength and package size in which the medicine was sold by the patentee or former patentee to each class of customer (wholesalers, hospitals, pharmacies and others) in each province and territory (Form 2 – Information on the Identity and Prices of the Medicine); the patentee’s submissions on therapeutic improvement of a new patented medicine; evaluations and reports by the Human Drug Advisory Panel on the scientific review of each new patented medicine first sold in Canada as a pre-requisite for the price review of the drug product; economic analysis of the price of a patented medicine; correspondence with patentees; and participation in departmental committees that liaise with Health Canada, the Canadian Agency for Drugs and Technologies in Health, the Common Drug Review, and provincial and territorial departments of Health.
This program excludes the collection of patient information.
Patented Medicine Price Review
Description: Records pertaining to policy development; documents filed by patentees as required under the Patent Act and the Patented Medicines Regulations, including submissions on therapeutic improvement of a new patented medicine and records pertaining to work of the Human Drug Advisory Panel on the scientific review of each new patented medicine first sold in Canada as a pre-requisite for the price review of the drug product; exchanges with patentees; and participation in departmental committees that liaise with Health Canada, the Canadian Agency for Drugs and Technologies in Health, the Common Drug Review, and provincial and territorial departments of Health.
Document types: Policies, guidelines, scientific and pricing data, analyses, reports, memoranda, policies, guidelines, procedures, agendas, minutes of meetings, legal opinions, document collections relevant to specific hearings and anticipated hearings, notices of hearing, affidavits, Board decisions.
Record Number: PMPRB ADM 005
Public Hearings before the Board
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. The price information gathered by the PMPRB forms the basis of its Annual Report to Parliament.
Patented Medicine Price Enforcement Activities
Description: Documents related to Voluntary Compliance Undertakings approved by the Chairperson and official Records of hearings held under the Patent Act. All documents pertaining to the administration and disposition of cases, motion and decisions, arrangements for hearings.
Document types: Correspondence, transcripts of proceedings, exhibits, pleadings notices, motions, decisions, and arrangements for hearings.
Record Number: PMPRB ADM 020
Pharmaceutical Trends
Through this program activity, the PMPRB provides analysis of pharmaceutical price trends and R&D 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 annually to Parliament through the Minister of Health on these analytical studies and its price review and enforcement activities as they relate to excessive pricing for patented drug products.
The PMPRB works in collaboration with the Canadian Institute for Health Information (CIHI) and participating federal/provincial/territorial public drug plans to produce analyses and reports under the National Prescription Drug Utilization Information System (NPDUIS). The purpose of NPDUIS is to provide 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.
CIHI is responsible for the collection of administrative claim-level data provided by public drug plans. CIHI’s Pharmaceuticals department uses this data to develop and maintain the NPDUIS database. This database is available in an analytical environment through a secure CIHI Portal. CIHI has applied the required mechanism to protect the privacy and confidentiality of the personal information. CIHI de-identifies all of the data in accordance with its Privacy Policy and in accordance with agreements established with data providers.
Subject to and in accordance with the Data Access Agreement between CIHI and the PMPRB, the PMPRB’s authorized users have “read-only access” to pre-defined fields in the NPDUIS database. The PMPRB does not collect claim-level data and has no means of relating the CIHI identifier back to an individual. The PMPRB accesses the NPDUIS database through the secure CIHI Portal where the claim-level data is analyzed in an analytical environment. Both CIHI and the PMPRB take the necessary precautions to ensure that claim-level data in whole or in part do not leave the CIHI premises.
Pharmaceutical Trends Reporting
Description: Records pertaining to pharmaceutical price trends and cost-drivers, and R&D spending by pharmaceutical patentees.
Document types: Scientific and pricing data, information on R&D expenditures by the pharmaceutical patentee selling patented medicines in Canada, including information on licensees, gross revenue from sales in Canada, expenditures in Canada for R&D pertaining to all medicines for human and veterinary use sold by the patentee (Form 3 – Revenues and Research and Development Expenditures Provided Pursuant to Subsection 88(1) of the Patent Act); analyses, reports, memoranda, procedures, methodologies, agendas, minutes of meetings, legal opinions.
This function excludes the collection of patient information. The PMPRB does not collect claim-level data.
Record Number: PMPRB ADM 010
Internal Services
Internal services constitute 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.
Acquisition Services
Acquisition Services involve activities undertaken to acquire a good or service to fulfil a properly completed request (including a complete and accurate definition of requirements and certification that funds are available) until entering into or amending a contract.
Communications Services
Communications Services involve activities undertaken to ensure that Government of Canada communications are effectively managed, well-coordinated, and responsive to the diverse information needs of the public. The communications management function ensures that the public – internal or external – receives government information, and that the views and concerns of the public are taken into account in the planning, management and evaluation of policies, programs, services and initiatives.
Financial Management Services
Financial Management Services involve activities undertaken to ensure the prudent use of public resources, including planning, budgeting, accounting, reporting, control and oversight, analysis, decision support and advice, and financial systems.
Human Resources Management Services
Human Resources Management Services involve activities undertaken for determining strategic direction, allocating resources among services and processes, as well as activities relating to analyzing exposure to risk and determining appropriate countermeasures. They ensure that the service operations and programs of the federal government comply with applicable laws, regulations, policies, and plans.
Information Management Services
Information management services involve activities undertaken to achieve efficient and effective information management to support program and service delivery; foster informed decision making; facilitate accountability, transparency and collaboration; and preserve and ensure access to information and records for the benefit of present and future generations.
Information Technology Services
Information technology services involve activities undertaken to achieve efficient and effective use of information technology to support government priorities and program delivery, to increase productivity, and to enhance services to the public.
Legal Services
Legal Services involve activities undertaken to enable government departments and agencies to pursue policy, program, and service delivery priorities and objectives within a legally sound framework.
Management and Oversight Services
Management and Oversight Services involve activities undertaken for determining strategic direction, and allocating resources among services and processes, as well as those activities related to analyzing exposure to risk and determining appropriate countermeasures. They ensure that the service operations and programs of the federal government comply with applicable laws, regulations, policies, and plans.
Materiel Services
Materiel Services involve activities undertaken to ensure that materiel can be managed by departments in a sustainable and financially responsible manner that supports the cost-effective and efficient delivery of government programs.
Real Property Services
Real property services involve activities undertaken to ensure that real property is managed in a sustainable and financially responsible manner, throughout its life cycle, to support the cost-effective and efficient delivery of government programs.
Travel and Other Administrative Services
Travel and Other Administrative Services include Government of Canada travel services, as well as those other internal services that do not smoothly fit with any of the internal services categories.
Classes of Personal Information
In the course of conducting the programs and activities of the PMPRB, categories of personal information may be accumulated which are not contained in the institution-specific Personal Information Banks described above, such as opinions, proposals, enquiries unrelated to the PMPRB mandate, mailing lists and other correspondence which may include names, addresses, telephone numbers, etc. This type of information is not normally retrievable by the name of an individual or other personal identifier. It can be located only if specific and sufficient details are provided concerning the event or activity of interest. The retention period of this information is controlled by the records disposal schedules of the general subject files in which it is stored.
Exclusion of Records
Under the Access to Information Act, section 24, and under sections 87 and 88 of the Patent Act, certain information supplied by patentees pursuant to the Patent Act and the Patented Medicines Regulations is privileged and may not be made public except in the course of a public hearing before a hearing panel of the Board.
Manuals
Additional Information
The Government of Canada encourages the release of information through requests outside of the ATIP process. You may wish to consult the PMPRB’s completed Access to Information (ATI) summaries. To make an informal request, contact:
Access to Information and Privacy Coordinator
Patented Medicine Prices Review Board
Standard Life Centre, 333 Laurier Avenue West, Suite 1400
Ottawa, Ontario K1P 1C1
Telephone: 613-288-9635
Toll free: 1-877-861-2350
TTY: 613-288-9654
Fax: 613-288-9643
Email: PMPRB.Information-Renseignements.CEPMB@pmprb-cepmb.gc.ca
Website: www.pmprb-cepmb.gc.ca
The Patented Medicine Prices Review Board conducts Privacy Impact Assessments (PIAs) to ensure that privacy implications will be appropriately identified, assessed and resolved before a new or substantially modified program or activity involving personal information is implemented. You may wish to consult the PMPRB’s completed PIA summaries.
Please see the introduction to this publication for information on formal access procedures under the provisions of the Access to Information Act and the Privacy Act. The following outlines how to make a formal ATIP request.
Mail your letter or Access to Information Request Form (Access to Information Act) or Personal Information Request Form (Privacy Act), along with any necessary documents (such as consent or the $5.00 application fee for a request under the Access to Information Act) to the following address:
Access to Information and Privacy Coordinator
Patented Medicine Prices Review Board
Standard Life Centre, 333 Laurier Avenue West, Suite 1400
Ottawa, Ontario K1P 1C1
Please note: Each request made to the Patented Medicine Prices Review Board under the Access to Information Act must be accompanied by an application fee of $5.00, cheque or money order made payable to the Receiver General for Canada.
Reading Room
In accordance with the Access to Information Act and Privacy Act, an area on the premises will be made available should the applicant wish to review materials on site. The address is:
333 Laurier Avenue West, Suite 1400, Room 1409
Ottawa, Ontario