PMPRB Interpretation Policy

Interpretation Policy

An interpretation policy is an overarching document that outlines the commitments, practices and tools to be applied by a department or agency when providing Canadians and businesses with information and guidance on regulatory obligations to be met. It also identifies the conditions under which written responses to questions will be provided.

Departmental Context

The Patented Medicines Prices Review Board (PMPRB) is an independent, quasi-judicial body which was established by Parliament in 1987 under the Patent Act. The PMPRB is mandated to protect the interests of Canadian consumers by ensuring that the prices of patented medicines sold in Canada are not excessive. If a price is found to be excessive, the PMPRB can hold public hearings and order price reductions and/or the offset of excess revenues. The PMPRB is also responsible for reporting to Parliament on trends in pharmaceutical sales and pricing and on research and development expenditures by patentees. The PMPRB developed this interpretation policy in order to provide clear and consistent information on how legislative and regulatory compliance guidance is communicated to stakeholders. It applies to:

• The Patent Act
• The Patented Medicines Regulations

The following describes the PMPRB’s commitments in the areas of Predictability, Service, Stakeholder Engagement and Improvement.

Predictability

Plain Language Commitment

• The PMPRB commits to providing guidance^{Footnote 1} in plain language to the fullest extent possible. In the Report on Plans and Priorities, Departmental Performance Report, and in the Management Response and Action Plan published in response to the 2012 Program Evaluation of the PMPRB, the PMPRB has made a commitment to expand plain language offerings throughout all PMPRB communications. The plans for meeting this commitment include the continued inclusion of an “In Brief” section in the Annual Report, the continued use of Executive Summaries in all National Prescription Drug Utilization Information System (NPDUIS) reports and the continued use of research briefs to highlight findings and policy implications of analytical studies conducted under the NPDUIS initiative.
• Frequently Asked Questions (FAQs) for the Patented Medicine Regulations are available on the Acts and Regulations web page. FAQs for all newly generated regulations and regulatory amendments that have business impacts will be developed and linked to final regulations on the Acts and Regulations web page.

Providing Guidance and Building Awareness

• The PMPRB communicates regularly with its stakeholders through a variety of means to facilitate the development of guidance documentation, and more broadly to ensure awareness of regulatory compliance requirements, including regular “outreach sessions” with stakeholders to provide guidance and advice. Guidance documents and other relevant information can be accessed on the PMPRB’s website. Information related to the Rules of Practice and Procedure for Hearings, the Compendium of Policies, Guidelines and Procedures (Guidelines), outreach sessions materials and the Patentee’s Guide to Reporting are also available on the PMPRB website.

Responding to Questions

• The PMPRB responds to enquiries by stakeholders in a clear, consistent, and professional manner ^{Footnote 2},^{Footnote 3} in the form that inquiries are made, whether orally or in writing. Common/frequently recurring inquiries will be responded to through FAQs.
• The PMPRB commits to acknowledging inquiries within 48 hours of receipt and, in the majority of cases, answering them within 5 working days.  For inquiries that require a longer response time, an acknowledgement will be provided with an estimate of the time required to respond. For the PMPRB’s time commitments associated with the completion of scientific and price reviews, please refer to the applicable Service Standards found on the website.
• The PMPRB does not provide legal advice as to how specific regulations may apply to particular circumstances. Compliance Status Reports issued by the PMPRB provide patentees with relevant information on the status of patented medicines, including average transaction price and non-excessive end-of-year average prices. The PMPRB may, on the request of patentees, pre-approve a price under certain conditions by issuing an Advance Ruling Certificate.

Service^{Footnote 4},^{Footnote 5}

Service Commitment

• The PMPRB is committed to excellence in service to all stakeholders by providing courteous and respectful responses to stakeholder inquiries. The PMPRB’s website includes Service Standards describing the timelines associated with the PMPRB’s completion of scientific and price reviews for patented medicines.

Service Accountability

• The PMPRB will address concerns raised by stakeholders related to their understanding of regulatory requirements through existing feedback mechanisms, such as those described in the Service Standards. Also, regular outreach sessions serve to improve communication between stakeholders and the PMPRB, as well as to promote openness and transparency in the regulatory process.

Staff Training

• The PMPRB makes every effort to ensure that staff have the necessary skills and technical knowledge to provide quality service and accurate guidance. Training sessions are provided to regulatory staff to ensure that consistent advice is given to patentees. One regulatory officer is assigned to each patentee and is responsible for answering all questions related to that patentee’s regulatory compliance obligations.  

Stakeholder Engagement

Commitment to Stakeholder Engagement

• The PMPRB is committed to engaging with its stakeholders as appropriate when developing, reviewing and/or refining practices and materials for providing information and guidance on regulatory compliance and answering questions, as appropriate.

Stakeholder Engagement Mechanisms

• The Guidelines provide direction to patentees on how to comply with relevant provisions of the Patent Act and the Patented Medicines Regulations. The PMPRB is required by the Patent Act to consult stakeholders before issuing any new Guidelines. The PMPRB’s Consultation Policy outlines its approach to stakeholder engagement. Clarifications to the Guidelines are communicated through the quarterly NEWSletter. Stakeholders are consulted on proposed amendments to the Guidelines through a written Notice and Comment process. An updated version of the Guidelines, reflecting changes and clarifications, is released annually in June.
• The PMPRB also engages stakeholders through multiple mechanisms including: bilateral meetings; conferences; formal consultations; working groups, newsletters;  webinars;  the PMPRB Twitter account, and by providing opportunities for feedback through a proactive Internet presence. For example, consultation opportunities may be found on Forward Regulatory Plan-Acts and Regulations-PMPRB.

Improvement

The PMPRB assessed its interpretation practices and, after consultation with stakeholders during outreach sessions in 2015, identified two areas for improvement: increasing the use of plain language in guidance documents and improving stakeholder engagement to assist patentees in understanding procedures and meeting regulatory requirements. By March 2017, the PMPRB developed and implemented strategies to realize improvements in these areas and measured performance through an annual questionnaire for stakeholders. An update on progress and activities was communicated to stakeholders in the May 2017 edition of the PMPRB NEWSletter, Volume 21, Issue 2.

For More Information

• Guide for Developing and Posting Interpretation Policies
• The Cabinet Directive on Regulatory Management
• The Red Tape Reduction Action Plan
• The Canada–United States Regulatory Cooperation Council

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Canada Gazette and Consulting with Canadians websites.

FAQs for Patented Medicines Regulations

Regulation Title: Patented Medicines Regulations

http://laws-lois.justice.gc.ca/eng/regulations/SOR-94-688/index.html

What is the purpose of this regulation?

The PMPRB is mandated to protect the interests of Canadian consumers by ensuring that the prices of patented medicines sold in Canada are not excessive. It is also responsible for reporting to Parliament on trends in pharmaceutical sales and pricing and on research and development expenditures by patentees. The PMPRB must have timely and accurate information in order to fulfill its mandate. Under the Patented Medicines Regulations, patentees must report information relating to the identity, price and sales of the medicine, revenues and R&D expenditures.

What are key elements of this regulation?

Patentees have the following filing requirements under the Patented Medicines Regulations:

Medicine Information Sheet (Form 1):

Patentees must file certain identifying information on patented medicines for which a Notice of Compliance (NOC) has been issued by Health Canada, or which are being offered for sale in Canada, including:

• the brand and generic name and therapeutic use of the medicine;
• the identity of the patentee;
• the Notice of Compliance of the medicine;
• the drug identification number assigned under the Food and Drug Regulations  to the patented medicine;
• the date on which the patented medicine is first sold in Canada;
• the product monograph or information similar to that contained in a product monograph; and
• the relevant patents.

Form 1 is to be submitted for each patented medicine within seven days of it being issued a NOC or being offered for sale in Canada, whichever comes first.

Information on the Identity and Prices of the Medicine (Form 2):

Patentees must also file certain pricing information on patented medicines for which at least one patent related to the medicine pertains, including:

• the quantity of the patented medicine sold in final dosage form;
• either the average price per package or net revenues from the sale of each dosage form, strength and package size in which the medicine was sold by the patentee or former patentee to each customer class in each province and territory in Canada
• the publicly available ex-factory prices of the patented medicine sold to each class of customer in each province and territory in Canada; and
• the publicly available ex-factory price for the patented medicine sold to each class of customer in each of the countries set out in the schedule to the Regulations (France, Germany, Italy, Sweden, Switzerland, United Kingdom and United States) if the patented medicine is being sold in one or more of the countries set out in the aforementioned schedule.

Form 2 is to be filed no later than thirty (30) days after the first day of sale in Canada of the new drug product. Thereafter, it must be filed semi-annually, on July 30, for the period of January 1 to June 30, and on January 30, for the period of July 1 to December 31.

Revenues and Research and Development Expenditures (Form 3):

Patentees must file expenditure information on scientific research and experimental development, including:

• the identity of all licensees in Canada of the patentee;
• the total gross revenues from all sales of patented medicines in Canada by the patentee;
• a summary of all expenditures made towards research and development pertaining to the patented medicine;

Form 3 is to be filed within 60 days after the end of the calendar year, i.e. before March 1.

How does this regulation affect Canadian businesses?

It imposes an obligation on Canadian businesses that sell patented medicines to report to the Board information relating to the identity, price and sales of those medicines, as well as revenues and R & D expenditures.

What is the timeline for implementation?

The Patented Medicines Regulations were initially promulgated on September 15, 1988 and were amended on November 7, 1994 and again on March 6, 2008.

Where can I get more information?

The following documents further explain the reporting requirements under the Patented Medicines Regulations.

Patentee's Guide to Reporting

Frequently asked questions – Patentees

E-mail: PMPRB.Information-Renseignements.CEPMB@pmprb-cepmb.gc.ca