Canadian Pricing & PMPRB Services

The PMPRB is a federal quasi-judicial agency with a mandate to ensure that the ex-factory prices of patented medicines sold in Canada are not excessive. The PMPRB exercises its mandate through the provisions of legislation, regulations and guidelines that limit the introductory prices of new patented medicines and restrict price increases for existing patented medicines. The PMPRB has the powers of a superior court and can order price reductions and repayment of excess revenues.

Unparalleled PMPRB expertise - The extent of our PMPRB experience exceeds that of any other consulting firm. The PDCI Market Access team includes several former senior PMPRB staff members. Our clients include most of Canada’s leading innovative pharmaceutical companies, bio pharmaceutical firms and industry associations.

Pricing Strategies for Canada

PDCI Market Access provides an effective pricing strategy as part of the Canadian marketing plan. We provide assistance in the following areas:

  • Defining pricing objectives
  • Identifying government regulations and policies impacting on pricing and reimbursement and developing strategies
  • Competitor pricing analysis

Patented Medicine Prices Review Board (PMPRB)

PDCI Market Access offers a complete range of PMPRB-related consulting services:

  • Strategies & Submissions - PDCI Market Access assembles and reviews the relevant information for each case, identifies the issues in the context of the Board’s Guidelines and develops effective strategies for optimizing pricing opportunities within the context of the PMPRB Guidelines.

    PDCI Market Access will prepare, verify and file all PMPRB reporting forms and submissions. If necessary, PDCI Market Access can supply the necessary international prices (as required by the PMPRB Regulations) for filing with the PMPRB.
  • Representation & Negotiation - PDCI Market Access will represent the client before Board staff for specific pricing or compliance issues, or, on an ongoing basis for all aspects of the client’s dealings with the PMPRB. PDCI Market Access provides advice and assistance preparing responses to PMPRB allegations of excessive pricing or failure to file information.
  • New Medicines / Price Increases - PDCI Market Access prepares comprehensive new medicine submissions in a format and style that clearly and concisely present the client’s position in the context of the Board’s Guidelines.
  • PMPRB Exchange Rates and PMPRB CPI Increases
  • PMPRB Workshops and Seminars

Training / Seminars / Workshops

PDCI Market Access offers on-site workshops, training seminars and presentations on all aspects of the PMPRB (see the outline below). These sessions can be arranged throughout the year and can be tailored to the client’s specific needs or provided on a general basis. On-site workshops are a cost effective way to ensure that all sectors of the company (marketing, government affairs, finance, etc.) are aware of the implications of PMPRB policies and guidelines. For more information, please contact Neil Palmer at (613) 742-7523.

 

Outline

Legal Basis

  • Patent Act
  • Patented Medicines Regulations
  • Excessive Price Guidelines

Mandate and Scope of Jurisdiction

  • Patent Status
  • Patent Dedication / Patent Pending
  • Rx vs. OTC

Filing requirements

  • Notification of Intent to Sell
  • Form-1 Identity of Medicine
  • Form-2 Prices and Sales
  • Form-3 Research & Development Expenditures

Excessive Price Guidelines

  • Existing Medicines

    • CPI Test, International Price Comparison
  • New Medicines

    • Scientific Review Procedures Categorization

      1. Line Extensions
      2. Breakthrough/ Substantial Improvements
      3. Other - little, moderate or no improvement Comparators and Dosage Regimens
    • Price Tests

      • Reasonable Relationship Test
      • Therapeutic Class Comparison Test
      • International Price Comparison Tests

Strategic Planning for New Medicines

  • Setting clear objectives / Developing a realistic plan
  • Timing and information gathering
  • Impact Analysis / Risk Assessment
  • Understanding PMPRBs objectives and concerns
  • Effective presentations to PMPRB staff
  • Building a working relationship with Board staff

New Medicine Submissions

  •  Layout
  • Description of Medicine and Patentee
  • Scientific Review
  • Application of Excessive Price Guidelines
  • Cost Effectiveness
  • Appendices
  • Follow-up  

PMPRB Compliance and Enforcement: Policies and Procedures

  • Investigations into excessive pricing
  • Voluntary Compliance Undertakings
  • Price Reductions
  • Repayment of Excess Revenues
  • Hearings
  • Board Orders
  • Double Damages
  • Appeals to the Courts

Case Studies

  • International Price Guidelines
  • Discounting /Average Selling Prices
  • Level Pricing / Titration Strengths
  • Patent Pending / Patent Dedication Comparators
  • Alternative Price Tests
  • Advanced Ruling Certificates
  • Voluntary Compliance Undertakings
Future Directions of the PMPRB
  • Mandate
  • Advisory Assistance
  • New Medicine Reviews
  • International Price Comparisons
  • Enforcement
  • Transparency
  • Consultations
  • Roles of Stakeholders

 

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PDCI Market AccessPricing and Reimbursement Solutions for the Innovative Pharmaceutical Industry