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The Patented Medicine Prices Review Board and the Review of its Excessive Price Guidelines

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The Patented Medicine Prices Review Board and the Review of its Excessive Price ... Created in 1987 as 'consumer protection' pillar of drug patent law reform ... – PowerPoint PPT presentation

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Title: The Patented Medicine Prices Review Board and the Review of its Excessive Price Guidelines


1
The Patented Medicine Prices Review Board and
the Review of its Excessive Price Guidelines
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  • Barbara Ouellet, Executive Director, PMPRB
  • 7th Annual Market Access Summit
  • December 3, 2008
  • Toronto

2
Purpose and Scope of Presentation
  • Purpose
  • Summary and analysis of the Boards Guidelines
    review over the last 3 years
  • Focus
  • Key principles and drivers
  • Unique approaches
  • Evolving nature of the review
  • Scope
  • Issues
  • Stakeholder engagement
  • Board involvement
  • Next steps

3
Governance
  • Arms-length agency Health portfolio
  • Created in 1987 as consumer protection pillar
    of drug patent law reform
  • Quasi-judicial tribunal
  • Unique structure
  • Remedial orders provided for in the Patent Act
    and enforceable in the Federal Court
  • Structure and Budget
  • 5 part-time members
  • 2008-09 Budget 11.5 million 72 employees

4
Mandate
  • Two-fold mandate
  • Regulatory To ensure that prices charged by
    patentees ( ex-factory  prices) for patented
    medicines sold in Canada are not excessive,
    thereby protecting consumer interests and
    contributing to Canadian health care
  • Reporting to report on pharmaceutical trends
    and on RD spending by pharmaceutical patentees,
    thereby contributing to informed decisions and
    policy-making
  • Key principles
  • Openness
  • Transparency
  • Fairness
  • Timeliness
  • Efficiency

5
Legislative Framework
  • Patent Act sections 79 to 103
  • Pricing factors
  • Creation of Guidelines (Ss. 96(4))
  • Remedial Powers
  • Distribution of excess revenues to provinces and
    territories
  • Patented Medicines Regulations
  • Filing requirements and timelines

6
Legislative Framework (contd)
  • Excessive Price Guidelines
  • Transparency and predictability of the price
    review process
  • Not binding on Board or patentee in a hearing
  • But, Federal Court ruled Board can use Guidelines
    in a hearing for rationale approach or
    methodology in considering price factors (ICN
    Pharmaceuticals Inc. LEO Pharma Inc.)
  • Ss. 96(5) of the Act requires that the Board
    consult with the F/P/T Health Ministers,
    consumers and the pharmaceutical industry

7
Impetus for Review of the Excessive Price
Guidelines
  • Last major changes made in 1994
  • Changing environment
  • International developments
  • Medicare Part D UK PPRS other developments in
    Europe
  • Canadian developments
  • Common Drug Review (CDR) amendments to/new
    provincial legislation (Québec Ontario) policy
    developments Bill C-51 (amendments to the Food
    and Drugs Act, includes progressive licensing and
    post-market surveillance)
  • Developments within the pharmaceutical industry
    globalization, mergers, partnerships
  • Changes in nature of new patented medicines
    fewer breakthrough chemicals, more incremental
    innovation
  • New delivery mechanisms
  • Targeted therapies (e.g., rare diseases and
    personalized medicines)
  • Third party reports to PMPRB of price increases

8
Impetus for Review (contd)
  • Need to ensure that Guidelines remain relevant
    and appropriate
  • Concerns expressed in early 2005 especially
    regarding
  • Categorization of new medicines not consistent
    with Health Canada's priority review and
    inadequate reflection of incremental innovation
  • Introductory prices seen as cost-driver
  • Other issues raised by stakeholders
  •  Any market 
  •  re-setting  (cost science)
  • Some issues identified by Board Staff
  • One price factor missing (international
    therapeutic class comparison)
  • Principles on which Board created unclear

9
Impetus for Review (contd)
  • Additional issues
  • April 2000 Board clarification on discretion in
    inclusion/exclusion of certain customer benefits
    in calculation of average (net) price
  • March 2007 Federal Court of Canada decision
    ruled that Board itself could not elect to
    exclude certain free goods
  • Led to further legal scrutiny of interpretation
    of the Regulations
  • January 2008 options to amend the Regulations
  • Boards August 18, 2008 Communiqué
  • Judicial Review of the Boards Communiqué

10
Engagement
  • Boards ownership and involvement
  • The Guidelines are the Boards
  • First in-depth review since 1994 current
    Guidelines pre-date all current Members
  • Visible engagement in the process
  • Outreach to stakeholders
  • Guidelines are not well know to many potentially
    interested parties
  • Identification of various stakeholder groups,
    e.g., consumers, patient advocacy groups, third
    party payers
  • Education
  • Guidelines and overall price regulatory regime is
    complex and detailed
  • Variety of tools
  • Maximize opportunity to input
  • Build and keep momentum

11
Challenges
  • Need to be clear on the problem / concern
  • Varying, often contradictory stakeholder views
  • Concepts are important
  • Need to drill down into technical, scientific and
    economic issues
  • Length of process means frequent updates /
    interactions are essential

12
Range of Approaches
  • Notice and Comment
  • Discussion Papers / Guides
  • Written stakeholder submissions
  • Multilateral Meetings
  • Five across the country
  • Bilateral Meetings
  • Industry sectors (innovative, biotech, generics),
    F/P/T governments, consumer groups, patient
    advocacy groups, third party payers

13
Range of Approaches (contd)
  • Stakeholder Working Groups
  • Therapeutic Improvement International
    Therapeutic Class Comparison Cost of Making and
    Marketing Price Tests
  • Outreach
  • Briefing sessions to stakeholders by Board Staff
  • Conference presentations
  • Updates in quarterly NEWSletter
  • Publications on Web site
  • E-Bulletin / Communiqués

14
Draft Revised Guidelines, August 20, 2008
  • Some issues received broad consensus via the
    Working Groups included in the draft revised
    Guidelines
  • 4 new levels of therapeutic improvement (TI)
  • Included new set of secondary factors to consider
  • Price tests
  • Aligned to 4 levels of TI
  • More opportunity for price premium as level of TI
    increases
  •  Any market  on an as needed basis
  • International Therapeutic Class Comparison (ITCC)
  • Included, but not to be used as a primary test
  • Others
  • Left for future consideration
  • Decision not to make Guidelines too comprehensive
    and prescriptive some flexibility for case by
    case consideration

15
Board Consideration of Submissions on Draft
Revised Guidelines
  • 44 submissions received
  • Board decided to meet bilaterally with
    representatives of the innovative industry (RxD
    and biotech) to provide an opportunity to hear
    about key issues of concern
  • At its October meeting, the Board began the
    review of submissions and consideration of
    changes/additions to the draft Guidelines more
    time is required

16
Challenges to the August 18, 2008 Communiqué on
Reporting
  • August 18 Communiqué
  • Mandatory reporting
  • All benefits linked to sales transactions
  • January 2009 implementation
  • Judicial Review of the Communiqué
  • Two Pfizer Canada Inc. RxD et al. (17
    patentees)
  • Issues challenging interpretation of Patented
    Medicines Regulations, specifically payments to
    3rd parties and others (not direct customers)
  • Expedited hearing being sought
  • Given this, the Board is suspending the
    requirement to report all benefits for the period
    of January 1 to June 30, 2009

17
Next Steps
  • Conclude Boards review of the Guidelines
  • Further ad hoc meetings with the industry and
    others likely
  • Further round of consultation on outstanding
    issues or any changes
  • Final publication of Guidelines coming into
    force and transition
  • Monitor and evaluate
  • Overall pharmaceutical environment
  • Application and impact of revised Guidelines
  • Implement mandatory reporting
  • Timeline to be determined based on expedited
    Court hearing

18
Summary
  • Guidelines Review
  • Number of complex issues
  • Open door for broad stakeholder participation,
    and range of issues and views
  • Opportunity for all stakeholders to develop a
    better understanding of overall regime
  • Direct involvement of the Board
  • Significant uptake of stakeholder recommendations
  • Engagement Approach
  • No previous process
  • Critical to reach out and find ways for
    meaningful involvement of broad range of
    stakeholders
  • The dialogue was iterative from issue
    identification to options to proposed directions

19
Summary (contd)
  • Way Ahead
  • Imperative that the Guidelines continue to be
    relevant and appropriate
  • Periodic updates likely, as needed
  • More staff outreach to facilitate understanding
    and application of the Guidelines

20
  • pmprb_at_pmprb-cepmb.gc.ca
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