Interacting with Government

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Presented to the biannual IPOPI Congress Netherlands October 2008

Presented to the biannual IPOPI Congress Netherlands October 2008

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  • I’d just like to conclude by encouraging you to engage as early as you can with the regulator with your development plans.with biotherapueitics, we recognise that the expertise is with you, while the responsibility to the public is at least partially with us. Please work with us, so that we can continue to deliver the best therapies to the Australian public.

Transcript

  • 1. WORKING WITH NATIONAL REGULATORS AND HEALTH AUTHORITIES What to expect and what to hope for ALBERT FARRUGIA SENIOR DIRECTOR GLOBAL ACCESS PLASMA PROTEIN THERAPEUTICS ASSOCIATION International Patient Organization for Primary Immunedeficiencies Congress, Hertogenbosch, the Netherlands October 2008
  • 2. Australian Treasury projections Effect of age group on health spending
  • 3. Australian Treasury projections Spending on health
  • 4. Australian Treasury projections Spending on health – sectorial breakdown
  • 5. What are the priorities of government officials?
    • 1 Get government re-elected
    • 2 Deliver micoreconomic reform (while husbanding votes)
    • 3 Deliver better population health outcomes (without
    • affecting 1 & 2)
    • Through
      • awareness of mood in marginal electorates
      • understanding of swinging voters’ core values
      • knowledge of market research mechanisms
  • 6. Precautionism is becoming a dominant policy feature
    • “… In the event of a future threat to the blood supply, the FDA should encourage small, low-risk solutions to large, difficult problems...” IOM Report 1995
    • “… If harm can occur, it should be assumed that it will occur. If there are no measures that will entirely prevent the harm, measures that may only partially prevent transmission should be taken…“ Krever Commission 1996
  • 7.
    • Cross section of Australians questioned about the importance of costs in setting priorities in health care.
    • Generally, respondents felt unfair to discriminate against patients with high cost illness and that costs should not be a major factor in prioritising .
    • Majority maintained this view when confronted with its implications in terms total number of people who could be treated and their own chance of receiving treatment if they fall ill.
    • Results suggest that
      • Concern with allocative efficiency, as usually envisaged by the economists, is not shared by the general public
      • Cost-effectiveness approach may be an excessively simple value system upon resource allocation decision making.
  • 8.  
  • 9. FDA PEI TGA
  • 10. Regulation of plasma derivatives
    • Produced in large batches from a homogeneous pool of starting material, through well-defined processes subject to standard pharmaceutical quality control.
    • Biologic drugs such as plasma derivatives cannot be considered as generic agents, and each manufacturing process requires individual assessment with full product specification.
    • In addition, each product has to be studied in the clinical setting prior to approval, as different brands of the same product have been shown to have different clinical properties and side effects
  • 11.
    • General properties leading to quality and safety may be reflected in standards of the pharmacopoeia.
    • But range of approaches to the manufacture results in significant differences between products.
    • This necessitates thorough evaluation for the potential effect of the process on the factors of interest and the impurities in the products.
    Regulation of plasma derivatives
  • 12. Regulation by the NRA … assuring quality, safety & efficacy
    • Establishing/maintaining a system of licensing & control
      • Dossier review and PAI
      • facility and product registration
      • inspection and enforcement
    • Providing standards and guidelines
    • Requiring that licence holders adopt and maintain appropriate quality systems
    • Providing competent, consistent, arrangements for post-marketing surveillance of products
    • NRA involvement in batch testing & release(?)
  • 13. “ The core of the voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interest and is recommended by either a consortium of consumer-oriented organizations or other interested persons.”
  • 14. Industry and regulators
    • DO NOT JUST ASK FOR ADVICE. SUBMIT A SOUND, TECHNICAL PROPOSAL DESCRIBING THE APPROACH TO A PROJECT.
    • DO NOT EXPECT THE REGULATOR TO DESIGN A PROJECT/PROTOCOL/DEVELOPMENT PROGRAM.
    • AVOID UNSUBSTANTIATED CLAIMS OR STATEMENTS. REGULATORY REVIEWERS ARE UNLIKELY TO ENDORSE SUCH INFORMATION.
    • DO UNDERSTAND REGULATORY AUTHORITIES POLICY AND ATTITUDES
    • DO TAKE ADVANTAGE OF THE OPPORTUNITY FOR PRE-APPLICATION MEETINGS
  • 15. “ Cheshire puss” she begun “would you please tell me which way I ought to go from here?” “That depends on where you want to get to” said the cat.
    • Forward planning with Regulatory bodies:
    • Strategic meetings
    • Pre Clinical Trial meetings
    • Pre Marketing Application Submission meetings.
    Alice in Wonderland
  • 16.  
  • 17.  
  • 18. Conclusions
    • Demographic changes are increasing pressures on health care budgets
    • Cost containment, particularly in the expensive pharmaceutical sector, is therefore a government priority
    • However, the biggest priority for governments remains getting re-elected
    • This allows consumers a continuing influence in health care policy