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Pharmaceuticals, the state and the global harmonisation process.

John Abraham1

  • 1Centre for Research in Health and Medicine, Department of Sociology, University of Sussex, School of Social Sciences, Arts E Building, Falmer, Brighton BN1 9SN, UK. J.W.Abraham@sussex.ac.uk

Australian Health Review : a Publication of the Australian Hospital Association
|November 6, 2004
PubMed
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Regulatory agencies prioritize pharmaceutical industry interests over public health, shifting to a

Area of Science:

  • Public Health Policy
  • Pharmaceutical Regulation
  • Health Economics

Background:

  • National regulatory agencies are legislated to protect and promote public health.
  • These agencies face increasing influence from the commercial interests of the pharmaceutical industry.
  • The concept of the 'competition state' redefines regulatory priorities towards industry competitiveness.

Purpose of the Study:

  • To analyze how pharmaceutical industry commitments shape and limit regulatory agencies' public health mission.
  • To investigate the evolution of the 'competition state' within regulatory frameworks.
  • To examine the role of the 'competition state' in global pharmaceutical regulatory harmonization.

Main Methods:

  • Comparative analysis of regulatory developments in the European Union (EU), Japan, and the United States (US).

Related Experiment Videos

  • Examination of legislative frameworks and policy shifts.
  • Review of evidence challenging claims made to legitimize global harmonization.
  • Main Results:

    • Regulatory agencies increasingly function as 'competition states,' prioritizing industry's global market position.
    • The 'competition state' model has been instrumental in the global harmonization of pharmaceutical regulations.
    • Evidence suggests that claims of maintained safety standards and accelerated innovation access during harmonization are not supported.

    Conclusions:

    • The shift towards a 'competition state' undermines the primary public health mission of regulatory agencies.
    • Global harmonization processes, driven by competition state principles, may not adequately protect public health or expedite patient access to necessary innovations.
    • Re-evaluation of regulatory priorities is needed to ensure public health protection remains paramount.