Pharmaceuticals, the state and the global harmonisation process.
This article examines how regulatory agencies' mission to protect and promote public health, enshrined in legislation, has been shaped and limited by commitments to the commercial interests of the pharmaceutical industry. It is argued that the regulatory state has become largely a 'competition state' which considers its primary role to be the maintenance of industry's competitive position in world markets. By examining regulatory developments across the EU, Japan and the US, I shall explain how the competition state became a building block for the global harmonisation process. To legitimise the global harmonisation process in terms of their mission to protect and promote public health, regulators claim that it does not lower safety standards and will accelerate the availability of pharmaceutical innovations to patients who need them. However, evidence is presented to suggest that these legitimising claims are not tenable.
Abraham
John
J
Centre 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
D016907:Adverse Drug Reaction Reporting Systems; D002986:Clinical Trials as Topic / Q000592:standards; D016265:Conflict of Interest; D019049:Developed Countries / Q000191:economics; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence*; D004465:Economic Competition; D005060:Europe; D005062:European Union; D006077:Government Agencies / Q000191:economics / Q000941:ethics / Q000458:organization & administration*; D006801:Humans; D007390:International Agencies / Q000191:economics / Q000941:ethics / Q000458:organization & administration*; D007391:International Cooperation; D007564:Japan; D040541:Marketing; D009937:Organizational Objectives; D011634:Public Health / Q000331:legislation & jurisprudence*; D012941:Social Responsibility; D014481:United States