Healthy Skepticism Library item: 1794

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Abraham J.
Pharmaceuticals, the state and the global harmonisation process.
Aust Health Rev 2004 Nov 8; 28:(2):150-60
http://www.aushealthreview.com.au/publications/articles/issues/ahr_28_2_081104/ahr_28_2_150-160.asp

Abstract:

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

Keywords:
Adverse Drug Reaction Reporting Systems Clinical Trials/standards Conflict of Interest Developed Countries/economics Drug Approval/legislation & jurisprudence* Drug Industry/economics Drug Industry/legislation & jurisprudence* Economic Competition* Europe European Union Government Agencies/economics Government Agencies/ethics Government Agencies/organization & administration* Humans International Agencies/economics International Agencies/ethics International Agencies/organization & administration* International Cooperation* Japan Marketing Organizational Objectives Public Health/legislation & jurisprudence* Social Responsibility United States