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Title: The globalization of pharmaceutical regulation
Author: Lambert, Rhiannon Beth
ISNI:       0000 0001 3604 3588
Awarding Body: University of Sussex
Current Institution: University of Sussex
Date of Award: 2008
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This thesis examines the social scientific features of globalisation in pharmaceutical regulation by investigating the nature and evolution of three key institutions of global pharmaceutical governance: The World Health Organisation (WHO); the World Trade Organisation (WTO); and the International Conference on the Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). Informed by theories of regulatory capture, corporatism, international organisation and globalisation, the key argument is that wh,e'n the globalisation of pharmaceutical regulation is examined as an historical process, it is possible to identify particular moments in time when such regulation has been re-directed to reflect the desires and needs of different interest groups. Specifically, after the development of a clear public health focus in the globalising activities of the WHO in the 1970s, mobilisation by the research-based transnational pharmaceutical industry successfully transformed the dynamics of global medicines governance to prioritise its business interests by the 1990s. A conceptual framework which sees globalisation as a set of processes eroding boundaries between human interaction in the spatial, temporal and cognitive dimensions is adopted. This facilitates the identification and assessment of the particular forms of globalisation exhibited by each of the three key institutions in their historical and political context in order to shed light on the overall tendencies in global pharmaceuticals governance. Empirical data to support the thesis consists of documentary evidence and 58 interviews with informants from the three institutions, pharmaceutical industry associations, drug regulatory agencies, civil society organisations and medical associations. Following an introduction, Chapters two and three explain the theoretical and methodological approach taken. Chapter four analyses the WHO's conduct in globalising medicines control until the 1990s, while Chapters five and six assess the activities of the WTO and the ICH together with their interactions with the WHO during and beyond the 1990s. Drawing on a case study of pharmaceutical regulation in South Africa, Chapter seven examines the impact of these global institutions on the nation-state. Finally, chapter eight synthesises conclusions from the evidence presented.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available