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Title: The impact of differing regulatory frameworks on post-patent pharmaceutical markets in the United Kingdom, United States and Germany 1990 to 1997.
Author: Mrazek, Monique Francine.
ISNI:       0000 0004 2666 952X
Awarding Body: University of London
Current Institution: London School of Economics and Political Science (University of London)
Date of Award: 2001
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This thesis analysed the effects of different regulatory frameworks on the post-patent pharmaceutical markets of the United Kingdom, Germany and the United States between 1990 and 1997. Firstly, an extensive search of peer reviewed and 'grey' literature was undertaken to develop an understanding of both the pharmaceutical and wider health policy environments during the period of study. Preference was given to prospective before and after studies with and without control groups, retrospective studies with and without controls, and case studies that were reinforced by similar supporting case studies. A comparative policy analysis of the regulatory frameworks of the three countries linked the actual or expected outcomes to pharmaceutical policies promoting the demand and supply of generic drugs. Secondly, this thesis analysed the effects of the different regulatory frameworks the cost of off-patent medicines. Molecules were selected for the study if they had experienced patent expiration between 1990 and 1997, as well as having experienced entry by two or more generic equivalents over the same time period. Contingency tables were calculated for each pair of variables analysed. The associations between the variables were tested by chi-square and the strength of the relationships was measured by Ganmia. Trends in the pricing and volume of the branded original and generic equivalents were compared. A statistical model was developed as a framework to determine significant factors affecting the market share of the original branded drug after patent expiration. The statistical model was estimated both by ordinary least squares regression and by a fixed-effects estimation. Finally, conclusions were drawn from the comparative analysis of these different regulatory approaches and policy implications are discussed.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available
Keywords: Internal and EU commerce & consumer affairs