The impact of differing regulatory frameworks on post-patent pharmaceutical markets in the United Ki...

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" The impact of differing regulatory frameworks on post-patent pharmaceutical markets in the United Kingdom, United States and Germany 1990 to 1997. "
Mrazek, Monique Francine.

Document Type	:	Latin Dissertation
Record Number	:	1095303
Doc. No	:	TLets391052
Main Entry	:	Mrazek, Monique Francine.
Title & Author	:	The impact of differing regulatory frameworks on post-patent pharmaceutical markets in the United Kingdom, United States and Germany 1990 to 1997.\ Mrazek, Monique Francine.
College	:	University of London
Date	:	2001
student score	:	2001
Degree	:	Ph.D.
Abstract	:	This thesis analysed the effects of different regulatory frameworks on the post-patentpharmaceutical markets of the United Kingdom, Germany and the United Statesbetween 1990 and 1997. Firstly, an extensive search of peer reviewed and 'grey'literature was undertaken to develop an understanding of both the pharmaceutical andwider health policy environments during the period of study. Preference was given toprospective before and after studies with and without control groups, retrospectivestudies with and without controls, and case studies that were reinforced by similarsupporting case studies. A comparative policy analysis of the regulatory frameworks ofthe three countries linked the actual or expected outcomes to pharmaceutical policiespromoting the demand and supply of generic drugs.Secondly, this thesis analysed the effects of the different regulatory frameworks the costof off-patent medicines. Molecules were selected for the study if they had experiencedpatent expiration between 1990 and 1997, as well as having experienced entry by two ormore generic equivalents over the same time period. Contingency tables werecalculated for each pair of variables analysed. The associations between the variableswere tested by chi-square and the strength of the relationships was measured byGanmia. Trends in the pricing and volume of the branded original and genericequivalents were compared. A statistical model was developed as a framework todetermine significant factors affecting the market share of the original branded drugafter patent expiration. The statistical model was estimated both by ordinary leastsquares regression and by a fixed-effects estimation. Finally, conclusions were drawnfrom the comparative analysis of these different regulatory approaches and policyimplications are discussed.
Subject	:	Internal and EU commerce consumer affairs
Added Entry	:	University of London