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