The present dissertation investigates the influence of brand as well as substance-related marketing attributes on prescription pharmaceutical sales within a state-controlled market. For this purpose, a systematic literature review was conducted in the first instance, during which knowledge about the most relevant research within this field was gathered. Consequently, over 538 publications were reviewed and indicated as being potentially relevant, leading to an eventual count of 98 core publications. However, most of these studies had been conducted in the mainly unrestricted US market. These findings were then summarised and statistically evaluated. In a second step, based on the literature review, a qualitative study, containing focus and Delphi groups, was then performed. The participants in these studies were involved in pharmaceutical marketing within a state-controlled prescriptions pharmaceuticals market. Consequently, the findings were slightly different to those derived by the systematic literature review. Based on this second step, seven hypotheses were proposed. In the third step, these hypotheses were tested, using collected data and a secondary market dataset provided by a market research institute. A statistical analysis was then performed, applying descriptive as well as multiple regression analytical methods. The evaluation of the results resulted in a conceptual model of physician targeting, leading to several theoretical, methodological and managerial implications.

The purpose of this thesis is to analyse how regulatory interventions in the market for pharmaceuticals can affect agents' decisions and market outcomes. The work is organized in four main chapters. The first chapter is theoretical and analyses firms' dynamic pricing under a Reference Pricing Scheme. In a new theoretical setting, we explore whether and why competition among firms' works, pointing out the role of the scheme in facilitating any collusive behavior.

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Contemporary academic and professional discourses on local African pharmaceutical manufacture have concentrated on technology, technology transfer, economies of scale, human capital, and markets for drugs; neglecting the financing of working capital and capital investment and the role played by banks. When finance is discussed, it is not discussed in depth and it is divorced from innovation and complexities surrounding financing of local African pharmaceutical manufacture. In this study, I investigated the financing of antiretroviral drugs (ARY) manufacture in Zimbabwe focusing on sources of finance for working capital requirements and capital investment to import technology. I also investigated technological capabilities surrounding access to finance and loan origination at pharmaceutical companies and banks respectively. Using a case study approach and multiple methods for data collection, I interviewed over 50 respondents from three Zimbabwean pharmaceutical companies, nine commercial banks, and one regional financial institution in addition to local and regional pharmaceutical manufacturers and policy makers in 2011 . I used examination, tabulation, categorisation and testing of data using both quantitative and qualitative evidence for data analysis. In line with literature on Zimbabwean enterprise finance, banks provided working capital finance but not capital investment finance. Bank short-term finance in conformity with African finance literature was characterised by high interest rates, high interest spreads, and low lending. The politics of lending offered an additional explanation to adverse selection and moral hazard explanations for the low lending, high interest rates, and high interest spreads in Zimbabwe. Pharmaceutical companies financed capital investment and a portion of working capital with internal funds, compromising rapid technological capability upgrading and innovation. Dependence on internal resources to fund capital investment and technology imports was driven by lack of investment and project finance capability to access offshore loans; as local banks could not advance foreign currency long-term loans. The theoretical implications of this study paint to the need to unravel an African context of the finance and innovation nexus surrounding technological capability upgrading and innovation in local African pharmaceutical manufacture.

Developed countries' publicly funded health care systems all share the similar task of deciding which pharmaceuticals should be reimbursed. DECD countries' pharmaceutical reimbursement systems achieve this task through a number of institutions some of which use Health Technology Assessment (HTA) including health economic analysis to inform decision-making. The reimbursement decisions influence the health outcomes of patients, produce signals of the demand curve to manufacturers and may have political consequences. The overall aim of this thesis is to examine the use of health economic analysis in DECD countries' reimbursement systems and the contribution of health economic analysis and other factors to decision-making. Chapter 2 provides a literature review of previous quantitative and qualitative studies examining the factors contributing to reimbursement decision-making in DECD countries. The review identified limited evidence for comparisons across DECD countries and outlined the methodological limitations of identifying influence. Chapters 3 and 4 categorise DECD reimbursement systems using a published framework. Application of the framework identified that Health Economic analysis is used by agencies operating in heterogeneous reimbursement systems with respect to the objectives, other institutions, processes, guidelines, interpretation and other factors considered alongside health economic analysis. Chapter 5 uses regression analysis to examine decisions by those agencies that similarly use clinical evidence and health economic analysis, and identifies common factors across four countries. Chapter 6 uses a qualitative methodology to match decisions for an agency using health economic analysis in comparison to one not and found evidence of the influence of health economic analysis alongside other evidence and process factors. Finally, chapter 7 concludes by outlining the differential contribution of health economic analysis depending on how it is used by the systems. The limitations are discussed and recommendations provided for further research.

The construction, commissioning and hand-over of pharmaceutical manufacturing buildings have become increasingly controlled by the requirements of regulatory agencies. Legislation requires that the process of validation is undertaken to establish that the facility is constructed in-line with the principles of pharmaceutical Good Manufacturing Practice (GMP). The validation process acts to ensure that the construction and building services systems are designed, installed and operate as intended and do not affect the quality of the manufactured product. A central objective of this thesis is to examine the sequential validation process and influencing factors that contribute to the facility attaining agency approval. A comprehensive review of the available literature indicates that projects regularly fail to meet their regulatory objectives due to the building provider and client's differing understanding and views of the validation process and of GMP. From this literature a validation model is derived and proposes that the design, installation and operation stages of the validation activity are time-series dependant sub-processes controlled through sensing, feedback and comparison. The research was largely qualitative, case-study based and used an interpretivist approach to analysis, which relied on participant observation and grounded theory techniques. Additional, external validation of the model was sought by collecting and analysing empirical data from an industry questionnaire The results of the study demonstrate that significant deviations between the model and the data exist and measures to construct compliant pharmaceutical buildings are often underdeveloped and result in unsuccessful project outcomes. The criteria by which the success of any construction project is judged are normally time, cost and quality. Time and cost are readily measurable, but the meaning of quality, in relation to the validation activity, can be more elusive and this is at the root of the problem of successful validation of pharmaceutical buildings.

The main purpose of the research was to examine the process of lobbying in the context of the pharmaceutical industry. It sought to explore "why" and "how" multinational companies carried out pharmaceutical lobbying in Argentina. The study aimed to build valid substantive theory that could be used to analyse pharmaceutical lobbying from different perspectives and used corporatism and pluralism to explain the relationship between the pharmaceutical industry and government. The application of interest groups formation theory permitted the identification of the pharmaceutical industry as an interest group and the identification of its lobbying style. Lobbying theories based on contribution payments and transmission of information were explored in order to understand the use of these policies in the process of pharmaceutical lobbying. The review of literature on American pharmaceutical lobbying helped in understanding the peculiar instruments and practices present in pharmaceutical lobbying and gave the reader an understanding of the characteristics of this market. The research took a phenomenological methodological approach and the research paradigm was post-positivist and constructivist. The researcher followed the grounded theory methodology approach of Strauss and Corbin. The researcher collected data through in-depth semi-structured interviews and participant observation of in-house and external pharmaceutical lobbyists as well as officials. The study made several contributions. Firstly, it positioned the pharmaceutical industry as an interest group in the pluralism-corporatism axis as a means to provide a framework for the understanding of its lobbying activities. Secondly, the study defined the lobbying style of the pharmaceutical industry in Argentina compared to lobbying performed in the USA and the EU. Thirdly, it provided a pharmaceutical industry basic lobbying model for Argentina that can be tested in other countries. Finally, it provided a model of cooperative or individual lobbying that stated when it was convenient to build coalitions.

Pharmaceutical drugs are often hailed as the poster child for the proposition that patents foster accelerated rates of innovation. This sentiment stems, in large part, from the significantly high research and development (R&D) costs endemic to the pharmaceutical sector. I argue that if the role of the patent regime is one of fostering higher amounts of investment in the R&D process, it is better served by a direct investment protection regime, where the protection does not depend upon whether or not the underlying idea behind the drug is 'new' and 'inventive', the two central tenets of patent law. Rather, any drug that successfully makes it past the regulatory filter ought to be entitled to protection, since its discovery and development entail significant investment and risk. Owing to the inadequacy of the current patent regime in appropriately protecting intensive pharmaceutical R&D investments from free-riders, I propose a comprehensive investment protection regime that protects all the investment costs incurred during the drug discovery and development process. Though similar to existing data protection regimes in some respects, it differs in others. Firstly, it enables a recovery of all R&D costs, and not only costs associated with clinical trials. Secondly, unlike patents and data exclusivity which offer uniform periods of protection, it rewards investments in a proportionate manner, wherein drug originators are entitled to protection against free-riders only until such time as they recoup their specific investments and earn a rate of return on investment that is dependent on the health value of the drug. Given that a pure market exclusivity based investment protection regime is likely to foster excessive pricing and subject the market to the dictates of a single firm, I advocate a compensatory liability model based on a novel cost sharing methodology, where follow-on entrants are free to manufacture the drug, but must pay a reasonable amount of compensation to the originator.