Th focus of this thesis will be the alleged excessive market power or abuse of market power by firms in the drug industry. To this end, it will be necessary to discuss such aspects of the industry as prices and profits, patenting and licensing, innovation, promotion and generic versus brand name prescription. But since it is essential to limit the area of investigation, these considerations will be entered into only as they relate to the main focus of the study. The drug products under discussion will be “ethical” products. These are products requiring prescriptions written by a doctor, and without which the buyer cannot purchase the drug, as contrasted with proprietary medicines, such as aspirin, which can be brought over the counter. The specific questions to which answers will be sought are as follows: (1) Assuming administered prices, found wherever pure competition does not prevail, are these prices socially evil? In this connection, we are concerned not with whether there is or is not sufficient evidence of price-fixing arrangements for a convisiton, but whether the degree of market power is harmful to the economy. In other words, how much competition is socially and economically useful? How “pure” can we expect competition to be? Are the prices in the drug industry too high in terms of unwarranted profits and the considerations of humanity related to the sale of medicines? Here, we shall be concerned with possible solutions. If prices are too high, what specifically causes this situation? What changes could be made to put prices within reach of the ordinary consumer without damaging the profit position of companies? What bearing does the possibility of prescription by generic names have on this situation? In the course of answering these questions, an attempt will be made to draw some definite conclusions on these highly controversial issues. Proposals and recommendations for further study will be presented.

The emergence of biotechnology necessitating change in traditional pharmacological research, cost cutting by hospitals and health insurers, and an increasing number of patent expirations have posed a considerable challenge to the pharmaceutical industry, which hitherto had been considered recession-proof. Responding to this challenge, the industry has undergone tremendous consolidation through mergers and acquisitions (M&As). These M&As have resulted in high concentration within the therapeutic classes of drugs, thereby raising anticompetitive concerns. / In order to allow the mergers to proceed, the Federal Trade Commission in the U.S. had required the merging entities to divest their R&D assets. The European Commission, on the contrary, had taken more permissive approach. / The thesis has argued that R&D divestitures in pharmaceutical cases have not been appropriate as anticompetitive concern arises owing to the acquisition of market power with drug purchasers, rather than the combination of R&D assets. The innovative nature of the industry, and the costs and risks involved in drug discovery make it hard to analyze the likely future state of the market. Ex-post analysis shows that divestiture in these cases proved counterproductive. / It is suggested that ex-post remedies like compulsory licensing and price regulation are preferable in pharmaceutical mergers, as they do not disrupt the companies' R&D structure. Moreover, these remedies could be applied once the anticompetitive concerns become apparent the merger is consummated, thereby allaying the uncertainty involved in the assessment of the future state of innovation markets.

No description available.

published_or_final_version / Business Administration / Master / Master of Business Administration

This study empirically examined the relationship between strategic orientation of an organization and the overseas activities it pursues. It is argued that the nature and extent of an organization’s overseas involvement will be a function of its dominant strategic orientation and the distinctive competences associated with such an orientation. Several hypotheses that build on the central notion of the "common thread", first articulated by Ansoff (1965), were developed and tested. Building on a systems typology of multinationals (Cheng & Ramaswamy, 1989), this study utilized many new measurement approaches that help measure level of internationalization in a multidimensional manner. Set in the drugs and pharmaceutical industry, the empirical effort used objective secondary data to characterize both dependent and independent constructs. Tests of the hypotheses indicated that distinct multinationality profiles were associated with different strategic orientations. Prospector organizations were found to emphasize their distinctive competences in research and development and marketing in their overseas efforts. They tended to operate a larger number of overseas R&D facilities and overseas sales offices than their Defender counterparts. Further, they also exhibited a marked tendency to spread these activities over a larger number of countries than Defender firms. These findings support the theoretical notion that every organization builds around its distinctive competences to achieve competitive advantage (Ansoff, 1965; Miles & Snow, 1978; Porter, 1980). It was hypothesized that Defender firms would exhibit higher levels of overseas production activity than Prospector firms in keeping with their competence in manufacturing and cost control. However, this hypothesis was not supported. Consistent with Horst (1972), further analysis revealed that the age of the firm may play a significant role in influencing internationalization of production activity. This study represents the first effort in applying a typology of strategy to examine multinational corporations. Further, the study provides evidence to show that: (a) Strategic orientation of a firm plays a central role in influencing its international endeavors, and (b) Firms with distinct strategic orientations pursue dissimilar combinations of overseas activities even when operating in similar country environments. These differences could be attributed to differences in strategic orientations. Besides raising concerns about the traditional economic theory of comparative costs, these findings provide several new avenues for organizational research. Building on this study many new research directions such as the performance implications of multinationality that have not been examined as yet could now be explored. / Ph. D.

Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, Technology and Policy Program, 2004. / Includes bibliographical references (p. 59-61). / Published findings report that it takes approximately eight years to bring a novel drug to market at an average cost of $800 million. Over the last ten years, the Food and Drug Administration (FDA) has helped to reduce the time from filing a new drug application (NDA) to granting marketing approval (i.e. the approval phase). However, there has been no alteration in the time required to progress from an investigational new drug application (IND) to an NDA filing (i.e. the clinical phase) over this same period. Since approval times began to decrease upon the initiation of the Prescription Drug User Fee Act (PDUFA), in this thesis I analyze the impact of PDUFA and calculate its benefits to companies. Due to the importance of getting new drugs to the market faster, I also investigate why there has been no significant change in the time required to test a drug clinically, and attempt to identify steps that could be taken to improve the clinical trial process. To investigate this, I evaluated ways in which the FDA and industry can work together to reduce clinical development times, without compromising safety. The results from this study show that PDUFA has had a significant impact on reducing approval times. More importantly, I determined that the direct costs of PDUFA are small in irmlparison to its benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug development has revealed potential steps both the FDA and industry can take to facilitate a more efficient process for assessing the safety and efficacy of drugs. Thus, this study represents an important step towards improving the development of medicines for the world. / by Matthew W. Strobeck. / S.M.

Submitted by Filipe dos Santos (fsantos@pucsp.br) on 2018-03-26T12:28:30Z No. of bitstreams: 1 Alyne Viana de Oliveira.pdf: 1727106 bytes, checksum: 3089f02be85c7d292d871f3440c180e3 (MD5) / Made available in DSpace on 2018-03-26T12:28:30Z (GMT). No. of bitstreams: 1 Alyne Viana de Oliveira.pdf: 1727106 bytes, checksum: 3089f02be85c7d292d871f3440c180e3 (MD5) Previous issue date: 2018-02-28 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES / The present work aims to analyze the participation of interest groups in the definition of the American foreign policy when defending their interests. Based on the two-level model proposed by Robert Putnam, it considers the impact of domestic actors in the decision-making process of the US foreign trade policy. From this perspective, we analyze how the pharmaceutical industry lobby is organized and its strategies to assert their interests and influence the formulation of the country's foreign policy, by using its financial resources and channels of influence with governamental institutions responsible for the definition of trade policy to pressure the US government in its international negotiations for regulations that would benefit the sector. Thus, the case study of the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) negotiations under GATT (General Agreement on Tariffs and Trade) demonstrates how the pharmaceutical lobby strategy proved to be efficient / A presente pesquisa tem como objetivo analisar a participação de grupos de interesse na definição da política externa norte-americana ao defenderem seus interesses econômicos. Com base no modelo do jogo de dois níveis proposto por Robert Putnam, considera-se o impacto dos atores domésticos no processo de tomada de decisão na política externa comercial dos Estados Unidos. Sob tal perspectiva, analisaremos como lobby da indústria farmacêutica norte-americana se organizou e quais estratégias foram adotadas por eles para fazer valer os seus interesses e influenciar a formulação da política externa do país, utilizando seus recursos financeiros e influência política junto a instituições governamentais responsáveis pela definição da política comercial para pressionar o governo norte-americano em suas negociações internacionais por regulamentações que beneficiassem o setor. Assim, o estudo de caso das negociações do acordo TRIPS (Trade-Related Aspects of Intellectual Property Rights) no âmbito do GATT (General Agreement on Tariffs and Trade) demonstra como a estratégia do lobby farmacêutico se revelou eficiente

Orientador: Carlos Gustavo Poggio Teixeira / Resumo: A presente pesquisa tem como objetivo analisar a participação de grupos de interesse na definição da política externa norte-americana ao defenderem seus interesses econômicos. Com base no modelo do jogo de dois níveis proposto por Robert Putnam, considera-se o impacto dos atores domésticos no processo de tomada de decisão na política externa comercial dos Estados Unidos. Sob tal perspectiva, analisaremos como lobby da indústria farmacêutica norte-americana se organizou e quais estratégias foram adotadas por eles para fazer valer os seus interesses e influenciar a formulação da política externa do país, utilizando seus recursos financeiros e influência política junto a instituições governamentais responsáveis pela definição da política comercial para pressionar o governo norte-americano em suas negociações internacionais por regulamentações que beneficiassem o setor. Assim, o estudo de caso das negociações do acordo TRIPS (Trade-Related Aspects of Intellectual Property Rights) no âmbito do GATT (General Agreement on Tariffs and Trade) demonstra como a estratégia do lobby farmacêutico se revelou eficiente. / Abstract: The present work aims to analyze the participation of interest groups in the definition of the American foreign policy when defending their interests. Based on the two-level model proposed by Robert Putnam, it considers the impact of domestic actors in the decision-making process of the US foreign trade policy. From this perspective, we analyze how the pharmaceutical industry lobby is organized and its strategies to assert their interests and influence the formulation of the country's foreign policy, by using its financial resources and channels of influence with governamental institutions responsible for the definition of trade policy to pressure the US government in its international negotiations for regulations that would benefit the sector. Thus, the case study of the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) negotiations under GATT (General Agreement on Tariffs and Trade) demonstrates how the pharmaceutical lobby strategy proved to be efficient. / Mestre

Submitted by Alyne Viana de Oliveira (alynevoliveira@gmail.com) on 2018-03-12T14:06:20Z No. of bitstreams: 1 DISSERTAÇÃO - Alyne Viana de Oliveira.pdf: 1914408 bytes, checksum: 8cfbfe498a2b7962ceccae0b1245a5f4 (MD5) / Approved for entry into archive by Satie Tagara (satie@marilia.unesp.br) on 2018-03-12T17:27:17Z (GMT) No. of bitstreams: 1 oliveira_av_me_mar.pdf: 1914408 bytes, checksum: 8cfbfe498a2b7962ceccae0b1245a5f4 (MD5) / Made available in DSpace on 2018-03-12T17:27:17Z (GMT). No. of bitstreams: 1 oliveira_av_me_mar.pdf: 1914408 bytes, checksum: 8cfbfe498a2b7962ceccae0b1245a5f4 (MD5) Previous issue date: 2018-02-28 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) / A presente pesquisa tem como objetivo analisar a participação de grupos de interesse na definição da política externa norte-americana ao defenderem seus interesses econômicos. Com base no modelo do jogo de dois níveis proposto por Robert Putnam, considera-se o impacto dos atores domésticos no processo de tomada de decisão na política externa comercial dos Estados Unidos. Sob tal perspectiva, analisaremos como lobby da indústria farmacêutica norte-americana se organizou e quais estratégias foram adotadas por eles para fazer valer os seus interesses e influenciar a formulação da política externa do país, utilizando seus recursos financeiros e influência política junto a instituições governamentais responsáveis pela definição da política comercial para pressionar o governo norte-americano em suas negociações internacionais por regulamentações que beneficiassem o setor. Assim, o estudo de caso das negociações do acordo TRIPS (Trade-Related Aspects of Intellectual Property Rights) no âmbito do GATT (General Agreement on Tariffs and Trade) demonstra como a estratégia do lobby farmacêutico se revelou eficiente. / The present work aims to analyze the participation of interest groups in the definition of the American foreign policy when defending their interests. Based on the two-level model proposed by Robert Putnam, it considers the impact of domestic actors in the decision-making process of the US foreign trade policy. From this perspective, we analyze how the pharmaceutical industry lobby is organized and its strategies to assert their interests and influence the formulation of the country's foreign policy, by using its financial resources and channels of influence with governamental institutions responsible for the definition of trade policy to pressure the US government in its international negotiations for regulations that would benefit the sector. Thus, the case study of the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) negotiations under GATT (General Agreement on Tariffs and Trade) demonstrates how the pharmaceutical lobby strategy proved to be efficient.