Thesis (MBA)--Stellenbosch University, 2003. / ENGLISH ABSTRACT: The purpose of this report is to create a better understanding of the new pharmacy initiatives in the South African market, with specific reference to the Nuclicks and Pick 'n Pay groups. In order to understand the respective business concepts better the following abstracts from each chapter of the study is given. Chapter one is basically the introduction to the study and describes the events that lead to the above mentioned corporate retailers to enter the pharmacy market place. An introduction to Hamel's business model theory is also discussed and identified as a possible means of evaluating the corporate retailers' business concepts. In Chapter two the strategic analysis of the South African retail pharmacy industry is performed. This analysis is performed to create an understanding of the different forces at work in the industry. Some of the key findings in this chapter are that changes to the pharmacy act and the way dispensing licences are going to be awarded creates uncertainty. The profit outlook of retail pharmacy, though on the decline, still compares favourably to other retailers. In chapter three the core concepts of Hamel's business model are presented in more detail and applied to the retail pharmacy environment. In his view, a strategy needs to change the industry rules. This chapter ends with the concept of wealth potential based on Hamel's teachings. The wealth potential concept is about creating cash flow and profits. A business model that is able to create customer benefits well below the cost of the competitors is regarded as efficient. By utilising the Hamel way the Nuclicks (chapter four) and Pick 'n Pay (chapter five) business concepts is unpacked. Both Nuclicks and Pick 'n Pay pharmacy business models are presented within the corporate framework of the groups. Nuclicks bought an established pharmacy franchise while Pick 'n Pay launched Healthpharm. Nuclicks creates a possible choke point by buying UPD. The Nuclicks pharmacy strategy is a more comprehensive health strategy, while Pick 'n Pay follows a more cautious approach. As franchising will playa major role in both pharmacy concepts, the theory of franchising is presented in chapter six. Telephonic interviews with Link franchisees are conducted and the possible reasons for the ambiguity that crept into the Link business model are discussed. As the Healthpharm franchise is a new concept, it is evaluated based on information gathered from press releases and the Healthpharm web-site. In chapter seven universal conclusions and recommendations, based upon the literature study and this investigation, are presented. One of the key findings are, success in the face of changes requires more than the current way of doing business. It requires an innovative thinking process. New business models have to be formulated that allows retail pharmacists to establish a focused and well-differentiated value proposition. This value proposition needs to be meaningful for consumers and must strengthen a pharmacy outlet's competitive position. / AFRIKAANSE OPSOMMING: Die doel van hierdie verslag is om 'n beter begrip vir die nuwe apteek inisiatiewe in die Suid-Afrikaanse mark te ontwikkel, met spesifieke verwysing na die Nuclicks en Pick 'n Pay groepe. Om die onderskeie besiqheidskonsepte beter te verstaan, word die volgende opsomming van elke hoofstuk van die studie uiteengesit. Hoofstuk een is 'n inleiding tot die studie en beskryf die gebeure wat aanleiding gegee het tot die bogenoemde korporatiewe kleinhandelaars se toetrede tot die apteek mark. 'n Inleiding van Hamel se besigheidsmodel teorie is ook bespreek en is geïdentifiseer as evaluering van die korporatiewe kleinhandelaars se besigheidskonsepte. Hoofstuk twee bied 'n strategiese analise van die Suid-Afrikaanse kleinhandelaars apteek industrie. Hierdie analise is geskep om beter begrip te ontwikkel vir die verskillende kragte wat inwerk in die industrie. Van die bevindinge in die hoofstuk is die veranderinge in die apteek wetgewing en die wyse waarop resepteer lisensies toegeken gaan word, en hoeveel onsekerhede dit tot gevolg het. Die wins vooruitsigte van kleinhandelaars apteke, alhoewel aan die afneem, vergelyk steeds gunstig met ander kleinhandelaars. In Hoofstuk drie is die kern konsepte van Hamel se besigheidsmodel in meer detail uiteengesit en toegepas op die kleinhandelaar apteek omgewing. Uit sy oogpunt, is 'n strategie nodig om veranderinge te weeg te bring in die industrie reëls. Hierdie hoofstuk eindig met die konsep van waarde potensiaal wat gebaseer is op Hamel se teorie. Hierdie waarde potensiaal konsep is gebaseer op die skep van kontantvloei en 'n Besigheidsmodel wat in staat is om die kliënt te begunstig heelwat laer as die koste van die teenstander, word beskou as effektief. Hamel se teorie is gebruik om Nuclicks (hoofstuk vier) en Pick 'n Pay (hoofstuk vyf) se besigheidskonsepte te analiseer. Beide Nuclicks en Pick 'n Pay se besigheidsmodelle word aangebied binne die korporatiewe raakwerke van die groepe. Nuclicks het 'n gevestigde apteek konsessie gekoop terwyl Pick 'n Pay vir Healthpharm begin het. Nuclicks het 'n moontlike 'wurgpunt" geskep deur die aankoop van UPD. Die Nuclicks apteek strategie is 'n meer omvattende gesondheidstrategie, terwyl Pick 'n Pay 'n meer versigtige benadering volg. Aangesien besigheid konsessie 'n belangrike rol speel in beide apteek konsepte, word die teorie van konsessie in hoofstuk ses behandel. Telefoniese onderhoude is gevoer met Link konsessiehouers en die moontlike redes vir die twyfelagtigheid van die Link besigheidsmodel word bespreek. Aangesien die Healthpharm konsessie 'n nuwe konsep is, word dit geëvalueer op grond van inligting wat versamel is uit die media en die Healthpharm webtuiste. In Hoofstuk sewe word universele afleidings en aanbevelings, gebaseer op die literatuurstudie en die ondersoek, uiteengesit. Een van die hoof bevindings was dat sukses benodig meer as die huidige manier van besigheid doen. Nuwe besigheidsmodelle moet geformuleer word, wat dit vir kleinhandelaar apteke moontlik sal maak om 'n gefokusde en goed gedifferensieerde waarde voorstel tot stand te bring. Hierdie voorstel moet betekenisvol wees vir die verbruiker en moet die apteek kompeterende posisie versterk.

藥廠在資訊科技的運用上，相較於電子業或其他高科技產業，一直都被認為是較保守的方式。究其原因，應為資訊科技在製藥業的競爭上，較難成為核心的競爭武器之一，因此，資訊科技在製藥業一直被定位為協助企業內部作業面的工具。而非協助企業達成營運目標的工具。然而，近十年來，大型跨國藥廠透過不斷地購併其他藥廠的方式，達成其擴大市場佔有率、鞏固產業中領先地位、縮短產品研發時間、及擴大產品線的廣度與深度的目的。並藉由購併後組織必須重整的過程，對組織進行人力的精減及成本的樽節。僅管跨國藥廠一直設法對人力及成本作有效的控制，但隨著購併不停地發生，不僅產品增多，組織也日益龐大，跨國藥廠所面臨到的財務、法律、人力資源、業務行銷、行政作業等各種事務也越來越繁雜。雖然跨國藥廠有其充沛的資源及豐富的跨國管理經驗，但若要能有效又即時地對全球各據點加以掌控，就必須對資訊科技的運用作全球的統一規劃，並建立全球資訊科技策略，以確實控管及協助各子公司的營運。而對各國的子公司，則應有能協助該公司在當地市場競爭的相對策略，資訊科技在市場激烈的競爭下，開始扮演越來越重要的角色。 本研究為探討性的個案研究，係以一跨國藥廠在台灣的子公司作為研究的個案，期望透過相關的文獻、對個案公司在資訊科技運用的探討、及個案公司主管對資訊科技的看法及需求，能夠達到以下的研究目的: 壹、了解跨國藥廠對資訊科技的運用現況。 貳、了解跨國藥廠發展狀況與營運方向，以規劃個案公司資訊科技的發展方向。 參、建立個案公司資訊科技策略，以提升運作績效，掌握時勢利基。 / The Pharmaceutical Industry, compared with Electronics Industry or other Hi-Tech Industries, is perceived to be relatively conservative in the application of Information Technology. The reason is being that Information Technology application to the Pharmaceutical Industry rarely plays any key role for market competition. As a consequence, Information Technology to the Pharmaceutical Industry has been an operational tool to support the back office functions, rather than a management tool to assist the business to achieve its operational goals. Nevertheless, in recent decade, giant transnational pharmaceutical companies are continuously achieving their objectives of expanding market shares, sustaining their leadership, shortening the time frame in Research and Development, and enlarging their product pipelines, through mergers and acquisitions. They have been re-deploying the human resources and implementing cost reductions by all means within the entire organization after merger and acquisition takes place and reorganization becomes necessary. Despite that transnational pharmaceutical companies have been striving to contain headcount and control expenses, they have found themselves facing to the increasingly complex operations in many aspects, including Finance, Legal, Human Resource Management, Sales and Marketing, and General Administration as a result of expansion in product pipelines and explosion in organization that comes along with mergers and acquisitions. Although transnational pharmaceutical companies have ample resources and well experienced in cross-nation management, they have to integrate their global information technology and establish a unified strategy for universal implementation, so as to enable monitoring and assisting the operations of all subsidiaries around the globe in an effective and timely manner. As such, Information Technology starts to play an increasingly important role in developing responsive strategies under the intense local market competition. This essay is a case study on a Taiwanese subsidiary owned by a transnational pharmaceutical company. It aims to achieve the following objectives by referring to relevant publications and observing the subject company’s information technology applications and their management’s views and needs on the above. 1. To understand the current applications on information technology by transnational pharmaceutical companies; 2. To understand the evolution track and business directions of transnational pharmaceutical companies to set an Information Technology development plan for the subject company. 3. To establish Information Technology Strategy for the subject company to improve operation efficiency as an advantage of obtaining timely and valuable information.

對製藥產業而言，不斷推出創新產品是其價值創造的最大動力。另一方面，市場之競爭與價格限制之壓力使所有的製藥業者莫不將提高研發的績效視為企業維持高成長的關鍵途徑。因而製藥企業一直面臨的巨大壓力便是要能快速、確實推出安全有效的新藥上市。隨著競爭模式的轉移，無形資產及知識創造之價值將是決勝的關鍵。受限於本土藥品市場規模的限制與有限的研發能量，本土製藥企業之新藥研發大多以發展階段的新藥開發為主而非風險大、時程長的新藥研究。於是瞭解智慧資本的創造、加值、運用與管理對製藥產業新產品開發績效之影響也將更為關鍵。本研究先就智慧資本之文獻與各種衡量模式進行歸納，並引用Skandia智慧資本導航者之架構，分別以人力資本、流程資本、創新資本與關係資本四個構面評量企業之創新智慧資本之內涵與建置，並試圖瞭解本土製藥產業創新智慧資本對新產品開發績效之影響，期能對我國產製藥產業智慧資本之管理方向提出建議，以提供業界進行創新智慧資本管理與發展之參考。 / The lifeblood of the pharmaceutical industry is its ability to produce innovative products. Additionally, both the heavy competition in the market and the trend of cutting price by the health insurance payers also force the industry turns their focus on increasing the performance of R&D to maintain the high growth rate. Therefore, how to launch a safe and effective new drug in a shortest time is a great challenge to the industry. Along with the changing of the core competitive advantages, the value of the intangible assets and knowledge creation become the key success factors. Linking intellectual capital management with R&D activities in pharmaceutical companies would be a critical factor in enhancing R&D performance. For a local pharmaceutical, limited by the market size and the R&D ability, the R&D activities would be more on the development phase than research phase. The relationship between intellectual capital with new product development would be more critical especially in this knowledge-base pharmaceutical industry. By literature review and adopting the intellectual capital assessment model of the Skandia Nevigator, the study divides the intellectual capital into human capital, processes capital, innovation capital and relationship capital and try to find the elements of innovative intellectual capital related to new drug development in a local pharmaceutical company. It also tries to find out how a local pharmaceutical company creates and manages its innovative intellectual capital. The research results show the current situation about intellectual capital of the case and will be provide a reference for the industry and further research.

產品標準在現今社會中扮演非常重要的角色，但也容易造成許多技術性貿易障礙。醫藥產品由於攸關人類身體的健康及安全，因此相較於其他行業，各國對藥品皆設有許多嚴格的產品標準及技術法規，對藥品的國際貿易產生嚴重的技術性貿易障礙。PIC/S制定共通的GMP標準，並且旨在降低醫藥產品在國際貿易及流通上所面臨的非關稅貿易障礙。台灣藥物食品檢驗局於2007年公告實施PIC/S GMP，預計於2013年開始全面實施。本研究關注的核心議題，主要將以WTO對技術性貿易障礙的主要規範原則，分析探討PIC/S降低醫藥產品技術性貿易障礙的功能。另外，台灣製藥業由於缺乏關鍵技術、藥廠家數眾多、生產規模小，惡性競爭十分激烈，未來實施PIC/S GMP後，對我國製藥業的衝擊不容小覷，因此本研究另一項主要議題是PIC/S GMP對我國製藥業及藥品貿易之可能影響。 / Product standards play an important role in modern societies. However, they also raise many concerns about technical barriers to trade, particularly for pharmaceutical products which must comply with numerous stringent product standards, such as GMP standards. Therefore, PIC/S aims at reducing the technical barriers to pharmaceutical trade by providing a common GMP standard, which the Bureau of Food and Drug Analysis of Taiwan declared to introduce PIC/S GMP in 2007, and to fully enforce in 2013. This study will examine how PIC/S decreases technical barriers to trade for pharmaceutical products with principals in the WTO TBT Agreement. In addition, since Taiwan pharmaceutical industry has low competitiveness for a long time, how PIC/S GMP will affect the pharmaceutical industry and international trade of Taiwan is another main issue of this study.

在各大藥廠明星藥品專利到期、新藥開發數量銳減的當下，全球首例植物新藥MediGene Veregen™ 的核准上市為製藥產業帶來新的希望，雖然製藥價值鏈與商品化模式已為人所熟知，但針對植物新藥特殊性所架構之商品化模式還是一個全新的議題，為了架構一個適合台灣中小型藥廠的植物新藥開發模式，本研究嘗試以技術層面為根基，從法規面、產品面與產業面深入探討MediGene Veregen™ 關鍵的成功因素，從中獲取值得台灣藥廠參考的經驗，同時考量台灣植物新藥開發的大環境限制因素，包括法規與健保，給予台灣藥廠一些植物新藥商品化策略建議。 本研究之架構以實務觀點出發，首先整理參考文獻以探討植物新藥包含的範圍與藥品開發流程，幫助藥廠了解植物新藥商品化需要具備的條件與資訊；接著針對台灣與美國在植物新藥方面審查上市之法規、流程與審核成果進行研究，結果顯示目前台灣有兩種植物新藥審查系統「中藥新藥」與「植物抽取新藥」，對廠商而言並不如美國單一系統來得便利；再者藉由探討植物新藥的價值鏈結構、法規結構、產品結構與產業結構，試圖架構植物新藥商品化模式；接下來以兩家新藥開發廠商為例進行實際個案研究，一家為成功推出植物新藥商品的德國藥廠MediGene AG，一家為台灣藥廠中天生技/合一生技，主要藉由分析MediGene Veregen™ 商品化過程的關鍵成功因素，比較中天生技/合一生技WH-1商品化模式的異同，探討是否有足以借鏡與改進之處。最後，歸納整理上述的研究做出結論，並且對於台灣藥廠提出策略建議，希望能對於台灣新藥開發公司有實質上的幫助。 / While the star drug patents of each big pharmaceutical company are expired one after another and the quantity of their newly developed drugs sharply declines in these years, MediGene Veregen™, the first botanical new drug in the world, enters the market and therefore brings a new hope for the pharmaceutical industry. Although the value chain and the commercialization model of pharmaceutical industry have been known and researched a lot, the specific construction of commercialization model for botanical drugs is still a brand new subject. In older to construct the model that is suitable for Taiwanese middle and small pharmaceutical companies for the process from development to commercialization of botanical new drugs, this research, based on the technical analysis, attempts to discuss the key success factors of MediGene Veregen™ through analyzing the aspects of the laws, regulations, industry and product itself. With the case study about the environmental limited factors of new drug development in Taiwan, including the laws and regulations as well as the health insurance, this research tries to offer Taiwan pharmaceutical companies some strategic suggestions for the development and commercialization of botanical new drugs. The structure of this research is based on the practical viewpoints. First, we reorganize the reference in order to define the scope of botanical new drugs and the processes of drug development. It can help pharmaceutical companies understand the conditions and information needed for botanical new drug commercialization. Then, our studies focus on the laws and regulations in Taiwan and the United States, as well as the application processes and approvals for botanical new drugs. The results show that there are two evaluation systems in Taiwan for botanical new drug applications. For those pharmaceutical companies, the dual system is not as convenient as the sole evaluation system in the States. Furthermore; based on the discussion on the structure of the value chain, laws, regulations, product and industry, this paper makes an attempt to construct a better commercialization model of botanical new drugs. Next, two pharmaceutical companies are chosen as case study in this paper. One is a German pharmaceutical company, MediGene AG, which launched the first botanical new drug. The other is a Taiwan pharmaceutical company, MicroBio Co., Ltd/Oneness Bio-Tech Co., Ltd. By analyzing the key success factors in the commercialization process of MediGene Veregen™ and comparing its commercialization model with MicroBio Co., Ltd/Oneness Bio-Tech Co. WH-1, we try to get any valuable idea and insight. Finally, our conclusion and strategic suggestions may have solid help for Taiwan botanical new drug pharmaceutical companies.

Patent protection grants the patent holder with a market monopoly, free from market competition allowing the patentee to charge any price; therefore medicines are sold at prices much higher than the marginal cost of production and distribution. The connection between international trade and intellectual property has aggravated human rights and public health concerns surrounding the inaccessibility of essential medicines. The World Trade Organisation‘s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement is an international instrument which has greatly impacted intellectual property rights protection and access to medicine. It has globalized intellectual property law by obliging all Members to subscribe to the minimum international standards of protection for intellectual property. South Africa is an example of the issues faced whilst attempting to bring their domestic laws into compliance with the Agreement. The government had to attempt to strike a balance between creating an effective intellectual property infrastructure whilst realizing the therapeutic needs of those affected by HIV/AIDS. The South African Patents Act 57 of 1978 did not comply with the Agreement and was subsequently amended in order to bring its patent legislation in full compliance with the Agreement. Currently, South Africa grants patents for new uses or formulations of existing medicines consequently lengthening the period of patent monopoly by allowing pharmaceutical companies to obtain new patents for slight modifications to existing medicines. It is submitted that South Africa‘s patent legislation is more extensive than is necessary under international law, examples of this being disclosure standards and the process for compulsory licensing. In addition, it has not made use of provisions in its existing law to take measures to improve access to essential medicines, nor has it implemented legislative amendments consequent to the flexibilities established in the Doha Declaration. This dissertation seeks to review the steps South Africa has taken in its compliance with the TRIPS Agreement with respect to the relevant intellectual property legislation that has been enacted, including its implications for access to essential medicines. The intention behind this dissertation is to assess the efficacy of the intellectual property legislation in South Africa and its impact on access to medicines. / Thesis (LL.M.)-Univeristy of KwaZulu-Natal, Durban, 2012.

[pt] As companhias farmacêuticas necessitam dirigir atenção à demanda crescente em trazer medicamentos ao mercado em uma forma econômica. A pressão sobre o preço está aumentando, e as vantagens de ter um período de exclusividade da utilização de suas patentes estão diminuindo, enquanto a produção de produtos genéricos está crescendo em todo mundo. Ter um portifólio de novas drogas é crítico, mas também é crítico ter habilidade de trazer essas drogas ao mercado em uma maneira eficiente e de baixo custo. Entretanto, as companhias farmacêuticas não podem mais contar unicamente em pesquisa e desenvolvimento e marketing para sobreviver, mas devem também confiar nos valores agregados pela gestão da cadeia de suprimentos (Supply Chain Management - SCM). Neste contexto, o presente trabalho tem o intuito de analisar o modelo de SCM global utilizado por uma grande empresa de medicamentos (Glaxosmithkline-GSK), através da apresentação das principais características de sua cadeia de suprimentos, da análise do planejamento e gerenciamento do suprimento e da demanda e da análise de práticas de SCM implementadas por esta empresa na Europa. / [en] Pharmaceutical companies need to address the growing demand for bringing medicines to market in an economical way. Price pressure is increasing, and the advantages of having a buffered patent window is decreasing as generic manufacturing is on the rise. Having a pipeline of new drugs is critical, but it is also critical the ability to bring them to market in a cost effective and efficient manner. However, pharmaceutical companies can no longer solely rely on research and development and marketing to survive, but must also rely on supply chain management to deliver value. Within this context, this dissertation intends to analyze the supply chain management model of a major pharmaceutical company (GlaxoSmithkline - GSK) throughout an overview of the key characteristics of its supply chain, supply and demand management and some examples of projects implemented in Europe.

En 1940, le biochimiste anglais Donald Woods propose une explication du mode d'action des nouveaux sulfamides antibactériens : l'inhibition compétitive. Son collègue Paul Fildes fonde sur cette base une nouvelle approche de la chimiothérapie, revendiquée comme rationnelle, un programme pour la recherche de nouveaux médicaments. Cette thèse explore l'impact de la théorie des antimétabolites, comme elle sera appelée, dans la recherche biochimique et pharmaceutique. La première partie retrace son élaboration dans le contexte de l'école de biochimie anglaise, puis sa reprise aux États-Unis à la suite de travaux menés en parallèle sur les vitamines. La seconde partie est consacrée au développement de deux programmes de recherche distincts dédiés aux antimétabolites, illustrant les modalités et fortunes divergentes d'appropriation de cette approche rationnelle. Le premier est une collaboration modeste entre le biochimiste Henry McIlwain et la firme pharmaceutique Glaxo pendant la guerre au Royaume-Uni. Le second consiste en la mise en place du programme de George Hitchings et Gertrude Elion chez Burroughs Wellcome aux États-Unis, souvent considéré comme l'origine du rational drug design actuel. La théorie des antimétabolites correspond aussi bien à l'ambition d'obtenir des chimiothérapies spécifiques qu'à un ensemble de pratiques dans le quotidien du laboratoire / In 1940, the British biochemist Donald Woods put forward an explanation of the mode of action of the new antibacterial sulfa drugs, competitive inhibition. His colleague, Paul Fildes, developed this work into a new approach to chemotherapy, which he qualified as a rational programme for drug discovery. This dissertation explores the impact of the theory of antimetabolites, as it came to be known, in biochemical and pharmaceutical research. The first part traces its development in the context of the British school of biochemistry and its further expansion in the United States following parallel research on vitamins. The second part deals with the construction of two distinct research programmes dedicated to antimetabolites, each one illustrating a different way of following this rational approach and their varying consequences. The first one is a modest collaboration between the biochemist Henry McIlwain and the Glaxo pharmaceutical company during the war in the United Kingdom. The second one corresponds to the establishment of George Hitchings' and Gertrude Elion's programme at Burroughs Wellcome in the United States, often considered as the origin of today's rational drug design. The theory of antimetabolites simultaneously embodied both the ambition of attaining specific chemotherapies, and a set of practices in day-to-day laboratory work

Uma das características mais marcantes da propriedade intelectual é a tensão existente entre interesses público e privado. Na seara das patentes, essa tensão se torna ainda mais evidente quando o objeto da propriedade privada é essencial à consecução de objetivos sociais, como é o claro caso dos medicamentos. Concebida para fomentar a inovação, oferecendo um crescente número de soluções aos problemas enfrentados pela sociedade, a patente deve servir de incentivo à atividade inventiva. Isso ocorre por meio do período de exclusividade concedido ao inventor, durante o qual somente ele está autorizado a explorar comercialmente o produto de seus esforços. Quando se trata de bens essenciais à manutenção da vida dos indivíduos, entretanto, a análise se torna mais complexa. Preços monopolísticos podem impedir o acesso a determinadas drogas e inviabilizar políticas de saúde pública, por exemplo. É o custo social de um sistema de proteção fundado no monopólio de exploração. A ausência de incentivos, entretanto, leva à ausência de investimentos em produtos inovadores (veja-se o claro exemplo das doenças negligenciadas), o que, por sua vez, também gera um custo social. Existe equilíbrio possível a essa equação? Ao regular como o conhecimento é compartilhado, e ao estabelecer limites ao que se pode (e não se pode) fazer com os produtos desse conhecimento, a propriedade intelectual assume papel central no debate que busca compreender a relação entre direito e desenvolvimento. É buscando contribuir para essa reflexão que a presente tese foi concebida. Pretende-se demonstrar que quando se olha para o desenvolvimento de forma integrada, o progresso econômico por si só deixa de ser suficiente para atender às necessidades de crescimento das nações. Logo, as justificativas econômicas ao sistema de proteção patentário também deixam de ser suficientes para, por si só, atenderem aos anseios de desenvolvimento dos mais variados países. O trabalho encontra-se estruturado em quatro capítulos principais. O primeiro apresenta o ambiente internacional no qual se dá, majoritariamente, a produção normativa em matéria de propriedade intelectual; bem como a trajetória que moldou o atual quadro brasileiro em matéria de patentes e acesso a medicamentos. O segundo capítulo analisa as principais teorias que justificam o sistema de patentes, bem como aquelas que evidenciam suas fragilidades, além de discutir alternativas possíveis de fomento à inovação. O terceiro capítulo, por sua vez, estabelece o conceito de desenvolvimento que pauta a análise central proposta pela tese e o quarto e último capítulo traça um desenho da realidade da indústria farmacêutica no Brasil, no qual fica evidenciado que a produção de novos conhecimentos, passíveis de gerar inovação na área da saúde, é uma das grandes fragilidades nacionais. Sob a ótica de uma concepção integrada de desenvolvimento, conclui-se que a atual estrutura normativa patentária, por não oferecer alternativas ao monopólio como fomento à inovação, é mais prejudicial do que benéfica ao desenvolvimento do país, sendo necessário conceber modelos alternativos de proteção que possam coexistir com o modelo vigente. / One of the most noteworthy features of intellectual property rights is the existing tension between public and private interests. Particularly in the field of patents, such tension becomes even more evident when the object of private property is key to the achievement of social goals, as is the clear case of medicines. Conceived to foster innovation and offer society an ever-increasing number of solutions to everyday problems, patents must function as real incentives to creative activity. This is feasible because for a limited period of time, the inventor is the sole detainer of the commercial rights to explore his invention. When goods are, as in the case of drugs, essential to people\'s lives, the analysis becomes much more complex. Monopolistic prices may hinder access to certain drugs and, thus, make public health policies more difficult. Based on monopoly rights, this protection system has social costs. Lack of economic incentives, on the other hand, may lead to shortage of investments in innovative products (see the case of neglected diseases, for instance), which also generates social cost. Is it possible to strike balance to this equation? By regulating how knowledge is shared, and by establishing limits to what can and cannot be done to knowledge products, intellectual property rights take on a key role in the debate that seeks to understand the relationship between law and development. This dissertation aims at contributing to such discussion, by primarily demonstrating that when development is conceived in a holistic manner, economic progress in itself no longer suffices nations. Thus, the economic rationale used for the patent system also ceases to fulfill development goals in a significantly increasing number of countries. The dissertation is divided into four main parts. Chapter one portrays the international environment in which most intellectual property issues are regulated, as well as the historical and political routes that led to the current Brazilian legal framework of patents and access to medicines. Chapter two analyses the main legal and economic theories that justify the existence of the patent system, as well as those that evidence its shortcomings. It further presents and discusses existing alternative options that may encourage innovation in this area. Chapter three establishes the concept of development that is central to the dissertation\'s main analysis, while chapter four tells the story of pharmaceutical production in Brazil. The central line traced through the dissertation makes it then possible to demonstrate how national knowledge production that may lead to pharmaceutical innovations is one of the country\'s main limitations. The use of a holistic view of development leads to the conclusion that the current patent framework is, in fact, inadequate and produces more damage than benefits to the development of Brazil, to the extent that it does not offer alternative solutions to monopoly power. Different incentive models that can coexist with the current system are, in this sense, desiderata.

L'étude théorique de l'impact de la brevetabilité sur l'innovation pharmaceutique révèle des relations ambivalentes. D'où l'intérêt de cibler l'étude sur un pays en particulier. La croissance notable que connaît l'industrie pharmaceutique locale, l'accent mis par l'Etat sur le développement de la R&D et de l'innovation pharmaceutique et l'abscence d'études antérieures sur cette question, sont autant de facteurs qui font de la Tunisie un cas intéressant pour analyser l'impact de la brevetabilité des médicaments sur l'innovation pharmaceutique locale. Après avoir analysé le potentiel d'innovation pharmaceutique endogène et exogène en Tunisie, d'abord, à travers une analyse descritive du Système Sectoriel National d'Innovation (SSNI) en Tunisie, puis à l'aide d'une enquête menée auprès des laboratoires pharmaceutiques locaux, nous avons construit un indice mesurant leurs potentiels de l'innovation pour en déterminer l'impact la brevetabilité. Les résultats empiriques montrent que la brevetabilité n'est une incitation à l'innovation que si la firme (l'industrie ou l'économie) se transforme d'une "imitatrice nette" en une "innovatrice nette". L'analyse empirique montre que l'industrie pharmaceutique tunisienne étant encore "imitatrice nette", à court terme, la brevetabilité des médicaments a un impact négatif sur l'innovation locale et apparaît comme une réforme "prématurée" à ce stade de développement. Tandis qu'à long terme, l'impact dépendra de l'efficacité du SSNI à mettre en place des moyens alternatifs d'accès aux technologies nouvelles à travers la création d'une dynamique d'attractivité aux investissements étrangers "innovation seeking". Les développements théoriques, les résultats empiriques et les enseignements tirés d'expériences étrangères suggèrent que ceci est d'autant plus réalisable que la Tunisie adopte une politique technologique plus ciblée et mieux réfléchie pour créer un véritable "marché" de l'innovation pharmaceutique, et ce à travers la dynamisation des interactions entre les acteurs publics et privés du SSNI. / The theoretical study of the impact of patentability on pharmaceutical innovation reveals ambivalent relationships. Thus, it is interesting to target the analysis on a particular country. The notable growth of the local pharmaceutical industry, the emphasis put by the State on the encouragement of pharmaceutical R&D and the absence of previous studies on this issue, are as many factors that make from the Tunisian pharmaceutical industry an interesting cas study of the impact of drugs patentability on pharmaceutical innovation. After having studied the endogenous and exogenous innovation potential in Tunisia, first throughout an analysis of the sectoral national innovation system (SNIS), then according to a survey led next to the pharmaceutical laboratories in Tunisia, we have constructed an index measuring their innovation potential and performances and determined the impact of patentability. The empirical results show that patentability is an incentive for innovation only if the firm (industry, economy) transforms from a "net imitator" into a "net innovator". The Tunisian pharmaceutical industry being at a stage of a net imitator, drugs patentability generates a negative effect on local innovation on the short run and seems a premature reform in Tunisia. However, in the long run, the impact depends on the efficiency of the SNIS in putting into effect alternative means to access new technologies by creating a dynamic of attraction towards pharmaceutical foreign investments "innovation seeking". The theoretical developments, the empirical results and the lessons taught from foreign experiences suggest that this is as much realizable as the Tunisian state adopts a technological policy more targeted and better thought in a sense of creating a genuine "market" for pharmaceutical innovation, throughout valorizing the human capital and boosting the interactions between the public and private actors of the SNIS.