The privileges arising from patent protection on pharmaceutical products often prevent the full realization of the right to health, especially in developing countries with scarce resources. This thesis first identifies the international agreements that have established the right to health in international law, obligations and violations associated with it, the problems encountered in the implementation of human rights on the field, compared with the implementation and sanctions associated with economic rights from the World Trade Organization regulatory framework. A comparative study of the legislative frameworks of both developed and developing countries will reveal to what extent Canada, the United States, the European Union, Brazil, India, and South Africa conformed with patent protection exceptions arising from international patent law to protect public health. Finally, the author identifies the crucial indicators that need to be considered in order to assess the conformity of a given approach with the right to health, before he underscores the temporary character of the relevant WTO measures, and the future stakes concerning an increased access to essential medicines. / Les droits issus des brevets d'invention sur les produits pharmaceutiques empêchent souvent la réalisation pleine et entière du droit à la santé, plus spécialement dans les pays en voie de développement ayant des ressources plus limitées. Ce mémoire de recherche retrace d'abord les accords internationaux ayant établi le droit à la santé en droit international, les obligations et les violations qui en découlent, la problématique quant à la mise en oeuvre des droits de l'homme sur le terrain, en comparaison avec la mise en oeuvre et les sanctions pour le non-respect de droits économiques dans le cadre réglementaire de l'Organisation Mondiale du Commerce (OMC). Ensuite, une étude comparative des cadres législatifs de pays développés et de pays en développement révèlera dans quelle mesure le Canada, les États-Unis, l'Union Européenne, le Brésil, l'Inde, et l'Afrique du Sud se sont conformés aux exceptions aux règles de protection issues du droit international des brevets pour cause de santé publique. L'auteur identifie finalement les points de première importance qu'il considère primordial de considérer afin d'évaluer si une approche conforme au droit à la santé a été respectée dans le commerce de médicaments essentiels, avant de souligner l'aspect temporaire des mesures courantes prévues dans l'OMC et des futurs enjeux quant à l'accroissement de l'accès aux médicaments essentiels. / "Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maîtrise en droit des biotechnologies". Ce mémoire a été accepté à l'unanimité et classé parmi les 10% des mémoires de la discipline. Commentaires du jury : "Le jury est impressionné par l'ampleur de la recherche et de la synthèse très instructive du débat Nord-Sud".

全民健康保險制度在台灣開辦以來已經快二十年了，在全民都有保險、給付的範圍從基礎到複雜的醫療照護完整、合約醫療機構相當普遍、就醫的方便性等，得到大多數台灣民眾的肯定。 但全民健保這一路實施下來卻為台灣帶來的龐大國家赤字。健保局針對於每年五千餘億的健保費用其中的藥品費用(為第二大支出，占了其中的25%)多次長期進行多種的藥費及藥價管控措施，低廉的新藥核價加上每兩年的藥價調查後的藥價調降，國外藥廠除了要配合健保的藥價政策外，還需要面對醫療機構對於現有藥品再降價的要求。長久下來，藥廠利潤逐年下降影響甚劇。 其中以今年七月所要實施二代健保中「藥品三同」對於原開發藥廠藥衝擊最大。衛生署所實施的三同政策，即是針對健保給付超過15年的藥品，實施「同成分」、「同品質」、「同價格」，調整為同價格。此一政策倘若實施，原開發藥廠利潤嚴重下降，可能會導致會放棄台灣市場，民眾只剩下國產學名藥可以選擇。再者，三同政策最大的瑕疵，在於只單方面考慮健保給付的藥價，卻忽略了藥廠製藥成本，此舉明顯不顧成本不同卻硬性規定價格，明顯違反市場機制，也違反健保精神。 專利藥到期的原開發藥藥廠要如何因應以縮小品質及價格的爭端，只著眼於一昧砍藥價來填補健保財務虧損，不仔細思考同成分就一定同品質的問題而將藥品砍至同一價格的健保署藥物品質認定及給付標準。 本研究探討之研究問題包括: 1)在台灣健保逐年調降藥價的政策下藥品三同政策前，原開發藥廠在台的經營模式為何,2)在政府政策培育下的學名藥如何日益茁壯來影響專利藥到期的原開發藥廠市場活動，3)藥品三同政策實施後對專利藥到期的原開發藥廠的衝擊4)主要獲利的專利藥品皆到期的台灣武田藥品公司未來的經營模式從主要價值活動面該如何調整因應。 本研究以Afuah A.(2004)經營模式架構，先從過去健保政策下原開發藥廠的營運模式做說明，再以目前健保政策環境因素的變化，如何影響個案公司的市場行銷活動，而活動又如何影響公司的資源、定位及成本。 本研究發現「藥品三同」對台廠學名藥因具有較佳的成本競爭優勢，對原開發藥廠產生威脅，但因原料的不穩定性讓病患、處方醫師無法信任。所以原開發藥廠除了監督政府長期對學名藥廠品質加以把關、用訴訟延緩學名藥的上市外、另外一方面併購國內學名藥廠，以配合醫療院所對於低價高品質藥品的需求。最後，專利藥到期的原開發藥廠從健保政策中與學名藥廠價格競爭獲得利潤，就必須改變營運模式，首要的就是降低成本。如何從採購及製造方面有效降低成本著手，進一步調整有形、無形資產投入、人員配置培養與組織等策略資源，以及定價、市場區隔等定位修正，是原開發藥廠需要深入思考的問題。 / National Health Insurance (NHI) program has been implemented in Taiwan for almost 20 years. It has earned recognition for the compulsory enrollment for all residents in Taiwan, the benefits covered from basic to complicated medical care, the prevalence of contract medical facility and the convenience of going to doctors. NHI, however, has caused fiscal deficit for the past few years. Drug cost, among the over 500,000,000,000 NTD health insurance fee, is the second largest expenditure, which takes up 25 percent of health insurance fee. Therefore, Bureau of National Health Insurance has taken measures to manage and control drug cost and drug price multiple times for a long period. Foreign pharmaceuticals have cooperated on the low-priced pricing for new drugs and have lowered drug price after drug price evaluation every two year. However, there is still demand from medical institution for lowering drug price. The profit is therefore significantly affected in the long run. Among the impacts, the significant one for research-based pharmaceutical companies is “three sameness of drug” in the 2nd generation NHI, which will be implemented in this coming July. This three sameness policy is to adjust those drugs which are covered by NHI for over 15 years and are of the same ingredients and quality to the same price. If this policy is put into practice, the profit of research-based pharmaceutical companies would plunge, which may result in their leave of Taiwan market. The domestic generic drugs, as a result, would be the only choice for the general public. Moreover, the major flaw of this three sameness policy is that it merely considers the drug price NHI covers, not the costs of pharmaceutical companies. That the drug price is set inflexibly without taking costs difference into consideration is against not only market mechanism but also the essence of NHI. The questions this study aimed to investigate were: 1. What have been the operating models of research-based pharmaceutical companies in Taiwan in the circumstances of drug price drop year by year before “three sameness policy”? 2. How have the government-sponsored generic drugs affected the market activities of drug patent expiration of research-based pharmaceutical companies? 3. What have been the impacts of “three sameness policy” on drug patent expiration of research-based pharmaceutical companies? 4. How should the operating model of Takeda Pharmaceuticals Taiwan, Ltd. adapt to, from the aspect of primary value activities, the condition of drug patent expiration of its profitable drugs? Based on the framework of operating model by Afuah A.(2004), this study began with the operating model of research-based pharmaceutical companies in former NHI policy. It then elaborated on how changes of the present NHI policy have influenced the marketing activities of the case company and how these activities have influenced the company’s resources, position and costs. This study reveals that “three sameness policies” is favorable for Taiwanese generic manufacturers for their costs competition. However, the instability of raw materials could not gain the trust of patients and doctors. Therefore, in order to cooperate on the demand for low-price and high-quality drug, researched-based pharmaceutical companies supervise the government’s check on the quality of generic manufacturers, employ litigation to suspend the launch of generic drugs or merge domestic generic manufacturers. If research-based pharmaceutical companies with drug patent expiration would like to compete with generic manufacturers and make a profit in NHI policy, they would have to change their operating model. How to reduce costs of purchase and manufacture and go further to adjust the input of physical and intangible assets, strengthen professional training of personnel and organization and modify strategies for pricing and market segmentation are the main issues worth considering.

Cette thèse vise à comprendre les freins à l’achat des médicaments génériques chez les patients-consommateurs. Plus particulièrement, notre recherche vise par le biais d’une étude qualitative et quantitative à améliorer l’efficacité des communications des acteurs de santé pour réduire le risque perçu à l’achat des génériques. Il s’agit plus précisément d’étudier les variables susceptibles d’expliquer l’attitude envers la substitution, mais aussi de comprendre les mécanismes impliqués, et de mettre en lumière les variables les plus à même à expliquer l’intention d’achat d’un médicament générique (vs princeps). Ainsi, nous avons cherché à explorer les facteurs explicatifs de la perception et de la réduction du risque envers les génériques à travers des entretiens semi-directifs individuels menés auprès de 24 patients-consommateurs. Les résultats de l’étude quantitative menée auprès de 303 personnes, soulignent que (1) le risque perçu envers la substitution et l’attitude envers les génériques médiatisent la relation entre le risque perçu envers les génériques et l’attitude envers la substitution, (2) la confiance dans la source d’informations (pharmacien et médecin) modère la relation entre l’attitude envers la substitution et l’intention d’achat d’un médicament générique (vs princeps) et (3) l’effet d’interaction entre le capital marque du médicament générique : faible (vs fort), la chronicité de la maladie : non chronique (vs chronique) et le taux de remboursement : 65% (vs 100%) sur l’intention d’achat d’un médicament générique (vs princeps) est validé. Sur un plan théorique, la recherche permet d’éclairer la littérature sur le risque perçu en matière de santé, notamment en mobilisant un concept issu de la médecine « l’effet nocebo». Les implications managériales sont multiples, tant pour les laboratoires pharmaceutiques génériqueurs, d’une part, que pour les pharmaciens, les médecins et enfin les pouvoirs publics décideurs des politiques de communication en faveur des médicaments génériques, d’autre part. / This thesis aims to understand the obstacles to the purchase of generic drugs in patients-consumers. More specifically, it aims, through a qualitative and a quantitative study, to improve the efficiency of communication of health actors to reduce the perceived risk in buying generics. More precisely, it intends to examine the variables that explain the patients-consumers attitudes towards the substitution, to understand the mechanisms involved in this process and to highlight the most likely variables that explain the intention of purchasing a generic (vs brand name) drug. Thus, we aimed to explore the factors that explain the perception and reduction of risks towards the generic drugs by conducting individual semi-structured interviews with 24 patients-consumers. The results of the quantitative study of 303 individuals point out that (1) the perceived risk towards the substitution and the attitude towards generic drugs mediate the relationship between the perceived risk towards generic drugs and attitude towards substitution, (2) the trust in the information source (pharmacist and physician) moderates the relationship between the attitude towards substitution and the intention of purchasing a generic (vs brand name) drug and (3) the interaction effect between the brand equity of generic drug : low (vs strong ), the chronicity of disease : non chronic (vs chronic) and the repayment rate : 65% (vs 100%) on the intention purchase generic (vs brand name) drug is validated. Theoretically, the research sheds light on the literature on the perceived risk in health, including mobilizing a concept from the medicine "Nocebo effect". The managerial implications are manifold for generic pharmaceutical industry as well as for pharmacists, physicians, and, finally government makers of communications policies for generic drugs.

隨著醫療科技的進展，人類對於疾病的成因、機轉、病程、及治療，在不斷地研究突破下，有著持續的進步而對人類的健康有著不可或缺的貢獻。其中藥品，正是人類對抗疾病最關鍵、也最普遍的方式之一，對公共衛生的重要性自不待言。 其中，由於生命科學的本質使然，開發新的藥品對於研究發展的倚賴，遠勝於其他產業，因此，創新研發藥廠對於開發一項新藥的平均投資，已達十三億美元之譜；此外，由於藥物對人體的生理功能、體內恆定能造成極大的影響，因此世界各國的醫藥衛生主管機關無不對於藥品的上市加以嚴格的管制，使得現今開發一項藥品平均約耗時十至十五年。藥品開發的巨大投入與耗時極長的開發期間，使得製藥產業亟需經由智慧財產權的制度來提供其投入研發創新之誘因。然而，因為智慧財產之保護，也使得新藥往往售價高昂而造成公眾近用之阻礙。而學名藥正是解決這樣的問題的關鍵之一，亦為世界各國所大力推動。在推動學名藥產業上，實驗實施免責為制度上極為重要的考量之一。本文及希望藉由對製藥產業特質之探究，美國普通法上以及成文法上實驗實施免責的探討，我國實驗實施免責之規定與判決之研究，來找出我國當下實驗實施免責的規定於製藥產業中適用時所可能發生的問題，以及相對應的可能改進方案。 本文第二章本章先行探討製藥產業之特質；第三章討論美國普通法上實驗實施免責之概念，並歸結出美國普通法上實驗實施免責的三項適用要件；第四章探討美國成文法上實驗實施免責之立法背景、相關判決以及對生物科技領域各層面的影響；第五章則先行探討世界貿易組織於「與貿易相關智慧財產權協定」中對於專利權之限制基礎。其後探討我國專利法中之一般實驗實施免責以及藥事法中針對製藥產業之實驗實施免責之相關規定，並由學者論述以及相關判決中，探討我國實驗實施免責之相關規定於製藥產業實務上所可能面臨之問題，並提出可能之解決方案。 / With the progress of medical technology, humans have been furthering the understanding of the etiologies, mechanisms, courses, and treatments of diseases. Such continued progresses have contributed significantly to improving human health. Among all the treatments, the pharmaceutical is one of the key and common ways with which humanity fight diseases. Its importance to public health is beyond doubt. Due to the nature of the life sciences, the pharmaceutical industry depends more on research and development than other industries do. Therefore, on average, it costs innovative pharmaceutical companies 1.3 billion U.S. dollars to develop a new drug. Furthermore, countries around the world pose strict regulations on new drugs’ entering the market since drugs cause huge impacts on the physiological functions and internal balances of the human body. Hence, it generally takes ten to fifteen years for a new drug to be fully developed. The enormous investment and lengthy developing period makes the pharmaceutical companies extremely dependant on the intellectual property system to provide them with the incentive for research and development. However, it is also because of the intellectual property protection that makes new drugs expensive and difficult for the public to access. The Generic drug, however, is one of the key solutions to solve this problem and is intensively promoted by countries all over the world. Regarding the promotion of the generic drug industry, the experimental use exemption is one of the vital systemic considerations. There are discussions on the characters of the pharmaceutical industry, on the common law and statutory experimental use exemptions of the United States, and on the related regulations and precedents of the experimental use exemption in Taiwan. Through the above discussions, the thesis is aimed at identifying the possible problems the regulations on experimental use exemption might cause when applied to the practice of the pharmaceutical industry and at proposing possible solutions to such problems. The characters of the pharmaceutical industry are discussed in Chapter two. The concepts and the criteria of the common law experimental use exemptions are discussed in Chapter three. The legislation background, related precedents, and impacts on the field of biotechnology of the statutory experimental use exemptions in the United States are illustrated in Chapter four. Lastly, in chapter five, the restrictions on patent right in the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization is first discussed. The related regulations on experimental use exemptions in Taiwan are later discussed. Lastly, through the scholars’ opinions and related precedents, the possible problems of application of the experimental use exemption in Taiwan are illustrated and the probable solutions are proposed.