「被忽視」的熱帶疾病(NTDs)中的寄生蟲疾病(Parasitic Diseases; PDs)除對非洲人群健康之危害甚鉅外，並進而對非洲地區社經體系造成嚴重衝擊與造成巨大的「失能調整人年」損失。由於不易取得治療PDs傳統基本藥物的問題，許多非洲民眾便以其部落社區的傳統治療師所採用的傳統草藥來進行PDs的治療，雖然這些傳統草藥容易取得，但是成分的內容和藥效品質甚或產生嚴重的致命副作用。雖然TRIPS協定第31條和杜哈宣言的第五和第六段對於製藥能力不足或大部分皆無製藥能力的貧窮國家，可以基於「國家緊急危難或其它緊急狀況」的事由，以強制授權方式取得專利藥或較便宜的學名藥以解決造成國家危難的特定公共健康事件，但是國際大藥廠認為無利可圖，不願意花費資金投注於預防或治療此類疾病藥物的相關研發外，高收入的國家為保護其大藥廠的藥物專利，也往往使用一些經濟制裁手段逼迫上述國家就制定國內專利法以保護其藥物專利。雖然經杜哈宣言修正TRIPS協定第31(f)條有關強制授權對外出口的障礙，但是出口國對於強制授權程序與是否能取得政治上和藥廠業者的支持，仍充滿困難。應用「專利池」可以減少交易成本或法律爭議而可調和「強制授權」與解決「權利耗盡」的爭議，有助於解決非洲開發中國家取得專利藥物的困境。PDs造成非洲開發中國家民眾失能等長期痛苦與健康生活損失，類推適用SARS模式，可依TRIPS協定第31條(b)與杜哈宣言第五段(c)將之視為「造成國家緊急危難或其它緊急狀況」的重大公共健康的事由而可行使強制授權。雖然「生醫專利池BVGH」的「非獨家個別授權與免授權費」的操作模式與傳統電信技術專利池不盡相同，但因藥廠不願投入治療PDs的傳統基本藥物存在的副作用與抗藥性的新藥研發，為鼓勵對治療PDs的藥物進行創新研發， BVGH彈性的授權方式與免繳交授權費，將有利於解決開發中國家未來取得新專利藥的困境。除BVGH外，建議結合全球獎勵基金以「激勵拉拔」的方式獎助願意投入治療PDs新藥研發並將專利自願授權給BVGH的藥廠。鑒於全球暖化與最近中東難民潮大量湧進歐洲，罕見的PDs可預期會大量傳播開來，將嚴重衝擊歐洲等先進國家良好的公共衛生體系，而使得「NTDs尤其是PDs不再只是專屬於貧窮國家的疾病，亦將常現於富有的先進國家」。這些NTDs疾病將提供藥廠進行新藥研發的利基，然而在未來可能產生專利池的反競爭問題，導致支配市場獨占性的隱憂值得關注。 / Parasitic diseases (PDs) not only cause the huge health hazards to African populations, but also they further severely impact on African socio-economic system as resulting in huge economic and health losses as assessed by disability adjusted life-years. Since it is not easy for Africans to access the essential medicine to treat PDs, many of them will seek for the help of local healers in tribal communities to treat PDs. Although these traditional herbs are readily available, the content and quality of drug ingredients may even cause serious fatal side effects. Poor countries with insufficiencies or lacks of the pharmaceutical capacities may still access the patented medicines or cheaper generics to solve the national crisis caused by the specific public health events through compulsory licensing (CL) based on "national emergency or the other emergency situations" according to TRIPS Article 31 and Doha Declaration on the fifth and sixth paragraph due to that the large international pharmaceutical companies consider unprofitable, unwilling to spend money to invest on the research and development (R&D) of new drugs for prevention or treatment purpose. Moreover, the high-income countries also tend to exert some of the economic sanctions to force those poor countries to enact national patent law in order to protect drug patents. Furthermore, the mandatory obstacle of exportation authorized by CL from the amended TRIPS Agreement Article 31 (f) by the Doha Declaration has been improved; nevertheless, it is still fraught with difficulties in utilization of CL for the exporting countries because this should be dependent on whether they may actually get the supports from political and the pharmaceutical industry. Application of patent pools model may benefit to reduce transaction costs or legal dispute thus reconciling and resolving issues related to CL as well as doctrine of patent exhaustion and that it is beneficial to help solve dilemma for African countries to access patented drugs. Because Africans severely suffer from disabled caused by PDs thus leading to long-term pain and health life losses, African countries can grant CL as PDs may be regarded as national crisis like SARS causing "national emergency or the other emergency situations" as authorized from TRIPS Agreement Article 31 (f) and Doha Declaration paragraph 5 (c). Although the practice of individual licensing with royalty-free for BVGH is somewhat different from that of traditional patent pools, this licensing practice mode is beneficial to innovation in new drugs R&D to improve the side effects and drug-resistance of traditional essential medicines and help African countries to access patented new drugs in the future. Finally, it is recommended to cooperate with Award Foundation to encourage incentive for pharmaceutical companies which contribute most to new drugs R&D and voluntary licensing to BVGH. Owing to global warming and recent emergence of huge refugees into Europe rare PDs will be obviously spread out thus causing severe impacts on well-established public health system as leading to emergence of PDs in developed countries like Europe. Altogether, such situations definitely provide a good incentive in new drugs R&D for pharmaceutical companies; however, it guarantees concerns on anti-competitive and monopoly issues derived by biomedical pools in the future.

本研究以Wendy Gordon教授三要件市場失靈理論為核心-即(一) 市場失靈的狀況現實存在，（二）支持被告的使用模式對社會而言利多於弊，以及（三）允許合理使用抗辯不會對於創作者的創作誘因產生實質損害-試圖以美國實務判決為藍本勾勒出可能的觀察構面與命題，並以此為基準以音樂產業為例推演可能的管理意涵，最後從制度面的角度檢討現行合理使用判決所出現的問題與可能的解決方式，研究結果及建議分述如下： 觀察構面與命題的發展 本研究以美國近二十年來重要合理使用判決為藍本，並將市場失靈區分為交易成本過高與正向外部性兩種類型，歸納出以下命題及觀察構面： 命題一：與著作權利人進行交易的交易成本越高，主張合理使用成功的機會越高。 H1:系爭著作物在使用當時若屬於無法尋得權利人的孤兒著作，成功主張合理使用的機會較高。 H2:系爭著作物若有著作權仲介團體代理或有交易成本低廉的授權平台，成功主張合理使用的機會較低。 H3:系爭著作物若有著作權管理資訊，成功主張合理使用的機會較低。 命題二： 被告利用型態對社會創造的正向外部性越高，成功主張合理使用的機會越高。 H4:系爭著作的利用方式若屬於對原著作物的諷刺或批評，成功主張合理使用的機會較高。 H5: 使用者使用的模式若能減少資訊流通障礙而非單純販售著作重製物圖利，成功主張合理使用機會較高。 市場失靈對著作權人的管理意涵 就正向外部性導致的市場失靈而言，當被告的利用模式產生的正向外部性越大，著作權授權交易無法完成對整體社會造成的效率損失越大，依據市場失靈理論的討論架構，法院支持被告合理使用主張的機會也越大。此時，權利人最佳的管理策略應該是更積極進行授權，並避免過度利用優勢談判地位抬高交易條件，最後導致授權交易無法進行。面對交易成本過高可能導致市場失靈，對權利人來說最佳的管理策略應該是使用各種可能的機制創造最有效率的授權市場，當市場的運行越具效率，交易成本越低，市場失靈的風險越低，法院支持利用人合理使用抗辯的機會也越低。管見以為，授權著作權仲介團體進行授權交易、自建授權平台、創新商業模式或與主流流通平台建立策略聯盟，是對權利人來說降低交易成本最佳的管理策略之一。 此外，從音樂與出版產業的發展歷程可以發現技術、法律與管理是彼此互為影響的構面，對於企業經營者來說，應有任何一項變動即牽一髮而動全身的敏銳，假定任何一項要素恆久不變或外生於其他兩構面的變化，均可能成為策略錯誤的原因。以上發現可歸納為三個命題： 命題三:著作利用產生的正向外部性越大，權利人越應該積極進行授權，避免過度利用優勢談判地位抬高交易條件，導致授權交易無法進行。 命題四: 權利人應積極建立便於使用的授權機制，降低交易成本及合理使用的風險。 命題五：技術、法律與管理模式三構面互相影響，任何一項要素變動，都可能驅動其他兩項要素的變化。 現行合理使用判決的問題與制度面的修正芻議 若市場失靈理論及本研究提出的命題與觀察構面被接受，本研究建議現行著作權法第六十五條第二項規定可修正如下： 著作之利用是否合於第四十四條至第六十三條規定或其他合理使用之情形，應審酌一切情狀，尤應注意下列事項，以為判斷之基準： 「一 利用之目的及性質，包括係為商業目的或非營利教育目的。 二 著作之性質。 三 所利用之質量及其在整個著作所占之比例。 四 利用結果對著作潛在市場與現在價值之影響。 五 利用結果產生的公共利益。 六 覓得著作權人以及取得授權的難易與成本。」 現行法下，法院在合理使用與判斷被告需賠償權利人全額損害兩者間沒有其他選擇，若法院考量正向外部性的存在後，認為被告的利用方式對整體社會有極大利益，並將正向外部性所帶來的好處納入最適授權金的計算，其數額或許將遠低於客觀上填補權利人所失利益與所受損害的價額，判定被告需賠償全額損害有悖於分配效率的要求。反面言之，若被告的利用嚴重損及該著作物最主要的經濟收益，判定合理使用對權利人又將衝擊過大。此時，法院將被迫在合理使用與全額損害賠償間進行二擇一的選擇。為給予法院更多救濟市場失靈的彈性，本研究建議在制度上應盡可能補足全額損害賠償與合理使用光譜的空缺，在立法上似可考慮將現行著作權法第六十五條第三項、第四項規定移至第四項與第五項，並增訂第三項條文如下：著作之利用雖不符合第四十四條至第六十三條規定或其他合理使用情形，但法院審酌一切情狀，尤應注意前項所列事項，得酌減損害賠償金額，若行為人利用方式未達商業規模者，並得免除或酌減行為人違反本法所需負擔的刑事責任。 嚴重市場失靈發生時，因為著作權人的市場利益未受影響，應支持著作利用人合理使用的主張。本此，對於特定類型的嚴重市場失靈，著作權法可以明定為合理使用。本研究建議現行著作權法第五十一條修正如下：「著作於個人或家庭或其他類似範圍內之使用為目的者，若該使用不影響著作權人可合理預期的市場利益者，不構成對著作財產權的侵害。」 / Along with the enlargement of the scope and duration of copyright, it is generally believed that barriers to continual innovation and knowledge distribution also increase. How to leverage fair use to best preserve public interest thus becomes a very important issue. Nevertheless, fair use is called the most unpredictable and difficult problem in copyright law. Using the market failure theory proposed by Wendy Gordon to explain the scope of fair use, this research collects landmark U.S. fair use cases as the basis to develop propositions that help the judiciary to deal with fair use cases, makes management suggestions to copyright holders and proposes several legal reforms to the current Taiwanese fair use law . This study suggests that a defendant’s chance to prevail on his fair use defense increase as the transaction cost increases. For illustration, if the work in dispute is an orphan work, a defendant has a stronger fair use case because the transaction cost he has to incur to find the copyright owner and reach a deal is higher. Similarly, if the work in dispute carries with it clear copyright management information, is managed by efficient intermediaries or placed on an efficient transaction platform, a defendant has a weaker fair use case. The reseach also argues that the higher the positive externality brought by a defendant’s uses, the stronger fair use case he has. If a defendant uses the work in dispute to create a parody or to facilitate information exchange, the defendant has a stronger fair use case due to the positive externality he creates. As managerial suggestions to copyright owners, this study maintains that copyright owners should make their best efforts to reduce transaction costs in connection with licensing and copyright transfers and actively engage in licensing to uses creating significant positive externalities. This helps reduce the possibility that potential users rely on fair use and end up paying nothing to copyright owners. To reduce transaction cost, copyright owners may consider building a licensing platform themselves, using intermediaries or forming strategic alliances with primary sale channels. As for positive externalities, it is suggested that copyright owners pay attention to the public interests recognized in the copyright law. This study also finds that technology breakthroughs, legal reshuffles and innovations in business model and management are inter-related. It is simply a mistake to regard one of the three constructs as being static if another construct has been changing. This research also proposes the following amendments to the current fair use law in Taiwan. As a matter of practice, Taiwanese judges rarely consider factors outside the four listed factors in Article 65(2) of the Taiwanese Copyright Law, even though the statute gives them wide discretion to consider other factors. To encourage the Taiwanese judiciary to apply the market failure theory in fair use cases, it is suggested that “the cost at which a user must incur to obtain a license” be added as the fifth factor and that“the public interests a user creates” be added as the sixth factor in Section 65(2). Secondly, to give judges more flexibility in close cases, it is suggested that judges should be given discretion to reduce the damages a defendant has to compensate copyright holders and discretion to reduce or release him from his criminal duty, even if the criteria for fair use are not fully satisfied. Lastly, if serious market failure occurs, it will be Pareto superior to allow defendants to use the work in dispute free of charge. It is generally recognized that most types of personal uses fall within the scope of serious market failure. This study thus proposes that Article 51 of the Taiwanese Copyright Law be amended to the effect that personal or familial uses are allowed so long as the profits copyright holders can reasonably expect are not adversely affected.

Submitted by Paulo Junior (paulo.jr@fgv.br) on 2010-05-13T21:02:37Z No. of bitstreams: 1 Cláudia Hoirisch.pdf: 1193444 bytes, checksum: 18921b0201a6008cb606c1dcc39797a0 (MD5) / Approved for entry into archive by Paulo Junior(paulo.jr@fgv.br) on 2010-05-13T21:03:02Z (GMT) No. of bitstreams: 1 Cláudia Hoirisch.pdf: 1193444 bytes, checksum: 18921b0201a6008cb606c1dcc39797a0 (MD5) / Made available in DSpace on 2010-05-14T12:29:32Z (GMT). No. of bitstreams: 1 Cláudia Hoirisch.pdf: 1193444 bytes, checksum: 18921b0201a6008cb606c1dcc39797a0 (MD5) Previous issue date: 2010-03-24 / The scope of this study is to evaluate the implementation process of the Compulsory License in the case of the antiretroviral efavirenz. This research is descriptive in nature and the medium of investigation was the case study. It was conducted during the months of October through December 2009 with semi-structured interviews containing open-ended questions with a group of Public Health policy makers and managers residing in the states of Rio de Janeiro, Sao Paulo and the Federal District who participated in the compulsory license process. These individuals were allowed to express themselves without any constraints in such a way that they could produce discourses. The Collective Subject Discourse (CSD) technique was then used for analysis of the discourses. The results revealed that Brazil has the technological capability to develop and produce antiretrovirals within a reasonably short period of time. The results further showed that the Compulsory License helped to curb spending on antiretrovirals and that the measure can be used to ensure access by the public to high-cost and strategic antiretroviral drugs for the Brazilian public health service (Unified Health System – SUS) in an environment with limited funds, whenever an impasse is reached in negotiations for price reductions with transnational pharmaceutical laboratories. / O objetivo deste estudo é avaliar o processo de implementação da Licença Compulsória no caso do anti-retroviral efavirenz. Esta pesquisa é de caráter descritivo, o meio de investigação foi o estudo de caso e foi conduzido com entrevistas semi-estruturadas contendo questões abertas para um conjunto de atores representativos da área da Saúde Pública que participaram do processo da licença compulsória residentes nos estados do Rio de Janeiro e São Paulo e no Distrito Federal durante os meses de outubro a dezembro de 2009. Permitiu-se que esses indivíduos se expressassem mais ou menos livremente de forma que eles produzissem discursos. Para a análise dos discursos, utilizou-se a técnica do Discurso do Sujeito Coletivo (DSC). Os resultados demonstraram que o Brasil possui capacitação tecnológica para desenvolver e produzir anti-retrovirais em um prazo relativamente curto. Os resultados mostram ainda que a Licença Compulsória ajudou a refrear os gastos com anti-retrovirais e que o instrumento pode ser utilizado para garantir o acesso da população a medicamentos anti-retrovirais de alto custo e estratégicos para o Sistema Único de Saúde em um ambiente de recursos limitados sempre que se chegar a um impasse na negociação para redução de preços com os laboratórios farmacêuticos transnacionais.

Kenyan labour laws inadequately protect HIV positive worker. The Constitution of Kenya, 1963, does not prohibit stereotypical attitudes adverse to HIV positive workers and discrimination on the basis of health status. It does not provide for the right to employment, health and health care services, and fails to delimit privacy and dignity rights. Under the Industrial Property Act, 2001, the basis for Government exploitation of patent through compulsory licensing is whimsical and parallel importing is not envisaged. Employers unilaterally draft employment contracts notwithstanding their unequal power relations to employees. The HIV and AIDS Tribunal institutionalises discrimination against HIV positive workers on the basis of the ambiguous ‘inherent job requirements.’ Plausible international labour laws and practices have no place in Kenya unless they are domesticated. SUMMARY This thesis interrogates the Kenyan labour laws and policies to identify their inefficiencies and suggest recommendations for reform. It commences with an analysis of the topical issues associated with the HIV positive worker. It then examines the extent of prevalence and ramifications of HIV/AIDS in Kenya. Subsequently, it studies the efforts made at the international and domestic arena in protecting the HIV positive worker. A comparative analysis is made of the laws protecting the HIV positive worker in a number of countries, namely, South Africa, United States of America and Australia. The thesis draws conclusions and recommends measures on how best to protect the Kenyan HIV positive worker. The labour laws should be amended to prohibit discrimination on the basis of health status, provide for right to affordable medication and work, allow negotiation of employment contracts, list international laws that Kenya ratifies without reservation as a source of law and delimit the concept of ‘inherent requirements of a job.’ The public should be sensitised to embrace HIV positive workers. Once the new Constitution is enacted, it should list socio-economic rights as fundamental rights and reform the office of the ombudsman to deal with complaints against private employers. / (LL.D.)

Dans les pays en développement (PED), les problèmes engendrés par le VIH/SIDA et l’inaccessibilité des antirétroviraux (ARV) s’avèrent être la cause de ravages extrêmement préoccupants à tous les niveaux (démographique, politique, social et économique). Dans le cadre de l’Organisation mondiale du commerce (OMC), et notamment de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (« Accord sur les ADPIC »), un nombre croissant de PED ont ou sont en train d’intégrer un standard international de protection des brevets de produits et de procédés pharmaceutiques à leur législation nationale. Cette intégration a eu et continue de jouer un rôle majeur dans la problématique de l’accès aux médicaments dans les PED. Les conditions et les effets du régime de protection des innovations suscitent de vifs débats entre les partisans d’une protection accrue des brevets et les défenseurs de l’accès aux médicaments essentiels. Une des principales motivations de notre travail de recherche est de fournir une étude permettant de trouver des solutions à la fois favorables à l’amélioration de l’accès aux médicaments et à la préservation de l’innovation. Le problème complexe de l’accès aux médicaments ARV dans les PED est influencé par la pluridisciplinarité et l’interdépendance de nombreux facteurs. Le système des brevets ne constitue pas « l’unique » solution au problème. Toutefois, il doit être plus sérieusement considéré dans sa fonction d’équilibrage entre l’intérêt privé et l’intérêt collectif. C’est un outil juridique précieux pour le développement économique et technologique des PED et la réalisation de l’intérêt commun contre la pandémie. / In developing countries, problems brought about by HIV/AIDS and inaccessibility of antiretrovirals (ARVs) are proving to be the cause of serious damages at all levels (demographic, political, social and economic). Within the context of the World Trade Organization, and in particular the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), a growing number of developing countries have integrated or are in the process of integrating into their national law an international standard of patent protection for pharmaceutical products and processes. Such integration continues to play a major role in the issue of access to medicines in developing countries. The conditions and effects of the protection regime respecting innovations give rise to heated debates between supporters of an increased patent protection and defenders of the access to essential medicines. One of the main motivations for our research is to provide a study that helps to find solutions that are both in favour of improving access to medicines and protecting innovation. The complex problem of access to ARV drugs in developing countries is influenced by the multidisciplinarity and interdependence of many factors. The patent system does not solve the problem on its own. However, it should be seriously considered in its function of balancing the private and collective interests. It is a valuable legal tool for the economic and technological development of the developing countries and to achieve the common interest against the pandemic.