Submitted by Luiz Felipe Barbosa (luiz.fbabreu2@ufpe.br) on 2015-03-05T12:22:16Z No. of bitstreams: 2 wanilza marques de almeida cerqueira, mestrado em Direito,PPGD_UFPE, 2012.pdf: 1317192 bytes, checksum: 30fb83d65c8c46a12f9afae40d417f72 (MD5) license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) / Made available in DSpace on 2015-03-05T12:22:16Z (GMT). No. of bitstreams: 2 wanilza marques de almeida cerqueira, mestrado em Direito,PPGD_UFPE, 2012.pdf: 1317192 bytes, checksum: 30fb83d65c8c46a12f9afae40d417f72 (MD5) license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) Previous issue date: 2012-02-24 / A regulamentação da propriedade intelectual pela Organização Mundial do Comércio (OMC) repercutiu nas questões de saúde pública dos Estados Membros. O princípio de single undertaking conferiu unidade à regulamentação da OMC e obrigou a aceitação de todos os acordos da organização. Um dos temas mais controversos regulamentados pela OMC foi propriedade intelectual. A OMC estipulou a regra que obriga os Membros a concederem patentes a medicamentos, anteriormente cada Estado era livre para dispor sobre a matéria conforme entendesse conveniente. A obrigação de patentear medicamentos pode inviabilizar políticas de promoção à saúde pública pelos Estados, por isso o TRIPS prevê o uso legítimo de flexibilidades à regra geral de patenteamento. No cenário pós-TRIPS, observa-se o fenômeno TRIPS-plus, que são regras elaboradas à margem da regulamentação da OMC e que diminuem ou inviabilizam a utilização das flexibilidades previstas no TRIPS. O objetivo da dissertação é analisar o TRIPS-plus, ponderar sobre seu impacto no acesso a medicamentos, demostrar como ele agride o sistema multilateral de regulamentação do comércio internacional traçado pela OMC e examinar as soluções propostas para a questão.

自19世紀以降，各國體認以國內法律為基礎的保護方式具有侷限性，因此開始嘗試以國際條約的方式對智慧財產權進行規範，產生了巴黎公約、伯恩公約、羅馬公約等國際協定，可定位為智慧財產權保護多邊貿易架構形成的第一階段，也是第一次各國國內立法朝國際保護靠攏的現象。1967年WIPO成立使多邊貿易架構顯得較為完備，然而在WIPO之運作架構下又因為不同國家的立場分歧未能進一步修正智慧財產權公約，多邊架構發展出現瓶頸，已開發國家未因此退出多邊貿易架構，反而選擇持續完善此多邊架構。TRIPS於1995年烏拉圭回合後生效，規定了嚴格且具體的執行規範，但是多邊架構未能於TRIPS後再取得重大成果，已開發國家和開發中國家在智慧財產權利益之立場分歧使得多邊架構之發展陷入僵局。已開發國家於TRIPS後時期選擇了另一種途徑，本文舉美國FTAs貿易政策為例，發現此時出現了暫時偏離多邊架構，改以雙邊架構為政策重心的分離，惟雙邊貿易政策經本文分析並無法產生美國的預期效果。 ACTA的發展可以定位出美國目前的政策走向，改採協商複邊貿易協定的方式，希望可以循FTAs政策的途徑，企圖讓ACTA此複邊架構的成果可以擴張到多邊架構中。本文認為2010年12月公布最終版本的ACTA能否順利生效仍屬未知數，即便順利生效，依其談判成果可以推定，已無法達到所有參與談判國的預期。不論已開發國家之後的政策走向為何，我們可以發現擁有智慧財產權利益國家的最終目標仍是提升國際間智慧財產權保護水準，過程中則變動地、持續地在多邊、複邊貿易架構中，選擇性執行能達成最終目標的政策，國際智慧財產權保護貿易架構中存在著各國政策反覆於多邊、複邊架構間來回擺盪的分合現象。 關鍵字：TRIPS、反仿冒貿易協定、智慧財產權保護、TRIPS-Plus / Countries found out that the protection of intellectual property based only on national law was insufficient. They chosen to base on international agreement from 19 century and concluded important treaties such as Paris Convention, Berne Convention and Rome Convention. This is the first phase in the process of which the intellectual property protection under the multilateral trade framework forming. WIPO was established at 1967 and completed the multilateral trade framework a little further. But countries had different positions thus could not obtain mutual recognition on specific issues. The developed countries did not walk away from the framework; nevertheless, they worked even harder to try to get some result. TRIPS came into force at 1995 after the Uruguay Round which is the most important multilateral agreement at the present day. The multilateral trade framework was stuck after TRIPS resulting from the gap between the developed and developing countries. The former began to work in other direction. We took the U.S. bilateral trade policy of FTAs as an example and found out there is a temporary departure from the multilateral trade framework at this phase. The U.S. policy of FTAs however didn’t achieve the goal expected. We could point out the next step of U.S. by observing the negotiation of Anti-Counterfeiting Trade Agreement (ACTA). U.S. took a different approach by negotiating the ACTA and hoped there will be a spillover effect from the plurilateral agreement to the multilateral framework. Negotiating parties announced the final draft of ACTA on December 3rd, 2010. After analyzing the final draft, we could make a conclusion that the result from the negotiation is not outstanding; moreover, it is not clear whether the agreement will come into force in time. No matter what kind of action will the developed countries take in the next, their final and utmost goal is always trying to protect the intellectual property and their related interest. Changing policy becomes the normal condition. This leads to the phenomenon that the intellectual property protection is continuously swaying from the multilateral side to the bilateral or plurilateral trade framework, and vice versa. Key Words: TRIPS, Anti-Counterfeiting Trade Agreement, Intellectual Property Protection, TRIPS-Plus

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.