This is a research proposal on access to medince and TRIP-Plus trend. In order to balance the interest of patent’s holder and society, as well as reduce the negative impact of protecting pharmaceutical patents on human right to health, the TRIPs Agreement has provided for some flexibilities and solutions, such as legal basis for parallel import and compulsory licensing
Title TRIPs, TRIPsplus trend and the public health in developing countries Outline The right to health is one of the basic and essential human rights, which is provided in international law as well as in national legislation (Article 25 of the United Nations' Universal Declaration of Human Rights 1948 and Article 12 of the 1966 International Covenant on Economic, Social and Cultural Rights). Implementing the right to health, which includes the right to access essential medicines, is one of the core obligations of every state and of the whole international community. The strong development of science and technology, especially in medical area, and the increase of pharmaceutical patents have brought to human life many benefits in terms of enjoying the human right to health In that context, the TRIPs Agreement was adopted, which provides a mechanism for protecting pharmaceutical patents In principle, it helps promote the research and development activities in medical field that can create more opportunities for human to have more new effective medicines to prevent and/or cure illness. Simultaneously, such protection of pharmaceutical can have negative impact on public health, as it can strict the medical access of human Particularly, such protection increases the price of medicine, which can be unaffordable to poor people, to developing countries in some circumstances; and, if the patent’s holder abuses his right to have pharmaceutical patent protected, he can harm to human right to health of others, by selling medicines with unreasonably high price, or by asking inappropriate requirements for licensing… In order to balance the interest of patent’s holder and society, as well as reduce the negative impact of protecting pharmaceutical patents on human right to health, the TRIPs Agreement has provided for some flexibilities and solutions, such as legal basis for parallel import and compulsory licensing… Besides, the international community has also called for the action of ensuring human right to health in the context of TRIPs, which can be seen via the Doha Declaration on the TRIPS agreement and public health, and the WTO Decision on Implementation of Paragraph 6 of the Doha Declaration. However, recently, a new trend in trade activities between states has been establishing, which is known as the TRIPsplus trend. The TRIPsplus trend provides a higher level of protection on patents in general and in pharmaceutical patent in particular, and also refuses many flexibilities provided in TRIPs Consequently, this trend creates more challenges to protecting public health as well as ensuring the right to access medicines of human, especially in developing countries. Therefore, it calls for concerns and consideration on the establishment of such TRIPsplus trend, in context of situation of public health and medical access in developing countries. A prominent example of the TRIPsplus trend, which is analyzed in this dissertation in order to clarify the trend of TRIPsplus, its nature and impacts, is the TransPacific Partnership Agreement (TPP Agreement). This dissertation aims to analyze the human right to health and critically analyze the protection mechanism on pharmaceutical patents under the TRIPs and TRIPsplus trend in terms of affecting the public health in general and in developing countries in particular. Introduction General overview and a brief history of the establishment of the TRIPs Agreement, the relationship between protecting pharmaceutical patents under the TRIPs Agreement and the medical access in general and in developing countries in particular, as well as the establishment of the TRIPsplus trend (with the example of the TransPacific Partnership Agreement TPP Agreement) and its new challenge towards protecting human right to health; Research questions and aims of the dissertation; Research methodology applied in the dissertation Chapter 1. The TRIPs Agreement and public health in developing countries (14p) 1.1 Overview on the TRIPs Agreement Brief history and background of the establishment of the TRIPs Agreement Aims and role of the TRIPs Agreement Brief content of the TRIPs Agreement 1.2 Public health and medical access in developing countries 1.2.1 Overview on the human right to health and medical access (definition and role in ensuring the development of human) 1.2.2 The reality of public health in developing countries The reality of illness in developing countries and reasons (hunger, poverty, lack of knowledge, environmental reasons, no access to preventing and/or curing medicines…) The reality of medical access in developing countries, limitation and reasons (poverty, lack of knowledge, stricted access to essential medicines due to protection of pharmaceutical patents…) 1.3 The relationship of the TRIPs Agreement and public health Overview on pharmaceutical patents: TRIPs Agreement covers all subjectmatters of IP rights (copyright, industrial design, trademark…); but the subjectmatter that relates and influences most on public health is patent, particularly pharmaceutical patent. It is the first time that pharmaceutical products can be protected under patent system in global level The protection of pharmaceutical patent under the TRIPs Agreement can promote the medical development: creates more motivation for research and development in pharmaceutical area, which leads to more new medicines that can help prevent and/or cure new health diseases, and new medicines that are more effective… The protection of pharmaceutical patent under the TRIPs Agreement can also strict the medical access: such protection leads to higher price of medicines, which can be unaffordable to developing countries, to poor people…; the abuse of such protection of right holder can prevent developing countries from accessing to protected essential medicines (due to unreasonable requirements for licensing those medicines…). Chapter 2. Ensuring the public health in developing countries under the TRIPs (12p) 2.2.1 Solutions from TRIPs – Flexibilities Parallel import: tackle with the negative impact of the TRIPs Agreement in creating high price medicines Compulsory license: prevent and tackle with the abuse of rights holder Transition period for developing and least countries Exceptions in protecting patent relating to public health (Article 27.2, 27.3, 30) 2.2.2 The Doha Declaration on the TRIPS agreement and public health 2001 2.2.3 The WTO Decision on Implementation of Paragraph of the Doha Declaration on the TRIPS Agreement and Public Health 2003 2.2.4 The Protocol amending the TRIPS Agreement 2005 Chapter 3. The TRIPsplus trend in the new context (14p) 3.1 The overview on TRIPsplus trend Definition of TRIPsplus and reasons for its establishment The recent development of TRIPsplus agreements What are the differences between the TRIPs and TRIPsplus protection?: the TRIPs plus trend provides a higher level of protection than the TRIPs Agreement; it also refuses some flexibilities provided in TRIPs 3.2 The TPP Agreement – prominent example of the TRIPsplus trend What is the TPP Agreement? 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Introduction General overview and a brief... Affecting Public Health in a Developing Country’ in Shadlen K C and others (eds), Intellectual Property, Pharmaceuticals and Public Health: Access to Drugs in Developing Countries (Edward Elgar Publishing Ltd 2013)... Brief content of the TRIPs Agreement 1.2 Public health and medical access in developing countries 1.2.1 Overview on the human right to health and medical access (definition and role in ensuring the development of human)