TRIPS

To what extent does the current international legal regime on the protection of intellectual property rights adequately address the issues associated with the protection of public health? The issue of access to medicines remains at a crossroad between the ongoing globalization of intellectual property rights (IPRs), and significant demand for drugs to meet critical public health needs among the world's poor. Campaigning by the governments of many low and middle-income countries (LMICs), alongside nongovernmental organizations (NGOs), has centered on the potential for trade agreements, notably the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), to hinder the availability of affordable medicines. The World Trade Organization’s (WTO’s) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 1994 pursued to implement a uniform set of intellectual property protection across member nations to provide greater stability in international economic relations. TRIPs include health related provisions for medicines such as compulsory licensing, parallel importing and addressing imbalances in research and development (R&D). Although these provisions were in the TRIPS agreement since its inception, nations never interpreted the provisions of the agreement in a manner consistent with the promotion of public health. Certain nations that were subject to the TRIPS agreement would enact legislation that maximized the protection of intellectual property rights but ignored public health crises affecting developing areas. Further and perhaps even more damaging, at the behest of the influential pharmaceutical lobby developed nations would threaten sanctions on countries that attempted to take advantage of parallel importing or compulsory licensing. For example in 1997, the United States notoriously threatened trade sanctions against South Africa unless they repealed a section of the Medicines and Related Substances Control Amendment Act which allowed compulsory licensing and parallel importing, despite it being TRIPS compliant. The most visible conflict was over AIDS drugs in Africa. Despite the role that patents have played in maintaining higher drug costs for public health programs across Africa, this controversy has not led to a revision of TRIPs. Attempts to settle the concerns around public health protections led to the Doha Declaration in 2001, followed by the Implementation of the Paragraph 6 Decision in 2003. Combined, the two declarations provide clarifications on the need for, and provisions available, to access generic medicines. One of the most important results was a waiver of Article 31(f) of the TRIPS agreement which states that a compulsory license can only be issued for primarily domestic use. This paragraph precluded generic drug production for export to countries without their own domestic capabilities, leaving the poorest countries without access to generic medicines. The waiver allowed a country to issue a compulsory license for either domestic use or export, on the basis of public health need. The adoption of the Doha Declaration triggered a number of actions at the international level aimed at addressing the tension between intellectual property rights IRPS and the right to health. A decline was seen in complaints against countries for inadequate IPR protection, registered by the US Trade Representative, from five in 1999 to one in 2002.some positive changes have been seen in enabling developing countries to gain access to essential drugs. Some of these countries have actively used the flexibilities of the Doha Declaration in order to achieve better and cheaper medicines for HIV/AIDS. Cambodia for example has implemented new patent legislation which excludes patent protection until 2016, explicitly citing the Doha Declaration as its justification. It was not until 2005 that the first country issued a compulsory license under the waiver on the grounds of protecting public health e.g. [Taiwan-Roche case]. The most notable action to date , to assert the waiver of Article 31(f), has been by the Thai government which authorized the Government Pharmaceutical Organization in November 2006 to manufacture generic versions of Stocrin until 2011, and to import generic versions from India until domestic production comes into line. Furthermore The Declaration has also been invoked as a basis for policy action at both national and regional level in the field of access to medicines. For instance, the European Parliament, in its resolution on the TRIPS agreement and access to medicines (12 July 2007), cited the Doha Declaration and asked the European council to support the developing countries which use the so-called flexibilities built into the TRIPS agreement (para. 8) Also, the implementation of Paragraph 6 of the Doha Declaration has been mentioned in a WTO dispute, not as a defensive argument, but to establish non-compliance with WTO obligations by the EU. India initiated dispute settlement consultations on 11 May 2010 with the EU in relation to the EC custom regulation as a result of the repeated detention of generic medicines produced in India while in transit through EU territory. However, an evaluation after five years of the adoption of the Declaration noted that developed countries had taken little or no action towards their obligations and were in some cases actually undermining the Declaration. Till date, this situation has not improved. The Doha Declaration has promoted only to a limited extent the incorporation of the TRIPS flexibilities in national laws and regulations and their effective use. Most national laws incorporated provisions on different modalities of compulsory licenses and government use for non-commercial purposes before the adoption of the TRIPS agreement. Although such provisions have been retained or modified to meet the agreement’s standards on the matter, only few developing countries have granted such licenses to address public health needs, particularly to ensure the supply of low-cost treatments for HIV in the last 10 years. Moreover, the US Agency for International Development (USAID) has been funding the Commerce department of Nigeria in providing it with technical assistance to rewrite its patent laws. The draft legislation demands far more stringent measures than are required by TRIPS Agreement. Furthermore in some limited cases, the Doha Declaration may have dissuaded countries from introducing TRIPS-plus demands for e.g. Us–Jordan FTA. The Declaration may have also played a role in limiting EU demands for TRIPS-plus protection in the European Partnership agreement signed with CARIFORUM countries. Furthermore The Bipartisan agreement on Trade Policy reached in May 2007 also reflected, to some extent, the concerns that led to the adoption of the Doha Declaration. On the basis of this agreement, this new Trade Policy mitigated some public-health TRIPS plus provisions demanded by the US government in FTAS with Peru, Colombia, Panama and South Korea. According to some commentators, however, the US government seems to have backtracked from the new Trade Policy in the proposals for a Trans-Pacific Partnership agreement, which, despite claims to the contrary in the office of the USTR White Paper on trade goals to enhance access to medicines, have raised concerns among civil society groups that they contain many new TRIPS-plus terms that are collectively more onerous than have ever previously been presented. Therefore, the Doha Declaration did not seem to have triggered a widespread increase access to medicines. This is because of many reasons firstly given the sensitivity of intellectual property rights issues; governments have been reluctant to review the adopted legislation to incorporate flexibilities not present in the existing legislation. secondly, and most importantly, a significant number of developing countries have entered into FTAS and other bilateral agreements that incorporate, in exchange for trade concessions, measures commonly referred to as ‘TRIPS-plus’ provisions –hat exceed the obligations under the TRIPS agreement and limit the capacity of developing countries to effectively issue compulsory licenses, allow parallel importation or use other TRIPS flexibilities. Thirdly, some developing countries (not involved in FTAS) do not seem to have received appropriate technical assistance and capacity-building to fully understand and incorporate the TRIPS flexibilities. And fourthly, the system established by the WTO Decision of 30 august 2003 are subject to a number of conditions and limitations (for instance, export of specified quantities of a medicine to a particular country). As a result of Doha Declaration, TRIPS flexibilities have been instrumental in perusing public health objectives in developing countries. Such example includes the compulsory licensing by Brazil in 2007, The Indian Patent Act 2005 and Thai Patent Act 1999. Yet, the declaration has not sufficient to prevent TRIPS-plus demands, concessions and commitments in FTAs and other bilateral agreements that may negatively affect access to medicines.As stated by Fredrick Abbott, ‘It appears to be the natural order of things that some are better off than others. Indeed unwillingness to drive a hard bargain and let the chips fall where they may could be taken as a lack of strength. With that said, the North is perilously close to standing by while more than 30 million people die prematurely from HIV/AIDS and its complications. The danger is clear and present. The disease can be controlled with existing medicines. We will not be able to say in hindsight, ‘If only we had known.’ Therefore there is a need of Changes to be made in the multi-lateral framework in order to make it easier for developing countries to utilize the flexibilities necessary to provide essential drugs, developed must also desist from preventing these countries from doing