ࡱ> oqn Cbjbj 4Vcc:\3\3AAAAA3A3A3A3A8kA,A3A^AA:AAABV2DdD4]]]]]]]+`bL]ADBBDD]ZFAAAA]ZFZFZFDAAAA]ZFD]ZFZFZAA\]+S{3AfE[x]<]0^[cZFc4\]ZFA\]DDD\3 ?:   Session 20: ϲʹ rules and public health in developing countries: The "Achilles' heel" or a pillar for development? Sub theme III: Coherence between the ϲʹ and other areas of global governance Moderator Mr Kwame Owino, Programme Coordinator, Institute of Economic Affairs, Kenya Speakers Ms Miriam W. Oiro Omolo, Trade Programme Officer, Trade Information Programme, Institute of Economic Affairs, Kenya Mr Atul Kaushik, Director, CUTS Geneva Resource Centre; Advisor Projects, CUTS International, India Mr Augusto Makiesse Kinkela, Third Secretary, Permanent Mission of Angola to the UN in Geneva Organized by Institute of Economic Affairs, Kenya Report written by MsMiriam W. Oiro Omolo, Trade Programme Officer, Institute of Economic Affairs, Kenya Thursday, 16 September 2010 16.30-18.30 Abstract Most developing countries have set their public health development goals in line with the millennium development goals, although achieving these goals has remained elusive for most countries of Sub-Saharan Africa (SSA). These challenges largely arise due to poor policy coordination and implementation. Most SSA countries that face challenges in achieving their public health development goals are also members of the ϲʹ. Development forms the core of the agenda of the current Doha negotiations. This session focused on the ϲʹ trading rules and how they impact on the public health development goals in African countries. The main objectives of the session were: to establish the general public health development goals in Sub-Saharan Africa; to establish the coherence/challenges of the ϲʹ rules with the public health development goals; to provide recommendations on the way forward. The questions that were to be addressed in the session were: Has the ϲʹϒs role contributed to achieving public health goals of developing countries in Africa? What coherences or contradictions are there between ϲʹ and public health development goals in African countries? Have developing countries taken advantage of the opportunities presented by the ϲʹ rules to achieve better public health? 1. Presentations by the panellists (a) Miriam Omolo, Trade Programme Officer, Trade Information Programme, Institute of Economic Affairs, Kenya MsOmolo commenced by recounting the story of Achilles from the Greek mythology, where it was foretold that he would die in a battle from an arrow. His mother, Thetis, took him to the river Styx which was supposed to offer powers of invincibility and dipped his body into the water. But as Thetis had held Achilles by the heel, his heel was not washed over by the water. Achilles grew up to be a man of war, and survived many great battles. However, one day an arrow was shot at him in a battle and lodged in his heel. The myth says that Achilles was killed by this arrow. This story can be likened to SSA and its engagement in international trade under the World Trade Organization (ϲʹ). Like Achilles, SSA has to deal with several battles, especially in creating functional health systems that can ensure its citizens receive quality medical care. Some of the challenges arising in achieving proper health systems are directly linked to the ϲʹ rules. She noted that every government is responsible for the careful management of its citizens well-being. This means that, for a government, the peoples health is a matter of national priority. Health policies should therefore cover both the provision and financing of health services by both private sector and the state. In this way a government will be able to establish health systems that serve the interests of the general public. African governments have set up health systems in order to provide and improve the health status of their countries. SSA countries have faced several challenges in trying to achieve their health objectives, including: adequate service provision, proper health information systems, lack of access to essential medicines, healthcare human resources and inadequate healthcare financing. There are several ϲʹ agreements which affect public health; the most important one that affects access to essential medicines is the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The Millennium Development Goal (MDG) Gap Task Force Report of 2009 shows that the availability of essential selected medicines in developing countries was low access in the public sector was 38.1per cent while in the private sector it stood at 63.3per cent yet the majority of citizens used public health facilities for their healthcare. She also outlined the common TRIPS flexibilities available to African countries: Compulsory licensing: when a government allows someone else to produce the patented product or process without the consent of the patent owner. Parallel imports: where products are marketed by the patent owner (or trademark- or copyright-owner, etc.) or with the patent owners permission in one country and imported into another country without the approval of the patent owner. Limiting the extent of test data protection: the test data submitted by companies can be used to approve subsequent applications for similar products which are normally generic in nature. Sub-Saharan African countries have not taken much advantage of these flexibilities; Zimbabwe used compulsory licensing in 2002 for the procurement of antiretroviral medicines. Similarly, Zambia and Mozambique used compulsory licensing in 2004 for production of antiretroviral medicines. No African country has used the test data protection flexibility. The gravity of this matter can be seen in the World Health Assembly of 2001, which noted that "the impact of international trade agreements on access to, or local manufacturing of, essential drugs and on the development of new drugs needs to be further evaluated". With this background, it would be important to ask if the ϲʹ rules are the Achilles heel or a pillar for development in the quest for quality healthcare in Africa. (b) Atul Kaushik, Director, CUTS Geneva Resource Centre; Advisor - Projects, CUTS International, India MrKaushiks presentation began on the premise that the ϲʹϒs interface with public health begins when trade impacts on public health. He noted that during a joint ϲʹ-World Health Organization (WHO) and World Intellectual Property Organization (WIPO) symposium, the Director-General of ϲʹ, PascalLamy, noted that there was a need to work together towards a stronger, broadly based and effective outcome, even though the negotiation process was entirely in the hands of ϲʹ members. Therefore, domestic policy coherence and the correct interpretation of ϲʹ rules in their implementation at the national level were important in determining their effect particularly the protection of intellectual property rights and the flexibility available to member states to interpret and implement these rules. Members that have used these flexibilities judiciously in implementing intellectual property rights through national legislation have benefited. India interpreted the criteria of patentability while considering the public health and interest, even though this was not defined in the TRIPS Agreement. This interpretation was meant to limit the patent monopoly, and while many multinational pharmaceutical companies are unsatisfied with that interpretation, the Indian courts accepted it in the public interest. The governments of countries where these multinationals are situated have refrained from bringing the issue to the ϲʹ for interpretation, therefore flexibilities should be honoured. It should be recognized that flexibility to interpret rules does not in itself enable developing countries to effectively use them if the rules are flawed in the first place. This is true, for example, in the case of those developing countries that do not have adequate manufacturing capacities in the pharmaceutical sector. The solution to this problem is found in Paragraph6 of the TRIPS Agreement, which was an amendment, and provided a mechanism to overcome rules relating to compulsory licensing of patents to ensure availability of affordable medicines to the needy in developing countries that do not yet have adequate manufacturing capacity for pharmaceuticals. In the seven years of availability of this additional flexibility, however, it has been used only once. On international rule making, the East African Community (EAC) circulated the final draft of the EAC Regional Intellectual Property Policy on the utilization of public health related ϲʹ-TRIPS flexibilities and the approximation of national intellectual property legislation for comments and consultations. It is undergoing national-level consultations to also harmonize it with the Draft EAC Anti-counterfeiting Bill, which will then be subjected to another wide stakeholder consultation process in November before being submitted to the EAC Council of Ministers of Health. This is the time for all stakeholders to input into the consultative process to ensure that the kind of judgment errors that necessitated the amendment of the TRIPS Agreement do not occur at the regional level. The ongoing negotiation for an Anti-Counterfeiting Agreement (ACTA) among ten countries and the European Union (EU) is another case in point, where both domestic and international policy coherence has become an issue. Although an enforcement agreement, the ACTA text may have implications for public health and, in particular, ease of access to affordable medicines, if enforcement of the entire range of intellectual property rights, including patents, at borders is included in the final text. (c) Augusto Makiesse Kinkela, Third Secretary, Permanent Mission of Angola to the UN in Geneva MrMakiesse highlighted three important points. First, he noted that many African countries did not assess the benefits of joining ϲʹ and how they could use the rules to benefit from trade. Many African countries have attempted to use compulsory licensing in order to access essential medicines, however most investors insist on compliance with the TRIPS Agreement without the flexibilities. Due to pressure from investors, they have to comply with TRIPS without using any flexibilities, as was the case in Ghana. Furthermore, less than ten SSA countries have applied the TRIPS flexibilities. This is because most of these countries do not know how to use these flexibilities, and where they do, they face the problem of being reported to WIPO. Secondly, technical assistance provided by international institutions has only focused on compliance with the TRIPS Agreement, this should change, however. Technical assistance facilities should also be used to examine how the flexibilities can benefit individual countries based on each countrys assessment of needs. Thirdly, there is limited infrastructural capacity that would encourage research on patents and flexibilities. This can be seen by the amount of resources allocated by African countries to research activities. As a result, SSA countries cannot take advantage of patents in the public domain to explore ways of developing new patents, as Asian countries such as India have done. There should be more investment in research in order to take advantage of such opportunities. He concluded by noting that most African countries have a wealth of traditional knowledge associated with certain genetic resources that were used to heal different diseases. Traditional knowledge should therefore be used by SSA countries to deal with public health issues such as access to essential medicines. 2. Questions and comments by the audience A participant from International Press Services (IPS) asked whether the removal of patents from border measures under ACTA would facilitate production of generic drugs and not hinder it. MrKaushik responded that the effect of removing patents from border measures under ACTA depended on a number of factors. If a good was in transit, confiscation of generic medicine would have a negative impact, however the availability of affordable medicines was not limited to the ease of shipment, but also depended on a wide array of other enforcement parameters which have been introduced to the ACTA and are TRIPS Plus. A participant from the Permanent Mission of Brazil to the ϲʹ noted that flexibilities were corroded by strategies such as regional agreements, TRIPS+ agreements and ACTA among others. Furthermore, the domestication of intellectual property laws by most African countries further corroded flexibilities since this was not necessary. This problem could be solved by turning flexibilities into mandatory exceptions and limitations in order to protect public policy objectives. MrKaushik responded to the concerns of making limitations and exceptions mandatory; this implied that the right is removed altogether i.e. not having the right or having flexibilities that limit rights to the extent that member countries exercise it within their national jurisdiction. MrRanjit from the Permanent Mission of India to the ϲʹ observed that the flexibilities are important because they allow developing countries some policy space to address key issues relating to development. However, the use of these flexibilities has been disheartening given the stigma attached the use of compulsory licensing. This is evidenced by the political outcry of the EU Trade Commissioner when Thailand used compulsory licensing in 2007; the watch list maintained under special 301 in the United States; the transit and patent provisions in ACTA; and the seizure of several shipments of generic drugs in the EU. All these are attempts to circumvent these flexibilities. Furthermore, the implementation of paragraph6, which was meant to address ϲʹ members with insufficient or no manufacturing capacities in the pharmaceutical industry, took three years to become operational and deliver HIV antiretroviral drugs to Rwanda. This paragraph was used once in seven years. It was intended to be an expeditious solution to the crisis in access to medicine for countries with insufficient or no manufacturing capacity, but experience shows that it has been neither expeditious nor a solution to public health needs. This is an opportunity for all to look at the obstacles to paragraph6. 3. Conclusions and way forward The ϲʹ TRIPS Agreement has affected access to essential medicines in SSA countries; this challenge was remedied by amendment of the Agreement (Paragraph6). However, the use of TRIPS flexibilities as a remedy has been hampered both by countries inadequate capacity to interpret and undertake research in order to take advantage of the flexibilities, and by covert actions of developed countries, who insist that the TRIPS Agreement be implemented without flexibilities when they invest in developing countries. These factors have contributed to the low utilization of these flexibilities. It is important to ascertain why most SSA countries have not utilized existing flexibilities to their own benefit.      FILENAME \p \* MERGEFORMAT DivImrd:#Imrd:HelenS:Public Forum:Publication 2010:2. 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