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TWN Info Service
on Intellectual Property Issues (Oct08/07) Best Regards Health:
Experts call on WHO to implement Health/IP Global Strategy
They were speaking at a seminar on the Implementation of WHO's Global Strategy & Plan of Action (GSPA) on Public Health, Innovation & Intellectual Property, organized by IQ Sensato, a Geneva-based NGO, at the end of September. Participants spoke in their personal capacity. Rodrigo Estrela, a diplomat with the Permanent Mission of Brazil, said that a "strong WHO" was a pre-condition for a new international environment created by the GSPA for those countries wishing to make use of the flexibilities contained in the TRIPS agreement and other agreements related to IP rights. If WHO is a "mere observer of processes", this will "undermine national and international conditions to undertake public health policies". James Love from Knowledge Ecology International called on the WHO to show leadership and imagination as the present systems of access and innovation are not sustainable. Nicoletta Dentico, Advisor to IQ Sensato, stressed the need to put in substance to the GSPA, adding that an important unresolved matter is the sustainable financing for R&D of developing-country diseases. The Intergovernmental Working Group that negotiated the GSPA did not resolve this issue, thus the World Health Assembly mandated the Director-General of WHO to set up an expert working group to examine current and future financing. The immediate terrain for implementation of the elements of GSPA is the discussion on virus and benefit sharing. Charles Clift of the UK Department for International Development (DFID) said that international organisations have an important facilitating role, in particular where collective action is required and that for implementation of GSPA, there needs to be "buy in from many different parts of WHO". For example, he said that the Draft WHO Medicines Strategy 2008-2013 does not mention GSPA at all but has a key role in implementation of Element 6 of GSPA, which is about improving delivery and access. He also said that there was a need to define the role of different parts of WHO in implementing the strategy and to ensure adequate staffing. He added that there was an important role for WHO in the selection of the Expert Working Group (EWG) to provide necessary weight and in guiding EWG to a conclusion that commands wide support and is capable of implementation. The critical issue is finding new sustainable financing mechanisms, he said, which will be the responsibility of the expert working group and "one of the most important outcomes" of the process. The GSPA was adopted at this year's World Health Assembly in May. It has been the subject of heated debate in the WHO in the last two years. Discussions on Element 5 on the application and management of IP and WHO's role on IP and health were among the most contentious issues. Resolution WHA 61.21, which adopted the GSPA, urged the WHO Director-General to finalize the outstanding components of the Plan of Action (POA), to prepare a quick-start programme with adequate budget provision and begin immediately to implement the elements of the GSPA that fall under the responsibility of WHO; and to establish an expert working group to examine finance and coordination of research and development, as well as proposals for new and innovative sources of funding. To date, there has been little information on how WHO intends to proceed with implementation, in particular how it intends to proceed with completing the POA, about the quick-start programme as well as the process by which the expert working group is to be selected. Malebona Precious Matsoso, who directs the WHO Department of Technical Cooperation for Essential Medicines, speaking at another seminar, said that the "silence of the WHO doesn't mean we haven't been doing work". Matsoso added that WHO had "consciously identified those partners we think need to work with us" and that the organisation had several meetings with different stakeholders. Matsoso also said the WHO is working on a "matrix" detailing activities mentioned in the global strategy which already exist, those which need scaling up, and those which constitute new work, so that the organisation can decide how to budget the programmes. Also, the WHO DG will inform Members on what will be done about paragraphs in the POA which are still in brackets. Matsoso compared the strategy to the Development Agenda at the World Intellectual Property Organization, saying that it would inform many different programmes at WHO and that it provides a guidance to WHO. Estrela said that Members were still in a negotiation process as the Plan of Action will be finalized in the next Executive Board in January 2009, adding that this will "lessen some persistent doubts concerning implementation and the role of WHO vis-a-vis other Organizations". He stressed that the GSPA which has been agreed, even if incomplete, does not represent a limitation of WHO's role. He said that the GS created a more positive environment for those countries wishing to make use of the flexibilities contained in the TRIPS agreement and other agreements related to IP rights. There was need for a "more balanced international environment" and the GS is an important step in order to change the environment and reveal to many developing countries that there is legal remedy against growing prices of medicines, poor quality of patents, and the TRIPS-plus-plus Agenda (specially when related to health sectors and health products and the negative impact such measures may have in access to health products), he said. He added that one pre-condition for such a new environment/new culture is a "strong WHO", i. e. an organisation which is not a mere observer of processes that, in the end, tends to undermine national and international conditions to undertake public health policies. On the implementation of paragraph 15 of the GS, he said that the objective was not to diminish the mandate of other Organizations, but for WHO to take the lead on "Health-Related Aspects of IP or Trade Issues", so that there is a balance between "trade-related" and "health-related" agendas. Paragraph 15 of the GSPA which is on "Principles" states that the WHO shall play a strategic and central role in the relationship between public health and innovation and intellectual property, bearing in mind other relevant intergovernmental organizations. He added that the GS goes beyond the Doha Declaration in that it spells out flexibilities such as bolar and research exemptions and covers controversial areas such as anti-competitive practices not only for access purposes but also for objectives related to innovation and research. The GS also promotes innovation by seeking alternative policy approaches and new incentives for R&D specially in those areas where the current IP system is not functioning very well, he added. Estrela also stressed on financing the Public Health and Innovation Programme in WHO, as a condition to implementing the GS, adding that Brazil has contributed about $500,000. James Love referred to the mention of exploratory discussions on an essential health and biomedical R&D treaty in the GS. He said that there was a need for independent assessment of drugs, and if clinical trials are done, it is information the entire world benefits from. The problem is that of having "collective action". The "next phase" has got to be "imaginative". With regard to access, he said that the present incentive system was expensive and that it was a market exclusivity system, which made access to medicines difficult since the prices were high. He suggested that this system was not sustainable. Either there is a "de-link" between the cost of R&D and the price of medicines or everyone "pretends" that the system is sustainable. He questioned whether there is leadership in WHO to look at these issues, and asked whether the WHO would appoint people that are insightful to the expert taskforce. Nicoletta Dentico said it was important for WHO to show "leadership" and that WHO should support member states not just on TRIPS flexibilities but also ensuring "needs innovation are secure". Peter Beyer from the Swiss Federal Institute of IP said that countries and stakeholders need to see what actions they have to implement and what they can do to implement, adding that governments have to take responsibility. He said WIPO and WTO should be in the lead with regards to the application and management of IP. He said that actions in Element 5 of the GS, on the application and management of IP, should feed into the work plan of WIPO's Committee on Development and IP. Clift from DFID, who headed the Commission on Intellectual Property Rights, Innovation and Public Health, whose report led to the global strategy, said he had many concerns about the global strategy. The document contains "too many commitments, that are too weak and too vague," and the progress indicators are not measurable. There is a "missing middle column" in the plan of action: there are actions to take on one side, and stakeholders on the other, but no detail on what needs to be done to meet objectives. As to what is required, he stressed on prioritising health financing at the national level, strengthening health system; developing enhanced and more sustainable funding mechanisms for R&D; creating systems for prioritisation of R&D, coordination and performance monitoring; developing further innovative financing mechanisms to promote development of, and access to, new health technologies; investigating new intellectual property mechanisms to promote innovation and access; monitoring the impact of intellectual property rights on innovation and access; improving the clinical trials and regulatory infrastructure to facilitate product introduction and monitoring progress against the targets in the plan of action. Chikosa Banda from
the He added that often
the donors determine the research priorities. In A Third World Network
official noted that the debate on virus and benefit sharing taking place
in WHO is relevant to the issues of access (i. e., to affordable vaccines
and antivirals) and innovation (since most of the influenza virus related
research and production of vaccines takes place in developed countries).
Since the WHO is looking to develop a more equitable framework for sharing
of viruses and benefits resulting from the use of the viruses, steps
should be taken to implement some elements of the GSPA.
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