- Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG)
- Expert Working Group on R&D Coordination and Financing
- Strategy and Plan of Action on Public Health, Innovation and Intellectual Property
- The Intergovernmental Working Group (IGWG)
- The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH)
The 66th World Health Assembly (WHA) held a session from 20 to 27 May 2013 in Geneva and adopted the draft resolution (pdf 27 KB) submitted to it, which provides for the creation of a global health research and development observatory at the Secretariat of the World Health Organization, as well as the launch of demonstration projects. The goal of these activities is to stimulate research and development for health products for diseases that disproportionally affect poor countries.
Consensus was achieved, not least because in an additional WHA decision (WHA 66(12), pdf 87 KB), it was held that the selection and conception of the demonstration projects are to be defined by a group comprised of political representatives and health experts in a meeting to be held over two to three days before the end of 2013.
A meeting of the Member States of the World Health Organisation (WHO) drew up a draft resolution on 26 – 28 November 2012, which will be submitted via the Executive Board of the World Health Organisation in January 2013 for acceptance by the World Health Assembly in May 2013. The recommendations in this draft resolution do not support the creation of a binding international research and development instrument, contrary to the recommendations of the CEWG. Instead, it is recommended that the WHO Secretariat hold a more extensive observer role. In addition, a few pilot projects in the field of research and development should be launched which meet the health needs of poorer countries, in order to see how the coordination of research work (in particular, in the field of neglected tropical diseases) can be improved.
The interdepartmental working group on health, innovation and intellectual property (IdAG GIGE) will closely follow further developments in this area and will define Switzerland’s position in consultation with the relevant federal offices.
The 65th World Health Assembly welcomed the analysis of the report by the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) and agreed (pdf 162 KB) to discuss the report’s recommendations (including the negotiation of a binding and international agreement on research and development) following national and regional consultation within the framework of a formal meeting of the WHO Member States. Such a meeting will be held in November 2012 and will report to the 66th World Health Assembly in May 2013 via the 132nd Executive Board in January 2013. Thus, the core recommendation of the CEWG, namely the negotiation of a binding global research and development agreement (R&D Treaty), while not being directly accepted, has nevertheless set in motion a process which is leading to intensive and serious discussion of the idea. Even when the said recommendation is regarded as supplementing the existing intellectual property law system, questions concerning the boundaries and limitations of such a possible agreement will still require the competence and input of the Institute.
According to the global strategy and plan of action on public health, innovation and intellectual property (WHA 61.21, paragraph 4.7), the director general of WHO appointed a group of experts in November 2008 to attend to the specific needs of developing countries in the matter of coordination and financing of research and development with regard to illnesses of the types I, II and III. The expert working group presented the Executive Board with a brief account in January 2010 and submitted their full report at the 63rd WHA in May 2010.
The report, but also the work of the group of experts in general, led, even at the 63rd World Health Assembly itself, to a controversial debate. Whilst mainly the representatives of the South American countries were hostile to the report and demanded new, resource-intensive intergovernmental action, the representatives of most of the industrial nations considered that the report formed a valuable basis on which to build.
Finally, the World Health Assembly decided to appoint a new consultative expert working group which should primarily continue and intensify the work begun by the present group of experts, but, if necessary, also examine other/new or rejected proposals. The consultative group of experts will be composed with strong involvement of the WHO member states and should present its final report to the World Health Assembly in May 2012.
This agreement was reached after days of discussion in a drafting group conducted by Switzerland (FOPH – Federal Office of Public Health).
The 62nd World Health Assembly approved in May 2009 the plan of action on public health, innovation and intellectual property in its entirety and unanimously. The WHO member states agreed to the three open points of the 61st World Health Assembly of May 2008 (references to various stakeholders, cost estimates and success indicators) and it was decided to insert the pending elements in the plan of action.
The WHO Secretariat had submitted a draft resolution for the acceptance and integration of the still pending elements in the plan of action. This draft resolution accepted the compromise proposed by the Friends of the Chair, and Switzerland successfully spoke for acceptance of the compromise proposal in order to avoid further negotiations on the matter, as this could possibly have negative consequences for Swiss interests.
It should be mentioned here that the WHO, as stakeholder in the plan of action on element
2.3 (c), - which concerned the discussion on a possible Health and Biometrical R&D Treaty (the contents of which are not at all clear) - was now cancelled.
Documents on the WHO website.
After two years of intensive negotiations the 61st World Health Assembly adopted by consensus on May 24, 2008 the strategy and an action plan and an accompanying resolution to address the relationship of public health, innovation and intellectual property rights.
The strategy and action plan implement the final report of the Commission on Intellectual Property Rights, Innovation and Public Health. They constitute an encompassing and ambitious program regarding the strengthening of the research and development of new drugs and vaccines concerning the diseases that predominantly affect these countries, and the promotion of access to these medicines.
After lengthy discussions, Member States reached a compromise on a wording on provisions in bilateral free trade agreements going beyond the TRIPS Agreement (5.2 b) and on competition policy (6.3 f - based on Article 8 paragraph 2 TRIPS Agreement), for lack of consensus they deleted the draft provisions on the role of data exclusivity provisions, patentability criteria and the fight against counterfeits.
Throughout the negotiations Switzerland actively supported a comprehensive strategy and action plan while at the same time guarding the existing patent protection system which encourages innovation in pharmaceuticals.
Relevant WHO documents can be found on the WHO-webpage.
Last week, Member States of the World Health Organization (WHO) gathered once again in Geneva to finalize a strategy and an action plan to address the relationship of public health, innovation and intellectual property rights. The main aim of the strategy and the action plan is to better address the needs of developing countries regarding the research and development of new drugs and vaccines concerning the diseases that predominantly affect these countries, and to promote access to these medicines.
The WHO intergovernmental working group on Public Health, Innovation and Intellectual Property (IGWG) met from 28 April to 3 May 2008 to resume its second session that began in November 2007. The delegations were able to reach a consensus on most of the open issues, including the question how to address the funding of the research needed. In Element 7 “Promoting sustainable financing mechanism” Member States agreed to install a “results-oriented and time-limited expert working group to examine current financing and coordination of research and developments”.
Due to a lack of time at the end of the week and diversions of view among Member States on some issues, especially relating to intellectual property rights, the consensus document (pdf) still contains a limited number of brackets with text that has not been agreed yet. This includes provisions on the competition policy, the role of data exclusivity provisions, the fight against counterfeits, as well as concerning provisions in bilateral free trade agreements going beyond the TRIPS Agreement.
Nevertheless, the working group adopted the document with the remaining bracketed text and sent it to the World Health Assembly for approval. The 61st WHA will convene from May 19 – 24 2008. Member States will have to find an agreement on the remaining open issues in this week.
Switzerland‘s position in the negotiations is one of actively supporting solution-based measures for expanding the development of medicines and vaccinations for the special needs of the developing countries and improving access to medicines while at the same time guarding the existing patent protection system which encourages innovation in pharmaceuticals. All relevant WHO documents.
The World Health Organization (WHO) intergovernmental working group on Public Health, Innovation and Intellectual Property (IGWG) met for the second time in Geneva from 5 – 11 November 2007. The working group aims to create a global strategy and plan of action on public health, innovation and intellectual property based on a first draft for a global strategy and plan of action by the WHO Secretariat.
Originally it was intended to finalize the strategy and plan of action during the second round of negotiations, however, as the week progressed, Member States realized that in spite of the delegates’ intense work, a further round of negotiations will be necessary in order to appropriately handle such a complex issue. Agreement was more or less met on all of the general parts of the strategy as well as on a large number of actions under the individual strategic items. The Swiss delegation was led by the Federal Office of Public Health and included a representative from the Federal Institute of Intellectual Property.
Switzerland‘s position in the negotiations is one of actively supporting solution-based measures for expanding the development of medicines and vaccinations for the special needs of the developing countries and improving access to medicines while at the same time guarding the existing patent protection system which encourages innovation in pharmaceuticals.
The working group anticipates meeting again in Geneva at the end of April. In the approaching round of negotiations, the Member States must approve the actual plan of action and the still mostly untreated Element 5 regarding intellectual property rights in order to finalize the entire plan of action and present it to the 61st World Health Assembly (WHA) for approval in May 2008. All relevant WHO documents.
The intergovernmental working group (IGWG), which has the task of drafting a global strategy and plan of action for implementing the CIPIH report, met for the first time in Geneva from December 4 – 8, 2006. Over 100 WHO member states discussed the foundation paper prepared by the WHO secretariat and presented it in revised form (pdf 84 KB) at the end of the week. The paper contains elements for the plan of action in Annex 1, and elements for a global strategy in Annex 2.
The WHO secretariat will prepare and publish a first draft for a strategy and plan of action based on this paper by June 2007. The WHO Member States then will debate the Secretariat’s draft during the second and, anticipated, last meeting of the IGWG in Fall 2007 and present the finalized strategy and plan of action to the 61th World Health Assembly (WHA) for approval in May 2008.
Switzerland participated in the negotiations through a delegation under the leadership of the Federal Office of Public Health (FOPH) including representatives from the Geneva mission, the Swiss Agency for Development and Cooperation (SDC), and the Institute.
Switzerland highly values the work of the group and hopes that the plan of action actually contributes to the improvement of the situation in developing countries in the end. The fact that WHO even agrees to take on the lack of research and development for medicines and vaccines for so-called neglected diseases and the task of improving access to medicines in developing countries in such a comprehensive way already needs to be seen as a success. Ten years ago this wouldn’t have even been imaginable.
From the point of view of intellectual property, the main concern is closing the gap in the area of research and development for medicines and vaccines for neglected diseases through complementary incentives to the existing patent system. The patent system can fulfill its key role as an incentive for investment in research and development for innovative medicines the best under working market conditions—supply and demand (return on investment). In the area of neglected diseases, however, there is often no ‘market’ because those at the demand end are missing the financial means to acquire. To nevertheless secure the development and availability of such medicines in developing countries, additional effort on the part of the international community and the countries involved is needed.
Switzerland presented the organization of its internal process for evaluating the recommendations of the CIPIH report in its introductory statement in Geneva and specified detailed measures already taken by Switzerland to implement several recommendations (in French, pdf 25 KB).
In addition, Switzerland was particularly active in Geneva so that the IGWG can propose its “potential areas for early implementation action” (so-called “low-hanging fruits" or “early harvest”) as per its mandate from the 60th WHA meeting in May 2007. In the framework of a meeting initiated by Switzerland, potential measures for early implementation that might be easily agreed upon were identified. The negotiations will be continued at a meeting of the WHO Executive Board in January 2007.
The WHO World Health Assembly, on May 22-27, 2006, agreed on a resolution on "Public health, innovation, essential health research and intellectual property rights: Towards a global strategy and plan of action" (pdf 27 KB) to implement the recommendations of the WHO/CIPIH report.
The resolution provides for the immediate establishment of an intergovernmental working group (IGWG) to work out a global strategy and action plan based on the recommendations of the CIPIH Commission. Such a strategy and plan of action shall aim at, inter alia, securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.
The CIPIH Commission presented its final report (pdf 2730 KB) to the WHO at the beginning of April 2006. The report contains 60 recommendations aimed at, among others, the governments, international organizations, pharmaceutical industry and universities involved.
Switzerland welcomes the main results and conclusions of the report. There is a need for an improved and sustainable basis for R&D, in terms of the special needs of developing countries, in order to supplement the existing intellectual property incentive system and to close the known gaps in the system regarding so called neglected diseases. In general, the report is a valuable contribution towards efforts to strengthen R&D for medicines against such diseases.
But it is also valuable to reposition these discussions within the larger context of sanitation issues and, above all, human development, the fight against poverty, in order to relativize--despite all--the role of medicines in solving the problems. Medicines are one factor in public health, necessary but not sufficient on their own. To prioritize public health and to give it the financial support needed at the national level and at the level of international cooperation is crucial.
The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) was established by the World Health Assembly in 2003. It consisted of ten members and was chaired by Ruth Dreifuss, the former Federal Councillor and President of the Swiss Confederation.
The Commission’s task was to provide an analysis of the relationship between intellectual property rights, innovation and public health. A major focus of the Commission’s work was the question of how to foster research and development of new medicines and vaccines for so-called neglected diseases, such as malaria or tuberculosis, which disproportionately affect developing countries. The patent system fosters research and development by granting patent holders the exclusive right to commercially market their invention/patented product for a limited time, during which the right holder can recoup his investment in research and development, allowing him to make a profit which can be reinvested into further innovation. By thus creating incentives for research and development, which is particularly costly in the field of pharmaceuticals, intellectual property rights play an important role in innovation concerning public health.
In the case of neglected diseases, however, the countries and people concerned have very limited financial resources, and thus, the market often is insufficient to function as an incentive for the pharmaceutical industry to develop such medicines. Due to this lack of market, the patent system is not enough to stimulate the mobilization of enough resources to develop new treatments for these diseases. The Commission sought to identify new incentive mechanisms to overcome this lack (for more information, see the CIPIH Framework Paper and the comments (pdf 109 KB) made by the Swiss Federal Institute of Intellectual Property - IPI, hereafter: ‘the Institute’).
The chair of the Commission, Ruth Dreifuss, and several members of the Commission’s secretariat met on April 19, 2005, with members of the Institute, the Swiss Federal Ministry of Health (BAG), the State Secretariat for Economic Affairs (SECO), and the Direction for Development and Cooperation (DEZA). The main focus of the meeting was on the current revision of the Swiss Patent Law (report on the meeting).
The Commission held a two-day workshop on background studies on May 30-31, 2005. This was followed by a one-day consultation (Open Forum) on 1 June 2005. The purpose of the Open Forum was to expose stakeholders to the issues identified by the Commission. The Institute presented various elements of the current revision of the Swiss Patent Law which are relevant to the work and report of CIPIH (see presentation, pdf 1305 KB).
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