TWN Info Service on Intellectual Property Issues (May10/09)
29 May 2010
Third World Network
 
WHA agrees to roadmap to take forward work on R&D, financing
Published in SUNS #6931 dated 27 May 2010
 
London, 26 May (Sangeeta Shashikant) -- The World Health Assembly (WHA) on 21 May agreed to a roadmap to address the shortcomings in the report of the Expert Working Group (EWG) on R&D: Coordination and Financing.
 
The report of the Expert Working Group (A63/6 Add. 1) had been criticized by many Member States of the World Health Organization (WHO) and civil society groups over the issue of process as well as over the substance of the report.
 
The roadmap was contained in a resolution adopted under the agenda item of "Public health, innovation and intellectual property: global strategy and plan of action" and requires the WHO Director-General to make available by the end of June 2010 information pertaining to the EWG report, such as all proposals considered by the EWG including their source, the criteria used to assess the proposals, the methodology used by the EWG, the list of the stakeholders that were interviewed and those who contributed information, and sources of statistics used.
 
More significantly, the roadmap establishes a Consultative Expert Working Group (CEWG) to address gaps in the EWG report as well as to take forward the work of the EWG.
 
The roadmap also identifies an extensive process for the selection of experts that will form the CEWG, placing particular emphasis on the transparent management of potential conflicts of interest as well as full transparency in the implementation of the CEWG's work-plan, in a bid to establish a more credible process and to avoid concerns of conflicts of interest and lack of transparency over the method of work employed that dogged the last EWG.
 
[The EWG was set up following WHA Resolution 61.21, which adopted the Global Strategy and Plan of Action on Public Health, Innovation and IP and requested the Director-General to "establish urgently a results-oriented and time-limited expert working group to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type 1 diseases".]
 
Many of the concerns voiced over the EWG report are captured in the Chair's Summary (A63/6 Add. 2) prepared following day-long consultations held on 13 May among WHO Member States, the Secretariat and some members of the EWG on the report of the EWG on R&D: Coordination and Financing.
 
These concerns include: (i) inclusion of recommendations in the executive summary but not in the report, that led to some confusion; (ii) the EWG had interpreted its mandate differently from what had been anticipated by some Member States, which resulted in Member States' expectations remaining unfulfilled; (iii) rejection of proposals submitted by some countries without due consideration or explanation; (iv) insufficient attention paid to the need to de-link the costs of R&D from the price of health products; (v) that the criteria used to evaluate proposals did not take proper account of the relevant aspects of intellectual property rights; (vi) that proposals for innovative financing mechanisms were common to those made for financing health and development in general; (vii) that little attention was paid to research into the broader health systems barriers that limit access to care.
 
Many of these concerns re-emerged during the WHA under the agenda item of "Public health, innovation and intellectual property: global strategy and plan of action", although there was some acknowledgment of the limited time-frame for the report to be completed, and the amount of work that went into it.
 
Generally, however, developing countries questioned the credibility and legitimacy of the EWG, pointing out the many flaws in the EWG report.
 
Ecuador, speaking on behalf of the Union of South American Nations (UNASUR), charged that the EWG had failed to fulfill the mandate that it had been given. Ecuador proposed starting an intergovernmental process.
 
[The UNASUR countries had submitted a draft resolution (A/63/A/Conf. Paper No. 3) with the aim of establishing an intergovernmental group to "make progress towards the development of innovative and sustainable financial mechanism for research and development, in accordance with element 7 of the global strategy on public health, innovation and intellectual property".]
 
Kenya, on behalf of the African region, expressed disappointment with the report. Although the report had promising elements, it fell short of the expectation for a deeper analysis of issues relevant to the African region, in particular, on alternative solutions to address the negative impacts of IP in poor countries, especially in the African region.
 
Kenya added that financing mechanisms that are more relevant to developing countries were needed. It also raised the issue of the leakage of the report to the pharmaceutical industry and conflicts of interest among the EWG members. It called for a new EWG and for transparency in the expert selection process.
 
Brazil said that while it had great expectations, the report turned out to have "many flaws" and lacked deep critical analysis, particularly on the issue of intellectual property.
 
Argentina labelled the EWG process as "not very credible", additionally referring to the lack of transparency in the selection of experts and the failure to adequately address IP issues, in particular the de-linking of the research cost and medicine prices.
 
Thailand said that the EWG that created the report "has no longer legitimacy", adding that a new working group should be "free of direct or indirect industry influence".
 
India said that the EWG report failed to capture the variety of problems that are linked to IP which emanate from curbing flexibilities under the WTO TRIPS Agreement and mandating TRIPS-plus measures. It added that developed countries are not only making their domestic IP laws TRIPS-plus but are also forcing the developing countries to accept such measures through FTAs (free trade agreements) or the financial aid route.
 
It also said that an issue of grave concern is the draft Anti-Counterfeit Trade Agreement (ACTA) among developed countries and some developing countries that has provisions that would allow for the seizure of generic drugs in transit and thus make the trade in cheap but quality, safe and efficacious generic drugs illegal and deny the patients access to such drugs. India said these issues were not sufficiently captured in the EWG report, which only focused on the role of IP as an incentive.
 
India also pointed out the many flaws in the EWG report. It said that the EWG report leaves what should have been the most important part of the work of the EWG to future work when it states "in-depth analysis is needed to determine which of the mechanisms or combination of mechanisms described above is most suitable for providing reliable, long-term, centralized funding and to link the funding to the efficiency of the partnerships".
 
India said that the EWG, having assessed the proposals, should have proposed the so-called combination of mechanisms that would deliver for health. However, "it failed to do so", India added, supporting the call for an intergovernmental process on the matter.
 
The developed countries were satisfied with the EWG report and thus saw no need for intergovernmental consultations on the matter.
 
Spain, on behalf of the EU, welcomed the EWG report and suggested that WHO Member States make use of the report as it stands. It added that it did not favour intergovernmental consultations.
 
The US, in support of the EWG report, said that the EWG's mandate was quite broad and thus open to interpretation by both the EWG and Member States. It said that it saw the report as providing a "menu of proposals" for countries to choose from, although not all of them are appealing to everyone, not even to the US.
 
The US disapproved of intergovernmental discussions, calling it "too expensive" for the organization.
 
Thus, generally, the roadmap that was established by the agreed resolution is a remedial measure to rectify the many failures of the EWG report to meet the expectations of developing countries on the matter.
 
The agreed resolution requests the Director-General:
 
"(1) to make available electronically by the end of June 2010: (a) all the proposals considered by the EWG including their source; (b) the criteria used to assess the proposals; ( c) the methodology used by the EWG; (d) the list of the stakeholders that were interviewed and those who contributed information; (e) sources of statistics used.
 
(2) to establish a Consultative Expert Working Group which shall:
 
(a) take forward the work of the EWG;
 
(b) deepen the analysis of the proposals in the EWG report, and in particular,
 
1. examine the practical details of the four innovative sources of financing proposed by the EWG report (in Chapter 5.3 of the report)
 
2. review the five promising proposals identified by the EWG report (in Chapter 5.6 of the report)
 
3. further explore the six proposals that did not meet the criteria applied by the EWG (in Annex 2 of the report)
 
( c) consider additional submissions and proposals from Member States, any regional and sub-regional consultations, and from other stakeholders;
 
(d) in carrying out b. and c., examine the appropriateness of different research and development financing approaches and the feasibility of implementation of these approaches in each of the six WHO regions, with sub-regional analysis, as appropriate.
 
[During the adoption of the resolution, Thailand proposed adding a line to the working group's terms of reference, stating "observe the scientific integrity and be free from conflicts of interest in its work (or undertaking)".]
 
3. To provide, upon request, within available resources dedicated to the financing of the Consultative Expert Working Group, technical and financial support for regional consultations, including meetings, in order to seek regional views to help inform the work of the Consultative Expert Working Group."
 
The agreed resolution also sets out the process through which the CEWG will be established.
 
The agreed resolution requests the Director-General:
 
" (a) to invite Member States to nominate experts who, following consultations within regional Committees to achieve gender balance and diversity of technical competence and expertise, shall be submitted to the Director General through the respective regional directors;
 
(b) to establish a roster of experts comprising all the nominations submitted by the regional directors;
 
( c) to propose to the Executive Board for its approval a composition of the Group drawing on the roster of experts taking into account regional representation according to the composition of the Executive Board, gender balance and diversity of expertise;
 
(d) upon approval by the Executive Board, to establish the Group and facilitate its work including consultation with the Member States and other relevant stakeholders, where appropriate."
 
The agreed roadmap also requests the Director-General:
 
(5) to put particular emphasis on the transparent management of potential conflicts of interests by ensuring full compliance with the mechanisms established by the Director General for that purpose;
 
(6) to ensure full transparency for Member States, the Consultative Expert Working Group will provide regular updates on the implementation of its work-plan. All documentation used by this Consultative Expert Working Group will be made available at the conclusion of the process;
 
(7) to submit the work-plan and inception report of the Consultative Expert Working Group to the 129th Executive Board, a progress report to the 130th Executive Board with a view to submitting the final report to the sixty-fifth World Health Assembly."
 
Further, the agreed resolution also urges Member States: "to support the work of the Consultative Expert Working Group by: a. providing, where appropriate, information, submissions or additional proposals; b. organizing and/or supporting, where appropriate, regional and sub-regional consultations; c. proposing names of experts for the roster."
 
According to IP Watch, the adopted resolution was hailed by David Chiriboga, Ecuador's Minister of Public Health, as a "good indication for countries of the developing world". (See IP Watch of 21 May 2010, "World Health Assembly Creates New Initiative For R&D Financing".)
 
Commenting on the agreed resolution, Sophie Bloemen of Health Action International called the WHA resolution "historical" in that it "scrupulously addresses the problems of the former EWG and its report".
 
It "represents a real opportunity and an imperative to move forward with the process of exploring and implementing innovative proposals for R&D that could structurally address some of the inefficiencies and flaws of the current R&D system, which does not meet the health needs of many in the developing world,'' she said.
 
Also commenting on the decision, Thiru Balasubramaniam of Knowledge Ecology International called the WHA resolution a "resounding victory for developing countries and those promoting transformative reforms in the way that research and development and access to medicine is managed."
 
He added that the resolution "puts the reform process back on track" with "a brand new opportunity and a fresh and strong mandate to de-link R&D cost from product prices. This is one of the most important steps yet in remaking the R&D system so it works for everyone."
 
Michelle Childs, Director of Policy Advocacy at MSF's Access Campaign, said that MSF was "very pleased" with the WHA resolution, adding that "Member States have recognized the limitations of the EWG report - in terms of process transparency and substance - and have put in place measures to address these".
 
"Crucially, they have addressed the fact that the EWG did not look at proposals to stimulate research and development against the principle of de-linking the cost of research from the price of the product," Childs added.
 
"The resolution also says that in the long-term, proposals that allow for sustainable change should be looked at. One of these is the R&D treaty - in 2009, the World Health Assembly said discussions on an R&D treaty would not be continued. Today, the WHA has mandated Member States to do just this," Childs further said. +