WHO: Concerns over draft text on R&D financing and coordination

 Source: SUNS
Geneva, 21 May (K. M. Gopakumar) — A draft resolution on health research and development (R&D) financing and coordination for the 66th World Health Assembly (WHA) has raised critical concerns.
The draft resolution is a follow-up to the Report of the World Health Organisation’s Consultative Expert Working Group (CEWG) on the implementation of the CEWG recommendations. Health ministers are scheduled to consider this at the 66th WHA, which is taking place from 20-28 May in Geneva.
The CEWG Report made a set of important recommendations with regard to coordination, monitoring and financing of R&D to meet the unmet R&D health needs of developing countries.
One of the key recommendations of the Report is the establishment of a legally binding instrument for the coordination and sustainable financing of R&D to address those unmet health R&D needs. The Report also recommended a set of principles and objectives of the instrument, which includes open innovation and de-linking of the cost of R&D from the price of products (See SUNS #7350 dated 16 April 2012).
The CEWG was established in 2010 to follow up on the Report of the Expert Working Group on R&D Financing and Coordination, to implement WHO’s Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (See SUNS #6482 dated 27 May 2008).
In particular, it was appointed to implement Element 7.1(a) of the Global Plan: ” … establish a results-oriented and time-limited expert working group under the auspices of WHO and linking up with other relevant groups to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing 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 I diseases; …”
[Initially, the WHO Director-General established the Expert Working Group on R&D Financing and Coordination under resolution WHA 62.16 to implement Element 7.1(a). The Group came under severe criticism from the WHO Member States and civil society organisations for its poor quality analyses and recommendations. (See SUNS #6847 dated 22 January 2010). As a way forward, the CEWG was established through resolution WHA 63.28.]
The 65th WHA in 2012 adopted resolution WHA 65.22 to carry out the follow-up on the CEWG Report. Among other things, it mandated an open-ended meeting, which was held on 26-28 November 2012. The 66th WHA will consider the outcome document of the open-ended meeting, which includes a report and the draft resolution as an appendix.
Both the report and the draft resolution raise serious concerns on the implementation of the CEWG recommendations to address the unmet health R&D needs of developing countries. Moreover, the legitimacy of the outcome document itself is in question.
Only 81 out of 194 WHO Member States attended the open-ended meeting, which is less than half of the WHO membership. Further, according to a developing country negotiator, at the time of the finalisation of the report and the draft resolution, there were only around 20 Member States inside the negotiating room. The same delegate also disclosed to this author that the delegate of Argentina, who was concerned about the many provisions in the draft resolution, could not effectively convey its views during the last three hours of the negotiation in the absence of interpretation.
One of the most contentious paragraphs in the open-ended meeting report is Paragraph 6, which states: “the open ended meeting of Member States strongly recommends that the Executive Board considers this report and its attached draft resolution with a view to recommending the adoption of the resolution by the World Health Assembly without reopening it”.
(One delegate wondered how one-tenth of WHO Member States could make such strong recommendations to the other 173-odd Member States to surrender their constitutional right.)
[The constitution of WHO and the Rules of Procedure of the WHA allow Member States to bring amendments to the draft resolutions at the WHA.]
Expressing concern over this issue, a joint civil society letter signed by MSF (Medecins Sans Frontieres), Oxfam, Knowledge Ecology International, Health Action International, Peoples’ Health Movement and the Third World Network requested WHO Member States, during the 132nd Executive Board meeting in January 2013, not to approve the document.
On the recommendation of the open-ended meeting against the reopening of the resolution, the letter queried that, “A draft resolution negotiated by a small number of Member States under less than ideal conditions should not include such a far-reaching recommendation to the Executive Board”.
Many Member States challenged this recommendation during the January Executive Board meeting, and the report and the draft resolution were not approved. (All draft resolutions for the WHA sessions have to be first approved by the Executive Board.)
One of the important shortcomings of the draft resolution is that it follows a piecemeal approach to the CEWG Report. The CEWG made recommendations on the following areas, viz. approaches to R&D, funding mechanisms, pooling resources, strengthening of R&D capacity and technology transfer and coordination. In order to implement these, it recommended a binding global instrument for R&D and innovation for health.
Thus, a binding instrument would be the overarching instrument to contain these three pillars. However, the draft resolution only adopts one of its recommendations, i. e. the establishment of a global health observatory. The CEWG also recommended the creation of an advisory mechanism for the coordination, but the draft resolution is silent on this.
Operating Paragraph (OP) 4.3 of the draft resolution states: “to establish a global health R&D observatory within WHO’s Secretariat in order to monitor and analyse relevant information on health R&D, building on national and regional observatories (or equivalent functions) and existing data collection mechanisms with a view to contributing to the identification of gaps and opportunities for health R&D and defining priorities in consultation with Member States, as well as, in collaboration with other relevant stakeholders, as appropriate, in order to support coordinated actions; …”
Thus, the objective of the observatory is to monitor and analyse relevant information on health R&D with a view to contributing to the identification of gaps and opportunities for health R&D and defining priorities. This is only one of the pillars of the CEWG recommendations. Monitoring, identification of gaps and prioritisation are important; however, they would not alone resolve the issue unless there is a mechanism to ensure sustainable finance and a new R&D mechanism to ensure both access and innovation based on an “open knowledge innovation” model as recommended by the CEWG.
According to OP 4.3, the Secretariat would identify gaps and opportunities on health R&D and define priorities in consultation with Member States and also “in collaboration with other relevant stakeholders, as appropriate”.
The term “other relevant stakeholders” normally implies collaboration with the pharmaceutical industry, which has a totally different perspective and approach to the unmet health R&D needs of developing countries. Further, the collaboration with any relevant stakeholders including the pharmaceutical industry should be free from conflict of interest. The draft resolution is silent about the issue of management of conflict of interest.
Another important concern is with regard to the process of finding solutions to the implementation of the outstanding recommendations of the CEWG. OP 4.7 of the draft resolution requests the WHO D-G “to convene another open-ended meeting of Member States prior to the Sixty-ninth World Health Assembly in May 2016, in order to assess progress and continue discussions on the remaining issues in relation to monitoring, coordination and financing for health R&D, taking into account all relevant analyses and reports, including the analysis of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination”.
Hence, the next concrete opportunity to discuss the outstanding recommendations of the CEWG is the open-ended meeting mentioned in OP 4.7 and the outcome of the open-ended meeting would be communicated to the 69th WHA in 2016. Thus, the open-ended meeting can be held between the 68th WHA and 69th WHA, i. e. between 2015 and 2016. This means that the process for finding solutions to outstanding recommendations has been postponed by more than three years if the open-ended meeting were to be held in 2016.
Moreover, there is an attempt to marginalise the importance of the CEWG recommendations. OP 7 states that the open-ended meeting, while discussing the remaining issues in relation to monitoring, coordination and financing for health R&D, would take into account all relevant analyses and reports, including the analyses of the CEWG Report. Thus, there is an attempt to move away from the recommendations of the CEWG Report.
The operational paragraphs of the draft resolution also lack clarity in terms of its implementation. For instance, OP 2(7) states: “to continue consultation, at national as well as at regional and global levels, including through the governing bodies of WHO, on specific aspects related to coordination, priority setting and financing of health R&D; …”
However, there is no clarity on how this would be implemented in practice. It is not clear whether there will be a standing agenda item for the discussion of specific aspects related to coordination, priority setting and financing of health R&D or whether it will be up to each Member State to propose this issue as an agenda item for each Governing Body meeting.
Further, the implementation of OP 2.7 would be in disarray in the absence of a corresponding mandate to the WHO Secretariat to facilitate the implementation of OP 2.7 in an effective manner. Similarly, OP 4(4) requests the WHO D-G “to facilitate through regional consultations and broad engagement of relevant stakeholders the implementation of a few health R&D demonstration projects to address identified gaps that disproportionately affect developing countries, particularly the poor, and for which immediate action can be taken”.
This is a proposal pushed by the European Union (EU). However, this operational paragraph lacks clarity with regard to the implementation of demonstration projects.
The CEWG Report recommended certain guiding principles for R&D. It recommends an open knowledge innovation approach to R&D . It further defines this approach and states: “We characterise these as ‘open knowledge innovation’, and define this as research and innovation that generate the knowledge which is free to use without legal or contractual restrictions”.
Towards this end, it recommends three R&D models, viz. open approaches to R&D and innovation, milestone prizes, equitable licenses and patent pools. Apart from the cost effectiveness of R&D, the CEWG finds these mechanisms can “also help to secure delinkage, inter alia, by encouraging competitive pricing of end-products”.
OP 4(4) is silent on whether the demonstration projects will be guided by this new approach to R&D and innovation. The key question is whether the implementation of demonstration of R&D projects would be guided by the business-as-usual mainstream R&D paradigm or the “open knowledge innovation” approach suggested by the CEWG. Further, the use of the words “particularly poor” poses the danger of narrowing down the scope of diseases that falls within the mandate of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.
The aim of the Global Strategy and Action Plan clearly states: “The global strategy on public health, innovation and intellectual property aims to promote new thinking on innovation and access to medicines, as well as, based on the recommendations of the CIPIH report, provide a medium-term framework for securing an enhanced and sustainable basis for needs driven essential health research and development relevant to diseases which disproportionately affect developing countries, proposing clear objectives and priorities for R&D, and estimating funding needs in this area.”
(CIPIH refers to the Commission on Intellectual Property Rights, Innovation and Public Health of global experts convened by the UK that produced a report in 2002.)
The engagement of “relevant stakeholders” is another problematic construction. As mentioned above, it means the engagement with pharmaceutical companies in practice, which has direct conflict of interest on this issue.
Similarly, OP 1 endorses the further development of the strategic work plan through broad engagement of public and private entities, academia and civil society. However, there is no process laid down to implement this endorsement except the engagement of relevant stakeholders in the context of the global R&D observatory (OP 4.5) and demonstration projects (OP 4.6).
Further, OP 4.5 and 4.6 generate worry on the duplication and repetition of the work already carried out by the CEWG and other actors, which are already in the public domain.
OP 4.5 requests the WHO D-G “to review existing mechanisms to assess their suitability to perform the coordination function of health R&D.” OP 4.6 requests the WHO D-G “to explore and evaluate existing mechanisms for contributions to health R&D and, if there is no suitable mechanism, to develop a proposal for effective mechanisms, including pooling resources and voluntary contributions, as well as a plan to independently monitor their effectiveness; …”
The Terms of Reference (ToR) of the CEWG set out in resolution WHA 63.28 clearly states: ” … (b) deepen the analysis of the proposals in the Expert Working Group’s report, and in particular: (i) examine the practical details of the four innovative sources of financing proposed by the Expert Working Group in its report; (ii) review the five promising proposals identified by the Expert Working Group in its report; and (iii) further explore the six proposals that did not meet the criteria applied by the Expert Working Group; …”
In addition, OP 2.2(d) of resolution WHA 63.28 mandates the CEWG, while “carrying out the actions in subparagraphs 2(b) and 2(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”.
In the absence of any direction to the Secretariat to build upon the recommendation of the CEWG, further deliberations to move forward on these two areas could be delayed.
NEGLECTED TROPICAL DISEASES
Further, the WHO Secretariat is currently engaged in a competing resolution on Neglected Tropical Diseases (NTD) with a potential conflict of approach recommended by the CEWG.
The draft resolution on NTD, however, is not yet publicly available. The version presented during the 132nd Executive Board meeting in January 2013 primarily urges Member States “to expand and implement interventions against neglected tropical diseases in order to reach the targets agreed by WHO and its partners in the London Declaration on Neglected Tropical Diseases and set out in WHO’s roadmap for accelerating work to overcome the global impact of neglected tropical diseases”.
The Bill & Melinda Gates Foundation, the World Bank and pharmaceutical transnational corporations are the main promoters of the London Declaration. Abbott, Astra Zeneca, Bayer, Becton Dickinson, Bristol Mayers Squibb, Gilead, Glaxo SmithKline, Johnson and Johnson, Merck, Novartis, Pfizer and Sanofi have endorsed the London Declaration.
On R&D, the London Declaration states: “Advance R&D through partnerships and provision of funding to find next-generation treatments and interventions for neglected diseases”.
The declaration is silent on any new approaches to R&D, which can address both innovation and access to medicines. It is disconcerting, therefore, that the Secretariat-initiated resolution on NTD is silent on the CEWG recommendations.
It is widely believed that the NTD initiative is to neutralise the efforts to implement the recommendations of the CEWG. Critics cite the absence of any direct or indirect reference to the CEWG recommendations in the draft resolution circulated during the January meeting of the Executive Board (EB).
During the Board’s deliberations, Ecuador, on behalf of UNASUR (Union of South American Nations), noted with concern that there were ambiguous areas of the discussion and a lack of correlation between the preamble and operative parts. Further, it stated that it is very important to continue to search for coordination strategies and setting priorities as well as funding for R&D at levels required to bring us beyond the status quo at the present.
Further, Ecuador called upon the EB to consider the possibility of strengthening OP 4.5 and OP 4.6 to streamline the coordination and funding mechanism. Finally, it proposed to amend OP 4.7 to advance the timeline of the open-ended meeting from 2016 to 2015.
China raised a procedural question on the last paragraph of the report, which strongly recommends the adoption of the resolution by the WHA without reopening it. Further, China said that even though the November meeting was open ended, not all members took part in the discussion and it also pointed out that the WHA is the paramount power of the organisation. Therefore, China suggested that it is best for the WHA to decide whether to discuss the resolution or not. In addition to the remark on the last paragraph of the open-ended meeting report, China suggested three amendments, terming it as friendly revisions, to OP 2.3, OP
4.3 and OP 4.4.
Bolivia, Cuba and Argentina supported the position of Ecuador and China.
The United States responded that despite elements it did not agree with in the resolution, it agreed because it was a way of moving forward. Hence, to more and better R&D investment in diseases affecting the poor. The US said that Ecuador should take the resolution as part of that package and not reopen it. By reopening part of the resolution, it would then reopen the entire package. Further, the US stated that it has no problems with the wording introduced by China; however, the US does not want to reopen any part of the resolution.
In response to a specific query referred by the Chair on the possibility of amending the draft resolution at the EB, the legal counsel of the WHO stated that “the WHA remains free to further discuss the Director-General’s report and the draft resolution”, thus confirming the possibility that the May session of the WHA can provide further amendments to the draft resolution.
As a result, “The Board noted the report of the open-ended meeting of Member States on the follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination and agreed that the comments made thereon by Member States would be brought to the attention of the Health Assembly”.
However, the Secretariat has not provided the comments made by Member States during the EB meeting as a WHA document. The footnote simply states: “See the summary record of the eleventh meeting of the Executive Board at its 132nd session, section 2.” This reference is given without a URL to access the document on the WHO website.
Echoing similar concerns, the medical journal Lancet in an editorial dated 26 January 2013 stated: “In April 2012, the Consultative Expert Working Group on Research and Development (R&D) recommended a framework for sustainable financing and coordination implemented through a legally binding convention. However, this week WHO’s Executive Board has been asked to endorse a less ambitious plan by member states for a more vaguely defined WHO Observatory on Global Health R&D, which is weak on concrete action despite international consensus that the current R&D model needs revision. The 2013 World Health Assembly should be more ambitious and put back on the agenda the proposal for new global rules to secure sustained financing mechanisms for essential health R&D”.
In a latest development, expressing concern on the draft resolution and the report of the open-ended meeting, more than 50 civil society organisations and concerned individuals jointly made this request: WHO Member States to consider the CEWG recommendations holistically including the central recommendation of the CEWG report which recommended to Member States that “formal intergovernmental negotiations should begin for a binding global instrument for R&D and innovation for health”.
The letter further urged “the World Health Organisation (WHO) and its Member States to exercise leadership, ambition and innovative thinking in developing new paradigms to take forward the work of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) in reconciling the objectives of stimulating medical innovation and ensuring access for all.”
It further reminded the WHO and its Member States of the objective of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property and states that the Plan is to secure “an enhanced and sustainable basis for needs driven, essential health research and development relevant to diseases that disproportionately affect developing countries”.
The letter stressed that “The CEWG identified the concept of de-linkage as the over-arching principle in which to secure this objective by de-coupling the cost of R&D from the price of health technologies including medicines, vaccines and diagnostic tools. The central recommendation of the CEWG report that Member States were asked to consider was the development of a legally binding global convention to address the unmet R&D needs of developing countries”.
The signatories of the letter are: AIDS Law Project Kenya; AIS-Bolivia; AISLAC; AIS-Nicaragua; Alianza LAC-Global por el acceso a medicamentos; All India Drug Action Network; American Medical Student Association; Asia Pacific network for people living with HIV (APN+); Bolivian Committee for Consumers Rights Protection – CODEDCO Bolivia; Center for Health, Human Rights and Development (Uganda); Center for Technology and Society; Fundacao Getulio Vargas; Delhi Network of Positive People (DNP+); Diverse Women for Diversity; Farmamundi (Spain); Federacion Medica Colombiana; Fundacion IFARMA (Colombia); GTPI/Rebrip – Grupo de Trabalho sobre Propriedade Intelectual da Rede Brasileira pela Integracao; dos Povos ; Health Action International; Health Gap; IDESAL Network – Bolivia IFARMA; Initiative for Health & Equity in Society; JUSTICIA, SALUD & DESARROLLO – Bolivia ; Kenya Treatment Access Movement; Knowledge Ecology International; Medecins Sans Frontieres – Access Campaign; Medicus Mundi International Network; Mision Salud Veeduria Ciudadana (Colombia); Navdanya (India); Oxfam; Peoples’ Health Movement; PHM Benin; PHM Bolivia; Politicas Farmaceuticas – Chile; Public Citizen (US); Public Health Association of Australia; Research Foundation for Science, Technology and Ecology; Salud por Derecho; SECTION27; Stop AIDS Campaign; The Berne Declaration; Third World Network; Treatment Action Campaign; and Universities Allied for Essential Medicines. +
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