WHO at the crossroads: negotiations to fund global R&D mired in eight pages of [bracketed] text

On Friday, 20 May 2016, the World Health Organization (WHO) published document A69/40, Follow-up to the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination — Report of the open-ended meeting of Member States.

This 23 page report contains the report of the open-ended meeting of Member States (OEM, 2-4 May 2016) which consists of two paragraphs, Appendix 1 (the program of the 2016 OEM), Appendix 2, the progress report by the Secretariat (published on 22 April 2016 in advance of the OEM), and Appendix 3, the heavily bracketed, 8 page draft decision/resolution on the CEWG follow-up which will be finalized in a drafting group during the 69th World Health Assembly (23 May 2016 to 28 May 2016).

The link to these WHO documents can be found here: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_40-en.pdf

The report of the open-ended meeting of member states to “assess progress and continue discussions on the remaining issues in relation to monitoring, coordination and financing for health research and development”, in its entirety, contains the following two illuminating paragraphs:

The Open-ended meeting of Member States to assess progress and continue discussions on the remaining issues in relation to monitoring, coordination and financing for health research and development was held from 2 to 4 May 2016 at WHO headquarters in Geneva as requested by resolution WHA66.22. The meeting was chaired by Mr Bhanu Pratap Sharma from India. Ms T. Dussey-Cavassini from Switzerland was elected as Vice-Chair. Representatives from Member States, intergovernmental organizations, nongovernmental organizations in official relations with WHO and special invitees attended the first two days of the meeting. The third day was a closed meeting for Member States only.

The meeting adopted its agenda and proceeded as outlined in the Proposed programme of work(see Appendix 1). The presentations that were made are available on the WHO website [1 http://www.who.int/phi/cewg-presentations/en/ (accessed 9 May 2016).] after seeking permissions from the presenters. A progress report was submitted to the open-ended meeting (see Appnedix 2) [sic]. The meeting also discussed the draft decision/resolution, set out in Appendix 3 of the present document, which is forwarded to the Sixty-ninth World Health Assembly for its consideration. The meeting recommended that the Health Assembly set up a drafting group to finalize discussions on the draft decision/resolution.

As noted above, the 8 page draft decision/resolution is heavily bracketed which means consensus has yet to be reached on many key elements of WHO’s work program on R&D. Here are some selected excerpts from the text:

2. [Reaffirming UNGA Resolution 70/1 on the 2030 Agenda for Sustainable Development and recalling the Means of Implementation, in particular target 3.b by which Member States agree to support, [the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of IP Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all]

2. alt. [Acknowledging that the 2030 Agenda for Sustainable Development, includes the commitment to support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of IP Rights regarding flexibilities to protect public health, and in particular, provide access to medicines for all]

7. [[Welcoming] [Noting [with interest] the establishment of] the High-Level Panel on Access to Medicines convened by the UN Secretary-General.]

8. [Recognizing the shared [common] responsibility of all Member States to invest in R&D for diseases in accordance with the scope of the CEWG Report
and in line with the Global strategy and plan of action on public health, innovation and intellectual property]

8. alt. [Underscoring that health R&D should be needs-driven and evidence-based and be guided by the following core principles: affordability, effectiveness, efficiency, and equity; and it should be considered as a shared responsibility]

1. URGES Member States

[Move to PP:] [Recognizing progress in the establishment] [Reaffirms the central role of] [Noting efforts to establish] the Global Observatory on Health Research and Development to consolidate, monitor [analyse relevant information on health R&D activities] and [identify gaps and opportunities on health research and development] [[to analyse relevant information on health research and development activities, [where market failures exist,]], including on [[related to]type II and III diseases and the specific R&D needs of developing countries in relation to type I diseases, [including]] antimicrobial resistance and emerging [infectious] diseases likely to cause major epidemics, [with a view to contributing to the identification of gaps and opportunities] for health research and development that informs prioritization and supports coordinated actions on health research and development; and urges[encourages]

(2) [[to promote and support] [[ensure] [provide] sustained [sustainable] funding for] the Global Observatory on Health Research and Development]

(2) bis. to provide support to the DG for the development of sustainable financing mechanisms for the full implementation of the CEWG strategic workplan agreed in WHA66.22

(3) to create, [, strengthen, [empower] and] or sustain appropriate [sustainable] national or regional [observatory] [mechanisms] to facilitate [annual] [regular] [reporting] of relevant information on [all] [health R&D capacities, public and private] [publicly funded] [on] health research and development [either directly] to the Global Observatory on Health Research and Development [or to other international survey mechanisms which directly feed into the Global Observatory]

(4) [to consider aspiring to meeting a benchmark for investments in R&D for diseases in accordance with the scope of CEWG at 0.01% of GDP in line with
the CEWG recommendations]

2. REQUESTS the Director-General:

(1) to expedite [within the [follow-up of the report of the CEWG] [context of CEWG] [and as part of the [priority activities] [core functions] of WHO]] the establishment of a fully [functioning] [functional] Global Observatory on Health Research and Development and explicitly include its operational costs in the regular Programme Budget [and sustain its activities[, including by utilising [preferably] financial resources from assessed [contributions] and [also] core voluntary contributions to WHO]]

(3) to promote the Global Observatory on Health R&D among all stakeholders, including through regular open-access publications and outreach activities and encourage all stakeholders to regularly share relevant information on health research and development with the Global Observatory on Health R&D

(4) to decide to establish an [geographically representative] [independent] [WHO expert advisory committee] [footnote] on health research and development, with [balanced] [due geographical and gender] representation] as an [independent] [coordination] mechanism for [identifying priorities for] [priority setting of,] [global] research and development [due to recognized market failures] [related to] [needs], [especially] for Type [II] III and [III] II diseases and specific R&D needs of developing countries in relation to Type I diseases [where market failure exists,] based on the analyses provided by the Global Observatory on Health Research and Development and to submit its terms of reference including [profiles of the] [general] composition [footnote] to the Seventieth World Health Assembly through the 140th session of the Executive Board for its consideration and adoption]

[Decides to establish an WHO expert [advisory] committee on health research and development, with balanced geographical and gender representation as
an [independent] coordination mechanism for priority setting of global research and development needs for Type II and III diseases and specific R&D needs of developing countries in relation to Type I diseases, [[and] [potential other areas] where market failure exists], based on the analyses provided by the Global Observatory on Health Research and Development.]

(7) [to [ensure] [promote] [that] policy coherence [guides] [within] WHO research and development activities [such as the [Research and Development Blueprint for Emerging Pathogens] [Emergency Research and Development Blueprint] and the [AMR Global Action Plan] [global development framework for innovation in antimicrobial medicines and diagnostics]] in terms of application of the core [CEWG] principles of affordability, effectiveness, efficiency and equity [and the objective of] [and] de-linkage identified in WHA resolution 66.22] [including where appropriate and in consultation with other stakeholders the Research and Development Blueprint for Emerging Pathogens and the AMR Global Action Plan]

(8) [to develop [draft] guidelines [to inform Member States and other stakeholders on the use of principles of affordability, effectiveness, efficiency and equity [and the objective of] [and] de-linkage identified in WHA resolution 66.22] in relevant R&D efforts] [that promote the implementation of the [CEWG] [WHA66.22] principles in R&D efforts [[funded] [established] by Member States and other [funders of research] [stakeholders]] [for submission to the 140th Session of the Executive Board]]]

(8) bis. [to convene an open-ended meeting after the publication of the report of the UN Secretary General High-Level Panel on Access to Medicines, and the UN High Level Meeting on Antimicrobial resistance in order to seek policy coherence on health innovation and access and inform further governmental discussions on the follow up to the Consultative Expert Working Group on Research and Development: Financing and Coordination;]

Alternative text for paras OP1 and OP2 (1) submitted by India & Switzerland at request of the Chair (to be integrated in appropriate location):
PP: Noting with concern the significant gap in funding the Strategic Workplan including the six selected demonstration projects

PP: Acknowledging the central role of the Global Observatory on Health Research and Development to consolidate, monitor and analyze relevant information on health research and development activities related to type II and III diseases and the specific R&D needs of developing countries in relation to type I diseases including antimicrobial resistance and emerging infectious diseases likely to cause major epidemics, 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 research and development and defining priorities and supporting coordinated actions on health research and development

OP 1 alt: Urges Member States (with foot note):

1) to make concerted efforts for the full implementation of the Strategic Workplan agreed in WHA66.22

2) to provide sustainable funding for the Global Observatory on Health Research and Development

3) to create, operationalize and strengthen, as appropriate, national Health Research and Development observatories or equivalent functions to provide regular information on relevant Health Research and Development activities to the Global Observatory on Health Research and Development or to other existing data collection mechanisms which provide regular reports to the Global Observatory on Health Research and Development

4) to secure necessary financial resources and the coordination required at all levels to support the demonstration projects

5) [to consider aspiring to meeting a benchmark for investments in R&D for diseases in accordance with the scope of CEWG at 0.01% of GDP in line with the CEWG recommendations]

6) [to provide support to the DG for the development of sustainable financing mechanisms for the full implementation of the CEWG strategic workplan agreed in WHA66.22]

OP2. Request the Director-General:

1) alt to expedite within the follow-up of the report of the CEWG [and in accordance with core functions of WHO] the further development of a fully functional Global Observatory on Health Research and Development and to explicitly include its operational costs in the regular Programme Budget

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