WHO Board To Address Reform Progress, R&D Financing, Lobbyists/ Foundations

Next week, the World Health Organization Executive Board will hold its biannual meeting. On the agenda are key subjects such as the WHO reform process, sharing of influenza viruses for R&D, and a controversial framework for the WHO’s engagement with actors such as non-governmental organisations, private entities, and foundations.

Also on the agenda is the effort to address the growing microbial resistance to antibiotics, and finding a way to finance research and development for diseases affecting primarily developing countries.

The 138th Executive Board meeting of the World Health Organization will take place from 25-30 January.

The draft meeting agenda [pdf] covers an array of subjects. This includes: an overview of the organisation’s reform implementation; the outcome of an intergovernmental meeting on the framework of engagement with non-state actors; the progress and implementation of the sharing of influenza viruses and access to vaccines in the frame of the pandemic influenza preparedness; a progress update on the evaluation of the global strategy and plan of action on public health, innovation and intellectual property; a high-level meeting on the global action plan on antimicrobial resistance; planning for an open-ended meeting on progress achieved by the Consultative Expert Working Group on Research and Development: Financing and Coordination; a report of the fourth meeting of the member state mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products; the status of financing of the programme budget 2016‒2017; and a report on the process for the upcoming election of the WHO director-general.

A preliminary time table for the meeting is here [pdf].

The Executive Board (EB) is composed of 34 individuals designated by member states, elected for three-year terms. The list of countries that can submit candidates, by region, is here.

WHO Reform

The EB is expected to take note of a report [pdf] by the secretariat on the progress of the WHO reform in the three reform workstreams: programmes and priority-setting, governance, and management. According to the report, the greatest progress has been made in programmatic reforms, less in governance and managerial reform.

One of the main objectives of the reform is to improve decision-making in governing bodies, A member state consultative process on governance reform was to complete its work by the 69^th World Health Assembly (WHA) in May 2016, and provide recommendations through the EB next week, in particular on working methods of the governing bodies. According to the report, the first meeting on governance reform was held in May 2015 and the second on 10-11 December 2015.

The working group agreed on 38 recommendations, contained in Appendix 1 of document EB/OMSMGR/2/2 (Appendix I). Those recommendations were further revised and a new list of 22 recommendations was issued by the chairperson on the Second Open Member States Meeting on Governance Reform, Amb. Jorge Lomónaco of Mexico. Those recommendations were discussed in December, but member states were unable to agree “due to several factors including lack of time,” the chairperson’s report [pdf] said.

The chairperson’s report contains a second revised version of the recommendations, his proposal as “a possible compromise.” According to the report, some member states proposed to extend the mandate of the working group, while other member states suggested that further work be conducted by the WHO Programme, Budget and Administrative Committee (PBAC). No agreement was reached on how to proceed.

Framework of Engagement with Non-State Actors

EB members are expected to look at a document [pdf] containing a draft framework of engagement with non-state actors, such as non-governmental institutions, philanthropic foundations, and the private sector.

The draft framework, under its present form, has text highlighted in green, which was agreed upon, and text highlighted in yellow, which did not meet consensus. Text without highlight has not been considered yet, according to the document.

The Open-ended Intergovernmental Meeting on the draft framework of engagement with non-State actors met from 8-10 July 2015, but did not conclude its work, and was resumed from 7-9 December.

According to the document, “the resumed meeting managed to agree on most parts of the framework, but some paragraphs still remain unresolved and will require further discussions.” The meeting is requesting the EB to extend its mandate so that it may resume its work for a final session between the EB and the WHA in May.

Some sections highlighted in yellow stand for example in the draft policy on engagement with private sector entities, concerning the pooling of contributions from multiple sources, and in the draft policy for engagement with non-governmental organisations, concerning the accreditation of NGOs.

Pandemic Influenza Preparedness

Two reports were submitted by the director general for the Board’s consideration: a biennial report [pdf] on the status of, and progress in, implementing the Pandemic Influenza Preparedness (PIP) Framework, and a report [pdf] on the outcomes of the Special Session of the PIP Framework Advisory Group, held in Geneva on 13-14 October (IPW, WHO, 22 October 2015).

The biennial report includes status and progress of laboratory and surveillance capacity, global influenza vaccine production capacity, the status of agreements entered into with industry, and the financial report on the use of the partnership contribution.

According to the biennial report, since 2014, “the secretariat of the PIP Framework has been actively conducting negotiations with over 20 influenza vaccine manufacturers and diagnostics companies from around the world to conclude additional agreements, and these negotiations are progressing.”

The report also underlines the issue of the definition of PIP biological materials. A Technical Expert Working Group was established in 2013 to tackle the issue. According to the report, genetic sequences data is increasingly being used to manufacture some vaccines and other influenza-related products.

“Although genetic sequence data fall within the PIP Framework, there are different views about whether they are included in the definition of PIP biological materials,” it says. “In considering the handling of genetic sequence data for influenza viruses with pandemic potential, the Advisory Group noted that the spirit of the Framework, as well as the need to maintain a level playing field in the sharing of viruses and in benefiting from doing so, must be kept in mind.”

The Advisory Group recommended to continue work on designing an appropriate system for handling genetic sequence data for influenza viruses with pandemic potential. The EB is expected to note the report.

Global Action Plan on Antimicrobial Resistance

EB members are expected to consider a report [pdf] on options to conduct a high-level meeting on antimicrobial resistance in 2016 on the margins of the United Nations General Assembly. The Global Action Plan on Antimicrobial Resistance was adopted in May 2015. Options considered are the convening of a high-level meeting of the UN General Assembly in September 2016 and a high-level side-event on the margins of the UN General Assembly in 2016.

Potential deliverables of the high-level meeting include a resolution and a political declaration. EB members are invited to note the report.

Global Strategy and Plan of Action on Public Health, Innovation and IP

Following a WHA resolution in May 2015, the WHO was expected to start a comprehensive evaluation procedure of the Global Strategy and Plan of Action on Public Health, Innovation and IP. According to the secretariat’s report [pdf], an ad hoc evaluation management group was convened to assist in selecting the evaluation team, reviewing the evaluation inception report and the draft evaluation report, and ensuring that the final draft meets appropriate quality standards.

The ad hoc evaluation management group is composed of six independent external experts, and two evaluation experts from the UN Evaluation Group. The evaluation team is expected to prepare the evaluation inception report for review and comments by the ad hoc evaluation management group, according to the report.

The Board is invited to note the report.

Consultative Expert Working Group (CEWG) on R&D: Financing and Coordination

A progress update [pdf] on the CEWG is on the agenda of the EB next week. In particular, the update gives the latest on the global health research and development observatory. According to the document, “work towards the establishment of a global observatory on health research and development is well underway with the launch of its first phase scheduled for January 2016.”

The first phase of the project includes collecting and collating available data on funding for health research and development, health products in the pipeline, clinical trials and research publications.

Six demonstration projects had been selected in 2013. According to the document, the six projects are at different levels of implementation, except the South African project, which is nearing finalisation of a proposal for expert review (demonstration of the potential of a single-dose malaria cure of artemether-lumefantrine through reformulation in a nano-based drug delivery system – Council for Science and Industrial Research, South Africa).

According to the update, the Ad-hoc Committee for the Demonstration Projects/Global Health Research and Development Observatory has been established. Demonstration project proponents are expected to submit their financial requirements to the committee. After meeting in June, the committee recommended allocation of funding for three projects.

An open-ended meeting of member states is scheduled to take place on 7-9 March. An outline provisional agenda for the meeting is in the annex of the progress update. The EB is expected to consider the progress update, provide guidance on the provisional agenda, the nomination of the chairman and vice-chairman, and the participation of non-state actors.

Substandard/spurious/falsely-labelled/falsified/counterfeit Medical Products

The fourth meeting of the Member State Mechanism for substandard/spurious/falsely labelled/falsified and counterfeit (SSFFC) medical products was held on 19-20 November. Issues discussed by the mechanism included the development of guidelines on “track and trace” technologies and of training material, and the establishment of a global focal point network.

According to the report [pdf] of the November session, member states leading implementation of activities under the mechanism provided updates, such as Brazil having convened an informal working group on 17 November on a discussion document “Framework/Guideline on developing a national plan for preventing, detecting and responding to SSFFC medical products.”

The United Kingdom presented the draft terms of reference for the Global Focal Point Network for SSFFC products, which was approved by the member state mechanism. The terms of reference as amended are in Appendix 1 of the report.

Argentina convened an informal working group on 16 November on existing technologies and track and trace models in use and to be developed by member states. A finalised document was accepted by the mechanism and is attached to the report in Appendix 2.

The fifth meeting of the mechanism is expected to take place in October or November 2016.

Financing of Programme Budget 2016-2017

According to a report [pdf] by the secretariat, in May 2015, a budget of “US$ 4384.9 million” for the financial period 2016–2017 was approved. This covers a “base” budget for the WHO’s six main categories of work of “US$ 3194.3 million,” to be financed by US$ 929 million in assessed contributions and “US$ 2265.3 million” in voluntary contributions, which represents an increase of 8 percent over the programme budget 2014–2015.

“Financing the programme budget has been consistently challenged by lack of transparency, unpredictability and non-alignment of resources, excessive earmarking of voluntary contributions, and increased vulnerability due to growing dependence on a few voluntary contributors,” said the report. A financing dialogue was established in 2013. On 5-6 November, member states, bilateral and multilateral donors and several non-state actors gathered for a financing dialogue session.

According to the report, during the financing dialogue, “There was general recognition that, although the funding outlook for 2016–2017 was encouraging, the mid-term perspective was more worrying.”

The WHO’s contributor base, although broadened over the past 10 years, still relies on 20 contributors for about 76 percent of its funding, down from 80 percent for the 2014-2015 biennium, the report said. Further efforts are needed to broaden the contributor base, it said, including by exploring new avenues of financing from “traditional and non-traditional donors, including development banks and intergovernmental organizations.” The EB is expected to note the report.

Election of WHO DG

According to a report [pdf] by the director general, the process for the election of the director general was revised in 2012 and in 2013 by the EB and the WHA. The DG suggests some additional changes, such as allowing the candidates to address the WHA. The EB is expected to consider the report and the suggestions.

The deadline for the submission of candidatures is expected to be in late September 2016, according to the report. WHO Director General Margaret Chan was elected on 1 July 2012 and her tenure will end on 30 June 2017.

Provisional Agenda of the WHA

The EB is expected to approve [pdf] the provisional agenda of the sixty-ninth WHA, which is scheduled to take place from 23-28 May.

It is also proposed that the 139^th session of the EB be convened on 30 and 31 May.