WHO Board addresses health R&D, sets March meeting to discuss CEWG resolution

Over 1,000 attendees, a longer than ever agenda—with time management by a song for punishment and a chocolate Caramello Koala as a reward—the 138^th World Health Organization (WHO) Executive Board (EB), chaired with humor and efficiency by Precious Matsoso, Director-General of the Department of Health, South Africa, concluded Saturday, January 30 after six days of discussion and debate.

The main headlines were WHO emergency reform, WHO reform in general, the Zika response, transitioning from the Millennium Development Goals to the Sustainable Development Goals, universal healthcare, preparation for the United Nations (UN) High-Level Meeting on noncommunicable diseases, the upcoming UN General Assembly Special Session on the World Drug Problem, Framework for Engagement with Non-state Actors, Global Action Plan on Strategies for antimicrobial resistance (AMR), pandemic influenza preparedness, and promoting the health of migrants. The full agenda, associated documents and nongovernmental organization (NGO) statements can be found here.

R&D featured prominently on the agenda

The need for global health research and development (R&D) and access to global health technologies featured prominently in many of the agenda items addressed under Health Systems and Preparedness, Surveillance and Response including:

• 8.2: Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits
• 10.2: Comprehensive evaluation of the global strategy and plan of action on public health, innovation, and intellectual property: progress update
• 10.3: Follow-up to the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), Planning for an open-ended meeting of Members States to discuss progress
• 10.4: Substandard/spurious/falsely-labeled/falsified/counterfeit medical products
• 10.5: Addressing the global shortages of medicines and the safety and accessibilities of children’s medication

R&D was also embedded as an important point within some of the key headline items including:

• 6.4: Public health dimension of the world drug problem including the context of the Special Session of the UN General Assembly on the World Drug Problem to be held in 2016
• 7.2: Health in the 2030 Agenda for Sustainable Development
• 8.1: Implementation of the International Health Regulations discussed with 9.1 2014 Ebola virus disease outbreak: follow-up to the Special session of the EB on the Ebola Emergency: section on information sharing on diagnostic, preventive and therapeutic products
• 8.5: Global Plan on antimicrobial resistance
• 9.2: Global health sector strategies: HIV, viral hepatitis, and sexually transmitted infections
• 9.3: Global vaccine action plan
• 9.4: Mycetoma

The EB accepted all of these topics for inclusion in the 69^th World Health Assembly (WHA) agenda.

A number of NGOs, including GHTC, weighed in on R&D and access related topics discussed at the EB meeting. Full NGO statements delivered at the meeting are available here.

Three resolutions related to health R&D introduced for WHA

Most of the EB agenda consisted of “recognizing reports,” “providing guidance,” and “reviewing draft strategies,” however, the EB decided to put forward three resolutions for consideration at the WHA in May that have clauses related to R&D:

1. Draft resolution on Health in the 2030 Agenda for Sustainable Development
2. Draft resolution addressing the burden of mycetoma
3. Draft resolution promoting the safety and accessibility of children's medicines

Small steps taken on CEWG

Agenda item 10.3, follow-up of the report of the CEWG, was particularly important for GHTC and other health R&D advocates. The EB discussed progress on the process and set the agenda for an open-ended meeting on the topic that will take place in March. This meeting is expected to result in a WHA resolution on possible WHO mechanisms for global health R&D priority setting, coordination, and a pooled fund for R&D.

During the discussion, member states and observers made the following interventions:

• All member states supported the Global Observatory on Health Research and Development, a WHO platform created by the CEWG process to collate information on health R&D activities globally to identify gaps and opportunities and define priority areas for new R&D investments.
• Many statements expressed disappointment that funds received to support R&D (US$10 million) are dramatically lower than funding pledges ($85 million).
• Statements were made calling for the new pooled fund to incorporate support for R&D on antimicrobial resistance and emerging infectious diseases, though there was not consensus on this point.
• Several participants questioned how the CEWG process is coordinating with the UN Secretary-General’s (UNSG) High-Level Panel on Access to Medicines.
• The assembly seemed unified on non-state actors being allowed to attend the open-ended meeting, while holding open the possibility of a closed session on financing and coordination of next steps.
• Many participants argued for the need to de-link R&D costs from product price to increase affordable access.
• It was acknowledged that the fund should de-risk investment for low- and middle-income countries.
• Participants recognized a need to interface between work streams—observatory, priority setting and coordination, and the pooled fund.
• Feedback was given on the demonstration projects chosen and not chosen.
• P. Sharma of India was nominated by consensus as the chair of the open-ended meeting.

The following NGOs made statements on this agenda point:

• GHTC (delivered through Global Health Council)
• Drugs for Neglected Diseases initiative
• Médecins Sans Frontières International
• Medicines for Malaria Venture
• Medicus Mundi International Organization for Cooperation in Health Care

GHTC’s statement requested that global health R&D NGOs be permitted to participate in the March open-ended meeting since product development partnerships and public-private partnerships are responsible for 58 percent of the product candidates currently in the pipeline. The decision was ultimately made to include civil society.

In wrapping up this agenda item discussion, Marie-Paule Kieny, WHO Assistant Director-General of Health Systems and Innovation, thanked Member States for their constructive requests and described this process as a marathon, not a sprint. She also highlighted the financial gap facing the current demonstration projects. Regarding the agenda of the open-ended meeting, she said that comments would be taken into consideration and proposed the following revised agenda:

• Day 1: Progress on strategic work plan and report from the UNSG High-Level Panel on Access to Medicines.
• Day 2: Presentations of work relevant to the CEWG: neglected tropical diseases; the global action plan for AMR; R&D Blueprint for action to prevent health epidemics; World Intellectual Property Organization (WIPO) research; and trilateral cooperation between WHO, the World Trade Organization, and WIPO on health, innovation, and access. Member state and Non-State actor statements.
• Day 3: Financing and Coordination.

Looking forward, the 69^th WHA agenda will very closely resemble the agenda of this 138^th EB since the main point of the January EB meeting is to set the agenda for the WHA. Therefore, it will include important R&D topics including outcomes from the March open-ended meeting, the resolution votes, and the strategic plans discussed at this EB.