The World Health Organization (WHO) is convening an 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 (CEWG) in Geneva, Switzerland at WHO headquarters from 2 May 2016 to 4 May 2016. The WHO has published the provisional agenda, the proposed program of work and progress report. The CEWG will be open to non-state actors for the first two days (2 May 2016 to 3 May 2016); the third day will be closed session for member states only.
The Chair of the 2016 CEWG is Mr. Bhanu Pratap Sharma, Secretary, Ministry of Health and Family Welfare, Government of India. The Vice-Chair is Ms. Tania Dussey- Cavassini, Vice-Director General, Ambassador for Global Health, Federal Office of Public Health, Switzerland.
The first substantive agenda item (to be discussed on Monday, 2 May 2016) is:
Assessment of progress and continuation of discussions on the remaining issues in relation to monitoring, coordination and financing for health research and development, 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
During the morning session, the WHO Secretariat, led by Dr. Marie-Paule Kieny, Assistant-General, Health Systems and Innovation, will present on the R&D Blueprint for “emerging pathogens likely to cause severe outbreaks in the near future” and R&D in the “context of the global action plan for antimicrobial resistance” (AMR).
In relation to the R&D Blueprint, the progress report (A/RDMCF/2) prepared by the WHO Secretariat in advance of the 2016 CEWG notes:
21. The research and development blueprint for action to prevent epidemics. The recent Ebola virus disease epidemic, preceded by the outbreaks of severe acute respiratory syndrome and the Middle East respiratory syndrome and followed by the continuing Zika virus epidemic, has highlighted the need for a robust research and development preparedness for emerging diseases likely to cause severe outbreaks in the near future and for which few or no countermeasures exist. Currently, there is insufficient investment into the development of treatments, vaccines and diagnostics for these severe, emerging epidemic-prone diseases. These diseases are unpredictable, tend to occur in low-resource settings and affect either a limited number of people or populations with low purchasing power. The research and development blueprint addresses the primary issue for which the global strategy and plan of action on public health, innovation and intellectual property was created: ensuring access to affordable, safe and effective health products for which existing market mechanisms fail to provide incentives for health research and development.
22. The blueprint is a global strategy and preparedness plan to ensure that targeted research and development can strengthen the emergency response by bringing medical technologies to populations in need during outbreaks and epidemics. In particular, the blueprint aims to reduce the time between the declaration of a public health emergency of international concern and the availability of effective tests, vaccines and medicines that can be used to save lives and avert crises.
23. As part of the blueprint, an initial prioritized list of severe, emerging, epidemic-prone diseases for urgent research and development was agreed during a meeting of experts convened by WHO (Geneva, 8 and 9 December 2015). This list comprises: Crimean-Congo haemorrhagic fever, filovirus diseases (for instance Ebola virus disease and Marburg haemorrhagic fever), Lassa fever, highly pathogenic emerging coronavirus diseases (severe acute respiratory syndrome and the Middle East respiratory syndrome), Nipah virus disease and Rift Valley fever. Diseases that are considered serious and require action by WHO to promote research and development as soon as possible includes chikungunya, severe fever with thrombocytopenia syndrome, and Zika virus disease. The priority status of the Zika virus disease was raised after the declaration of a public health emergency of international concern by the Director-General on 1 February 2016 because of the ongoing outbreak of Zika virus infection associated with an increase in the number of cases of Guillain-Barré syndrome and microcephaly. Further work by the Secretariat includes defining the current status of basic and applied research for these prioritized epidemic-prone diseases, for incorporation into the work of the Global Observatory on Health Research and Development and to facilitate and coordinate the development of technology road maps to identify how to accelerate research and development for effective diagnostics, vaccines, therapeutics and other medical and information technology for the priority, epidemic-prone diseases. Other important developments concentrate on supporting improved regulatory preparedness for healthcare products epidemic control. The Secretariat is not engaged in research and development as such as part of the blueprint.
24. A research and development response during an epidemic relies on the existence of the rightconditions – or an enabling environment – to facilitate timely and efficient action. This means that there must be, for example, a system in place for coordinated action, broad agreement on data and sample sharing, governance of research and development, and standards of care. This constitutes another area of work being covered in the research and development blueprint. Assessment of the effectiveness of the blueprint will rely on evaluating its ability to create such an enabling environment for research and development preparedness in developing countries, and on the impact that research and development plans on availability of medical technologies for the next outbreaks or epidemics.
25. Work is continuing to explore options for adequate and sustainable funding for priority research for severe, emerging, epidemic-prone diseases, for example through aligning and making more efficient use of existing funds and through linking this stream of work with related discussions of the Consultative Expert Working Group. A report on options for strengthening information-sharing on diagnostic, preventive and therapeutic products and for enhancing WHO’s capacity to facilitate access to these products, including the establishment of a global database, starting with haemorrhagic fevers, which contains further information on the research and development blueprint, is being submitted to the Sixty-ninth World Health Assembly for consideration.
In relation to the WHO global action plan on antimicrobial resistance, the WHO Secretariat notes:
As for neglected diseases, investment into the development of new antibiotics is insufficient, resulting in a meagre research and development pipeline. However, contrary to diseases of interest in the global strategy and plan of action on public health, innovation and intellectual property, the antibiotic market remains a commercial market and the diseases caused by resistant bacteria are not Type II and III diseases, but affect all countries. Therefore, the global action plan on antimicrobial resistance, under its Objective 5 on developing the economic case for sustainable development, requests the Director-General to explore options for the establishment of new partnerships to identify research and development priorities, to foster the development of new antibiotics, diagnostics, vaccines and other interventions, to improve the coordination of existing research and development related initiatives, to ensure access and to establish open collaborative research and development models.
27. To implement this part of the global action plan on antimicrobial resistance, the Secretariat and the Drugs for Neglected Diseases initiative have collaborated in the establishment of the Global Antibiotic Research and Development Facility, an independent product development partnership to develop new antibiotic treatments to counter antimicrobial resistance and to promote their responsible use for optimal conservation while ensuring equitable access for all. The Facility will work closely with all stakeholders in the field of antibiotic research and development from countries of all income
(a) address global public health and specific needs of developing countries, targeting products that industry will not develop owing to lack of profitability;
(b) pilot the use of alternative incentive models that support conservation of and access to new antibiotics based on the experience of the Drugs for Neglected Diseases initiative in implementing alternative research and development models for neglected diseases; and
(c) ensure that new antibiotics are affordable to all.
The Board of the Drugs for Neglected Diseases initiative approved the role of the initiative as an incubator for the initial start-up phase of this new facility until it becomes an independent entity. The Secretariat will not be directly involved in product research and development activities related to this initiative.
Following discussions on the R&D Blueprint and AMR, Ruth Dreifuss, co-chair of the United Nations Secretary-General’s High-Level Panel on Access to Medicines (HLP) will present on the work of the HLP during the morning session (2 May 2016).
The Monday afternoon session will be devoted to policy coherence in health R&D. After policy coherence, the WHO secretariat will make presentations on the state of play of 1) the global health R&D observatory, 2) coordination of health R&D and 3) demonstration projects. The UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) will make a presentation on their proposal on a pooled fund for R&D. The OEM will provide the opportunity for WHO member states, intergovernmental organizations and civil society organizations to glean more details on the McKinsey-TDR report on a Health Product Research and Development Fund: A Proposal for Financing and Operation (the report was funded by the Swiss government).
One revelation briefly touched upon by the McKinsey/TDR report is that the WHO is developing a “broad WHO Prioritization Mechanism to set priorities based on data collected by the WHO Global Observatory on Health Research and Development (R&D)”. The report notes that “the exact structure and mandate of the WHO Prioritization Mechanism had not been defined during the preparation of the report. However, the financing and downstream coordination mechanism described in this report will be applicable in putting into operation any priorities set by the WHO Prioritization Mechanism” (Page vii, Health Product Research & Development Fund: A Proposal for Financing and Operation).
The morning session of day 2 (Tuesday, 3 May 2016) of the CEWG will continue discussions on the pooled fund, demonstration projects, coordination of health R&D and the global observatory and possibly, policy coherence.
Tuesday afternoon will start off with a presentation by Policy Cures on the current funding situation for R&D related to the priority diseases of the CEWG. This will be followed by a discussion on establishing a “voluntary pooled fund” for health R&D and the financing of the “strategic workplan” (presumably the future of the WHO demonstration projects and the WHO observatory).
The last item on Tuesday’s agenda is listed in an anodyne manner: “Discussion “on the remaining issues in relation to monitoring, coordination and financing for health research and development””. Under this item, it is expected that WHO member states will discuss an R&D Agreement, progressive de-linkage and norms on the transparency of R&D costs.
The third day of the CEWG is a closed meeting of member states that will decide on the way forward, perhaps in the form of a decision point or resolution for consideration by the 69th World Health Assembly (23-28 May 2016).