WHO Executive Board To Address Reform, R&D Financing, Ebola, Budget

The upcoming World Health Organization Executive Board annual January meeting will be an unusually long 10 days. Included in the list of issues to be addressed are the engagement of the organisation with lobbyists and donors, antimicrobial resistance, and the potential establishment of a pooled fund of voluntary contributions for research and development for diseases primarily affecting developing countries.

The 136th WHO Executive Board will take place in Geneva from 26 January to 3 February. The Executive Board (EB) is composed of 34 members, which are elected for three-year terms. The EB is expected to agree on the agenda for the upcoming World Health Assembly (from 18-26 May) and adopt resolutions to be forwarded to the Assembly.

All the EB documents are here. The preliminary daily timetable is here [pdf].

Non-State Actors

Part of the WHO reform, the engagement with “non-state actors” (lobbyists, donors, and other interested non-governmental parties) was discussed at the last World Health Assembly and a draft framework was produced (IPW, WHO, 23 May 2015).

This comes in response to concerns by some member states about undue influence of private entities in the work of the WHO, and conflicts of interest on the one hand, and the interest of some other members wishing to open the organisation’s door wider to non-state actors on the other.

The report on the non-state actor framework provided by the secretariat contains the main issues raised by member states, and the secretariat’s proposals for addressing these issues, according to the WHO. The annex of the report lays out a revised version of the draft framework of engagement with non-state actors.

One of the main issues raised by member states was conflicts of interest. Several countries called for a stronger approach or policy on conflict of interest, according to the WHO, which specified that a section has been added to the draft framework on the management of institutional conflict of interest and other risks of engagement.

The WHO notes that a lack of engagement with non-state actors “would create a risk to WHO’s relevance and to the Organization’s role as the directing and coordinating authority of international health work,” however, “any uncontrolled engagement could place WHO’s integrity, impartiality and reputation at risk.”

For WHO, notes the report, “the most important institutional conflicts of interest arise in situations where the economic interests of private sector entities are in conflict with the Organization’s interests, its independence and impartiality in setting norms and standards.”

The new section includes “provisions on how conflict of interest will be managed through due diligence, risk assessment, risk management and strengthened oversight by member states,” says the report.

In the same vein, according to WHO, member states underlined the fact that WHO should only accept financial resources from private sector entities if “potential conflicts of interest are ruled out, and if this engagement does not compromise WHO’s integrity and reputation.” The WHO also proposed that the director general “can set up pooling mechanisms to protect WHO further from any undue influence of private sector entities.”

To answer concerns of some members WHO states that some non-private sector entities may be influenced by private sector entities, WHO said the provisions distinguishing private sector entities from other groupings of non-state actors can now be found in the section defining non-state actors and the section on due diligence.

“Any non-State actor clearly influenced by private sector entities will be considered as a private sector entity. Thus, engagement with such entities will be circumscribed by the policy on engagement with private sector entities with its more stringent rules,” it says.

Some member states also had suggested that private sector involvement should be open to member states’ scrutiny and that member states should be involved in due diligence, according to WHO. The suggestion by the WHO is that “the oversight function of Member States in respect of engagement with non-State actors will be significantly strengthened.”

Substandard Medical Products

Following the third meeting of the member state mechanism for so-called substandard/spurious/falsely-labelled/falsified/counterfeit medical products held in Geneva on 29-31 October, an outcome document [pdf] was issued in order to report back to the WHA through the EB, according to WHO.

Annex III of the document includes a list of prioritised activities by the member state mechanism for 2014-2015. The list is as below:

1. Develop recommendations for the Health Authorities engaged in the detection of SSFFC medical products and establish a strengthening and tool-generating programme to contribute to Member States’ training
2. Create a focal point network for the exchange of information and consultation at large among Member States and establish an ongoing virtual exchange forum
3. Establish a working group to survey the technologies, methodologies and “track and trace” models in place and to be developed to analyse their advantages and disadvantages and to survey the available authentication and detection technologies and methodologies and analyse their advantages and disadvantages
4. Identify WHO areas working on the issue of access to quality, safe, efficacious and affordable medical products and request a report on the current state of affairs
5. Create a working group to develop and leverage existing recommendations for effective risk communication and recommendations for awareness campaigns on SSFFC medical products and related actions, activities and behaviours.
6. A proposal for a study on the public health and socio-economic impact of SSFFC medical products
7. Governance, management and secretariat costs to support the above activities

According to the WHO, activity A will be led by Brazil, activity B will be supported by Switzerland and the United Kingdom, activity C will be led by Argentina, and activity D and F will be led by the WHO secretariat (the others are not specified).

R&D: Financing and Coordination

The EB is expected to consider the establishment of a pooled fund for voluntary contributions towards research and development for type III diseases (affecting overwhelmingly developing countries) and type II diseases (affecting both rich and poor countries, but with a substantial proportion of the cases in poor countries). The fund would also be used for specific research and development needs of developing countries in relation to type 1 diseases (affecting vulnerable populations).

The fund would be hosted by the Special Programme for Research and Training in Tropical Diseases (UNICEF/UN Development Programme/World Bank/WHO joint programme).

According to the follow-up [pdf] of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), the fund would follow the principles formulated by the CEWG, “namely delinkage of the delivery price from research and development costs, the use of open knowledge innovation and licensing for access.”

“The contractual arrangements for the funding of projects will ensure that any future health technologies financed through the fund will be accessible to those in need. Arrangements could include clauses on at-cost or preferential pricing, non-exclusive licensing agreements or licences to WHO or the Special Programme,” according to the follow-up document.

The Executive Board also is expected to consider a report [pdf] by the WHO on the Global Strategy and Plan of action on Public Health, Innovation and Intellectual Property.

Nongovernmental Knowledge Ecology International (KEI) has posted analyses on the R&D work at the upcoming Executive Board, here and here. They note that the report describes “the contours of how such a fund operate, under the management of TDR and its relationship with the proposed Global Health Research and Development Observatory and the ‘future coordination mechanism’.” TDR refers to the WHO Tropical Disease Research section.

Global Vaccine Action Plan

The Board is expected to note an assessment report on the Global Vaccine Action Plan, prepared by the Strategic Advisory Group of Experts on immunisation, who reviewed progress against each of the indicators for the goals and strategic objectives of the plan, according to WHO.

The assessment report on the Global Vaccine Action Plan is available here [pdf].

Ebola, Budget, Financial Strategy

On 25 January, a special session on the Ebola virus will be held, focused on the situation related to Ebola outbreak in West Africa. Documents for this session can be found here.

The EB will also consider the draft proposed programme budget [pdf] for 2016-2017, method of work [pdf] of the governing bodies, and a draft financial strategy [pdf].

An additional item on the agenda is an update on a renovation strategy of the Geneva WHO buildings.

Non-Communicable Diseases

The last World Health Assembly (WHA, the annual member state meeting held in May) requested the WHO to report on the role of WHO in the follow-up to the high-level meeting of the United Nations General Assembly to undertake a comprehensive review and assessment of the progress achieved in the prevention and control of non-communicable diseases (NCDs), which took place on 10-11 July 2014.

The NCDs the WHO is looking at are: cardiovascular diseases, cancer, chronic respiratory diseases and diabetes.

The WHO has issued a proposed work plan for the global coordination mechanism [pdf] on the prevention and control of non-communicable diseases covering the period 2016-2017. The global coordination mechanism is submitted to the board for consideration.

Antimicrobial Resistance

A draft global action plan [pdf] on antimicrobial resistance, which was requested by the last WHA will be presented to the EB for consideration. According to the WHO, the draft global action plan sets out five strategic objectives: “(1) to improve awareness and understanding of antimicrobial resistance; (2) to strengthen knowledge through surveillance and research; (3) to reduce the incidence of infection; (4) to optimize the use of antimicrobial agents; and (5) to ensure sustainable investment in countering antimicrobial resistance.”

Industry Focus: Engagement of Non-State Actors

According to Mario Ottiglio, director of public affairs and global health policy for the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the main area of focus for the upcoming EB is the draft framework for WHO engagement with non-state actors.

“IFPMA would support a framework that shows direct commitment to increase transparency but also sheds some light on what the stakeholders are accountable for,” he told Intellectual Property Watch. Accountability has to be a key driver of the framework, he said.

“Commercial interests are not the only interests where conflicts can apply,” he explained. “Engagement with actors other than the private sector can lead to conflicts of interest from both the perspective of the WHO as well as the partnering organisation.”

The issue is really how member states are going to interpret the rules and provisions of the framework, he said, as overly stringent rules could potentially impact partnerships between the private sector and WHO. It is important that the same approach is taken vis à vis all non-state actors, he said, and this is not yet clear in the draft framework.

On the Global Vaccine Action Plan, Ottiglio said IFPMA should be launching a report in the coming days on what industry has done to support the plan.

MSF Warns against Unaffordable Prices

Meanwhile, Médecins sans Frontières (MSF) is focused on access and new models of research and development that separates the cost of R&D from the product price in the Global Action Plan, an MSF representative told Intellectual Property Watch.

“We hope that the proposed fund from the CEWG will meet the ambitions of the original report, but until now we have not seen member states commit the funds nor the political backing to implement the report’s recommendations,” he said.

On drugs, in some places, the last line of available antibiotics is being used, so MSF is very sensitive to the lack of new antibiotics and supportive of the various efforts to introduce new R&D models. In particular, MSF supports pull and push funding to develop new antibiotics as well as diagnostics that are adapted to the settings in which they work.

On the Global Vaccine Action Plan, MSF remains concerned that the prices of new vaccines has resulted in unaffordable prices, mainly due to the high prices charged by multinational companies, the lack of competition for new vaccines and the lack of transparency for the cost of existing vaccines.

That lack of transparency makes it difficult for countries to negotiate prices and in some instances, developing countries pay a higher price for new vaccines than developed countries, they said. The Global Vaccine Action Plan should in particular make country vaccine price information (prices paid in the public sector) available to WHO and other technical partners to help increase price transparency, they added.

On Ebola, all R&D initiatives should be shared with the WHO product development coordination team, MSF said, adding that it also wants to see target product profiles, for example for diagnostics, that have been developed by WHO, are applied to different efforts to develop appropriate medical tools.

According to MSF, there are intellectual property rights on the various vaccines and treatments being developed for Ebola.

“We are concerned that existing patents could lead to high prices, reduce competition and prevent development of adapted products,” they said.

“But our concern is not focused immediately on IP but that substantial public funding is being dedicated to development of these products without public funders setting any terms and conditions in return for such funding,” said the MSF representative. At present there is no requirement by key donors to ensure product developers meet conditions of affordability and availability of those treatments both now and in the future.”

Funders should be putting more conditions on the R&D funding that they are providing as some of these products should be developed as public goods and there should be assurance that these products will be distributed on an equitable basis once they are shown to be safe and effective, MSF suggested.

 

Image Credits: Catherine Saez