Special Feature: WHO Still On Trail Of New Financing For R&D For Poor Populations’ Medical Needs

World Health Organization members are expected to meet this spring to assess progress and discuss potential solutions to the lack of financing for research and development for diseases affecting primarily developing countries.

The WHO Executive Board last week discussed and noted a report by the WHO secretariat for the preparation of the open-ended meeting. The exact date of the meeting is not certain, according to WHO officials, but would likely be in March or April.

The 138^th Executive Board (EB) meeting took place from 25-30 January. The EB document EB138/39 [pdf], a report by the director general, presented a draft outline of the provisional agenda for the open-ended meeting.

According to the document, in May 2013, “the Health Assembly adopted resolution WHA66.22 on follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination [CEWG].” The resolution asked the WHO director general to convene an open-ended meeting before the May 2016 World Assembly “to assess progress and continue discussions on the remaining issues in relation to monitoring, coordination and financing for health research and development…”

The CEWG agenda includes the establishment of the WHO Global Observatory on Health Research and Development, launched in January, which will collect and collate data on funding for health research and development, health products in the pipeline, clinical trials and research publications. The CEWG also includes six “demonstration” projects, which were selected in 2013.

The demonstration projects were intended not to be ordinary development projects, but rather to try new ways to fund the research, Marie-Paule Kieny, WHO assistant director-general for health systems and innovation, told Intellectual Property Watch. Some of the demonstration projects needed time to come into compliance, she said, including intellectual property provisions.

A broader principle of the CEWG is finding alternatives that de-link price from the cost of doing research and development.

Neither the observatory nor the projects has received their projected level of financial support. The CEWG also is working on a coordination mechanism, and a pooled voluntary fund. For the pooled fund, member states asked to explore options, and the WHO Tropical Disease Research (TDR) department is being asked to start it, according to Kieny.

Members Support Global Observatory

During the EB discussion, Brazil noted the underfunding of the demonstration projects and the global observatory, he asked how the CEWG would coordinate with the United Nations High-Level Panel on Access to Medicines (IPW, Public Health, 16 December 2015; IPW, Public Health, 1 February 2016).

Brazil suggested Bhanu Pratap Sharma, secretary in India’s Department of Health and Family Welfare, act as chair of the open-ended meeting. This was seconded by Nepal and Switzerland.

Liberia, for the WHO Regional Office for Africa, supported the global observatory and said a true mapping of available resources in individual countries could help their capacities.

Time for Government Funding; US Sees US$4 Billion Potential

So far, the secretariat has received only US$7.65 million out of the needed US$85 million over 2014-2017, as stated in EB138/39. And Kieny noted that some of the $7.65 is only in pledges, so WHO is still waiting on the payments.

During the CEWG process, it was suggested to make voluntary contributions of 0.01 percent of each nation’s (including the smallest economies) gross domestic product.

The United States remarked on the lack of funding for the demonstration projects. The US has met the 0.01 percent level of contribution, US officials told Intellectual Property Watch, through the more than US$1 billion already budgeted to research and development for neglected diseases under the National Institutes of Health. The WHO secretariat said later that the US is the only country that met the 0.01 percent target so far.

The $7.65 million collected so far is aimed at the demonstration projects, and came from voluntary contributions or pledges from Brazil ($1m), India, Norway, South Africa and Switzerland (the US contribution is not counted in this). Switzerland ($2m) and Norway (about $500,000) pledged as matching grants for contributions from low- and middle-income member states on a basis of a “half-dollar for each dollar,” according to the secretariat document EB138/39.

The EB document said 97 percent of the received funds have been used already. WHO’s Marie-Paule Kieny said in an interview afterward that the pledges need to be turned into cash now, as the funding is needed to take the work forward. But she also said that all of the $85 million is not needed up front but rather along the way.

Meanwhile, the US said in the meeting that totalling up 0.01 percent of the past two years’ GDP of the middle-income countries alone would equal some $4 billion.

“We would welcome for the discussion on this matter to include how to bring voluntary funding to scale at the member state meeting,” the US delegate said. “Given the limited investment from governments in demonstration protects we hope that this stocktaking exercise will explore concepts such as the establishment of innovative public-private partnerships, which can contribute to financing goals, in ways that still promote the concept of de-linkage of price with intellectual property in low income countries,” he added.

“One of the significant problem in neglected disease therapeutic development is the risk aversion of venture philanthropy in this space,” he said.

Need to Accelerate R&D Efforts

India welcomed the agenda for the open-ended meeting but said some “critical elements” need to be emphasised. “The urgency to accelerate R&D efforts to meet the health needs of developing countries has been reinforced by many recent developments including the Ebola crisis, the emergence of AMR [antimicrobial resistance] and the increasing barriers to access new medicines,” the Indian representative said.

The focus of the CEWG “is not only on access and affordability but also on new medicines, diagnostics and vaccines,” he said.

“The CEWG agenda must be inclusive and go beyond the demonstration projects or the global health R&D observatory,” he said, and added that full attention is needed on “the elaboration of an R&D agreement for essential health research and developing a sustainable financing mechanism.”

India also called for the participation of “relevant non-state actors” in the process, given their strong interest, and they “should be allowed to participate and share their perspectives on implementing the CEWG agenda.”

Colombia also stressed the important of easier access to drugs, in particular for hepatitis C and cancer, underlining that the high cost of drugs could be brought down by strong conditions for competition.

WHO Details Agenda for Open-Ended Meeting

Kieny told the EB that WHO is “happy to see that the interest remains among all stakeholders in spite of the long life of this topic in WHO.”

“If I dare compare with a racing competition,” she said, “this looks like marathon more than sprint, but even with marathon we are getting somewhere.”

The financial gap so far to bring the demonstration projects to a successful completion and the observatory stands at US$75 million out of a total of US$85 million, she said, “so we are very far from reaching the goal, and I don’t even envisage the figure like US$4 billion mentioned by the US, which seems very far from what we have been able to raise so far. But member states might want to discuss during the open-ended meeting of a financial mechanism.”

On the open-ended meeting agenda, Kieny said the WHO has worked on an agenda for the 3-day meeting that is more developed that the one included in the EB document. It is not proposed to have a first day focussing on the overall progress of the strategic work plan, which was accepted by member states, as well as a presentation from the United Nations High Level Panel on Access to Medicines, “so everybody understands what this is.”

During the second session, she said, a presentation would be made on work relevant to the CEWG and in particular neglected tropical diseases, the R&D blueprint, the global action plan on antimicrobial resistance, the World Intellectual Property Organization Re:Search, the trilateral cooperation on health innovation and access between WHO, WIPO, and the World Trade Organization. Every session would be followed by member state discussions, she said.

Financing and coordination of R&D would then be discussed, she added. “We propose to have the first part of the meeting open to civil society,” and member states would have to decide if they want the last session open or closed, she said.

NGOs Call for Urgent Financing

A number of non-governmental organisations called for urgent action to fund research and save lives. All NGOs statements made at the EB are here.

Medicines for Malaria Venture (MMV), said in its statement, “The upcoming open-ended meeting should be an opportunity to invite innovative collaborations driven by a public health mandate, such as product development partnerships, to contribute to this important discussion.”

The Drugs for Neglected Diseases initiative (DNDi) in its statement, praised the establishment of the Global Observatory. “Our experience over the last decade has shown it is possible to work openly and collaboratively with a variety of partners to develop affordable and appropriately adapted drugs, provided there is clear definition of needs target product profiles, careful coordination of partners and policies to ensure equitable access.”

“We urge member states to consider more ambitious financing goals to ensure the level and sustainability of funding required,” the DNDi representative said. DNDi is a beneficiary of such funding.

Medicus Mundi International (MMI), also speaking on behalf of Universities Allied for Essential Medicines, the People’s Health Movement, the Third World Network, and Knowledge Ecology International, said in its statement that the main recommendation of the CEWG report was “a legally-binding R&D [research & development] Agreement for medical technologies to address the unmet health needs of developing countries due to market failure.”

“The current budget gap of $75 [million] out of $85 million dollars for the demonstration projects and observatory shows that voluntary funding is unsustainable. This highlights the need for mandatory contributions for a new R&D framework,” the MMI representative said.

Médecins Sans Frontières (Doctors without Borders – MSF) in its statement warned against the fragmentation of proposals to solve “the interconnected innovation crises,” including Ebola, infectious diseases, and antimicrobial resistance, which was also evoked by India.

“As we look ahead to the open-ended meeting, we hope that time is made for member states to evaluate other proposals for R&D blueprints and frameworks being considered by WHO and other forums, in order to ensure coherence with both the CEWG recommendations and the Global Strategy and Plan of Action (GSPA),” the MSF representative said.

 

Image Credits: William New