Public health advocates urge WHO action on alternative R&D financing

The Open-Ended Meeting of Member States to Assess Progress and Continue Discussions on the Remaining Issues in Relation to Monitoring, Coordination and Financing for Health Research and Development took place from 2-4 May. The first two days were open to nongovernmental groups, which offered views, followed by one day of closed governmental negotiations.

The outcome report and draft decision from the meeting is available here. Sections marked yellow indicate a relative degree of agreement, according to a source, but most of the document is in brackets indicating lack of agreement so far.

Hopes have been running high that governments will finally agree on alternative ways to fund R&D for medical products including medicines, diagnostics and vaccines for diseases predominantly affecting poor populations. Some of this hope stems from the UN Secretary General’s High Level Panel on access to medicines, which is working fervently to bridge “policy incoherence” on this issue and issue a report next month (IPW, Public Health, 19 March 2016).

But last week’s WHO meeting showed little progress, though a number of proposals are now on the table for the 18-26 May World Health Assembly to discuss (IPW, WHO, 9 May 2016).

Some were concerned about the slow progress.

“It was a low energy negotiation,” Knowledge Ecology International President James Love said afterward. “It should have been about finding how to structure an agreement so that countries find in it their interest to fund R&D as a public good. That did not happen last week.”

Interventions by IGOs, NGOs

Numerous international and nongovernmental organisations made statements to the open-ended meeting. Below are highlights of a few received by Intellectual Property Watch.

The Drugs for Neglected Diseases initiative (DNDi)’s Bernard Pécoul said there is insufficient R&D into neglected diseases, emerging infectious diseases, and antimicrobial resistance, according to notes from his remarks. Patients are unable to access new hepatitis C treatments because of price, he said.

These examples illustrate how the system to drive and finance medical innovation is failing to deliver on different fronts, he said, adding that all are public health priorities and many are priorities for all countries, regardless of income level.

Pécoul said this underlines the need for a comprehensive framework that ‘connects the dots’ and addresses all areas of market failure. There is no longer a clear division between diseases and countries.

“By multiplying different R&D frameworks for different diseases, we will perpetuate fragmentation and duplication,” he said, according to the notes. “We will fail to address the common critical problems:  no coordination, no globally agreed priority setting, and no norms that guide different R&D initiatives.”

He described lessons learned from DNDi efforts that he said have shown alternative approaches to R&D are possible. He said it is vital to set priorities based on public health needs rather than commercial gain, and to have coordination of the multiple partners involved in R&D.

He also said approaches based on the CEWG principles of open innovation, de-linkage, and affordable access allow for needs-driven, lower cost and more efficient R&D. Public leadership is needed, he said, and urged member states to support the new WHO Global Observatory and pooled fund, to request acceleration of priority-setting, and to ask for a policy framework.

Médecins Sans Frontières (MSF, Doctors Without Borders), in its statement, also said it supports the fund, but that the scope needs to “’join the dots’ so that all areas of market failure are covered,” whether diseases mainly affecting developed or developing nations. This means the fund should cover emerging infectious diseases like Ebola and others in the WHO Global R&D blueprint, as well as development of new antibiotics.

“The proposed fund should have a clear mandate that ensures that all calls for proposals make clear that successful applications will implement the innovation for access principles formulated in the CEWG report and summarized in WHA 66.22 – ‘affordability, effectiveness, efficiency and equity,’” it said, including ‘de-linkage of the cost of research and development from the price of health products.’ This should apply to the management of intellectual property.

“We believe there is an important role for governments to take their responsibility to set priorities in R&D,” MSF said. Nevertheless, the question of whether member states are ready to decide on a fund should not limit discussions on the follow-up of the broader CEWG report recommendations, it said.

Last week, MSF also issued a report on R&D, called, “Lives on the Edge: Time to align medical research and development with people’s health needs.”

Health Action International, Knowledge Ecology International (KEI) and STOPAIDS gave a joint statement during the meeting. They highlighted the CEWG’s emphasis on delinkage in 2012, said little progress has been made since then, noted the UN High-Level Panel and the need for policy coherence, and said the Global Observatory should help with transparency of markets for pharmaceuticals.

“It is challenging but important for the WHO to reach consensus on the modalities for discussions about new agreements on funding R&D,” the groups said. “In our view, the parties should show flexibility on many issues, including the nature of the instrument or instruments that would be considered. What is important is for governments to agree to build models for funding R&D that do not rely on high prices, and that public health needs should shape funding priorities.”

Separately, KEI called for:

• The WHO should convene a meeting to consider the incentives that would induce member states to fund medical R&D as a public goods.
• The R&D Observatory should collect and publish data on R&D costs, as well as the text and/or the terms of licenses on publicly funded R&D

Oxfam, in its statement, highlighted the UN High Level Panel as a unique opportunity on these issues. “We hope that the panel’s report reinstates the supremacy of the human right to health over intellectual property rights,” it said.

Two areas are likely to move forwards with delinking of financing R&D from pricing of products, it said: AMR and R&D for emerging infections.

Oxfam took issue with the lack of funding for WHO efforts to find alternative funding for R&D, particularly that member states have not funded the demonstration projects to which they all agreed.

“We urge the CEWG to establish mechanisms for all countries to contribute an obligatory % of GDP to R&D for medical technologies as a matter of urgency as part of an overall R&D framework,” it said.

The group also called for transparency, such as in the real cost of R&D, the patent status in all countries, clinical trials, free trade agreement negotiations, and pricing.

I was born in 1994. This was the year the TRIPS agreement was negotiated. For my entire lifetime people have been dying because they do not have access to the medicines they need. – UAEM student

Meanwhile, Universities Allied for Essential Medicines (UAEM) offered perhaps the most striking intervention, from a medical student who said: “I was born in 1994. This was the year the TRIPS agreement was negotiated. For my entire lifetime people have been dying because they do not have access to the medicines they need.” [TRIPS refers to the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights]

“And for more than half of my life you, the World Health Organisation, have been discussing this and have given the mandate to several working groups to ‘explore innovative approaches to ensuring access to medicines for people most in need’,” she said. “Progress has been painfully slow and meanwhile patients continue to suffer and die.”

The issue no longer affects only low and middle income countries, but “is a global issue affecting all countries,” the group said. “Sustainable, systemic and global solutions for all types of diseases are needed now to address the root causes of the existing access and innovation crises.”

UAEM noted that the CEWG recommended a global legally-binding framework to ensure sustainable funding and coordination of R&D.

“The weekend before last, hundreds of students from all over Europe gathered to call for a new approach to biomedical R&D that focuses on patients and their needs, not profits,” the speaker said. “Over 450 academics including 4 Nobel Laureates also sent a letter [pdf] to this open ended meeting supporting an R&D Agreement.”

“For us, as the future generation, this is an urgent moral issue,” the group said. “We cannot afford to delay the discussion of an R&D Agreement any more, we cannot afford that the Observatory is almost the only outcome from this meeting presented at the WHA.”

UAEM led a march from WHO to the Place des Nations in front of the UN Office in Geneva during last week’s meeting.

Medicus Mundi, another group, at the WHO Executive Board in January also highlighted the R&D issue, urging member states “to ensure that the final agenda includes the discussion of the R&D Agreement.”

“CEWG recommendations are to be implemented as a single framework, including financing priority areas identified by the Observatory, by means of de-linkage and open access approaches,” the group said. “We are concerned with the current fragmented implementation.”

And it said the budget gap of 88% for WHO efforts on this shows the need for mandatory contributions for a new R&D framework.

Source: Intellectual Property Watch