After a decade-long process of analysis and deliberations on ways to better address the health needs of developing countries, a recently released report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) will be discussed this week at the 65th World Health Assembly (agenda item 13.14). The Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, welcomes the experts' conclusion that 'the time has now come for WHO Member States to begin a process leading to the negotiation of a binding agreement on R&D relevant to the health needs of developing countries'.
A decade ago, R&D for poverty-related neglected diseases was at a virtual standstill. Since then, there have been significant changes in the landscape for these diseases, with now some 150 new R&D projects, including for drugs, diagnostics, and vaccines, in the pipeline. This progress stems from international pressure and the engagement of new public and private actors and donors in both endemic and non-endemic countries, as well as initiatives such as product development partnerships (PDPs), which were set up to fill the gaps left by policy and market failures.
However, despite incremental progress, the essential health needs of the vast majority of the world's population are still largely unmet, current R&D efforts are still too fragmented, and financing is still far too fragile. Genuine therapeutic breakthroughs that are adapted to the needs of patients in resource-limited settings and that have the potential to fundamentally transform the treatment of many neglected diseases, notably those with the highest death rates, have yet to make their way through costly clinical trials and reach patients in need.
As a not-for-profit R&D organization that has delivered six new treatments for neglected patients and that has advocated for increased public responsibility and a more enabling environment for neglected disease R&D, DNDi welcomes the analysis and findings of this report.
'The analysis from the WHO consultative expert working group clearly shows that it is time to better coordinate current initiatives, secure additional and sustainable financing of essential health R&D, and strengthen WHO's role in setting R&D priorities so that innovation addresses those most in need and patient access is ensured', said Dr Bernard Pécoul, Executive Director of DNDi.
DNDi published a policy brief to relate the findings of the report to its experience in R&D for neglected diseases. DNDi's own 'lessons learned' include four essential key components:
1. New financing mechanisms are necessary to provide adequate and sustainable funding, secure new funding sources, and engage public responsibility in addressing global health needs.
2. R&D strategies based on open innovation models are critical to boost innovation globally, reduce duplication and costs of R&D, and speed up delivery of new medicines to patients. Such open innovation initiatives supported by public funding should be designed to secure access for patients by delinking the costs of R&D from the price of products, delivered as public goods.
3. Increased involvement of disease-endemic countries in the coordination of R&D, especially in defining priorities based on patient needs and in allocating resources to identified priorities, is essential.
4. Innovative regulatory pathways are needed to ensure timely patient access to treatments, reduce total costs of delivering treatments, and ultimately support greater capacity strengthening in disease-endemic countries.
'We have to give a clear response to the millions of patients who suffer and die every day from neglected diseases, not only in Africa but in all developing countries. Eighty per cent of the world's population will directly benefit if their needs and their voices are reflected in the decisions taken today by the world's governments and the WHO', said Dr Monique Wasunna, Assistant Director, Research, Kenya Medical Research Institute (KEMRI) and Head of DNDi Africa. 'This is a unique chance to make a real and lasting difference to stimulate and sustain innovation and access for neglected patients.'
'Despite this time of financial constraint, additional and sustainable financing for clearly defined priorities is necessary', said Dr Pécoul. 'It is imperative that governments and the WHO take responsibility for defining a new framework for better coordination of essential health R&D to address the needs in developing countries and for generating new funds for this purpose. After a decade of discussions, it is time now to act.'
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development organization working to deliver new treatments for neglected diseases, in particular sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, specific helminth infections, malaria, and paediatric HIV. DNDi was established in 2003 by Médecins Sans Frontières/Doctors Without Borders (MSF), the Oswaldo Cruz Foundation (FIOCRUZ) of Brazil, the Indian Council of Medical Research (ICMR), the Kenya Medical Research Institute (KEMRI), the Ministry of Health of Malaysia, and the Pasteur Institute of France. The Special Programme for Research and Training in Tropical Diseases (WHO-TDR) serves as permanent observer.
Since its inception in 2003, DNDi has delivered six new treatments for neglected patients: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease.
DNDi has helped establish three clinical research platforms: Leishmaniasis East Africa Platform (LEAP) in Kenya, Ethiopia, Sudan, and Uganda; the HAT Platform based in the Democratic Republic of Congo (DRC) for sleeping sickness; and the Chagas Clinical Research Platform in Latin America. Strong regional networks such as these help strengthen research and treatment-implementation capacity in neglected disease-endemic countries. www.dndi.org