Overall political consensus and initial financial commitments secured during recent World Health Assembly, laying foundations for publicly-led research and development to bridge innovation of and access to essential health tools in developing countries
At the recent 67th World Health Assembly (WHA) in Geneva, a global political consensus by the Member States gave a solid ‘go-ahead’ to advance a process that began over a decade ago to ensure that research and development (R&D) for the priority health needs of developing countries benefits from global public leadership. The process, referred to as the Consultative Expert Working Group (CEWG) process, notably aims at securing sustainable financing and coordination to fundamentally link innovation and access to essential health tools. Initial financial commitments were announced by France, Switzerland, Brazil, and Kenya.

During the Assembly, Member States adopted a decision, which:

• Notes progress made, notably the four ‘demonstration projects’ selected and initiated, and requests progression of the four additional demonstration projects in the selection list;
• Calls for indicators to measure innovative aspects of the projects, including financing, use of open access models, multi-sectoral research platforms, and delinkage, among others;
• Requests the WHO Secretariat to  explore the establishment of a pooled fund for voluntary Member State contributions, potentially to be hosted by the Special Programme for Research and Training in Tropical Diseases (TDR),  stipulating that  it cover R&D for type III diseases (those primarily affecting developing countries), type II diseases (occurring in developed and developing countries but affecting the latter in substantially greater proportion), and the specific R&D needs of developing countries in relation to type I diseases (occurring equally in developing and developed countries). It also stipulated that Member States play a role in the governance of the funding mechanism.

‘We welcome the commitment of Member States to move this process forward by exploring a pooled funding mechanism, implementing demonstration projects, and creating an R&D observatory to help determine global health R&D priorities’, said Dr Bernard Pécoul, Executive Director of DNDi. ‘This is a major step forward, one that we hope will help to build a global framework to sustain innovative approaches to addressing the market and public health policy failures that have left neglected patients without adequate treatments.’

Since its creation in 2003, DNDi has advocated for increased public responsibility and a more enabling environment in which to carry out patient needs-driven R&D. DNDi decided to propose two demonstration projects to the WHO CEWG process, including the selected  project: ‘The Visceral Leishmaniasis Global R&D and Access Initiative’. Through its implementation, DNDi aims to demonstrate that coordination, transparency, capacity building, and innovative research and financing incentives can boost development and delivery of treatments for patients in need, and also ensure that the cost of treatments is not linked to the investment made in their development. The interim outcomes will be examined in 2016, at an open-ended meeting of Member States prior to the 69th WHA.

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About the Visceral Leishmaniasis Global R&D and Access Initiative
The Visceral Leishmaniasis Global R&D and Access Initiative addresses some of the critical R&D gaps in order to provide supporting tools to meet the WHO elimination goals for visceral leishmaniasis (VL). VL is generally fatal without treatment. VL occurs on five continents with endemic transmission reported in 98 countries. VL is one of the most neglected tropical diseases despite the fact that it is the most deadly parasitic disease after malaria. Although the number of treatment options for VL has increased in the past decade, the existing therapies for VL have serious drawbacks in terms of safety, resistance, stability, and cost, and have low tolerability, long treatment duration, and difficult administration in field settings.

The VL Global Initiative’s aim is to demonstrate that health R&D can be incentivized and optimized through:

• innovative incentive mechanisms:

• • to fill R&D gaps, such as the NTDs Drug Booster,
  • to finance R&D notably through pool funding,
  • to increase knowledge, decrease the risk of failure, raise the resources needed, capitalize on existing resources, and
  • develop affordable drugs applying the principle of de-linkage;
• strengthening cross-regional coordination with multidisciplinary partners, and key role of endemic countries.

http://www.who.int/phi/implementation/demo_project_dnd_i/en/

About Drugs for Neglected Diseases initiative (DNDi)
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease, malaria, specific filarial infections, and paediatric HIV.DNDi has established regional disease-specific platforms, which bring together partners in disease-endemic countries to strengthen existing clinical research capacity, as well as to build new capacity where necessary. In East Africa, one such platform is the Leishmaniasis East Africa Platform (LEAP). Since its inception in 2003, DNDi has delivered six treatments: 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 pediatric dosage form of benznidazole for Chagas disease.

DNDi was established in 2003 by Médecins Sans Frontières (MSF or Doctors Without Borders), the Kenya Medical Research Institute (KEMRI), the Indian Council of Medical Research (ICMR), Brazil’s Oswaldo Cruz Foundation (Fiocruz), the Ministry of Health of Malaysia, and the Institut Pasteur in France, with the UNICEF/UNDP/World Bank/World Health Organization’s Special Programme for Research and Training in Tropical Diseases as a permanent observer. www.dndi.org

Press contacts:

Violaine Dällenbach, Press & Communications Manager, DNDi (Headquarters)
Tel: +41 22 906 92 47 / Mobile: +41 79 424 14 74 / vdallenbach@dndi.org

Oliver Yun, Communications Manager, DNDi North America
Tel: +1-646-616-8681 / Mobile: +1-646-266-5216 / oyun@dndi.org