As part of its mission and since its inception, DNDi has advocated for increased public responsibility and a more enabling environment for neglected disease R&D.
DNDi statement at 138th session of the WHO Executive Board
DNDi statement at 68th World Health Assembly
“Demonstration Financing: Considerations for a Pilot Pooled International Fund for R&D”
A new paper recently commissioned by DNDi examines the possibilities of creating a pooled international R&D fund for the Demonstration Projects that were selected as part of the process following on the report of the WHO Consultative Expert Working Group on Research and Development (CEWG): “Demonstration Financing: Considerations for a Pilot Pooled International Fund for R&D.”
Authored by Suerie Moon of the Harvard School of Public Health, the paper explores the:
- Potential Limitations and Opportunities;
- Principles and Policies; and
- Governance Arrangements
of a Pilot Pooled International Fund (pPIF) for the four Demonstration Projects.
The paper is available here.
WHO CEWG process: Identification of Health R&D Demonstration Projects
WHO Member States from every regions are currently going through a selection process of “demonstration projects” in order to provide evidences on innovative mechanisms to fund and coordinate public health R&D to address unmet medical needs of developing countries and to contribute to further discussion on a sustainable global framework as recommended by the Expert Working Group on Financing and Coordination (CEWG).
DNDi has been involved in the overall CEWG process. Specifically, DNDi has submitted two candidate demonstration projects with the aim to demonstrate that projects can be optimized through guiding principles such as cross-regional collaboration of existing networks, open-innovation and knowledge sharing, equitable access to new products, and sustainable funding secured through existing and new funding mechanisms. DNDi is also partner in another candidate demonstration project, on cutaneous leishmaniasis, submitted by the US Food and Drug Administration and Osaka University.
On December 3-4 2013, after weeks of consultations, MSs and experts assessed 22 proposals for the identification of health R&D Demonstration Projects, and finally selected 7+1 projects – including DNDi and partners’ project on Visceral Leishmaniasis
At the end of the December meeting, MSs requested that the secretariat seek further elaboration from the original proposers of the 7+1 short-listed proposals on innovative aspects of their projects, and that the so-called “addendum” were reviewed at the 134th meeting of the WHO Executive Board (EB) on January 20-25 January 2014.
Summaries of the 7+1 proposals as well as addendum submitted to the WHO Secretariat: http://www.who.int/phi/implementation/7_1_demo_proj_informal_document.pdf
Finally, as the outcome of the EB, Members Sates requested the WHO secretariat to “consider the demonstration projects in the order listed (..) and taking into account the additional information received with the participation of the Chair and Vice-Chair of the CEWG, as appropriate start convening virtual or direct meetings with stakeholders interested in funding and/or implementing the projects (…)”. Report of these initial steps will be released at the World Health Assembly for further consideration.
Read more about the DNDi demonstration project on the WHO website:
Projects submitted by DNDi and its partners
- The Visceral Leishmaniasis (VL) Global R&D & Access Initiative (Submitted and selected)
- Addendum to the “The Visceral Leishmaniasis (VL) Global R&D & Access Initiative” project
- Chagas R&D Accelerator Initiative: A Coordination Mechanism For Accelerating The Development Of New Health Tools For Chagas Disease (Submitted)
To mark its 10 year anniversary, DNDi has issued a report that explores the lessons learned from a decade of research and development (R&D) of new treatments for neglected diseases via a cost-effective, innovative, not-for-profit drug development model.
An Innovative Approach to R&D for Neglected Patients:
Ten Years of Experience and Lessons Learned by DNDi
This report provides elements to stimulate current discussions on the way forward for sustainable mechanisms to provide health tools for developing countries.
DNDi’s cost of development ranges from EUR 6-20 million for an improved treatment, and EUR 30-40 million for a new chemical entity. However, the usual attrition in the field of R&D for infectious diseases, and the inherent risk of failure, should be taken into account, bringing the cost range of an improved treatment to EUR 10-40 million, and EUR 100-150 million for a new chemical entity.
At an international event in New York on 13 and 14 December 2012 organized by DNDi and MSF, ‘Lives in the Balance’, a group of the key actors in the field of Chagas disease – from R&D to treatment access and prevention – announced their plans to join forces to address the needs of Chagas disease patients. The ‘Global Chagas Disease Coalition’ calls for increased collaboration to change the course of this disease that affects millions throughout Latin America and beyond.
Following the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), which will be discussed at the upcoming World Health Assembly (agenda item 13.14) in May 2012. This report makes major recommendations to implement the ‘WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Rights’ in a sustainable manner, notably by strengthening financing and coordination of health research to address the needs of developing countries. DNDi has issued a policy brief: concerning the CEWG report: ‘Transforming Individual Successes into Sustainable Change to Ensure Health Innovation for Neglected Patients: Why an Essential Health R&D Convention Is Needed’. Based on our own experience, the brief outlines the factors that we deem essential, in the long term, for enhancing R&D to respond to the needs of neglected patients in developing countries: open innovation and pro-access IP management, sustainable financing mechanisms, coordination of R&D with commitment from endemic countries, and innovative regulatory pathways.
DNDi POLICY BRIEF, April 2012
“Transforming Individual Successes into Sustainable Change
to Ensure Health Innovation for Neglected Patients:
Why an Essential Health R&D Convention Is Needed“
In Europe, DNDi works together with partners from civil society and seven other PDPs in order to advocate also for more leadership of the European Union (EU) in addressing research gaps for poverty-related and neglected diseases. The new upcoming EU Framework for Research and Innovation “Horizon 2020” and the continuation of a revised EDCTP programme will be unique opportunity to demonstrate active leadership in the area of product-oriented and patient driven world-class research. The two position papers suggest to policy leaders, how this can be done.
POSITION PAPER, April 2012
endorsed by DNDi and 7 other PDPs for the EU to engage in NTDs R&D
“Research & Innovation for Neglected Diseases:
from product development partnerships (PDPs)
for Inclusion in Horizon 2020″
Call endorsed by 24 civil society organizations, global health networks and PDPs
“Call to EU leadership on global health R&D”
POSITION PAPER, April 2012
endorsed by DNDi and 30 NGOs and PDPs for the EU to engage in NTDs R&D
“Research and Development for poverty related and neglected diseases:
A priority in the new EU research framework HORIZON 2012″
December 2011 – Call to Action for Latin America to Boost Innovation and Access for Neglected Patients in the Region
6 ACTIONS FOR 2012 AND BEYOND
DNDi’s 4th Partners’ meeting took place this year in Rio de Janeiro, Brazil, on December 2nd. DNDi’s progress in bringing new treatments to neglected patients was reviewed and the main challenges in access to new tools were evaluated, resulting in a Call to Action. More than 260 participants including international health researchers, policy makers, and experts from around the world participated.
Read the Call to Action
In July 2009, on the occasion of the Centenary of the discovery of Chagas disease, DNDi launched a campaign to draw attention to the huge gaps in treatments for Chagas patients. ’Research on Neglected Diseases. Time to Treat Chagas Disease!’ brought to light the stark realities surrounding the disease.
In June 2008, before the G8 Summit in Japan, DNDi released a statement endorsed by the World Health Organization (WHO) urging the G8 governments to support both, control programmes and R&D initiatives for NTDs.
Read the press release
In February 2009, DNDi and Médecins Sans Frontières called for a scale-up of R&D in the form of increased governmental and private sector commitments to combat deadly neglected diseases that afflict millions of the world’s poorest.
Read the press release
In June 2005, for example, DNDi launched a global appeal supported by 19 Nobel Laureates to trigger off strategic mobilisation about the need for government leadership in ensuring a sustainable commitment towards boosting essential health innovation. More on the appeal
More Sustainable Resources Needed
Despite the establishment of Product Development Partnerships like DNDi and new commitments from public and private donors, funding for scientific and medical innovation for diseases that disproportionably affect the developing world remains inadequate.
The R&D funding gap is particularly severe for the most neglected tropical diseases, which offer virtually no commercial market to product developers. Greater investment, complemented with innovative funding mechanisms and incentives, are needed from both governments and the private sector to ensure that these efforts are sustained and strengthened.
Today, global neglected disease R&D funding in 2009 totalled US$ 3.2 billion (including malaria, tuberculosis and HIV/AIDS). Of this amount, only US$ 162 million – about 5% – was spent on the kinetoplastid diseases (sleeping sickness, leishmaniasis, and Chagas disease), which are the focus of DNDi ’s efforts.
More information on the G-Finder report 2010, Neglected Disease Research and development: Is the gobal financial crisis changing R&D? [PDF 5.8MB!]
Enabling R&D Environment
Public leadership is needed to implement policy changes that will support development of new, essential health tools, to ensure equitable access for affected populations; and to contribute to the development of innovative, needs-based measures such as intellectual property management policies to encourage needs-driven R&D, technology transfer, an enabling regulatory environment and strengthening of research capacities in developing countries.
DNDi and the George Institute launched in February 2010 a new report on the challenges of registering new drugs for neglected diseases in the African context. There is a need to think about new mechanisms and pathways to ensure the urgent approval of new drugs.
Download the report here
More information on this
Although a comprehensive, sustainable solution to the problem of neglected disease R&D has not yet emerged, governments, experts, and industry have proposed a number of new ideas, including both “push” mechanisms to finance R&D, and “pull” incentives to spur private sector investment.
In 2006, WHO has established an expert working group to examine current financing and coordination of R&D, as well as new proposals to stimulate innovation related to Type II (that occur in both rich and poor countries such as HIV/AIDS and tuberculosis) and Type III diseases (those overwhelmingly or exclusively occurring in the developing countries such as sleeping sickness and African river blindness).
All discussions on going are critical to moving forward and concrete actions must be taken if we are to bring new treatments to patients who desperately need them.