Not-for-profit research and development can address deadly market failure for neglected patients, paper shows

Berlin, Germany – 30 October 2019

15 years of an ‘experiment in innovation’ to discover and develop affordable new treatments in the public interest

In its first 15 years, the Drugs for Neglected Diseases initiative (DNDi) has proven that not-for-profit research and development (R&D) can deliver effective and affordable new treatments to help fill the drug development pipeline for neglected diseases, an area that was suffering from a deadly lack of attention when the organization was created in 2003, according to a new report released today at the two-day DNDi & Founders’ Symposium in Berlin, Germany.

The report, entitled “15 years of needs-driven innovation for access“, is an in-depth overview of both the successes and challenges DNDi has experienced in delivering and advocating for public-interest, needs-driven R&D.

DNDi 2019 Model Paper cover page

15 years of needs-driven innovation for access
Key lessons, challenges, and opportunities for the future

Download report
Download executive summary

“DNDi is among a small number of non-profit product development partnerships working in R&D for the public interest, with a particular focus on the discovery and development of affordable new treatments for neglected diseases and neglected populations,” said Dr Soumya Swaminathan, Chief Scientist of the World Health Organization, a founding partner of the initiative.  “In 15 years, DNDi has developed successful collaborative approaches, from early research through to patient access, and we can learn from their achievements – such as the delivery of the first oral treatment for sleeping sickness last year, and their global collaborations exchanging expertise worldwide. We must also take note of the considerable challenges these initiatives face, and recognize that these innovations are on the critical path to achieving universal health coverage.”

These issues are being discussed today by over 150 leaders in public health who gathered in Berlin, on the sides of the World Health Summit, to celebrate DNDi’s 15-year anniversary and discuss the lessons learnt from its alternative R&D model in an evolving – and increasingly unpredictable – global health environment.

“The World Health Summit 2019 provides an opportunity to reflect on 15 years of the DNDi experience to reinvigorate R&D for neglected indications— and draw lessons learned from this important endeavour to leverage public, private and academic research and development worldwide to introduce new treatments and advance universal health coverage,” said Ilona Kickbusch, Chair of the International Advisory Board at the Graduate Institute of International and Development Studies’ Global Health Centre.

The report, contributes to the current global debate about how to sustain innovation in the public interest, by reflecting on the characteristics of DNDi’s alternative, non-profit model for R&D, including:

  • A commitment to R&D cost transparency, which informs the debate around how much it costs to develop drugs: Adjusting for attrition, DNDi estimates that it can develop and register new combinations or new formulations of existing treatments for €4-32 million, and an entirely new chemical entity for €60-190 million.[1]
  • A model driven by therapeutic needs: While innovation in biomedical R&D is driven most often by market interests, DNDi’s model is based on patients’ needs. The use of public-interest “target product profiles” to guide R&D includes concerns around access and affordability from the outset.
  • Harnessing the best of public, private, non-profit and philanthropic sectors to bring the best science to the most neglected and drive knowledge creation through open and collaborative approaches.
  • Leadership from disease-endemic countries: Having low- and middle-income countries drive research has built on existing research capacities and helped create new “innovation ecosystems” in countries affected by neglected disease.
  • Ensuring financial and scientific independence can guarantee a needs-based approach to priority setting and decision-making.
  • Piloting and incubating new approaches to innovation to promote public health-driven R&D, and engaging as an informed advocate for a more effective and more equitable biomedical R&D system.

 

 

DNDi owes its successes to collaborations with a large global network of over 180 partners from the pharmaceutical industry, academia, health ministries, other NGOs, treatment providers, and patients and their communities, as well as our donors,” said Dr Bernard Pécoul. “We are the conductors of a ‘virtual orchestra’, and the eight new treatments we have delivered in the past 15 years would not exist without the commitment and shared vision of our partners and donors.”

DNDi was created in 2003 by seven founding partners: the Indian Council of Medical Research (ICMR), the Oswaldo Cruz Foundation in Brazil (Fiocruz), the Kenyan Medical Research Institute (KEMRI), the Malaysian Ministry of Health, the Institut Pasteur of France, and Médecins Sans Frontières (MSF), with the participation of the World Health Organization Special Programme on Research and Training in Tropical Diseases (WHO/TDR). Faced with the lack of safe and effective medicines to treat people with neglected tropical diseases, MSF committed a portion of its 1999 Nobel Peace Prize award to the exploration and launch of DNDi as an alternative, not-for-profit model for drug development.

The DNDi experiment was born from the frustration felt by MSF doctors unable to treat patients because of the lack of adapted or affordable tools”, said Dr Christos Christou, President of MSF International. “Fifteen years later, the concrete results of DNDi’s needs-driven R&D model are clear, with treatments delivered that have helped us improve and save the lives of patients in the field. Looking ahead, MSF and DNDi will keep working together for all those neglected populations in need around the world.

 

 

[1] Figures do not include post-registration studies and access costs, nor in-kind contributions from pharmaceutical partners

 

 

About DNDi

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development organization working to deliver new treatments for neglected diseases – notably leishmaniasis, sleeping sickness, Chagas disease, specific filarial infections, and mycetoma – as well as treatments for neglected patients, particularly those living with paediatric HIV and hepatitis C. Since its inception in 2003, DNDi and its partners have already delivered eight innovative treatments to improve the quality of life and health of patients. www.dndi.org

 

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