Identification of Health R&D Demonstration Projects
The demonstration projects
These projects should aim at developing health technologies (medicines, diagnostics, medical devices, vaccines, etc.) for diseases that disproportionately affect developing countries and for which identified R&D gaps remain unaddressed due to market failures. The projects must demonstrate effectiveness of alternative, innovative and sustainable financing and coordination approaches to address identified R&D gaps.
Meeting to Examine Additional Information Received – 10 March 2014
The meeting to examine the additional information received in relation to the 7+1 demonstration projects identified by the Global Technical Consultative Meeting took place on 10 March 2014 at WHO headquarters. The former Chair and Vice-Chair of the CEWG, facilitated by the Secretariat and observed by Member States, assessed the 7+1 identified projects based on the 6 additional questions posed to proponents. The purpose of this assessment was to determine which of the 8 proposals were ready enough to move forward with stakeholder meetings before the World Health Assembly and which required more work.
Based on this assessment, it was determined that the Secretariat will move forward with convening stakeholder meetings for the following 4 proposals:
- The Visceral Leishmaniasis (VL) Global R&D & Access Initiative - Drugs for Neglected Diseases initiative (DNDi), submitted via AFRO and EMRO.
- Exploiting the Pathogen Box: an international open source collaboration to accelerate drug development in addressing diseases of poverty – Medicines for Malaria Venture (MMV), submitted via EURO.
- Development of Class D Cpg Odn (D35) as an Adjunct to Chemotherapy for Cutaneous Leishmaniasis and Post Kala-Azar Dermal Leishmaniasis (Pkdl) - United States Food and Drug Administration (US FDA), et al., submitted via AMRO.
- Development for Easy to Use and Affordable Biomarkers as Diagnostics for Types II and III Diseases - African Network for Drugs and Diagnostics Innovation (ANDI), et al., submitted via AFRO.
Noting the significant public health impact and scientific and technical merit of the remaining 4 projects, it was agreed that although these projects are not ready enough to move forward to the implementation stage, the Secretariat will assist the proponents of these proposals in improving the innovative aspects of their projects (if they so desire):
- Multiplexed Point-of-Care test for acute febrile illness - Translational Health Science and Technology Institute (THSTI), India, et al., submitted via SEARO.
- Demonstration of the potential of a single dose malaria cure of artemether-lumefantrine through reformulation in a nano-based drug delivery system - Council for Industrial and Scientific Research, South Africa, et al., submitted via AFRO.
- Development of a Vaccine Against Schistosomiasis Based on the Recombinant Sm14 A Member of the Fatty Acid Binding Protein: Controlling Transmission of a Disease of Poverty - Oswaldo Cruz Foundation (Fiocruz), et al., submitted via AMRO.
- Dengue vaccine development - Health Systems Research Institute (HSRI), Thailand, et al., submitted via SEARO.
Health R&D Demonstration Projects at the 134th WHO Executive Board
On 24 January 2014, the 134th Executive Board adopted a decision which laid out the next steps with respect to the selection of demonstration projects. The EB requested the Director-General to consider the 7+1 demonstration projects in the order identified by the Global Technical Consultative Meeting of Experts and, with the participation of the Chair and Vice-Chair of the CEWG as well as 1 Member State (acting as an observer) from each of the six WHO regions, to take into account the additional information received from the proponents.
This evaluation meeting will take place at WHO Headquarters in Geneva on 10 March 2014. Based on this evaluation, the EB decision requests the Director-General to start convening meetings for stakeholders interested in funding and/or implementing the project(s). These meetings will aim to further develop project plans and mobilize the financial resources necessary for implementation of the projects.
As per the selection procedure agreed upon by Member States at the 134th Executive Board, the six Member States participating as observers are:
- African Region: Congo
- Region of the Americas: Cuba
- Eastern Mediterranean Region: Egypt
- European Region: Malta
- South-East Asia Region: Sri Lanka
- Western Pacific Region: Philippines
Conclusion of the Global Technical Consultative Meeting on Identification of Health R&D Demonstration Projects, 3-5 December 2013
The meeting ended after three days of deliberations. On 3 and 4 December, 19 experts from all six WHO regions evaluated 22 shortlisted proposals received from the six regional offices after due regional consultative processes.
Experts were asked to provide a Declaration of Interest (DOI) with respect to individual proposals. Seven experts were found to have some potential conflicts of interest with specific proposals and were therefore asked to recuse themselves from the discussions and decisions on the relevant proposals.
Employing an agreed assessment framework, the proposals were assessed by the experts in three rounds. Finally, 7 plus 1 projects were identified as demonstration projects to be submitted to the Executive Board for consideration:
7+1 Identified demonstration projects
- The Visceral Leishmaniasis (VL) Global R&D & Access Initiative
- Multiplexed Point-of-Care test for acute febrile illness
- Demonstration of the potential of a single dose malaria cure of artemether-lumefantrine through reformulation in a nano-based drug delivery system
- Exploiting the Pathogen Box: an international open source collaboration to accelerate drug development in addressing diseases of poverty.
- Development Of A Vaccine Against Schistosomiasis Based On The Recombinant Sm14 A Member of The Fatty Acid Binding Protein: Controlling Transmission Of A Disease of Poverty.
- Development Of Class D Cpg Odn (D35) As An Adjunct To Chemotherapy For Cutaneous Leishmaniasis And Post Kala- Azar Dermal Leishmaniasis (Pkdl)
- Development for Easy to Use and Affordable Biomarkers as Diagnostics for Types II and III Diseases
- Dengue vaccine development
On 5 December 2013, Member States held a discussion on the outcome of the technical consultation, which was partially opened to NGOs in official relations with WHO as well as to the experts that participated in the 3-4 December meeting. After discussion among Member States, it was agreed that further work was needed to elaborate upon the innovative aspects of the 7 plus 1 identified proposals. In consultation with the former Chair of the CEWG and as per the mandates of resolution WHA66.22 and decision WHA66(12), a list of the following six elements was agreed to be sent to the proponents for further elaboration on how the project:
- Intends to delink the price of the final product from the cost of the R&D.
- Utilizes collaborative approaches, including open knowledge innovation approaches.
- Utilizes licensing approaches that secure access to your research outputs and final products.
- Proposes and fosters financing mechanisms including innovative, sustainable and pooled funding.
- Fosters effective and efficient coordination mechanisms amongst existing organizations/initiatives.
- Strengthens capacity for research, development and production, including through technology transfer, in developing countries.
This request was sent to proponents of the identified 7+1 proposals and feedback was received by 15 January 2014. The following document, containing summaries of the 7+1 proposals as well as the clarificatory addenda submitted to the Secretariat, will be provided to the Executive Board:
Global Technical Consultative Meeting on Identification of Health R&D Demonstration Projects
When: 3 - 5, December 2013
Where: WHO Headquarters, Geneva
The projects to be reviewed by the experts in December originate from a regional selection process conducted by each of the six WHO regional offices.