Public health, innovation, intellectual property and trade

CEWG Demonstration Projects: Background and Process

Timeline:

  • 2008, 61st WHA: Resolution WHA61.21, adopted Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI).
  • 2010: WHA63.28, established the Consultative Expert Working Group on R&D: Financing and Coordination (CEWG).
  • 2012: WHA65.12, welcomed the analysis of the CEWG report and agreed on conducting consultations at various levels to discuss the CEWG report.
  • 2012, 26-28 November, global open-ended meeting of Member States, a draft resolution was negotiated to follow-up on CEWG report and a strategic work-plan was agreed.
  • 2013, May, WHA66.22, adopted the resolution as such that was agreed between the Member States in the November 2012 open-ended meeting. Among other items the resolution requested theWHO Director-General to facilitate through regional consultations and broad engagement ofrelevant stakeholders the implementation of a few health research and development demonstration projects to address identified gaps that disproportionately affect developing countries, particularly the poor, and for which immediate action can be taken.
  • 2013, June/July: 6 WHO regional offices issued calls for submission of proposals for projects.
  • 2013, November: WHO regional offices shortlisted 22 projects for consideration.
  • 2013, 3-4 December 3-4: A global technical consultative meeting of experts identified 7+1 proposals that have the potential to be demonstration projects.
  • 2013, 5 December: Member States requested additional information from the proponents on the innovative aspects of the 7+1 proposals.
  • 2014, January: The 134th WHO Executive Board adopted decision EB134(5), identifying next steps – examination of the additional information and convening of stakeholder meetings. The decision also requested the Secretariat to identify indicators to measure success in this process.
  • 2014, 10 March: As per EB134(5), the former Chair and Vice-Chair of the CEWG, examined the additional information received and identified 4 projects that are ready for implementation.
  • 2014, 7-10 May: Stakeholder meetings held for the four selected demonstration projects.
  • 2014, 19-24 May: 67th WHA - Member States adopt decision WHA67(15), which asks, among other things, the Secretariat to "expedite the process" of the other four projects (that were not selected)
  • 2014, 26-27 August: Demonstration projects workshop meeting co-hosted by WHO and Fiocruz held in Rio de Janeiro. Proponents of the other four projects had the opportunity to discuss their proposals with experts, who provided their recommendations.
  • 2014, 30 September: The Ambassadors of France, South Africa and Switzerland co-hosted a meeting of Member States to discuss the CEWG agenda. ADGs Dr Marie-Paule Kieny (HIS) and Dr Hiroki Nakatani (HIV/AIDS, TB, Malaria, NTDs) presented the state of current work, future steps, and the roadmap for cooperation between WHO and TDR.
  • 2014, October: Proponents from Thailand withdrew; other proponents who attended the Rio workshop submit revised versions of their proposals to the Secretariat.
  • 2014, 7 November: The former Chair and Vice-Chair of the CEWG re-assess the revised proposals. Additional information is requested from CSIR South Africa, who were unable to attend the Rio workshop.
  • 2015, 26 January - 3 February: 136th WHO Executive Board

Demonstration Projects: Selection and Implementation

JUNE – NOVEMBER 2013: Regional Calls for Submissions and Shortlisting Process

Following a regional selection process, each regional office shortlisted four proposals to be included on the list of projects to be assessed by a group of experts at a global technical consultative meeting.

3-5 DECEMBER 2013: Global Technical Consultative Meeting on Identification of Health R&D Demonstration Projects

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
    • PLUS 1: 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.

24 JANUARY 2014: 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 were:

  • 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

10 MARCH 2014: Meeting to Examine Additional Information Received

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 6 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.
  • 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.

7-10 MAY 2014: Stakeholder Meetings for Selected Demonstration Projects

The Secretariat convened stakeholder meetings for each of the four selected demonstration projects at WHO headquarters in Geneva from 7-10 May 2014 as follows: DNDi (7 May), USFDA (8 May), MMV (9 May), ANDI (10 May). These stakeholder meetings brought together project proponents with current and potential partners and donors to discuss project plans, resource needs and next steps in implementation of the selected projects.

19-24 MAY 2014: Health R&D Demonstration Projects at the 67th World Health Assembly

The Secretariat presented a report which contained a draft framework of process indicators to determine success in relation to the demonstration projects process. Member States adopted decision WHA67(15), which noted the progress made and the draft indicators and laid out next steps.

26-27 AUGUST 2014: Joint WHO-Fiocruz Demonstration Projects Workshop, Rio de Janeiro

Decision WHA67(15) requested the Director-General to "expedite the progress" of the other four projects which were not selected for immediate implementation during the assessment by the former Chair and Vice-Chair of the CEWG on 10 March 2014. To follow through on this mandate, the Secretariat, in coordination with Oswaldo Cruz Foundation, Brazil (Fiocruz) organised a technical workshop in Rio de Janeiro. The workshop, hosted by Fiocruz, took place between 26-27 August 2014. It brought together project proponents with experts on CEWG principles and recommendations and gave participants an opportunity to ask questions, make clarifications, discuss, debate and provide recommendations on proposals and project plans. Following this workshop, the proponents of three projects (THSTI, CSIR South Africa, and Fiocruz) submitted revised versions of their proposals to the Secretariat. The proponents from Thailand decided to withdraw their project from the process.

30 SEPTEMBER 2014: Meeting of Member States co-hosted by France, South Africa and Switzerland

The Ambassadors of France, South Africa and Switzerland co-hosted a meeting of Member States to discuss the CEWG agenda. WHO Assistant-Director Generals Dr Marie-Paule Kieny (Health Systems and Innovation) and Dr Hiroki Nakatani (HIV/AIDS, TB, Malaria, Neglected Diseases) presented the current state of work, future plans and outlined the cooperation between WHO and TDR on behalf of the Secretariat.

07 NOVEMBER 2014: Meeting to Examine Revised Proposals

On 07 November 2014, the former Chair and Vice-Chair of the CEWG, Dr Claudia Chamas and Dr John-Arne Rottingen met to re-evaluate the revised proposals submitted by THSTI, CSIR South Africa and Fiocruz. The meeting followed the same process as the meeting to evaluate proposals that took place on 10 March 2014, with the same six Member State observers invited to be present. The meeting took place in Geneva, with Dr Rottingen participating via videoconference.

26 JANUARY – 03 FEBRUARY 2015: 136th WHO Executive Board

The Secretariat progress report on the demonstration projects is contained in Document EB136/30/Add.1. The report contains an overview of progress since the 67th WHA in May 2014, as well as a summary of an initial evaluation of the selected demonstration projects based on approved “process” indicators (contained in Document A67/28, above) and the innovative components. The document containing the entire evaluation and analysis by the Secretariat can be found below: