Accelerating development and integration of therapeutics against Neglected Tropical Diseases (NTDs) in sub-Saharan Africa

Call updates

20 December 2024

Jul 26, 2024 4:40:24 PM

The 2nd stage deadline has been postponed to 01/10/2024

Jul 23, 2024 10:24:03 PM

EVALUATION RESULTS (STAGE 1)

Published: 17/01/24

Deadline: 04/04/24

Available budget: EUR 136 432 000 

In accordance with the call conditions, the evaluation of the first-stage proposals was made looking only at the criteria 'Excellence' and 'Impact'. The threshold for both criteria was 4. The overall threshold (applying to the sum of the two individual scores) was set for each topic/type of action with separate call-budget-split at a level that allowed the total requested budget of proposals admitted to stage 2 be as close as possible to 3 times the available budget (and not below 2.5 times the budget):

• HORIZON-JU-GH-EDCTP3-2024-01-03-two-stage: 8 points

 The results of the evaluation for each topic are as follows:

Summary of observer report:

The evaluations were in the estimation of both observers impartial, fair and equitable. No issues of confidentiality were seen to arise.

This was, in particular, enabled by a careful selection of experts and recorders as well as ensuring that any experts or recorders with a COI were excluded from the discussions of the proposal in question. The use of the SEP platform for all aspects of the reports (IER, CR and QC) also reinforced the confidentiality of the evaluation.

No issues of non-conformity were observed and the evaluation followed all the applicable rules. The eligibility of proposals was determined by the Unit prior to the assignment of experts to proposals. Any issues of proposals being not being “in scope” were discussed by the experts during the consensus meetings. 

We recently informed the applicants about the evaluation results for their proposals. 

For questions, please contact EC-GLOBAL-HEALTH-EDCTP3@ec.europa.eu

Apr 10, 2024 10:05:41 PM

Call HORIZON-JU-GH-EDCTP3-2024-01-two-stage closed on April 4th, 2024.

240 proposals have been submitted.

The breakdown per topic is:
HORIZON-JU-GH-EDCTP3-2024-01-03-two-stage: 28

Evaluation results are expected to be communicated in July 2024.

Accelerating development and integration of therapeutics against Neglected Tropical Diseases (NTDs) in sub-Saharan Africa

TOPIC ID: HORIZON-JU-GH-EDCTP3-2024-01-03-two-stage

Type of grant: Call for proposals

General information

Programme: Horizon Europe Framework Programme (HORIZON)

Call: Research and Innovation actions supporting the Global Health EDCTP3 Joint Undertaking (HORIZON-JU-GH-EDCTP3-2024-01-two-stage)

Type of action: HORIZON-JU-RIA HORIZON JU Research and Innovation Actions

Type of MGA: HORIZON Action Grant Budget-Based [HORIZON-AG]

Status: Open for submission

Deadline model: two-stage

Opening Date: 18 January 2024

Deadline dates:
04 April 2024 17:00 (Brussels time)
12 September 2024 17:00 (Brussels time)

Topic description

ExpectedOutcome:

This topic aims at supporting activities that contribute to at least two of the expected impacts for this call. Proposals under this topic should aim at delivering results that are contributing to the following expected outcomes:

• Accelerate development of therapeutics towards registration to make progress in the control and elimination of NTDs in sub-Saharan Africa;
• Improve the understanding of barriers for progression of existing and new therapeutics against NTDs through the R&D pipeline;
• Generate evidence-based recommendations on how to better integrate research and innovation in efficient supply chains for NTDs;
• Gain a better understanding of different country or region-specific health and research needs, to ensure a better case management of patients with NTDs;

Scope:

Background:

There is some progress in eliminating and eradicating NTDs as per WHO publication^[1] in October 2023: “nineteen countries in Africa have eliminated at least one NTD and there are currently 18 million fewer people requiring interventions against NTDs. Togo achieved a world first by eliminating four NTDs. Guinea worm disease (dracunculiasis) is on the verge of eradication; sleeping sickness (T. b. gambiense human African trypanosomiasis) has been eliminated as a public health problem in seven countries; and the number of reported Buruli ulcer cases decreased by 71% between 2010 and 2021”. However, diseases such as schistosomiasis, onchocerciasis, and other NTDs continue to affect hundreds of millions of people who are most often society’s poorest, in sub-Saharan Africa. The WHO Global report provides information for 2021-2022 on regional progress in Africa NTDs^[2].

Many of NTDs are vector-borne diseases (NTD vector control is in scope of topic HORIZON-JU-GH-EDCTP3-2024-CALL1-01-05 of this call: new tools, technologies and approaches for vector control in sub-Saharan Africa), have animal reservoirs and are associated with complex life cycles. The epidemiology of NTDs is complex and multifactorial, often related to environmental conditions, that makes their public-health control challenging. Moreover, COVID-19 pandemic severely disrupted health systems, including conduct of clinical trials, supply chains for NTD therapeutics and health products and the implementation of prevention strategies. Thus, pharmaceutical interventions combined with interventions such as house improvements, improved access to safe water, sanitation and hygiene (WASH) are also critical in the prevention for the majority of the NTDs, especially^[3] for Trachoma, Soil-transmitted helminthiases (STHs), Schistosomiasis and Dracunculiasis.

Scope:

The proposals submitted to this call topic are expected to address at least one of the following activities in scope:

• Conduct clinical trials on therapeutics for NTDs in the scope of the Global Health EDCTP3JU:

Buruli ulcer, dengue and chikungunya, dracunculiasis (guinea-worm disease), echinococcosis, foodborne trematodiases, human African trypanosomiasis (sleeping sickness), leishmaniases, leprosy (Hansen disease), lymphatic filariasis, mycetoma, onchocerciasis (river blindness), rabies, schistosomiasis, soil-transmitted helminthiases, taeniasis/cysticercosis, trachoma, and yaws. Global Health EDCTP’s remit will not cover chromoblastomycosis and other deep mycoses, scabies and other ectoparasites, and snakebite envenoming.

• For existing therapeutics for specific indications, there is need to conduct clinical trials of combination therapies against multiple diseases and applicability to vulnerable populations
• For infections where therapeutics are lacking entirely, clinical trials will be required for the development of new interventions (early stage) or extension of indications (re-purposing)
• Implementation research of pharmaceutical interventions for several NTDs and, when possible, their mainstreaming into national health systems in combination with other control measures

Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and health products (TEI-MAV+) is encouraged. The proposals could show, for example, willingness to enter into technology transfer agreements with African counterparts - including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.

Activities related to community engagement are encouraged in the context of developing new pharmaceutical interventions targeting NTDs.

Applicants need to concisely describe any prior research findings and explain how the proposal builds on these results.

The research to be conducted must involve vulnerable groups, including participants from poorer, underserved or hard-to-reach communities in sub-Saharan Africa. The full range of relevant determining characteristics (sex, gender, age, socio-economic status, etc.) needs to be considered.

Applicants are also encouraged to provide methodologies for translating research findings into public health practice and policy guidelines.

The proposals should involve all stakeholders, most notably policy makers, public health authorities, health care professionals and end-users. Activities related to community engagement are encouraged in the context of developing new pharmaceutical interventions targeting NTDs. International cooperation is encouraged, and the proposed implementation research for pharmaceutical interventions is expected to be multidisciplinary through the involvement of medical sciences, psychological sciences, social sciences and the humanities.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. The details of these joint activities will be defined during the grant agreement preparation phase.

Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement of Lranco/Lusophone countries if possible. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.

^[1] Ending the neglect: lessons from a decade of success in responding to Neglected tropical diseases in Africa

^[2]Global report on neglected tropical diseases 2023 (who.int)

^[3]Information on cross-cutting issues in NTDs | InfoNTD

Expected Impact:

Activities funded under the 2024 work programme of the Global Health EDCTP3 JU calls for proposals should contribute to:

• reduce the individual, social, and economic burdens of infectious diseases in sub-Saharan Africa through the development and uptake of new or improved interventions, and
• increase health security in sub-Saharan Africa and globally by reducing the risk of outbreaks and pandemics and enhancing national and regional capacity to address antimicrobial resistance.
• Progressing towards the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African (SSA) countries;
• Enable the implementation of the short- and medium-term actions foreseen by the AU EU Innovation Agenda (adopted in July 2023) in the area of public health and the EU Global Health Strategy (November 2022);
  • Improve equitable access to a full range of essential health services from health promotion to disease prevention and affordable quality treatment, rehabilitation and palliative care to fight communicable diseases;
  • Expand partnerships based on equal footing, co-ownership, mutual interest and strategic priorities;
• Provide evidence for informed health policies and guidelines within public health systems in SSA and at international level;
• Enhance sustainable global scientific collaboration in health research and international cooperation across SSA;
• Develop novel, innovative HIV therapeutics for reducing the disease burden of HIV in SSA
• Research on existing Malaria vaccines and development of new promising candidates
• Accelerating development and integration of therapeutics against neglected tropical diseases (NTDs) in SSA;
• Tackle Antimicrobial Resistance (AMR) through R&D in novel and existing antimicrobials
• Develop new tools, technologies and approaches for vector control in SSA;
• Develop innovative digital health solutions for SSA.
• Build appropriate local capacity.

General conditions

1. Admissibility conditions: described in Annex Aand Annex E of the Horizon Europe Work Programme General Annexes

Proposal page limits and layout: described in Part B of the Application Form available in the Submission System

2. Eligible countries: described in Annex Bof the Work Programme General Annexes

A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.

3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes

Replacing relevant sections in General Annex B to the Horizon Europe work programmes on eligibility (“Entities eligible for funding”)

To become a beneficiary, legal entities must be eligible for funding.

To be eligible for funding, applicants must be established in one of the following countries:

• The Member States of the European Union, including their outermost regions: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden;
• The Overseas Countries and Territories (OCTs) linked to the Member States: Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR);
• Countries associated to Horizon Europe ^[1]: Albania, Armenia, Bosnia and Herzegovina, Faroe Islands, Georgia, Iceland, Israel, Kosovo ^[2], Moldova, Montenegro, New Zealand (associated to Pillar II 'Global Challenges and European Industrial Competitiveness' as from the Work Programmes 2023 onwards, including for the institutionalised European partnerships), North Macedonia, Norway, Serbia, Tunisia, Turkey, Ukraine.

Until association agreements start producing legal effects either through provisional application or their entry into force, transitional arrangements apply. The transitional arrangements apply, at the time of the adoption of this Work Programme, with regard to the following countries and legal entities established in these countries, with which association negotiations are being processed or where association is imminent):

1. Canada

2. Morocco

• The following countries which are constituent states of the EDCTP Association ^[3]: Benin, Burkina Faso, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Gabon, The Gambia, Ghana, Guinea-Bissau, Guinea-Conakry, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Republic of the Congo, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.

Consortium composition

Unless otherwise provided for in the specific call conditions, for all actions, due to the policy objectives of the Global Health EDCTP3 JU, legal entities forming a consortium are eligible to participate in actions under the programme provided that the consortium includes:

• At least three legal entities independent from each other and established in different countries, where legal entities are eligible to receive funding;
• At least one independent legal entity established in a Member State or an associated country; and
• At least one independent legal entity established in a sub-Saharan African (SSA) country that is a member of the EDCTP Association.

This condition applies to both Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA).

Specific cases:

Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary^[4] which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.

Associated partners — Entities not eligible for funding (and therefore not able to participate as beneficiaries) may participate as associated partners, unless specified otherwise in the specific call conditions.

International organisations – International European research organisations are eligible to receive funding. Other international organisations are not eligible to receive funding unless their participation is considered essential for implementing the action by the granting authority. International organisations with headquarters in a Member State or associated country are eligible to receive funding when provided for in the specific call conditions.

Specific rules regarding legal entities that may be the coordinator of an indirect action

In accordance with Article 110(2) of the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe^[5], where entities established in a third country without an agreement to protect the financial interests of the Union participate with funding in an indirect action, the financial coordinator of the indirect action must be established in a Member State or associated country. Of the SSA countries members of the EDCTP Association, only South Africa concluded such an agreement at the moment.^[6]

Scientific project leader

If the coordinator is not established in a country in sub-Saharan Africa (SSA), the designation of a scientific project leader established in a SSA country member of the EDCTP Association with the roles as described below is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity.

The scientific project leader oversees the project scientific governance and leadership. For this purpose, proposals must include a work package where the details of scientific project leadership are laid down. The scientific project leader should indicatively perform the following tasks:

• During the call for proposals and selection process, coordinate meetings on and drafting of the full project proposal;
• Work with the coordinator and other beneficiaries on the drafting and negotiation of the consortium agreement and other legal agreements among the beneficiaries;
• Act as the key contact point for the Global Health EDCTP3 JU regarding all scientific action governance issues, steer and provide oversight in the development of the scientific actions, without prejudice to the tasks entrusted directly to the coordinator as per the Model Grant Agreement;
• Support and collaborate with the coordinator on its monitoring activities and the adoption of appropriate internal measures, to ensure that beneficiaries are fulfilling their obligations regarding budget, timeline, deliverables, and scientific quality;
• Review the action’s deliverables and reports before their submission by the coordinator;
• Lead the work packages(s) related to the tasks of scientific project leadership.

Annex 1 to the grant agreement and the consortium agreement should address the relationship of the scientific project leader with the coordinator regarding their respective tasks, for example sharing of the information received from or sent to the Global Health EDCTP3 JU on all issues of interest for the proper scientific management of the action.

^[1] The list is correct at the time of adoption of this work programme. Please see the Horizon Europe List of Participating Countries on the Funding & Tenders Portal for up-to-date information on the current list and on the position for Associated Countries.

https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/list-3rd-country-participation_horizon-euratom_en.pdf

^[2] This designation is without prejudice to positions on status and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.

^[3] The list is correct at the time of adoption of this work programme. For an update, please check the EDCTP Association website www.edctp.org

^[4] See Article 187 EU Financial Regulation 2018/1046.

^[5] Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014. OJ L 427, 30.11.2021, p. 17–119;

https://eur-lex.europa.eu/eli/reg/2021/2085

^[6] https://research-and-innovation.ec.europa.eu/strategy/strategy-2020-2024/europe-world/international-cooperation/south-africa_en

4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes

5.Evaluation and award:

• Award criteria, scoring and thresholds are described in Annex Dof the Work Programme General Annexes

Replacing the scores and weighting section in General Annex D to the Horizon Europe work programmes as regards Research and Innovation Actions (RIA) second stage of two-stage evaluations.

Scores and weighting

Evaluation scores will be awarded for the criteria, and not for the different aspects listed in the table. For full applications, each criterion will be scored out of 5. The threshold for individual criteria 1 (Excellence) and 2 (Impact) will be 4 and for criteria 3 (Quality and efficiency of the implementation) will be 3. The overall threshold, applying to the sum of the three individual scores, will be 12.

Proposals that pass the individual threshold and the overall threshold will be considered for funding, within the limits of the available call budget. Other proposals will be rejected.

Nota bene, for the first stage of the two-stage evaluation, the scores and weighting as indicated in Annex D of the General Annexes of the Horizon Europe work programme 2023/2024 apply. Furthermore, the scores and weighting for Coordination and Support Actions apply.

• Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual

• Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes

6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes

Also in line with Article 114 of the Council Regulation 2021/2085, participants will be subject to the following additional exploitation obligations:

1. Participants must – up to four years after the end of the action (see Data Sheet, Point 1) – use their best efforts to ensure that resulting health technologies and services will be broadly available and accessible, as soon as possible and at fair and reasonable conditions. In this respect, if, despite a participants’ best efforts, the results are not exploited within one year after the end of the action, participants must (unless otherwise agreed in writing with the granting authority) use the Horizon Results Platform to find interested parties to exploit the results.
2. In case the participants cannot fulfil the preceding obligation, the participants must (if requested by the granting authority) grant non-exclusive licences - under fair and reasonable conditions - to their results to legal entities that commit to rapidly and broadly exploiting the resulting health technologies and services and ensure that they are broadly available and accessible, as soon as possible and at fair and reasonable conditions.
3. In case of transfer of the ownership or licensing of results, participants must pass on such additional exploitation obligations to the legal entities exploiting the results.
4. For up to four years after the action (see Data Sheet, Point 1), the funding body must be informed every year about the status of the development of the product and any other exploitation of the results through an annual report that is due on each anniversary of the end of the grant agreement.

Implementing the provision on affordable access as defined in Article 114 of the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe^[1], grants awarded under this topic will have to submit the following deliverables:

1. Stewardship plan

Participants must prepare stewardship plans outlining how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse or abuse of health technologies (e.g. antimicrobials). A draft plan must be submitted after half the duration of the project has elapsed and a final plan must be submitted with the final report.

2. Global access plan

With the final report, participants must submit an appropriate and proportionate global access plan that covers registration targets, plans to meet demand, flexible approaches to IP and other strategies that reflect ability to pay and ensure that economic barriers to access are low.

^[1] Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014; OJ L 427, 30.11.2021, p. 17

Specific conditions

7. Specific conditions: described in the [specific topic of the Work Programme]

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