Mobilisation of Emergency funding for Mpox outbreak research response

Call updates

Jun 28, 2024 2:32:02 PM

EVALUATION RESULTS

Published: 14.05.2024

Deadline: 29.05.2024

Available budget: EUR 6 500 00

The results of the evaluation for topic HORIZON-JU-GH-EDCTP3-2024-Mpox are as follows:

Number of proposals submitted (including proposals transferred from or to other calls): 17
Number of inadmissible proposals: 0
Number of ineligible proposals: 1
Number of above-threshold proposals: 11
Total budget requested for above-threshold proposals: 14 600 241 EUR
Number of proposals retained for funding: 5
Number of proposals in the reserve list: 4
Funding threshold: 14.5
Ranking distribution:
Number of proposals with scores lower or equal to 15 and higher or equal to 14: 5
Number of proposals with scores lower than 14 and higher or equal to 13: 3
Number of proposals with scores lower than 13 and higher or equal to 10: 8

Summary of observer report:
“The Global Health EDCTP3 Work Programme 2024 foresees funding to be mobilized in case of a Public Health Emergency. Following the declaration of National Public Health Emergency by national authorities in DRC, the emergency call was triggered which led to a fast-track organisation of a call for proposals: setup, publication, evaluation and award. Due to the nature of the call and the need to unlock and allocate funding swiftly, the process was led in the most streamlined way, with shortened evaluation time and a number of evaluators per proposal kept to the minimum requirements. EDCTP3 team was very well equipped and skilled to coaching and helping the experts to properly do the assessment and not leave the emergency situation compromise the final outcomes.

The overall evaluation process was executed in full compliance with the procedures, code of conduct, and guiding principles of fairness, transparency, and equal treatment of proposals.

EDCTP3 staff ensured that for all the proposals associated to this call, all actors involved were fully informed about the background guidance and legal documents, procedures and standards of quality. The organization and management went smoothly.

The briefing materials made available to the external experts were of the highest quality as they provided all the relevant information in a clear and comprehensive way. Experts were asked to declare any potential conflict of interest and to ensure confidentiality of all information.

The evaluation process was robust. No preferential treatment of any proposal was observed by the observer or reported by any expert. The discussions were fair and consistent with open and detailed online deliberations covering all the criteria and sub criteria to ensure clarity of issues arising and providing impartial feedback to applicants. Global Health EDCTP3 continues putting significant effort into assigning proposals to evaluation groups that cover all the key disciplines relevant to the topic.”

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

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

Jun 5, 2024 10:46:53 AM

Call HORIZON-JU-GH-EDCTP3-2024-Mpox has closed on the 29/05/2024.
17 proposals have been submitted.
Evaluation results are expected to be communicated before end of June.

Mobilisation of Emergency funding for Mpox outbreak research response

TOPIC ID: HORIZON-JU-GH-EDCTP3-2024-Mpox

Type of grant: Call for proposals

General information

Programme: Horizon Europe Framework Programme (HORIZON)

Call: Mobilisation of Emergency funding for Mpox outbreak research response (HORIZON-JU-GH-EDCTP3-2024-Mpox)

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

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

Status: Forthcoming

Deadline model: single-stage

Planned Opening Date: 14 May 2024

Deadline dates: 29 May 2024 17:00 (Brussels time)

Topic description

ExpectedOutcome:

This topic aims at supporting activities that contribute to answering the most pressing questions raised by public health responders to the Mpox Public Health Emergency (PHE), as part of the efforts to manage and prevent the spread of the current epidemic. Proposals should result in new knowledge to manage and prevent future outbreaks and should strengthen the capacities of at-risk countries to respond to epidemics.

To that end, proposals submitted under this topic should aim at delivering results that are contributing to the following expected outcomes:

• Provide novel, critical and timely insights into the Mpox outbreak and/or potential avenues for its management or prevention, focusing on the most affected population, specifically children, pregnant women and immunosuppressed individuals.
• Be timely, with rapid activation, to enable early and valuable outcomes and results to be produced and/or to support access time-dependent resources.
• To contribute to the public health preparedness and response in the context of the ongoing Mpox epidemic.

Scope:

The Global Health EDCTP3 Work Programme 2024 ^[1] foresees funding to be mobilised in case of a Public Health Emergency (PHE). This mechanism allows rapid mobilisation of research funding with or without a call for proposals in exceptional and duly substantiated emergencies. Global Health EDCTP3 considers a situation as an emergency if it is unforeseen and presents a serious and immediate risk to human health.

Following the Mpox outbreak in the Democratic Republic of Congo (DRC), first reported in 2023, the DRC Government, Africa CDC, World Health Organization (WHO) and partners have been closely monitoring it. From 1 January through 12 November 2023, a total of 12 569 suspected Mpox cases, including 581 suspected Mpox deaths (case fatality ratio: 4.6%), had been reported in 156 health zones from 22 out of 26 (85%) provinces of the DRC ^[2]. In 2024, and as of 29 March, 4 488 cases have been reported, of which 319 have been confirmed. A total of 279 deaths have been reported in the country in 2024 (CFR: 6.7%)^[3].

On 13 April 2024, a High-Level Emergency Regional Meeting ^[4] was held in Kinshasa, to discuss the ongoing epidemic of Mpox in DRC and the potential risk of transmission to neighbouring countries and beyond. On the same day, the Ministry of Health (MoH) of DRC assessed the situation and considered the ongoing outbreak as a Public Health Emergency which requires a rapid and efficacious response. Aligning with this statement, the High-Level Meeting ended with a Communiqué (dated 13 April 2024) whereby twelve Ministers of Health and international partners called for a coordinated response to the outbreak and for the establishment of an Africa Taskforce for Mpox Coordination among Member States affected and at-risk of Mpox. These documents include a call to accelerate research and regulatory processes to enable access to vaccines, diagnostics and therapeutics for affected populations including children.

In the light of rising numbers of cases being reported in the DRC and the high public health risk, the Global Health EDCTP3 is activating the emergency funding mechanism to support research and innovation projects and activities as part of the Joint Undertaking’s response to the emergency.

The Global Health EDCTP3 invites proposals for Research & Innovation Actions (RIA) to support research activities in DRC and neighbouring or affected countries, to manage and/or prevent the spread of the current Mpox outbreak.

Proposals should address one or more of the following areas:

1. Vaccines research and development:

   Trials should focus on both pre-exposure prophylaxis and post-exposure prophylaxis.

2. Clinical trials for therapeutics:

   Proposals should include trials on therapeutic products in the context of the Monitored Emergency Use of Unregistered Interventions (MEURI), such as tecovirimat (approved by the European Medicines Agency for use in the European Union) and other promising therapeutic candidates. Research on pain management strategies should integrated in the proposed R&D efforts.

3. Surveillance strategies, evaluation of rapid diagnostics and epidemiological studies:

   Proposals should provide data on epidemiological characteristics such as geographical spread, viral genotype, and pathogenicity, clinical information on host susceptibility and host immune responses. This work is foreseen to use and evaluate available diagnostic tools to ensure improved surveillance.

Moreover, proposals should ensure:

• Focus on the most affected population, specifically children, pregnant women and immunosuppressed individuals.
• Alignment with the national priorities of the DRC and neighbouring countries as well as the African Taskforce for Mpox Coordination.
• Partnership with researchers and public health institutions in DRC and neighbouring countries.
• Strengthening of national and local research capacity.
• Coordination and collaboration with other research and/or humanitarian activities operational in the countries affected.
• Alignment with the Africa CDC Task Force recommendations for rapid activation of R&D activities to control the outbreak.
• Compliance with International Council on Harmonisation – Good Clinical Practice (ICH-GCP), regulatory and ethical standards.
• Commitment to open access and data sharing principles, including appropriate data management and governance plans.
• Demonstrate alignment/synergy with DRC national government health service delivery policy and plans, where appropriate.

Proposals should provide novel, critical and timely insights into the Mpox outbreak and/or potential avenues for its management or prevention, focusing on the most affected population, specifically children, pregnant women and immunosuppressed individuals.

Proposals must be timely, with rapid activation, to enable early and valuable outcomes to be established and/or to access time-dependent resources.

Proposals funded under this mechanism must share the relevant generated data within 30 days after generation with all parties that need and can use the findings to address the PHE.

^[1] https://globalhealth-edctp3.eu/resources/work-programme-2024

^[2] https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON493

^[3] https://www.ecdc.europa.eu/en/news-events/outbreak-mpox-caused-monkeypox-virus-clade-i-democratic-republic-congo

^[4] https://www.afro.who.int/media-centre/statements-commentaries/united-fight-against-mpox-africa

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, United Kingdom.

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

The following derogation to the evaluation procedure described in General Annexes F applies to open invitations to submit applications:

In order to ensure a balanced portfolio covering responses to different aspects of the public health emergency, grants will be awarded to applications not only in order of ranking, but also to those projects that enhance the quality of the project portfolio through synergies between projects and avoidance of overlaps, provided that the applications attain all thresholds.

• Indicative timeline:This Call will be open for a maximum period of 2 weeks.

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.

The action may also include justified derogations from the standard limits to financial support to third parties (maximum EUR 60 000 unless justified). Where applicable, the relevant grant agreement options will be applied.

Implementing the provision on affordable access as defined in Article 114 of the Council Regulation 2021/2085, grants that implement clinical studies 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.

Specific conditions

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

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The submission system is planned to be opened on the date stated on the topic header.

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