Strengthening ethics and regulatory capacity
HORIZON JU Coordination and Support Actions
Basic Information
- Identifier
- HORIZON-JU-GH-EDCTP3-2023-01-05
- Programme
- HORIZON-JU-GH-EDCTP3-2023-01
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- May 10, 2023
- Deadline
- July 4, 2023
- Deadline Model
- single-stage
- Budget
- €15,300,000
- Min Grant Amount
- €5,000,000
- Max Grant Amount
- €5,000,000
- Expected Number of Grants
- 3
- Keywords
- HORIZON-JU-GH-EDCTP3-2023-01-05HORIZON-JU-GH-EDCTP3-2023-01Clinical researchClinical trialsGlobal healthInfectious diseasesPublic healthRegulatory affairs
Description
Expected impacts of the calls under the 2023 work programme of the Global Health EDCTP3 JU
Activities funded under the 2023 calls for proposals should contribute to:
- Achieve SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African countries;
- Enable the implementation of the short and medium term actions foreseen by the AU EU Innovation Agenda[1] (expected to be adopted in June 2023) in the area of Public Health
- Provide evidence for informed health policies and guidelines within public health systems in sub-Saharan Africa and at international level;
- Strengthen clinical research capability in sub-Saharan Africa to rapidly respond to emerging epidemics;
- Enable a regulatory environment that can ensure effective development, delivery, and uptake of new or improved safe health technologies guaranteeing that trials in sub-Saharan African countries meet international standards;
- Increase cost effectiveness of public investment through collaboration of funders of clinical trials in the area of infectious diseases in sub-Saharan Africa;
- Strengthen health systems to ensure uptake of effective health technologies and innovations;
- Enhance sustainable global scientific collaboration in health research and international cooperation across sub-Saharan Africa.
- Improve opportunities for training of researchers and healthcare professionals in sub-Saharan Africa.
[1]Working document of the AU EU Innovation Agenda available online at: https://research-and-innovation.ec.europa.eu/system/files/2022-02/final_au-eu_ia_14_february.pdf
Expected Outcome:Projects funded under this Call for Proposals should contribute to the following outcomes:
- Stronger functionality, recognition, and performance of National Ethics Committees (NECs) and National Regulatory Agencies (NRAs) working in sub-Saharan Africa (SSA);
- Clinical trials authorised in these areas meet the appropriate standards;
- Improved efficiency regarding the process of clinical trial protocol authorisation for the development of new or improved health technologies;
- Improved efficiency of the NRAs concerning clinical trials oversight with alignment to continental initiatives of African Medicine Agency (AMA) and African Medicines Regulatory Harmonisation (AMRH);
- Better equipped health research systems to integrate new or improved health technologies;
- Sustainable health research strategies for both NECs and NRAs;
- Adoption of standardised training of both ethics committees and regulatory boards available in SSA through EDCTP partners;
- Generation of principles towards harmonised oversight for certification of clinical trial ethics and regulatory bodies in SSA countries;
- Creation of sustainable links and collaboration between NECs and NRAs and other important structures, such as clinical trial registries, research integrity offices and data access committees;
- Establishment of systematic reviews and data sharing in compliance with global requirements;
- Implementation of digital technologies to facilitate ethical and/or regulatory review processes.
The aim of this call is to improve the functionality, recognition and performance of NECs and NRAs for carrying out clinical trials in SSA countries.
Despite ongoing efforts by different partners and agencies, ethics, and regulatory oversight in SSA countries requires prioritisation and ownership by these countries to ensure sustained strengthening with a long-term perspective. There is a need to better understand the challenges that these countries are facing. They include the varied levels of clinical trial activity, with no health research legislation in some of them; as well as the need of better quality control, certification and accreditation of ethics and regulatory bodies, adherence to common international standards and open data access. Coherent linkages between ethics and regulatory functions are needed, as well as linkages with clinical trial registration and more systematic research reviews. Furthermore, better systems and technologies, including more external expertise and digitalisation for processing research application review and handling of documentation and data, are required.
Several initiatives have already established capacity development tools and structures that add value to the capacity development efforts of ethics and regulatory agencies in SSA[1] and should be taken into consideration.
The projects funded under this call will support the SSA countries to establish and/or develop own robust capacities for ethics review and national medicines regulatory systems. This also includes support towards national and international collaboration in compliance with established international standards. This scheme targets proposals with active involvement of NECs and/or NRAs from SSA countries, and in particular with those countries with the highest infectious disease burden.
Proposals should address several of the following activities:
- Improvement of the efficiency of the functioning of NECs and NRAs through the introduction of innovative systems, reliance practices and/or technologies that would facilitate the various functions of these bodies with better quality outputs and improved timelines;
- Development of national health research legislation;
- Promotion of quality control systems and processes for NECs and NRAs, as well as certification and accreditation of the various bodies, as well as adherence to international standards;
- Promotion of international cooperation in ethics and regulatory activities through transfer of promising and successful innovative systems and/or technologies from other regions in Africa or other continents, fostering national and regional collaboration among these bodies;
- Creation of linkages between ethics and regulatory functions with other important structures, such as clinical trial registries, whilst simultaneously enforcing the sharing of data in compliance with global requirements;
- Promotion of the adoption and update of AVAREF, WHO and other international standards and best practices, by countries, groups of countries, or regional harmonisation initiatives;
- Support already established training centres to provide both innovative training, and mentorship to NECs and NRAs.
- Development or scale-up of innovative systems and technologies that support ethics and regulatory functions, training, networking and promotion of good practices and evidence-based adoption of accreditation models from relevant internationally endorsed/peer-reviewed documented sources.
Proposals should clearly indicate the mismatch between the country disease burden, research activity and level of ethical review and regulatory oversight that justify the need for support in these areas.
Linkages of the proposal to relevant on-going initiatives and regional bodies is encouraged and should be demonstrated.[2] Plans to foster bi-lateral links between the European Medicines Agency (EMA) and the national ethics and regulatory authorities in the SSA countries of the participants are encouraged.
Each proposal should have at least two new technical staff members recruited to the NEC/NRA team to be trained and integrated in the new functions proposed in the action. The new staff members should have a well-defined function and objectives in the participating NEC and NRA with a systems approach. The new staff members should stay in the team for at least two years and participate in relevant networking and international events.
Particular attention should also be paid in the proposal for ensuring complementarity and coherence with other activities supported by the European Union and EU Member States in the countries involved. This concerns for example the EDCTP Regional Networks of Excellence[3] and the Team Europe initiative on Manufacturing and Access to Vaccines, Medicines, and Health Technologies (MAV+) in Africa[4] or other health Team Europe initiatives[5] of the Global Gateway investment package.
To strengthen the clinical research capacity in the SSA regions with the highest disease burden, the quality of the transfer of knowledge should be taken particularly into account when evaluating the criterion ‘impact’.
Proposals should provide details on the steps to be taken to ensure gender balance and contribute to have representation from French speaking and Portuguese speaking SSA countries in the project team.
[1]WHO AFRO, through AVAREF, has established a training course for ethics committees in both English and French. AUDA-NEPAD has established Regional Centres of Regulatory Excellence (RCOREs) designated with regulatory science expertise and training capabilities. Moreover, WHO has also developed standards for ranking maturity of regulatory boards as a measure to indicate advancement in capacity of these agencies.
[2]These initiatives include: the African Medicines Agency (AMA), the Africa Vaccines Regulators Forum (AVAREF), the Regional Centres of Regulatory Excellence (RCORE) in Africa, the WHO-TDR-SIDCER initiative (Strategic Initiative for Developing Capacity in Ethical Review), the Pan African Clinical Trials Registry (PACTR), the African Medicines Regulatory Harmonisation (AMRH) and the Africa Centre for Disease Control and Prevention (ACDC) and WHO-AFRO.
[3]EDCTP regional networks of excellence strengthen regional networking and provide platforms for research training and multicentre studies http://www.edctp.org/our-work/edctp-regional-networks-of-excellence/
[4]The Team Europe initiative (TEI) on Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+) https://ec.europa.eu/commission/presscorner/detail/en/ip_21_2594 directly funds the European Medicines Agency (EMA), African Medicine Agency AUDA-NEPAD (AMA) and the World Health Organization (WHO).
[5]Team Europe Initiative with Africa on sustainable health security using a One Health approach https://europa.eu/capacity4dev/tei-jp-tracker/tei/sustainable%C2%A0health-security-africa
Eligibility & Conditions
General conditions
2. Eligible countries:
The conditions are described in General Annex B except for the specific conditions for GH EDCTP3 funding as regards Entities eligible for funding and Consortium composition, the specific issue of legal entities from which countries can be the coordinator and the obligation to designate a scientific project leader. Participation conditions related to Russia’s illegal invasion of Ukraine are also set out below.
Replacing relevant sections in General Annex B to the Horizon Europe work programmes on Eligibility
Entities eligible to participate
Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, the currently context does not allow the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government-controlled territories of Ukraine. Therefore, such legal entities are not eligible to participate in any capacity. This criterion also applies in cases where the action involves financial support given by grant beneficiaries to third parties established in Russia, Belarus or in non-government-controlled territories of Ukraine (in accordance with Article 204 of the Financial Regulation No 2018/1046).
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, North Macedonia, Norway, Serbia, Tunisia, Turkey, Ukraine. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement[3];
- The following low- and middle-income countries which are constituent states of the EDCTP Association[4]: Burkina Faso, Cameroon, Congo, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.
Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.
Consortium composition
Unless otherwise provided for in the specific call conditions, for all actions, due to the policy objectives of the GH 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 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.
Specific cases:
Affiliated entities – Affiliated entities are eligible for funding if they are established in one of the countries listed above.
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 on which legal entities can be the coordinator of an indirect action
According to article 110 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 shall 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.[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 GH EDCTP3 regarding all scientific action governance issues, steer and provide oversight in the development of the scientific actions, acting as the key contact point for the GH EDCTP3 JU for these matters including external communication, other than the ones 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 GH 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]Association of New Zealand is expected to take effect during 2023.
[4]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.
[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
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes
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Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes
Replacing relevant section in General Annex D to the Horizon Europe work programmes
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.
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Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual
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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
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme
Scientific Project Leader
For all projects under this topic, 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 in the introduction is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity.
Grant Conditions - EC objection to transfer of ownership to a third party in a third country
According to the Horizon Europe rules, and to protect Union interests, the right for the GH EDCTP3 to object to transfers of ownership of results or to grants of an exclusive licence regarding results should apply to participants. Therefore, the provisions set out in General Annex G to the Horizon Europe work programmes on the right to object apply generally. It should be noted that in accordance with the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe[1] and the Model Grant Agreement, the right to object applies also to participants that have not received funding from the JU and for the periods set therein.
[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
Documents
Call documents:
Standard application form — call-specific application form is available in the Submission System
Standard application form (HE CSA)
Standard evaluation form — will be used with the necessary adaptations
Standard evaluation form (HE CSA)
MGA
Call-specific instructions
Additional documents:
Annex 2 - In-kind contributions (IKAA plan)
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.
IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
European IPR Helpdesk assists you on intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
Partner Search Services help you find a partner organisation for your proposal.
Latest Updates
EVALUATION RESULTS
Call Identifier: HORIZON-JU-GH-EDCTP3-2023-01
Published: 14/04/2023
Deadline: 04/07/2023
Available budget: 74.3 million EUR
The results of the evaluation are as follows
Number proposals submitted: 99
Number ineligible proposals: 8
Number of above-threshold: 46
Total budget requested for above-threshold proposals: 152.8 million EUR
Number of Main list: 25
Number of Reserve list: 8
Number of rejected proposals due to budgetary resources: 13
Number of proposal upgraded from Reserve list to Main list: 2
We recently informed the applicants about the evaluation results for their proposals.
For questions, please contact us at [email protected]
Call Single Stage HORIZON-JU-GH-EDCTP3-2023-01 closed on July 4th, 2023.
A total of 99 proposals were submitted.
The breakdown per topic is:
- HORIZON-JU-GH-EDCTP3-2023-01-01: 25 proposals
- HORIZON-JU-GH-EDCTP3-2023-01-02: 18 proposals
- HORIZON-JU-GH-EDCTP3-2023-01-03: 28 proposals
- HORIZON-JU-GH-EDCTP3-2023-01-04: 10 proposals
- HORIZON-JU-GH-EDCTP3-2023-01-05: 18 proposals
Evaluation results are expected to be communicated on Friday 24th October 2023 at the earliest.
The call deadline has been postponed to 04/07/2023