Tackling Antimicrobial Resistance (AMR) through R&D in novel and existing antimicrobials

Opened

Programme Category

EU Competitive Programmes

Programme Name

Global Health EDCTP3 Joint Undertaking

Programme Description

The Global Health EDCTP3 Joint Undertaking (GH EDCTP3) builds on the first and second European and Developing Countries Clinical Trials Partnership programmes. This new joint undertaking (JU) is a partnership between the EU and the EDCTP Association, whose members are several European and African countries. The partnership will deliver new solutions for reducing the burden of infectious diseases in SSA and strengthen research capacities to prepare and respond to re-emerging infectious diseases in this region and across the world.

Programme Details

Identifier Code

HORIZON-JU-GH-EDCTP3-2024-01-04-two-stage

Call

Tackling Antimicrobial Resistance (AMR) through R&D in novel and existing antimicrobials

Summary

This topic focuses on Tackling Antimicrobial Resistance (AMR) through R&D in novel and existing antimicrobials. Tackling AMR requires multi-modal interventions, the collaboration of many disciplines and countries. Antimicrobial stewardship (AMS) could further reduce the burden of drug-resistant infection. The WHO defines AMS as a coherent set of integrated actions which promote the responsible and appropriate use of antimicrobials to help improve patient outcomes across the continuum of care. Responsible and appropriate use of antimicrobials includes prescribing only when needed, selection of the optimal drug regime, drug dosing, route of administration and duration of treatment following proper and optimized diagnosis. These actions are complemented by the implementation of infection prevention and control (IPC), enhancing water, sanitation and hygiene (WASH), and optimizing vaccination coverage.

AMR is one of the Global Health issues which can hugely benefit from the employment of the One Health approach. AMR transmission is a critical global problem affecting humans, the environment, and animals. Hence, proposals need to have the One Health approach at their centre.

Furthermore, the availability and access to existing antibiotics is also a challenge. In particular, efforts to ensure equitable access to antibiotics in LMICs that experience the highest burden of AMR, are needed.

Detailed Call Description

Proposals must address at least two of the following areas, with the delivery of the first bullet point being compulsory:

  • Conduct R&D on the better use of existing antimicrobials to reduce AMR and provide data to contribute to their equitable access in SSA, and/or conduct late-stage clinical R&D on novel antimicrobials with improved properties (efficacy, safety, resistance pattern, useability) for infections within the scope of EDCTP3 to reduce AMR;
  • Develop innovative antimicrobial stewardship strategies in human health on how to tackle AMR based on the One Health approach within the scope of EDCTP3 in SSA;
  • Develop and implement cost effective, acceptable and feasible infection prevention and control (IPC) strategies, in reducing AMR in healthcare facilities and communities.

Only proposals focusing their research on existing and/or novel antimicrobials from phase 3 onwards will be eligible. Neither pre-clinical research nor early-stage clinical trials in the context of product development are within the scope of this call.

The inclusion of industry partners involved in the development and/or manufacturing of the antimicrobials in the consortium is strongly encouraged.

Where possible, collaboration and coordination with the Team Europe Initiative on Sustainable Health Security in Africa or Manufacturing and health products (TEI-MAV+) is encouraged. The applicants 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.

Environmental aspects relating to antimicrobial resistance in the production of antimicrobials and the waste of antimicrobials should be considered.

Existing antimicrobials are classified as those already on the market, but impacted by AMR, and in need of improvement of their use to minimise AMR, whilst by novel antimicrobials we refer to those in the clinical trial development pipeline, but not yet on the market.

Applicants are encouraged to work among international sectors and actors, including human and veterinary medicine, agriculture, finance and environment experts. Applicants need to concisely describe any proven research evidence of previous findings and explain how the proposal builds on these results.

Proposals should present a sound assessment of the feasibility of the proposed work, in particular as regard to the proposed clinical interventions.

Vulnerable populations need to be included in the clinical study population, including children, pregnant women, people with co-infections and comorbidities, older people and people living in hard-to-reach communities (unless excluded for physiologic or metabolic reasons).

Call Total Budget

€24.000.000

Financing percentage by EU or other bodies / Level of Subsidy or Loan

Expected EU Contribution per project: 6.000.000

Thematic Categories

  • Health
  • Research, Technological Development and Innovation

Eligibility for Participation

  • Central Government
  • International Organisations
  • Legal Entities
  • Other Beneficiaries
  • Researchers/Research Centers/Institutions
  • State-owned Enterprises

Eligibility For Participation Notes

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.

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: Albania, Armenia, Bosnia and Herzegovina, Faroe Islands, Georgia, Iceland, Israel, Kosovo, 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: 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 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.

Call Opening Date

18/01/2024

Call Closing Date

12/09/2024

EU Contact Point

EDCTP – Europe Office
Postal and visiting address: Anna van Saksenlaan 51, 2593 HW The Hague, The Netherlands
Telephone: +31 70 344 0880

EDCTP – Africa Office
Postal address: P.O. Box 19070, Tygerberg 7505, Cape Town, South Africa
Visiting address: Francie van Zijl Drive, Parowvallei 7505, Cape Town, South Africa
Telephone: +27 21 938 0690
Fax: +27 21 938 0569

Contact Form in the website