Global collaboration action for the development of TB drugs for therapy and chemoprophylaxis in adults and children in sub-Saharan Africa

Global collaboration action for the development of TB drugs for therapy and chemoprophylaxis in adults and children in sub-Saharan Africa is sponsored by European Commission — Horizon Europe. Expected Impact: Expected impact The actions funded under this topic should contribute to achieve the reduction of disease burden in SSA through increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investment. Proposals are expected to include the effective in-kind and/or financial contribution of contributing partners, in order to produce more meaningful and significant effects enhancing the impact of the related research activities. Applicant consortium The contributions from contributing partners should correspond to the amounts they have committed in the letter of endorsement requesting to become a contributing partner (Article 9 Council Regulation (EU) 2021/2085 [1] ). Their contributions can consist of financial contributions and/or in-kind contributions. Applicant contributing partners must submit a first draft of the endorsement letter to the Programme Office before the deadline for submission of the second-stage applications [2] . For details on the process on becoming a Global Health EDCTP3 contributing partner, please consult the Guide for contributing partners . In case of in-kind contribution (even combined with financial contribution), contributing partners become a part of the applicant consortium and participate in the project, as appropriate i.e. as beneficiaries or affiliated entities in the meaning of Article 8 of the Horizon Europe model grant agreement. Also, Global Health EDCTP3 contributing partners can be a country, an international organisation or any public or private legal entity, other than the Global Health EDCTP3 members or their constituent or affiliated entities (please consult the Guide for contributing partners ). Expected Outcome: Background Tuberculosis (TB) remains a prominent global health challenge. According to the WHO’s Global TB Report 2024, the global rise in the number of TB incident cases, likely as effect of the disruption of TB services during the COVID-19 pandemics, has slowed and started to stabilise. The total number of people infected with TB was 10,8 million in 2023, a small increase from 10,7 million in 2022 although still much higher than 10,4 million in 2021 and 10,1 million in 2020. Globally, 80% of the number of deaths by TB occurred in the WHO African and South-East Asia regions, with 16 out of 30 countries located in sub-Saharan Africa (SSA). Most of the TB deaths among people with HIV occurred in the African Region. Adolescents and adults account for over 80% of the TB burden and are the main source of transmission, including transmission to children. Millions of people affected by TB are missing out on quality care each year, including on access to affordable diagnostic tests and treatment, especially in low- and middle-income countries. TB affects populations inequitably and contributes to the cycle of ill health and poverty, with malnutrition currently being the most prevalent contributor to the incidence of TB and inadequate living conditions contributing to the spread of M. tuberculosis and its impact on the community. Investments in building robust, integrated, and resilient health systems, including in TB prevention, detection and treatment services and research and development infrastructure and community responses can advance universal health coverage and contribute to effective prevention and response. It is urgent to scale up comprehensive efforts to close long-standing gaps in prevention, diagnosis, treatment, and care of people at risk of TB, including children and immune-compromised individuals. In terms of TB research and innovation, the following fields should be prioritised for TB drugs for therapy, chemoprevention or chemoprophylaxis according to the WHO Global TB Report 2024: new preventive drug treatments to prevent the progression to TB disease including patients with latent TB infection, and simpler, shorter treatments for TB disease. Ongoing TB therapeutics trials are targetin

Programme areas: Horizon Europe (HORIZON), Global Challenges and European Industrial Competitiveness, Health

Keywords: Child health, Clinical trials, Drug development, clinical phases, Global health, Immunology, Infectious diseases, Poverty related diseases, Public health, Respiratory systems, Statistics in clinical trials, Phase II, Statistics in clinical trials, Phase III, Tuberculosis, Africa, Clinical Trial, Clinical studies, Drug development, EDCTP, EDCTP3, Global Health, Health interventions, Implementation research, Medical interventions, Mother's health, Phase II, Phase III, Poverty-related diseases, Prevention, Respiratory tract, Sub-Saharan Africa

Deadline stages: 2026-03-04, 2026-09-17

EU Funding & Tenders Portal EU Funding & Tenders Portal * Results & Innovation support * SME Self-assessment tool Home Funding Calls for proposals Global collaboration action for the development of TB drugs for therapy and chemoprophylaxis in adults and children in sub-Saharan Africa Global collaboration action for the development of TB drugs for therapy and chemoprophylaxis in adults and children in sub-Saharan Africa HORIZON-JU-GH-EDCTP3-2026-01-TB-01-two-stage * Conditions and documents * Partner search announcements HORIZON-JU-GH-EDCTP3-2026-01-two-stage (HORIZON-JU-GH-EDCTP3-2026-01-two-stage) HORIZON-JU-RIA HORIZON JU Research and Innovation Actions HORIZON Action Grant Budget-Based [HORIZON-AG] 04 March 2026 17:00:00 Brussels time 17 September 2026 17:00:00 Brussels time The actions funded under this topic should contribute to achieve the reduction of disease burden in SSA through increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investment.

Proposals are expected to include the effective in-kind and/or financial contribution of contributing partners, in order to produce more meaningful and significant effects enhancing the impact of the related research activities.

The contributions from contributing partners should correspond to the amounts they have committed in the letter of endorsement requesting to become a contributing partner (Article 9 Council Regulation (EU) 2021/2085[1]). Their contributions can consist of financial contributions and/or in-kind contributions.

Applicant contributing partners must submit a first draft of the endorsement letter to the Programme Office before the deadline for submission of the second-stage applications[2]. For details on the process on becoming a Global Health EDCTP3 contributing partner, please consult the Guide for contributing partners.

In case of in-kind contribution (even combined with financial contribution), contributing partners become a part of the applicant consortium and participate in the project, as appropriate i.e. as beneficiaries or affiliated entities in the meaning of Article 8 of the Horizon Europe model grant agreement.

Also, Global Health EDCTP3 contributing partners can be a country, an international organisation or any public or private legal entity, other than the Global Health EDCTP3 members or their constituent or affiliated entities (please consult the Guide for contributing partners). Tuberculosis (TB) remains a prominent global health challenge.

According to the WHO’s Global TB Report 2024, the global rise in the number of TB incident cases, likely as effect of the disruption of TB services during the COVID-19 pandemics, has slowed and started to stabilise. The total number of people infected with TB was 10,8 million in 2023, a small increase from 10,7 million in 2022 although still much higher than 10,4 million in 2021 and 10,1 million in 2020.

Globally, 80% of the number of deaths by TB occurred in the WHO African and South-East Asia regions, with 16 out of 30 countries located in sub-Saharan Africa (SSA). Most of the TB deaths among people with HIV occurred in the African Region. Adolescents and adults account for over 80% of the TB burden and are the main source of transmission, including transmission to children.

Millions of people affected by TB are missing out on quality care each year, including on access to affordable diagnostic tests and treatment, especially in low- and middle-income countries. TB affects populations inequitably and contributes to the cycle of ill health and poverty, with malnutrition currently being the most prevalent contributor to the incidence of TB and inadequate living conditions contributing to the spread of _M.

tuberculosis_ and its impact on the community. Investments in building robust, integrated, and resilient health systems, including in TB prevention, detection and treatment services and research and development infrastructure and community responses can advance universal health coverage and contribute to effective prevention and response.

It is urgent to scale up comprehensive efforts to close long-standing gaps in prevention, diagnosis, treatment, and care of people at risk of TB, including children and immune-compromised individuals.

In terms of TB research and innovation, the following fields should be prioritised for TB drugs for therapy, chemoprevention or chemoprophylaxis according to the WHO Global TB Report 2024: new preventive drug treatments to prevent the progression to TB disease including patients with latent TB infection, and simpler, shorter treatments for TB disease.

Ongoing TB therapeutics trials are targeting particularly multidrug-resistant tuberculosis (MDR-TB), exploring promising agents as well as the potential of host-directed therapies. Various combination regimens with new or repurposed drugs, as well as host-directed therapies, are in Phase II or Phase III/IV trials.

In Phase II, more than 25 trials are ongoing mainly addressing new drugs, shorter therapeutics regimens, MDR-TB and extensively-drug resistant TB (XDR-TB), and novel combinations. Several other challenges including long treatment regimens and adverse side effects need to be addressed. TB and leprosy are both caused by mycobacteria being _Mycobacterium tuberculosis_ and _M.

leprae_ respectively and share similar challenges related to transmission, diagnosis, and prevention in (co-) endemic settings. Post-Exposure Prophylaxis (PEP) has emerged as a promising intervention to prevent disease progression in individuals at risk due to potential infection, particularly in close contacts.

Recognising the often-overlapping endemic areas, needs, tools and approaches in TB and leprosy prevention, intervention studies are needed of integrated approaches that may offer an efficient way to address both diseases simultaneously. Several promising TB drugs have also shown activity against _Mycobacterium leprae_, showing potential for a unified PEP strategy preventing both diseases.

The proposals submitted under this topic should aim to deliver results that are directed, tailored towards and contributing to improve TB-related outcomes in adults, and/or children in SSA. In addition, proposals are also expected to lead to reduced burden of disease related to MDR-TB and XDR-TB and/or improved TB interventions in the most vulnerable populations, particularly children.

Proposals submitted under this topic should address the following points: * Advance the clinical development by generating clinical data (Phase IIa trials and beyond) to progress towards registration of new TB drugs, improved or shorter therapeutics TB regimens, chemoprophylaxis and/or more comprehensive interventions combining therapeutics and chemoprophylaxis.

In addition, proposals submitted under this topic are also encouraged to: * Generate clinical data with a focus on priority populations, including women of childbearing potential and pregnant women, and particularly children, especially for assets in late-stage development. * Generate clinical data progressing development of new or improved treatment regimens for MDR-TB and XDR-TB.

Pulmonary TB disease, extrapulmonary TB forms, latent TB, DR TB, MDR TB, and XDR TB are considered in scope for this topic. Combination of chemoprophylaxis with vaccines, and combination of chemoprophylaxis with host-directed therapies are in scope as well. For proposals developing treatment of latent TB, focus should be on individuals with increased risk of progressing to active disease.

Proposals can address co-infections or co-morbidities of TB, including HIV/AIDS, but not as the primary objective of the proposal. Sex/gender differences and the effects of age should be duly taken into account when relevant. For Phase III studies, applicants are encouraged to ensure an adequately statistically powered study allowing for sex/gender and age specific analysis when relevant.

Treatment decision algorithms can be included but not as the primary objective of the proposal. It is highly important to implement solutions as soon as possible.

The granting authority will therefore base its funding decision relevant to this topic on the ranking of the proposals considering a portfolio approach taking into account late stage (phase III) proposals versus valuable more early-stage proposals, all graded above the threshold.

The development of prophylactic vaccines, diagnostics and monoclonal antibodies, Phase I a/b clinical trials of single and/or combination drugs, and implementation research in early phase studies are **not in scope**. Preclinical studies are considered out of scope of the topic.

However, preparatory activities conducted during the preclinical phase can be considered in scope if they enable the conduct of the clinical study/ies in scope (these activities include but are not limited to protocol writing, development/evaluation of laboratory tests, Chemistry, Manufacturing, and Controls (CMC) related activities, etc.).

For all Global Collaboration Actions such as this topic, proposals submitted are expected to leverage financial and/or in-kind contribution from contributing partners. Proposals should define the activities of their project in its entirety, including details of the component(s) for which Global Health EDCTP3 funding is requested and the component(s) that are to be financed by contributing partners.

Each contribution should be well described and budgeted in each proposal, so that the activities and related costs that are covered by the in-kind or financial contribution(s) are clearly identified. Applicants need to concisely describe any prior relevant research findings and explain how the proposal builds on available data (including data generated in scope of earlier EDCTP programmes if available).

Full details of the development milestones, including specific go/no-go criteria for the implementation of the proposed clinical trial(s) must be included, as well as specific plans for the subsequent regulatory approval process, which should aim at obtaining relevant market authorisation. and an access strategy that will allow patients in low-resource settings to access the final product.

The applicants are encouraged to consider the latest innovations and advances in the clinical trial design and research methods to evaluate promising interventions allowing shorter development timings. Applicants are also encouraged to follow the WHO Guidance for best practices for clinical trials.

Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers or clinical Investigators, health care professionals, policy makers, public health authorities and end-users.

Applicants should provide methodologies for translating research findings into public health practice and policy guidelines and are encouraged to follow guidance provided in the EDCTP Knowledge Hub Research into Policy Toolkit.

Where possible and relevant, collaboration and coordination with the AU-EU Health Partnership’s –Manufacturing and Access to Vaccines, medicines and health technologies (MAV+) hub or similar African initiatives is encouraged.

The applicants could show, for example, willingness to enter into technology transfer agreements with their 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.

Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from SSA countries, including active participation of Franco/Lusophone countries, if possible. Collaboration with other international research groups with relevant experience is very much encouraged.

Applicants are also reminded of the expectation of reaching out to institutions/organisations in countries with high disease burden but with relatively lower research capacities.

**Post-Exposure Prophylaxis (PEP) research – leprosy focus** In the context of studies on TB post-exposure prophylaxis, the Leprosy Research Initiative will co-fund one or more projects also targeting leprosy post-exposure prophylaxis (PEP), for instance, through integrated implementation of PEP or by evaluating or validating a uniform PEP regimen for both diseases in a clinical trial.

The objective and funding of the leprosy-related objective is to be included in the proposal with a total indicative JU budget of 5 million EUR. The selected project(s) will contribute to advancing knowledge and strategies for PEP in the context of TB and leprosy, aligning with broader institutional goals in infectious disease control.

[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 [2] The Global Health EDCTP3 Programme Office will ask the applicant contributing partner to revise the letter in case it significantly departs from the template letter published on the Global Health EDCTP3 website or is missing any compulsory elements.

The final decision as to acceptance or rejection of a new contributing partner rests with the Global Health EDCTP3 Governing Board. The submission session is now available for: HORIZON-JU-GH-EDCTP3-2026-01-LRTI-02-two-stage, HORIZON-JU-GH-EDCTP3-2026-01-HIV-03-two-stage, HORIZON-JU-GH-EDCTP3-2026-01-TB-01-two-stage Topic conditions and documents #### 1.

Admissibility Conditions: Proposal page limit and layout described in Annex A and 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 B of 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 Eligible Conditions The conditions are described in General Annex B except for the specific conditions for the Global Health EDCTP3 JU funding as regards entities eligible for funding and consortium composition, the specific rule for countries where the coordinator may be established and the obligation to designate a scientific project leader as below.

**Specific conditions replacing the relevant sections in General Annex B to the Horizon Europe Work Programmes** **A. Entities eligible for funding** This section applies to both Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA). 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[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]]: Albania, Armenia, Bosnia and Herzegovina, Canada (associated to Pillar II 'Global Challenges and European Industrial Competitiveness', including for the institutionalised European partnerships, and for award procedures implementing Union budget for the year 2024 and onwards), Faroe Islands, Georgia, Iceland, Israel, Kosovo[[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.]]

, 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, Republic of Korea (Pillar II only), Switzerland, 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): Egypt, Morocco, . * The following countries which are constituent states of the EDCTP Association[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.]]

: Benin, Burkina Faso, Burundi, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Eswatini, Gabon, The Gambia, Ghana, Guinea-Bissau, Guinea-Conakry, Kenya, Liberia, Malawi, Mali, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.

Legal entities which are established in countries not listed above (including in low-and middle-income countries that are not members of the EDCTP Association) will be eligible for funding if provided for in the specific call topic conditions, or if their participation is considered essential for implementing the action by the granting authority. **B.

Consortium composition** Unless otherwise provided for in the specific call conditions, for all actions, due to the policy objectives of Global Health EDCTP3, legal entities forming a consortium are eligible to participate in actions under the programme provided that the consortium includes as beneficiaries: * At least three legal entities independent from each other and each established in a different country, where legal entities are eligible to receive funding; * At least one independent legal entity established in a Member State, or in an associated country to Horizon Europe that is a member of the EDCTP Association; and * At least one independent legal entity established in a sub-Saharan African 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). For the two CSA (2) topics under call HORIZON-JU-GH-EDCTP3-2026-03 in case the applicant consortia opt for including the EDCTP Association as coordinator, the EDCTP Association must not be counted as one of the three independent legal entities necessary to ensure the eligibility of the consortium composition.

**Affiliated entities**— Affiliated entities are eligible for funding under the same conditions as beneficiaries.

**Associated partners**— Entities not eligible for funding and therefore not able to participate as beneficiaries or affiliated entities (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out 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[[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_, p.

17–119_.]] , 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 coordinator of the indirect action must be established in a Member State or associated country, or South Africa.

**Scientific project leader** If the coordinator is not established in a country in SSA (_please see previous paragraph_), 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 Global Health EDCTP3 on all issues of interest for the proper scientific management of the action. 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. #### 5a. Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

#### 5b. Evaluation and award: Submission and evaluation processes **Specific conditions related to Scores and weighting** **Replacing the scores and weighting section in General Annex D to the Horizon Europe Work Programmes as regards second stage of two-stage evaluations, for Research and Innovation Actions (RIA). **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 criterion 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 CSAs and the first stage of the two-stage evaluation of RIAs, the scores and weighting as indicated in Annex D of the General Annexes of the Horizon Europe work programme 2023/2025 apply.

_ In addition to the aspects of award criteria included in General Annex D, the following aspects are taken into consideration during the evaluation of second-stage proposals: For the ‘impact’ criterion: Production of meaningful and significant effects enhancing the impact of the relevant research activities via the inclusion of effective in-kind and/or financial contribution of contributing partners.

For the ‘quality and efficiency of the implementation’ criterion: Leveraging of financial and/or in-kind contributions from contributing partners that are equal or greater than the requested JU contribution, in order to ensure the necessary resources and effort for the action. are described in Annex F of the Work Programme General Annexes and the Online Manual. #### 5c.

Evaluation and award: 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 Implementing the provision on affordable access as defined in Article 114 of the Council Regulation 2021/2085[[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, _p. 17_.]]

, grants awarded under this topic will have to include in their Plan for the exploitation and dissemination of results including communication activities to be submitted during the project as a deliverable also the following: Participants must include in their Plan for the exploitation and dissemination of results[[For more information on the Plan for the exploitation and dissemination of results, please consult the General Annexes of Horizon Europe Work Programmes.]]

an appropriate and proportionate access plan that demonstrates their strategies to ensure that the products and services that they develop based or partly based on the results of clinical studies undertaken by their project are affordable, available and accessible to the public (market and end-users) at fair and reasonable conditions.

This covers registration targets, plans to meet demand, flexible approaches to IP, engagement with regulators and manufacturers where relevant and other strategies that reflect ability to pay and ensures that economic barriers to access are low.

In addition, participants should add, if relevant, as part of the plan, an outline on how to achieve the optimal use of an intervention including, for example, how to avoid irrational use, overuse or abuse (e.g. antimicrobials). The plan is to be submitted with the second-stage proposal.

In addition to any updates during the project, a final version of the Plan for the exploitation and dissemination of results including the above access plan, must also be submitted with the final report of the project.

Also in line with Article 114 of the Council Regulation 2021/2085[[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]], 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. described in Annex G of the Work Programme General Annexes.

**JU right to object to transfer/exclusive licensing** Global Health EDCTP3 may, up to four (4) years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5 of the Model Grant Agreement.

In addition, in accordance with Article 24(3) of Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe[[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, _p. 17_.]]

and the Model Grant Agreement, the right to object applies also to participants that have not received funding from the JU. **Information sharing regarding the proposals and the evaluation results** Applicants should be aware that the following information regarding their proposals may be shared with the members of the JU Committee of the EDCTP Association: 1.

Following eligibility check of the applications: aggregated country level data i.e. number of applicants, funding requested, organisation type; 2. For successful proposals, following Global Health EDCTP3 Governing Board decision on the call evaluation results: number; acronym; title; duration; role; country; legal name; PIC; legal type; total cost; requested JU contribution; 3.

Regarding project information following Grant Agreement (GA) signature: signature date of the GA; number, acronym, title, and duration of projects; role, country, legal name, PIC, legal type, URL, total cost, requested JU contribution, FC received, FC given, and IKOP of participants; 4.

Under specific conditions and following Global Health EDCTP3 Governing Board approval of the request of EDCTP Association, for proposals on the reserve list and unsuccessful proposals: number; acronym; title; duration; role; country; legal name; PIC; legal type; total cost; requested JU contribution.

**Access to information and involvement of contributing partners** To promote transparency and accountability, Global Health EDCTP3 may invite any contributing partners providing financial contributions under a certain topic to propose one representative as observer to participate in the evaluation process under confidentiality safeguards.

This possibility does not apply to contributing partners that are part of a consortium submitting a proposal under the relevant topic.

**Documents and information** By applying under any topic, participants consent that the JU reserves the right to share information and documents relevant to their application and where applicable their grant agreement and its implementation with contributing partners as identified and providing financial contributions under the relevant topic.

This information and documentation will only be shared under confidentiality safeguards for policy and monitoring purposes. They include: Global Health EDCTP3 may consult the relevant contributing partners for the purpose of assessing the project reports and deliverables.

For all projects under this topic, if the coordinator is not from a country in SSA, the designation of a scientific project leader 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.

Annual Work Programme 2026 Global Health EDCTP3 Calls for proposals #### Application and evaluation forms and model grant agreement (MGA): **Application form templates**_— the application form specific to this call is available in the Submission System_ **_Note:_**_despite blind evaluation being mentioned in the standard application form for stage 1 proposals of the two-stage calls available in the Funding and Tenders Portal (at the stage of adoption of this Work Programme), please note that the calls included in this WP are not part of the ‘blind evaluation pilot’, therefore no anonymisation is required for stage 1 proposals of the two-stage calls.

_ Standard application form (HE RIA IA Stage 1) **Evaluation form templates**_— will be used with the necessary adaptations_ Standard evaluation form (HE RIA, IA and CSA Stage 1) **Model Grant Agreements (MGA)** **Call-specific instructions** Information on clinical studies (HE) #### Additional documents: HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4.

Health HE Main Work Programme 2026-2027 – 15. General Annexes HE Framework Programme 2021/695 HE Specific Programme Decision 2021/764 EU Financial Regulation 2024/2509 Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Online Manual Funding