Description

Background

Poverty-related diseases (PRDs) represent a huge burden in many communities in sub-Saharan Africa. Investments for developing new drugs, vaccines, microbicides and diagnostics for PRDs are being made by various entities including pharmaceutical companies and public-private partnerships. Following registration of new and improved clinical interventions, there is a significant challenge of ensuring that these products reach the target populations and that their safety and effectiveness is assessed in real world settings. Currently health systems in PRD endemic areas in sub-Saharan Africa are either weak or not adequately prepared for delivery and uptake of new or improved clinical interventions and to monitor their effectiveness and safety. Concerted collaborative efforts are needed to strengthen the governance, personnel and infrastructures for uptake as well as effectively deliver and monitor the implementation of new cost-effective interventions for PRDs in endemic areas.

Scope

The purpose of this Call for Proposals is to support distinct strategic actions (Coordination & Support Actions) which are part of a large-scale programme of actions that is supported by EU, national and/or international development assistance initiatives and/or other funders, including relevant WHO initiatives where appropriate, for strengthening the capacity of health systems to effectively deliver new products and to monitor their post-market safety(1). This should lead to better planning for the introduction of new medical interventions for PRDs; improved delivery; and, better understanding of the safety profile of and reporting mechanisms for products introduced in sub-Saharan Africa.

Proposals addressing one or both of the following topics are particularly encouraged: 

Development of pharmacovigilance (PV) capacities in sub-Saharan Africa

• Activities may include: analysis of the current PV policies, regulations and infrastructure in sub-Saharan African countries (e.g. with the use of the Indicator-based Pharmacovigilance Assessment Tool (IPAT)); implementation of tools, technologies or mechanisms to establish and/or improve the efficiency of systems for adverse event detection, reporting, analysis and dissemination to relevant stakeholders; support of staff from sub-Saharan African countries to attend training courses in established PV training centres. Initiatives aligned with the African Medicines Regulatory Harmonization Programme (AMRH) are particularly encouraged.

Translation of research into policy and practice

• Activities may include: the development of methodological tools for the successful translation of research into public health programmes or practices; optimising strategies for widespread adoption and institutionalisation of research results within public health systems; or, the evaluation of research uptake activities. This may entail the analysis of established methods and frameworks from the field of policy analysis to improve the understanding of the process of health policy development in a given sub-Saharan African country and international context. Proposals should clearly define the activities and mechanisms to be used within the project, including details of any collaboration with public authorities, international organisations or commercial partnerships that will be established in order to achieve the expected impact.

Proposals must present the large-scale programme of actions in its entirety, clearly indicate for which part EDCTP2-funding is requested and how the financing of the other parts is ensured if applicable, and present its relevance to reaching the objectives of the EDCTP2 programme, in particular to increase the impact of EDCTP-funded activities and their results. The ambition and design of the proposed large-scale programme of actions as well as the relevance of the proposed strategic action for the large-scale programme of actions must be presented clearly. Supporting information on the composition and scale, as well as on the management structures and procedures of the large-scale programme of actions must be presented to enable assessment of their appropriateness.

EDCTP considers that proposals for activities of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals for actions of a different duration.

The large-scale programme of actions must be of a sufficient scale and ambition to justify EDCTP support in combination with financial support from EU, national, international development assistance initiatives and/or other funders. EDCTP considers that at least half of the costs of the large-scale programme of actions should be supported by EU, national and/or international development assistance initiatives and/or other funders (such as EDCTP2 Participating States, relevant WHO initiatives or other third parties), in order to ensure complementarity and increase the impact of the results of EDCTP-funded activities.

Expected impact

Actions funded under this Call for proposals should increase the readiness of health systems to introduce and absorb new interventions for PRDs and increase the coverage, accessibility and effectiveness of existing evidence-based interventions in endemic areas in sub-Saharan Africa. Furthermore, PV-related actions should contribute to the establishment and/or strengthening of sentinel surveillance systems in sub-Saharan African countries where new drugs or vaccines are implemented, in addition to developing a cohort of PV-trained staff to lead and manage the PV process in these countries.

Proposals that clearly document major financial support from EU, national and/or international development assistance initiatives will be considered to have a higher impact.

Eligibility

At least one legal entity established in a European Participating State(2) or a sub-Saharan African country(3).

‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.

Notes:

1. The EDCTP2 basic act (Annex II, 2d, 2e and 3f) requires EDCTP to “establish cooperation and launch joint actions with Union, national and international development assistance initiatives, including where appropriate, relevant WHO initiatives, in order to ensure complementarity and increase the impact of the results of EDCTP-funded activities.”
2. Legal entities in the following European countries: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.
3. Legal entities in the following sub-Saharan African countries are eligible to apply: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Sudan, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

Procedure and application process

Submission and evaluation procedure

This is a two-stage application procedure. For the first stage, a letter of intent must be submitted by 29 September 2016 via EDCTPgrants. Applicants will be notified of the first-stage outcome before 22 December 2016. Successful applicants in the first stage will be invited to submit a full proposal. The deadline for submission of full proposals is 2 March 2017.

Stage 1: Letters of Intent

For the evaluation of the first stage (Letters of Intent), only the criteria Excellence and Impact are evaluated. Within these criteria, only the aspects in bold will be considered. The threshold for both individual criteria will be 4. The overall threshold, applying to the sum of the two individual scores, will be set at the level such that the total requested budget of proposals admitted to stage 2 is as close as possible to three times the available budget. The actual level will therefore depend on the volume of proposals and funding request per proposal received. The threshold is expected to normally be set at 8 or 8.5. Successful applicants will be invited to submit a full proposal in the second stage.

Stage 2: Full proposals

For the evaluation of the second stage (Full Proposals), evaluation scores will be awarded for the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5. The threshold for individual criteria is 3 and the overall threshold for the sum of the three individual scores is 10. Applicants have the opportunity to submit a written response to the expert reviewers’ comments prior to an expert review committee meeting convened by EDCTP to finalise the funding recommendations.

Evaluation criteria, scoring and thresholds

Following an admissibility and eligibility check, letters of intent and full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5.

The following aspects are considered under the evaluation criteria:

1. Excellence

• Fit with the scope and objectives of the EDCTP2 programme and the call topic description.
• Importance, relevance/pertinence and clarity of the objectives.
• Soundness of the concept and credibility of the proposed approach/methodology.
• Clarity, pertinence and importance of the strategic vision.
• Soundness of the concept.
• Quality of the proposed coordination and/or support measures.

2. Impact

• The extent to which the outputs of the proposed work would contribute, at the European, African and/or International level, to each of the expected impacts listed in the work plan under the relevant topic.
• Likelihood to result in major advances for the field.
• Effectiveness of the proposed measures to exploit and disseminate the project results (including management of IPR), and to manage research data where relevant.
• Sustainability of capacity beyond the end of the grant, where relevant.
• Contribution to networking, where relevant.

3. Quality and efficiency of the implementation

• Quality and effectiveness of the work plan, including extent to which the resources assigned to work packages are in line with their objectives and deliverables.
• Appropriateness of the management structures and procedures, including risk and innovation management, and how responsibilities for research data quality and sharing, and security will be met.
• Complementarity of the participants within the consortium, and the extent to which the consortium as whole brings together the necessary expertise.
• Appropriateness of the allocation of tasks and resources, ensuring that all participants have a valid role and adequate resources in the project to fulfil that role.
• Feasibility and appropriateness of the methods and project management to achieve the objectives within the timeframe of the grant.
• Compliance with national and international standards of research, Good Clinical Practice, ethics and safety related issues.
• Participants have the operational capacity, to carry out the proposed work, based on the competence and experience of the individual participant(s).
• Quality of the leadership and a clear and effective governance structure.

Financial provisions

The call budget is 10 million EUR.

The requested EDCTP contribution per project should not exceed 3 million EUR. The funding level is 100% of eligible costs.

Grant agreement

The Coordinator is required to sign a grant agreement with EDCTP (EDCTP2 mono-beneficiary grant agreement or multi-beneficiary grant agreement) within three months of receipt of the conditional award letter. In the case of actions involving multiple beneficiaries, all Participants (legal entities) in the project must sign a consortium agreement.

Application process

• The application must be submitted online via EDCTPgrants
• Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible

Documents and more information

Documents

• Second stage: application form template (Word)
• First stage: application form template (Word)
• EDCTP2 annual work plan 2016 (PDF)

More information 

• For questions related to this call for proposals, please contact: Dr Michelle Singh at singh@edctp.org
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org or +31 (0) 70 344 08 80.
• For guidance on online application procedure, please refer to the Guidance for applicants.
• For more information about EDCTP2 procedures, please refer to the EDCTP2 Grants Manual and EDCTP2 FAQs

Projects funded under this call

EXIT-TB
Translation research into policy and practice: scaling up evidence-based multiple focus integrated intensified TB screening to end TB in the East African Region

National Institute for medical research (NIMR), Dar es Salaam, Tanzania with partners from Ethiopia, Kenya, Norway, Sudan, Tanzania, Uganda, and United Kingdom
Grant agreement: CSA2016S-1608
Project coordinator: Dr Esther S. Ngadaya, (NIMR, Tanzania)
Starting date: 1 April 2018
Duration: 54 months
Total project value: EUR 5,848,634
EDCTP grant amount: EUR 2,924,274
Co-funding from: University of Addis Ababa (Ethiopia); Centre for Global Health Research – KEMRI (Kenya); University of Bergen (Norway); Institute of Endemic Diseases – University of Khartoum (Sudan); Kilimanjaro Clinical Research Institute (Tanzania); National Institute for Medical Research (Tanzania); and Infectious Diseases Institute – Makerere University (Uganda).
Project website

PAVIA
Pharmaco Vigilance Africa

Stichting Amsterdam Institute for Global health and Development (AIGHD), Amsterdam, the Netherlands, with partners from Ethiopia, Italy, the Netherlands, Nigeria, Swaziland, and Tanzania
Grant agreement:CSA2016S-1627
Project coordinator: Prof. Frank Cobelens (AIGHD, the Netherlands)
Starting date: 1 March 2018
Duration: 48 months
Total project value: EUR 12,800,000
EDCTP grant amount: EUR 3,000,000
Co-funding from: United States Agency for International Development (United States of America).
Go to project website

PROFORMA
Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa

Karolinska Institutet (KI), Stockholm, Sweden, with partners from Ethiopia, Kenya, Rwanda, Tanzania, and the Netherlands 
Grant agreement:CSA2016S-1618
Project coordinator: Prof. Eleni Aklillu (KI, Sweden)
Starting date: 1 March 2018
Duration: 60 months
Total project value: EUR 6,000,000
EDCTP grant amount: EUR 3,000,000
Co-funding from: Pharmacy and Poisons Board (Kenya), Karolinska Institutet (Sweden), Swedish International Development Cooperation Agency (Sweden), Muhimbili University of Health & Allied Sciences (Tanzania), Tanzania Food and Drugs Authority (Tanzania).
Project website; PROFORMA on CORDIS