Annexes to COM(2013)498 - Participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly undertaken by several Member States - Main contents
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| dossier | COM(2013)498 - Participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly ... |
|---|---|
| document | COM(2013)498  |
| date | May 15, 2014 |
OBJECTIVES OF THE EDCTP2 PROGRAMME
EDCTP2 shall contribute to the following objectives:
(1) General Objective
EDCTP2 shall contribute to the reduction of the social and economic burden of poverty-related diseases in developing countries, in particular in sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, suitable and affordable medical interventions (1) for poverty-related diseases, in partnership with sub-Saharan Africa.
(2) Specific Objectives
In order to contribute to the general objective, EDCTP2 shall achieve the following specific objectives:
| (a) | an increased number of new or improved medical interventions for HIV/AIDS, tuberculosis, malaria and other poverty-related diseases, including neglected ones, and by the end of the programme to have delivered at least one new medical intervention; to have issued approximately 30 guidelines for improved or extended use of existing medical interventions; and to have progressed the clinical development of approximately 20 candidate medical interventions; |
| (b) | strengthened cooperation with sub-Saharan African countries, in particular on building their capacity for conducting clinical trials in compliance with fundamental ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union, the European Convention on Human Rights and its Supplementary Protocols, the World Medical Association’s Declaration of Helsinki of 2008 and the standards on good clinical practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); |
| (c) | better coordination, alignment and, where appropriate, integration of relevant national programmes to increase the cost-effectiveness of European public investments. Moreover, the research priorities should be established in an objective-orientated manner in order to accelerate results and contribute to the control and eradication of poverty-related diseases, including neglected ones; |
| (d) | extended international cooperation with other public and private partners to ensure that the impact of all research is maximised and that synergies can be taken into consideration and achieve leveraging of resources and investments; |
| (e) | an increased impact due to effective cooperation with relevant Union initiatives, including its development assistance. |
(3) Operational Indicators and Objectives
In order to reach the specific objectives set out in point 2, the following indicators shall be monitored during the course of the EDCTP2 programme:
| (a) | Support clinical trials on new or improved medical interventions for poverty-related diseases, including neglected ones, through partnerships between European and developing countries, in particular sub-Saharan Africa: Indicator: increase the number of supported clinical trials to at least 150, compared to 88 under EDCTP1, that lead to new products, processes, methodologies, diagnostics, treatments or preventions. Indicator: sustain or increase the proportion of clinical trials funded by the EDCTP2-IS with African leadership. Indicator: aim to increase the number of peer-reviewed scientific articles published to three times that of EDCTP1. |
| (b) | Support research capacity-building activities in sub-Saharan Africa enabling clinical trials to be conducted and help to reduce the brain drain: Indicator: aim to sustain or increase the participation of sub-Saharan African countries in the EDCTP2 Programme. Indicator: increase the number of fellowships to sub-Saharan African researchers and MSc/PhD students from 400 under EDCTP1, strongly encouraging and supporting them to continue their research career in sub-Sahara Africa following their fellowship. Indicator: increase the number of capacity-building activities supported for conducting clinical trials in sub-Saharan Africa from 74 under EDCTP1. |
| (c) | Develop a research agenda for EDCTP2 based on common criteria for priority setting and common evaluation, whilst recognising that contributions from national programmes and EDCTP may differ. Target: at least 50 % of the public investment by Participating States are integrated, aligned or coordinated through the EDCTP2 Programme. |
| (d) | Ensure efficiency of the implementation of the EDCTP2 Programme: Target: administrative costs are below 5 % of the EDCTP2-IS budget. |
| (e) | Establish cooperation and launch joint actions with other public and private funders. Target: increase the contributions received from developing countries to at least EUR 30 000 000 compared to EUR 14 000 000 under EDCTP1. Target: obtain additional contributions, either public or private, of at least EUR 500 000 000, compared to EUR 71 000 000 under EDCTP1. |
| (f) | 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. |
(1) For the purpose of this decision, ‘medical interventions’ encompass measures whose purpose is to improve or sustain health or alter the course of a disease, in particular prevention and treatment based on medicinal products such as drugs, microbicides or vaccines, including their delivery modality, follow up of treatment and prevention in the affected population as well as medical diagnostics to detect and monitor disease/health evolution.
ANNEX II
ACTIVITIES AND IMPLEMENTATION OF THE EDCTP2 PROGRAMME
(1) Activities
The EDCTP2 Programme shall include the following activities:
| (a) | promoting networking, coordination, alignment, collaboration and integration of national research programmes and activities on poverty-related diseases, including neglected ones, at scientific, management and financial level; |
| (b) | supporting clinical trial research and related activities on poverty-related diseases, in particular HIV/AIDS, malaria, tuberculosis and other poverty-related diseases, including neglected ones; |
| (c) | fostering capacity development for clinical trials and related research in developing countries, in particular in Sub-Saharan Africa, through grants for: career development of junior and senior fellows, promoting mobility, staff exchange grants, research training networks, strengthening ethics and regulatory bodies, mentoring and partnerships at individual or institutional or regional level; |
| (d) | establishing cooperation and launching joint actions with other public and private funders; |
| (e) | assuring awareness, endorsement and acknowledgment of the EDCTP2 Programme and its activities through advocacy and communication, not only at Union level and in developing countries, but also at global level. |
(2) Programme definition and implementation
The EDCTP2 Programme shall be implemented by the EDCTP2-IS on the basis of an annual work plan and a multiannual strategic work plan prepared by the EDCTP2-IS, in consultation with the relevant stakeholders, and adopted by the General Assembly of the EDCTP2-IS following international peer-review and subject to the prior approval by the Commission.
The annual work plan shall identify topics and activities to be implemented, including calls for proposals to be launched by EDCTP-IS to select and fund indirect actions, as well as the budgets and EDCTP2 funding for those topics and activities. Where appropriate, EDCTP2 may exchange information with other public or private initiatives, including those under Horizon 2020.
The annual work plan shall differentiate between the activities funded or co-funded by the Union and those funded by Participating States or other revenues.
The multiannual strategic work plan shall set a common strategic research agenda which shall be prepared and updated on an annual basis.
EDCTP2-IS shall monitor the implementation of the activities included in the work plan, including indirect actions selected through calls for proposals it manages. It shall allocate and manage funding to those in accordance with this Decision and the effective implementation of activities selected and identified in the previous work plans.
(3) Deliverables expected from the implementation of the EDCTP2 Programme
An annual report shall be provided by the EDCTP2-IS, which shall give a detailed overview of the implementation of the EDCTP2 Programme. That overview shall provide information on each activity selected in accordance with the work plan, including indirect actions selected through calls for proposals managed by the EDCTP2-IS. Such information shall include a description of each activity, including indirect action, its budget, the value of the funding allocated to it if any, and its status.
With regard to calls managed by the EDCTP2-IS, the annual report shall moreover include information on the number of projects submitted and selected for funding, the detailed use of the Union’s financial contribution, the distribution of national and other contributions including specification on the type of in kind contributions, the types of participants, country statistics, brokerage events and dissemination activities. The annual report may also include, when appropriate, information on measures taken to facilitate access to products stemming from EDCTP2.
The annual report shall also include information on the progress towards achieving the EDCTP2 Programme objectives set out in Annex I.
In addition, the EDCTP2-IS shall provide any report and information foreseen by this Decision and the agreement concluded with the Union.
ANNEX III
GOVERNANCE OF THE EDCTP2 PROGRAMME
The organisational structure of the EDCTP2 Programme shall be as follows:
| (1) | The EDCTP2-IS shall be governed by a general assembly (‘GA’), in which all Participating States are represented. The GA’s principal responsibility shall be to ensure that all necessary activities are undertaken to achieve the objectives of the EDCTP2 Programme, and that its resources are properly and efficiently managed. It shall adopt the annual work plan. The GA shall decide by consensus. Failing consensus, the GA shall take its decisions by a majority of at least 75 % of the votes. The Union, represented by the Commission, shall be invited to all GA meetings as an observer, and shall receive all necessary documents. It may take part in discussions. |
| (2) | The GA shall appoint a Management Board that shall supervise the secretariat of the EDCTP2-IS (‘SEC’) established by the GA as the executive body of the EDCTP2 Programme. The Management Board shall consist of such number of Board Members as the GA may determine, but not less than five. SEC shall have at least the following tasks:
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| (3) | A Scientific Advisory Committee (‘SAC’) shall advise the GA on the strategic priorities of the EDCTP2 Programme. The SAC shall be appointed by the GA and consist of European and African independent experts competent in areas relevant to the EDCTP2 Programme, taking into account gender balance. The SAC shall have the following tasks:
In exercising its tasks, the SAC shall monitor and promote high standards of ethical conduct of clinical trials and engage with vaccine regulatory authorities. The SAC may recommend to the GA the setting up of scientific subcommittees, task forces and working groups. The GA shall establish the number of SAC members, their voting rights and the arrangements for their appointment in accordance with Article 40 of Regulation (EU) No 1290/2013. The GA may set up specialised working groups under the SAC with additional independent experts for specific tasks. |