The second EDCTP programme will retain focus on HIV, tuberculosis and malaria; phase II and III clinical trials; and sub-Saharan Africa. It will build on the current objectives and achievements and expand to include all clinical trial phases (i.e. I-IV), including operational research on health services optimisation, Neglected Infectious Diseases (NIDs) endemic in sub-Saharan Africa, closer collaboration with the pharmaceutical industry, like-minded product development partners and development agencies. The programme will also allow collaborative research with other developing countries outside sub-Saharan Africa when possible and desirable.

EU support for EDCTP-Plus
In March 2012, EDCTP received a Coordination and Support Action (CSA) grant from the European Commission under the EU Framework Programme 7 to consolidate the achievements of the current programme and prepare for EDCTP2. These preparations are distinct from the current EDCTP research activities and structured in the EDCTP-Plus project. Implementation of these activities started in 2012 and will continue in 2013.

EDCTP-Plus aims to ensure that the EU-Africa research partnership remains strong and to lay the foundation for implementing and managing the EDCTP2 programme in view of the proposed expansion of scope and budget. A number of related priority areas and activities have been identified for the EDCTP-Plus project:

• The mapping of national programmes and research activities related to major poverty-related and neglected infectious diseases in order to strengthen integration and alignment of African and European research activities
• Following the work to increase engagement with the private sector which was funded by the member states, EDCTP will work closely with a range of potential partners including Small- and Medium sized Enterprises, Product Development Partnerships (PDPs) and like-minded organisations. The current EDCTP programme is recognised for its contributions to capacity development and to the coordination and networking of researchers and institutions in Africa and Europe. Related follow-up activities will consolidate and reinforce these achievements through continued support to ethics and regulatory bodies, the Pan-African Clinical Trial Registry and the regional Networks of Excellence
• Communications and advocacy activities will ensure the visibility of EDCTP-funded activities and that all stakeholders are informed during this critical period
• Finally, EDCTP’s operational processes and systems are being improved and updated in order to ensure that the operational systems and management are ready for a programme of expanded scope and budget. To ensure that the impact of EDCTP2 can be closely measured, a robust monitoring and evaluation framework will also be developed.

To support this preparatory work in 2012, EDCTP recruited new members of staff, namely: a North-North Networking Manager, a North-North Networking Officer, a Project Officer and an Information Technology Officer. Additional staff will be recruited in 2013.

Public endorsements of EDCTP2
In 2012, a broad range of advocacy, research and funding organisations as well as PDPs have publicly expressed strong support for a second EDCTP programme, especially for the expansion of the scope to include neglected infectious diseases. Several PDPs urged the European Union and its Member States to invest in research and development for poverty-related and neglected infectious diseases (PRNIDs). These position papers included:

• Saving lives and creating impact: EU investment in poverty-related neglected diseases, a report written by Policy Cures, an independent research and advisory group in the field of neglected diseases, and funded by DSW (Deutsche Stiftung Weltbevölkerung) which assessed the impact of EU funding for PRNIDs R&D and highlighted the return on investment for both developing countries and the EU (September 2012)
• Call to EU leadership in global health research and development published by 23 non-governmental organisations working in the field of global health (September 2012)
• Creating the tools of tomorrow: investing in global health R&D, an appeal published by the Bill & Melinda Gates Foundation, DSW, the Global Health Technologies Coalition (in which 40 nonprofit organisations participate), and Policy Cures (May 2012)
• Key recommendations for inclusion in Horizon 2020 of research and innovation regarding neglected diseases focussed on NIDs and was published by a group of global PDPs in order to advocate the PDP-approach and to give specific recommendations for EDCTP2 (May 2012)
• Research and development for poverty-related and neglected diseases: a priority in the next EU Research Framework Programme “Horizon 2020” endorsed by more than 30 organisations which advocated prioritisation of research for poverty related diseases (April 2012).

Expanding European membership in EDCTP2
National representatives from current and prospective member states of EDCTP convened in Copenhagen, Denmark on 15 May 2012. The meeting was hosted by Statens Serum Institut with the support of the Danish Presidency of the European Union. The Danish presidency was represented by the Danish Ministry for Science, Innovation and Higher Education. The aim of the one-day meeting was to provide information on the strategic opportunities and benefits offered by participation in the EDCTP2 programme and to provide a forum for discussion between current and prospective EDCTP member countries. The goal was to begin the process to expand European membership of EDCTP in preparation for EDCTP2 and thereby leverage investments in European national research programmes of relevance to poverty-related diseases.

EDCTP actively seeks to promote a wider European membership in order to further integrate the European clinical research effort regarding PRNIDs. In November 2012, Finland informally expressed willingness to join EDCTP2.

Implementation challenges and opportunities of EDCTP2
The European Commission discussed preparations for EDCTP2 with EDCTP-EEIG Member States, Associated Countries and prospective new partner countries during a two-day meeting in Brussels, 27-28 September 2012. The aim of this meeting was to discuss preparations for the legislative proposal by the Directorate General (DG) for Research & Innovation. Participants discussed a wide range of issues pertaining to the practical implementation of EDCTP2. These included strategic and operational issues related to the partnerships within EDCTP ranging from a global portfolio approach to joint programming, including the cofunding at project and programme level; partnership with other funders; EDCTP’s role in multi-funded large-scale clinical trials; scientific scope of EDCTP2; further integration of the sub-Saharan African countries in EDCTP decision making processes; and rules for participation in Horizon 2020.

The meeting was an important milestone in the preparation of the proposal for EDCTP2 and was attended by representatives from Belgium, Denmark, France, Italy, Portugal, Spain, Sweden, Switzerland and United Kingdom; and observers from Finland and Latvia, the Bill & Melinda Gates Foundation, the European Investment Bank, and the European Commission Directorate General for Development & Cooperation – Europe Aid.

High-Level Conference on EDCTP2 in South Africa
A high-level conference to consult African and international stakeholders on the second programme of the European & Developing Countries Clinical Trials Partnership was held in Cape Town, South Africa on 5 November 2012. The conference was jointly organised by the Department of Science & Technology of South Africa, the European Commission and EDCTP.

The objective of the conference was to provide a forum to discuss with African and European stakeholders needs and expectations; and for African and European governments to endorse EDCTP2 and express commitment to the programme. Invited participants included African and European ministers and senior representatives from governments, PDPs, patient organisations and the research community. The 244 participants at the meeting heard presentations from 15 senior speakers and also two panel discussions, each of which was followed by contributions from the floor. The conference was opened by the Minister of Science and Technology of South Africa, Hon. Derek Hanekom.

Four strategic issues for EDCTP2 were addressed. These included lessons learnt from the current programme; the scope of EDCTP2; the role and commitment of the participating European and African countries; and participation of the private sector (in particular, pharmaceutical companies, PDPs, private foundations and philanthropic organisations) in EDCTP2. The speakers were unanimous in praising the achievements of EDCTP so far, and in welcoming the broadening of the remit of the second programme while maintaining focus on the core objectives. Máire Geoghegan-Quinn, European Commissioner responsible for Research, Innovation and Science, described EDCTP as “a beacon of hope” and “a brilliant success story for EU-Africa research cooperation”. She said the fight against poverty-related diseases was a global challenge in which Europe could and must make a major contribution. Representatives from African and European countries, research institutions, the Bill & Melinda Gates Foundation, and the private sector represented by European Federation of Pharmaceutical Industries and Associations (EFPIA), and GlaxoSmithKline also expressed appreciation and continued support for the work of EDCTP.

Many speakers highlighted the importance of equality within the partnership. For example, Maria da Graça Carvalho MEP, described EDCTP as, “a genuine partnership with Africa, in which African partners have retained a high degree of ownership and leadership”. The need for African governments to participate more actively was stressed by several speakers. Also much referred to was the need to increase the involvement of other partners – including industry, philanthropic organisations and foundations, and communities themselves. It was regarded as essential that research supported by EDCTP should be translated into effective new products that reach those most in need.

Many participants took the opportunity to join the organised visits to witness the research work funded by EDCTP at clinical trial centres and institutions in the Cape Town area, including the South African Tuberculosis Vaccine Initiative (SATVI) laboratories, the Khayelitsha TB vaccine site, and the research and teaching institutions at Groote Schuur and Tygerberg Hospitals.