On 15 September EDCTP celebrated its third anniversary and the Secretariat staff took time to reflect on gains that have been made in the past three years. Greatly missed was Dr Odile Leroy who has recently stepped down as the Partnership’s Executive Director to take up the post of Executive Director of the European Malaria Vaccine Initiative (EMVI). Dr Leroy will be remembered as the person who has established a firm foundation for EDCTP including putting in place the current best practices being followed by the organisation such as standard operating procedures, transparent review mechanism, and quality control and quality assurance measures. We wish to put on record how much we have appreciated her hard work and guiding hand and wish her every success in her new post. The General Assembly of EDCTP hopes to identify a successor to Dr Leroy by the end of the year. 

In the current issue of the newsletter, we report on the First EDCTP investigators’ meeting that brought together policy makers, regulatory authority personnel and EDCTP funded scientists and other researchers working on poverty-related diseases. These met in Cape Town to share their experiences and to network. A detailed report of this meeting will soon be available including on our website. The investigators’ meeting was followed by a very productive meeting of the DCCC members who deliberated on many issues including the establishment of centres of excellence. Among other very important functions, DCCC is responsible for identifying capacity gaps and research needs in Africa. This issue of the newsletter also has news of the recently awarded grants and advocacy activities of the High representative. We also report on the site visit that took place in Burkina Faso and on the First African Vaccine Regulatory Forum that was held in Accra, Ghana and organised in partnership with the World Health Organisation. There is good news of new funding from four EDCTP-EEIG member states (Sweden, Germany, Belgium and the UK) demonstrating the strong commitment of European states towards integration of national programmes.

The Eleventh DCCC Meeting, Cape Town, 26-27 July

The eleventh meeting of the EDCTP Developing Countries Coordination Committee (DCCC) took place at MRC in Cape Town from 26 to 27 July 2006 soon after the Investigators’ Meeting.

At the meeting members discussed the recommendations to EDCTP from the investigators that included:

• To extend senior fellowship projects with more funding
• To reinforce capacity building through training of personnel, ethics and regulatory bodies
• To foster collaboration between investigators and policy makers
• To promote and strengthen South-South and North-South networking
• To devise a strategy for accreditation of Clinical Trial sites
• To revisit co-funding and budget cuts associated with EDCTP grant.

Also addressed were:

• The need to involve more African countries in the newly proposed funding of large grants by EDCTP i.e. call strategies and co-funding modalities with both European states and African organisations
• Ways of enhancing regional capacity building and ownership of programmes in Africa; including linkages with NEPAD initiatives such as the Biosciences Eastern and Central Africa (BecA)
• Ways of involving local ethical bodies while building their capacity within the grant applications without causing conflicts of interest in the process.

Four Member States contribute to EDCTP with new funds

The EDCTP is based on Article 169 of the European treaty that allows the European Commission to co-fund the Joint Programme of the member states. Several member states have demonstrated their commitment towards integration of their national programmes, by committing additional funds for collaborative research within the EDCTP. The Swedish Agency for International Development Cooperation (SIDA) research board has recently approved 10 million Swedish Kronor (approximately 1 million €) per year over the next three years, with provision to provide the same level for a further two years. The funds will be disbursed directly to the EDCTP secretariat. Germany has enhanced its national participation in the EDCTP Joint Programme by earmarking 1 million EUR per year in its national budget lines for the next three years. The United Kingdom Medical Research Council is negotiating an additional 5 million UK pounds for EDCTP activities (about 7.5 million e) for the period 2007-2010. The Institute of Tropical Medicine in Belgium has committed 500.000 e per year from its institutional funding by the Belgian and Flemish governments for the period 2007-2010, negotiations are under way to obtain additional co-funding.

A full report of the meeting will be available electronically on our website and in hard copies soon.

Advocacy conducted by High Representant

During the last quarter Dr Pascoal Mocumbi, the EDCTP High Representative (HR) represented EDCTP in various meetings. These included the Third National Health Conference on “Voice and Proposal: Policies for the Right to Health 2006-2011” that took place in Lima, Peru from 10-12 July 2006 were he spoke on “World Health and social determinants”. This was followed by the Second Conference of Intellectuals from Africa and the Diaspora (II CIAD) in Salvador da Bahia, Brazil. In his presentation he highlighted EDCTP as an innovative partnership that would contribute in the retention of African health professionals in Africa and attract the diaspora to return home and contribute to sustainable development of the continent. At the meeting the HR also met with Professor Alpha Omar Konare, Chairperson of the African Union (AU) and Advocate Bience Gawanas, the AU Commissioner for Social Affairs and briefed them on EDCTP activities in Africa.

In August, Dr Mocumbi participated in the Geneva forum organised by the Geneva University Hospitals and the Medical School of the University of Geneva in collaboration with the Geneva International and Non-governmental Organisations active in health and care. At this forum that was dedicated towards global access to health, Dr Mocumbi spoke on public private partnerships as a possible solution for the future and discussed on the strengthening of the long-term capacity in the public sector.

September was equally busy for Dr Mocumbi. During the month he attended the Second Conference on Regulation in the Pharmaceutical Industry which discussed access to life-saving medication at the Basel Institute on Governance, Switzerland, and spoke on the development of new clinical interventions to fight poverty-related diseases. On 12 September Dr Mocumbi met with senior officials at the Directorate General of Development at the European Commission (EC) in Brussels to advocate for a better coordination of research and development and to explore opportunities for capacity development in non-established sites. This was complemented with the development agenda of EC in Africa where it was agreed to include capacity development in the agenda for the up-coming meeting between the African Union Commission and the EU Commission in Addis, Ethiopia in October 2006.

Dr Pascoal Mocumbi (High Representative); Mr. Simon Belcher (Financial Manager), and Dr Michael Makanga (Capacity Development Manager), made a site visit to Burkina Faso from the 4-8 September 2006. The team visited Nanoro District Health Centre located in the centre of Burkina Faso and the Centre Muraz, a national institute of medical research located in Bobo Dioulasso. These sites are preparing to undertake an EDCTP supported multicentre study on the evaluation of three artemisinin-based combinations for treating uncomplicated malaria in African children, which will be conducted in collaboration with Professor Umberto D´Alessandro as a project coordinator and Dr Tinto Hamidou a Burkinabe investigator.

The team along with the Partnership Board Member from Burkina Faso, Dr Sodiomon Bienvenu Sirima had separate meetings with several officials including: The head of delegation of the European Union in Ouagadougou, Burkina Faso, Mme Sari Soumalainen; Deputy Minister of Research, honourable Eloi Bambara; Director in charge of Health Research in Ministry of Health, Dr Hien Sié Roger; Director General of Pharmarcies, Medicines and Laboratories, Dr Mahamadou Compaoré; Representative of the World Health Organisation Country Representative, Dr Kane Ibrahim; the National Ethics Committee Chairperson, Dr Ouaba Bindi, and the Head of Research Collaboration at the Belgium Embassy in Ouagadougou, Mme Marie-Goretti Nyirarukundo among others.

On September 19-22, 2006, The AFRO Vaccine Regulators’ Forum (AVAREF) held its first meeting in Accra Ghana. The forum was organised by the World Health Organisation (WHO) and as one of the collaborative activities aimed at strengthening regulatory capacity in Africa with funding from the EDCTP and the Netherlands-African Partnership for Capacity Development and Clinical Interventions against Poverty related Diseases (NACCAP).

The launching of AVAREF is in response to the critical need to establish a system to support National Regulatory Authorities (NRAs) in the assessment of clinical trial applications, evaluation of clinical trial data, monitoring of clinical trials and evaluation of marketing authorisation dossiers in Africa.

The forum aimed at:

• providing scientific information to regulators of African countries that are involved in clinical trials of poverty related diseases, meningitis, rotavirus and other priority vaccines, on issues relevant to clinical trials evaluation and plans for registration in Africa
• promoting communication and collaboration between clinical trial sponsors, clinical research organisations, NRAs and ethics review committees both in Africa and developed countries
• identifying the need for expert support to the African NRAs for the regulatory review of clinical trials applications, evaluation of clinical data for registration purposes and other NRA functions
• identifying needs for developing regulatory guidelines and procedures for the evaluation of vaccines.
  identifying additional training needs to be facilitated by WHO;
• identifying capacity needs of NRAs in the evaluation of clinical trial application, monitoring, registration dossiers and post approval safety monitoring
• promoting of networking among African NRAs to facilitate sharing of expertise and skills in the review of clinical trials, monitoring and evaluation of vaccines and harmonisation of guidelines for these processes.

Professor Charles Mgone, Head of Africa Office and Dr Michael Makanga the Capacity Developing Manager represented EDCTP at the forum.