Developing Guidelines for Health Research in Africa

Brussels, Belgium-March 13, 2008-A roundtable on the development of guidelines for health research in Africa took place during the high level conference “Science with Africa,” organized by the UN Economic Commission for Africa and the African Union in Addis Ababa, Ethiopia, from 3–7 March 2008. Participation included African and international experts and policy makers in the fields of health research and bioethics. Within the overall aim of the conference to improve African participation in global R&D as well as to increase investment in science and technology in Africa, the roundtable launched a core initiative in developing the legal and regulatory frameworks for best practices in science and ethics in African health research.

African countries suffer from a disproportionately high percentage of the global disease burden while possessing remarkably low investment in health research. Clinical trials and other directed research engagements are particularly important for finding new prophylactic, diagnostic, and therapeutic interventions that will address prominent diseases on the continent, such as HIV/AIDS, TB, malaria, sleeping sickness, and cancer. These trials have to be supported by clear guidelines in Good Clinical Practice, informed consent, ethical review, genetics, and other areas, taking into account the specific needs of African communities and the continent as a whole.

“Clear guidelines for health research in African countries are not only necessary to develop cures against the major diseases, but they also offer an opportunity for African states to attract investment from international companies,” stated Francis Crawley, executive director of the Good Clinical Practice Alliance–Europe and co-initiator of the roundtable. Much of the roundtable focused on identifying the needs of African countries for guidelines in clinical trials and other areas of health research. It also provided a key opportunity for leading African and international partners to develop a consensus position on the organization of the project.In the opinion of Arne Koeppel, policy advisor at Intelligence in Science (ISC), a Brussels-based consultancy and co-organizer of the roundtable, the Science with Africa conference offered a unique opportunity to forge the political will needed to ensure the success of a directed pan-African engagement. “Without involving the leadership and decision-makers of countries where guidelines are most needed, the impact of any resulting guidelines will be less satisfying. This conference provided an exceptional leverage point toward ensuring success by bringing together scientists, experts, policymakers, and politicians from across the continent. This was an ideal platform for us to initiate the African guidelines project,” Arne Koeppel reflected.

The roundtable was chaired by Avril Doyle, member of the European Parliament. She stressed the growing commitment of the European Union to health research in developing countries, pointing out the increased involvement of the European Parliament, European Commission, and Member States to improving European partnership with Africa. “Still,” she stressed, “much much more can and should be done by Europe. Clinical trials that contravene established ethical guidelines in developed countries should not be allowed to be implemented in developing countries,” Doyle pointed out. She also gave particular attention to the need for the support of the global pharmaceutical industry in ensuring that the highest standards are discussed and implemented in Africa.

Leading African researchers and ethicists presented the existing experiences and achievements in various African countries as models for establishing standards for Good Clinical Practice, informed consent, ethical review, genetics, working with communities, and other key elements of health research. The participants used the discussion sessions to examine the existing gaps and needs for standards in health research as well as to establish a first roadmap for the project. Pierre Effa of the Cameroon Bioethics Society and a co-initiator of the project concluded that the roundtable demonstrated that there was a rich inventory of material and experiences within the African, European, and international communities to draw on as well as an enormous interest to move forward rapidly on this project.

The experts concluded that Africa must develop its own guidelines for ethics, Good Clinical Practice, and other key areas for promoting investment and outcomes in African health needs. The AfroGuide Project on the Development of Guidelines for Health Research in Africa was launched. Model laws will also be developed to strengthen African legal and regulatory systems for health research that promotes public health. The work will be carried out by an international collaborative group closely cooperating with national, African, and international leaders in health research and health policy.

The roundtable participants established an African project secretariat at the Cameroon Bioethics Society in Douala, Cameroon, and an international project secretariat at the Good Clinical Practice Alliance–Europe in Brussels. In the coming months, a series of workshops in Africa, Europe, and North America will be organised in order to consult with and involve interested and relevant stakeholders, including the pharmaceutical industry, in order to begin the process of selecting, drafting, and implementing African guidelines.

A key event is the upcoming 1st Pan-African Bioethics Congress to be held on 28–30 May 2008 in Yaound, Cameroon, where ethicists, health experts, scientists, policy makers, and politicians from across Africa and the international community will meet to discuss the first drafts of guidelines and model laws. This overall aim of this conference is to boost health research investment and to mobilize African strengths for achieving the millennium development goals.

At the plenary session concluding the Science with Africa conference, the African Union and the United Nations Economic Commission for Africa demonstrated their commitment to providing the leadership necessary for achieving the outcomes of the roundtable: linking health research to health policy and health care through shared African standards.