EDCTP at NEPAD workshop on harmonisation of drug registration in Africa

From 24 to 26 February, 138 stakeholders came together in a NEPAD workshop organised to invite project proposals for strengthening harmonisation of regulatory functions at regional economic community (REC) level of Africa. During the meeting, the Bill & Melinda Gates Foundation (BMGF) and the Department for International Development (DfID) of the United Kingdom expressed their interest to fund projects on harmonisation of drug registration in Africa within a consortium of donors of like-minded organisations and funders such as EDCTP. The regional economic communities represented in the workshop and likely to submit proposals for funding were the Community of Sahel-Saharan States (CEN-SAD), Common Market for Eastern and Southern Africa (COMESA), Economic Community of West African States (ECOWAS), East African Community (EAC), Economic Community of Central African States (CEEAC/ECCAS), Southern African Development Community (SADC), Intergovernmental Authority of Development (IGAD) and Arab Maghreb Union (AMU/UMA).

Urgent need for funding and political support
There is urgent need to increase access to priority essential medicines by reducing the time it takes for beneficial therapies to reach patients in need in high disease burden countries of Africa. National Drug Regulatory Authorities (NDRAs) have a vital function to ensure registration of drugs, vaccines and medical devices for legitimate use by patients in the countries in need. Many countries in African have weak or non-existent NDRA.

Funding is central to a functional regulatory structure. However, many African governments are yet to meet their commitment of spending 15% of their national budgets on health and 2% of the health budget on health research development. Harmonisation of drug registration at regional levels will ensure that governments make savings and increase patient reach with generic interventions at a rapid rate, that donors and international organisations benefit from the rapid patient reach and contribute to attainment of Millennium Development Goals (number 4, 5 and 6) and that pharmaceutical manufacturers save costs from single dossier submissions and fast registration processes. Apart from funding the process of harmonisation this will require political support and acceptable legal frameworks.

NEPAD workshop for projects to strengthen regulatory framework
With financial support from BMGF and DfID and technical support from WHO and the Clinton Foundation, NEPAD organised a workshop to invite project proposals for strengthening harmonisation of regulatory functions at regional economic community (REC levels) of Africa. The meeting took place in Johannesburg from 24 to 26 February and was attended by 138 people from NDRAs, RECs, BMGF, Clinton Foundation, DfID, NEPAD, WHO, Council on Health Research for Development (COHRED), European and Developing Countries Clinical Trials Partnership (EDCTP), European Medicines Agency (EMEA), European Commission (EC), German Technical Cooperation (GTZ) and United Nations Industrial Development Organization (UNIDO).

According to reports during the workshop BMGF and DfID have expressed interest to fund such types of projects from within a consortium of donors of like-minded organisations and funders. The regional economic communities represented in the workshop and likely to submit proposals for funding were the Community of Sahel-Saharan States (CEN-SAD), Common Market for Eastern and Southern Africa (COMESA), Economic Community for West African States (ECOWAS), East African Community (EAC), Economic Community of Central African States (CEEAC/ECCAS), Southern Africa Development Community (SADC), Intergovernmental Authority of Development (IGAD) and Union Arab Maghreb (AMU/UMA).