June 7, 2012 – The conduct of clinical trials is vital to speeding up the development of and access to affordable essential medicines, technologies and other health interventions as well as building evidence and support for new solutions. However, in order to promote and protect the safety of future users – medicine and other trials must be controlled by competent Medicines Regulatory Authorities (MRAs).

Currently, most of Africa’s 54 countries have a Medicines Regulatory Authority in place, but to date there has been no systematic attempt to assess and describe the levels of expertise and competence of these authorities. One of the challenges to get such information is a lack of consensus or benchmark on the scope and competencies needed for the optimal functioning of MRAs in Africa. In addition, there is no generally agreed performance or outcome metrics that exist for the assessment of MRAs.

This clearly has major implications for low- and middle-income countries where efforts to strengthen the capacity of MRAs are sporadic and uncoordinated, even though lack of competent MRAs are seen by many as a key obstacle to improving access to essential drugs in Africa.

Consequently, it seems obvious that we need to create a basic map and assess the capacities of African MRAs in order to create benchmarks, diagnose strengths, weaknesses, and gaps, and implement monitoring and evaluation of capacity-building interventions.

The MARC project (Mapping African Research Ethics Review Capacity; http://www.researchethicsweb.org/) is funded by the EDCTP (European and Developing Countries Clinical Trials Partnership) and jointly operated by the Council on Health Research for Development (COHRED) and the South African Research Ethics Training Initiative (SARETI) (http://sareti.ukzn.ac.za/Homepage.aspx). MARC is creating a web-based map of African MRAs and their institutional capacities. In doing this, we are utilising COHRED’s existing Health Research Web (HRWeb) platform (www.healthresearchweb.org) to create an interactive space through which we can inform and engage with all research establishments, sponsors, researchers and the general public on the issue of MRAs.

It is also gratifying to note that the Pharmaceutical Manufacturing Plan for Africa (PMPA) http://www.unido.org has now reached the implementation stage. At the last meeting of the Technical Committee of the Pharmaceutical Manufacturing Plan for Africa (TC-PMPA), members succeeded in finalising the draft business plan, which is now ready and will be submitted to the special session of the Conference of Ministers of Health in June 2012 in Addis Ababa- Ethiopia.

The PMPA has a two-pronged approach. Firstly, it aims to facilitate the establishment of stronger coordination systems for programme interventions in the pharmaceutical sector in Africa.  Secondly, it intends to strengthen Africa’s ability to produce high quality, affordable, safe and efficacious essential medicines in order to contribute to improved health outcomes and the realization of economic benefits.

The lack of coordination of stakeholders working in this area has been a major challenge to the success of various pharmaceutical initiatives in Africa to date. To help resolve this, the African Union seeks to involve all interested parties at all stages of the implementation of the business plan to ensure that there is widespread support and synergy. In this regard, COHRED has been recognised as one of the key stakeholders who can play a major role by providing technical support to governments through its “Strengthening Pharmaceutical Innovation in Africa” project (http://www.cohred.org/2010/06/strengthening-pharmaceutical-innovation-in-africa/). Insufficient regulatory oversight and capacity, as is currently tackled by the MARC project, was also identified by the TC-PMPA as a major factor hampering achievement in improved quality standards.

It is envisaged that COHRED’s work on mapping Medicines Regulatory Authorities in Africa under the MARC Project will complement the initiative to harmonise African MRAs by the New Partnership for Africa’s Development (NEPAD Agency). Our contribution could include: the provision of a free MRA database for information exchange; creating a link between Research Ethics Committees (RECs) and MRAs; integration and harmonisation of MRA functions regionally and increased interaction among regulators.

Additionally, describing the capacity of MRAs could expedite approval of conducting Phase 0 and I (First-in-Human) clinical trials in those African countries where strong capacity has been developed and this would be a huge contribution to speeding up medicines access in Africa.

COHRED remains committed to serve on the TC-PMPA and provide technical support to strengthen capacity of the pharmaceutical innovation initiative in the areas of research and development as well as medicines regulatory oversight. But we can do much more with more support – from you and others, for example:

• creating a continuous MRA education programme that includes public and private sector expertise and will bring much needed, high-level inputs and opportunity for inter-country exchange;
• help regionalise MRA activities so that strong and weaker bodies can have the benefit of joint action – particularly in the context of regional economic communities, and
• we can help governments and MRAs think through their own goals and intentions more clearly: is it mostly to increase access to essential medicines or more to become a player in the pharmaceutical world; and, is it better to focus on procurement, production or research and development – are some key questions for countries to answer.

Best wishes,

Carel.