Ensure medical products used in Africa are safe and effective

The Covid-19 pandemic poses a challenge to low- and middle-income countries in ensuring that experimental human models for clinical trials of vaccines are conducted in an efficient way while complying with internationally acceptable standards.

Scientists and researchers also experience delays in the approval of protocols for clinical trials for Covid-19 medical products, which will jeopardise patients’ needs.

Given the crisis and the need to ensure clinical trials and medical products are approved based on internationally acceptable standards, the ministers of the 3rd African Union Bureau of the Specialised Technical Committee On Education, Science and Technology held a virtual ministerial meeting on April 9 to promote and maintain a high-level African ministerial dialogue to facilitate consensus on the education, science, technology and innovation response to Covid-19.

They adopted urgent and transformative measures to ensure continuity of education on the continent and mitigate the disruptions caused by the coronavirus disease.

One of the recommendations of the meeting is to build on the structures established by the African Medicines Regulatory Harmonization (AMRH) Initiative, coordinated by the African Union Development Agency-NEPAD, as well as with working linkages with the networks of centres established by the Africa Centres for Disease and Control Prevention (Africa CDC) and the African Scientific Research and Innovation Council.

This is underpinned by establishing a Strategic African Research and Innovation Emergency Response on the epidemiology of Covid-19, therapies, vaccines and technologies; identifying and testing the efficacy of existing and potential drugs and vaccines for clinical trials; and novel treatment combinations, including traditional medicine and practices on Covid-19.

AUDA-NEPAD, in collaboration with the African Union Commission, Pan African Parliament, World Health Organization (WHO), the Bill and Melinda Gates Foundation, the World Bank and the AMRH Partners, has been instrumental in developing and coordinating the implementation of the four frameworks – Pharmaceutical Manufacturing Plan For Africa (PMPA), AMRH Initiative, AU Model Law on Medical Products Regulation and the establishment of African Medicines Agency.

The AMRH initiative continues to assist countries and regional economic communities (RECs) to strengthen and harmonise their national regulatory systems through its governance structures, which include the African Medicines Regulators Conference as the Assembly and a recognised body of the AU.

AUDA-NEPAD is coordinating two technical committees on clinical trials oversight; and medical devices and in vitro diagnostics established under the AMRH Initiative with a view to providing the needed technical guidance to AU member states and RECs on regulatory approval of imports, procurement and sale of medical products for Covid-19.

This is done through convening the African Vaccines Regulatory Forum (AVAREF), established by WHO in 2006, responsible for clinical trials and ethics oversight, and the African Medical Devices Forum (AMDF), which focuses on medical devices and in vitro diagnostics regulation.

The AVAREF joint review approach, which proposed Covid-19 clinical trial applications, has already been successfully applied to important vaccines against meningitis, malaria, rotavirus, pneumococcal pneumonia and Ebola and has been extended to other therapeutic interventions.

This process retains local country insights so that participating agencies do not compromise protection of citizens by a top-down approach. Through this approach, AVAREF will make available an online platform (SharePoint) for joint reviews of clinical trial applications for preventive, diagnostic and therapeutic interventions related to the Covid-19 pandemic.

Participating countries will post their queries online for real-time response from sponsors/applicants. Through virtual meetings, participating countries will conduct joint reviews of clinical trial applications on Covid-19 and discuss pertinent issues on how regulators and ethics committee members can better prepare and respond to the pandemic.

In recognition of regulatory challenges that African countries are facing, AUDA-NEPAD, in collaboration with AMRH Partners, is advocating the implementation and/or ratification of the four key frameworks: the PMPA, the AMRH Initiative, the AU Model Law on Medical Products Regulation (Model Law) and the treaty for the establishment of the AMA.

AU member states are also encouraged to adopt the guidelines for conducting clinical trials that were adopted by the AVAREF Assembly and the African Medicines Regulators Conference in 2017.

Through these and other regional initiatives, the safety and efficacy of medicines and medical devices have been and will continue to be assured using the expertise at hand.

Therefore, the African Union continues to encourage member states to uphold the highest levels of ethical and scientific standards when testing for the safety and efficacy of medicines and medical devices, including those aimed at curbing the current and future pandemics.

Ms Ndomondo-Siqonda is the head of Health Programmes at AUDA-NEPAD.