/ 28 January 2022

Manufacturing in Africa needs a strong regulatory framework

Dr Margareth Ndomondo-Sigonda, Head of Health Programmes at AUDA-NEPAD

Success towards resource mobilisation and infrastructural improvements aimed at establishing in-country vaccine production is steadily moving on an upward trajectory in some countries in Africa. New Covid-19 infections have been on the rise, accelerated by low vaccination rates and the emergence of new variants. However, some countries have made concerted efforts to renew their emergency preparedness and response to better address challenges and embrace the opportunities presented by the pandemic. The surge in recent new infections has been predominantly fuelled by subsequent mutations of the coronavirus including the emerging Delta and Omicron variants, which have increased the need for urgent and timeous action.

Africa has reported approximately 10.4-million positive Covid-19 cases and 223 966 confirmed deaths (as at 19 January 2022), and mass vaccination presents the most promising hope to control the pandemic. It has therefore become pivotal for all African Union (AU) member states to organise themselves and devise mutually beneficial collective actions to respond to the pandemic. 

Chimwemwe Chamdimba, Principal Policy Specialist at AUDA-NEPAD

The African Medicines Agency (AMA) is an initiative that will enable a continental harmonisation of regulations relating to the manufacturing of vaccines and other medical products. The Agency is a collective effort aimed at spurring local pharmaceutical  production by establishing a supportive structure in which all member states can work together to respond to current and future emergency health crises such  as Covid-19. 

Africa’s collective political will and key commitments to vaccine manufacturing 

The continent experienced notable challenges regarding the timely and equitable procurement of vaccines as compared to high income countries (HICs). During the initial and on-peak stages of the pandemic it relied more on the Covid-19 Vaccine Global Access (COVAX) facility, but since 2020 it has since started getting vaccines through the African Vaccine Acquisition Trust (AVAT). As at  19 January 2022, only 10.09% of the continent’s eligible population had been fully vaccinated owing to the impact of delayed vaccine acquisition. 

The delays have led to the continent scrambling for available vaccines and importing 99% of its supply from HICs, which have offered them at escalated prices and during times when new infections have already reached their peak. Although the AU has procured an estimated 400-million vaccines through the AVAT for the next year, this supply needs to increase sevenfold if Africa is to ensure the full vaccination of at least 70% of its eligible population by September 2022.

Africa should not have to depend on the rest of the world for a timeous and equitable supply of critical vaccines and therapeutics, and that is why collective action by all African states is critical for the establishment and operationalisation of the Africa Medicines Agency through the fast-tracked signing and ratification of the AMA treaty.

The importance of AMA treaty and its ratification by African Union member states

The AMA treaty, adopted at the AU Ordinary Session of the Heads of States and Government in 2019, builds on the efforts of the Africa Medicines Regulatory Harmonisation Initiative (AMRHI) led by AUDA-NEPAD (African Union Development Agency – New Partnership for Africa’s Development). The AMA will lead to regulatory system strengthening and harmonisation, and provide an enabling environment for the development of the pharmaceutical and related medical products’ industries. These efforts will promote local vaccine production and pharmaceutical production on the continent. As at 1 December 2021, a total of 18 member states have ratified the AMA and submitted instruments of ratification to the  African Union Commission (AUC).

South Africa and Nigeria have facilities for vaccine manufacturing, research innovation and development. South Africa has achieved tremendous milestones in its Covid-19 response, including mobilising financing for local vaccine manufacturing through the newly established Pfizer-COVAX partnership. Rwanda which was notably the first country to sign the treaty in June 2019 has entered into an agreement with the  International Finance Corporation (IFC) to develop vaccine manufacturing capacity in the country.  

Medical products produced and regulated within these countries and others in Africa would reach more people and gain credibility within and outside Africa with the “birth” of AMA.  Efforts are also being made by the other countries that have facilities for vaccine manufacturing to sign and ratify the AMA Treaty. The treaty came into force on 5 November 2021, 30 days after the 15th country ratified and submitted instruments of ratification to the AUC. The AUDA-NEPAD and African Union envision all 54 countries adopting the treaty and preparing for its operationalisation at country level.

The lack of regulatory harmonisation at continental level is one of the major barriers to realising local vaccine production and ensuring effective regional integration to address health emergencies and the development of adequate pharmaceutical products. The delay in ratifying the AMA treaty means that member states and their in-country national regulatory authorities continue to be faced with constraints from conflicting legislation, lack of capacity building, technology transfer and adequate skills to set up local vaccine manufacturing processes, insufficient domestic financing to respond to public health crises and prolonged dependency on high income countries’ support in responding to current and future health emergencies.

— Dr Margareth Ndomondo-Sigonda, Head of Health Programmes at AUDA-NEPAD; Chimwemwe Chamdimba, Principal Policy Specialist at AUDA-NEPAD