Ratify African Medicines Agency to strengthen vaccine manufacturing and health systems in Africa

Before the first case of Covid-19 in Africa was reported in Egypt on 14 February 2020, there were already great concerns for the continent’s health systems and their ability   to withstand a global pandemic. Since then, Covid-19 cases have been reported in all 55 African Union Member States with countries experiencing second and third waves, and with more people losing lives than in the early months of the global pandemic. Economies continue to be disrupted and several countries continue to have new variants of the virus. The socioeconomic costs of the virus have been tremendous and caused huge suffering. There is continued concern about the risk to health of people living with other pandemic diseases such as HIV/AIDS and TB, while many people continue to lack access to health services as Covid-19 remains the focus. Without urgent action, the economic impact of the coronavirus pandemic could span a generation.

The political will and global commitment to collaboration that we have seen in the fight against Covid-19 needs to be harnessed to move Africa forward and to support equitable access to vaccines. In recent months, African leaders have shown a keen interest in increasing vaccine manufacturing capacity on the continent. With Africa currently reliant on imports for 99% of the vaccines it needs, there is no doubt that more must be done to ensure that more vaccines are manufactured locally, where they are needed. 

Most African health systems face challenges, including the risk of substandard and falsified vaccines and health products entering the supply chain, and nascent monitoring systems to identify adverse events and use data to improve results. Another challenge is the protracted processes for review of clinical trials applications and unclear and inefficient processes for ethical review with National Regulatory Authorities, which slow down product development and, ultimately, access to vaccines.

It is in everybody’s interest to consider how regulatory conditions could accelerate clinical trials and the development and uptake of safe and effective vaccines and other health products on the continent; how an optimal set of regulations can encourage innovation and ensure alignment with international standards. To this end, the World Health Organization (WHO) created platforms such as the African Vaccine Regulatory Forum (AVAREF). Established with the initial support of the European Developing Country Clinical Trials Partnership, the AVAREF is an informal capacity-building effort and reliance mechanism aimed at improving the regulatory oversight of international clinical trials being conducted in Africa. 

Similarly, the African Medicines Regulatory Harmonisation initiative (AMRH), of which AVAREF is a Technical Committee, supports countries to issue marketing authorisations for products. AMRH uses a reliance-based, non-binding joint review and inspection mechanism for medicines registration and quality assurance, which supports countries to issue marketing authorisations for products.

Increasing vaccine manufacturing in Africa will require partnerships between governments and companies to advance technology and knowledge transfer and expand high-quality manufacturing capacity. This will lead to investment in logistics, workforce, and all aspects of health systems. With an effective regulatory framework, these steps will strengthen the continent’s health systems far beyond Covid-19 and build capacity to produce life-saving vaccines for other diseases, in preparedness for future health needs.

As the continent works to increase its vaccine manufacturing capacity, there is an even greater need to strengthen the regulatory environment in Africa, in alignment with international standards. This will facilitate co-ordination of decisions and guidance to countries concerning technical standards and the efficacy  of vaccines. It remains critical to build dynamic regulatory systems that can support the timely review and approvals of clinical trials applications, including novel trial designs for emergency use vaccines. 

Such systems will also provide for quality assurance and enforcement; dossier review, product registration and marketing authorisations; pharmacovigilance and timely information-sharing. African countries are in the process of embracing new Guidance on Emergency Expedited Regulatory Authorisation and Access to Covid-19 Vaccines in Africa, to ensure alignment in the introduction of Covid-19 vaccines. This is a good example of regulatory co-ordination for our mutual health. 

Many African countries have domesticated the AU Model Law on Medical Products Regulation, which forms the basis for development of the capacity required for functional and competent national medicines regulatory agencies. These agencies need to be able to oversee local manufacturing and clinical trials, and deliver effective regulatory oversight of vaccines and medicines markets. However, medical product regulators in Africa have limited resources and are very over-stretched.

The African Medicines Agency (AMA) Treaty was adopted by the African Union in 2019 as a regularly framework to provide a means of addressing fragmentation in regulatory decision-making, to accelerate clinical research and the introduction of new products, including vaccines. It is a means to strengthen regulatory capacity to enable African vaccine producers to not only produce locally, but also export across the continent and beyond, something they cannot currently do.

Among the benefits of AMA is that it will prepare the continent to respond to ongoing and new health threats, while also reducing the prevalence of substandard and falsified medicines and vaccines.

There are benefits of the AMA to all African countries, whether large or small, and whether they host their own manufacturing industries for medical products or not. A consistent voice on regulatory issues, the pooling of expertise from across the continent, and more efficient harmonised legal and procedural requirements can all be facilitated by a unified African Medicines Agency that promotes work-sharing, reliance and mutual recognition in a transparent manner. I urge every African Union member state to sign and ratify the AMA to become a member. This will increase each nation’s ability to deal with disease outbreaks and address ongoing and evolving epidemiological concerns, ensuring rapid uptake of essential medical products.

H.E. Michel Sidibé, African Union Special Envoy on African Medicines Agency 

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