Medicines are highly regulated products — as they should be, to protect the public health of citizens. Regulatory enforcement and oversight of medicines are equally important to ensure patient safety. Much has been published about technical & human resource capacity needs in Africa for such regulatory oversight. 

Read: New Report: Every African country depends on pharmaceutical imports – here is a new way out – Development Reimagined

For many years the African Medicines Regulatory Harmonisation (AMRH) initiative attempted to address numerous capacity challenges by proposing common standards across countries including the adoption of the AU Model Law on Medical Products Regulation as an instrument to guide AU Member States in the enactment or review of national medicines laws.

However, during the Covid-19 pandemic, the need for such harmonised standards became more critical as a result of the need to regulate vaccines coming into African markets. This generated increased momentum to ratify the creation of the African Medicines Agency (AMA), which aims to consolidate regulation of medicines across the continent and be the overarching oversight agency for the regulation of medicines in all countries in Africa. 

A lot has been published about the lack of resources and technical resources at the medicines regulatory agencies in Africa.

Read: Advancing African Medicines Agency through Global Health Diplomacy for an Equitable Pan-African Universal Health Coverage: A Scoping Review. 

In SA, we are well aware of the issues that plagued the former Medicines Control Council and now the SA Health Products Regulatory Authority (Sahpra), such as the backlog of regulatory application processing. 

Almost every country in Africa has its own medicines legislation and technical guidelines for regulatory oversight for medicines across the value chain from research and development to registration, manufacturing and distribution. This has meant that resources cannot be shared efficiently across countries and National Medicines Regulatory Agencies (NMRAs) and that companies need to adhere to different standards depending on the country requirements where they intend to make their medicines available. 

This increases the cost of doing business for both multinational and local generic pharmaceutical companies alike with the inadvertent public health consequences of hampering availability of medicines in these markets. 

Transporting and supplying medicines across borders has been challenging in the absence of harmonised regulations without necessary exemptions, which is less than ideal. Companies have been, in many cases, reluctant in seeking medicine registration in certain markets as it did not always make sense to do so, based on market size, impact on manufacturing operations to meet country-specific requirements and the increase in cost and complexity of doing business in certain markets.

A way to address these issues was regulatory harmonisation, which started in the early 2000s with marginal successes — championed by the African Union Development Agency (Auda-Nepad) with support from the WHO and World Bank and also the EMA, i.e., the African Medicines Regulatory Harmonisation Initiative (AMRH). 

The initiative specific to vaccines was called African Vaccine Regulatory Forum (Avaref).

The Covid-19 pandemic and the need to register vaccines and make them available at short notice — without compromising on regulatory oversight — amplified the need for harmonised regulation of medicines across markets in Africa. 

This renewed energy has contributed to the accelerated signing of the Treaty for the Establishment of the African Medicines Agency by more than 30 countries. This demonstrates political will and leadership at a country/member state level to make the AMA a reality. This has been seen as a positive step and has been broadly supported – but what will it take to operationalise the AMA ultimately?

Operationalising the AMA

The ratification of the AMA treaty by more than 15 countries, paves the way for further legal reform which would need to take place to operationalise the AMA. Rwanda has been selected to host the AMA, after several countries had volunteered to do so. 

In parallel, many NMRAs are also aggressively pursuing the next level of recognition via the WHO Benchmarking process — this will provide NMRAs international recognition based on rigorous WHO auditing and assessments of the technical & operational capacity of the NMRA.

African countries that have achieved maturity level 3 (ML3) status (meaning “stable, well-functioning and integrated regulatory systems”) include: Egypt, Ghana, Nigeria, Rwanda, South Africa and the United Republic of Tanzania. 

South Africa is now pursuing ML4 while at the same time, there are also regional harmonisation initiatives at various stages of implementation, including Ecowas, EAC and SADC.

These are all positive developments and take the continent a few steps closer to overall regulatory harmonisation. 

However, the following factors also need to be considered strongly:

Operational governance: The AMA has not completed the process of appointing its treaty-mandated Director-General who doubles up as the head of the AMA Secretariat and its CEO. This is a critical appointment in ensuring that the organs of the AMA, such as the Technical Committees which are responsible for technical guidance on specific areas or regulatory expertise, function and do so at a level appropriate for the business of the AMA.

Financial sustainability: Revenue models of the agency need to be looked at carefully. At present, most of the agencies are funded partially from central government budgets and supplement their income from regulatory fees generated by industry applications. This could potentially disappear; depending on the structures, very few agencies may have the ability to retain their generated income, which will generally go back into the general fiscus.

Predictability, transparency & governance: At present, the processes for regulatory review are not always predictable, transparent and well-governed — this could be related to resourcing constraints. Just looking online, not many NMRAs have functioning up-to-date websites where one can access pertinent information required by companies to comply with regulatory requirements for the registration of medicines

Recognition and reliance: Over the last couple of years, many academics have published papers on the need for implementation of what is referred to as ‘reliance models’ which essentially refers to NMRAs recognising the decisions of other regulatory agencies which are considered as benchmark agencies, therefore alleviating the need for lengthy local reviews and technical resources. This would theoretically shorten the time it would take to register a new medicine. However, the structure, governance and approach to implementing reliance models needs to be established and agreed.

Alignment of standards: At present most countries regulate medicines through national legislation — this would mean that national legislative processes would be required to amend such legislation to adopt/accommodate regional and/or continental legislation and regulatory frameworks. Either this or exemptions would need to be agreed upon and published which would alleviate the need for compliance with local legislation. Anything outside of this would make it difficult for companies to operate in markets where there are so-called grey areas — we have had such a scenario in SA with the regulation of combination medical devices and subsequently with the supply chain regulations of medical devices which still need to be resolved.

Human resources and technical capacity: We are already starting out with the deficit in this area which is well documented by the WHO and others. There are proposals for Regional Centres of Excellence for the training of regulators. However, these are yet to be fully implemented. The harmonised model speaks to work sharing but it is unclear how exactly this would work across NMRAs and RECs.

Communications and use of technology: Regulation of medicines and other healthcare products are governed by complex technical standards and processes which are updated from time to time. In order to be compliant with these processes and requirements, companies seeking to register products in specific markets will need to understand the latest regulatory requirements.  

It is equally important for civil society and patients to understand which medicines are available in their countries — to alert them to any potential counterfeit and/or substandard products on the market. At present, many NMRAs do not have functioning websites where such information could be easily obtained. It would be critical for the AMA to establish a communication portal which is accurate, up-to-date and easily accessible.

Adaptability and context: Keeping up with innovation cycles of medicines, medical devices, vaccines and other categories of regulated health products is challenging under normal circumstances and will be even more so in this context. Therefore ongoing capacity development will be key and adapting tertiary education to develop professionals with specific skills required for regulatory oversight will also be key. There needs to be linkages with the private sector to understand the future of innovation in the sector. In addition, optimal communication with the private sector and civil society in the implementation planning processes as well as public accountability of the AMA will be critical to success. DM/MC

This is the second in a series of articles showcasing research by the Nelson Mandela School of Public Governance at the University of Cape Town. The school has been hosting a series of roundtable research discussions which aim to make actionable policy recommendations to develop regional value chains in the healthcare and pharmaceutical sector across Africa through leveraging opportunities presented by the implementation of the African Continental Free Trade Agreement (AfCFTA). More details can be found on the School’s website, including Policy Briefs & Summary Reports from roundtable discussions:  

Kirti Narsai has 25 years’ experience in the healthcare sector and has held several board positions in organisations with Pan-African interests. She was appointed to the task teams of the Partnership for African Vaccine Manufacturing (PAVM).  She currently runs her own consultancy (HealthValue Consulting (Pty) Ltd) focusing on strategic advisory services to governments, multilaterals and other organisations in the healthcare sector and also holds a part-time position as Principal Researcher at the leading research on healthcare value chains in the context of the AfCFTA. 

Reitumetse Benedict Phiri is the Founder and Managing Director of IusPrudentia Specialist Counsel. He has provided strategic litigation and dispute resolution leadership as well as legal counsel in transactions within the Pharmaceuticals and Healthcare, Telecoms, Technology, Mining and Energy industries across Africa and for multinational clients for over 16 years. He is a sought-after and regular contributor of analysis on topical legal events in South African and African broadcast media. Prior to founding IusPrudentia, Reitumetse Benedict was employed at leading international law firms, Dewey & LeBoeuf and Fasken Martineau DuMoulin. Reitumetse Benedict also led management consulting giant McKinsey & Company’s Africa legal support function for 5 years.