Analysis

A new dawn in regulating Africa’s medicines: the African Medicines Agency

Karrar Karrar, Save the Children UK; Arabella Moore, Jessica Lewington, and Julie Henri, ENGINE MHP

This year’s World Immunization Week comes at a time when vaccinations are in the spotlight more than ever, as the world looks to immunise at pace against the greatest pandemic in decades.

For the vaccine roll-out to be successful in preventing future waves of infection and national lockdowns, Governments, the pharmaceutical industry and health regulators are facing the biggest challenge of their time – immunising the whole adult population from COVID-19 in a matter of months.

Progress is palpable in high-income countries; we’ve seen 50 percent of the population in the UK already vaccinated, and similar levels in Israel (60 percent) and the United States (41 percent). In fact, Governments in these countries are meeting population targets ahead of schedule, and are able to roll-out vaccines to younger, and less vulnerable people, as they move through their impressive pandemic vaccination campaigns.

But this is not the case for most of the global population.

Within the first 100 days of the global vaccine rollout marked on 9 April 2021, the World Health Organization (WHO) announced that the target for COVID-19 vaccinations had not been met, with 14 countries yet to start their vaccination programmes and delays in vaccine production and delivery worldwide.

At a time when over 87% of COVID-19 vaccine doses go to high income or upper middle-income countries, the disparities between wealthy and poor-resourced countries felt by often neglected populations are now too stark not to respond; the need for new mechanisms and processes that accelerate medicine and vaccine access are undeniable.

Alongside global structures such as the ACT-A and COVAX facility, the African continent has shown remarkable leadership throughout this pandemic at a regional level. This has come in the form of strong political commitments and strong leadership from the African Union and Africa Centres for Disease Control (CDC).

On the backdrop of these pandemic-specific initiatives, there are some important, systemic and sustainable steps being made – most notably, the African Medicines Agency (AMA).

The AMA aims to provide regulatory harmonisation across the African continent, safe and speedy clinical trials and simplification of the registration and commercialisation of safe and affordable medicines. It has been in fruition for many years, starting in 2009 with the establishment of the African Medicines Regulatory Harmonisation Initiative (AMRH), and the involvement of many key partners across governments, civil society, and industry. This led up to the adoption of a treaty by the African Union Assembly in 2019 to establish the AMA, which aims to enhance regulatory oversight across the continent and meet the challenges of access to quality, safe, and efficacious medicines.

Notwithstanding the complexity of improving access to medicines in the continent, strengthening national and regional regulatory systems lays the foundation to achieving timely access to quality medicines and vaccines.

However, despite Government commitments to support the establishment of the AMA, to date, only 8 member states have ratified the AMA Treaty in their national parliaments – well below the minimum of 15 Member States needed for the AMA to come into force.

MHP Health invited global expert Karrar Karrar, Access to Medicines Adviser at Save the Children UK, to share his views on the significance of the AMA for the future of access to medicines and vaccines across Africa. Karrar highlights the urgent calls that need to be made for country ratification and establishment, particularly amid the urgency of widespread COVID-19 vaccination across the world.

This is a critical moment for vaccine and wider pharmaceutical access in some of the poorest parts of the world. As well as World Immunization Week, which is calling for attention on the need for renewed focus on routine immunisation services in addition to expedited access to the COVID-19 vaccine in all corners of the world, this month the African Union and Africa Centres for Disease Control  organised a conference to discuss Africa’s vaccine manufacturing for health security as just 10.73 million COVID-19 vaccines have been administered on the African continent – which represents just 2 percent of the global number of people vaccinated.

Health regulatory issues were a recurring theme at the meeting as the current fragile regulatory environment has resulted in the circulation of falsified and substandard pharmaceuticals in Africa.

The COVID-19 vaccine is no exception to the rule: 2,400 doses of a fake COVID-19 vaccines were seized by Interpol in South Africa in March this year. In addition to fuelling mistrust, this situation also results in serious affordability issues as patients opt to purchase higher priced branded versions of medicines due to their perceived higher quality. Bearing in mind most people buy their medicine out of their own pockets, this situation continues to push more families and vulnerable people into poverty.

The ratification of the AMA is an urgent call to action which is still outstanding.

Global access to pharmaceuticals as a lifesaving commodity is a fundamental human right. Despite this, 2 billion people globally still lack access to medicines, with the African continent hardest hit. Africa’s pharmaceutical market is heavily reliant on imports with very little local production. The continent imports 70-90 % of the medicines it consumes, and when it comes to vaccines, imports account for 99% of volumes consumed. We have seen it play out again during the COVID-19 pandemic, as the WHO, UNICEF, CEPI and Gavi had to support 44 African countries with the COVAX programme to guarantee safe and affordable access to COVID-19 vaccines as of March 2021.

Weak or immature pharmaceutical regulatory systems across Africa adversely impact every aspect of access to medicines including availability, affordability, acceptability, accessibility, and quality of medicines. There are 54 national regulatory authorities for medical products in the continent with many lacking the technical and financial resources to perform their core regulatory functions. This has meant that WHO concentrates 90% of its regulatory strengthening work in Africa.

Could the inception and successful operationalisation of the AMA remedy Africa’s long-standing access to medicines challenges?

Pharmaceutical companies require functioning regulatory systems to operate in any jurisdiction. Before a pharmaceutical product, like the COVID-19 vaccine, can be sold in a country, it must be registered with the national regulatory agency. However due to technical and capacity constraints, national regulatory systems in LMICs often have lengthy processing times. This has hindered access to new, innovative medicines as large research-based pharmaceutical companies avoid or delay launching their new products in these countries. This can result in delays as long as 4 to 7 years compared to high-income countries. COVAX was specifically set-up to avoid delay in access to the COVID-19 vaccine by-passing long processes and windy regulatory systems in LMICs.

 Progress from pharmaceutical companies to integrate access to medicines into their business practice has been noted in the latest Access to Medicine Index. Yet, over 50% of key products are still not covered by an access strategy for LMIC markets. Streamlined regulatory systems would encourage manufacturers to register their medicines in more countries and minimize delays in approval. It would also boost local production of medicines and reduce the risk of counterfeit medicines entering the African pharmaceutical market.

Now is the time

There is widespread support for the AMA among industry, patient organisations, development agencies, and Government representatives themselves. In February and March 2021, the International Alliance of Patients’ Organizations called upon Heads of State of the African Union to ratify the African Medicines Agency Treaty. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) made a similar call in January this year, describing the AMA as “the unique opportunity to become one of the most efficient and modern regulatory systems in the world.”

African governments now have the opportunity to lay the foundations to achieve a prosperous pharmaceutical ecosystem that will ensure that Africa has access to safe and affordable medicines. The operationalisation of the African Medicines Agency provides the vehicle to make this ambition a reality. With no time to waste, the health of Africa is hanging in the balance.

Source: IFPMA. The African Medicines Agency: towards a unified continental regulatory framework