An African Medicines Agency, the continent’s first super-regulator, could be approved as soon as next year.
The African Medicines Agency (AMA)’s remit will be to speed up the availability of affordable medicines that are needed on the continent and reduce dangerous, spurious, substandard and falsified medicines. It is modelled on the workings of the European medicines agency (EMA), which carries out scientific evaluations and monitors the safety of medicines within 28 EU countries plus nations of the European Economic Area.
But while the EMA serves a market of over 500 million people living in the EU, the AMA will work on behalf of 54 member states, serving 1.13 billion people.
Like EMA, AMA will not replace national regulators, which will continue their work to register drugs that are safe and efficacious for their own populations.
Instead, AMA will provide regulatory guidance and scientific opinions on complex molecules, as well as traditional medicines and emerging issues, such as pandemics. It will keep an eye on adverse effects of medicines and vaccines once they reach the market.
And importantly, AMA will also conduct inspections of manufacturing facilities to check that drugs are being manufactured at good international manufacturing quality standards. Many regulators struggle to inspect the hundreds of manufacturing facilities making medicines and vaccines (sometimes there are no inspections for five years at a time). It will also help to evaluate and coordinate products for public health emergencies, such as Ebola.
The agency has been set up by African Heads of State and Government with help from the World Health Organization (WHO) Regional Committee for Africa, as the result of a long-standing strategy to improve regulatory capacity on the continent.
Today some of the 54 countries do not have staff nor expertise to cope with the sheer volume and complexity of new medicines they are expected to authorise, said Margareth Ndomondo-Sigonda, AMA’s programme coordinator at NEPAD, the technical agency of the African Commission.
“You have products like biological products, some new vaccines and new molecules that the majority of African countries do not have the capacity to assess those molecules,” she said. “These are the kinds of things you expect the African medicines agency to do.”
For developers, this particular function will be crucial. Dr Mercè Caturla, Global Access Regulatory Lead for Africa & WHO Global Regulatory Affairs at Janssen Pharmaceuticals, said: “At least from an industry perspective one of the functions of AMA will be to centralise the review of those new medical products and centralise the expertise. You don’t need to have experts in every country and region in all these therapeutic areas.”
The ability to assess multi-country clinical trials is crucial too, said Dr Nathalie Strub-Wourgaft, medical director at Drugs for Neglected Diseases initiative (DNDi), a public-private partnership that has created drugs registered in the African market. Today, there is joint scheme already set up to assess multi-country trials of vaccines, called AVAREF, which managed most recently the trials of an Ebola vaccine. But there has been nothing for medicines and devices.
Luckily, AMA is expected to help transition AVAREF into one that does just that. “That is fantastic because that means that it provides access to clinical trials that have been well assessed, increase quality because of increased reviewers, but improve timelines for more efficiency for needed products,” she said. She welcomed adverse effect monitoring too (while one or two adverse effects reported in any one country might be brushed off, AMA might collect several similar effects across the continent that will alert it to a serious problem, she said).
Poor regulation results in cheap, adulterated, fortified and spurious medicines, said Ndomondo-Sigonda. It is hoped that AMA will provide a better environment for legitimate and good-quality manufacturers to flourish, and improve local manufacturing.
“They are assured of the market and across the continent there is an incentive to whoever wants to invest in producing medicines locally,” she said.
Today, few drugs produced in African manufacturing sites have been prequalified by the WHO, a process which vets good-quality medicines around the world. And only when these are prequalified will international donors such as GAVI and the Global Fund for AIDS, Tuberculosis and Malaria consider buying them. Today these organisations tend to buy from approved manufacturers on other continents – from Russia to India – and import them to Africa. Very few come from Africa.
So far, Ndomondo-Sigonda’s team is putting together a raft of plans – including a draft treaty and business plan to establish the African Medicines Agency. It will be consulted on over the coming months, and – they hope – approved by the African Union Congress, at its meeting next year.
Once approved, the treaty will require signatures from 15 states before they can begin in earnest, to create the agency, choose a head and headquarters and begin raising funds.
That might seem like a long-winded process, since it was decided to create the AMA at a meeting of the African Ministers of Health in Luanda, Angola in April 2014. But DNDi’s Nathalie Strub-Wourgaft says it’s not. “It’s going fast. If you think about how long it took Europe to set up the EMA, it was over 45 years,” she said.
AMA is the last step in a long-running strategy to harmonise pharmaceuticals and regulation on the continent that came about 10 years ago when the African Union first proposed a new pharmaceutical manufacturing plan for Africa. Then, it proposed several strategies to increase the number of medicines made by African manufacturers – one of which was the need to sort out the regulatory situation.
That regulatory strand of the plan became the African Medicines Regulatory Harmonisation (AMRH) Programme, which since its launch in 2012, has encouraged Africa’s existing economic regions to collaborate on regulations and registering medicines. The East African economic area, for instance, which encompasses five countries, has paired nations with well-functioning regulators with those that do not in order to train and assist in analysing dossiers. Kenya has helped Zanzibar, Uganda has paired with Rwanda, and Tanzania with Burundi.
The AMRH has also assisted countries to incorporate the African Union Model Law on Medical Products Regulation, which was adopted by the African union in 2016. The law ensures that all the regulators are legally tasked to carry out regulatory tasks in similar ways. That could dramatically speed up regulatory processes according to Ndomondo-Sigonda, who has managed AMRH. It would compel agencies to use decisions from other agencies in the region or even outside the region. Seven countries, including Zimbabwe and Zanzibar have so far incorporated the law into their national statute books, and it is expected that the AMA will take this on too.
Harmonisation is key, said Dr Amadou Sall, director of vaccine producer Institute Pasteur in Senegal. “Having an agency to make sure that there is harmonisation of different regulations may be good,” he said. “Once you licence in one place you may be able actually to go to other places. The AMA may be beneficial for different populations and also for companies to get on the market.”
If there are any concerns, it is the potential bureaucracy surrounding the AMA, which is seen as evolving from AMRH. Already AMA adds not only to the 54 existing regulators but it will exist alongside another set of agencies that have been developing in regional economic areas, as part of the AMRH plan. Janssen’s Caturla worried that the regions aren’t talking to each other enough and AMA must help with that.
And importantly, it still not altogether clear exactly where the roles of the regional regulatory organisations will end and the AMA will begin. That’s because some regions are more advanced than others in setting up agencies. While some are well advanced, others may not materialise at all, because of lack of political commitment and money. Some contain so many member states, they are becoming unwieldy and there is talk of separating into sub-regions.
What’s clear is that nobody intends to replicate each other’s roles. For her part, Ndomondo-Sigonda welcomes any help regional regulatory authorities can provide because they will be vital to improving the medicine situation in Africa.
“We support regional agencies and still feel that they will have a role. But at the end of the day, it’s about who will finance those institutions,” she said. Whatever happens, she added, it will be up to the AMA to take up the slack where there are gaps in regional regulatory capacity.
By Tatum Anderson