In the past, patients in Africa could wait up to 8 years to access medicines already approved in the US, the EU and in other Western countries. The AMA will help narrow this disparity and make a material impact on the quality and timeliness of health outcomes in Africa. It makes for an exciting milestone in the harmonisation of medicines’ regulation there.
“The regional consolidation that has been put in place over the past 10 years means that today, we file in Africa shortly after doing so in the US and Europe, and are closing the gap on the historical lag in filing” says Nevena Milisavljevic, Regional Regulatory Policy Lead.
In addition to bringing medicines to patients faster, capability is also being built alongside the review efficiencies. “Delegate countries draw on the expertise of others from other countries, and the learning and the capacity building grows”, says Dorah Diale, Head Regulatory Affairs, South Africa, reflecting on the success of ZaZiBoNa, a joint review procedure spanning a number of countries in southern Africa.
Ghana and Tanzania also each now have stable, well-functioning and integrated regulatory systems that meet WHO standards. And in South Africa, it is now possible to submit applications for marketing approval at the same time as in the US and EU.
One unified medicines agency in Africa means more medicines to patients, faster. “We are seeing improvements, greater responsiveness and acceleration of regulatory processes” says Dorah Diale, “it gives me confidence that we must be doing something right”.
Frank Loeffler, East Africa General Manager, is pragmatic but enthusiastic: “I know that there can be a gap between intention and reality but my hope is that we now put resources and attention into ensuring that the intent is coming through and that we are not getting stuck in bureaucracy”. He is convinced that the AMA will encourage more healthcare companies to come to Africa, and increase the options for treatments for the high unmet needs across the care continuum. “Yes, Africa has areas that are not developed, but it also has advanced health systems, hospitals and qualified healthcare professionals. And it has leaders who can form multinational agreements”, he adds.
For Philip Anderson, General Manager in Ghana, the new agency will be able to leverage best practices from across the continent in areas like early access, early use authorisation, the mentoring and growth of regulatory procedures. He also sees benefits in terms of costs to society through regulatory efficiencies. “In Africa we are discouraging philanthropy, and prefer sustainable commercial development. That’s why we encourage the establishment of AMA”.
While there is still a long way to go, significant progress was made over the past years. The status quo is shifting, timelines are compressing through working together, and building on what has been done to date at different levels across the subregions of Africa.
Another expectation is that AMA will also stimulate more clinical research in Africa. In 2020 the impact of COVID-19 on Black, Asian, and Middle Eastern communities1 underlined the historic gaps in clinical research and forged a greater industry commitment to address imbalances. Clinical trials need to be more inclusive and show greater generalisability of data to the disease population at large.
Addressing inclusion is also important for the applicability of
This shift will also matter in Africa, where Roche colleagues have been struggling for years to respond to the question from regulators of “Has this medicine been tested in our population?” While a number of locally initiated trials have been ongoing for several years, Roche is now embarking on a global approach to the representation challenge and increasingly working with Roche Africa colleagues to consolidate and build further capacity.
At the time of writing, Roche has over 50 active clinical studies ongoing in Africa at differing phases of maturity. This includes several oncology trials and a pivotal (i.e. to demonstrate efficacy) oncology trial in Kenya, another first in the industry. Roche is also partnering with the African Academy of Sciences, a cross-pharma organisation focused on harmonising regulatory pathways and streamlining access to available clinical trial sites and key opinion leaders across the continent.
“We have to fix the omissions”, says Abiola Idowu, Head Regulatory Affairs, Nigeria. “Before there was hesitation, now there is scientific interest” adds Frank Loeffler. “We had courageous leaders in Europe, the Middle East and Africa, and this freedom— trusting our view and letting us explore and invest to discover— has led to a good direction on clinical trials in Africa. Now we are pushing at a more open door”.
While there are enduring challenges in low and middle income countries, there is also a growing middle class across many African countries. Some see this as a unique opportunity for the AMA to become one of the most efficient and modern regulatory systems in the world. It can take the lead, learn from others and leapfrog established regulatory systems elsewhere through the experience gained from a decade of harmonised activities on the continent.
“We cannot now ignore the African continent, the people here are young and dynamic, and will comprise 25% of the world’s entire population very soon”, says David Gibbons, General Manager, Roche South Africa. As elsewhere, the COVID-19 pandemic has set back health systems in Africa, even while the continent overall proved relatively resilient due to the lower average age of the population.2
But the global pandemic has refocused thinking. The crisis exposed health systems to the importance of real time clinical data. This was strikingly exemplified with the UK’s RECOVERY trial, which advanced the evolving understanding of the virus and effectiveness of interventions on a day-by-day, week-by-week basis, quickly building and improving the clarity of scientific understanding. “There’s a chicken and egg question about whether economies should invest first in the health of their people and then in the economy, or build the economy in order to invest in the health of their people. If you register innovative drugs and bring them to the continent and commercialise them, this supports development”, says David. And further, if registrations can be run in lockstep with other regions, it stimulates generics businesses for the post-patent life of the innovation as well.
Roche stands ready to work together with health ecosystems to build resilience for the future. “As a medical doctor I want for Africa what everyone at Roche wants for patients everywhere, namely access to high quality healthcare” says Bart Vanhauwere, Area Head Africa at Roche. “It’s in the interest of the world that disparities and gaps be closed. One continent should not be left behind”.
Pew Research Centre, Populations skew older in some of the countries hit hard by COVID-19
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