Africa’s often frustrating pharmaceutical sector is moving towards a regulatory makeover, which if approved will provide the prospect of faster market access for industry, and cheaper prices to the consumer. But because individual country regulators are at very variable stages of development, consensus on the setting up of a new African Medicines Agency remains uncertain.
It has the potential to vastly improve the speed of getting drugs to market…
Pharma sector value is expected to reach $45bn by 2020. It is growing at between 6% and 11% per annum, primed by the emerging middle classes and fuelled by imports from China and India.
Made in africa
With companies seeing the growth potential of Africa’s markets, there has been a flurry of recent activity. For example, India’s NRB Group is setting up a $12m pharmaceuticals production plant to manufacture drugs to fight HIV and tuberculosis that will first serve the local market and then the wider Southern African region. In October 2016, Morocco’s Cooper Pharma signed a deal to build a plant to make antibiotics in the Kigali Special Economic Zone in Rwanda. The plant should be up and running in 2019.
Governments like South Africa’s and Nigeria’s are using their procurement budgets to help local manufacturers. In May, Nigerian president Muhammadu Buhari’s government approved a local content provision that ministries and agencies must locally source 40% of their goods and services, a move celebrated by the Pharmaceutical Manufacturers Group. Last year, Pharmaceutical Society of Nigeria’s president, Ahmed Yakasai, told reporters: “Only 30-35% of medicines sold in Nigeria are produced locally. We have agreed with the federal government to boost local drug production to 70%.”
Across the continent, the pharmaceuticals sector remains fraught with problems. High official prices and complex and often inefficient regulation leave the sector wide open to illicit imports and production. Drugs that should only be administered by qualified pharmacists receiving prescriptions from trained doctors are being sold out of wheelbarrows on market corners. The knock-on impact of improper usage on bacterial resistance is well documented. And on the continent with the highest incidence of tuberculosis, the implications are profound.
Many doctors will tell their patients to go and get an antibiotic that is labelled as having 400mg of an active ingredient when they know the patient needs maybe half of that. But they do not trust the quality of the drug, so ‘to be on the safe side’ they prescribe more in the hope that their patient will at least get the desired level.
Africa represents around 11% of the world’s population, and yet it is estimated to harbour about a quarter of the global disease burden. Put in perspective, the pharma spend still only represents 2% of the global market, despite 92% of all HIV infections being in Africa and a rapidly growing appreciation that non-communicable diseases are at a higher incidence in Africa than in Europe.
Shift in attitude
Problems related to quality, price and red tape leave consumers short-changed and local manufacturers struggling to compete with large-scale foreign producers, particularly from China and India. The stark reality is that for maybe 30% of Africa’s population, pharmaceutical preparations are just not affordable; and then another 40% buy within the informal sector.
Not surprisingly, ‘big pharma’ has changed tack completely over the past couple of decades. Companies like GSK, Novartis and Sanofi now emphasise helping to develop health systems rather than just trying to sell drugs. A properly regulated and efficient health system will bring them much greater reward in the long term than a haphazard system that rewards the illicit traders.
There is also a big move towards the development of social businesses. It was unthinkable a few years ago, but big pharma has become a significant driver of primary health care. Here they are, helping nurses to provide essential services with efficacious drugs whilst also selling – for a profit – nutritious and affordable foods, solar lanterns and the like.
And now there is hope of taming Africa’s regulatory system which, for a continent with so many countries, has long been a significant constraint on the sector’s development. The new initiative – called the African Medicines Regulatory Harmonisation (AMRH) programme – is being overseen by the African Union (AU) and managed by the New Economic Partnership for Africa’s Development out of South Africa.
The problem is simple: medicines are always needed and they are big business. But if you liberalise import laws, you will get swamped with counterfeits and products of uncertain origin. If you implement strict regulation, then you drive up the cost of the medicine and increase the margins for smugglers and illicit producers. The solution proposed by the AMRH is to develop an African Medicines Agency (AMA) that can perform quality assessments on new medicines – rather than each country doing it independently. Then food and drug agencies can quickly decide which drugs to allow.
Africa would be split into five pharma trading regions that can encourage local manufacturing within each zone. The AMA would then take on the huge role of receiving registrations from manufacturers on a single template, validating the data and the manufacturing source, and holding the information securely on behalf of the countries’ drug regulatory authorities. It has the potential to vastly improve the speed of getting drugs to market, something that is especially important with anti-viral therapies and treatments for emerging infections such as Ebola.
Conceived as a four-year project, the AMRH began as a resolution taken at the first joint AU/World Health Organisation Ministerial Conference held in Luanda in 2014. The draft legal and institutional framework documents on the establishment of the AMA were presented at a special side meeting of the World Health Assembly in May, and will be discussed at the third biennial AMRH conference scheduled for Accra from 27-29 November. The roadmap anticipates formal adoption during 2018.
It would be revolutionary if the AMA can be formed and given legal status by AU member states. But it is still going to take some huge diplomacy to get a protocol approved because of the disparities that exist between countries in terms of their technical and legal frameworks. It will be a key test of the AU’s authority and relevance to see the initiative through this negotiation stage.
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