Africa Focus
Andrea Tithecott Partner, Head of Regulatory, Head of Healthcare
Clive D’Souza Paralegal, Corporate Commercial
Soha Wahid Paralegal, Corporate Commercial
In this article, we examine a number of challenges impacting the security of the healthcare and life sciences sector in African countries. Top of everyone’s agenda of course is the availability of vaccines, particularly the Covid-19 vaccine.
On a more general note, we consider the status of existing healthcare regulatory frameworks in African countries in terms of opportunities for improvement. Arguably, the greatest challenge across the African continent, is to adopt a macro-approach to healthcare systems and the regulatory environment. We look at the need for Africa to harmonise the regulatory environment in such a way so as to bring stability to the health. security of the African population which would make investment from international investors a more attractive prospect.
In this article, we break down the problems faced by African countries with regard to vaccine access, and in particular, access to Covid – 19 vaccinations. That being said, the issues specific to Covid-19 vaccines are representative of the same challenges that are faced by any medical products producer in entering the African market, whether it be a pharmaceutical product, other vaccine, or medical device. Therefore, the recommendations we make here are generally applicable to all types of medical products.
At present, local production capabilities for vaccine production accounts for less than 1% of the total global capacity. There are understood to be only 12 production facilities, either in operation or in the pipeline across Algeria, Egypt, Morocco, Rwanda, Senegal, and South Africa, and no facilities at all in rest of the countries. These facilities are expected to produce COVID 19 vaccines for a population of 1.3 billion people.
The global roll-out of Covid – 19 vaccines has not been as successful when compared with most developed countries that are administering booster doses, and in some countries, a second booster, while people in many African countries are yet to receive their first dose. Of the estimated 9 billion Covid-19 vaccines doses produced and delivered globally, Africa has only received approximately 500 million doses (6% of vaccines in comparison to representing 17% of the global population) while 26% of people in Africa have received their first dose, less than 10 % have been fully vaccinated. Despite the urgent need to increase vaccination, many countries across the continent of Africa have received too few vaccines from the existing global supply.
The Covid – 19 pandemic has shown vulnerability in ensuring access to vital drugs, vaccines and health technologies in Africa. More specifically, it has underscored the critical gap in vaccine manufacturing as a whole: Before Covid – 19, Africa produced less than 1 percent of the vaccines that it consumed. The International Monetary Fund intended to vaccinate 40% of the global population by the end of 2021 and 70% percent by mid-2022. However, as of now, only seven out of the 55 countries on the African continent have reached the 40% mark. Africa remains reliant on COVID-19 vaccine imports and donations – the priority is to guarantee predictability in vaccine deliveries through organisations such as the World Health Organization’s vaccine sharing scheme, the COVAX and the African Vaccine Acquisition Trust. The challenges of putting in place a vaccine ecosystem across Africa are enormous, This is due to the current situation of insufficient local production facilities only serving to compound the primary problems, that are:
the high cost of vaccine development;
vaccine market fragmentation;
lack of harmonized regulations and registration procedures;
lack of technological know-how;
restrictions concerning intellectual property, or unwillingness to share or transfer such rights;
competition with generics manufacturers, enabling more affordable vaccines;
the cost and availability of raw materials;
capacity and number of local vaccine manufacturers;
logistical complexities of providing vaccines to remote or rural locations; and
the need for improving and training workforce capacity across Africa.
What is urgently needed are the funds and the tools to produce and manufacture vaccines in a long-term, focused, coordinated manner. This must be achieved through a top-down approach through collaboration between African nation governments and related stakeholders, Additionally, there should be strong collaboration with global vaccine producers, pharmaceutical companies, corporate investors and philanthropists, adopting a long-lens approach.
Enabling Africa to become a center for vaccine research and development must be at the center of the strategy as African country populations represent 17% of the global population and are often the most severely affected by outbreaks of contagious disease, In a globally connected world, this must be prioritized for epidemic and global pandemic risk control.
From a legal perspective, one of the ways to improve the availability and supply of imported vaccines (while local production capacity is improved) is through harmonising and standardizing vaccine regulations and registration processes.
At present, a producer intending to introduce and supply any medical product, be it a pharmaceutical, vaccine, or device, is challenged with different regulations and registration procedures in each country. The approval of vaccines go through different processes in each country and this inevitably increases time, cost, and supply issues for producers and distributors.
A unified and single harmonising primary law and one approval process in place for all countries would be desirable, and has already been proposed by the African Union and the Africa Centre for Disease Control (the “African CDC”). There are a number of harmonised regulatory frameworks in operation successfully around the world, for example, in the European Union, and in Australia, allowing such models to be benchmarked and re-imagined for adoption across African countries so as to ensure that there is a smooth process in place for medical product companies looking to enter the African market.
Currently, almost all African governments have a version of a National Medical Regulatory Authority responsible for national law and policy for medical products. Each nation sets its own laws, regulations, governance mandates and processes.”
Currently, almost all African governments have a version of a National Medical Regulatory Authority responsible for national law and policy for medical products. Each nation sets its own laws, regulations, governance mandates and processes. This is very burdensome for companies seeking entry to the wider African market. Differences in registration procedures, systems of inspection, differences in compliance standards, quality management systems, mandatory ISO or other certification, and continuous assessment mechanisms, substantively increase the complexity and cost of doing business.
One of the most important priorities that African governments ought to consider is the harmonisation of rules and regulatory processes. We have touched upon this topic in the context of vaccine registrations, but now take a wider-lens look.
In our opinion, African nations would benefit substantially from harmonization of healthcare and life sciences regulatory frameworks at a strategic level, through greater collaboration between African governments and through regional treaties and policy-making.
A good example where this has worked well, is in the Gulf Cooperation Council (GCC) countries and the wider Arab region, for example, through the Arab Free Trade Agreement, and GCC Council of Health Ministers, where a regional approach is taken to (amongst other things) pharmaceutical supply and pricing, in order to reduce inconsistency of national regulatory frameworks, reduce price, and make medicines affordable for all.
A more unified approach would reduce compliance barriers, bureaucracy, and consequent risk of non-compliance, creating a more attractive, faster, and easier place for investors and the private sector entry into the market. A good example of where such improvement would reap short-term gains is through the harmonisation of regulations that control intellectual property rights across the continent, allowing protection of patents, confidentiality and protection for technical information, security and product quality benefits, along with easier and consistent enforcement of such rights.
One of the ways in which medicine and vaccine producers can gain access to the market is through public-private partnerships and collaborations with governments across Africa. There have been some examples of successful infrastructure healthcare PPPs in the more developed African economies. However, more uniform regulation and policies at regional level will allow wider benefits for continental Africa, such as through enabling strategic projects to occur (and creation of centers’ of excellence) where they are most needed, and spreading benefits to a wider continental population. It is estimated that the healthcare and wellness sector in Africa has a potential of $259 billion in business opportunities, and creating 16 million jobs by 2030.
There is a promising future for the healthcare and life sciences sector in Africa. Growth projections in population size, and growth in wealth, coupled with emerging market opportunities will allow market access on an unparalleled scale for medical product producers. As a priority, the continent needs access to vaccines, and security of supply through local vaccine manufacturing. The current weaknesses as proposed with regard to the manufacture, supply, production and the lack of uniform regulation must be harmonized to increase attractiveness for investment and for the local population to have better quality and access to medicines.
Africa is home to 17% of the world’s population, which is expected to rise to 25% by 2050, therefore an Africa with access to better healthcare resources and cooperation amongst the various inter-governmental organisations and healthcare regulators for access to vaccines and other healthcare products and devices is crucial in the interest of not just the African continent but for global public health as a whole.
For further information, please contact Andrea Tithecott or Christina Sochacki.
Published in September 2022
