4.5 How can the AfCFTA be leveraged for profitability and growth in African markets?

the continent. Through partnerships with UNIDO and the The Deutsche Gesellschaft für Internationale Zusammenarbeit GmbH (GIZ), AUDA-NEPAD, Dr Lartey and his team established a training course that focused on pharmaceutical technology.

He stressed the importance of establishing good relationships amongst key stakeholders, including pharmaceutical regulators and pharmaceutical manufacturing associations for advocacy.

In terms of local pharmaceutical manufacturing, Dr Lartey identified four key challenges. The first relates to infrastructure including access to electricity, water, and effluent treatment, which were lacking. Addressing these challenges proved difficult. Secondly, the market dynamics of working in small economies exposed what an integrated economy can do for emerging economies. For example, Nasdaq meant product registration costs were much lower in Ghana and Nigeria. Thirdly, barriers to regulation especially in registering products from English-speaking to French-speaking African countries proved near impossible. Finally, access to capital is difficult to secure, especially borrowing for construction.

Today’s environment provides the following opportunities: to start, awareness that Africa needs industrial growth has translated into the establishment of industrial parks, with the necessary infrastructure (electricity, water and transport systems). The AfCFTA expands the market potential for products. Regulatory barriers have been addressed by the African Medicines Regulatory Harmonisation (AMRH) to some extent by establishing the African Medicines Agency. Once fully operational, this will enable companies to register medicines in one country and distribute them across the continent without experiencing any problems.

With regards to access to capital, the Federation of Pharmaceutical Manufacturers Association negotiated with the African Union, to establish a fund for African pharmaceutical development. This was endorsed by the Executive Council of the Specialised Technical Committee on Health, with the AUC and AUDA-NEPAD. The pandemic necessitates the reactivation of this fund for the pharmaceutical sector.

Dr Simon Agwale identified specific areas hampering productive practices on the continent and provided strategies on how to overcome these barriers. He talked about the hesitancy amongst vaccine manufacturers to invest due to high costs which run into the millions of US dollars. Secondly, he observed that sustaining manufacturing on the continent requires thinking outside the box – with a model that goes beyond “fill and finish”. Sustainability will also need a focus on upstream processes such as drug substance manufacturing. Technology transfer must take place from experienced manufacturers to those at the local level, bridging the finance gap by creating advanced purchase commitments.

Like Dr Lartey’s presentation, Dr Agwale stressed the need to establish collaborative partnerships to aid the manufacturing process. This approach proved helpful in the production of the Human Papillomavirus (HPV) vaccine to prevent cervical cancer. This platform has also been used to develop Ebola and Covid vaccines. The virus-like particle allows manufacturers to work with different variants simultaneously. In developing the vaccines, the move to commercialisation would require further testing and clinical trials.

Vaccine manufacturing facilities must be designed based on the manufacturing process that is developed for a specific vaccine. The establishment of these facilities has also benefitted from international partnerships including with Merck KGA which specialises in the supply of manufacturing equipment. Other partners have provided capital investment, resources, knowledge, and technology transfer using a plug and play approach, where the facility is developed remotely and then shipped to the final location, once completed. This model will be used until the facilities in Nigeria are fully operational.

An important area includes the development of surveillance tools, which are needed for detecting and monitoring different diseases on the continent. Partnerships with AfroMedics have helped with the detection of multiple diseases simultaneously.

Mr Rajinder Suri provided an external assessment of the opportunities. On the backdrop of the Covid-19 pandemic, Mr Suri said, “any adversity brings with it an opportunity.” He stated that Africa’s population of over 1.38 billion and a GDP growth of over USD 2.5 trillion gives Africans an opportunity to manufacture for Africa in Africa. The current vaccine demand translates to over USD 1 billion and is expected to triple in the next decade to USD 5 billion. This huge opportunity considers the vaccine inequities, and the unique support through political will, research, regulators and technology. The environment is conducive for vaccine manufacturing grounded on four pillars, namely: 1) Technology, 2) Infrastructure, 3) Investment: Access to Capital, and 4) People: Human Resources.

He cast sight beyond Covid-19 to plan for future pandemics and diseases by promoting effective technology transfer. He reiterated Dr Agwale’s point about platform technologies for the manufacture of various vaccines and also endorsed the move away from a sole focus on “fill and finish” facilities. Mr Suri also asked who will design and build the facilities that are required to do this and confirmed the complexities of building vaccine facilities.

Mr Suri agreed with the need for timely and sustained investments. He identified the relevance of innovative funding mechanisms that allow for recovery and pay-back in the long term. He pointed out that a competent workforce is the most important pillar and gives life to the shells that are facilities. Universities and biotech institutions need to provide expertise along with all parts of the value chain including production, quality control, quality assurance, engineering and regulation. In addition to formalised education, additional training within the facilities is also important.

He talked about the affordability and quality of vaccine products from India, and how the Indian experience provides useful learning points. He added that partnerships between existing manufacturers with tested facilities are necessary to pass on knowledge and expertise. Mr Suri listed some of the partnerships between manufacturers, including those that help with planning for manufacturing facilities. Instead of shifting all vaccine manufacturing to local facilities, Mr Suri argued that a list of critical vaccines should be provided. The identification