Ideas & Debate

Right policies can spur investment in African vaccines

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Inadequacies in drug production and challenges posed by counterfeit and substandard products have often crippled access to medicines in Africa.

To tackle this, the African Union (AU) called for strengthened, improved and harmonised regulation of medicines, medical products and technologies across the continent.

On February 11, 2019, in Addis Ababa, Ethiopia, heads of state and governments during their 32nd Ordinary Session adopted the African Medicines Agency (AMA) treaty to provide support for weak regulatory systems.

The new African Medicines Agency Treaty currently has 28 signatories, accounting for more than half of the African Union's 55-member states.

South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that are yet to even sign, let alone ratify, the treaty document, which was first approved by the African Union in 2019.

Recent research done by PATH Africa reveals that Africa has a strong pharmaceutical industry yet the majority of pharmaceutical goods are imported.

About 25-30percent of pharmaceuticals and less than 10 percent of medical supplies in the continent is sourced locally. Africa has few international pharmaceutical companies that invest locally.

Right policies can strengthen incentives for better investment in the future, and regional cooperation is essential.

According to the World Health Organization (WHO), Africa has 14 percent of the world's population, but just 1 percent of all vaccines used in the continent are produced locally, revealing the area's extreme vulnerability and overdependence on foreign supply.

The WHO aims to help African companies make Covid vaccines by scaling up production of lifesaving vaccines from 1 percent to 60 percent by 2040.

African countries have of late made major strides with scientists in South Africa reproducing Moderna’s Covid-19 vaccine.

Kenya has signed a memorandum of understanding with Moderna to establish the first mRNA manufacturing facility in Africa and has embarked on the journey towards manufacturing of human vaccines through the formation of Kenya Biovax Institute Ltd.

These milestones will eventually lead to an increase in demand to a growing need for quality control, certification and accreditation of ethics and regulatory bodies, and adherence to common international standards towards vaccines manufactured within Africa.

Despite these milestones, Africa’s vaccine production has a long way to go in regard to issues of funding, technology transfer and creation of a common front in relation to standardising regulatory systems.

While national regulatory authorities are responsible for ensuring timely access to innovative, effective, and safe therapies, many are limited in their ability to ensure a robust regulatory system capable of licensing and monitoring novel medicines and medical devices, as well as addressing substandard and falsified products.

In light of these challenges, the Government of Kenya should work on streamlining health product regulatory systems. Kenya's Ministry of Health is in charge of ensuring that citizens' constitutional rights to health and access to high-quality medical treatment are protected.

This includes establishing sound policies and strategies that encourage Kenyan pharmaceutical production. Broad policy frameworks, as defined in the Kenya National Pharmaceutical Policy, support the delivery of cost-effective pharmaceutical services to the general public and the UNIDO supported initiative to strengthen the sector.

Two important strategies and frameworks, The Kenya National Pharmaceutical Sector Development strategy 2012 and the Kenya GMP Roadmap 2015-2019 are now being used as a blueprint in most regions in Africa.

A cost-benefit analysis undertaken by PATH in collaboration with the Pharmacy and Poisons Board highlights the benefits of AMA ratification and how it will effectively deal with the challenge of circulation of low-quality, substandard and falsified drugs and inconsistent enforcement of manufacturing standards.

The government should support regulatory harmonisation by ratifying AMA in alignment with the AU heads of state pledge and support regulatory harmonisation through adequate support to the Pharmacy and Poisons Board to attain WHO maturity Level 3 to allow Kenya to export the manufactured vaccines. Further, a regional framework must be developed at EAC and anchored to AMA.

To secure Kenya/EAC’s potential to grow and scale vaccine development and manufacturing over the next two decades, Kenya together with partner EAC countries should rally up AMA’s ratification.

The ratification will help in addressing human capital issues and infrastructure related to harmonisation of medicines and medical products regulatory framework, reviewing policies and identifying avenues for access to finance for enhancing national capacity for medicines regulation and control in Kenya.

The ratification will also enable the Kenyan pharmaceutical industry to mitigate challenges posed by complex requirements that include meeting pro forma requirements.

The importance of establishing supportive mechanisms for common usage in order to boost local pharmaceutical products cannot be overstated, which is why AMA must be a part of the EAC’s broader regulatory regime.

The pharmaceutical industry has a direct impact on Kenyans' health and safety, as well as being a major contributor to the national economy and a driving force behind international trade and collaboration.

Medical products and health technology are essential components of Universal Health Care (UHC), which is a crucial pillar of Kenya’s Big 4 Agenda. For Kenya and the region to attain UHC, prevention should be at the forefront and that is why vaccine manufacturing is critical.