• With 1.4 billion people, Africa is home to only 375 drug manufacturing companies.
• Africa imports 95% of its medicine needs while contributing only 3% to global production of the same.
• Benefits of boosting local production include more affordable medicines.
• Establishing partnerships and collaborations are some of the ways to enhance local production of pharmaceuticals.

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A report by WHO in 2022 showed that diseases such as HIV and Malaria in sub-Saharan Africa accounts for 85% and 95% of global HIV and malaria cases respectively. 73% of the estimated 1.6 million people who die annually from AIDS are Africans.

This disproportionate disease burden coupled by a lack of affordable, safe, effective and quality medicines has left the region exposed and vulnerable to preventable pre-mature deaths. It is therefore time that key players in the region strengthen the public health system through strategies such as enhancement of production of medicines and in essence boost self-reliance.

A region with approximately 1.4 billion people, Africa is home to only 375 drug manufacturing companies. Out of this figure, only 3 have the capacity to produce Active Pharmaceutical Ingredients (APIs) while the rest focus on late-stage value addition; final formulation and packaging.

Compared to regions with roughly similar populations, such as China and India having 5,000 and 10,500 manufacturing facilities respectively, the continent is underperforming.

Why Produce locally?

More affordable medicines

High cost of medicines has always been a huge impediment to quality healthcare in Africa. Ironically, for a region with a poverty rate of between 33-54% (sub-Saharan region) health is largely financed through out-of-pocket payments. With adequate production capacity and utilization, drug production in Africa can drop the cost of medicines to affordable levels.

The total cost of ownership of imported medicines is a figure that includes original cost of production, manufacturer’s margin, taxes and freight costs to the distributor. All these components serve to push the landing costs to higher levels. If these products were to be manufactured locally at the same scale, there would be a massive drop in the freight costs and therefore effectively pushing the prices down.

Improved access to life-saving health products and technologies

During drug importation, a substantial amount of time is lost during transportation, customs clearance and extra regulatory paperwork. This, in effect increases the time it takes for medicines to reach patients whose lives could be on the line.

In addition, events such as the Covid-19 pandemic and the Suez Canal blockade of 2021 show that international logistics and supply chains are not completely fool proof. Local production of medicines in our view, has the potential to massively reduce lead times and protect patients against unreliable supply chains.

Favorable balance of trade

With increased local production of medicines, African countries can move the needle and transition from being largely trade deficit to trade surplus nations. The resulting favorable balance of trade ensures that countries export more than what they import leading to increased inflow of foreign currency. Consequently, sparking economic growth and overall improved standards of living.

Increased levels of safe, quality and effective medicines

Africa has been grappling for decades with the challenge of counterfeit and sub-standard medicines in its market. A large contributor of this is the high costs of medicines that result in players seeking cheaper and more affordable poor-quality medication to meet its needs. Although not a silver bullet, local production coupled with strengthening of local regulatory bodies can substantially improve the quality of medicines in the region.

 

How do we enhance local production?

Establish regional hubs that consolidate production

The full benefit of local production of medicines can only be realized if the production capacities and utilization levels of manufacturing plants are of a large enough scale to compete with other markets like India. The current African pharmaceutical manufacturing space as it is, is highly fragmented. It is only through economies of scale that local medicine production can make health care affordable.

Member states of blocs such as the East African Community (EAC) and South African Development Community (SADC) should consolidate resources to build big drug manufacturing plants that take advantage of economies of scale. As a group purchasing block such institutions can enjoy enhanced purchasing power and will be able to negotiate cheaper prices for raw materials.

Align laws, regulations and policies to promote local manufacturing

With a 20% share of global supply, India is the number one single producer of generic medicines in the world. In addition, the country is the largest manufacturer of vaccines globally. The country has structured its policies in a way that favors local production of pharmaceutical products in an unimaginable scale. Africa can borrow from this.

For example, countries can make a provision for 100% Foreign Direct Investment (FDIs) under the automatic route for greenfield pharmaceuticals (construction of a pharma manufacturing plant from the ground up). For brownfield pharmaceuticals (utilization of an existing manufacturing facility and infrastructure) Governments can allow an automatic 70% FDI while the balance of 30% can go through an approval process.

Governments can also enhance local production of medicines through redress of taxes on equipment and raw materials used in the manufacture of health products and technologies. Additionally, they can expedite time to market by cutting down on unnecessary bureaucratic procedures and incentivize local procurers & insurance companies to prioritize purchase of locally produced products.

Enhance human resource capacity

 A key component of a successfully enhanced local production venture is a human resource pool with the requisite knowledge and skills to spearhead the process. African universities need to restructure their pharmacy curriculum to ensure graduates are equipped with the skills that will develop the sector.

By 2014, 70 graduates from 8 African countries completed the Industrial Pharmacy Advanced Training (IPAT) at Kilimanjaro School of Pharmacy, Tanzania. As well, the University of Nairobi introduced a Master’s program in Industrial Pharmacy. All these efforts lead the continent to the right path in enhancing the pharma manufacturing sector and should be replicated across other African universities that offer the pharmacy program.

Build strong partnerships and collaborations

A key factor that has limited local production of medicines is trade-related intellectual property rights. It has been noted that African drug companies have struggled to negotiate with patent holder companies to gain licenses for innovator medicines, while this is granted to companies in other regions of the world. This is because such patent holders do not consider the market demand compelling enough to export their products to.

The result of this is African patients are unable to access new innovative health products that could be a game changer to public health. It should be noted that so far, Africa has not shown ability to implement Trade-Related Intellectual Property Rights (TRIPs) agreements on exclusive and non-exclusive licensing.

 “Africa can no longer outsource the healthcare security of its 1.3 billion citizens to the benevolence of others.” 

African Development Bank Group President, Dr. Akinwumi Adesina

African countries should ramp up their efforts to partner and negotiate with patent holding companies to allow manufacture of originator drugs through a win-win structural arrangement.

Strengthen the regulatory capacity and systems

Cheaper but poor-quality medicines have sipped through the seams of weak regulatory systems in Africa. This has directly translated into treatment failures, increased morbidity and mortalities in the region. Drug regulatory agencies (DRAs) need to be adequately resourced financially, infrastructure-wise and in terms of human resource capacity so as to cope with proposed increased production.  

For example, as at September 2020, there are only 9 WHO pre-qualified laboratories in the African region with the capacity of assessing quality of medicines in its market. This needs to be upscaled. State DRAs may also consider collaboration through aligning regulatory systems and create synergy and strength thereby enhance efficiency. Efforts are currently underway to harmonize regulatory systems in the region. The African Union has established a specialized health agency, African Medicines Agency (AMA) whose main task is to spearhead regulatory harmonization in the region. As at July 2023, 35 AU member states have either signed and/or ratified the AMA treaty. This would be similar to Europe where they have an integrated agency; European Medicines Agency (EMA).

It is important to note that there are ongoing regional efforts to boost local manufacture of medicines in the continent. In 2007 for example, in an AU summit in Accra, AU heads of state and Government of the AU endorsed the Pharmaceutical Manufacturing Plan for Africa. The vision is to develop a competitive and enduring integrated manufacturing pharmaceutical industry in Africa.

In 2022, the African Development Bank Board of Directors approved establishment of the African Pharmaceutical Technology Foundation. The objective is to enhance Africa’s access to technologies that underpin manufacture of medicines, vaccines and other health products.