As Africa seeks greater pharma self-reliance, think generics

11 Oct.,2022

 

Pharma Intermediates

Over the past two years, we have seen that when global medical demand exceeds supply in a public health emergency, wealthier regions use their bigger wallets to get priority access over poorer ones. This is why there is growing consensus -- in Africa and beyond -- that the continent must greatly expand its capacity to manufacture the variety of medical products, including pharmaceuticals, medical equipment, and consumables, that are required to meet both urgent and routine health needs

How can countries in Africa expand manufacturing capacity?

Unsurprisingly, the focus has been on vaccines, and a great deal of progress is being made in boosting vaccine production capacity in Africa. However, if we zoom out a bit from the challenge of COVID-19 vaccine production, it is clear there are other areas where the continent should be self-reliant. Routine generic medications—products like fever reducers and analgesics which are available in pill form—are a case in point. As with vaccines, Africa’s generics industry is at early-stage development, similar to where Asia was in the 1980s. Generics production offers a tremendous opportunity for the private sector to focus investments and build capacity. 

This is a good time for Africa to be expanding in generic medications, given where the market is globally. Back in the 2000s, China emerged as a global leader in pharmaceuticals production, including in active pharmaceutical ingredients (APIs), which are the building blocks for medicines, and generics. However, China faces rising production costs, in part due to pandemic-driven supply chain disruptions that may persist. India has emerged as a global leader in producing pharmaceuticals, although it relies heavily on China for the active pharmaceutical ingredients.

African producers could be competitive globally with both tablet formulations and injectable generics. Injectables are pharmaceutical products that can be injected either by the patients themselves or by a healthcare worker at a pharmacy, clinic, or hospital, and they are used in specific clinical settings such as in trauma, cancer care, and surgery. While the generics market has historically been dominated by drugs ingested in pill form, injectable generics are becoming more popular, in part because they are faster-acting and the medical community along with pharmaceutical researchers are quickly developing novel formulations in oncology and other specialty therapeutic areas. One longstanding IFC client, for example, Jordan-based Hikma, has ramped up its output of injectables in recent years to comprise 40 percent of its total portfolio. Another IFC client, Uganda-based Abacus, has also significantly expanded its sterile injectable operations to meet the continent’s growing demands. Similarly, pharmaceutical companies in Latin America are growing their portfolio in this area as our client case studies of Roemmers in Argentina, NeolPharma in Mexico and Procaps in Colombia show.

Challenges in pursuing business opportunities

One of the key enablers for scaling up pharma manufacturing is the evolution of a strong regulatory system. For example, the AMA (Africa Medicines Agency) has been working to strengthen regional harmonization to support technical cooperation between the regulatory bodies of different countries on the continent. Governments need well-functioning systems in place to track the pharma supply chain to prevent counterfeits. In both the areas, the World Bank Group, including IFC within that, has various initiatives underway. In addition, governments can look at the infrastructure requirements faced by producers and see how to incentivize or support building the industry, and they can provide infrastructure support for power, water, and utilities to support the industry (as done in Bangladesh, India, China) in addition to production linked incentives for key pharmaceutical intermediates (as has been done by India).

Attention also has to be paid to maintaining systems for securing and transporting these medicines. Sterile injectables are mostly now administered by healthcare professionals, unlike pills that patients can take on their own after doctor prescription. This means that a workable logistics plan needs to be devised for transporting these medications from factory floor to clinic or pharmacy without any degradation in efficacy or safety and with proper cold chain infrastructure. This means developing cold chain logistics in Africa to support the pharma eco-system. IFC is already working on this through its engagement with the private and public sectors to analyze and build investment opportunities for more advanced and available cold storage facilities in Africa and elsewhere.

Where should companies start in planning a product line?

Given safety and quality imperatives, it may make sense to begin by producing something that is straightforward from a manufacturing process standpoint. Take saline solutions. This might not sound like the most exciting or innovative product, but it’s worth remembering that most patients in hospitals receive a saline solution at some point during their stay, so this is a large market. As a manufacturer starts to expand, so too can their portfolio, crossing the spectrum from simple to complex products. In oncology, injectables are becoming favored as they can offer options to the patients such as reducing the need for surgery—for instance, providing alternatives to mastectomy in breast cancer cases.

The World Bank Group is already supporting efforts in the pharmaceutical manufacturing domain, such as through IFC’s partnership with Kenya-based Universal Corporation LTD. We must continue this essential work to help Africa expand its manufacturing capacity by turning to other countries, regions, and product lines to meet patient demand. Self-reliance in medical supplies is no longer an aspiration, it’s an imperative, a lesson we have learned the hard way during the pandemic.