Let me share a few statistics;

Out of the less than 400 pharma producers in Africa, 80% are concentrated in North Africa and only 5 are able to manufacture active pharmaceutical ingredients1.

An estimated 22 countries in the continent don’t have any local pharmaceutical manufacturing plant domiciled within their borders.

Only 4 countries have more than 50 pharma manufacturers.

These numbers, if nothing else, prove that the continent still has a lot to do to be self-reliant and transition from the current over-dependence on foreign imports.

There are initiatives (in this article referred to as the 3As) that have been launched in the continent by organizations such as the African Union (AU) aimed at revamping the African pharmaceutical sector.

Their overall goal is to boost local manufacturing, strengthen regulatory systems and remove barriers to pharmaceutical trade.

African Pharmaceutical Technology Foundation (APTF)

Source: African Development Bank

Two key success factors historically missing in Africa that hinder the continent’s ability to optimize its pharmaceutical industry performance are; technology and financing.

Without access to cutting-edge innovation and capital investment, the continent has had to play catch up to its European and Asian counterparts.

A recent example is the covid vaccine saga; where there was documented inequity2 in access to lifesaving jabs particularly for Africans. Equipped with the right technology and capacity to develop and manufacture its own vaccines, many lives in the region would have been saved.

This is why the inception of the African Pharmaceutical Technology Foundation (APTF) is deemed by many as a stroke of genius.

A brainchild of the African Development Bank, APTF’s goal is to build capacity of Governments, pharma companies and research organizations with the aim of strengthening the African pharmaceutical sector. The Foundation aims to open doors to new technology crucial to discovery, development and production of health products in the continent3.

Having already established a secretariat in Kigali, Rwanda4, it is expected that in 2024, APTF’s operations will take center stage in changing the landscape of the region’s pharma sector.

Some of the programs5 the foundation will be focusing on include;

A regional biosimilars program:

Production of biosimilars is a complicated and extremely challenging venture to engage in. Because of the sheer complexities of these products (including insulin, infliximab and vaccines), it is natural that their GMP benchmark, approval, registration and overall regulatory processes would pose as a stumbling block to their production.

APTF has therefore launched the biosimilars program geared towards consolidating investments and creating technological partnerships that strengthen the capacity of African countries. One such partner that the foundation has successfully secured is the European Investment Bank.

Regional Centers of Excellence Program:

The foundation has created this program designed to increase learning through collaboration. Various institutions including universities, research centers, private companies and public sector will come together and create a network that facilitates capacity building across the region. This program is specifically targeted to yield a vibrant vaccine ecosystem that will allow self-reliance in production of safe, quality, efficacious and affordable vaccines.

The cGMP program:

Most African pharmaceutical companies are locked out of regional and international trade due to their inability to attain WHO recommended GMP compliance. Lack of requisite infrastructure, technology and personnel has meant that these companies are unable to play at the global league.

To alleviate this, APTF plans to first identify the specific gaps these companies are facing and thereafter facilitate the necessary investments to bridge them.

African Medicines Agency (AMA)

Back in February 2019, the African Union Treaty for the establishment of the African Medicines Agency was adopted in the 32nd ordinary session decision of the Assembly Heads of State and Government. Less than 2 years later, in November 2021, the threshold of 15 member countries was crossed and the Agency came into force6.

Source: African Union Development Agency (AUDA-NEPAD)

With the Republic of Rwanda and the African Union Commission having finalized an agreement last year to host the Agency’s headquarters in Kigali, its operations are expected to kick into gear in 2024.

Among many functions, it is expected that this collaborative initiative will play a crucial role in;

• Ensuring harmonized pharma legislation through development of similar standards, policies and regulations.
• Supporting the growth and development of Africa’s pharma manufacturing sector.
• Coordinating joint inspections of Active Pharmaceutical Ingredient manufacturing sites.
• Encouraging more clinical trials in the continent by facilitating coordinated reviews of these applications.
• Encouraging sharing of pharma related information.
• Identification of substandard and falsified medicines in the region.

The Agency seeks to pursue its mission of providing leadership in creating an enabling regulatory environment for Pharmaceutical Sector Development in Africa. 

Among the 55 AU member countries, 27 have so far ratified the treaty expressing their commitment in ensuring the continent has access to quality, safe and efficacious health products7.  

Countries such as Burundi, Comoros, Cote d’Ivoire, Equatorial Guinea, Madagascar, Mozambique, Republic of Congo and Togo that have signed but yet to ratify the treaty are expected to do so this year. While the countries yet to sign; including economic powerhouses such as South Africa and Nigeria are also primed to board the AMA plane.

Many this year will be watching keenly to see how this initiative of regulatory harmonization unfolds in the region.

Needless to say; 2024 is poised to be a pivotal year for AMA.  

African Continental Free Trade Area (AfCFTA)

It is well documented that Africa imports majority of its health product needs.

Unforeseen events such as the Covid pandemic highlighted all too well that this overreliance may be catastrophic in the face of supply chain disruptions. Currently, it is estimated that only 3% of the pharmaceutical commodity needs are met through intra-African trade.

97% is either imported or locally produced but not traded within the continent.

In steps the African Continental Free Trade Area (AfCFTA).

Source: AU-AfCFTA

The AfCFTA is a free trade area that canvasses most of the African region. It is, in fact, the largest free trade area in the world by virtue of the number of countries in the pact8.

The African Continental Free Trade Area agreement that came into force in May 2019, currently has 54 AU member states as signatories and is expected to be a landmark covenant that changes the face of Africa’s economic landscape.

The agreement is seen as an opportunity to lift 30 million people in the continent out of extreme poverty and increase income of 68 million others who live on less than $5 a day1.

The main objective of AfCFTA is to enhance trade within the African continent specifically in value added production including that of health products and technologies. In fact, a World Economic Forum report has earmarked the pharmaceutical sector as a key potential beneficiary of the agreement.

This opens a huge door of possibilities.

With the increased ability to freely trade within the region, it is expected that local pharmaceutical manufacturers will be able to supply the continent with products at more reasonable prices. Progressively, this will allow companies to penetrate the regional market and eventually grow into a formidable competitor. Particularly against international counterparts that have historically dominated the African market.

Other benefits to the African pharmaceutical market could include:

• Enhanced capacity of local companies to supply the international market.
• Strengthened regional pharma supply chains.
• Improved regional coalitions that will increase the continent’s purchasing power of raw materials in the manufacture of medicines.

With operationalization of the AfCFTA, measures to enhance trade that simplify unnecessary bureaucratic and customs processes are expected to translate to a $450B jump in income in Africa by 20358.

As the secretariat sits in Accra, Ghana, it is hoped that this agreement will alleviate some of the continent’s overreliance on foreign economies.

Conclusion

The challenges that are faced in the African pharmaceutical sector are many. However, no one can argue that the potential is there.

As shown by the 3As, innovation and collaboration remain key in the continent’s ability to harness its potential and finally become a formidable source in the pharmaceutical industry.

It’s a beautiful challenge that will need all African countries to pull together, establish political goodwill and consolidate resources.

This may not all happen in 2024 but the hope is that it will be a launching pad on which we achieve the dream of having a robust, dynamic and self-reliant African pharmaceutical industry.

Will it happen? Only time will tell.