• Wednesday, April 24, 2024
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Innovative solutions for sustainable local pharmaceutical manufacturing in Africa

Good Manufacturing Practices (GMP) and its impact on pharmaceutical quality in Africa

Despite having almost 17% of the world’s population, Africa accounts for only 3% of global drug production. Limited local manufacturing means most countries in sub-Saharan Africa import 70 to 90% of their pharmaceutical consumables, a stark contrast to comparable populations in China and India, which import 5% and 20% respectively.

The COVID-19 pandemic put a spotlight on Africa’s poor pharmaceutical manufacturing capacity, as the continent remained among the last in line to access essential medical supplies and tools — from personal protective equipment and diagnostics to treatments and vaccines. However, these challenges are not peculiar to the pandemic. Rather, they represent the continent’s long-standing, inequitable access to lifesaving medical products.

Consequently, the last few years have seen concerted efforts being made to strengthen Africa’s local pharmaceutical manufacturing capacity to meet the needs of the continent. African countries are making progress in building their drug and vaccine manufacturing capabilities. The Africa CDC has also set an ambitious target to manufacture 60% of Africa’s routine vaccine needs by 2040. Yet, there is a wide gap that must be closed to achieve a self-reliant pharmaceutical industry in Africa.

There is an urgent need to implement innovative solutions that tackle the existing challenges in Africa’s pharma industry

Benefits of local pharmaceutical manufacturing in Africa

Reduced reliance on imports will enable Africa to be better prepared and responsive to current and future endemic and pandemic diseases which could save thousands of lives and reduce disease burden. Localizing pharma manufacturing would also mitigate risks of supply chain disruption, accelerate priority vaccine access, and generate substantial economic impact.

In the long-term, investment into R&D and technological development could increase the capacity for manufacturing of more complex molecules to tackle other diseases that are on the rise in Africa, such as cancers.

Strategies to strengthen Africa’s capacity for local pharmaceutical manufacturing

There is an urgent need to implement innovative solutions that tackle the existing challenges in Africa’s pharma industry. Real advancement requires strong partnerships between governments, international and multilateral organizations, and private sector engagement. In view of these, Bloom Public Health proposes the following solutions:

1. Establishment of pharmaceutical hubs: The high cost of pharmaceutical manufacturing, lack of supportive infrastructure for the regulatory compliance of pharmaceutical manufacturing companies, poor regulatory policies, and limited access to affordable and reasonable funding are among the many factors responsible for the poor local pharmaceutical manufacturing capacity in Africa.

To address this, Bloom Public Health proposes the establishment of pharmaceutical hubs. These are compact modern-day pharmaceutical industrial estates that will bring together pharmaceutical companies and service providers to co-locate and share infrastructure, providing regulatory support and access to affordable funding. Bloom Public Health is championing this initiative through the Pharmacity project in Nigeria, with the physical construction of Nigeria’s premier pharmaceutical manufacturing park already underway in Ebonyi State, Nigeria.

2. Supporting WHO PQ of African local manufacturers: Pharmaceutical manufacturers that attain WHO PQ of their product have opportunities for increased sales and market access by conferring eligibility for international, donor-sponsored tenders for medicines; improved capacity to manufacture products for entry into stringently regulated markets; and increased potential to compete successfully for contract manufacture for local markets, amongst other benefits. Unfortunately, high upfront cost, poor technical support and limited expertise, and weak regulatory systems pose barriers to the attainment of WHO PQ by African local manufacturers.

Read also: African Vaccine Academy: Building local talent for sustainable vaccine manufacturing

To tackle this challenge, Nigeria’s National Institute for Pharmaceutical Research and Development (NIPRD) and its technical partner, Bloom Public Health in a World Bank-funded program, will commence support of selected Nigerian pharmaceutical manufacturers through the process of WHO PQ. Bloom Public Health will provide full technical support for the selected companies, including accessing gaps in the companies’ technical capacities and quality management systems when compared with global standards. This will be the biggest pharmaceutical intervention in Nigeria and an outstanding model for other African countries.

3. Home-grown talent and skills development: The poor pharmaceutical manufacturing talent and know-how in Africa remains a critical challenge to building a self-reliant pharmaceutical industry. Pharma manufacturing requires an extensive skill set, particularly in areas of biopharma, quality assurance, regulatory competence, etc. Unfortunately, fresh graduates and professionals within the pharmaceutical workforce often lack relevant skills to seamlessly fit into the drugs, vaccines and biologics manufacturing industry.

To address this, Bloom Public Health and its technical partner, Biotech Training Facility, Netherlands, are set to launch the African Vaccine Academy (AVA). The AVA is an African-wide initiative that will provide training on general bio-manufacturing processes with access to self-paced eLearning interactive training materials, webinars and virtual classrooms, as well as practical hands-on biopharmaceutical training at Biotech Training Facility in Leiden, Netherlands.

The AVA will precede the establishment of the African Pharmaceutical Academy (APA), an on-site pharmaceutical training academy that will deliver training to new graduates in Sub-Saharan Africa and will aim to impact needed skills and expertise relevant to the pharmaceutical industry across the continent.

In Conclusion: The realization of the right to healthcare and access to medicines in Africa is contingent on the development of a sustainable, local pharmaceutical manufacturing industry on the continent. Therefore, to build more resilient health systems for current and future generations in Africa, concerted efforts must be made to implement innovative solutions that tackle the existing issues in Africa’s pharmaceutical industry.