Access to affordable, safe, and quality medicines is a key to achieving the Sustainable Development Goal (SDG) 3 to ensure healthy lives and promote well-being for all at all ages. However, substandard and falsified (SF) medicines have remained a global scourge and concern for the health community worldwide.
To address these challenges of substandard and falsified drugs and to ensure that pharmaceutical products used for the prevention, treatment and diagnosis of priority diseases like HIV, tuberculosis, and malaria are safe, appropriate and meet stringent quality standards, the WHO established the Prequalification of Medicines programme in 2001. The WHO prequalification (PQ) aims to provide qualified, safe and efficacious medicines for United Nations’ (UN) procurement agencies and to countries for bulk purchasing and distribution of medicines in resource-limited countries.
To address the issues of high upfront cost, it is essential that African governments see the critical need for investment in the WHO PQ of pharmaceutical companies as a non-negotiable pathway to strengthening the pharmaceutical sector
Till date, over 680 medicines have been qualified across the globe. Unfortunately, Africa lags behind as only South Africa, Morocco and Uganda have prequalified pharmaceutical manufacturing companies with the right to take part in international tenders for medicines and sell their pharmaceutical products to other countries across the globe. As we enter the post-covid-19 era, it is even more crucial to rethink pharmaceutical supply chain and re-emphasize the need to have quality manufacturing in areas where the disease burden is high. Africa needs to have many companies with WHO prequalified products.
Benefits of WHO prequalification for pharmaceutical manufacturing companies
The attainment of WHO PQ by pharmaceutical manufacturers in Africa holds several benefits for the companies, individual countries, and Africa as a whole. WHO PQ is based on assessment of a product dossier submitted by the pharmaceutical manufacturing company seeking prequalification of their medical products, using internationally accepted regulatory standards of quality, safety and efficacy, and inspection of the corresponding manufacturing sites to ensure conformity with WHO Good Manufacturing Practices (GMP).
Pharmaceutical manufacturers that attain WHO PQ of their product establish their capability to produce medicines that consistently meet stringent standards of quality in line with WHO specifications and global standards. This provides 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; increased potential to compete successfully for contract manufacture for local markets; and faster registration.
It is worth mentioning that UN agencies and other donors and agencies require WHO PQ for bulk purchasing of medicines. This shows that the WHO prequalified status offers a significant advantage.
At the national and continental level, WHO PQ means an increased availability of quality-assured medicines and the building of national capacity for sustainable local manufacturing and monitoring of quality medicines, as well as the positioning of Africa’s pharmaceutical sector as a global competitor.
Barriers to achieving WHO prequalification in Africa
A major barrier to achieving WHO PQ in Africa is the high upfront cost. Pharmaceutical companies would need to invest several millions of dollars to upgrade their factories and to hire or train qualified professional and technical personnel in order to meet WHO PQ requirements. Without the support from government or donor agencies, most pharmaceutical companies lack the capacity for such enormous capital investment.
Another significant barrier is the poor technical support and limited expertise about achieving WHO PQ. Most pharmaceutical companies have limited information on the specific requirements for WHO PQ and the application process. Attaining WHO PQ is a highly technical process, requiring comprehensive technical and professional support from experts in the field. Another barrier is weak regulatory systems.
Potential strategies to overcome barriers
To address the issues of high upfront cost, it is essential that African governments see the critical need for investment in the WHO PQ of pharmaceutical companies as a non-negotiable pathway to strengthening the pharmaceutical sector. Investment from government and foreign donors is needed to reduce the financial burden of WHO PQ on pharmaceutical companies. Government support through incentives related to taxes and other waivers will be beneficial. Above all, a guaranteed procurement plan will be an excellent incentive for such investment. This model was a great motivation for achieving WHO PQ in Uganda and should be replicated.
Exploring Public-Private Partnerships (PPPs) is a strategy to address issues of lack of technical know-how. A good example is the strategic partnership between Nigeria’s National Institute for Pharmaceutical Research and Development (NIPRD) and its technical partner, Bloom Public Health. In a World Bank-funded program, NIPRD and Bloom Public Health will commence support of selected Nigerian pharmaceutical manufacturers through the process of WHO PQ. This will be the biggest pharmaceutical intervention in the country and will be a great model for other African countries.
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; conducting technical workshops on the process of WHO PQ; etc. This project will achieve the first ever WHO PQ of pharmaceutical companies in Nigeria.
Conclusion
WHO PQ is critical to strengthening Africa’s pharmaceutical sector. Government support, as well as incentives, and developing mechanisms for strategic partnerships are essential to achieving WHO PQ of pharmaceutical companies and sustainable availability of quality, efficient, and safe medicines in Africa.
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