The World Health Organisation in 2001 established the WHO Prequalification of Medicines programme (WHO PQ) – a global standard to ensure medicines are safe and properly produced. WHO PQ plays a critical role in addressing the global scourge of substandard and falsified medicines, ensuring the quality of lifesaving medicines used today by millions of people across the globe.
It guarantees that drugs, vaccines, diagnostics, vector-control products, and devices used for the prevention, treatment and diagnosis of priority diseases like HIV, tuberculosis, and malaria are safe, efficacious and meet stringent quality standards.
WHO Prequalification is the backbone of global health procurement. It aims to provide quality, safe and efficacious medicines for United Nations’ (UN) procurement agencies and to countries for bulk purchasing and distribution of medicines in resource-limited countries. It also supports the response to public health emergencies. Thus, medicines prequalification has made it possible to believe that everyone in the world will have access to quality, safe and efficacious medicines.
The Case for WHO Prequalification in Nigeria
Although over 680 medicines have been qualified across the globe, in Africa, only South Africa, Morocco, Kenya, and Uganda have pharmaceutical manufacturing companies with WHO prequalified products. Hence, only these have the right to take part in international tenders for medicines and sell their pharmaceutical products to other countries across the globe.
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).
The attainment of WHO PQ by pharmaceutical manufacturers in Nigeria will establish their capability to produce medicines that consistently meet stringent standards of quality in line with WHO specifications and global standards.
This will provide 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.
Thus, facilitating international procurement and distribution of locally produced medicines in Nigeria. Annually, billions of dollars worth of products are donated to Africa without local participation in the tender because they are not WHO prequalified.
Achieving WHO PQ also requires close collaboration with well-functioning National Medicines Regulatory Authorities (NMRAs) to provide the required approvals and ongoing oversight for continued regulatory compliance
Challenges confronting WHO PQ in Nigeria
One of the major barriers to achieving WHO PQ in Nigeria is the high upfront cost. Pharmaceutical manufacturers 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. Unfortunately, without the support from government or donor agencies, most Nigerian 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 Nigerian 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.
Proposed solution – Nigeria’s biggest pharmaceutical intervention is underway
To address the challenges of WHO PQ in Nigeria, in February 2023, Nigeria’s National Institute for Pharmaceutical Research and Development (NIPRD) and its technical partner Bloom Public Health, in the World Bank-funded initiative, kicked off a project to support selected Nigerian pharmaceutical manufacturing companies who produce malaria medications in the attainment of Good Manufacturing Practices (GMP) and also support them through the process of WHO PQ.
Through this project, 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; and drafting an institutional development plan for the selected companies as road maps to the attainment of WHO PQ. Onsite practical technical assistance will be provided to the selected companies.
This project is by far Nigeria’s biggest pharmaceutical intervention and will achieve the first ever WHO PQ of pharmaceutical companies in Nigeria. It will have a tremendous impact on the Nigerian health system and build national capacity for sustainable manufacturing, as well as position the pharmaceutical industry in Nigeria as a global competitor.
It is noteworthy that achieving WHO PQ also requires close collaboration with well-functioning National Medicines Regulatory Authorities (NMRAs) to provide the required approvals and ongoing oversight for continued regulatory compliance that are prerequisites for WHO PQ. In line with this, Bloom Public Health has also partnered with Biotech Training Facility, Netherlands, to establish the African Vaccine Academy (AVA). The AVA will support the training of regulatory personnel to fill critical knowledge gaps and create a critical mass of regulatory experts for African NMRAs.
In Conclusion: WHO PQ will create huge public health and economic impact in Nigeria by ensuring an increased availability of quality, efficacious and safe medicines and reducing reliance on imports for public health interventions. Therefore, this ongoing initiative by NIPRD and Bloom Public Health is a golden opportunity that Nigerian pharmaceutical companies must leverage on to increase their capacity for local manufacturing and strengthen Nigeria’s pharmaceutical sector.
