A comparative assessment of the legislative and regulatory frameworks for local manufacture of vaccines in South Africa and Egypt

Abstract

Healthcare systems in low-and middle-income countries in Africa are highly dependent on immunisation programmes and the availability of vaccines to manage infectious disease outbreaks and, together with clean water and access to health care, serve as the cornerstone of prevention. A dependable supply of quality vaccines is crucial in maintaining a country’s health care needs. Local manufacture of vaccines in Africa is vastly inadequate to meet the healthcare needs of the continent. South Africa, like most low-and middle-income countries, is highly reliant on external supplies of vaccines to meet its healthcare needs. This makes the health care system extremely vulnerable during public health emergencies and pandemics. A well-developed policy, legislative and regulatory framework is crucial in supporting local vaccine manufacturing activities. The study investigated the framework that currently exists for local vaccine manufacturing in South Africa in comparison to Egypt as a similar middle- income country with a rapidly advancing local vaccine manufacturing industry. The comparative analysis enabled the formulation of strategies and recommendations to overcome barriers to local manufacturing of vaccines in South Africa. A qualitative study utilising comparative content analysis, was used to compare the policy, legislative and regulatory frameworks in South Africa with that of Egypt. The study found that South Africa and Egypt have adopted vaccine policies of the African Union. South African legislation is well developed with the relevant regulations to support local vaccine manufacturing. Detailed guidelines for vaccine manufacturing activities are present in South Africa and Egypt that are aligned with international regulatory bodies. The South African Health Products Regulatory Authority has established itself as the frontrunner for regulatory harmonisation in Africa. Strong collaboration between national regulators and vaccine manufacturers is needed. National Regulatory Authority harmonisation on the African continent is the cornerstone for supporting the local vaccine manufacturing industry.