An Evaluation of the Regulatory Environment in South Africa: Improving the Review Process and Patients' Access to Medicines

Abstract

National regulatory authorities (NRAs) are responsible for the evaluation of medicines and for ensuring that only those products which meet the requirements of quality, safety and efficacy are registered and made available to patients. The NRAs are required to effect such regulatory mandates efficiently and ensure timely patients’ access to medicines. Many NRAs, especially in resource-limited settings or emerging markets face challenges in fulfilling these mandates as resources are stretched to capacity. Adopting a risk-based approach to medicine evaluation can provide relief for NRAs striving towards improved regulatory performance. The NRAs may implement facilitated regulatory pathways, appropriate frameworks for benefit-risk (BR) assessment and abridged review processes in order to leverage reliance mechanisms and good regulatory practices to improve regulatory efficiencies.

The aim of this research was to evaluate the regulatory environment in South Africa with a view to improve the review process for medicines and to ensure their timely access by patients. This was achieved through a review of the legislative framework and historical context supporting the new regulatory environment in South Africa and the transition from the Medicines Control Council (MCC) to South African Health Products Regulatory Authority (SAHPRA). The regulatory performance of the South African regulatory authority and how it compared to that of other agencies was evaluated and the strategies supporting enhanced BR assessment and reliance mechanisms were appraised.

Various methodologies were considered in determining an appropriate study design and a mixed method approach, including a combination of self-administered questionnaires, focus groups and a case study, was adopted to support achieving the study objectives. A questionnaire was used to evaluate the review process of the MCC and the results demonstrated that the MCC was not able to meet target timelines for the review of new active substances (NASs). A comparison was made between the MCC and other similar NRAs using the same questionnaire. The results indicated that the MCC had similar requirements to other agencies and all the NRAs conducted a full assessment of applications for the registration of NASs. However, the approval times for the MCC were considerably longer. Further investigation into these lengthy timelines resulted in the analysis of the performance metrics of the MCC between 2015-2017 and of SAHPRA in 2018. A case study approach and focus group were used to evaluate strategies for enhanced communication of BR assessments and a questionnaire and two focus groups were conducted to understand the implications of the application of an abridged review in the evaluation of NASs. The results of these studies culminated in the development of a proposed improved model for the regulatory review process of new active substance (NASs) for SAHPRA.

This programme of research has presented, in a seminal piece of work, key recommendations for the improvement of the regulatory review process as it may be applied by SAHPRA. The results from this work provide, for the first time, a baseline against which future improvements, implemented by SAHPRA, may be measured. The implementation of these recommendations will contribute towards an enhanced regulatory performance, underpinned by good regulatory, good review and good reliance practices. This will result in a stream-lined review process, improved regulatory responsiveness, consistency, transparency and accountability and ultimately patients’ timely access to medicines.