Legal tools to improve access to highly priced innovative medicines in South Africa

Abstract Objectives Although access to medicines is a basic human right, restricted access to highly priced innovative medicines is a global concern. This article explores the various ways that existing legal frameworks, such as the Medicines and Related Substances Act, the Patent Act, and the Competition Act, are used, or not, to access highly priced innovative medicines in South Africa (SA). Methods A narrative review of health and related legislation was undertaken to identify where access to medicines aspects existed, and their strengths and weaknesses in improving such access. No ethics approval was required as this was a review of public records. Key findings Various legislative instruments could possibly be used to improve access to highly priced medicines in SA. The existing legal tools have, however, not been used to their full potential to enable improved access to innovative medicines. Conclusions SA should review its patent examination and patent opposition processes, and make effective use of international trade flexibilities. Individual patient approvals for use of non-registered medicines need to be made transparent, including price information. The potential use of exclusions from the Medicines and Related Substances Act needs to be explored. In particular, the limitations of existing legislation need to be noted as National Health Insurance is implemented.