Autologous Stem Cell Therapy: An Analysis of the South African Regulatory Regime

Abstract

This article analyses the regulation of autologous stem cell (ASC) therapy in South Africa. The analysis is structured in three parts: In the first part of the analysis it is argued that ASC preparations qualify qua registrable medicine in the subclass of biological medicine within the regulatory framework established by the Medicines and Related Substances Control Act (Medicines Act). In the second part of the analysis it is argued that ASC therapy is indeed subject to regulation, primarily in terms of the regulatory framework established by the Medicines Act that effectively requires an ASC therapy to pass the rigorous test of clinical trials before it may be prescribed or supplied to a patient. It is further argued that there exist various layers of additional regulatory rules – some from the regulatory framework established by the Medicines Act and some from the regulatory framework established by the Human Tissue Act – pertaining to the harvesting, storage and preparation activities of the ASC therapy process. In the third part of the analysis a possible human rights challenge to the regulation of ASC therapy is explored: an argument is developed that employs the right to control one’s own body to argue for special exemption of ASC therapy based on its autologous nature that differentiates it from mass-produced medicine. With reference to case law, it is argued that such challenge will fail. Finally, it is argued that the system of clinical trials that is core to the current regulation of medicine in general and ASC therapy in particular is aligned with human dignity. It is therefore concluded that ASC therapy is not only comprehensively regulated in South Africa, but also that the current regulatory regime is for the public good and aligned with our country’s commitment to human rights.