Regulatory crackdown on stem cell therapy: What would the position be in South Africa?

摘要

This article attempts to answer the question of whether stem cell therapy falls within the current South African regulatory framework, using the Regenexx case in the USA as an example. The USA regulator, the Federal Drug Administration (FDA), is seeking to regulate the Regenexx autologous stem cell therapy as a 'drug' and a 'biological product'. The opposing position taken by the inventors of the Regenexx therapy is that re-implantation of one's own body parts can in principle not be a 'drug' and that the FDA is exceeding its mandate. In this article arguments are presented that the Regenexx therapy would qualify as a 'biological medicinal product' in the South African regulatory framework established in terms of the Medicines and Related Substances Control Act. As such, the Regenexx therapy would be subject to registration with the Medicines Control Council (MCC) as a legal precondition for its commercialisation. Furthermore, in order to convince the MCC of the safety, efficacy and quality of the Regenexx therapy, such therapy must - similar to any other new medicine - first be subjected to clinical trials. It is therefore concluded that stem cell therapy is indeed comprehensively regulated in South Africa, and that a recent opinion expressed in this journal that there exists a 'legislative vacuum' with relation to the regulation of stem cell therapy in South Africa is plainly incorrect.