Meeting the standard : an overview of European biobank regulation and a comparison to the current South African position

Abstract

Due to the fascinating new developments in biomedicine such as stem cell therapy and tissue engineering, contemporary medicine is moving away from being a reactionary process to being a process which focuses on the maintenance of health by being personal, predictive, preventative and participatory.1 This means that medicine is moving away from the traditional forms of treatment, to a point where treatment and experimentation almost merge, and thus it is also moving away from the known forms of regulatory frameworks and mechanisms. In fact, the proper and best method of regulating biomedicine is uncertain and will be subject to a process of trial and error for many years. This is true on a global scale and also on a local South African one. This regulatory process is also slowed down and delayed to some extent while each role player, be that an authority or institution or practitioner or researcher or even country, attempts to solve all the issues individually since this leads to a nonconformist and confusing mass of incoherent binding and nonbinding legal and ethical documents, guidelines and rules. This in turn hinders sharing of information, data and ultimately knowledge and subsequent development.2 A uniform system would encourage and facilitate sharing and this would lead to collaboration and better and faster development of biomedicine.