Human tissue legislation in South Africa: Focus on stem cell research and therapy

Abstract

The South African (SA) legislative framework follows a hierarchical structure aligned with the relevant level of government (national, provincial or local) responsible for applying and monitoring the legislation, with the overarching and progressive Constitution as the supreme law. Delegated legislation (also known as secondary or subordinate legislation, e.g. regulations) ‘adds flesh’ to Acts of Parliament, or other forms of original legislation. The control and use of human tissue in South Africa is primarily governed by the National Health Act and relevant regulations, although other national acts, in differing degrees, are also relevant to this complex field. These include, among others, the Medicines and Related Substances Act, the Consumer Protection Act, the Children’s Act and the Inquest Act. Regulations generally only require ministerial and not parliamentary approval and are therefore (theoretically) easier to amend. In principle, the drafting of Acts should be preceded by policy documents, which contain broad foundational guidelines or a statement of intent in the area in question. Another useful source in the interpretation of legislation, albeit not officially recognised as legislation, is guidelines (sometimes referred to as standards), that may provide greater granularity than the regulations. Although neither policy documents nor guidelines are directly legally binding, a lack of compliance with the latter may have legal significance. In this article, the components of the hierarchical structure relevant to the legal regulation of human tissue in SA will be examined, with a specific focus on stem cell research and therapy. A critical analysis of the accuracy, relevance, redundancy and completeness (or lack thereof) of these components will be provided. Furthermore, recommendations outlining the procedures that should be undertaken to remedy the inadequacies of the current legislative framework will be suggested. Given the well-defined structure of this framework and the relative youth of human tissue legislation in SA, the legislator has an opportunity to mirror the values and principles embodied in the Constitution by addressing these inconsistencies, and in the process develop a globally-applicable and appropriate legislative model in the fields of stem cell research and therapy.