Regulatory challenges relating to tissue banks in South Africa: Impediments to accessing healthcare

Abstract

The demand for human tissue in the medical context has increased rapidly since the early 1980s, when the use of human bone in allografts in orthopaedic surgery became the norm. During the 1990s, the demand for human tissue turned towards tissue-engineered products in the field of regenerative medicine. Tissue engineering, as an established and growing interdisciplinary field comprising different specialties, such as medicine, materials science, cell biology, genomics and chemical engineering, aims to develop biological substitutes to restore, maintain or improve tissue function, thus offering patients the chance to regain normal functionality in their bodies. The purpose of this article is to explore some of the gaps that exist in the current regulatory framework that governs tissue banks in South Africa (SA), and to make certain recommendations aimed at closing these gaps. The discrepancies and gaps cause confusion and may lead to undesired and unforeseen consequences regarding the use of human tissue, as well as prejudice the welfare of patients in SA.