Regulation and governance of tissue- and cell-based therapies in Europe: Ethical controversy and the politics of risk
As I described at the beginning of Chapter 1, the sourcing of human biological materials for use in research and health treatments raises issues relating to the circumstances of the procurement (for example. donor selection, consent), the processing of those materials – whether as whole organs or divided into smaller parts (tissues and cells) – quality and safety (free from contamination), storage of the materials (for example in a tissue bank) and distribution. Additionally, the application of industrial processes and commercialization of tissue-based technologies raise controversial ethical issues relating to the ‘commodification’ and exploitation of human tissue. These complex exchange relationships within ‘tissue economies’ have been a focus of increased regulatory activity at national and international levels (Faulkner et al. 2006, 2008, Kent et al. 2006b). Biotechnology innovation has created new possibilities for the use of human tissues and cells and is associated with the emergence of new regulatory institutions and instruments (Brown et al. 2006a). This chapter examines the relationship between regulation and innovation and how new regulatory institutions and instruments have developed in the EU that govern the production and use of tissue-and cell-based therapies.