Medical Technologies and EU Law:The Evolution of Regulatory Approaches and Governance,

The regulatory evolution of medical technologies in the European Union offers a unique perspective with regard to highlighting significant elements of both European science policy and the development of European institutions, especially regarding the passage from their (primarily) economic to their political phases. Since the early 1990s, while establishing a market for biotechnology, the European Communities have been developing some policy-related visions of technoscience and its potential risks, and framing the concept of European citizenship through European values and rights. From this perspective risks do not represent a mere technical dimension, a value-free, allegedly neutral combination of science and norms. Instead, ‘regulatory science’ appears as a complex activity where facts cannot be purified of values, but require discussion and negotiation. The concept that provides an adequate account of the relationship between science, technology, law, policy and politics is co-production. According to this notion, knowledge and regulation should be looked at as processes generating and influencing each other. The medical technology analysed in this chapter, and followed throughout its regulatory history of changes and metamorphoses, is xenotransplantation (XT): the clinical use of cells, tissues and organs between species. This biomedical technique has evolved from its primary focus on organs to (what is legally defined in the European context as) Advanced Therapy Medicinal Products (ATMP), namely cell therapy, gene therapy, and tissue engineered products.