Tissue-Engineered Technologies: Scientific Biomedicine, Frames of Risk and Regulatory Regime-Building in Europe

Abstract

Tissue engineering is one potential arm of the much-heralded regenerative medicine. We use the concepts of technological zone, risk framing and regulatory jurisdiction to analyse what risks are formulated in the zone of tissue engineering and whether those risks are reflected in emerging regulatory policy in Europe. In the regulatory jurisdictions of the European Union, public health risks have become increasingly important. Tissue engineering challenges pre-existing regulatory frameworks. Scientific–industrial actors formulate the risks of tissue engineering in three primary frames: technological safety risk; therapeutic efficacy risk; and economic risk. Study of the prevailing configuration of European Commission institutions and the EU process of regulatory regime-building for tissue engineering shows that risk frames are mobilized selectively. Whilst the technological safety frame and the economic frame are strongly mobilized, therapeutic efficacy—especially comparative efficacy—is not. Additionally the regime avoids any Europe-level position on the so-called ethics of sourcing and engineering tissues and cells. Efficacy and ethics are defined as the jurisdiction of national authorities, underpinned by the subsidiarity principle. Outcomes include the likely banning of certain therapeutic technologies by European countries that have objections to products deriving from controversial materials and processes, and the prevention of adoption of products due to efficacy concerns, so creating new imbalances in the European therapeutic marketplace. Consequently, the tissue-engineered medical products that European societies consume, at least in the near term, will reflect the medically defined needs of the European population to a limited and patchy extent.