European Law and New Health Technologies

Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money.

All European governments regulate their development, marketing, and public financing - as do several European level institutions, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so through traditional ‘command and control’ legal measures, guidelines, soft law, ‘steering’ through redistribution of resources and private or quasi-private regulation.

This project analyses European law - in this broad sense - and its relationships with new health technologies. It uses interdisciplinary insights to shed new light on defining features of the relationship and especially risk, rights, ethics and markets. The project explores the way in which European law’s engagement is to be legitimated, and some of the implications for citizenship.

With the roles of risk, rights ethics and markets as our focus, and looking across the project we conclude there are a variety of relationships between European law (in its broad sense) and NHTs, as conceived by the contributors in the substantive chapters of the book to be published. Overall we can say that markets have a very important – perhaps the most important – role as being central, certainly to EU engagement with NHTs, but given the centrality of markets, also to the way in which the rights, especially from the European Convention, but also eg from the European Patent Office relate to NHTs. Broadly speaking it appears that risk, rights, ethics and markets often overlap. Risk tends to operate as a key support for markets in that assurances of product/process safety help to maintain the consumption of NHTs. Rights and ethics might sometimes appear to act as countervailing forces to markets, but they also help to legitimate and provide further assurances as to the quality and safety of NHTs. Right, rights, ethics and markets work together to produce legitimacy for European law’s engagement with NHTs. The operation of European law, and the dominance of markets, raises significant legitimacy concerns for notions of European (and national) citizenship, including ‘biomedical citizenship’.



Although traditional ‘command and control’ regulatory strategies play a strong role in the production, development and dissemination of NHTs, the project points to the importance of future legal scholarship paying attention also to the significant ‘new governance’ and policy contexts in which such ‘hard law’ takes effect. The project also indicates the importance of interdisciplinary methodologies – especially those bringing together insights from law, regulation theory and STS – to enrich understandings of the relationships between European law and NHTs.