Regulating human genetics: The changing politics of biotechnology governance in the European Union

Human genetics poses new political issues for the governance systems of the EU and, in so doing, graphically illustrates the regulatory problematic of innovative health technologies (IHTs). Civil society, industry and the scientific community are registering new, and conflicting, political demands on the governance policy community of the EU. At the same time, the traditional reliance of that community on technocratic networks as the mainstay of policy formation and implementation is no longer a sufficient mechanism for maintaining the legitimacy of the process. New policy networks imbued with different value systems are rapidly making inroads into the previously impermeable policy community of EU governance. Recognising the limitations of the existing means for securing agreement to regulatory change, the institutions of the EU are adapting their stance, or stances, and seeking new methods of engagement both with the expanding numbers of NGOs in the human genetics arena and the public at large. To an extent, there is institutional competition between the departments of the European Commission, the Council of Ministers and, most particularly, the European Parliament for pole position in the business of policy agenda setting. Fuelled by the regulatory difficulties already experienced in biotechnology by GM foods and GM crops, that competition is rapidly causing a sea-change in the political culture of governance policy making at EU level.