Alternative Rule-Making within European Bioethics – Necessary and Therefore Legitimate?

There are two core principles in the law and ethics of biomedical research that could be considered universally accepted: first, all handling of personal data and human biological samples is conditioned by the informed consent of the individual involved; second, all medical research on human biological samples and personal data should be placed under the review of research ethics committees. These concepts are included in international, regional and national guidelines, rules and regulations for processing of data and biobanking. However, the legal implementations are carried out within each national legal order, by national organs enacting administrative decisions applicable within the state. In order for the research project to function in a multinational setting, the EU has developed soft law tools and governance mechanisms to facilitate European biomedical research. The question is whether this can be considered valuable and legitimate on the grounds of enhancing conditions for medical research.