The European Group on Ethics (EGE) acknowledge the promises nanomedicine offers to healthcare by applications in diagnostics, treatment and preventive methods. They insist on imposing adequate safety measures, stimulating public participation and prospective technology assessment and research on ethical, legal and social implications of nanomedicine. Public participation should be stimulated by opinion surveys as well as academic and public debates on problems and possibilities of present and near-future nanomedicine. The EGE expects the current legal framework to be adequate in principle for governing nanomedicine. These regulations may have to be adapted to accommodate specific properties of nanomedicine products. Policy makers will have to investigate applications falling under overlapping regulations. The EGE calls for comparative research on intellectual property rights and nanomedicine, especially concerning the balance between knowledge protection and information dissemination.

The opinion extensively reviews the state of the art of nanomedicine, the legal background at EU and global level and problems and concerns of ethics, governance and policies. They explicitly address toxicology and human health, bioethical questions and social ethics. EGE adopts the definition of nanomedicine coine by the European Science Foundation (ESF): The science and technology of diagnosing, treating and preventing disease and traumatic injury, of relieving pain, and of preserving and improving human health, using molecular tools and molecular knowledge of the human body. Nanomedicine development should be governed by existing fundamental values and rights as stated in many European and

international documents. Safety should be safeguarded by the competent authorities and institutes through proper risk assessment, overviewing the safety and security aspects of nanomedicine and capacity building for addressing accidents. Risk assessment should be carried out before market introduction of nanomedicine products. Policy makers should examine if existing regulations should be amended to this end, especially for nanocosmetics. Safety, security and social implications including in developing countries of nanomedicine should be examined by prospective technology assessment, not just post-factum. The EGE addresses legal issues, especially the impact of nanomedicine on shifting the balance between knowledge protection and information dissemination and the interests of industry versus developing countries. The availability of nanomedicine tests, information and consent in clinical trials, economics and research funding, communication and public trust, and medical as well as non-medical uses are also addressed. The EGE proposes a number of measures including a webportal on ethics of nanomedicine, stimulating nanoethics research and networking and a database to stimulate information sharing. The opinion will have to be revised within five years.