Parliamentary Assembly

Draft recommendation

1Nanotechnology is the manipulation of matter on an atomic and molecular scale. Nanomaterials involve structures having dimensions of nanometres (nm), that is one billionth (or 10-9) of a metre, typically between 1 and 100 nanometres in size. At such dimensions, materials can show significantly different physical, biological and/or chemical properties from materials at bigger dimensions, which opens up a range of new possibilities for technology.

2Nanotechnology and its myriad applications have the potential for enormous benefits (in particular in the field of “nanomedicine”), but also for serious harm. As with most emerging technologies, many risks, both to public health and to the environment, are as yet poorly understood. However, commercial applications of nanotechnology are already in widespread use. Regulations have struggled to keep up with the pace of scientific innovation.

3For years, the Parliamentary Assembly and the Committee of Ministers of the Council of Europe have been advocating the need for a culture of precaution incorporating the precautionary principle into scientific and technological processes, with due regard for freedom of research and innovation. In 2005, the Heads of State and Government of the Council of Europe gave undertakings in the Final Declaration of the 3rd Summit of the Council of Europe “to ensure security for our citizens in the full respect of human rights and fundamental freedoms” and to meet, in this context, “the challenges attendant on scientific and technical progress”.

4The Assembly believes that, in keeping with these undertakings, the Council of Europe, as the only pan-European body with a human rights protection mandate, should set legal standards on nanotechnology based on scientific knowledge and the precautionary principle, which will protect 800 million Europeans from risk of serious harm, while encouraging nanotechnology’s potential beneficial use.

5The Assembly thus recommends that the Committee of Ministers work out guidelines on balancing benefits and risks to public health and the environment in the field of nanotechnology which:

5.1respect the precautionary principle while taking into account freedom of research and encouraging innovation;

5.2allow for consistent application across borders, across the origins of nanomaterials (synthetic, natural, accidental, manufactured, engineered) and across the functional uses and biological fate of the nanomaterials under regulation;

5.3seek to harmonise regulatory frameworks, including of risk assessment and risk management methods, protection of researchers and workers in the nanotech industry, consumer and patient protection and education (including labelling requirements taking into account informed consent imperatives), as well as of reporting and registration requirements, in order to lay down a common standard;

5.4are negotiated in an open and transparent process, involving multiple stakeholders (national governments, international organisations, the Parliamentary Assembly, civil society, experts and scientists) in the framework of a dialogue which transcends the Council of Europe area;

5.5can be used as a model for regulatory standards worldwide;

5.6could first take the form of a Committee of Ministers recommendation, but could also be transformed into a binding legal instrument if the majority of member States so wish, for example in the form of an additional protocol to the 1997 Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164, “Oviedo Convention”);

5.7aspire to create an international interdisciplinary centre to be the world’s knowledge base in the field of nanosafety in the near future;

5.8will be able to promote the development of an assessment system of ethical rules, advertising materials and consumer expectations, regarding research projects and consumer products in the nanotechnology field impacting on human beings and the environment.

6The Assembly recommends that the Council of Europe’s Committee on Bioethics (DH-BIO) be entrusted with a feasibility study on the elaboration of possible standards in this area, based on paragraph 5 of the present recommendation, as a first step in the start of negotiations on the topic with a multiple stakeholder approach.