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Nanomedicine ethical, regulatory, social and economic environment

Final Report Summary - NANOMED ROUND TABLE (Nanomedicine ethical, regulatory, social and economic environment)

Nanomedicine is the application of nanotechnology in medicine and healthcare at the molecular level. To put this in context, the molecules in our bodies and the structures inside our cells operate at the scale of about 100 nanometres or less - a nanometre is one-billionth of a metre. Although very promising, nanomedicine may add new dimensions to many ethical, societal and economic issues. For the promises to be realised and to achieve the maximum benefit of nanomedical innovations for everyone, the way has to be paved for a safe, integrated and responsible approach to nanomedicine. This will also be a necessary condition for the sustainable competitiveness of nanomedical research and development in Europe, and of its healthcare industry. It is therefore of primary importance to understand the possible impacts and consequences of nanomedicine in advance.

The NANOMED ROUND TABLE brought together expert stakeholders from across Europe within five working groups, each of which considered a specific field highly relevant to decision-making regarding nanomedical innovations. The working groups' key findings were as follows:

(1) Patients' needs - Our research shows that patients want nanomedicine and they want to know more about it from reliable sources. The European Commission, national governments, and trade and research associations all have a role to play in ensuring dialogue with, and information provision to patients.
(2) Ethical and societal aspects - Ethical engagement with nanomedicine needs to begin with the very concept of 'nanomedicine', a word that now groups diverse research activities together. Nanomedical researchers, physicians, patients, and policy makers will all benefit when, on the basis of philosophical and social analysis, the programme and purpose of nanomedicine are better understood and more clearly defined.
(3) Economic impact - Reliable data is needed to predict the impact of nanomedicine on healthcare costs and benefits, and market growth. This information is required to enable the EMEA to make decisions on early interventions and national authorities to make reimbursement decisions.
(4) Regulation - A proactive regulatory system is required that ensures better coordination and harmonisation of regulatory procedures, early dialogue with users and stakeholders, and takes account of the economic cost implications of regulation. Given its recently enhanced role, it seems reasonable to suggest that DG SANCO should take the lead in encouraging European level regulatory bodies to achieve this aim. At Member State level, national governments should encourage national regulatory bodies to take similar action.
(5) Communication - The European Commission should provide credible and accessible sources of balanced information about nanomedicine, to facilitate understanding and dialogue.

Nanomedical applications are not just a theoretical possibility - for example, the NANOMED ROUND TABLE identified 45 different types of products that are already on the market. However, the field of nanomedicine is still a relatively new one. This means that as this report is published, Europe is at an ideal moment to consider the impacts and consequences of nanomedicine, as well as action required as a result. The policy recommendations of the final reports of this round table exercise thus serve as a timely and substantial response to the need for genuine engagement and involvement of all the key stakeholders (public and private) in the nanomedical field in preparing the groundwork for optimised and collective decision-making at the European level.