Hosted by the NanoMed Round Table and STOA, the specially organised seminar made recommendations in all key areas - Applications, Health-Economic Impact, Patient Needs, Regulatory, Ethics and Communication Issues – with a view to enabling EU policy makers to ensure fast translation of R&D results into clinical applications in what has already been identified a major area for strategic investment in the new Framework 7 programme.
The call for action is based on the findings of three European Commission funded projects – NanoMed Round Table and EuroNanoBio - and the Nanomedicine European Technology Platform which during 2009 gathered information and advice from more than 100 leading experts from academia, industry, regulatory agencies and patient organisations throughout Europe to build the most comprehensive picture to date of the nanomedicine sector.
According to Prof Sir John Beringer, Chair of the Nanomed Round Table, the free exchange and sharing of information and the mutual involvement of the many experts in these and other national and European projects has provided a solid basis for making recommendations for the successful and sustainable competitiveness of nanomedical research and development in Europe and of its healthcare industries.
"Nanomedical applications are not just a theoretical possibility – for example, the Round Table has identified forty-five products that are already on the market. However, the field of nanomedicine is still a relatively new one. This means that Europe is at an ideal moment to consider the impacts and consequences of nanomedicine, as well as action required as a result. We believe that action must be taken as soon as possible. By doing too little or too late or nothing, we would significantly risk hindering or even blocking the development of nanomedicine in Europe to the detriment of European research and development, its healthcare industries, and, most importantly, patients - which includes all of us."
The key recommendations are
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 EMA to make decisions on early interventions and national authorities to make reimbursement decisions.
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.
Patients' Needs – 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.
Communication – The European Commission should provide credible and accessible sources of balanced information about nanomedicine, to facilitate understanding and dialogue.
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.