The report, which was compiled following a request from European Commission President José Manuel Barroso, recognises the huge potential that nanomedicine offers in terms of developing new diagnostic, treatment and preventive methods.
On safety, the group proposes that measures be established to verify the safety of nanomedical products and devices, and calls on the relevant authorities to carry out a proper assessment of the risks and safety of nanomedicine.
"The Group considers it necessary for appropriate safety research to be carried out and information provided to the public before medical devices and medicinal products derived from nanotechnologies are marketed," states the report, adding that, "the Group considers it paramount that no nano-based products enter the market without risk assessment, thereby securing their safety with regard to users' health."
However, while knowledge gaps remain, researchers should not be afraid of admitting their existence. "Transparency is essential for public trust," the authors write. "This also holds for openness about uncertainties and knowledge gaps."
The group recommends that there should be an EU website on ethics and nanomedicine, where citizens can find information and pose questions to researchers. Furthermore, academic and public debates should be held on the issues raised by forthcoming developments in nanomedicine.
The report also places a strong emphasis on the importance of carrying out more research into the ethical, legal and social implications (ELSI) of nanomedicine. They recommend that up to 3% of the nanotechnology research budget be set aside for ELSI research. They also call on the European Commission to set up a dedicated European Network on Nanotechnology Ethics, financed through the Seventh Framework Programme (FP7). This network would bring together experts from a range of fields, promote deeper understanding of the ethical issues arising from nanotechnology and nanomedicine, promote education in these fields and work to ensure that ethics become embedded in research practices in nanomedicine and nanotechnology.
Looking beyond Europe, the group suggests that the Commission fund a study on the social effects on nanomedicine in developing countries. "Such research should also focus on macroeconomic trends, trade implications and possible international problems, and in particular examine the risk of creating a nano-divide which could widen the gap between the developed and developing countries," the authors write.
On the legal front, the group does not believe that structures set up specifically to deal with nanomedicine are needed right now. However, they suggest monitoring existing regulatory systems to ensure they do address all nanomedical products.
The European Commission spent over 1.36 billion on nanotechnology research under the Sixth Framework Programme. The nanotechnology budget under FP7 is 3.5 billion, and around 100 million per year is expected to be allocated to projects in the field of nanomedicine.
For further information, please visit:
http://ec.europa.eu/european_group_ethics/index_en.htm
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