From 23 – 25 March 2009, the Drug Information Association (DIA) held its annual EuroMeeting in Berlin. During the presentation by Richard Moore, Institute of Nanotechnology, I learned that prescription drugs prove to be ineffective in 30% – 60% of patients1 and that 16% of the drugs approved in the USA are linked to severe adverse drug reactions2. These figures, if confirmed, would once more justify the need for a different clinical investigation approach for pharmaceuticals and medical devices, a position which Eucomed has been defending for several years.
Also during the conference, the European Commission reiterated its opinion that we cannot wait for the modifications introduced by 2007/47/EC to take effect before taking urgent measures to recast the medical devices regulatory system. This position, which is not shared by several member states authorities, as it was apparent during the Q&A session, is of particular concern for Eucomed. Eucomed does not have, in fact, evidence of any issue which could justify the Commission’s hurry and there is an open question on what is the trigger for this position of the Commission.
– Dario Pirovano, Consultant, Regulatory Affairs, Eucomed
1 Spear, B.B. et al. (2001), Trends Mol. Med. 7, 201-204
2 H-G Xie & F.W. Frueh (2005), Personalized Medicine 2(4), 325-337