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Today's clinical trials lead to the therapies of tomorrow; without these we would have no safe and efficient treatments. Conducting clinical trials involves adherence to a number of strict rules (established in the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use," E6), including the obligation to obtain informed consent from each participating individual. However, obviously there are several groups of patients who are not able to give consent. The European Directive 2001120/EC of 4 April2001 states that these subjects can be included in a clinical trial only if informed consent of the patient's legal representative can be obtained. This is especially relevant for patients in intensive or emergency care medicine. It is obvious that a legal representative cannot be produced or consulted in these patient groups. However, no proven diagnostic or therapeutic measures can be developed for these patients without clinical trials. Instead of setting up rules to protect these vulnerable patients and their special needs the Directive does the opposite: the law prohibits research, hinders therapeutic progress, and thereby violates the Helsinki Declaration (provision 6: " ... even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research ... "). With regard to Austria the EU Directive is the cherry on top of another irritating legislation. The Austrian Medical Device Act (Medizinproduktegesetz BGBl, 1997/21, Austrian Law on Medical Devices) states that clinical trials with medical devices can be performed only if the patient has given informed consent. There are no provisions for exceptions [1]. This prevents any research being carried out in Austria that involves medical devices for emergency conditions or in the intensive care setting. It is truly disappointing that European legislation extends this unique Austrian peculiarity to drug research, neglecting values of solidarity. It is a very NEWS

The European Directive: a further blow to science in intensive care medicine in Austria