Gruppennützige klinische Arzneimittelprüfungen mit einwilligungsunfähigen volljährigen Patienten

In the face of the continuing increase in sufferers of dementia and the insufficient ways of treating this condition at the moment and despite vehement criticism, German legislators have decided to allow the conducting of medical tests for the benefit of sufferers of the same medical condition on groups of people who warrant protection to be extended to adult patients who are unable to consent to such tests through the fourth amendment to the German Medicine Act (AMG). This proposed reform does not only pose ethical but also numerous legal problems. In particular, through their decision the legislators are justifying such tests by equating the test subject’s anticipated consent with a patient’s decree. In this study, the author addresses, among others, the questions of what requirements need to be stipulated in terms of medical consultation before consent to the administering of such tests is established, how specific or definite that consent must be and what action should be taken if a subject who is unable to give their consent to such tests is innately opposed to them.