title: [Critique of compulsory responsibilities of insured persons in endangerment according to the therapeutic drug law].
abstract: The authors discuss the 5th amendment of the law which regulates the application of therapeutical drugs in Germany (Arzneimittelgesetz), regarding the probands' insurance according to section 40 (3), from the viewpoint of the ethics committee of the Medical Chamber of Rheinland-Pfalz introduced under State (Land) law to protect patients and probands. The authors criticize a number of regulations which might have disadvantages for patients and probands in the case of damage (injury), after they have participated in therapeutical drug trials for the benefit of the general public and by taking a certain personal risk. To overcome these problems, specific proposals for the improvement of the law are being made.
authors.affiliation: Aus der Ethikkommission der Landesärztekammer Rheinland-Pfalz.
authors.forename: C
authors.initials: C
authors.lastname: Rittner
authors.forename: J
authors.initials: J
authors.lastname: Schaper
authors.forename: I
authors.initials: I
authors.lastname: Wessler
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D017041:Ethics Committees; D005104:Expert Testimony / Q000331:legislation & jurisprudence*; D005858:Germany; D006801:Humans; D010344:Patient Advocacy / Q000331:legislation & jurisprudence*