Legal requirements for drug testing in children in Germany.

Since 1966 the problem of evaluation of drugs for use in man has increasingly become the subject of both international and national consideration. It was generally felt, that there is a need for a special protection for children being the subjects of the clinical evaluation of drugs. A new impulse with regard to the protection of children was recently set by the Council for International Organizations of Medical Sciences. German legislation has included these international convictions and recommendations pertaining to the performance of clinical trials. Articles 40 and 41 of the German Drug Law of 1976 are an emanation of WHO principles as well as of the Declaration of Helsinki. These articles include special provisions for the protection of children as volunteers of clinical trials, because clinical trials in children are indispensable for research on diseases of children. It is laid down in the Law that children should never be subject of research that might equally well be carried out on adults. The willing cooperation and, as far as feasible, consent of the child and its custodians has to be sought. The German Law provides that trials in healthy children may take place only with regard to diagnostic and prophylactic drugs, not with regard to the therapeutics. Article 41 of the German Drug Law permits the clinical evaluation of drugs in ill children. Therapeutic drugs may, however, be tested in children only under the condition that the drug is determined to cure the special disease under which the child is suffering. Special aspects of the clinical evaluation of drugs in children, not contained in the law, need further discussion and clarification.