Legal regulation of medical research involving minors in Germany
Germany does not currently have any comprehensive special statutory regulations governing research on human beings. Special laws are in place, first and foremost, for the clinical testing of pharmaceuticals (Medical Products Act - AMG) and medical devices (Medical Devices Act - MPG). With the Fourth Law on amendments of pharmaceutical and other regulations of December 20, 2016, the Regulation (EU) No. 536/2014 ("on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC"), which was adopted by the European Parliament and the Council of the European Union on April 16, 2014, was transposed into national law. This new EU regulation replaced the previously applicable Directive No. 1901/2006.
The following laws and ordinances contain the pertinent provisions on human experimentation:
Gesetz über den Verkehr mit Arzneimitteln - Arzneimittelgesetz - AMG [Medical Products Act], especially §§ 40–42a. Online Version
Gesetz über Medizinprodukte - Medizinproduktegesetz - MPG [Medical Devices Act], especially §§ 20–21. Online Version
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Online Version
Regulation (EG) No. 1901/2006 of the European Parliament and oft he Council of 12 December 2006 on medical products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Online Version
Fourth Law on the amendments of pharmaceutical laws and other regulations of 20 December 2016. (German) Online Version
More details concerning the legal situation in respect of research involving minors cf. Michael 2004 and Magnus 2006; in 2007 Sprecher presented a survey with regard to comparative law (Germany, Switzerland, European and international law):
Michael, N. (2004): Forschung an Minderjährigen. Verfassungsrechtliche Grenzen. [Research involving minors. Limits of constitutional law.] Berlin: Springer (Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim 19. [Publications of the institute for German, European and international medical law, public health law and bioethics of the universities of Heidelberg and Mannheim 19.]).
Magnus, D. (2006): Medizinische Forschung an Kindern. Rechtliche, ethische und rechtsvergleichende Aspekte der Arzneimittelforschung an Kindern. [Medical research involving children. Legal, ethical and other aspects with regard to comparative law in medicinal product research in children.] Tübingen: Mohr Siebeck (Studien zum ausländischen und internationalen Privatrecht 170[Surveys about foreign and international private law 170.]).
Sprecher, F. (2007): Medizinische Forschung mit Kindern und Jugendlichen nach schweizerischem, deutschem, europäischem und internationalem Recht. [Medical research involving children and adolescents on the strength of Swiss, German, European and international law.] Berlin: Springer (Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim 29 [Publications of the institute for German, European and international medical law, public health law and bioethics of the universities of Heidelberg and Mannheim 29.]).