Work package E: Legal regulations
breast milk
Currently, the classification, i.e., the legal nature of human donor milk is unclear in Germany. There are neither normative regulations nor supreme court decisions on this. Overall, it will be necessary to clarify which basic legal obligations exist for the production of safe HM and its administration within hospitals. In particular, it should be investigated whether and how supervisory authorities are to be involved in the process of donating breast milk, and whether registration, notification, approval, verification or even licensing procedures and obligations are to be fulfilled prior to the first administration of human donor milk in a clinic. In the next step, the basic outlines of the obligations for donor milk banks resulting from the identified regimes will be outlined and elaborated. Based on these findings, we will examine whether the regime opened up by the legal nature is capable of conclusively regulating human donor milk or whether there is a need for supplementation through further development of the law. The (future) legal fate as well as the need for legal regulation of the donation of HM largely depend on the current legislative developments at the EU level. In July 2022, the European Commission presented a draft of an extensive regulation on substances of human origin (COM/2022/338 final), which also includes the donation of HM. It remains to be seen whether this regulation will come into force.