Alicia FitzgeraldDie Spende von Frauenmilch – von der Gewinnung bis zur Verabreichung

About this book deutschenglish

Despite the medically evident benefits for premature and newborn babies, its widespread use in everyday neonatology and its long tradition, breast milk donation lacks special legal regulations, as well as legal evaluation through case law and literature.

The existing legal uncertainty in Germany prevents those involved from the politically desired and, in order to reduce postnatal mortality, necessary nationwide expansion of breast milk donation.

As the first comprehensive scientific treatise, this work therefore deals with the classification of the legal qualification and regulatory framework of breast milk donation.

In view of the fact that, due to its nature and its nutritional and health-promoting effects, human milk touches on the definition of numerous regimes, the legal nature of human milk is examined in detail and the obligations of human milk bank operators arising from it are outlined. The work critically examines whether and at what levels the application of food law to the human substance is appropriate.

It will also be examined whether there is comparability with the blood donation regulated in the TFG at the level of collection and administration - particularly with regard to infection risks, the legal interests of donors and recipient infants and resource-conserving handling. Are some transfusion law regulations to be applied analogously?

Fortunately, the EU has now recognized the need to regulate the donation of human milk and has addressed this by adopting Regulation (EU) 2024/1938 for all “Substances of Human Origin”, which will come into force in mid-2027 and is briefly described in the appendix of this publication. The regulation will harmonize and tighten safety and quality requirements for the handling of human substances throughout Europe by means of complex regulations. In many respects, the content of the regulations coincides with the obligations set out in the dissertation.