The European Commission on Thursday proposed new rules for donating and receiving vital substances of human origin. In addition to blood, this should also include tissues, cells, or breast milk.
New quality and safety standards
“The aim is to give more patients across the EU access to the treatments they need, regardless of where they live,” the European Commission said. The cross-border exchange of therapies must be facilitated and uniformly high standards of quality and safety must be guaranteed. The new rules are intended to replace the 2002 and 2004 guidelines, respectively.
Since then, on the one hand, new threats of infectious diseases have emerged, on the other hand, blood, tissue and cell processing technologies have advanced, announced the EU Commission. Furthermore, the protection of donor health was not sufficiently taken into account and the specifications were not applied uniformly across the EU.
Breast milk also affected
The new proposal covers all substances of human origin, except solid organs. Among other things, the rules should be extended to breast milk. Donors and recipients of transfusions and transplants, for example, as well as offspring of artificial insemination, must also be better protected. National supervisory authorities should be supported by the EU with training, for example. Innovations should be promoted through the creation of a “common procedure for the evaluation and approval” of preparations made from human substances. All bodies relevant to the safety and quality of the preparations will have R in the future.
Parliament and states advise
Now, the EU Parliament and EU states need to agree on a position on the EU Commission’s proposal before they can negotiate a common line.