The EU Commission on Thursday proposed new rules for donating and receiving vital substances of human origin. In addition to blood, this should also include tissue, 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 should be made easier and uniformly high quality and safety standards should be guaranteed. The new rules are intended to replace guidelines from 2002 and 2004 respectively.
Since then, on the one hand, new threats from infectious diseases have arisen, on the other hand, the technologies for processing blood, tissues and cells have advanced, the EU Commission announced. In addition, the health protection of donors has not been sufficiently taken into account and the specifications have not been applied uniformly throughout the EU.
Breast milk also affected
The new proposal will cover all substances of human origin except solid organs. Among other things, the rules are to be extended to breast milk. Donors and recipients of transfusions and transplants, for example, as well as offspring from artificial insemination, should also be better protected. National supervisory authorities are to be supported by the EU with training, for example. Innovations are to be promoted by creating a “common procedure for the assessment and approval” of preparations made from human substances. All bodies that are relevant to the safety and quality of the preparations will have to register in the future.
Parliament and states advise
Now the EU Parliament and the EU states have to agree on a position on the EU Commission’s proposal before they can negotiate a common line.