EU Adopts New Rules on Cross-Border Transfer of Substances of Human Origin

The Council of the European Union on May 27 adopted new rules on the cross-border transfer of substances of human origin, including blood, tissues and cells used in healthcare. The scope of the existing rules were expanded to include "human breast milk and intestinal microbiota" and other substances that may be applied to humans in the future.

The new regulations include steps to boost cross-border exchanges and access to these substances by establishing an EU-level coordination board for substances of human origin to support member states implementing the regulations, the council said. The measures introduce "common EU-wide procedures" for assessing the preparations of the substances and require member states to designate a national authority for the substances, it said.

Additional authorization and inspection requirements will be imposed for "establishments that both process and store, release, import or export substances of human origin," the council said. A new IT platform also will take root to register and exchange information on "related activities."

The council also said donations of substances of human origin "should be voluntary and unpaid as a matter of principle" and a "rapid alerts system" would be established to "cope with serious incidents or reactions that are likely to pose a risk for recipients or donors."

The regulations now go to the European Council and the European Parliament for signature, and will enter into force after being published in the EU's Official Journal.