MEPs and EU ministers have reached a political agreement on new rules to improve safety for donors and recipients of blood, tissue, and cells, updating quality standards set more than 20 years ago.
ADVERTISEMENTThe deal was struck by EU lawmakers on the evening of Thursday (14 December) after a month of inter-institutional negotiations aimed at providing Europe’s healthcare system with new measures for some of the most common medical interventions such as blood transfusion, bone marrow transplants, and in vitro fertilisation.
The scope of the previous legislative framework was broadened by the European Commission from the original blood and tissue to include other substances of human origin (SoHo) such as stem cells, corneas, embryos, sperm, microbiota, and breast milk.
“The new rules will ensure that these products respect high safety and quality standards while tackling the risk of shortages and promoting greater innovation in the sector,” EU Health Commissioner Stella Kyriakides said after the deal.
The provisional agreement was made possible after hashing out the last pending issue of voluntary and unpaid donations, an open wound in the negotiations.
The voluntary and unpaid donations (VUD) principle is enshrined in the EU Charter of Fundamental Rights and prohibits the commercialisation of the human body or its parts but leaves the door open to forms of compensation for living donors.
Such compensation may involve reimbursement for loss of earnings or any other justifiable expense incurred in the medical donation procedure.
However, a definition of compensation was never established at the EU level and the main criteria for settling incentives to donate have been left to the discretion of the member states. As a result, EU countries have opted for very different implementing provisions of the VUD principle, ranging from tax benefits to paid days off work.
No payments for donors - in principle
In a bid to reduce this legislative ambiguity, negotiators on the file have established that living donors should not be provided with payments or financial incentives to donate, as a matter of principle.
However, member states will be allowed to lay down measures to compensate donors by setting transparent criteria, including through fixed-rate allowances (as already happens in countries like Austria, Germany, Czechia, and Hungary) or non-financial forms of compensation.
A principle of 'financial neutrality’ was added by lawmakers to the Commission’s initial proposal to include an upper limit to such compensation together with some guarantees that no financial gain or loss is incurred by the donor after the donation.
The negotiators agreed as a counterpoint that promotional activities supporting donations such as campaign billboards or television and press advertisements do not refer to compensation.
Lawmakers hope to fend off the risk of compensation being used as an incentive to recruit donors or lead to the exploitation of vulnerable people.
Contacted by Euronews, key sector stakeholders remained cautious preferring to wait for publication of the final text before commenting on the deal's details.
A spokesperson of the European Blood Alliance (EBA), an association representing more than 80% of the EU’s blood services, welcomed the introduction of ‘financial neutrality’ as compliant with the principle of voluntary non-remunerated donations. “If confirmed, this is very good news,” the spokesperson added.
Meanwhile, a representative of the Plasma Protein Therapeutics Association (PPTA) told Euronews that it is important that EU countries have kept the flexibility to set up a collection and compensation model of their choice.
The political deal needs to be formally endorsed by both the European Parliament and the EU Council after the necessary work at the technical level, but it is now extremely likely that will come into force before the EU elections and the beginning of the new legislative term.
