EU Parliament approves text on donation of substances of human origin

The European Parliament approved the revision of safe and quality standards for substances of human origin (SoHO), settling the controversy on the compensation for donors and guaranteeing the EU’s autonomy on supply.

With 483 votes in favour, 52 against and 89 abstentions, EU lawmakers on Tuesday (12 September) approved the text on the new SoHO rules, following its acceptance in the Parliament’s health committee (ENVI).

Thanks to the “crucial” draft law, substances that are currently under different legislative frameworks depending on the member states will be harmonised with better coordination and exchange of information in the EU, French MEP Nathalie Colin-Oesterl? (EPP), rapporteur for the file, said in a press release after the vote.

The proposed new rules on SoHO aim at providing both donors and patients with a future-proof and harmonised framework for transplants and donations while maintaining some limits on the supply side of these therapies.

This revision updates the current framework, set more than 20 years ago, on tissues, blood and cells.

The new document adds to the regulation substances that were not contemplated before like breast milk and microbiota, adding to the list that already included blood, plasma, skin, embryo, sperm and corneas.

All of these substances are used every day in the EU for transfusions, therapies, transplantations or medically assisted reproduction.

The Commission estimates that 25 million units of blood are transfused every year. During the same period of time, 165,000 babies are born with medically assisted reproduction, 4,500 cornea transplants are carried out to restore sight and 2,000 skin transplants treat burn injuries.

The Parliament started its work after a proposal from the European Commission published last July. The main objective is to harmonise the system for transplants and donations while setting limits on the supply side of these therapies.

The idea is to ensure that the EU is independent of the supply of these substances. For this, the Parliament has agreed to create a list of critical SoHOs and to establish a national emergency and continuity of supply plans.

During the past months of work in the Parliament, there has been one topic that has raised controversies in the discussions: how to handle compensation.

EU lawmakers have now settled that donation should be based on the principle of voluntary unpaid donation (VUD), agreeing with the Commission’s proposal.

The approved report also agrees to define ‘compensation’ as “making good of any quantifiable losses and reimbursement of expenses associated with donation” and adopts the principle of ‘financial neutrality of donation’ – meaning that no financial gain or loss will be incurred by the donor as a result.

This has been an especially thorny issue as no lawmakers or stakeholders agree on the way to go. The dilemma has been on how to ensure compensation is fair while ensuring that it does not become an incentive to recruit donors or exploit vulnerable people.

However, despite a compromise being reached in the parliament, stakeholders are still divided.

After the vote, Peter O’Leary, executive director of the European Blood Alliance (EBA) celebrated that the report strengthens “the protection of the health and wellbeing of our donors and patients”.

He added that the agreement on voluntary unpaid donation increases the resilience and continuity in the supply of SoHO.

The Plasma Protein Therapeutics Association (PPTA) considers that the report from the parliament, by setting “too restricted” rules on compensation, risks the collection of plasma.

They state that the new rules should maintain a broad and open definition of compensation, allowing member states to choose their method, always under the VUD principle.

The discussion is now in the hands of the EU institutions that will start interinstitutional conversations hoping to reach an agreement by the end of the year.

[Edited by Nathalie Weatherald]