EU Council reaches negotiating position on substances of human origin

The Council of the EU approved on Wednesday (25 October) its position on the revision of safety and quality standards of substances of human origin (SoHO), which has been welcomed by patients’ associations and parliamentarians.

The future SoHO regulation aims to better protect donors, recipients and children born after medically assisted reproduction (MAR) and to provide more flexibility to keep up with future scientific developments.

“Through this new regulation, we will create more harmonised and flexible provisions, strengthening the already existing system and making it future-proof,” José Miñones Conde, the health minister of Spain, which currently chairs the EU Council, said in a press release after the agreement was reached.

The text updates the current legislation, set more than 20 years ago, adding breast milk and intestinal microbiota to the list of SoHO that already includes blood, plasma, skin, embryo, sperm, and corneas.

“Up-to-date and high safety and quality standards for blood, tissues and cells are essential in order for citizens to have confidence in their health care systems,” Conde said.

The text also ensures the EU’s autonomy of these substances so that European patients do not lack them, by creating a platform common to all member states for monitoring and information sharing.

“The EU SoHO Platform, a new common IT platform to register and exchange information on related activities, will be a crucial digital tool for the effective implementation of the new framework,” said the Council.

According to the European Commission, 25 million units of blood are transfused every year and Europe imports 40% of the blood needed.

During the same period of time, 165,000 babies are born with MAR, 4,500 cornea transplants are carried out to restore sight, and 2,000 skin transplants are done to treat burn injuries.

Controversy over compensation

The Council also agreed on the voluntary unpaid donation (VUD) system to compensate donors, sticking with the Parliament and Commission’s proposal. In other words, donors can be compensated for their donations, but they cannot earn or lose money when doing it to avoid financial motivation or exploitation of the human body.

“The principle of voluntary and unpaid donation is also stressed in the compromise text, in order to safeguard this important principle,” the Council said in the press release.

The proposal for regulating standards of quality and safety for SoHO was presented by the Commission on 19 July 2022.

The European Parliament gave the green light to the new SoHO deal on 12 September at a plenary session in Strasbourg, after agreeing on the most controversial point of the text: the compensation of the donors.

Back in July, Spanish socialist Nicolás González, a shadow rapporteur of the file, told Euractiv after the vote on the report in the Parliament’s health committee that the “priority has been to maintain the altruistic character of the donations and we believe that this has been achieved”.

French MEP Nathalie Colin-Oesterlé (EPP) said the Parliament’s priorities are enhancing the safety of donors and recipients, securing supplies, encouraging the development of innovative medical techniques and facilitating the circulation of substances in Europe through better coordination.

“I welcome the adoption of the Council’s general approach today. As rapporteur, I look forward to starting negotiations with the member states by reaffirming Parliament’s priorities,” she told Euractiv.

Positive reactions

Patients’ associations also welcomed the text adopted by the Council.

“The Council acknowledges the need for flexibility, recognising the diversity of national healthcare systems, and the importance of maintaining and putting in place models and infrastructure that would be most efficient for member states to increase plasma donations,” Maarten van Baelen, executive director of the Plasma Protein Therapeutics Association, told Euractiv.

European Blood Alliance was also “very pleased” that the Council agreed its negotiating mandate. “This ensures the EU stays on track to adopt the regulation before the end of this European Parliament’s mandate in June 2024,” the EBA told Euractiv.

Discussions on the final text with EU lawmakers will start on November 6. The Spanish EU Council Presidency hopes to find a provisional deal before the presidency ends on 31 December.

[Edited by Zoran Radosavljevic]