New EU regulation on human tissue and blood safety passed by European Parliament

7 months ago 37

The EU Parliament adopted new rules for the use of blood, human tissues, and other substances of human origin (24 April). The so-called SoHO regulation (substances of human origin), is an important update of directives that are more than 20 years old. The focus is on safety and security of supply.

The regulation was adopted with 461 votes in favour and 56 against. The most controversial aspect was whether there should be any form of compensation for donors.

Members of the European Parliament (MEPs) agreed that states will be able to compensate living donors, but promotion campaigns should not feature this as an incentive.

Various countries already offer fixed compensation (Austria, Czechia, Germany, Hungary), and the regulation once enacted will also allow non-financial forms of compensation.

French MEP Nathalie Colin-Oesterlé (EPP) who was the lead rapporteur said: “This law constitutes a new chapter in building a strong European Health Union […] it strengthens the national collection systems, lowering the risks of shortages, and is based on the fundamental ethical principle of voluntary and unpaid donation.”

The original directive was born out of the contaminated blood scandal where plasma donations in the US were found to have a high risk of carrying hepatitis risk. This was due in part to the fact that the US allowed financial compensation and attracted vulnerable groups such as sex workers and drug addicts to make donations.

Some of the resulting products were purchased in Europe, most notably in the UK, where there is an ongoing legal battle from those who lost loved ones through HIV or hepatitis infections at the time.

Substances included in the regulation include skin, embryos, sperm, and corneas. The new regulation also adds breast milk and microbiota for fecal transplants to treat gastrointestinal problems.

The European Blood Alliance (EBA) welcomed the parliament’s adoption, Executive Director, Peter O’Leary called it “a historic step forward for patients, donors, and all European citizens.” The main concern for EBA is ensuring safety and a resilient supply of SoHO in Europe.

The new proposals include donor registries, minimum standards of data collection, and more background checks on donor health. This is particularly important to ensure people don’t donate more than is needed.

While EBA welcomed the new requirements, they argue that national monitoring of sufficient supplies of products should be complemented by an equally robust European strategy in the near future.

They also recognise that much work will be needed at a local and national level, to implement the new rules to the agreed deadlines.

It is hoped that the Council can sign off the deal before the European elections in June.

[Edited by Rajnish Singh]