News - September 15, 2023
European Parliament adopts substances of human origin (SoHO) text
On 12 September 2023, the European Parliament adopted the report on new rules governing the use of so-called substances of human origin (SoHO) intended for human application. The Council still needs to adopt its official position, with the Spanish Presidency hoping to kick off Trilogues by the end of its mandate in December 2023.
The report aims to improve the safety and quality standards for both donors and recipients of blood, plasma, skin, embryo, sperm, and corneas, as well as breast milk and microbiota. As the rapporteur on the file, Nathalie Colin-Oesterlé (FR, EPP), stated in her opening remarks, “This regulation is of great importance for the health and well-being of millions of EU citizens who benefit from blood transfusions, medical-assisted procedures and other applications of SoHOs.”
Parliament’s position also improves coordination between authorities responsible for collecting and handling blood, organs and tissues, and seeks to create better autonomy for the bloc, building up local and regional collections and reducing the EU’s dependency on countries like the U.S. for plasma donations.
EUCOPE’s key points following the plenary vote
Voluntary Unpaid Donation
The plenary vote confirmed the position of the ENVI committee on most of the key issues. MEPs demanded that the donation of those substances should always be voluntary and unpaid, with donors able to receive compensation or reimbursement for losses or expenses related to the donation process. They stress that compensation should not be used as a way to recruit donors or result in the exploitation of vulnerable people.
There is a concern that based on the text adopted by the European Parliament, countries like Germany, Austria, Hungary and the Czech Republic – which currently allow plasma donors to receive a fixed-rate allowance – would not be able to do so anymore as amendments proposed by the EU Parliament permit donor compensation only for ‘quantifiable’ losses.
Patient Blood Management (PBM)
The EU Parliament has adopted a recital, Recital 37 b (new), which acknowledges and explicitly calls out PBM. This was a key ask from EUCOPE, and the amendment reflects some of the messaging delivered by EUCOPE. This opens the door for further action on PBM at the national level, with a reference to EU legislation codifying the concept.
SoHO Coordination Board (SCB)
Based on internal discussions, we understand that the EU Parliament decided not to include the amendments concerning borderline products with substances of human origin (SoHO) and limit the references to products covered by other Union Acts in the SoHO Regulation. The discussions around borderline and distinguishing medical products would be captured as part of the pharmaceutical package. Amendments to this effect have already been prepared by EUCOPE and its Alliances, thus, this issue will be addressed through our ongoing advocacy. Regrettably, however, no reference was made to microbiota and its context vis-à-vis SoHO Preparation.
With the European Parliament’s position adopted, we must now await the Council position, which is expected in December 2023 or January 2024, after which Trilogues can begin. EUCOPE will continue to monitor the developments at the Council level.