Brussels, 27 May 2024
The Council has adopted new rules aimed at improving the safety and quality of blood, tissues and cells used in healthcare and facilitating cross-border circulation of these substances in the EU.
The Regulation on Substances of Human Origin (SoHO) will ensure better protection for donors and recipients, as well as for children born following medically assisted reproduction. The new rules aim to strengthen the existing legal framework while also increasing flexibility in order to keep up with scientific and technical developments.
Under the new regulation, member states may choose to apply stricter measures to protect their citizens.
Substances of human origin: more than just blood, tissues and cells
The text adopted today broadens the scope of SoHO to include human breast milk and intestinal microbiota. It also aims to future-proof the EU’s legislation by covering other SoHO that may be applied to humans in the future and by allowing more flexible future updates.
The regulation covers a wide range of activities from registration and testing of donors, collection and processing to human application and clinical outcome monitoring of substances of human origin.
A common EU framework
In addition to improving quality and safety, the regulation aims to increase harmonisation and facilitate cross-border exchanges and access to SoHO, including by:
- setting up an EU-level SoHO coordination board supporting member states in the implementation of the regulation
- introducing common EU-wide procedures for the authorisation and assessment of SoHO preparations
- requiring member states to designate a SoHO national authority and other competent authorities to authorise SoHO preparations and ensure independent and transparent oversight of SoHO-related activities
- setting out additional authorisation and inspection requirements for establishments that both process and store, release, import or export substances of human origin
- establishing a new common IT platform, the EU SoHO platform, to register and exchange information on related activities
Voluntary and unpaid donation
Under the new regulation, donations of SoHO should be voluntary and unpaid as a matter of principle, and donors must not be provided with financial incentives to donate. Living donors may receive compensation or reimbursement as appropriate in line with national legislation.
Vigilance, supply continuity and national plans to respond to emergency situations
The regulation also provides for a rapid alerts system to cope with serious incidents or reactions that are likely to pose a risk for recipients or donors. Member states should also make reasonable efforts to ensure the sufficient, adequate and resilient supply of critical SoHO in their countries, including by drawing up national emergency plans, including measures to respond to critical shortages.
Next steps
The regulation will now be signed by both the Council and the European Parliament. It will then enter into force following publication in the EU’s Official Journal.
Background
The existing directives on bloods, tissues and cells were adopted in response to the transmission of communicable diseases in the 1980s and 1990s. Their recent evaluation showed that patients, donors and children born from donated eggs, sperm or embryos were not fully protected from avoidable risks, as the current framework is not up to date with scientific development. Moreover, member states have been applying different oversight systems. This has hampered the cross-border exchange of blood, tissues and cells and has not promoted innovation in this sector.
On 19 July 2022, the European Commission presented a proposal for a regulation on standards of quality and safety for substances of human origin intended for human application. The proposal builds upon lessons learnt, including from the recent COVID-19 pandemic. It addresses the risk of disease transmission by blood, tissues and cells and the need for sufficiency of supply. The Council and the European Parliament reached a provisional agreement on the regulation on 14 December 2023.