Key takeaways
The new regulation broadens the scope of SoHO to human breast milk and intestinal microbiota and covers a variety of activities, ranging from registration and testing of donors, collection and processing to human application and clinical outcome monitoring of substances of human origin.
In addition, the regulation establishes an EU-level coordination board for SoHOs, introduces common EU procedures for the authorization and assessment of SoHO preparations, requires member states to designate a national authority and other competent authorities to authorize preparations and ensure independent and transparent oversight of related activities, sets out additional authorization and inspection requirements for establishments working with SoHOs, and establishes the new EU SoHO IT platform.
The regulation also provides for an early warning system to deal with serious incidents and reactions, which may create a risk to recipients or donors, and requires member states to implement a system to ensure a sufficient and adequate supply of SoHO, including through the development of national contingency plans to deal with possible critical issues.
According to that regulation, SoHO donations should, in principle, be voluntary and unpaid, and donors should not receive financial incentives. Living donors may receive compensation or reimbursement, as appropriate, in line with national legislation.
The regulation will become applicable once it is published in the Official Journal of the European Union.
