The EU Council adopts a new regulation on the donation of blood and human tissue

Loam EU Council adopted new rules aimed at improving the safety and quality of blood, tissues and cells used in healthcare and facilitating their cross-border trade. “The Substances of Human Origin (SoHO) Regulation will provide better protection for donors and recipients, as well as children born as a result of medically assisted reproduction. The new rules aim to strengthen the existing legal framework, while increasing flexibility to keep pace with scientific and technical developments,” the Council note reads. Under the new regulation, Member States may decide to apply more stringent measures to protect their citizens. The adopted text expands the scope of SoHO to include breast milk and intestinal microflora. Furthermore, it aims to future-proof EU legislation by taking into account other SoHOs that could be applied to humans in the future and allowing for more flexible future updates. The Regulation covers a wide range of activities, from donor registration and testing, collection and processing, to human use and monitoring of clinical outcomes of substances of human origin.

In addition, the Regulation aims to increase harmonization and facilitate cross-border trade and access to SoHO, including by establishing a SoHO Coordination Committee at European level to support Member States in implementing the Regulation; introduction of common procedures at the European level for the authorization and evaluation of SoHO preparations; requiring Member States to designate a national authority and other competent authorities to authorize SoHO preparations and ensure independent and transparent supervision of related activities; establish additional permitting and inspection requirements for facilities that process and store, release, import or export substances of human origin; and establish a new common IT platform, the EU SoHO platform, to register and exchange information on related activities. According to the new regulation, donations must, in principle, be voluntary and unpaid, and donors cannot receive financial incentives. Living donors may receive compensation or reimbursement in accordance with national legislation.

The regulation also provides for an early warning system to respond to serious incidents or reactions that may pose a risk to recipients or donors. Member States must also make reasonable efforts to ensure sufficient, adequate and stable supplies of critical SoHO in their countries, including by developing national contingency plans that include measures to respond to critical shortages. The regulation will now be signed by the Council and the European Parliament and will enter into force after publication in the Official Journal of the EU.

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