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Commission welcomes political agreement on new rules on substances of human origin

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The Commission welcomes the political agreement reached on 14 December between the European Parliament and the Council to further increase the safety and quality of substances of human origin (SoHO). As proposed by the Commission in July 2022 and as part of the actions to build a strong European Health Union, the new rules will ensure that citizens are better protected when donating or receiving substances such as blood, tissues, cells, breast milk or microbiota.

The new rules include a range of measures that fill regulatory gaps, in order to support the functioning of this essential healthcare sector. In addition, they aim at facilitating the cross-border circulation of SoHO and promote greater cooperation between national public health authorities. Furthermore, the Regulation now tackles concerns regarding sufficiency of supply, highlighted by the COVID-19 pandemic.

The European Parliament and the Council will now have to formally adopt the new Regulation, which will start to apply 3 years after its adoption. Once adopted and implemented in all Member States, the Regulation will replace the rules for safety and quality set out in two Directives (2002/98/EC, for blood and blood components, and 2004/23/EC, for tissues and cells), and their implementing acts.

Health and Food Safety Commissioner Stella Kyriakides (pictured) said: “I warmly welcome yesterday's agreement, which will bring direct benefits to millions of patients across the EU and will add another important pillar to our European Health Union. Healthcare depends on substances of human origin for a wide range of interventions – from blood transfusions and bone-marrow transplants to In Vitro Fertilisation, to name just a few. The new rules will ensure that these products respect high safety and quality standards, while tackling the risk of shortages and promoting greater innovation in the sector.”

More information available in the press release and factsheet.

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