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

December 15, 2023 by European Union Leave a Comment

This article is brought to you in association with the European Commission.

The Commission welcomes the political agreement reached today 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 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 proposal will also facilitate innovation through a common EU procedure to assess and authorise new SoHO preparations, proportionate to the risks involved. Additionally, it will establish a SoHO Coordination Board (SCB) with and for the Member States, to support the implementation of the new Regulation and provide legal clarity.

Some of the key features of the new Regulation include better protection of recipients, donors and children born from medically assisted reproduction, through:

A wider scope of EU rules to cover all substances of human origin except solid organs, such as faecal microbiota and human breast milk;
Improved protection of donors and recipients of SoHO therapies, as well as children born from medically assisted reproduction;
Registration of all entities that carry out activities that could affect the safety and quality of SoHO;
Reinforced expertise, building on existing technical bodies, notably the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines & HealthCare (Council of Europe), to keep technical guidelines up to date;
Proportionate, risk-based measures to strengthen national oversight, as well as EU support measures for national authorities (such as training and IT).

Next steps

The European Parliament and the Council will now have to formally adopt the new Regulation, which will 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.

Quote(s)

I warmly welcome today’s agreement, which will bring direct benefits to millions of patients across the EU and add another important piece to our European Health Union. Our healthcare depends heavily 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.
Stella Kyriakides, Commissioner for Health and Food Safety – 14/12/2023

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