EBA Statement on the new SoHO Regulation

The European Blood Alliance (EBA), the association of not-for-profit Blood Establishments, welcomes the European Commission’s proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application, published today, 14 July 2022. Twenty years after the current blood directive was adopted, this proposal builds on that landmark legislation which ensured safety and quality of blood products across Europe, reinforcing its most fundamental principles: blood as a key human resource, voluntary non-remunerated donation, and donor protection.

In addition, the EBA is equally pleased that the European Commission listened to blood establishments, and many other stakeholders, who called for a more agile legal framework that is quicker to adapt to the latest scientific evidence and to innovative approaches and products.

Pierre Tiberghien, President of EBA, said:

“This proposal is a very good basis to ensure that European citizens can continue to expect safe and high-quality blood products, while also strengthening patient and donor protection and granting EU’s legal framework a much-needed flexibility to adapt to new scientific evidence and innovation.”

EBA will now analyse the proposal in more detail on the basis of adequacy and safety of blood supply and we call on members of the European Parliament and representatives in the European Council to listen to the views of EBA and blood establishments as they consider any changes to this proposal.

About EBA

The European Blood Alliance (EBA) is an association of not-for-profit Blood Establishments, with 28 members throughout the European Union, United Kingdom, and EFTA States. Our mission is threefold:

• To contribute to the availability, quality, safety and cost-effectiveness of the blood and tissue supply for the citizens of Europe by developing and maintaining an efficient and strong collaboration amongst European blood and tissue services.
• To increase public and professional awareness of voluntary and non-remunerated donation (VNRD) of blood and blood components, and of preparation of blood components as an indispensable therapeutic means to help patients.
• To assist European blood establishments to continuously improve their performance, based on scientific and ethical principles for the benefit of patients.

EBA strives towards this mission by assisting our members to improve performance through collaboration, to engage in regulatory affairs to promote best practice and to facilitate information collection and knowledge exchange.

Contact:

Peter O’Leary, Executive Director;  info@europeanbloodalliance.eu