Press Release

SoHO Regulation: COMECE releases Position Paper ahead of final trilogue negotiation

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The Commission of the Bishops’ Conferences of the European Union (COMECE) releases a position paper on Wednesday 25 October 2023 calling for an in-depth debate on the SoHO proposed regulation in the context of the ongoing inter-institutional negotiations between the EU Council and the Parliament. Read the Position Paper [ENIT]

The EU Bishops welcome the general necessity of the regulation on quality and safety standards for substance of human origin (SoHO). COMECE acknowledges the great importance of substances of human origin for modern medical care”, as well as the principle of voluntary and unpaid donation included in the draft regulation.

Last September, the European Parliament adopted its position on the SoHO regulation. The draft law is now being negotiated in the so-called trilogue between the three main EU institutions to establish a final legal position. Today, the EU Council finalised its position on this regulation.

In this context, COMECE calls upon the EU Member States to conduct a comprehensive analysis of the draft through an in-depth debate specifically on the handling of fertilised oocytes (in vitro/in vivo), as well as embryos and fetuses, and the relationship of the SoHo Regulation with national regulations when ethical issues are involved.

While welcoming the general will to regulate the use of human substances in European Union, COMECE, in a statement released last September, expressed its concerns on the broad definition of the term ‘human substances’ and denounced the risk of an unacceptable degradation of prenatal human life. In view of the final negotiations, COMECE shared its Position Paper with all its Member Bishops’ Conferences.


Position Paper [ENIT]