ESHRE letter to MEPs about amendments to the SoHO regulation

May 2023

In July 2022, the European Commission has published a Proposal for a Regulation on Substances of Human Origin (SoHO) intended for human application (SoHO proposal). In the European Parliament, this proposal is being discussed in the Committee on Environment, Public Health and Food Safety (ENVI). Until March 2023, the Members of the European Parliament (MEPs) in the ENVI Committee had the opportunity to table amendments to the SoHO proposal. The MEPs tabled 874 amendments, and the ENVI Committee will vote on these amendments in June 2023. Based on the results of this vote, a report will be prepared that will be voted on in the plenary of the European Parliament in September 2023. The final report will be presented to the European Commission and the Council and will form the basis of the Parliament’s position in the negotiations between these three institutions (trilogue negotiations).

We have carefully analysed the amendments that were tabled by the members of the ENVI Committee, paying particular attention to those amendments that will have an impact on Medically Assisted Reproduction (MAR) and the role of professional societies. On 22 May, we shared a letter with our position on the amendments with all members of the ENVI Committee. The letter can be downloaded here.

With this letter, we aim to contribute to a SoHO Regulation that takes the specificities of the MAR sector into account, covers all SOHO used in MAR, uses accurate and clear definitions, and provides strong protection for offspring born from MAR.