Major updates in European legislation were the focus for a recent ESHRE campus, notably the forthcoming Substances of Human Origin (SoHO) Regulation which becomes effective in August 2027. Nearly 200 participants attended the meeting, organised by SIGs Safety and Quality in ART and Ethics and Law, where discussions and exercises covered all issues around the improvement of standards in IVF labs.
Paula Nolan from the UK’s Human Fertilisation and Embryology Authority opened the event by sharing her experience as an inspector, and highlighting ways to build trust and excellence through empathy. She illustrated the human impact of inspections, including the emotional toll on staff, and offered practical strategies for maintaining transparency and preparedness during audits.
Deirdre Fehily (Belgium), formerly of the European Commission’s Directorate General for Health and Food Safety SoHO Team, outlined the upcoming EU-level framework, which sets high-level standards of care, rather than technical rules. The latter are instead issued by the European Centre for Disease Prevention and Control (ECDC), European Directorate for the Quality of Medicines and HealthCare (EDQM) or national authorities (1). Any SoHO preparation, such as embryos, will require authorisation by the competent authority following assessment of clinical evidence, novelty and safety. Key priorities include patient protection, supply continuity and digitalisation.
A major novelty in the SoHO Regulation is the stronger focus on donor protection, and particularly third-party donors. Individuals providing gametes for within-relationship use are not classified as SoHO donors; their safety is the responsibility of their healthcare team. Offspring from medically-assisted reproduction are granted protection equivalent to SoHO recipients (2).
Nathalie Vermeulen (Belgium), ESHRE’s Deputy Managing Director and previous guideline methodologist, described how the organisation’s evidence-based guidelines contribute to the quality of care and how they complement regulatory frameworks. The guidelines are often referred to in EDQM recommendations, making ESHRE a vital reference point in shaping standards. Any ESHRE member may propose new guideline topics, potentially influencing future EU-level policies.
Kersti Lundin (Sweden), past ESHRE Chair, explained how laboratories can align with the SoHO standards by adhering to EDQM and ECDC guidelines. A key change is the shift from risk assessment to risk-benefit evaluation before authorising new processes. Enhanced clinical outcome monitoring and full traceability—from donors and recipients to gametes and embryos—will become essential. The discussion also touched on national autonomy and the administrative burden of compliance.
Linda Savolainen (Sweden) highlighted the complexities of Sweden’s decentralised system, which involves three competent authorities managing regulatory oversight, product licensing, inspection and reporting. She said that outdated national legislation and the absence of a specific MAR offspring registry pose challenges to long-term monitoring and follow-up.
Borut Kovacic (Slovenia), Chair-elect of ESHRE and EDQM Advisory Board Director, discussed the human side of compliance. Beyond legal obligation, he said, adherence to regulations ensures standardised, high-quality care. The quality manager’s role extends to coordination and motivation, fostering teamwork through daily reporting, writing standard operating procedures, and active communication. Empathy in patient interaction is also essential. The leader of the IVF centre must ensure the laboratory maintains zero tolerance for error while nurturing a high-trust culture.
Arianna D’Angelo (UAE) presented several UK cases to illustrate deviations from protocol. One involved a chlamydia-positive sperm donor whose samples led to the birth of 11 children. Investigation revealed that only one staff member handled samples without witnessing procedures, prompting formal reporting and Clinical Pathology Accreditation accreditation of the andrology lab. The lack of peer support, she noted, caused staff distress.
Bryan Woodward (UK) followed with a case of an email containing confidential information sent to the wrong patient. The incident sparked discussion on digital communication, with experts recommending secure, encrypted alternatives for all patient contact.
The meeting shifted to risk management. Kelly Tilleman (Belgium) outlined the principles of Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA) for identifying process errors in laboratory and clinical work. Johan Guns (Belgium) expanded on environmental risk management and introduced the MiRCA tool, a method available online for integrating multiple RCA approaches.
In a practical session led by Alessandra Alteri (Italy), participants applied RCA, FMEA and MiRCA methods to a simulated case based on a real oncology incident, fostering group discussion and collective problem-solving.
The last day of the event was focused on registries and broader perspectives. Johanna Tassot (ESHRE’s policy officer) presented the EuMAR project which aims to develop the first pan-European registry collecting cycle-by-cycle data on MAR treatments (3). Tested in Portugal, Slovenia, Germany and Estonia, the system anonymises data but allows linkage of cycles from the same individual, including cross-border cases, and thereby will facilitate calculation of cumulative outcomes. A closing event with a presentation of the pilot study results will be organised in Brussels in December 2025, before starting the EuMAR2 phase to expand participation.
After discussing EuMAR, which is mainly activity reporting, the focus shifted to reporting of serious adverse reactions and events (SARE) and registries of donors. A series of speakers compared SARE registries across the UK, Belgium, Romania, Norway, Sweden and Finland. The contrasts were notable: some countries report all events, others only severe or even suspected cases; some publish results publicly, others do not. Responsibilities for reporting and investigation also vary—some nations share them between agencies, others separate these duties (4).
National donor registries from the UK, Romania, Norway, Sweden and Spain were also briefly discussed. Speakers underscored persistent challenges in cross-border traceability, which complicates the rights of donor-conceived individuals seeking information about their genetic origins.
The workshop concluded with an ethics session. Nicola Williams (UK) discussed donor compensation regulations in the EU and UK, analysing them from the perspectives of liberal theory and debates over the commodification of the human body. Laura O’Donovan (UK) reflected on how legal frameworks are designed to improve patient care yet sometimes fall short in practice, illustrating the tension between legislative intent and real-world implementation.
The Palermo workshop underscored how the forthcoming SoHO Regulation will redefine IVF quality management across Europe. By integrating ethical oversight, scientific precision and patient-centred care, the field is moving toward a more harmonised and transparent future. The discussions revealed that successful adaptation depends not only on legal compliance, but also on education, empathy and collaboration among all professionals involved in assisted reproduction.
References
1 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance) (available at https://eur-lex.europa.eu/eli/reg/2024/1938)
2 ESHRE. Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO Regulation) – summary for professionals in the field of medically assisted reproduction (September 2024, available at https://www.eshre.eu/Europe/Factsheets-and-infographics)
3 https://www.eshre.eu/Data-collection-and-research/EuMAR
4 ESHRE Special Interest Group Safety and Quality in ART, and Ethics and Law; Alteri A, Tilleman K, Vermeulen N, Baccino G, Rodriguez-Wallberg KA, D’Angelo A, Bounartzi T, Veleva Z, Mertes H. To err is human, also in medically assisted reproduction: a cross-sectional study on error management practices. Hum Reprod. 2025 Aug 1;40(8):1432-1439. doi.org/10.1093/humrep/deaf115
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