On 6 August 2024, the European Union (EU) Regulation on Substances of Human Origin (SoHO) entered into force. This new law will replace the current Tissues and Cells Directive and regulate SoHO treatments, including any treatments using gametes and embryos, in the EU and the European Economic Area (EEA). Many aspects of the Tissues and Cells Directive were kept in place, but there will be some substantial changes that professionals in the field of medically assisted reproduction (MAR) should be aware of.
Firstly, a new terminology was introduced for MAR. While the Tissues and Cells Directive applied the term “partner donation” when a couple used its own gametes for their fertility treatment, the SoHO Regulation refers to this situation as “within-relationship use”, clearly emphasizing that the partners in this setting are not donors. The term “non-partner donation” from the Tissues and Cells Directive, i.e., the case where individuals donate gametes or embryos to people with whom they do not have an intimate physical relationship, will be referred to as “third-party donation”, aligning the language of the Regulation with the accepted terminology in the MAR field.
Not only will the SoHO Regulation use a new term for third-party donors, it will also introduce several provisions that aim to improve the protection of this group. This is a novel aspect of the framework, since the Tissues and Cells Directive had a narrower focus on the protection of recipients. Under the SoHO Regulation, any serious complications in donors, such as ovarian hyperstimulation syndrome (OHSS) or bleeding in oocyte donors, will have to be reported to the competent authority. Moreover, if donors are treated with medication or subjected to a surgical procedure for their donation, it will become mandatory to monitor their health following the donation. Also, if frequent donations may have a negative influence on the donor’s health, clinics or gamete banks will have to verify by means of registries that donors are not donating more often than what is considered safe.
To ensure that there is no undue inducement for individuals in a financially vulnerable situation to donate SoHO, the Regulation states that donations should be voluntary and unpaid and that any compensation should endeavour to financial neutrality, i.e., compensating the donor’s losses but not creating any substantial financial gain for the donor. To achieve this, Member States will be obliged to set limits for the maximum compensation that donors can receive for the different types of SoHO donations in their country.
The SoHO Regulation also introduces a number of provisions to ensure the protection of offspring from MAR, mainly aiming to avoid the transmission of severe genetic diseases from third-party donors. Insofar as this is allowed under national law, donors shall be tested for potentially life-threatening, disabling or incapacitating conditions with a significant prevalence in the population. Furthermore, there will be an obligation to report the transmission of genetic conditions from a third-party donor if the condition led to pregnancy loss or might result in a life-threatening, disabling or incapacitating condition in the offspring.
The new rules on donor and offspring protection, as well as the revised rules on recipient protection, are presented in the Regulation as high-level standards. The legal text does not specify any details, such as what should be included in the post-donation health monitoring, how many oocyte donations are considered safe, or which genetic conditions donors need to be tested for. Under the Tissues and Cells Directive, all such technical rules were set out in legislation, which for instance stated exactly which infectious diseases donors need to be tested for. However, this system has proven to be too slow to keep up with the rapid changes in the SoHO sector. Thus, the SoHO Regulation now includes a reference to the most recent guidance by the European Centre for Disease prevention and Control (ECDC) and the European Directorate for the Quality of Medicines and healthcare (EDQM), stating that the standards of the Regulation shall be considered met if the guidance of these two organisations is followed. This means that these two expert bodies will in the future play an even more important role for the SoHO field in the EU.
Most of the rules of the SoHO Regulation will start applying in August 2027. During the three-year transition period, the EU will prepare further legal acts with guidance for the implementation and put new structures in place, such as a SoHO Coordination Board composed of representatives of all Member States and the EU SoHO platform, a digital platform that will, among others, contain all relevant resources for the different stakeholders and be used for communication between actors in the SoHO field.
ESHRE’s EU Affairs Committee (EUAC) has been actively following the process leading to the SoHO Regulation and aims to monitor and support its implementation in the MAR sector. To help MAR professionals navigate the legal text, the EUAC has prepared a summary with the most important changes, which can be accessed here. The full SoHO Regulation can be accessed in the Official Journal of the European Union.
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