TISSUE & CELL LEGISLATION

The EU’s tissue and cell directives will shortly be superseded by a new single legislation; ESHRE outlines the ‘key considerations’

The European Commission has published its proposed legislation for substances of human origin (SoHO) and is presently in a consultation phase.

Published 15 November 2022

The European Commission has published its proposed legislation for substances of human origin (SoHO) and is presently in a consultation phase. ESHRE, in a hybrid meeting for MEPs in November, reviewed the proposal’s implications for assisted reproduction from both the institutional and patient perspective. ESHRE secures large EU data collection grant.

It's now more than two decades since European legislation was planned to set common standards of quality and safety for the ‘donation, procurement, testing, processing, preservation, storage and distribution’ of human tissues and cells. The proposals were adopted by the European Parliament in 2004 and set out in an initial directive.(1) The directive was largely concerned with tissue and cell applications, with apparently little specific attention applied to the fertility sector, despite the evident involvement of gametes and embryos. Thus, as the directive was implemented in law over the next few years, subject to two implementation directives (blood plus tissues and cells), those sections relevant to the treatment of infertility were largely incorporated into national ART legislations. National competent authorities became – and remain - responsible for the implementation of the requirements established in the EU legislation.

Throughout this time the directives have remained under scrutiny, of both the Commission itself and ESHRE, as the Society continued to seek through its policy engagements to represent the ART sector in Europe and ensure that its professional voice was heard. ESHRE even then was responsible for Europe’s largest registry and treatment database, with access to annually collected data on the safety and efficacy of treatments. Meanwhile, while an EU evaluation of the directives, published in 2019, acknowledged gains in transfusion and transplantation, it also recognised that the 2004 legislation had barely kept pace with the speed of technology in ART (notably vitrification), the threat of communicable diseases (covid-19), cross-border treatments and gamete donation, and ‘increasing commercialisation’ in the sector. Specifically, the Commission noted that current legislation failed to protect patients from avoidable risks ‘due to out-of-date technical rules’, and that donors and children born from donated eggs, sperm or embryos ‘are exposed to avoidable risks’. A revision was thus scheduled for 2022.

ESHRE, through its EU affairs committee, has taken an ever greater part in the consultations which have now laid the groundwork for this revision (evident, for example, in its report on the protection of gamete donors and children born to recipients) and in providing a range of briefing materials and position statements.(2)

Finally, in July 2022, ‘a proposal for a regulation on substances of human origin’ was published by the Commission.(3) This would effectively repeal the former directives and in its place present a harmonised single legal framework claiming ‘stronger rules for greater safety and quality’ and now applied to blood, tissue, cells, and assisted reproduction.

The proposal is now in its discussion phase but, once agreed and adopted, is likely to become law within two or three years thereafter. As part of that discussion, and as a briefing service to MEPs, ESHRE took a leading part in a round-table meeting in November in the European Parliament to underline the proposal’s ‘key considerations’ in assisted reproduction. The broad aims of the new SoHO regulation as set out in the draft proposal are to:
* Ensure safety and quality for patients and protect them from avoidable risks linked to the application of SoHOs
* Ensure safety of SoHO donors and children born from donated eggs, sperm or embryos
* Strengthen harmonisation of oversight
* Encourage the development of safe and effective innovative SoHO therapies
* Improve the resilience of the sector, reducing risk of shortages (as was evident during the covid-19 pandemic).

More specifically Deirdre Fehily, representing the European Commission, told the roundtable meeting that the most striking introductions for the ART sector would be to strengthen the protection of gamete and embryo donors ‘before, during and after’ their donation. This would include information and consent, greater safeguarding, donor health evaluation, and a possible European registration of donors with donor adverse event reporting.

Similarly, this greater degree of protection would be applied to offspring, for whom risk of genetic disease transmission would require assessment. However, Fehily pointed out that existing legislation (communicable disease transmission) protects offspring whether the sperm or eggs used to create the embryo ‘were from their biological parents or from SoHO donors’.

While largely supportive of the proposals, ESHRE is currently preparing its own position statement on the proposals. Former ESHRE Chair Kersti Lundin in her presentation to the roundtable meeting raised what is likely to be at least one contentious question in the SoHO text – that on definitions of families and patients having fertility treatment. At the basic level, said Lundin, the proposal defines autologous treatment (couples using their own eggs and own sperm) as ‘within-couple use’, while treatment with donor gametes or embryos is defined as ‘third-party donation’. Lundin was thus emphatic that couples who use their own gametes are not considered as ‘donors’. There is no increased risk of transmitting an inheritable condition when using autologous cells as there is in third-party donation - and for which stricter protocols of protection and reporting would apply.

The proposals emphasise the necessary support of professional – and patient - expertise in setting standards and monitoring technical advances. Indeed, in its presentation to the round-table Fertility Europe emphasised the need for patient representation in these developments, while throughout the meeting – and indeed throughout the past decade – ESHRE emphasised its advisory credentials as a representative of the ART sector. ESHRE Chair Carlos Calhaz-Jorge described the Society, through its membership and activities, as the ‘go-to’ group best positioned to ‘provide expertise in the field at the European level’. And today, as evident for more than two decades, much of that activity strength must lie in the registry data of the EIM Consortium, now collecting national ART results since 1999. As the reach of the EIM grows, and as its former Chair Christine Wyns told the MEPs, so its value will increase in a greater standardisation of definitions and metrics, and in the greater accumulation of prospective data – allowing for improvement in vigilance and surveillance and in interconnection with other registries.(4) This, said Wyns, is a vision in line with the SoHO regulation’s own proposal.

* The alignment of ESHRE’s EIM data collection with the Commission’s objectives has been underlined by the recent award of approximately 1.2 million euro for the development of the EuMAR (European monitoring of Medically Assisted Reproduction) data registry. The project will run between January 2023 and December 2025. The EuMAR data registry will be the first ‘overarching’ European, standardised, web-based data registry, with cycle-by-cycle data entries from professional groups. ESHRE expects the EuMAR registry will be a first step towards increased uptake of surveillance and vigilance in assisted reproduction, which in turn will allow improved safety and efficacy monitoring.



1. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32004L0023
2. See for example https://freepub.edqm.eu/publications and https://www.eshre.eu/Europe/Position-statements/EUTCD
3. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52022PC0338&from=EN
4. https://www.eshre.eu/Europe/Position-statements (see Registries)

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