Fertility Across Jurisdictions: International Perspectives

The European regulation of assisted reproduction has troubled policymakers since people started travelling abroad for fertility treatment. The second session of the Progress Educational Trust's 2021 annual conference 'Reproducing Regulation: Who Regulates Fertility and How?' addressed this regulatory challenge with a discussion of such highly topical and contentious subjects as fertility add-ons, donor anonymity and regulating assisted reproduction more widely across a politically and culturally diverse Europe.

Sponsored by the European Society of Human Reproduction and Embryology (ESHRE) and chaired by their senior research specialist Dr Nathalie Vermeulen, 'Fertility Across Jurisdictions: International Perspectives' neatly illustrated the challenges presented by cross-border reproductive care. The first speaker, Professor Anja Bisgaard Pinborg, chief consultant at Rigshospitalet's Juliane Marie Centre in Copenhagen, Denmark, addressed the controversial issues around fertility add-ons – a matter of much recent debate (see BioNews 1079). Defined as an optional extra or supplementary treatment likely to involve an additional cost on top of a routine cycle, some add-ons have attracted attention for costing hundreds or thousands of pounds each while being founded on missing or unreliable evidence.

The Human Fertilisation and Embryology Authority has responded to concerns by developing a traffic light system to help inform patients of the quality of evidence for certain add-on procedures. EHSRE will also produce its own guideline list of add-ons. Professor Pinborg explained how such systems are designed to help inform patients of the experimental nature of add-ons and generate a culture of openness, while also emphasising the importance of responsible innovation. A balance must be struck between protecting the patient and necessary innovation, said Professor Pinborg, who stressed that it is important to ensure the need for evidence-based treatments does not inhibit new initiatives or limit research – adding that patients should not be the ones to pay for innovation. A further challenge for policymakers raised during questions is the difference in the provision of add-ons observed between European countries. Professor Pinborg observed that higher levels of state funding are associated with fewer issues with add-ons. This highlights the need for regulation in countries with higher levels of private fertility provision.

Professor Heidi Mertes, from Ghent University, Belgium, provided further illustration of the challenge of European regulation by discussing donor anonymity. Despite an observed trend away from donor anonymity, the approach in Europe can be described as patchwork: some countries are not allowing anonymous donation, others only allow anonymous donation, while some counties have a mixed system. The difficulty of achieving a consensus in Europe on this issue is illustrated by the range of powerful arguments for abandoning donor anonymity (including reference to the rights of the donor-conceived person to know their genetic origins, harm avoidance and the importance of honesty and openness in the family) and also the robust responses to these issues – are children's rights protected in law?

Could affirming the significance of the genetic link increase harm rather than reduce it? Indeed, some believe that genetic essentialism should be rejected, particularly given that we are seeing more families created without genetic ties. Furthermore, a discussion of donor anonymity not only raises issues over the rights of the donor to maintain anonymity, or who may now be in a very different position to when they donated, but also those of the donor's children. Professor Mertes said there is a need to reframe the debate – what do we agree on and what don't we agree on? For example, while we may all agree to some extent on the donor's privacy rights, the balancing of interests and indeed the donor-conceived person's right to know their genetic origin appears to be more contested.

The next two speakers provided perspectives on the development of regulation in two traditionally conservative countries – Ireland and Portugal. Dr Edgar Mocanu, consultant in obstetrics and gynaecology at the Rotunda Hospital in Dublin, Ireland, outlined attempts dating back to the 1990s to introduce regulation of assisted reproduction in Ireland, where anonymous donation has recently been banned (see BioNews 958). Despite a political will to introduce regulation since recommendations were made in 2005, it was not until 2020 that a legal framework for donor ART came into force (see BioNews 935). The legislation bans anonymous gamete donation in Ireland and gives donor-conceived people a right to access information about their donor's identity once reaching 18. It also gives the Irish state the right to inform people they were donor-conceived once they become 18.

From a Portuguese perspective, Professor Carlos Calhaz-Jorge, chair of ESHRE, explained how difficulties in reaching a consensus in a socially conservative society meant that progressive regulation of fertility treatment was not seen until 2006. Legislative initiatives were pushed through by a small number of committed MPs who endorsed open-minded social values and acceptance of sexual and reproductive rights. The perspectives from Ireland and Portugal gave a sense of the complexities faced by European regulators, not only confronted with a lack of consensus on important issues but the need, also, to grapple with diverse and deep-rooted political and cultural processes.

The questions that followed picked up on several important aspects of the discussion. Cross-border treatment and accessing donor information online is a stark reality. Professor Mertes reiterated that cross-border rules rest upon common agreement and consensus and that there are only a handful of areas where such rules have been agreed internationally. Dr Mocanu reflected that some patients simply prefer anonymous donation and will travel abroad. For him, this was an intimate and personal decision, albeit a difficult one. It's a choice that individuals make, and it is not the role of the state to regulate how we make such decisions.

In a similar vein, the speakers were asked about mandated disclosure for the state to inform donor-conceived children. Professor Mertes said this would be overstepping a boundary and would not necessarily take the donor-conceived person's interests in mind. Despite all the progress made in Europe to introduce progressive regulation amid the realities of cross-border treatment and the complexities of socio-political differences, it is clear there remain many tricky hurdles to come. Rather than building consensus, the acceptance of differences on important matters may well open the sluice for regulatory development – although, of course, not everybody will agree.

The Progress Educational Trust (PET) would like to thank the sponsors of its conference – the Anne McLaren Memorial Trust Fund, the Edwards and Steptoe Research Trust Fund, ESHRE, CooperSurgical, Ferring Pharmaceuticals, Hart Publishing, Merck, the Society for Reproduction and Fertility, Theramex, TMRW Life Sciences, Vitrolife and the Institute of Medical Ethics.

Register now for PET's free-to-attend online events in 2022:

• Whole Genome Sequencing at Birth: What Research Can, and Should, Be Done with a Baby's Genome? (19 January 2022)

• Adding Up What We Know: A Global Perspective on Fertility Treatment Add-Ons (26 January 2022)

• Prioritising Patient Safety: How to Minimise Risk in Fertility Treatment (9 February 2022)

• Whole Genome Sequencing at Birth: Genomic Data, A Resource from Cradle to Grave? (16 February 2022)

• Whole Genome Sequencing at Birth: Workforce Implications for Healthcare Professionals and Beyond (16 March 2022)