Laws governing the use of embryos in research need modernising to enable potential scientific breakthroughs that benefit patients, according to experts. Evidence presented at the annual conference of UK-based charity Progress Educational Trust (PET) also shows people in some countries face barriers to donating their surplus embryos after fertility treatment. This is despite their willingness to offer them to other patients or to medical studies.
The aim of the PET event was to debate current policies governing embryology and ART. In the UK, laws are largely defined by an expert committee chaired by Mary Warnock which gave human embryos a ‘special status’. Similar protections apply in other countries such as the 14-day limit on research.
The PET event began with insights into the implications for clinics of prolonged embryo storage, barriers to donating research, and management of embryo disposition. Data from Nordic countries presented by Aisling Ahlstrom shows storage time limits vary widely, as is the situation across Europe, with an ever-increasing extension of storage time: Denmark has no limit whereas Iceland recently extended the limit to a 35-year cut off. While cryopreservation is regarded as a successful technique, cryostorage management poses major challenges for clinics including tracking of cryopreserved embryos especially as the numbers and storage time are increasing.
How can clinics also respect patient wishes regarding surplus embryos especially when patient contact is lost and embryos may be unclaimed, unpaid for, or the patient has moved to another country? To ensure people don’t ‘regret their choices’, Dr Ahlstrom, who is a member of ESHRE’s executive committee, said shared decision making is crucial, and it is necessary that informed consent be considered as an ongoing process from the start to the end of cryopreservation rather than a one-time decision. However, this is time-consuming for clinics and can be stressful for patients: Dr Ahlstrom said regulation was the way to standardise practices further such as SoHO and good practice guidelines for which she said ESHRE is a ‘strong advocate’.
As with clinics, the scope for research on embryos in vitro depends on the practices and policies in the country where it is carried out. In her presentation, ESHRE chair Karen Sermon discussed the pros and cons of laws in Belgium dating from 2003. Overall, the legislation is regarded as liberal with an acceptance of all types of research directed at therapeutic purposes and at increased medical knowledge. The creation of embryos for research, for example, is allowed but not reproductive cloning.
Informed consent from patients around embryo donation is key said Professor Dr Sermon who added there is a ‘willingness’ among people in Belgium who have undergone IVF/ICSI to donate. A fundamental need exists, she said, for research on human embryos because results from animals cannot be extrapolated to humans (‘a mouse is not a human’). Nevertheless, she said reproductive health research was underfunded as a whole including by the EU, possibly because of the ‘ethical resonance’ but that ESHRE wants to change minds on this. The authors of an article by ESHRE’s ethics committee have recommended that the 14-day limit for research is extended to 28 days (1) and that embryo-like structures (ELSs) should not currently be given the same moral status as natural embryos unless in future they pass relevant tests. The UK fertility regulator the Human Fertilisation and Embryology Authority (HFEA) also announced at the PET conference that it is recommending, for the first time, a law change to extend the limit to 28 days (in the UK). This is on the basis that embryos are cultured for the shortest time possible to achieve the desired research outcome.
But elsewhere, change looks uncertain. Despite being Belgium’s neighbour, Germany’s laws around the handling and purpose of embryos could not be more prohibitive, complex and punitive. The country’s 1990 Embryo Protection Act does not even allow embryo selection in fertility treatment, only selection of pronuclear (PN) stage oocytes, a rule which also applies to cryopreservation (unless in exceptional circumstances). Hence, researchers and clinics must go through ‘legal gymnastics’ to avoid breaking the law according to Verena Nordhoff, a member of ESHRE’s executive committee.
In her presentation, Dr Nordhoff, from the University of Munster, suggested that patients in Germany are disadvantaged including those who want to donate their surplus embryos. While egg donation remains illegal, embryo donation is possible yet Dr Nordhoff said this has resulted in only a few births because non-commercial organisations that facilitate these do not actively advertise. And any relaxation of strict embryo laws appears likely. The coalition government pledged to review the ban on altruistic surrogacy and egg donation but the coalition collapsed last month meaning such a review is uncertain.
Sponsored by ESHRE, the last session of the day focused on ethical considerations around the use of human embryos and ELSs in research and ART. Data from the HFEA, as presented by Lucy Frith, shows that very few embryos are donated to others to use in their fertility treatment, although numbers are rising slowly, with 534 embryos donated to others in 2013 and 1117 in 2019. Consequently, the number of surplus frozen human embryos in storage in the UK is at the highest level such records began and tens of thousands of embryos have been discarded (2).
This situation raises moral and ethical issues said Professor Frith, a member of ESHRE’s ethics committee, executive committee and from the University of Manchester’s Centre for Social Ethics and Policy. Her research based on patients in the US suggests people are faced with a dilemma when faced with a bill for storing their embryos. They don’t know what to do with them, she said, and many wish they had received more information when undergoing treatment, and to have discussed options such as donating to research. Professor Frith said one that could be explored to encourage donation of surplus embryos to others, is the one used in New Zealand which allows donors to vet and choose recipients for example.
Ultimately governments have the final decision on laws governing embryo use and research. There are also still many ethical issues that need resolving such as whether ELSs have the biological potential of developing into a foetus. And some people remain firmly opposed to embryo research and donation. But a message from the PET conference is that embryos are a valuable resource which can help advance understanding of human biology and disease, and should not be wasted.
References:
1 Writing Group of the ESHRE Ethics Committee, Guido Pennings, Wybo Dondorp, Mina Popovic, Susana Chuva de Sousa Lopes, Heidi Mertes. Ethical considerations on the moral status of the embryo and embryo-like structures. Human Reprod Volume 39 (11), Nov 2024, 2387–2391, https://doi.org/10.1093/humrep/deae228
2 Yishang Yue and Calum MacKellar. A quantitative analysis of stored frozen surplus embryos in the UK. The New Bioethics. https://philpapers.org/rec/YUEAQA
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