The HFEA sets out its ambition for law reform

The Human Fertilisation and Embryology Authority (HFEA) has published its recommendations for modernising the fertility sector's 33-year-old law, with a focus on four key areas.

The UK's fertility law – the Human Fertilisation and Embryology Act 1990 (as amended) – was the first of its kind anywhere in the world. The UK has long been a world leader in regulating fertility treatment, and in research involving human embryos.

But much has changed in 33 years. The number of patients having treatment has increased ninefold, with just over 6000 IVF patients in 1991 compared with nearly 52,000 in 2021. Patients increasingly look for advice and information online rather than speaking to their GP. Additionally, scientific advances and new technologies in the field are developing at pace.

With so much change, it's now time to consider how the law should also change.

Our 15 proposals cover four areas where the HFEA believes the law should be modernised in the interests of patients, professionals, and researchers: patient safety and promoting good practice, access to donor information, consent, and scientific developments and innovation.

Patient safety and promoting good practice

The UK fertility sector is very different from when the law was first introduced. Today, over two-thirds of patients fund their own treatment meaning that they are now consumers as well as patients. This change in their relationship with clinics means our regulatory powers need to be updated. For example, the only formal sanction available to us is to suspend a clinic's licence with immediate effect, revoke the licence or apply additional conditions, for example requiring a clinic to stop donor treatment temporarily.

In addition, more fertility services are being offered that fall outside the remit of the Act. The market is moving online, with some virtual services acting as 'networks' introducing patients to fertility treatment and offering a range of services other than those – such as egg collection – that are legally required to take place in licensed clinics. And some virtual clinics do give a misleading impression that they are regulated, including citing an 'HFEA regulatory fee' in their price lists, even though they are not HFEA-regulated and licensed treatments take place elsewhere.

Where 'fertility services' are offered, the HFEA should be acting in the interests of patients. While we have no desire to double up on the remits of any other healthcare regulator, we should ensure that, when fertility-related services take place outside of licensed clinics, patients are clear that they are not covered by HFEA oversight.

Good regulation should try to achieve the greatest impact with the most proportionate sanction. For example, it would often be more proportionate to impose a financial penalty, which the HFEA is unable to do at present.

Consent

Consent in fertility treatment is more complex than in any other medical treatment. The current consent requirements of the Act are far more detailed and stringent than for any other types of human tissue. This is in part because consent to fertility treatment involves more than one person, and requires patients to consider potentially challenging scenarios, including making decisions about what might happen in the event of their death (or loss of mental capacity).

The consent regime in the Act should be simplified where possible and updated to reflect modern family structures such as same-sex couples. It should also be updated to require automatic record-sharing between clinics and the NHS central records systems, to support more joined-up and safer patient care.

The Act should be extended to allow for patients to give consent to research embryo banking meaning more patients could donate their precious embryos for important research when they have finished treatment.

Donor identifiability

Nowhere in this field has the pace of social and technological change been more rapid than in the growing popularity of direct-to-consumer DNA testing and social media. This has had a significant impact on donor identifiability such that the current system, where identifiable information about a donor can only be disclosed to the donor-conceived person at 18 and only upon request no longer reflects reality.

The HFEA is recommending that the law be changed so that parents can find out who a donor is from the birth of a child, and also that clinics should be required by law to inform donors and recipients of the potential for a donor's identity to be discovered through means such as DNA testing websites or social media.

There has understandably been a great deal of media attention on our proposals around donor identifiability. We know the proposals are a significant departure from the current law, and we are recommending a gradual approach to reach this position by having in-depth discussions with a wide range of stakeholders, including professional bodies, patient and donor groups, donors and donor-conceived individuals, and licensed centres within the fertility sector.

Any new system should uphold the principles that there be an official 'record of truth', and the law should require the HFEA to collect data about children born through donation.

Scientific developments

Scientific and medical advances in the fertility sector including research on embryos is developing at pace. The restrictions in the Act (including, for example, the '14-day rule') reflect both the social consensus and the scientific limitations of the time. As things stand, the entire Act would need to be re-opened to accommodate some developments in research or clinical practice, and so the pressure on parliamentary time means that such change happens rarely. We believe the Act should be amended to 'future proof' it, so that it is better able to accommodate future scientific developments and new technologies.

We know that many scientists have called for the law to be updated, and that a recent public dialogue (see BioNews 1213) found people supportive of change with the right oversight from us. For example, the HFEA could have the power to extend the 14-day rule for specific projects. Equally, we know from our consultation (see BioNews 1181) that there are varied views, and continued public engagement is also needed in this area.

Next steps

Any decision to update the law is for the Government and ultimately Parliament. We would expect that there would be further government consultation on some of these areas before any change to the law. In the meantime, we will continue to regulate effectively within the current law while continuing to work with others to call for change.

You can read our recommendations in full on our website.

Julia Chain will give a presentation about the HFEA's law reform recommendations at the 2023 PET Annual Conference – How Much Change Do We Want? Updating Fertility, Embryo and Surrogacy Law – taking place on Wednesday 6 December 2023.

Note that due to recently announced UK rail strikes, this conference will now be taking place entirely online.

Find out more and register here.