UK fertility law needs modernising

In just 30 short years, science and research, as well as clinical techniques used in fertility treatment have progressed beyond expectation. However, scientific development is, in places, starting to push against, or go beyond, the boundaries of what is permissible under UK fertility law. It is time to modernise the law and the UK's fertility regulator – the Human Fertilisation and Embryology Authority (HFEA) – has launched a consultation to determine how best to do that.

In 1991 there were under 7000 in vitro fertilisation (IVF) cycles carried out; today there are around 70,000 annually. In total, there have been around 1.3 million IVF cycles and over 260,000 donor insemination (DI) cycles, resulting in over 390,000 babies born.

The Human Fertilisation and Embryology (HFE) Act has enabled science and clinical expertise to thrive in that time, but it is no longer fully reflective of modern-day fertility practice or able to flex to emerging fertility techniques. We have opened a consultation that explores the themes of scientific development, consent, patient protection, and donor anonymity, the aim of which is to futureproof the Act for years to come.

We welcome responses to the consultation from professional sector experts, as well as patients themselves, ensuring that a broad range of views are considered when our final recommendations are submitted to the Department of Health and Social Care (DHSC). While the HFEA is looking at what changes we would like to see, any decision to update the law is for the Government and ultimately Parliament to decide.

Enhancing patient safety

Set up in 1991 by the HFE Act, the HFEA works independently from the Government and is responsible for licensing, monitoring, and inspecting fertility clinics and research centres to ensure patients receive high-quality and safe care.

The HFEA has set out how it seeks to enhance patient safety by updating the Act to require automatic record-sharing to take place between clinics and NHS records systems. This would allow information about patients' fertility treatment to be shared within other clinical settings including hospitals and within primary care. This happens in healthcare outside of the fertility sector already; we want to further protect patients and improve their care by doing the same. Comparable provision would also need to be made for record-sharing with private providers where fertility patients are receiving other medical treatment.

The consultation seeks views on the HFEA having a more flexible and proportionate range of regulatory powers, ensuring patient need is at the heart of the fertility sector and the treatments on offer are appropriate. We are asking for views on whether the HFEA should be more easily able to impose conditions, suspend all, or part of a service for a specific period of time, and to levy a fine in some circumstances.

Scientific developments

If the sector is to remain at the forefront of fertility treatment innovation and embryo research, we need to look at how research is regulated and improve the Act's ability to cope with rapidly changing developments in science.

In order to support innovation, the Act could be amended so it is less prescriptive. The HFEA is seeking views on whether it could encourage innovation by allowing the HFEA to oversee trial programmes for low-risk novel processes on an individual basis. Additionally, to ensure that major scientific developments are not unduly delayed, the HFEA is exploring whether processes should be established to allow such developments to be explored and regulated on an individual basis. This could include, for example, a greater use of regulations through secondary legislation or statutory instruments, whilst considering public views. This could be similar to the regulation written into the HFE Act in 2008 that required positive approval of the resulting statutory instrument of the Mitochondrial Donation Regulations 2015.

Consent relating to embryo research is another area where we feel reform is required. We believe that the current 'specific named project' rule, where consent can only be taken for a named project, should be extended to include the option of broader consent that enables patients to donate to a research bank to store embryos. This would allow the bank to allocate the stored embryos to suitable research projects when needed and allow more patients who wish to support research, to do so. However, patients should continue to have the option to donate their embryos directly to a specific named research project if that is their preference.

Donation

Donor conception led to more than 4100 births in 2019, accounting for 1 in 6 births using IVF in the UK. However, the rise in ancestry websites and consumer DNA testing kits challenges assumptions about anonymity and controlled information release. The risk of donors being contacted directly, without accurate information from the HFEA and before the law allows is high, questioning whether the current law is still appropriate.

The HFEA is seeking views on whether, as part of the consent process, clinics should be legally required to inform donors and recipients about the possibility that any children born from donation could discover their donor's identity before they are 18. This would change what is currently HFEA guidance into a legal requirement.

The HFEA is also consulting on whether the law should require all donors and recipients to have implications counselling before starting treatment. We too, are asking whether the Act should be amended to provide parental and donor choice to opt for anonymity until age 18 (as now) or identifiable information on request after the birth of a child. These proposed reforms are particularly timely as we embark on Opening the Register later in 2023.

The HFEA is held up as an example of excellence overseas for its innovative regulatory work and is key in identifying where change within the HFE Act is needed. It is important now that sector experts and patients themselves help us futureproof UK fertility law by responding to this consultation. Only then will we have a law that is fit for the modern world.