Fertility law needs modernising, says UK regulator

The Human Fertilisation and Embryology Authority (HFEA) has today opened a consultation on proposed changes to UK fertility law.

The Human Fertilisation & Embryology Act (HFE Act), the law that governs fertility treatment and human embryo research in the UK, is over 30 years old and while medicine, science and society have moved on, the HFEA say the law itself has largely stood still*. As a result, the law doesn’t reflect modern fertility practice and is inflexible in responding to scientific innovation.

Julia Chain, Chair of the Human Fertilisation & Embryology Authority (HFEA) said:

“Much of the fertility law has stood the test of time remarkably well but modern fertility practice, emerging possibilities in research that could benefit patients and the changing expectations of donors and of families, are not reflected in the sector’s 30-year-old law.

“The HFE Act is the cornerstone of fertility regulation enforced by the HFEA to ensure clinics provide services to patients that are safe and of a high standard; we are uniquely positioned to see where the law works well and where it doesn’t.

“With input from an expert advisory group, we have identified where the law needs to be modernised in the interests of patients and their families. This includes providing more up to date powers for inspecting and regulating fertility clinics in the interests of patients and greater choice around donor anonymity. However, it’s important to note that any decision to update the law is for the Government and ultimately Parliament to decide.”

Professional sector experts as well as patients themselves, are being urged to respond to the consultation which opens today (Tuesday 28 February). Changes being considered by the HFEA include:

Patient safety and promoting good practice:

• Creating a broader and more proportionate range of regulatory powers so the HFEA can more rapidly impose conditions, suspend all, or part of a service for a specific period of time, or impose financial penalties where there have been serious non-compliances.
• Providing the HFEA with broader powers to address fertility services outside licensed fertility clinics.
• Making patient care an explicitly-stated principle of the Act, allowing the HFEA to take proportionate action where patient safety is at risk.

Access to donor information:

• Providing parental and donor choice where they can opt for anonymity until age 18 (as now) or identifiable information on request after the birth of a child.
• Ensuring all those using donation services have accessed information about the implications (known as implications counselling) of their decision before starting treatment.
• Placing a legal requirement on clinics to inform donors and recipients about the risk of donor conceived children finding out their donor’s identity before the law currently allows at 18 via DNA testing websites.

Consent:

• Considering simplifying the consent system to an ‘opt out’ model
• Supporting more joined-up and safer patient care at fertility clinics and within primary care by allowing automatic record-sharing between clinics and the NHS central records systems; this is already an established model that is used across other specialisms in healthcare.
• Giving patients more opportunity to support research projects by allowing them to give consent for their embryos to be stored for research more generally and used when needed. The opportunity for patients to donate to a specific research project, as stated in current law, should remain.

Scientific developments:

• Encouraging innovation by allowing the HFEA to authorise trials for low-risk new practices, with appropriate controls available if the initial promise is not demonstrated in practice.
• Future proofing the law to ensure it is better able to respond to scientific developments and so speed up the potential for new treatment options for patients. This would allow Parliament to approve significant new scientific and clinical developments by means of regulation without re-opening the Act every time.

Each year around 60,000 patients use fertility services in the UK.

Set up in 1990 by the Human Fertilisation and Embryology Act, the HFEA is the UK’s independent regulator of fertility treatment and research using human embryos. It works independently from the Government and is responsible for licensing, monitoring, and inspecting fertility clinics to ensure patients receive high quality care.

Through the HFEA consultation, the HFEA seeks views on the Authority itself having a more flexible range of regulatory powers, ensuring patient care is at the heart of the fertility market and the treatments being offered are grounded in evidence.

“The fertility sector is a unique area of healthcare in the UK and has become far more commercialised over time,” said Julia. “Today over 60% of patients in England pay for treatment themselves.

“There is great care being offered in both the NHS and private sector. But the enforcement powers we currently have – suspending or removing a licence – are too slow and blunt. We need a more agile and gradual approach like other regulators which help shape clinic behaviour and address serious non-compliance quickly. A good example of this is with treatment add-ons. As noted in the recent Women’s Health Strategy, changes to the HFEA’s regulatory powers may be needed to ensure only treatments that have been proven to be effective are recommended by clinics.

“We also want patients to be at the heart of fertility law - the HFE Act. It should acknowledge the quality of patient care as a key outcome, making the law more patient centred and in line with modern day medicine.”

The HFEA is also considering an approach that’s conducive to scientific development. Julia said: “Scientific and social attitudes move on far quicker than law and under the current regime, innovation is left in the waiting room until approval is given to reopen the Act.

“With an ability to carefully regulate clinical trials, monitor the outcomes and - providing that scientific, legal, and ethical questions are resolved - approve or reject based on the evidence, we can innovate at pace and improve patient outcomes without the need to reopen the entire fertility law each time. The UK is regarded as a world leader in fertility innovation and this recommendation, along with others, will further secure this position.”

The HFEA consultation is open from Tuesday 28 February 2023 for a period of six weeks. Fertility experts, patient and sector organisations and patients themselves can view the consultation via hfea.gov.uk.

The HFEA will submit its final recommendations to the Department of Health and Social Care (DHSC) later in the year.

Ends

For more information or for interviews with a HFEA spokesperson, please contact press.office@hfea.gov.uk or call 020 7291 8226.

For out of hours requests, please call the duty press officer on 07771 981920.

Notes to editors

• The HFEA’s final recommendations will be informed by patient and professional facing organisations and experts, in addition to patients themselves via this consultation.
• The HFE Act was updated in 2008 in response to technological developments that have arisen since 1990 and changes in society. It included a recognition of same-sex couples as legal parents of children conceived through donor sperm, eggs or embryos (gametes), it replaced the reference to “the need for a father” with “the need for supportive parenting” and it included a ban of sex selection for non-medical reasons. The 2008 amendments also allowed artificial gametes to be created for use in research but prohibited for use in treatment.

About the HFEA

• The HFEA is the UK’s independent regulator of fertility treatment and research using human embryos
• Set up in 1990 by the Human Fertilisation and Embryology Act, the HFEA is responsible for licensing, monitoring, and inspecting fertility clinics - and taking enforcement action where necessary - to ensure everyone accessing fertility treatment receives high quality care.
• The HFEA is an ‘arm’s length body’ of the Department for Health and Social Care, working independently from Government providing free, clear, and impartial information about fertility treatment, clinics and egg, sperm and embryo donation.
• The HFEA collects and verifies data on all treatments that take place in UK licensed clinics which can support scientific developments and research and service planning and delivery.
• Around 4,100 children in the UK are born each year through the help of a donor (2019). The HFEA holds records of all donors and children born since 1991.
• The HFEA is funded by licence fees, IVF treatment fees and a grant from UK central government. For more information visit, hfea.gov.uk.