Modernising the regulation of fertility treatment and research involving human embryos
The HFEA has made proposals to change the law on the regulation of fertility treatment embryo research.
The proposals can be found here.
The report analysing the responses to our consultation can be found here.
The public consultation document can be viewed here.
‘Now is the time for change’, says HFEA, as recommendations made to government on modernising fertility law
The Human Fertilisation and Embryology Authority has set out a range of recommendations to modernise the UK’s 33-year-old fertility law.
The proposals made by the UK-wide regulator of fertility treatment and embryo research aim to ‘future-proof’ the law, so it better reflects the significant changes in the size and structure of the fertility sector, in attitudes to fertility treatment, and in medical and scientific developments.
The 15 proposals cover four areas where 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.
The UK fertility sector is very different from when the law was first introduced, with most patients funding their treatment, which changes the relationship between patient and clinic. The proposals aim to give the HFEA a wider and more effective range of regulatory tools to protect patients and promote their interests. The reforms also aim to decrease unnecessary regulatory burden and give a greater focus on serious non-compliances, and fix a range of significant ‘technical’ issues that will provide greater certainty to clinics and patients.
The science surrounding research on embryos, as well as new technologies is developing at pace, bringing potential new treatment options as well as new ethical issues that the current law cannot address.
Consent in fertility treatment is more complex than other medical treatment and the proposals aim to simplify consent for most patients and make it easier to consent to research.
The proposals would also modernise access to donor information, reflecting the impact of the growth in social media and direct-to-consumer DNA testing.
Julia Chain, Chair of the HFEA, said:
“The current law does not reflect the range and type of fertility treatment on offer today, nor modern regulatory standards. We think there should be changes that will ensure the law can continue to effectively protect patients, as well as support the scientific advances that can help them have a much-wanted child.
“The number of patients having fertility treatment has increased from just over 6000 in 1991 to nearly 52,000 in 2021. The fertility sector has also changed, leaving our current regulatory powers out of step with patient expectations and regulatory standards.
“Today most patients fund their treatment themselves, which has changed their view of this area of healthcare to being consumers with active choices to be made. Many UK regulators have a wider and more effective range of powers to improve compliance and protect patients and consumers than those available to the HFEA.
“Our proposals would improve patient safety and protection, and maintain the UK’s position as a country where scientific and clinical innovation can flourish. In all our work, the special status of the human embryo will remain a guiding principle as its potential makes it different from all other human tissue.”
The HFEA’s recommendations are:
Patient safety and promoting good practice:
- The HFEA should have greater freedom to decide the regularity and form of inspections
- The HFEA should have a broader and more proportionate range of regulatory enforcement powers
- The HFEA should have the power to impose financial penalties
- The Act should be revised to include an over-arching focus on patient protection
- The Act should be revised to accommodate developments in the way fertility services are provided
Access to donor information:
- The Act should be amended to enable the removal of donor anonymity from the birth of any child born from donation
- Clinics should be required by law to inform donors and recipients of the potential for a donor’s identity to be discovered through, for example, DNA testing websites, social media or means other than the HFEA Register
- The Act should require all donors and recipients to have implications counselling sessions before starting treatment
Consent:
- There should be an overhaul of the consent regime in the Act
- The Act should be updated to require automatic record-sharing between clinics and the NHS central records. This would support more joined-up and safer patient care at hospitals and within primary care. Patients would be able to opt out of this
- The Act should be amended to allow patients donating embryos to consent to research embryo banking
Scientific developments:
- The Act should explicitly give the HFEA greater discretion to support innovation in treatment and research
- The Act should be amended to ‘future proof’ it, so that it is better able to accommodate future scientific developments and new technologies
Julia said:
“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, with a lasting impact on donor anonymity. We need to balance the law with what is taking place in reality.
“We recommend the law is changed so that parents can find out who a donor is from the birth of a child. Our proposal reflects the fact that the current system, where identifiable information about a donor is disclosed to the donor-conceived person at 18 and only upon request, can no longer effectively keep up.
“We know this a significant departure, and so a gradual approach to reach this position may be best, but it should be the aim to future proof the law.
“Today we also publish the full consultation report which shows the range of views we received, which were extremely helpful in our developing the recommendations and we are grateful to all those who took the time to share their views with us.”
For further information please see the following:
Information about the Legislative Reform Advisory Group, as well as previous meeting minutes and papers.
Our blog posts on Modernising the Act:
Review date: 6 February 2026
