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‘Now is the time for change’, says HFEA

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
  • There should be the possibility of appointing Deputy PRs and PRs with a broader range of qualifications or experience
  • 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
  • The appeals process in the Act (and associated Regulations) should be amended to allow for challenges to licensing decisions to be resolved in a more efficient and proportionate way

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


  • 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 more information or for interviews with a HFEA spokesperson, please contact or call 020 7291 8226.

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

Notes to editors

  • The UK has long been a world leader in the regulation of fertility treatment and research involving human embryos. The Human Fertilisation and Embryology (HFE) Act 1990 (the Act) was the first law of its kind in the world. It established the Human Fertilisation and Embryology Authority (HFEA) and the regulatory regime which we oversee
  • Any change in the law would be for government and Parliament
  • The proposals were developed with input from experts within and beyond the fertility sector, as well as in a wider public consultation. Among those who responded to the consultation were those affected by fertility treatment, including patients and partners, parents of donor-conceived individuals, donor-conceived individuals themselves, and donors; professional staff working in fertility clinics; academics; lawyers; researchers; and interested members of the public. The views we received generally supported updating the law and gave valuable insight into how it could be changed
  • The HFE Act was last significantly updated in 2008 in response to technological developments that had 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 treatments and outcomes taking place in licensed clinics since 1991.
  • The HFEA is funded by licence fees, IVF treatment fees and a grant from UK central government. For more information visit,

Review date: 14 November 2025