HFEA comments on the news that eight babies have been born after mitochondrial donation treatment

Peter Thompson, Chief Executive of the HFEA, said:

“Ten years ago, the UK was the first country in the world to licence mitochondrial donation treatment to avoid passing the condition to children. For the first time, families with severe inherited mitochondrial illness have the possibility of a healthy child. Although it’s still early days, it is wonderful news that mitochondrial donation treatment has led to eight babies being born.

“Only people who are at a very high risk of passing a serious mitochondrial disease onto their children are eligible for this treatment in the UK, and every application for mitochondrial donation treatment is individually assessed in accordance with the law. These robust but flexible regulatory processes allow the technique to be used safely for the purposes that Parliament agreed in 2015.”

Professor Frances Flinter, Chair of the HFEA’s Statutory Approvals Committee, said:

“We are pleased to see the peer-reviewed papers published in the New England Journal of Medicine that explain what has happened to those patients who the HFEA authorised to have mitochondrial donation treatment at the Newcastle Centre at Life. These are patients for whom there was no other option to have a healthy baby who is genetically related to them, and we are delighted for those families.

“The HFEA will continue to oversee the safe use of mitochondrial donation treatment and assess each application as families come through the programme. These results are testimony to how the UK continues to be a world leader in the use of new medical techniques to change lives.”

Ends

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

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Notes to editors

• As of 1 July 2025, 35 patients have been given approval for mitochondrial donation treatment by the HFEA Statutory Approvals Committee. These decisions are made on an individual case by case basis where there are no other options for the families involved and in strict accordance with the law. The published papers set out that 25 of those patients have undergone pronuclear transfer (mitochondrial donation treatment.)
• More information can be found about Mitochondrial donation treatment and all decisions are published on our website under Newcastle Fertility Centre at Life ‘reports archive’, Licence Committee – other.
• More information on the law and HFEA guidance can be found in the HFEA Code of Practice from page 307.
• The law was changed to allow Mitochondrial donation treatment under licence in the UK under the Human Fertilisation and Embryology (Mitochondrial) Regulations 2015.
• The HFEA continues to review clinical and scientific developments in assisted reproductive technology including embryo testing. You can see papers from our Scientific and Clinical Advances Advisory Committee here. The committee discussed Mitochondrial Donation in January 2022, July 2023 and October 2024.

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 of 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 4,300 children in the UK are born each year through the help of a donor (2023). The HFEA holds records of all donors and children born since 1991.
• The HFEA is funded by licence fees, IVF treatment fees and a small grant from UK central government. For more information, visit hfea.gov.uk.