The HFEA publishes annual ‘State of the Fertility Sector’ report

The Human Fertilisation and Embryology Authority (HFEA) has published its annual snapshot of regulatory work for the year.

Today’s State of the Fertility Sector 2023/24 report showed that incidents in the UK fertility sector remain rare, with over 99% of the almost 100,000 cycles being carried out without incident.

The report provides a snapshot of the HFEA’s regulatory work for the year, covering the number of inspections, reported incidents and non-compliances, and sets out how regulatory oversight can identify concerns and lead to improvements for patients and clinic staff.

When incidents do occur, they are taken very seriously. The HFEA ensures incidents are thoroughly investigated by clinics by putting in place increased regulatory oversight until the incident is closed and any lessons learnt have been integrated into practice.

The HFEA has a legal requirement to inspect licensed premises at least every two years, undertaking additional inspections where concerns have been raised or identified.

Five additional inspections took place this year, where significant concerns had been identified, for example where incidents had been reported or complaints were raised.

In March 2024, the HFEA suspended the Homerton Fertility Clinic’s licence due to the potential risks to the safety of patients, gametes and embryos following three reported incidents. The suspension was lifted in August as the HFEA is satisfied that measures are in place to provide safe and effective care to patients.

Peter Thompson, Chief Executive of the Human Fertilisation & Embryology Authority (HFEA), said:

“Patient care is always our priority, so it’s promising to see that the number of serious incidents in fertility clinics remains low. Patients can continue to be reassured that the risk of an incident in their care is very small.

“Incidents in fertility clinics are rare but distressing for those patients involved. It is a rare occurrence for the HFEA to suspend a clinic licence, but a necessary one where there is potential risk to patients, gametes and embryos.

“Reporting adverse incidents is a statutory requirement. We also share information of potential issues to ensure the wider sector learns from these. This is recognised as one of the best ways of ensuring incidents and their causes are identified and can lead to improvements for patients and clinic staff.”

The State of the Fertility Sector 2023-2024 report found that:

• There were 581 incidents and near misses reported to the HFEA in 2023/24, 52 fewer than in 2022/23:
  • 289 Grade C incidents, a decrease of two when compared to the previous year.
  • 202 Grade B incidents, a decrease of 24 when compared to the previous year.
  • 1 Grade A incident, the first time since 2019/20.
  • 62 near misses, a decrease of 27 when compared to the previous year.
  • 27 incident grades yet to be assigned.
• The number of inspections increased from 85 in 2022/23 to 104 in 2023/24, due to license length changes that occurred during the COVID-19 pandemic as well as five additional inspections.
• The number of non-compliances identified increased from 187 to 226. The increase is explained by an increase in the number of inspections. Of these non-compliances, six were identified as ‘critical’, 105 were identified as ‘major’ and 115 were identified as ‘other’ non-compliances.
• The HFEA continues to work with clinics to ensure everything possible is done to prevent and manage ovarian hyperstimulation syndrome (OHSS). Fewer OHSS incidents were reported in 2023/24. In 2023/24, there were 53 cases of severe and critical OHSS reported by UK clinics, occurring in less than 0.1% of cycles, a decrease of 11 compared to the year before.
• The number of patient complaints increased from 59 in 2022/23 to 69 in 2023/24. Out of the 69 complaints received, 55 were informal and 14 were formal. The HFEA does not have a statutory duty to investigate patient complaints, but actively monitors and reviews the information received to feed into the inspection process. The HFEA discusses formal complaints with the clinic and encourages them to further engage with the complainant to try to resolve the issues raised.

You can view the State of the Fertility Sector 2023-24 report on the HFEA website.

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 contact the duty press officer on 07771 981920.

Notes to editors

• Incidents are graded as:
  • Grade A: involves severe harm to one person, or major harm to many
  • Grade B: involves serious harm to one person, or moderate harm to many
  • Grade C: involves minor harm
  • Near miss: an event not causing harm but has the potential to cause injury or ill health.
• This report also uses preliminary treatment data for 2022 from the HFEA Register of fertility treatments. The HFEA has recently launched a new data submission system for licensed clinics and has migrated its fertility treatment and outcomes data to a new database. This data migration has resulted in delays that have prevented the validation of the 2020-2022 treatment and pregnancy data and 2019-2022 birth outcome data.
• The figures supplied in this report are from our data warehouse containing Register data as of 16 May 2024. Results are published according to the year in which the cycle was started.
• In 2019/20 we introduced Quarterly Clinical Governance Updates (shared via our Clinic Focus newsletter), which provide centres with detailed insight into non-compliances in a timely manner to help them improve compliance and prepare for inspections. These updates also contain details of incidents and complaints to ensure centres reflect on their own practice to help prevent further recurrence. As a result, this State of the Fertility Sector report provides a high-level overview of sector-wide compliance.

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.
• 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.