Image: Human Tissue Authority, Wikimedia Commons Attribution
UK Releases First Operational Data Under New Mandatory Overseas Transplant Reporting Laws
The Human Tissue Authority (HTA) has released the first operational data under the UK’s mandatory overseas transplant reporting regime, introduced in April 2024 following amendments made through the Health and Care Act 2022.
On 1 April 2024, the Human Tissue Act 2004 (Supply of Information about Transplants) Regulations 2024 came into force in England, Wales, and Northern Ireland. The Regulations require specified clinicians to report to the HTA if they become aware that a patient has received an organ transplant outside the UK, or if they reasonably suspect an offence relating to organ trafficking, commercial organ dealing, or modern slavery may have occurred. Failure to report is itself a criminal offence.
The Regulations operationalise amendments introduced through the Health and Care Act 2022, which expanded UK offences relating to commercial organ dealing and transplant-related exploitation to conduct occurring overseas. Together, the reforms were intended to strengthen the UK’s ability to identify transplant tourism and possible organ-trafficking activity involving UK residents.
The momentum behind the legislation developed over several years through parliamentary concern regarding forced organ harvesting and transplant tourism, particularly in relation to allegations involving China’s transplant system.
The reforms were supported by cross-party parliamentarians, including Lord Philip Hunt of Kings Heath, Lord Alton of Liverpool and Baroness Finlay alongside advocacy from human-rights organisations, medical ethics groups, transplant professionals, and campaigners seeking stronger safeguards against UK involvement in overseas organ-trafficking practices.
The first official operational data under the regime was published by the HTA in November 2025 and covers the period April 2024 to March 2025. According to the HTA reporting data and 12-month evaluation report:
- 39 reports were received during the first year of operation;
- all reports came from England;
- 38 reports related to overseas transplants under Regulation 4;
- only 1 report was submitted under Regulation 3 on the basis of a direct “reasonable suspicion” that a transplant-related offence may have occurred;
- 23 reports had been assessed at the time of reporting;
- 11 of those assessed reports were referred to police for investigation due to concerns that a transplant-related offence may have been committed;
- 15 reports remained under assessment, with additional information still being gathered before a decision could be made.
The HTA stated that the first year of reporting provided an “informative baseline” because no previous statutory reporting mechanism had existed for overseas transplants involving UK-based recipients. The evaluation report also identified several operational issues emerging during implementation.
First, the HTA noted that clinicians may require clearer guidance regarding what indicators should trigger a suspicion-based report, particularly given that almost all notifications received during the first year were submitted simply on the factual basis that an overseas transplant had occurred.
The HTA also reported that additional information was frequently requested from clinicians, including donor identity and donor-recipient relationship information, and that missing address information sometimes complicated referral of cases to the appropriate police force.
The report further noted that awareness of the reporting regime had initially been promoted through targeted clinician communications and presentations delivered in conjunction with NHS Blood and Transplant (NHSBT). No reports were received from Wales or Northern Ireland during the first twelve months, and the HTA indicated that the introduction of a similar duty in Scotland from 1 July 2025 would likely prompt a renewed UK-wide clinician engagement programme.
An NHSBT/HTA implementation briefing also indicated that most early reports related to patients travelling overseas for kidney transplantation. The briefing emphasised the role of the Regulations in identifying possible transplant tourism and supporting police referral pathways where concerns arise.
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