Citation, commencement, extent and application
1.—(1) These Regulations may be cited as the Human Tissue Act 2004 (Supply of Information about Transplants) Regulations 2024 and shall come into force on 1st April 2024.
(2) These Regulations extend to and apply in England and Wales, and Northern Ireland.
Interpretation
2. In these Regulations—
“donor” means a person who donates one or more organs, whether donation occurs during lifetime or after death;
“recipient” means a person who receives a transplant of one or more organs;
“relevant clinician” means any of the following whether practising as such a clinician in a transplant centre or a non-transplant centre—
a specialist nurse involved in living donor care;
a specialist nurse involved in recipient care;
a transplant surgeon;
a physician involved in living donor care;
a physician involved in recipient care.
Supply of information regarding specified offences
3.—(1) Where a relevant clinician has reasonable suspicion that one or more of the offences listed in paragraph (2) may have been committed, the clinician must, as soon as reasonably practicable, supply to the Human Tissue Authority(1) such information specified in Schedule 1 as is known by the relevant clinician.
(2) The offences are—
(a)sections 32 (prohibition of commercial dealings in human material for transplantation), 32A (offences under section 32 committed outside UK) and 33 (restriction on transplants involving a live donor) of the Human Tissue Act 2004(2);
(b)section 2 (human trafficking) of the Modern Slavery Act 2015(3), where section 3(4) (meaning of exploitation) of that Act applies in relation to the person; and
(c)section 2 (human trafficking) of the Human Trafficking and Exploitation (Criminal Justice and Support for Victims) Act (Northern Ireland) 2015(4), where section 3(4) (meaning of exploitation for purposes of section 2) of that Act applies in relation to the person.
(3) Paragraph (1) does not apply where—
(a)the reasonable suspicion arose other than in the course of the relevant clinician’s profession; or
(b)the relevant clinician has reason to believe that another relevant clinician has previously supplied information to the Human Tissue Authority in connection with the same suspected offence.
Supply of information regarding organ transplants performed outside the United Kingdom
4.—(1) Where the conditions in paragraph (2) are met, the relevant clinician must, as soon as reasonably practicable, supply to the Human Tissue Authority such information specified in Schedule 2 as is known by the relevant clinician.
(2) The conditions are—
(a)in the course of their profession, the relevant clinician becomes aware of an organ transplant having taken place outside the United Kingdom; and
(b)the recipient is—
(i)habitually resident in England, Wales or Northern Ireland, whether they are a United Kingdom national or not; or
(ii)a United Kingdom national who is not habitually resident in England, Wales or Northern Ireland.
(3) In this regulation “United Kingdom national” means an individual who is—
(a)a British citizen, a British overseas territories citizen, a British National (Overseas) or a British Overseas citizen;
(b)a person who under the British Nationality Act 1981(5) is a British subject; or
(c)a British protected person within the meaning of that Act.
(4) Paragraph (1) does not apply if the relevant clinician has reason to believe that another relevant clinician has previously supplied information to the Human Tissue Authority in connection with the same organ transplant as referred to in paragraph (2)(a).
Supply of information
5. A supply of information under these Regulations does not breach any obligation of confidence owed by the person supplying the information.
Signed by authority of the Secretary of State for Health and Social Care
Andrea Leadsom
Parliamentary Under Secretary of State
Department of Health and Social Care
29th February 2024