The Human Organ Transplants (Unrelated Persons) Regulations 1989

Statutory Instruments

1989 No. 2480

MEDICAL PROFESSION

The Human Organ Transplants (Unrelated Persons) Regulations 1989

Made

29th December 1989

Coming into force

regulations 1 and 2

1st January 1990

regulation 3

1st April 1990

Whereas a draft of this instrument was laid before Parliament in accordance with section 2(7) of the Human Organ Transplants Act 1989(1) and approved by a resolution of each House of Parliament:

Now therefore, in exercise of powers conferred by section 2(3) of the Human Organ Transplants Act 1989 and of all other powers enabling me in that behalf, I hereby make the following Regulations:—

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Human Organ Transplants (Unrelated Persons) Regulations 1989.

(2) Regulations 1 and 2 of these Regulations shall come into force on 1st January 1990 and regulation 3 on 1st April 1990.

(3) In these Regulations:—

“the Act” means the Human Organ Transplants Act 1989;

“the Authority” means the authority constituted by regulation 2 of these Regulations;

“donor” means a living person from whom it is proposed to remove an organ;

“recipient” means a person into whom it is proposed to transplant an organ.

Constitution of the Unrelated Live Transplant Regulatory Authority

2.—(1) There is hereby constituted for the purposes of section 2(3) of the Act an authority called the Unrelated Live Transplant Regulatory Authority.

(2) The Authority shall consist of a chairman appointed by the Secretary of State and of such number of other members appointed by him, not being less than 7 or more than 11, as he thinks fit.

(3) The chairman and at least 3 other members of the Authority shall be registered medical practitioners and at least 4 members of the Authority shall be persons who are not, and have not at any time been, registered medical practitioners.

(4) The tenure of office of the chairman and any other member of the Authority shall be on such terms and for such period as the Secretary of State shall specify on appointing him.

(5) The procedure of the Authority shall be such as the Authority may determine.

Transplants between persons who are not genetically related

3.—(1) The prohibition in section 2(1) of the Act (restriction on transplants between persons not genetically related) shall not apply in cases where a registered medical practitioner has caused the matter to be referred to the Authority and where the Authority is satisfied:—

(a) that no payment has been, or is to be, made in contravention of section 1 of the Act;

(b) that the registered medical practitioner who has caused the matter to be referred to the Authority has clinical responsibility for the donor; and

(c) except in a case where the primary purpose of removal of an organ from a donor is the medical treatment of that donor, that the conditions specified in paragraph (2) of this regulation are satisfied.

(2) The conditions referred to in paragraph (1)(c) of this regulation are:—

(a) that a registered medical practitioner has given the donor an explanation of the nature of the medical procedure for, and the risk involved in, the removal of the organ in question;

(b) that the donor understands the nature of the medical procedure and the risks, as explained by the registered medical practitioner, and consents to the removal of the organ in question;

(c) that the donor’s consent to the removal of the organ in question was not given under duress and was not obtained by coercion or the offer of an inducement;

(d) that the donor understands that he is entitled to withdraw his consent if he wishes, but has not done so;

(e) that the donor and the recipient have both been interviewed by a person who appears to the Authority to have been suitably qualified to conduct such interviews and who has reported to the Authority on the conditions contained in sub-paragraphs (a) to (d) above and has included in his report anaccount of any difficulties of communication with the donor or the recipient and an explanation of how those difficulties were overcome.

K. Clarke

One of Her Majesty’s Principal Secretaries of State

29th December 1989

Explanatory Note

(This note is not part of the Regulations)

These Regulations make provision for cases in which the prohibition of transplants between living persons who are not genetically related in section 2(1) of the Human Organ Transplants Act 1989 does not apply.

Regulation 2 provides for the establishment and constitution of the Unrelated Live Transplant Regulatory Authority for the purposes of section 2(3) of the Act.

Regulation 3 specifies the conditions which are required to be satisfied in cases to which the Regulations apply. These include the Authority being satisfied that no payment has been or is to be made for a human organ in contravention of section 1 of the Act.

(1)

1989 c. 31.