Human Organ Transplant Regulations 2004

Human Organ Transplant Act 1987

(Section 32)

Human Organ Transplant
Regulations 2004

2025 REVISED EDITION

(2 June 2025)

[1 July 2004]

Citation

1.  These Regulations are the Human Organ Transplant Regulations 2004.

Definitions

2.  In these Regulations —

“donor”, in relation to a living donor organ transplant, means the person from whom a specified organ is or will be removed for the purpose of its transplantation into the body of another living person;

“recipient”, in relation to a living donor organ transplant, means the person into whose body a specified organ is or will be transplanted.

Forms for Parts 2 and 3 of Act

3.—(1)  The form for authorising the removal of any organ from the body of a person under section 4(1) of the Act is Form 1 in the First Schedule.

(2)  For the purposes of section 8(1) of the Act —

(a) the prescribed form is Form 2 in the First Schedule; and

(b) a person who is unable to read or understand English may complete and submit an official translation of Form 2 in Malay, Mandarin or Tamil that is available on the specified website.

(3)  For the purposes of section 8(2) of the Act, the prescribed form is Form 3 in the First Schedule.

(4)  For the purposes of section 10(1) of the Act —

(a) the prescribed form is Form 4 in the First Schedule; and

(b) a person who is unable to read or understand English may complete and submit an official translation of Form 4 in Malay, Mandarin or Tamil that is available on the specified website.

(5)  For the purposes of section 10(2) of the Act, the prescribed form is Form 5 in the First Schedule.

(6)  In this regulation, “specified website” means the website at https://www.liveon.gov.sg.

Approval and appointment of transplant ethics committees

4.—(1)  For the purpose of enabling transplant ethics committees to be appointed under Part 4A of the Act —

(a) the licensee of a hospital must, with the approval of the Director‑General, establish a panel of not less than 3 persons, who must be medical practitioners employed or otherwise connected with the hospital; and

(b) the Director‑General must establish —

(i) a panel of medical practitioners; and

(ii) a panel of lay persons,

comprising the numbers of medical practitioners and lay persons, respectively, determined by the Director‑General.

(2)  A member of any of the panels in paragraph (1) is to be appointed for a term of not more than 2 years and —

(a) he or she may be re-appointed with the approval of the Director‑General; and

(b) his or her appointment may at any time be terminated by the Director‑General.

(3)  The licensee of a hospital must, when applying for the approval of the Director‑General under sub‑paragraph (a) of paragraph (1), submit to the Director‑General the names and curriculum vitae of the persons nominated for the panel referred to in that sub‑paragraph.

(4)  Subject to paragraphs (5) and (6), the licensee of a hospital must, from time to time as the circumstances may require, appoint a transplant ethics committee comprising —

(a) one member from the panel mentioned in paragraph (1)(a);

(b) one member from the panel mentioned in paragraph (1)(b)(i) who is not employed or otherwise connected with the hospital; and

(c) one member from the panel mentioned in paragraph (1)(b)(ii).

(5)  Where it comes to the notice of the licensee of a hospital in which any living donor organ transplant is intended to be carried out, whether from the information provided in the application form for the written authorisation of the transplant ethics committee of the hospital or otherwise, that —

(a) a prior application for written authorisation under section 15(1) of the Act has been made to a transplant ethics committee in respect of the same prospective donor and prospective recipient; and

(b) the transplant ethics committee mentioned in sub‑paragraph (a) has refused to grant written authorisation,

the licensee must —

(c) seek the approval of the Director‑General if the licensee desires to proceed with the appointment of a transplant ethics committee under paragraph (4); and

(d) decline to appoint a transplant ethics committee if the Director‑General does not grant his or her approval.

(6)  The licensee of a hospital may, with the approval of the Director‑General, appoint one or more additional members to the transplant ethics committee.

(7)  Subject to the provisions of the Act and these Regulations, a transplant ethics committee may make rules to regulate its own procedure.

(8)  The licensee of a hospital may, with the approval of the Director‑General, change the membership of the panel mentioned in paragraph (1)(a).

Procedures of transplant ethics committees

5.—(1)  Every transplant ethics committee must assess and give its written assessment, in a timely manner, of an application for its written authorisation of a living donor organ transplant under section 15(1) of the Act.

(2)  The quorum of any meeting of a transplant ethics committee is 3 members, of whom —

(a) one must be a medical practitioner employed or otherwise connected with the hospital;

(b) one must be a medical practitioner not employed or otherwise connected with the hospital; and

(c) one must be a lay person,

and a decision must not be made unless such a quorum is present.

(3)  Subject to paragraph (6)(b), where an application for the written authorisation of a transplant ethics committee is assessed at a meeting of the transplant ethics committee, a person —

(a) who is directly involved in the care of the donor or the recipient; or

(b) who will be involved in the removal of any specified organ from the body of the donor or the transplantation of the specified organ to the body of the recipient,

must not be present at the meeting.

(4)  A decision at any meeting of a transplant ethics committee must be adopted by a consensus of the members present.

(5)  Every transplant ethics committee must —

(a) submit a copy of the report of every decision made by it in authorising any living donor organ transplant or otherwise to the Director‑General within 7 days of the date of the decision; and

(b) keep and maintain every report referred to in sub‑paragraph (a).

(6)  A transplant ethics committee may, when assessing any application for the written authorisation of a living donor organ transplant —

(a) request for any additional information or document to be provided by the applicant that it may consider necessary; or

(b) interview the donor, the recipient or any other person in relation to the application.

Additional considerations for giving of written authorisations

6.  Every transplant ethics committee must, in addition to the considerations specified in section 15(2) of the Act, have regard to the considerations of public interest and community values when assessing an application for its written authorisation of a living donor organ transplant.

Review of decisions by transplant ethics committee

6A.—(1)  An applicant for review who is aggrieved by the decision of a transplant ethics committee to refuse to grant written authorisation under section 15(1) of the Act may make a written application to the Director‑General to require the transplant ethics committee to review its decision.

(2)  The applicant for review must make the written application to the Director‑General —

(a) within a period of 21 days after the date on which the decision of the transplant ethics committee first comes to the notice of the applicant for review; or

(b) within any further period that the Director‑General allows, either before or after the end of that 21‑day period.

(3)  The applicant for review must, in his or her written application to the Director‑General, set out the grounds on which he or she is applying to the Director‑General to require the transplant ethics committee to review its decision.

(4)  Upon receipt of the written application, the Director‑General may, as he or she sees fit —

(a) dismiss the application; or

(b) direct the transplant ethics committee to review its decision, and specify the considerations that the transplant ethics committee must have regard to, as directed by the Director‑General under section 15(3) of the Act.

(5)  In this regulation, “applicant for review”, in relation to a living donor organ transplant, means —

(a) the person who made the application for the written authorisation of a transplant ethics committee under section 15(1) of the Act;

(b) the prospective donor; or

(c) the prospective recipient.

Period of validity of written authorisation

6B.—(1)  For the purposes of section 15(1) of the Act, every written authorisation of the transplant ethics committee of a hospital is valid for the period of time determined by the transplant ethics committee, not being a period longer than 60 days from the date the written authorisation is granted.

(2)  Upon the expiry of the validity period of a written authorisation as determined by the transplant ethics committee of a hospital in accordance with paragraph (1), a living donor organ transplant must not be carried out in the hospital involving the same prospective donor and prospective recipient except within the validity period of a fresh written authorisation of the transplant ethics committee of the hospital.

Forms for Part 4A of Act

7.—(1)  The form for applying for the written authorisation of a transplant ethics committee under section 15(1) of the Act —

(a) must be in Form 1 in the Second Schedule; and

(b) must be made by the medical practitioner who is principally responsible for the care of the donor.

(2)  The form for authorising, or otherwise, the removal of a specified organ from the body of a living person by a transplant ethics committee under section 15(1) of the Act must be in Form 2 in the Second Schedule.

Offence

8.  Any person who makes any declaration or statement in relation to an application for the written authorisation of a transplant ethics committee under section 15(1) of the Act which is false or misleading in a material particular shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $2,000 or to imprisonment for a term not exceeding 12 months or to both.