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No. S 213

Human Organ Transplant Act

(Chapter 131A)

Human Organ Transplant Regulations 2004

In exercise of the powers conferred by sections 15A (3) and 19 of the Human Organ Transplant Act, Mr Khaw Boon Wan, Senior Minister of State, Ministry of Finance, charged with the responsibility of the Minister for Health, hereby makes the following Regulations:

Citation and commencement

1. These Regulations may be cited as the Human Organ Transplant Regulations 2004 and shall come into operation on 1st July 2004.

Definitions

2. In these Regulations, unless the context otherwise requires —

“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.

[S 300/2022 wef 06/04/2022]

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 shall, with the approval of the Director, establish a panel of not less than 3 persons, who shall be medical practitioners employed or otherwise connected with the hospital; and

(b)

the Director shall establish —

(i)	a panel of medical practitioners; and
(ii)	a panel of lay persons,

comprising such numbers of medical practitioners and lay persons, respectively, as the Director may determine.

[S 439/2009 wef 01/11/2009]

[S 300/2022 wef 31/12/2021]

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

(a)	he may be re-appointed with the approval of the Director; and
(b)	his appointment may at any time be terminated by the Director. [S 439/2009 wef 01/11/2009]

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

[S 439/2009 wef 01/11/2009]

(3) Subject to paragraphs (3A) and (4), the licensee of a hospital shall, from time to time as the circumstances may require, appoint a transplant ethics committee comprising —

(a)	one member from the panel referred to in paragraph (1)(a);
(b)	one member from the panel referred to in paragraph (1)(b)(i) who shall not be employed or otherwise connected with the hospital; and
(c)	one member from the panel referred to in paragraph (1)(b)(ii). [S 439/2009 wef 01/11/2009]

(3A) 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 [S 300/2022 wef 31/12/2021]
(b)	the transplant ethics committee referred to in sub-paragraph (a) has refused to grant written authorisation,

the licensee shall —

(i)	seek the approval of the Director if the licensee desires to proceed with the appointment of a transplant ethics committee under paragraph (3); and
(ii)	decline to appoint a transplant ethics committee if the Director does not grant his approval. [S 439/2009 wef 01/11/2009]

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

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

(6) The licensee of a hospital may, with the approval of the Director, change the membership of the panel referred to in paragraph (1)(a).

[S 439/2009 wef 01/11/2009]

Procedures of transplant ethics committees

5.—(1) Every transplant ethics committee shall 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.

[S 300/2022 wef 31/12/2021]

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

(a)	one shall be a medical practitioner employed or otherwise connected with the hospital;
(b)	one shall be a medical practitioner not employed or otherwise connected with the hospital; and
(c)	one shall be a lay person,

and no decision shall 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,

shall not be present at the meeting.

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

(5) Every transplant ethics committee shall —

(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 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 such additional information or document to be provided by the applicant as 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 shall, 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.

[S 300/2022 wef 31/12/2021]

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 to require the transplant ethics committee to review its decision.

[S 300/2022 wef 31/12/2021]

(2) The applicant for review shall make the written application to the Director —

(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 such further period as the Director allows, either before or after the end of that 21-day period.

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

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

(a)	dismiss the application; or
(b)	direct the transplant ethics committee to review its decision, and specify such considerations that the transplant ethics committee shall have regard to as the Director may direct under section 15(3) of the Act. [S 300/2022 wef 31/12/2021]

(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; [S 300/2022 wef 31/12/2021]
(b)	the prospective donor; or
(c)	the prospective recipient. [S 439/2009 wef 01/11/2009]

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 shall be valid for such period of time as the transplant ethics committee shall determine, not being a period longer than 60 days from the date the written authorisation is granted.

[S 300/2022 wef 31/12/2021]

(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), no living donor organ transplant shall 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.

[S 439/2009 wef 01/11/2009]

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)	shall be in Form 1 in the Second Schedule; and
(b)	shall be made by the medical practitioner who is principally responsible for the care of the donor.

[S 300/2022 wef 31/12/2021]

(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 shall be in Form 2 in the Second Schedule.

[S 300/2022 wef 31/12/2021]

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.

[S 300/2022 wef 31/12/2021]

Revocation

9. The Human Organ Transplant Regulations (Rg 1) are revoked.

Made this 19th day of April 2004.

MOSES LEE

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:18/1 Vol. 6; AG/LEG/SL/131A/2003/1 Vol. 1]