Human Organ Transplant (Amendment No. 2) Regulations 2009

Status:

Published in Subsidiary Legislation Supplement
on 25 Sep 2009

No. S 439

Human Organ Transplant Act

(Chapter 131A)

Human Organ Transplant (Amendment No. 2) Regulations 2009

In exercise of the powers conferred by section 21 of the Human Organ Transplant Act, the Minister for Health hereby makes the following Regulations:

Citation and commencement

1. These Regulations may be cited as the Human Organ Transplant (Amendment No. 2) Regulations 2009 and shall come into operation on 1st November 2009.

Amendment of regulation 4

2. Regulation 4 of the Human Organ Transplant Regulations 2004 (G.N. No. S 213/2004) (referred to in these Regulations as the principal Regulations) is amended —

(a)

by deleting paragraph (1) and substituting the following paragraphs:

“(1) For the purpose of enabling transplant ethics committees to be appointed under Part IVA 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.

(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.”;

(b)

by deleting paragraphs (2) and (3) and substituting the following paragraphs:

“(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.

(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).

(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 15A(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 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.”; and

(c)

by deleting paragraph (6) and substituting the following paragraph:

“(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).”.

New regulations 6A and 6B

3. The principal Regulations are amended by inserting, immediately after regulation 6, the following regulations:

“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 15A(1) of the Act may make a written application to the Director to require the transplant ethics committee to review its decision.

(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 15A(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 15A(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 15A(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.

(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.”.

Amendment of Second Schedule

4. The Second Schedule to the principal Regulations is amended by deleting Forms 1 and 2 and substituting the following Forms: