Healthcare Services (Human Tissue Banking Service) Regulations 2023

No. S 413

Healthcare Services Act 2020

Healthcare Services
(Human Tissue Banking Service)
Regulations 2023

In exercise of the powers conferred by section 57 of the Healthcare Services Act 2020, the Minister for Health makes the following Regulations:

PART 1

PRELIMINARY

Citation and commencement

1. These Regulations are the Healthcare Services (Human Tissue Banking Service) Regulations 2023 and come into operation on 26 June 2023.

Definitions

2. In these Regulations —

“authorised person”, in relation to a deceased donor, means the person who may give all or any part of the body of the deceased donor under section 4 of the Medical (Therapy, Education and Research) Act 1972;

“collect”, in relation to any human tissue, means to remove the human tissue from the body of a donor;

“donor” means an individual, whether living or deceased, from whose body any human tissue is removed for the purposes of transplant or other clinical use;

“General Regulations” means the Healthcare Services (General) Regulations 2021 (G.N. No. S 1035/2021);

“incidental finding”, in relation to any examination or test on any human tissue collected from a donor, means any observation, result or other finding about the donor that is disclosed or discovered by or during the examination or test and has potential health or reproductive importance to the donor, but is not related to the purpose or objective of the examination or test;

“licensee” means a person who holds a licence to provide a human tissue banking service;

“living donor”, in relation to any human tissue, means a donor who is alive when the human tissue is removed from the donor;

“personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing a human tissue banking service;

“recipient”, in relation to any human tissue transplanted or used for the purpose of treating or preventing a human disease, means an individual to whose body the human tissue is transplanted or in whose body the human tissue is used;

“transplant”, in relation to any human tissue, means —

(a)

to remove the human tissue from any part of the body of the donor; and

(b)

to transfer the human tissue to —

(i)	the donor’s body, whether it is the same part of the donor’s body from which the human tissue was removed or another part of the donor’s body; or
(ii)	the body of any other individual,

whether or not the human tissue is processed, altered or manipulated after its removal from the donor’s body;

“transplanting clinician”, in relation to any human tissue, means the medical practitioner who carries out the transplant of the human tissue;

“transplanting licensee”, in relation to any human tissue, means a person who holds a licence to provide an acute hospital service or ambulatory surgical centre service and performs or intends to perform a transplant of the human tissue;

“validated container”, in relation to the storage of any human tissue, means a container that is validated to store the human tissue in the conditions that will ensure that the human tissue will remain appropriate for its intended use.

Application of Regulations

3. Unless otherwise expressly provided in these Regulations, the provisions of these Regulations —

(a)	apply in addition to the provisions of the General Regulations; and
(b)	prevail if, and to the extent that, there is any inconsistency between these Regulations and the General Regulations insofar as the matter relates to a licensee.

Specified services

4. For the purposes of section 9A(1) of the Act, the services set out in the First Schedule are specified services for a human tissue banking service.

Notification of handling, processing, etc., of additional types of human tissue

5. A licensee that intends to handle, process, test, store or distribute any type of human tissue that is not set out in the First Schedule must give the Director‑General written notice of the licensee’s intention no later than 2 months before the licensee intends to start handling, processing, testing, storing or distributing that type of human tissue.

Prohibited service delivery modes

6. A licensee must not provide a human tissue banking service using any of the following service delivery modes:

(a)	any premises other than permanent premises;
(b)	using a conveyance;
(c)	by remote provision.

Made on 20 June 2023.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/35 Vol. 1]

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