Act binds Government
56.—(1) Except as otherwise provided in subsection (2), this Act binds the Government and applies to the Government, including any human biomedical research conducted under the supervision and control of the Government.
(2) Nothing in this Act renders the Government liable to prosecution for an offence under this Act.
(3) To avoid doubt, no person is immune from prosecution for any offence under this Act by reason that the person is employed by, seconded to or engaged to provide services to the Government.
Power to exempt
57.—(1) The Minister may, either generally or in a particular case, and subject to such conditions as the Minister may impose, exempt, either permanently or for such period as the Minister may think fit, from all or any of the provisions of this Act —(a)
any person, research institution or tissue bank;
(b)
any class of persons, research institutions or tissue banks;
(c)
any ministry or department of the Government;
(d)
any human biomedical research or tissue banking activity;
(e)
any class of human biomedical research or tissue banking activity;
(f)
any human biological material or human tissue; or
(g)
any class of human biological material or human tissue.
(2) In the exercise of the Minister’s powers under subsection (1), the Minister may consult any advisory committee appointed under section 5 but the Minister is not bound by such consultation.
Designation of persons by Minister
58.—(1) The Minister may designate any of the persons specified in subsection (2) —(a)
to hear and determine in the Minister’s place any appeal or a specific appeal under section 54;
(b)
to refer any appeal or a specific appeal to an Appeals Advisory Panel established under section 55(1); or
(c)
to exercise all or any of the Minister’s powers conferred under section 55 or 57,
and any reference to the Minister in section 54, 55 or 57 includes a reference to the person so designated.
(2) The following are the persons who may be designated by the Minister for the purposes of subsection (1):(a)
the Second Minister (if any) for his or her Ministry;
(b)
any Minister of State or Senior Minister of State, for his or her Ministry.
Service of documents
59.—(1) A document that is permitted or required by this Act to be served on a person may be served as described in this section.
(2) A document permitted or required by this Act to be served on an individual may be served —(a)
by giving it to the individual personally;
(b)
by sending it by prepaid registered post to the address specified by the individual for the service of documents or, if no address is so specified, to the individual’s residential address or business address;
(c)
by leaving it at the individual’s residential address with an adult apparently resident there, or at the individual’s business address with an adult apparently employed there;
(d)
by affixing a copy of the document in a conspicuous place at the individual’s residential address or business address;
(e)
by sending it by fax to the fax number last known to the Director‑General or authorised officer giving or serving the document as the fax number for the service of documents on the individual; or[Act 11 of 2023 wef 01/05/2023]
(f)
by sending it by email to the individual’s last email address.
(3) A document permitted or required by this Act to be served on a partnership (other than a limited liability partnership) may be served —(a)
by giving it to any partner, secretary or other similar officer of the partnership;
(b)
by leaving it at, or by sending it by prepaid registered post to, the partnership’s business address;
(c)
by sending it by fax to the fax number used at the partnership’s business address; or
(d)
by sending it by email to the partnership’s last email address.
(4) A document permitted or required by this Act to be served on a body corporate (including a limited liability partnership) or an unincorporated association may be served —(a)
by giving it to the secretary or other similar officer of the body corporate or the unincorporated association, or the limited liability partnership’s manager;
(b)
by leaving it at, or by sending it by prepaid registered post to, the body corporate’s or unincorporated association’s registered office or principal office;
(c)
by sending it by fax to the fax number used at the body corporate’s or unincorporated association’s registered office or principal office; or
(d)
by sending it by email to the body corporate’s or unincorporated association’s last email address.
(5) Service of a document under subsection (1) takes effect —(a)
if the document is sent by fax and a notification of successful transmission is received, on the day of transmission;
(b)
if the document is sent by email, at the time that the email becomes capable of being retrieved by the person to whom it is addressed; and
(c)
if the document is sent by prepaid registered post, 2 days after the day the document was posted (even if it is returned undelivered).
(6) This section does not apply to documents to be served in proceedings in court.
(7) In this section —“business address” means —(a)
in the case of an individual, the individual’s usual or last known place of business; or
(b)
in the case of a partnership (other than a limited liability partnership), the partnership’s principal or last known place of business;
“last email address” means —(a)
the last email address given by the addressee concerned to the Director‑General or authorised officer giving or serving the document as the email address for the service of documents under this Act; or[Act 11 of 2023 wef 01/05/2023]
(b)
the last email address of the addressee concerned known to the Director‑General or the authorised officer giving or serving the document;[Act 11 of 2023 wef 01/05/2023]
“residential address” means an individual’s usual or last known place of residence.
Jurisdiction of courts
60. Despite any provision to the contrary in the Criminal Procedure Code 2010, a District Court has jurisdiction to try any offence under this Act and has power to impose the full penalty or punishment in respect of the offence.
Protection from personal liability
61. No liability is to lie personally against the Director‑General, any authorised officer or any other person authorised by or acting under the direction of the Director‑General who, acting in good faith and with reasonable care, does or omits to do anything in the execution or purported execution of this Act.[Act 11 of 2023 wef 01/05/2023]
Amendment of Schedules
62.—(1) The Minister may at any time, by order in the Gazette, amend the First, Second, Third, Fourth or Fifth Schedule.
(2) The Minister may, in any order made under subsection (1), make such incidental, consequential or supplementary provision as may be necessary or expedient.
Regulations
63.—(1) The Minister may make regulations for carrying out the purposes and provisions of this Act and for prescribing anything which may be prescribed.
(2) Without limiting subsection (1), the Minister may make regulations with respect to all or any of the following matters:(a)
the duties of research institutions, appointing bodies of institutional review boards, and researchers;
(b)
the qualifications of researchers;
(c)
the composition, duties, procedures, responsibilities and powers of institutional review boards;
(d)
the duties and responsibilities, qualifications of and training to be received by members of institutional review boards;
(e)
the practices, procedures and other requirements for the conduct of human biomedical research or tissue banking activity, including —(i)
the standards to be adhered to in the conduct of any human biomedical research or tissue banking activity;
(ii)
the procedures for the selection of research subjects for any biomedical research and for obtaining the appropriate consent for their participation as donors or subjects in such human biomedical research;
(iii)
the appropriate consent required for the participation of minors and other vulnerable persons as research subjects in human biomedical research;
(iv)
the records and documents to be maintained by research institutions, researchers or tissue banks and the information to be contained in such records and documents;
(v)
the furnishing to the Director‑General of such information, returns and reports as the Director‑General may require or as may be prescribed in connection with the administration and enforcement of this Act; and[Act 11 of 2023 wef 01/05/2023]
(vi)
the requirements pertaining to specific types of human biomedical research or tissue banking activity;
(f)
the procedures and requirements in relation to obtaining appropriate consent and the form of consent;
(g)
the requirements for the protection of the identity of individuals in relation to individually‑identifiable human biological material and health information;
(h)
the requirements in relation to the reporting of and investigations into any serious adverse event;
(i)
the duties, procedures, responsibilities and powers of inquiries committees;
(j)
the establishment of a scheme of accreditation for research institutions, researchers or institutional review boards (as the case may be) in relation to their compliance with the requirements of this Act;
(k)
the licensing of tissue banks and tissue banking activities;
(l)
the forms necessary for the administration of this Act; and
(m)
the fees and charges payable under or for the purposes of this Act.
(3) The Minister may, in making any regulations, provide that any contravention of or failure to comply with any regulation shall be an offence punishable with a fine not exceeding $20,000 or with imprisonment for a term not exceeding 2 years or with both.
Saving and transitional provisions for legacy human biological material
64.—(1) This Act, with the exception of sections 30 (prohibited human biomedical research), 31 (restricted human biomedical research), 32 (commercial trading of human tissue prohibited) and 33 (advertisements relating to commercial trading of human tissue prohibited), does not apply to any legacy human biological material or any information derived from such material.
(2) Despite subsection (1), regulations made under section 63 may provide for the requirements and conditions in relation to the use of legacy human biological material for human biomedical research that are different from the provisions of this Act.
(3) In this section, “legacy human biological material” means —(a)
any human biological material which has been removed from a human body, whether living or dead, at any time before 1 November 2019;
(b)
any biological material from the body of a dead person which has been stored for the purposes of human biomedical research at any time before 1 November 2019,
and which has been rendered non‑identifiable within the meaning of section 27(3) at any time before 1 November 2019.
Saving and transitional provisions
65.—(1) Every research institution which immediately before 1 November 2017 was supervising and controlling the conduct of human biomedical research may continue supervising and controlling the conduct of human biomedical research as if this Act had not been enacted for a period of 12 months after that day or for such other longer period as the Director‑General may in any particular case allow.[Act 11 of 2023 wef 01/05/2023]
(2) Every person who immediately before 1 November 2017 was conducting any human biomedical research may continue conducting the research as if this Act had not been enacted for a period of 12 months after that day or for such other longer period as the Director‑General may in any particular case allow.[Act 11 of 2023 wef 01/05/2023]
(3) For a period of 2 years after 1 November 2017, the Minister may, by regulations, prescribe such additional provisions of a saving or transitional nature consequent on the enactment of this Act as the Minister may consider necessary or expedient.
Source: Singapore Statutes Online (Attorney-General's Chambers), © Government of Singapore.
