Commercial trading of human tissue prohibited
32.—(1) Subject to subsections (4) and (5), a contract or an arrangement under which a person agrees, for valuable consideration, whether given or to be given to himself or herself or to another person, to the sale or supply of any human tissue from his or her body or from the body of another person, whether before or after his or her death or the death of the other person (as the case may be) is void.
(2) A person who enters into a contract or an arrangement of the kind referred to in subsection (1) and to which that subsection applies shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both.
(3) Any person who —(a)
gives or offers to give valuable consideration for the sale or supply of, or for an offer to sell or supply, any human tissue from the body of another person other than for the purpose of transplantation to his or her body;
(b)
receives valuable consideration for the sale or supply of, or for an offer to sell or supply, any human tissue from the body of another person;
(c)
offers to sell or supply any human tissue from the body of another person for valuable consideration;
(d)
initiates or negotiates any contract or arrangement for the sale or supply of, or for an offer to sell or supply, any human tissue from the body of another person for valuable consideration other than for the purpose of transplantation to his or her body; or
(e)
takes part in the management or control of a body corporate or body unincorporate whose activities consist of or include the initiation or negotiation of any contract or arrangement referred to in paragraph (d),
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both.
(4) Subsections (1) and (3) do not apply to or in relation to —(a)
a contract or an arrangement providing only for the reimbursement of any expenses necessarily incurred by a person in relation to the removal of human tissue in accordance with the provisions of any other written law;
(b)
any scheme introduced or approved by the Government granting medical benefits or privileges to any human tissue donor and any member of the donor’s family or any person nominated by the donor; and
(c)
any contract, arrangement or valuable consideration providing only for the defraying or reimbursing, in money or money’s worth, of such costs or expenses that may be reasonably incurred by a living person in relation to —(i)
the removal, transportation, preparation, preservation, quality control or storage of any human tissue;
(ii)
the costs or expenses (including the costs of travel, accommodation, domestic help or child care) or loss of earnings so far as are reasonably or directly attributable to that person supplying any human tissue from his or her body; and
(iii)
any short-term or long-term medical care or insurance protection of that person which is or may reasonably be necessary as a consequence of his or her supplying any human tissue from his or her body.
(5) Nothing in this section will render inoperative a consent or an authority given or purporting to have been given under this Act in relation to any human tissue from the body of a person or in relation to the body of a person if a person acting pursuant to the consent or authority did not know and had no reason to know that the human tissue or the body was the subject matter of a contract or an arrangement referred to in subsection (1) or (3).
(6) This section and section 33 do not apply to any human tissue where any of the following provisions applies to that tissue:(a)
section 13 or 14 of the Human Organ Transplant Act 1987 (Prohibition of trading in organs and blood);
(b)
section 13 of the Human Cloning and Other Prohibited Practices Act 2004 (Prohibition against commercial trading in human eggs, human sperm and human embryos).
Advertisements relating to commercial trading of human tissue prohibited
33.—(1) No person may issue or cause to be issued any advertisement relating to the buying or selling in Singapore of any human tissue or of the right to take any human tissue from the body of a person.
(2) In this section, “advertisement” includes every form of advertising, whether in a publication, or by the display of any notice or signboard, or by means of any catalogue, price list, letter (whether circulated or addressed to a particular person) or other documents, or by words inscribed on any article, or by the exhibition of a photograph or a cinematograph film, or by way of sound recording, sound broadcasting or television, or in any other way, and any reference to the issue of an advertisement is construed accordingly.
(3) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both.
Notification of tissue bank
34.—(1) A research institution must notify the Director‑General of any tissue bank which the research institution is directly or indirectly operating or which is part of the research institution.[Act 11 of 2023 wef 01/05/2023]
(2) A tissue bank must notify the Director‑General of its particulars unless a research institution has made a notification of that tissue bank in accordance with subsection (1).[Act 11 of 2023 wef 01/05/2023]
(3) A notification for the purposes of subsection (1) or (2) must be submitted to the Director‑General in such form and manner, with such particulars and within such time as may be prescribed, and must be accompanied by such fee as may be prescribed.[Act 11 of 2023 wef 01/05/2023]
(4) Any person who contravenes subsection (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
(5) Any person who, in submitting a notification for the purposes of subsection (1) or (2) —(a)
makes any statement or furnishes any document which he or she knows to be false or does not believe to be true; or
(b)
by the intentional suppression of any material fact, furnishes information which is misleading,
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
Duties of tissue bank
35.—(1) Every tissue bank must, in respect of any tissue banking activity to be conducted under its supervision and control —(a)
submit a notification in such form and manner, and within such time as may be prescribed, before the commencement of any tissue banking activity conducted under that tissue bank’s supervision and control; and
(b)
submit, in accordance with section 36, a declaration of compliance in respect of all tissue banking activities conducted under its supervision and control in the preceding 12 months, or such other period of time as the Director‑General may require.[Act 11 of 2023 wef 01/05/2023]
(2) Every tissue bank must, in respect of any tissue banking activity which is carried out under its supervision and control —(a)
supervise, review and proactively monitor the conduct of the tissue banking activity;
(b)
designate a principal person in charge to be responsible for ensuring that the tissue bank complies with this Act;
(c)
formulate and implement appropriate standards, policies and procedures to supervise, review and monitor the conduct of the tissue banking activity;
(d)
investigate any areas of concern and take such remedial measures as appropriate;
(e)
ensure that the tissue banking activity —(i)
is in compliance with the requirements of this Act; and
(ii)
is conducted in accordance with its standards, policies and procedures referred to in paragraph (c);
(f)
ensure that if any human tissue under its supervision and control is to be exported or otherwise removed from Singapore to a place outside Singapore, the export or removal is carried out in accordance with prescribed requirements, including but not limited to requirements in relation to consent from the donor;
(g)
ensure that if any human tissue is to be removed from its supervision and control in circumstances other than in paragraph (f), the removal is carried out in accordance with prescribed requirements, including but not limited to requirements in relation to approval for the removal of individually‑identifiable tissue from an institutional review board and scientific endorsement by experts on the merits of the research for which the tissue rendered non‑identifiable within the meaning of section 27(3) are removed; and
(h)
perform such other functions and duties as may be prescribed by the Minister.
(3) Every tissue bank must notify the Director‑General, in such form and manner as may be prescribed, of —(a)
the commission of any suspected offence or contravention under this Act or the regulations;
(b)
the occurrence of any serious adverse event; and
(c)
such other matters as may be prescribed.[Act 11 of 2023 wef 01/05/2023]
(4) The designation of a principal person in charge by a tissue bank under subsection (2)(b) does not absolve or relieve the tissue bank of any of its obligations or duties under this Act.
(5) To avoid doubt, the delegation of any obligation or duty under this Act to another person or service provider under a contract or other arrangement does not absolve or relieve the tissue bank of any of its obligations or duties under this Act.
(6) Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
(7) Any person who contravenes subsection (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
Declaration of compliance by tissue bank
36.—(1) The declaration of compliance that a tissue bank is required to submit to the Director‑General under section 35(1) for all tissue banking activities conducted under the supervision and control of the tissue bank must be in such form and submitted in such manner and within such time as may be prescribed and must be accompanied by —(a)
such particulars, information and documents as may be prescribed;
(b)
if required by the Director‑General, a statutory declaration by the tissue bank verifying any information contained in or related to the declaration of compliance; and[Act 11 of 2023 wef 01/05/2023]
(c)
such fee as may be prescribed.[Act 11 of 2023 wef 01/05/2023]
(2) A tissue bank must notify the Director‑General —(a)
of any change in the information submitted under subsection (1)(a), within 30 days after the occurrence of the change or such longer period as the Director‑General may allow in any particular case; and[Act 11 of 2023 wef 01/05/2023]
(b)
of its intention to cease operating as a tissue bank at least 30 days before the cessation of operation or such shorter period as the Director‑General may allow in any particular case.[Act 11 of 2023 wef 01/05/2023]
(3) Any person who, in submitting a declaration of compliance referred to in subsection (1) or any notification referred to in subsection (2) —(a)
makes any statement or furnishes any document which he or she knows to be false or does not believe to be true; or
(b)
by the intentional suppression of any material fact, furnishes information which is misleading,
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
(4) Any person who contravenes subsection (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.
Restrictions on activities relating to human tissue
37.—(1) No person may remove any human tissue from a donor unless —(a)
where the tissue is to be removed for a therapeutic or diagnostic purpose but will also be or is likely to be used for research purposes, appropriate consent has been obtained for these research purposes in addition to the consent obtained for the therapeutic or diagnostic purpose; or
(b)
where the tissue is to be removed for a research purpose, appropriate consent has been obtained for the tissue to be removed from the donor.
(2) No person may remove any human tissue from any of the following persons unless the removal of the tissue was primarily for a therapeutic or diagnostic purpose:(a)
an adult who lacks mental capacity;
(b)
a minor who lacks mental capacity;
(c)
a minor who lacks sufficient understanding and intelligence to give consent.
(3) Despite subsection (2), an institutional review board may waive the requirement that the tissue be removed, from any person referred to in that subsection, primarily for a therapeutic or diagnostic purpose if the board is satisfied that —(a)
the removal of the tissue involves no more than minimal risk to that person; and
(b)
there are reasonable grounds for believing that the proposed areas of research cannot be carried out without the use of the tissue from the class of persons to which that person belongs.
(4) No person may store any human tissue for subsequent use in research unless that person is reasonably satisfied that —(a)
appropriate consent has been obtained for the tissue to be stored for subsequent use; and
(b)
the storage is in accordance with any conditions or restrictions specified as part of the appropriate consent.
(5) No person may supply any human tissue to another person for use in research unless that person is reasonably satisfied that —(a)
appropriate consent has been obtained for the tissue to be used in research;
(b)
the intended use is in accordance with any conditions or restrictions specified as part of the appropriate consent; and
(c)
the recipient is informed of the requirements referred to in paragraphs (a) and (b).
(6) No person may use any human tissue in research unless that person is reasonably satisfied that —(a)
appropriate consent has been obtained for the tissue to be used in research; and
(b)
the intended use is in accordance with any conditions or restrictions specified as part of the appropriate consent.
(7) No person may use any human tissue that has been —(a)
removed from the donor where the sole purpose or one of the purposes of the removal is research;
(b)
stored for use in research; or
(c)
supplied for use in research,
for any purpose other than research unless that person is reasonably satisfied that the use is in accordance with the conditions or restrictions (if any) specified as part of the appropriate consent for its use in research.
(8) In the case of any human tissue which has been imported from a place outside Singapore, whether on its own or as part of a human body or body part, it is sufficient compliance with subsection (4), (5), (6) or (7) for a person to prove that there is documentary evidence that consent has been given in accordance with the legal or ethical requirements of that place.
(9) Where the human tissue was removed from a donor for a therapeutic or diagnostic purpose, no person may store, supply or use the tissue for research or for any other purpose unless the medical practitioner or healthcare institution responsible for the medical treatment of the donor had completed all necessary therapeutic or diagnostic procedures and no longer requires the tissue or part of the tissue for the treatment.
(10) This section does not apply to —(a)
the removal, storage or supply of any human tissue in the course of a post-mortem examination conducted in accordance with the Coroners Act 2010 or carried out pursuant to the order of a Coroner made under that Act;
(b)
the removal, storage or supply of any organ as defined in the Human Organ Transplant Act 1987 and carried out in accordance with that Act; and
(c)
the removal, storage or supply of all or any part of a human body or a post-mortem examination carried out in accordance with the Medical (Therapy, Education and Research) Act 1972.
(11) Any person who contravenes this section shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 5 years or to both.
Compelling person to donate tissue
38. Any person who —(a)
by means of coercion or intimidation, compels another person against that person’s will to allow his or her tissue to be removed from his or her body;
(b)
by means of coercion or intimidation, compels another person (A) against A’s will to give A’s consent or to refrain from withdrawing A’s consent for the removal of tissue from the body of another person (B);
(c)
by means of deception or misrepresentation, causes another person to allow or continue to allow his or her tissue to be removed from his or her body; or
(d)
by means of deception or misrepresentation, causes another person (A) to give A’s consent or to refrain from withdrawing A’s consent for the removal of tissue from the body of another person (B),
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 10 years or to both.
Restrictions on disclosure of information on tissue donor
39.—(1) No person may disclose any individually‑identifiable information on any donor of human tissue which has come to that person’s knowledge except —(a)
with the consent of the donor or the donor’s legal representative, as the case may be;
(b)
when it is necessary to do so in connection with the administration or execution of anything under this Act;
(c)
when ordered to do so by a court;
(d)
where the information is publicly available;
(e)
to any person or class of persons to whom, in the opinion of the Director‑General, it is in the public interest that the information be disclosed;[Act 11 of 2023 wef 01/05/2023]
(f)
where any other right of disclosure arises under this Act or any other written law or rule of law; or
(g)
in such other circumstances and to such persons as may be prescribed.
(2) No person receiving any individually-identifiable information of a donor may disclose any individually-identifiable information of the donor, if at the time when the person received the information or material, the person knew or had reasonable grounds to believe that it had been communicated or supplied to him or her in contravention of this Act or any other written law or rule of law.
(3) Any person who contravenes subsection (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.
Source: Singapore Statutes Online (Attorney-General's Chambers), © Government of Singapore.
