Part of a comprehensive analysis of the Human Biomedical Research Act 2015
All Parts in This Series
Prohibition of Commercial Trading of Human Tissue and Related Offences
The Human Biomedical Research Act 2015 (HBRA) strictly prohibits the commercial trading of human tissue to uphold ethical standards and prevent exploitation. Section 32(1) explicitly states:
"Subject to subsections (4) and (5), a contract or an arrangement under which a person agrees, for valuable consideration... to the sale or supply of any human tissue... is void." — Section 32(1), Human Biomedical Research Act 2015
Verify Section 32 in source document →
This provision exists to ensure that human tissue is not commodified, preserving human dignity and preventing unethical profit-making from human biological materials. The law voids any contract involving the sale or supply of human tissue for valuable consideration, thereby eliminating any legal basis for commercial transactions in this context.
Further reinforcing this prohibition, Section 33(1) bans advertisements related to the buying or selling of human tissue:
"No person may issue or cause to be issued any advertisement relating to the buying or selling in Singapore of any human tissue..." — Section 33(1), Human Biomedical Research Act 2015
Verify Section 33 in source document →
This restriction prevents the promotion or facilitation of commercial trading, which could otherwise encourage unethical practices or exploitation of donors.
Violations of these provisions attract severe penalties to deter non-compliance. Section 32(2) prescribes:
"A person who enters into a contract... 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." — Section 32(2), Human Biomedical Research Act 2015
Verify Section 32 in source document →
Similarly, Section 33(3) imposes equivalent penalties for advertising offences. The high fines and lengthy imprisonment terms reflect the seriousness with which the legislature treats the protection of human tissue from commercial exploitation.
Notification and Duties of Tissue Banks
To ensure proper oversight and ethical management of human tissue, the HBRA mandates notification and operational duties for tissue banks. Section 34(1) requires research institutions to notify the Director-General of any tissue bank they operate:
"A research institution must notify the Director‑General of any tissue bank which the research institution is directly or indirectly operating..." — Section 34(1), Human Biomedical Research Act 2015
Verify Section 34 in source document →
This notification requirement enables regulatory authorities to maintain a comprehensive registry of tissue banks, facilitating monitoring and compliance enforcement.
Section 35(2) outlines the duties of tissue banks, including supervision, review, and proactive monitoring of tissue banking activities, designation of a principal person in charge, and formulation and implementation of appropriate standards, policies, and procedures:
"Every tissue bank must... supervise, review and proactively monitor the conduct of the tissue banking activity; designate a principal person in charge... formulate and implement appropriate standards, policies and procedures..." — Section 35(2), Human Biomedical Research Act 2015
Verify Section 35 in source document →
These duties exist to ensure that tissue banks operate responsibly, maintain high ethical and safety standards, and are accountable for their activities.
Additionally, Section 36(1) requires tissue banks to submit a declaration of compliance in a prescribed form and manner:
"The declaration of compliance that a tissue bank is required to submit... must be in such form and submitted in such manner and within such time as may be prescribed..." — Section 36(1), Human Biomedical Research Act 2015
Verify Section 36 in source document →
This declaration serves as a formal attestation of adherence to regulatory requirements, facilitating ongoing oversight.
Failure to comply with notification or declaration requirements attracts penalties. For example, Section 34(4) states:
"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." — Section 34(4), Human Biomedical Research Act 2015
Verify Section 34 in source document →
Similarly, Sections 35(6) and 36(4) prescribe comparable penalties for breaches of duties and declaration submission respectively. These sanctions incentivize tissue banks to maintain transparency and compliance.
Restrictions on Activities Relating to Human Tissue
The HBRA imposes strict controls on the removal and use of human tissue to protect donor autonomy and privacy. Section 37(1) mandates that no human tissue may be removed without appropriate consent:
"No person may remove any human tissue from a donor unless... appropriate consent has been obtained..." — Section 37(1), Human Biomedical Research Act 2015
Verify Section 37 in source document →
This provision safeguards individual rights by ensuring that tissue removal is voluntary and informed.
Section 38 criminalizes coercion or intimidation to compel tissue donation:
"Any person who... by means of coercion or intimidation, compels another person against that person’s will to allow his or her tissue to be removed... shall be guilty of an offence..." — Section 38, Human Biomedical Research Act 2015
Verify Section 38 in source document →
This protects donors from abuse and upholds ethical standards in tissue procurement.
Section 39(1) restricts disclosure of donor information to protect privacy:
"No person may disclose any individually‑identifiable information on any donor of human tissue which has come to that person’s knowledge except..." — Section 39(1), Human Biomedical Research Act 2015
Verify Section 39 in source document →
Confidentiality is critical to maintaining trust in biomedical research and tissue banking.
Penalties for contravening these restrictions are substantial. Section 37(11) provides:
"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." — Section 37(11), Human Biomedical Research Act 2015
Verify Section 37 in source document →
Section 39(3) prescribes fines and imprisonment for improper disclosure of donor information:
"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." — Section 39(3), Human Biomedical Research Act 2015
Verify Section 39 in source document →
These penalties emphasize the importance of respecting donor rights and confidentiality.
Definitions and Scope of Advertisement Restrictions
The HBRA defines "advertisement" broadly in Section 33(2) to capture all forms of promotion related to human tissue trading:
"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... or by way of sound recording, sound broadcasting or television, or in any other way..." — Section 33(2), Human Biomedical Research Act 2015
Verify Section 33 in source document →
This expansive definition ensures that no medium can be used to circumvent the prohibition on commercial trading advertisements, thereby closing potential loopholes.
Cross-References to Other Legislation
The HBRA acknowledges the interplay with other statutes regulating human biological materials to avoid overlap and conflict. Section 32(6) exempts tissues covered under the Human Organ Transplant Act 1987 and the Human Cloning and Other Prohibited Practices Act 2004:
"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)." — Section 32(6), Human Biomedical Research Act 2015
Verify Section 32 in source document →
Similarly, Section 37(10) excludes activities conducted under the Coroners Act 2010, Human Organ Transplant Act 1987, and Medical (Therapy, Education and Research) Act 1972:
"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." — Section 37(10), Human Biomedical Research Act 2015
Verify Section 37 in source document →
These cross-references clarify the regulatory boundaries and ensure that the HBRA complements existing legislation without duplication.
Conclusion
The Human Biomedical Research Act 2015 establishes a comprehensive regulatory framework governing human tissue to uphold ethical standards, protect donor rights, and ensure transparency and accountability in tissue banking and research. Key provisions prohibit commercial trading and advertising, mandate notification and compliance duties for tissue banks, restrict activities relating to tissue removal and use, and safeguard donor confidentiality. The Act prescribes stringent penalties for non-compliance, reflecting the importance of these protections. Cross-references to other relevant statutes ensure coherence within Singapore’s legal landscape governing human biological materials.
Sections Covered in This Analysis
- Section 32 – Prohibition of commercial trading of human tissue
- Section 33 – Prohibition of advertisements relating to commercial trading of human tissue
- Section 34 – Notification requirements for tissue banks
- Section 35 – Duties of tissue banks including supervision, compliance, and reporting
- Section 36 – Declaration of compliance by tissue banks
- Section 37 – Restrictions on activities relating to human tissue including consent and use
- Section 38 – Prohibition against compelling persons to donate tissue
- Section 39 – Restrictions on disclosure of donor information
- Section 33(2) – Definition of advertisement
- Cross-references to Human Organ Transplant Act 1987, Human Cloning and Other Prohibited Practices Act 2004, Coroners Act 2010, Medical (Therapy, Education and Research) Act 1972
Source Documents
For the authoritative text, consult SSO.