Part of a comprehensive analysis of the Human Biomedical Research Act 2015
All Parts in This Series
Binding Effect of the Act on the Government and Its Exemption from Prosecution
The Human Biomedical Research Act 2015 explicitly states that the Act binds the Government and applies to any human biomedical research conducted under the Government’s supervision and control. This is articulated in Section 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." — Section 56(1)
Verify Section 56 in source document →
This provision ensures that government-conducted biomedical research adheres to the same regulatory standards as private entities, promoting uniformity and accountability in research practices. However, the Government is exempted from prosecution under the Act, which protects it from legal liabilities that could impede public health initiatives or research activities. This exemption balances the need for oversight with the practicalities of governmental functions.
Ministerial Powers to Exempt and Delegate
Section 57 empowers the Minister to exempt persons, institutions, ministries, activities, or materials from all or any provisions of the Act, either generally or in particular cases, and subject to conditions the Minister may impose:
"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..." — Section 57(1)
Verify Section 57 in source document →
This power exists to provide flexibility in the application of the Act, allowing the Minister to tailor regulatory requirements to specific circumstances, such as emerging technologies or unique research contexts that may not fit neatly within existing provisions.
Further, Section 58 authorises the Minister to designate persons to exercise certain powers or hear appeals under the Act:
"The Minister may designate any of the persons specified in subsection (2) to hear and determine in the Minister’s place any appeal or a specific appeal under section 54..." — Section 58(1)
Verify Section 58 in source document →
This delegation mechanism facilitates efficient administration and adjudication of appeals, ensuring that decisions can be made promptly by qualified individuals without overburdening the Minister.
Service of Documents and Definitions Relevant to Service
Section 59 outlines the methods and effects of serving documents under the Act, providing clarity and legal certainty in procedural matters:
"A document that is permitted or required by this Act to be served on a person may be served as described in this section." — Section 59(1)
Verify Section 59 in source document →
To support this, Section 59(7) defines key terms related to service addresses:
"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 (b) the last email address of the addressee concerned known to the Director‑General or the authorised officer giving or serving the document; “residential address” means an individual’s usual or last known place of residence." — Section 59(7)
These definitions ensure that service of documents is conducted in a manner that is both practical and legally effective, reducing disputes over whether proper notice has been given.
Jurisdiction of the District Court and Penalties for Offences
Section 60 confers jurisdiction on the District Court to try offences under the Act and empowers it to impose the full range of penalties:
"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." — Section 60
Verify Section 60 in source document →
This provision ensures that offences under the Act are dealt with expeditiously at the District Court level, facilitating effective enforcement.
Regarding penalties, Section 63(3) authorises the Minister to prescribe offences and penalties by regulation, including fines and imprisonment:
"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." — Section 63(3)
Verify Section 63 in source document →
This penalty framework serves as a deterrent against non-compliance, ensuring that the regulatory regime has teeth to uphold standards in human biomedical research.
Protection from Personal Liability for Officials
Section 61 provides protection from personal liability for the Director-General, authorised officers, or other persons acting under the Director-General’s direction, provided they act in good faith and with reasonable care:
"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." — Section 61
Verify Section 61 in source document →
This provision encourages officials to perform their duties diligently without fear of personal legal repercussions, thereby promoting effective enforcement and administration of the Act.
Minister’s Power to Amend Schedules and Make Regulations
Section 62(1) empowers the Minister to amend the various Schedules to the Act by order published in the Gazette:
"The Minister may at any time, by order in the Gazette, amend the First, Second, Third, Fourth or Fifth Schedule." — Section 62(1)
Verify Section 62 in source document →
This flexibility allows the regulatory framework to adapt to evolving scientific knowledge and policy needs without requiring full legislative amendments.
Complementing this, Section 63(1) authorises the Minister to make regulations for carrying out the purposes and provisions of the Act:
"The Minister may make regulations for carrying out the purposes and provisions of this Act and for prescribing anything which may be prescribed." — Section 63(1)
Verify Section 63 in source document →
These regulations provide detailed rules and procedures necessary for the effective implementation of the Act.
Saving and Transitional Provisions for Legacy Materials and Ongoing Research
Sections 64 and 65 contain important saving and transitional provisions to address human biological materials and research activities existing before the Act’s commencement:
"This Act, with the exception of sections 30, 31, 32 and 33, does not apply to any legacy human biological material or any information derived from such material." — Section 64(1)
Verify Section 64 in source document →
This exemption recognises the practical difficulties and ethical considerations in applying new regulations retroactively to existing materials.
"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..." — Section 65(1)
Verify Section 65 in source document →
This transitional arrangement provides research institutions with a grace period to comply with the new regulatory regime, ensuring continuity and stability in ongoing research projects.
Cross-References to Other Legislation
The Act carefully delineates its scope by excluding certain activities governed by other statutes, as set out in the Second Schedule. These include:
- National public health research under section 59A of the Infectious Diseases Act 1976;
- Collection and compilation of health information for epidemiological or statistical purposes under the National Registry of Diseases Act 2007 and the Statistics Act 1973;
- Clinical trials of health products under the Health Products Act 2007;
- Clinical trials of medicinal products under the Medicines Act 1975.
"3. National public health research as defined in and conducted in accordance with section 59A of the Infectious Diseases Act 1976. 4. Collection and compilation by the National Registry of Diseases of health information for epidemiological or statistical purposes in accordance with the National Registry of Diseases Act 2007. 5. Collection and compilation of health information for statistical purposes in accordance with the Statistics Act 1973. 6. Clinical trials of health products conducted in accordance with the Health Products Act 2007. 7. Clinical trials of medicinal products conducted in accordance with the Medicines Act 1975." — Second Schedule
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These cross-references prevent regulatory overlap and confusion, ensuring that each statutory regime governs its respective domain effectively.
Conclusion
The Human Biomedical Research Act 2015 establishes a comprehensive regulatory framework governing human biomedical research in Singapore. Key provisions ensure that the Act binds the Government while exempting it from prosecution, empower the Minister with exemption and delegation powers, and provide clear procedural rules for service of documents. The Act also delineates jurisdictional authority for offences, prescribes penalties for non-compliance, and protects officials acting in good faith. Ministerial powers to amend Schedules and make regulations allow the framework to remain responsive to scientific and policy developments. Transitional provisions safeguard ongoing research and legacy materials, while cross-references to other legislation clarify the Act’s scope. Collectively, these provisions promote ethical, accountable, and effective human biomedical research.
Sections Covered in This Analysis
- Section 56(1)
- Section 57(1)
- Section 58(1)
- Section 59(1), (7)
- Section 60
- Section 61
- Section 62(1)
- Section 63(1), (3)
- Section 64(1)
- Section 65(1)
- Second Schedule
Source Documents
For the authoritative text, consult SSO.