Statute Details
- Title: Human Biomedical Research (Tissue Banking and Notification — Exemption) Regulations 2019
- Act Code: HBRA2015-RG5
- Legislation Type: Subsidiary legislation (SL)
- Authorising Act: Human Biomedical Research Act 2015 (Section 63)
- Commencement: 1 November 2019 (as indicated by the legislative history)
- Latest Version Noted: 2025 Revised Edition (2 June 2025), current as at 27 March 2026
- Key Provision: Section 2 — Exemption for tissue banking activities regulated under other legislation
What Is This Legislation About?
The Human Biomedical Research (Tissue Banking and Notification — Exemption) Regulations 2019 (“Tissue Banking Exemption Regulations”) create a targeted exemption from parts of Singapore’s Human Biomedical Research Act 2015 (“HBRA”). In practical terms, the Regulations recognise that some tissue banking activities are already regulated under other specialised health and medicines legislation. Where that is the case, the HBRA’s specified requirements do not apply.
The Regulations focus on tissue banking activities that are conducted solely for particular categories of research or clinical trials. These categories are tied to three statutory regimes: (i) national public health research under the Infectious Diseases Act 1976, (ii) clinical trials of health products under the Health Products Act 2007, and (iii) clinical trials of medicinal products under the Medicines Act 1975. The exemption is therefore not a general “free pass” for tissue banks; it is an exception designed to avoid duplicative regulation.
Importantly, the Regulations also include a “to avoid doubt” clarification. If a tissue bank conducts activities concurrently with, in addition to, or not solely for the exempt purposes, then the HBRA requirements return to apply for the relevant activity. This makes the scope of the exemption highly fact-sensitive and compliance-critical.
What Are the Key Provisions?
1) The exemption from HBRA sections 34–37 (Section 2(1)). The core operative provision is Section 2(1). It states that Sections 34, 35, 36 and 37 of the HBRA do not apply to an individual, body of persons, or tissue bank that conducts tissue banking activities solely for its own research or own clinical trial, provided the activity falls within one of the listed descriptions.
While the extract provided does not reproduce the content of HBRA sections 34–37, the legal effect is clear: the HBRA imposes certain obligations on tissue banking and related governance/notification matters, and these Regulations carve out an exemption where the tissue banking is already governed by other legislation. For practitioners, the immediate task is to map the HBRA sections being excluded to the compliance steps that would otherwise be required (for example, authorisation, notification, or other regulatory controls, depending on how those HBRA provisions operate in the HBRA scheme).
2) “Solely for the purpose of own research or own clinical trial.” Section 2(1) contains two important qualifiers. First, the tissue banking activity must be conducted solely for the purpose of the individual’s, body’s, or tissue bank’s own research or own clinical trial. This language suggests that the exemption is intended for tissue banks operating within their own research/clinical trial programmes, rather than for broader commercial or multi-purpose tissue banking.
Second, the exemption is not triggered merely because the tissue is used in a clinical trial. The tissue banking activity itself must be for the specified purposes and must be conducted solely for those purposes. Practically, this requires careful internal scoping: what the tissue bank does, what it stores, and how it uses the tissue must align with the exempt categories.
3) The three exempt categories (Section 2(1)(a)–(c)). Section 2(1) then limits the exemption to tissue banking activities that fall within any of the following descriptions:
- (a) National public health research as defined in and conducted in accordance with section 59A of the Infectious Diseases Act 1976.
- (b) Clinical trials of health products conducted in accordance with the Health Products Act 2007.
- (c) Clinical trials of medicinal products conducted in accordance with the Medicines Act 1975.
These categories are significant because they tie the exemption to compliance with the relevant “parent” regulatory frameworks. In other words, the tissue bank cannot rely on the exemption alone; it must also ensure that the underlying research or trial is conducted in accordance with the relevant Infectious Diseases, Health Products, or Medicines regime.
4) The “to avoid doubt” limitation (Section 2(2)). Section 2(2) is a compliance safeguard. It provides that an individual, body of persons, or tissue bank that conducts any tissue banking activity concurrently with, in addition to, or which is not solely for the purposes specified in paragraph (1) must comply with sections 34, 35, 36 and 37 of the Act in relation to that activity.
This means the exemption is not all-or-nothing at the organisational level. If a tissue bank has mixed activities—some within the exempt categories and others outside them—the HBRA requirements apply to the non-exempt activity. Practitioners should therefore consider whether the tissue bank can operationally segregate activities and maintain clear records demonstrating that particular tissue banking activities are “solely” for the exempt purposes.
How Is This Legislation Structured?
The Regulations are concise and effectively consist of a single substantive provision. The structure is as follows:
- Section 1 (Citation): Provides the short title of the Regulations.
- Section 2 (Exemption for tissue banking activities regulated under other legislation): Sets out the exemption and its conditions, including the three exempt categories and the “to avoid doubt” limitation.
From a practitioner’s perspective, the Regulations function as a narrow interpretive and compliance tool within the broader HBRA framework. Rather than creating a new regulatory regime, it adjusts the application of existing HBRA provisions to avoid duplication where other laws already govern the relevant research or trials.
Who Does This Legislation Apply To?
Section 2 applies to an individual, a body of persons, or a tissue bank that conducts tissue banking activities. The exemption is conditional and depends on the purpose and regulatory context of the tissue banking activity.
In scope are tissue banking activities that are conducted solely for the individual’s/body’s/tissue bank’s own research or own clinical trial, and that fall within one of the three categories linked to the Infectious Diseases Act 1976, Health Products Act 2007, or Medicines Act 1975. If the tissue bank’s activities are mixed, or not solely for those purposes, the HBRA sections 34–37 apply to the non-exempt activity.
Why Is This Legislation Important?
This legislation matters because it directly affects regulatory burden and compliance strategy for tissue banks and research institutions. Tissue banking can be subject to multiple layers of governance depending on the end use of the tissue—particularly when the tissue is used in clinical trials of health products or medicinal products. The Regulations provide a mechanism to prevent duplicative application of HBRA requirements where the same activity is already regulated under more specific legislation.
For lawyers advising tissue banks, the key significance lies in the conditional nature of the exemption. The “solely” requirement and the Section 2(2) limitation mean that compliance is not merely a matter of identifying the trial type. It also requires operational controls: clear documentation of purpose, segregation of tissue banking activities, and ensuring that the underlying research/trials are conducted in accordance with the relevant Infectious Diseases, Health Products, or Medicines regimes.
From an enforcement and risk perspective, the Regulations reduce the chance of over-regulation but increase the importance of fact-specific assessment. If a tissue bank cannot demonstrate that its tissue banking activity is confined to the exempt purposes, it may be required to comply with HBRA sections 34–37. That could entail additional approvals, notifications, or governance steps depending on the content of those HBRA provisions.
Related Legislation
- Human Biomedical Research Act 2015 (HBRA) — particularly Sections 34, 35, 36 and 37, and Section 63 (authorising provision)
- Infectious Diseases Act 1976 — Section 59A (national public health research)
- Health Products Act 2007 — clinical trials of health products
- Medicines Act 1975 — clinical trials of medicinal products
Source Documents
This article provides an overview of the Human Biomedical Research (Tissue Banking and Notification — Exemption) Regulations 2019 for legal research and educational purposes. It does not constitute legal advice. Readers should consult the official text for authoritative provisions.