Mr Speaker, this Bill is bringing an expansion of the Health Sciences Authority's functions.
Under clause 6, HSA will take on responsibility for regulating human biomedical research and human tissue activities, regulating biological agents and toxins, assisting the Minister or Director-General of Health in administering or enforcing the Acts listed in the new First Schedule, and providing administrative services to the healthcare profession regulatory bodies.
The Bill also strengthens and standardises investigatory powers under the relevant regulatory statutes. For example, clause 26 introduces new powers under the Human Biomedical Research Act to inspect and copy electronic material, operate electronic equipment, obtain data from electronic systems and require assistance to access electronically stored information, while clause 38 introduces corresponding powers under the Healthcare Services Act.
The Bill also strengthens or standardises investigatory powers under the relevant regulatory statutes, including powers to enter and inspect premises, operate electronic equipment, copy electronic data and require the disclosure of information needed to obtain access to such data.
I support the consolidation. There is a real case for bringing related regulatory functions together in a single competent hub. At the same time as these substantial responsibilities are gathered within HSA, I also note that the Bill reduces the number of members who must be present before the Authority’s board may transact business, and removes the present statutory ceiling on the size of the board.
The more responsibility we gather within a single institution, the clearer must be the account we require of its exercise. I am therefore a bit puzzled that while we give a body substantially wider responsibilities and, in the same Bill, make it possible for fewer of its board members to transact the Authority's business. Let me turn to this issue first.
The board that must supervise all of this
A statutory board is governed by the people who sit on it, and the law determines how many must be present before it may transact business.
Today, section 9 of the Health Sciences Authority Act provides that five members form a quorum. HSA's website presently lists a Chairperson and ten other members.[1] The quorum is about 45%.
Under Clause 5 of this Bill, the quorum will become the higher of three members or one-third of the Authority's membership.
Clause 3 will also replace the existing membership range with a requirement that the Authority have at least seven members. It imposes no maximum.
Let me put the effect more precisely: where the Authority has nine members or fewer, three will suffice where five were previously required. Where it has between ten and twelve members, four will ordinarily be sufficient. At thirteen members, the quorum returns to at least five.
If HSA’s composition remains at the present Chairperson plus ten members, when Clause 5 or the new Section 9 kicks in after the bill is passed, the quorum will fall from five members to four.
Will the Minister confirm whether that is the intended immediate effect of the clause?
Mr Speaker, a fixed quorum has been replaced by a proportion at the same time that the ceiling on membership has been removed. However large the Authority becomes, it may ordinarily transact business with only about one-third of its members present. A body of twenty-one members, for example, may transact business with seven.
The concern is not that the quorum will fall indefinitely as the Authority grows. The concern is that the Bill establishes one-third, rather than the present fixed requirement of five, as the enduring standard for the Authority's collective decision-making.
I would like to ask the Minister what problem this provision was drafted to solve. Has the Authority been unable to meet because five members could not be assembled?
I urge the Minister to look again at Clause 5 and consider requiring the higher of five members or one-third of the Authority. This would preserve the safeguard Parliament previously considered appropriate while allowing the quorum to rise if the Authority becomes substantially larger. If the purpose of consolidation is to achieve stronger and better-coordinated oversight, the governance arrangements of the Authority itself should reflect the same objective.
Who answers for what
In 2003, a laboratory-acquired SARS infection highlighted the importance of strong national biosafety oversight and contributed to the enactment of the Biological Agents and Toxins Act.
This Bill transfers responsibility for administering the Biological Agents and Toxins Act from the Director-General of Health to the Chief Executive of HSA through clauses 18 to 22, while clause 6 also empowers HSA to assist in administering or enforcing a range of other health legislation listed in the new First Schedule, including the Infectious Diseases Act.
As responsibilities move, accountability must remain clear. Regulated institutions, research participants and members of the public should be able to identify which authority made a decision, who is responsible for it and where complaints or appeals should be directed.
Will MOH and HSA publish, before the first transfer date, a clear statement setting out their respective responsibilities for policy, licensing, inspection, investigation, enforcement, review and complaints?
The Bill also provides that HSA may assist the Minister or the Director-General of Health in administering or enforcing various Acts. What will that assistance mean in practice? For example, under the Infectious Diseases Act, which functions will remain with the Minister or the Director-General, and what command arrangements will apply during a public health emergency similar to SARS or COVID?
Finally, as more licensing, inspection and enforcement functions are brought together within a single organisation, what safeguards will ensure appropriate separation between those functions?
What Parliament and the public will be able to see
The Cordlife episode demonstrates the importance of regulatory transparency. Significant failures can remain undiscovered for long periods if incidents are not reported and regulators do not otherwise detect them.
HSA already publishes annual reports. Following these transfers, will the Minister commit to including dedicated reporting on regulatory performance, including the number of inspections conducted, significant incidents reported, enforcement actions taken, licence suspensions or revocations imposed, investigations commenced and concluded, and the deployment of auxiliary authorised officers?
The Cordlife episode illustrates why such reporting matters. According to MOH's public statements, temperature excursions dated back to November 2020, were not disclosed during or after a September 2022 routine inspection, and the matter came to light only after a public complaint in July 2023. Parliament and the public should be able to assess not only whether serious incidents occur, but how they were detected, how quickly they were addressed, and whether regulatory interventions were effective.
Appropriate confidentiality protections may sometimes be necessary. However, Parliament and the public should still be able to assess whether the transferred functions are being exercised effectively.
Data, research records and digital evidence
The Bill strengthens investigative powers concerning electronic records and digital systems.
Under clause 26, the proposed new section 45(2)(a) of the Human Biomedical Research Act permits authorised officers to inspect and copy electronic material. The proposed new sections 45(2)(i) and 45(3) permit them to operate electronic equipment, convert relevant data into documentary form, transfer that data to storage devices and remove those devices.
The proposed new section 45(10)(d) permits officers to require assistance, including usernames, passwords and other authentication information, to gain access to computers, electronic devices and electronically stored information.
Such powers may be necessary for effective investigations. However, healthcare and research systems often contain extensive clinical, research and genetic information unrelated to the suspected contravention.
I would therefore like to ask the Minister what safeguards will govern the collection, access, retention and disposal of electronic information obtained during investigations. How will HSA ensure that access remains necessary, proportionate and limited to information relevant to the investigation?
Where larger datasets must initially be obtained, what procedures will be used to identify and segregate information relevant to the investigation from unrelated material? What retention policies will apply after investigations conclude, particularly given that the proposed new section 45(12) entitles an authorised officer, without payment, to keep information or things, or copies or extracts, provided under section 45(9)(a)? How will usernames, passwords and other authentication information disclosed under the proposed new section 45(10)(d) be protected and subsequently disposed of?
The Bill also provides for records and information, including data in any form, to be transferred to HSA. Under clause 9, the proposed new section 36A of the Health Sciences Authority Act 2001 includes “records and information (including data) in any form” within the definition of an asset, while the proposed new sections 36B and 36E provide respectively for the transfer of relevant assets and liabilities and for specified Government records to become records of HSA. Corresponding provisions for the second transfer are found in clause 10, particularly the proposed new sections 36F, 36G and 36J.
Will access rights be reviewed before migration rather than simply replicated in the new environment?
Auxiliary authorised officers
The Bill allows the appointment of auxiliary authorised officers, including suitably qualified private individuals, under clauses 24 and 34 of the Bill respectively.
Given that these officers may exercise important regulatory and enforcement functions, the Government should clearly explain their scope of authority, training requirements, supervision arrangements, complaints processes and safeguards against conflicts of interest. Regulated institutions and members of the public should be able to readily ascertain the legal basis on which any inspection, entry or request is made.
Will the Minister also clarify what training, supervision and conflict-of-interest safeguards will apply to auxiliary authorised officers, and what recourse will be available if a regulated institution believes that an officer has acted improperly or exceeded the limits of appointment?
The institutions that must live with this
These reforms should not impose unnecessary administrative burdens on regulated institutions. Existing licences, approvals and compliance records should continue seamlessly after each transfer date.
Will the Minister confirm how ongoing applications, inspections, investigations and appeals will be handled during the transition? Will institutions continue to have access to previously submitted records?
Will a transition guide be published before commencement, identifying the responsible authority, contact points and any procedural changes for each transferred function? For smaller institutions with limited compliance resources, will HSA adopt a risk-proportionate approach and provide practical guidance and more assistance?
Independence of healthcare professional regulation
The Bill also gives HSA the function of providing administrative services to bodies responsible for regulating persons under the listed healthcare profession regulatory Acts.
Administrative services may appropriately be shared. However, there is an important distinction between supporting a decision and making it. HSA may provide the administrative support, but decisions on registration, complaints, investigations, disciplinary proceedings and professional standards must remain with the professional regulatory bodies such as the Singapore Medical Council, which Parliament established for that purpose.
A healthcare professional facing a complaint or disciplinary proceeding must have confidence that the decision is being made by the relevant statutory board.
A patient who has made a complaint must likewise have confidence that the matter is being considered by the proper body, independently and according to law.
Can the Minister confirm that HSA's role will be confined to administrative services and will not extend to statutory decision-making concerning registration, professional standards, complaints, investigations or discipline?
Who will determine the allocation of staff supporting each professional regulatory body?
What safeguards will ensure that confidential information concerning complaints, fitness to practice, investigations and disciplinary matters is appropriately segregated and accessible only to staff authorised to support the relevant regulatory body?
A person corresponding about a disciplinary matter should be able to tell, from the letter or email received, whether the communication is an administrative communication from HSA or a decision or direction of the relevant professional board.
Transfer of employees
Successful implementation will depend on the officers carrying these functions forward.
I welcome the Bill's protections preserving continuity of service and terms no less favourable than those enjoyed immediately before transfer.
I would like to ask how affected officers will be consulted. Also, what steps are being taken to preserve institutional knowledge and ensure continuity for ongoing applications, investigations and disciplinary matters?
Mr Speaker, in Mandarin please.
议长先生，这项法案把卫生部的一些公共卫生监管工作，以及医护专业监管机构的行政支援工作，交由卫生科学局负责。这样的整合有助于集中专业知识，提高效率。
在支持法案整体方向的同时，我认为其中一项董事会治理安排值得进一步审视。卫生科学局目前公布的董事会共有十一名成员。按新规定计算，只需四人出席即可开会，比目前法定的五人更少。卫生科学局的权力和职能正在扩大，但董事会会议的最低法定人数反而下降，这与加强问责和监督的目标似乎并不完全一致。我希望部长重新考虑这项条文。毕竟，权力越集中，问责就必须越清楚。
对于受委任协助执法的人员，当局必须制定严格的资格、培训、监督和利益冲突申报制度。公众和受监管机构也必须清楚知道这些人员拥有哪些权力、在什么情况下可以进入处所，以及有关决定可通过什么机制提出申诉。
涉及生物医学研究、人体组织、病人资料和遗传资料时，当局必须确保这些资料在转移、查阅、使用及销毁过程中，继续获得严格和妥善的保护。
卫生部和卫生科学局也应清楚说明双方的分工，尤其是在涉及执照、调查和执法决定时，让公众知道由谁作出决定，以及应向哪个机构提出投诉。
虽然卫生科学局会为医护专业监管机构提供行政支援，但这些机构在注册、纪律处分和专业标准方面的独立职能，必须继续受到保障。 对于中小型科研机构和科技初创企业，当局应提供清楚的过渡安排和支援渠道。受影响的员工也应获得充分的沟通和培训，确保经验和专业知识不会在重组过程中流失。
议长先生，我支持这项法案。
Conclusion
Mr Speaker, notwithstanding the concerns and clarifications I have raised, I support the Bill.
