Health Sciences Authority (Amendment) and Other Matters Bill

Coordinating Minister for Social Policies and Minister for Health.

Mr Speaker, on behalf of the Minister for Health, I move, "That the Bill be now read a Second time."

Singapore's strong healthcare reputation rests in part on a regulatory system that safeguards patients and public health while enabling Singaporeans to benefit from safe and effective healthcare innovations. But healthcare is evolving rapidly with increasing integration across new models of care, digital health, genomics and artificial intelligence (AI). These may not fit neatly within traditional regulatory boundaries and hence, our regulatory ecosystem must also evolve and respond in an equally integrated manner. This is the purpose of today's Bill.

Today, our regulatory ecosystem is organised across three agencies. First, the Ministry of Health (MOH) regulates healthcare services, health information, human biomedical research and biosafety. Second, the Health Sciences Authority (HSA) regulates health products such as medicines and medical devices. Third, the Secretariat of Healthcare Professional Boards (SPB) supports the various Healthcare Professional Boards and Councils in their regulation of healthcare professionals such as doctors, dentists, nurses, pharmacists and allied health professionals.

This approach has served Singapore well and we have progressively modernised our regulatory frameworks over time.

HSA is well regarded, having attained the World Health Organization's (WHO's) maturity level 4 for both the regulation of medical devices and medicines as well as being one of the first global agencies to be designated as a WHO Listed Authority for its medicines regulatory system.

We enabled the regulation of telemedicine and home medical services under a new Healthcare Services Act. Earlier this year, we enacted the Health Information Act to govern and safeguard key health information, including in the National Electronic Health Record. We are now planning for the statutory registration of psychologists, including clinical psychologists and educational psychologists, to promote higher care standards and support better care outcomes.

But services, products, professionals and health information increasingly intersect. With oversight and regulatory touchpoints across different agencies, there may be gaps in handling complex or cross-cutting cases, with implications not only for regulated entities but also for patient safety and access.

Let me use three examples to illustrate this.

First, AI in healthcare. AI has huge potential to improve patient care and we want to enable its safe adoption. Regulating AI cuts across multiple domains – registration of products that utilise AI under the Health Products Act by HSA, deployment of AI within healthcare services under the Healthcare Services Act by MOH, and use of AI by healthcare professionals is governed by the respective professionals’ ethical codes and professional standards.

An integrated regulatory function will bring these efforts together, enabling one party to consider the governance of AI holistically – from product safety and clinical deployment to institutional governance and professional accountability. This also gives AI developers, healthcare institutions and users a single point of contact, and facilitates clearer and more consistent regulatory guidance for safe and responsible adoption of AI.

Second, retail pharmacy. Licensing of pharmacies, currently under the Health Products Act, centres primarily on the premise where health products are sold and distributed. But pharmacies are increasingly becoming service touchpoints, for example, for flu vaccinations and not just product supply outlets. MOH’s Community Pharmacist Influenza Vaccination Sandbox that was rolled out over the past year has shown positive results and we are looking at mainstreaming these services.

So, our regulation must look at the full patient journey more coherently – from the health product supplied, the healthcare service delivered and the professional standards expected. Doing so will enable clearer rules for providers, stronger safeguards for patients and a framework that can support new pharmacy-based care models as they emerge.

Third, enforcement cases also increasingly span multiple domains. Take the example of a clinic being investigated by MOH for the improper prescription of codeine. Because codeine is a controlled drug, HSA will also need to investigate the potential supply sources of the codeine. At the same time, the doctor’s professional conduct will need to be taken up by the professional regulator. What begins as a single incident can require three agencies to investigate different, but interconnected, aspects of the same case. Today, these agencies already work closely together. But as such cases grow more complex and frequent, we need a more integrated approach for more timely and decisive actions.

The Bill therefore proposes to consolidate health regulatory functions and establish an integrated health regulatory function under HSA. This is not simply an organisational restructuring but an opportunity to lay the foundation for a more coherent, future-ready system that protects patients while enabling timely access to beneficial healthcare innovations, for patients’ benefit.

Under the consolidated structure, we can expect three significant changes in how we will operate and the value to different stakeholders.

First, for industry, innovators and healthcare providers – greater clarity and predictability. Companies developing medicines, digital health solutions or healthcare providers with new models of care increasingly operate across regulatory boundaries. An integrated regulator will allow licensing applications and enquiries to be managed by one agency, making information and responses more coordinated and clearer for stakeholders.

Second, one integrated function will enable greater regulatory alignment and clearer guidance for both clinical care and research. For example, biomedical research may be interdisciplinary and intersect across health products, health information and biosafety. Bringing together expertise in these areas will allow industry, researchers and research institutions to receive more aligned regulatory guidance, particularly for complex or emerging areas. This will better protect research participants while helping promising science navigate a clearer pathway from research to eventual clinical application.

Third, where the public has to come into contact with the regulator, we would have one streamlined interface with them, whether it is about a medicine that they purchased, the device used in their care or the healthcare service provider or professional caring for them.

Most importantly, with an integrated regulator that has visibility across the entire healthcare journey, HSA will be better placed to identify risks that cut across these domains and take coordinated, decisive action when needed. This will benefit the public and patients in ensuring their safety.

Moving ahead, MOH will continue to set national health policies and be responsible for stewarding Singapore’s healthcare system, including the design of care models, healthcare financing, system planning and the development of system-wide capabilities in workforce and digital health infrastructure. MOH will retain regulatory policy and strategic oversight, while HSA will take on and integrate the regulatory functions within the scope of this Bill in support of and as aligned with MOH’s mission.

I will now take Members through the key amendments in this Bill.

Clause 6 amends section 11 of the Health Sciences Authority Act to expand HSA’s functions and enable consolidation across three areas.

First, HSA will administer and regulate the Human Biomedical Research Act (HBRA) and the Biological Agents and Toxins Act (BATA), taking over these functions from MOH. These are established Acts, with well-defined policies and scope.

Second, HSA officers will assist the Minister and Director-General of Health (DGH) in administering or enforcing specified MOH Acts in the First Schedule of the Bill, such as the Healthcare Services Act and the Health Information Act when it commences. As explained earlier, MOH will continue to set policy and strategic direction, while HSA will support the operationalisation of these Acts, including the licensing, inspection and enforcement of healthcare services as well as the enforcement of other legislations, such as the Infectious Diseases Act and Human Organ Transplant Act.

Third, HSA will take on the functions of the SPB to support the Professional Boards and Councils in delivering on their regulatory mandate. I would like to emphasise that the Professional Boards and Councils’ existing self-regulatory and disciplinary roles remain unchanged.

To support HSA in taking on these expanded roles, several consequential amendments have been introduced in the Bill.

Clause 3 amends section 5 of the Health Sciences Authority Act to allow the Minister to appoint the necessary number of board members to support HSA’s expanded functions. Clause 4 also allows the Minister to appoint a Deputy Chairperson to support governance and continuity, given HSA’s increased breadth and complexity of its functions.

Clauses 9 and 10 provide for the legislative transfer of resources to HSA, covering the relevant assets, liabilities and employees from MOH and the Singapore Medical Council (SMC), where the SPB is housed. Affected officers will be transferred on terms no less favourable than what they enjoy in their current organisation. The aim of the legislative transfer of employees is to enable a smooth transition while protecting affected employees and their existing benefits. Beyond the legislative change, we are also working on other aspects of the transition to allay anxieties, address concerns and ensure a smooth transition and adjustment for staff.

Clauses 19 and 22, and clauses 24, 28, 29 and 32 amend various provisions under BATA and HBRA, respectively, to replace references to the DGH with the Chief Executive Officer of HSA or CE(HSA). Moving ahead, CE(HSA) will exercise powers under BATA and HBRA, taking over from DGH. Provisions have also been made so that DGH is consulted in considering approvals on more complex matters.

Clauses 24 and 34 amend HBRA and HCSA, respectively, to allow HSA officers and qualified private sector individuals to be appointed to support the administration and enforcement of those Acts. This allows the Government to draw on specialist expertise that may not always reside within the public sector, but with clear restrictions. For instance, appointed individuals are limited to enter and inspect premises or conveyances only with consent and during normal business hours. Safeguards will also be put in place to ensure that only suitably qualified individuals are deployed with their work being subject to review and oversight.

Clauses 43 to 59 amend the relevant MOH Acts, such as the Allied Health Professions Act, the Medical Registration Act and the National Registry of Diseases Act, to enable the appointment of officers of public authorities, so that HSA officers can be appointed to support the administration of these Acts.

Clause 60 sets out the saving and transitional provisions to ensure a smooth handover. Existing approvals and permits will automatically be carried over and regulated entities will not need to reapply or restart any processes.

We will implement the changes in two phases to stage and better manage the transition. First, MOH's regulatory functions and manpower will be transferred to HSA in November 2026. Thereafter, SPB's functions and manpower will be transferred to HSA by end 2027. This consolidation is an investment in our regulatory officers and regulatory capabilities. By bringing functions together, we can create broader career pathways, deepen regulatory expertise and strengthen HSA’s position as a trusted health regulator, building multidisciplinary regulatory capabilities for the future.

Sir, this Bill is not simply about moving functions from one agency to another. Healthcare is being reshaped by AI, genomics and new care models, and our regulatory system must be capable of evolving around it. By establishing HSA as Singapore’s integrated health regulator, we are building a system that is more coherent for the healthcare institutions, clearer for the healthcare professionals, more predictable for industry and ultimately, more responsive for patients.

Good regulation must achieve both protection and progress. It must safeguard patients while enabling them to benefit from advancements in healthcare. It should provide clarity without unnecessary complexity and remain robust and agile to changes. This Bill is a key milestone, laying the foundation for a future-ready regulatory system trusted by the public and our stakeholders. I am confident this transformation will serve Singaporeans well. Mr Speaker, I beg to move.

Question proposed.

Mr Melvin Yong.

Mr Speaker, I stand in support of the Bill. Bringing more healthcare regulatory functions under HSA makes good sense. As healthcare becomes more complex, there is value in having stronger coordination across regulation, licensing, enforcement and oversight.

But moving functions from one organisation to another does not, by itself, necessarily make regulations better. The real test is whether this leads to better outcomes, where we build a more trusted, responsive and worker-conscious healthcare regulator. Will consumers be better protected? Will healthcare workers and professionals be treated fairly? Will our regulatory officers have the capabilities and support needed to do their jobs effectively?

As a labour Member of Parliament (MP) and President of the Consumers Association of Singapore (CASE), I would like to focus my speech on these two groups of stakeholders affected by this transition – that is, our healthcare workers and our consumers.

First, we must take care of the officers affected by this restructuring. The Bill provides for the transfer of regulatory functions and employees to HSA, which will progressively take on a wider range of responsibilities. But it is our officers on the ground who make the regulatory system work.

As we all know, regulatory work is highly specialised. Many have accumulated valuable knowledge and experience over the years. We should retain this expertise and give our officers opportunities to grow with the new organisation.

I therefore have two questions for the Minister of State. First, can the Minister of State assure the House that employees affected by the transfer will not be disadvantaged in their remuneration, employment benefits and career progression? Second, what training and reskilling opportunities will be provided, particularly where job scopes change as HSA becomes a more integrated regulator?

There is also the question of workload. Consolidation should not simply mean moving functions from one organisation to another and asking the same number of officers to do more and more. Therefore, as HSA assumes greater responsibilities, we should ensure that manpower, specialist capabilities, digital tools and training grow in tandem. Can the Minister of State share what workforce and capability planning has been taken to support HSA's expanded mandate, particularly for licensing, inspections, investigations and enforcement?

My second point concerns the Bill's provisions for auxiliary authorised officers. The amendments allow suitably qualified individuals to conduct certain regulatory functions. This may be useful as healthcare regulation becomes increasingly specialised. However, where regulatory powers are exercised by individuals who may not be public officers, we must ensure that public accountability is not diluted.

I would therefore like to ask: what qualifications and training will these officers be required to have? How will potential conflicts of interest be managed? And what confidentiality and accountability requirements will apply to them?

For example, if an auxiliary officer has previously worked for or has commercial relationships with an organisation in the sector being inspected, how will this conflict be identified and managed? It may therefore be useful for MOH and HSA to publish clear governance arrangements covering appointment criteria, conflict management and training requirements. There should also be a clear avenue for a healthcare provider or member of the public to raise concerns if necessary.

Sir, my third point is from the consumer's perspective. At CASE, I have seen that when something goes wrong, consumers do not always know which agency or which regulator they should approach. This can be particularly confusing in healthcare. A problem may involve a healthcare provider, the conduct of a healthcare professional or even a health product. Sometimes, it may involve more than one at the same time.

From the consumer's perspective, the organisational chart is not important. They do not distinguish between agencies, statutes and regulatory boundaries. They simply want to know: who can help me in a timely manner?

If one objective of this restructuring is better coordination, then I hope we can translate this into a simpler experience for the consumer. Can MOH consider developing a "no wrong door" approach, where a consumer can raise a healthcare-related complaint and have it routed seamlessly to the appropriate regulatory body?

Consumers should not need to navigate the boundaries between HSA, MOH and the various Professional Boards and Councils before they know where to seek help.

There is another opportunity arising from this consolidation. Individual complaints can sometimes provide an early warning of a much larger problem. One complaint may appear isolated, but when similar complaints emerge across different channels, they may reveal a systemic issue involving a healthcare provider, a product, misleading claims and even patient safety.

An integrated regulator should be better positioned to connect these dots. I therefore ask whether HSA intends to aggregate and analyse complaints and regulatory intelligence across its different functions, and establish mechanisms to receive relevant intelligence from frontline organisations, including consumer organisations such as CASE, and the other professional bodies in the healthcare sector. The objective should not simply be to resolve individual complaints, but to identify patterns early enough for intervention to take place before more consumers are affected.

Lastly, Mr Speaker, as we strengthen consumer and patient protection, we must also ensure that our healthcare professionals are treated fairly. The relationship between patient protection and professional fairness should not be viewed as a trade-off. Instead, public confidence is strengthened when healthcare professionals know that processes are rigorous, transparent and fair.

The Bill enables HSA to provide administrative support to the statutory bodies regulating healthcare professionals. Can the Minister of State clarify how the new arrangement will preserve the independence of these Professional Boards and Councils, particularly in decisions relating to registration, professional standards and disciplinary matters, while HSA takes on a greater administrative and supporting role?

There is also an important worker consideration. When a healthcare professional is subject to a complaint or a disciplinary proceeding, the outcome can have a major impact on his or her career and livelihood. We must protect patients, but we must also ensure due process and timely resolution for the healthcare worker concerned. Prolonged uncertainty is difficult for everyone involved.

Can the Minister of State therefore share whether this consolidation could lead to clearer service standards and more timely processing of complaints and disciplinary cases, while preserving the independence of the Professional Boards and fairness to all parties?

Sir, this Bill presents an opportunity to strengthen trust in Singapore's healthcare regulatory system. We should use this opportunity to improve outcomes and support officers who carry out the regulatory work. After these changes are implemented, I hope both MOH and HSA will track tangible outcomes, such as licensing turnaround times, complaint resolution times and the timeliness of enforcement action.

I would also encourage MOH and HSA to monitor whether consolidation results in a reduction in regulatory burden for healthcare institutions and professionals. Where reporting requirements overlap or where information is already available administratively, we should seek to streamline processes and reduce duplication.

At the end of the day, the measure of success should not be how many functions we have consolidated under the new HSA, but whether this restructuring helps us build not just a bigger regulator, but a better regulator. That means a coordinated, responsive and trusted regulator that better safeguard public health by supporting its officers, upholding fairness for our healthcare professionals and most importantly, giving both patients and consumers greater confidence that their interests will be protected.

Sir, notwithstanding my clarifications, I support the Bill.

Mr Dennis Tan.

Mr Speaker, this Bill is bringing an expansion of the HSA's function. 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 DGH 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 HBRA 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 HCSA.

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 this 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 may transact business and removes the presence statutory ceiling on the size of the authority. 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 a few of its members to transact the authority's business.

Let me turn to these issues first, the board that must supervise all of this. The 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 nine of the Health Sciences Authority Act provides that five members form a quorum. HSA's website presently lists a Chairperson and 10 other members. 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 board membership.

Clause 3 will also replace the existing board membership range with a requirement that the authority must have at least seven members. It imposes no maximum.

Let me put the effect more precisely. Where the authority has nine members or fewer, the three will suffice, where five were previously required, where it has between 10 and 12 members, four will ordinarily be sufficient. At 13 members, the quorum returns to at least five. If HSA's composition remains at the present Chairperson plus 10 members, when clause 5 or the new section 9 kicks in after the Bill is passed today, the quorum will fall from five members to four. Will the Minister of State confirm whether that is the intended immediate effect of the clause?

Mr Speaker, a fixed quorum has replaced by a proportion at the same time that the ceiling of 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 21 members, for example, may transact business with seven. The concern is not that the quorum will fall indefinitely as the board grows, the concern is that the Bill establishes one-third, rather than the present fixed requirement of five as the enduring standard for the board's collective decision-making.

I would like to ask the Minister of State what problem this provision was drafted to solve. Has the board been unable to meet because five members could not be assembled? I urge the Minister of State to look again at clause 5 and consider requiring the higher of five members or one-third of the board, this would preserve the safeguard that Parliament previously considered appropriate, while allowing the quorum to rise if the board becomes substantially larger.

If the purpose of consolidation is to achieve stronger and better-coordinated oversight, the governance arrangements of the board itself should reflect the same objective.

Next, 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 BATA. This Bill transfers responsibility for administering the BATA from the DGH to the CE HSA through clauses 18 to 22, while clause 6 also empower 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 the decision, who is responsible for it, and where complaints or appeals should be directed. Will MOH and HSA publish, before the first transfer day, 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 DGH 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 DGH, and what command arrangements will apply during a public health emergency similar to SARS or COVID-19?

Finally, as more licensing inspection and enforcement functions are brought together within a single organisation, what safeguards will ensure appropriate separation between those functions?

Next, 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 Ministry 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 comments 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 stated 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 and interventions were effective. Appropriate confidentiality protections may sometimes be necessary. However, Parliament and the public should still be able to assess whether the transfer functions are being exercised effectively.

Next, 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 HBRA 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 these devices.

The proposed new section 45(10)(d) permits officers to require assistance, including user names, 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 system often contain extensive clinical research and genetic information unrelated to the suspected contravention.

I would therefore like to ask the Minister of State what safeguards will govern the collection, access, retention and disposal of electronic information obtained during investigations. How will HSA ensure the access remains necessary, proportionate and limited the information relevant to the investigation?

Where larger datasets may 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 user names password and other authentication information disclose 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 and I quote, "records and information (including data) in any form", unquote, 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?

Next, auxiliary authorised officers. The Bill allows the appointment of the 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 of State 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 act improperly or exceeded the limits of appointment?

Next, the institution 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 of State 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 institution with limited compliance resources, will HSA adopt a risk proportionate approach and provide practical guidance and more assistance?

Next, 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 administrative support, but decisions on registration complaints, investigations, disciplinary proceedings and professional standards must remain with the professional regulatory bodies, such as the SMC, 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 the law.

Can the Minister of State 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 administrative communication for HSA, or a decision on the direction of the relevant professional body.

Next transfer of employees. Successful implementation will depend on 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,

(In Mandarin): [Please refer to Vernacular Speech.] Mr Speaker, this Bill transfers some of MOH's public health regulatory functions, as well as administrative support for the healthcare professional regulatory bodies, to HSA. Such consolidation will help centralise expertise and improve efficiency.

While I support the overall direction of the Bill, I believe that one aspect of the board's governance arrangements deserves further scrutiny. HSA's published board currently comprises 11 members. Under the new provisions, a meeting may be held with only four members present, fewer than the current quorum of five. HSA's powers and functions are expanding, yet the minimum quorum for board meetings is being reduced. This does not appear entirely consistent with the objective of strengthening accountability and oversight. I hope the Ministry will reconsider this provision. After all, the greater the concentration of power, the clearer the accountability must be.

For persons appointed to assist with enforcement, the authorities must establish stringent requirements governing qualifications, training, supervision and the declaration of conflicts of interest. The public and regulated entities must also be clearly informed of the powers these persons possess, the circumstances in which they may enter premises and the mechanisms through which the relevant decisions may be appealed.

Where biomedical research, human tissue, patient information and genetic data are concerned, the authorities must ensure that such information continues to be subject to stringent and proper safeguards during its transfer, access, use and disposal.

MOH and HSA should also clearly explain their respective responsibilities, particularly, in relation to licensing, investigations and enforcement decisions, so that the public knows who makes each decision and which agency complaints should be directed to.

Although HSA will provide administrative support to the healthcare professional regulatory bodies, their independent functions in registration, disciplinary matters and professional standards must continue to be safeguarded. The authorities should provide clear transitional arrangements and support channels for small and medium-sized research institutions and technology startups. Affected employees should also receive adequate communication and training to ensure that experience and expertise are not lost during the restructuring. Mr Speaker, I support the Bill.

(In English): In standing the concern and clarifications I have raised, I support the Bill.

Mr Yip Hon Weng.

Mr Speaker, Sir, in 1960, a newly appointed medical reviewer in the United States (US) received an application for a sedative already sold widely overseas and promoted as safe, including for pregnant women. Routine approval was expected. But the evidence troubled her, so she withheld approval.

To the public, nothing appeared to happen: no commercial launch in the US and no apparent crisis. Keep that quiet decision in mind. Its significance lies not in what followed, but in what it prevented.

In healthcare, safety rests on an invisible contract of trust. We depend on regulators to detect risks that residents cannot see, and to act before those risks become tragedies.

Parents banking cord blood trust that storage standards will hold. Patients using connected devices trust that their software is secure. Families placing an elderly parent in a nursing home trust that standards will hold in their absence.

Singapore knows the cost when that contract is broken. Approximately 17,000 Cordlife clients had cord-blood units in six tanks that came under investigation. Subsequent audits identified further governance, incident-reporting and operational lapses, and MOH stopped new cord-blood collection and processing. For affected families, this was no administrative defect. They may face years of uncertainty over whether their child’s cord blood will remain viable when needed.

As Vice Chair of the Government Parliamentary Committee (GPC) for Health and having worked previously in MOH’s Smart Regulation Division, I support this Bill. I saw first-hand that effective regulation requires better judgement, not simply more rules.

The Bill transfers MOH’s Regulatory Compliance, Regulatory Transformation and Surveillance and Enforcement Divisions to HSA, expanding its responsibilities across healthcare services, biomedical research and biological agents. It transfers administrative support for Professional Boards while preserving their statutory and disciplinary independence. I welcome safeguards preserving transferred officers’ service, remuneration and accrued benefits. Reform must protect the public and those expected to deliver it.

Bringing regulatory intelligence, science and enforcement together can better protect Singaporeans. But larger is not automatically better.

HSA must extend its reach, exercise restraint and demonstrate readiness. Reach means acting where harm occurs. Restraint means keeping power within trusted boundaries. Readiness means protecting patients while enabling safe progress. Good regulation is not measured by how fast or slow it moves. It moves at the speed the evidence allows.

First, Mr Speaker, Sir, powers mean little if a regulator cannot reach suppliers, support the frontline or intervene before harm spreads. Youth vaping makes this urgent. This Bill creates no new anti-vaping powers; its relevance is whether consolidation makes enforcement more intelligent.

Vaporisers can carry etomidate and other harmful substances. They are concealable and sold through private messaging channels to the young.

I have received encouraging feedback from several schools that detected student-vaping incidents have fallen substantially year on year. But detection is not prevalence. Lower numbers must not mask activity moving underground. Supply chains may change their methods; their commercial purpose remains. The legal authority to tackle vaping sits under the Tobacco and Vaporisers Control Act. But transferring MOH's Surveillance and Enforcement Division should strengthen HSA's ability to act under those existing laws.

Will HSA publish indicators showing whether consolidation strengthens intelligence-led action against importers, online sellers and distributors, and whether falling school incidents reflect genuine reductions rather than displacement underground? Enforcement must be felt upstream, where profits are made, not merely downstream, where an addicted young person is easiest to catch.

Schools also have a practical problem. Their internal toolkits have limits. Teachers are educators, mentors and counsellors, not forensic investigators. If every teacher becomes an enforcement officer, we risk weakening the pastoral trust needed to identify addiction early and help a student recover. Will HSA use its additional institutional capacity to provide trained mobile enforcement support to schools, operating under the proper statutory powers and backed by a clear escalation protocol and named operational contact?

Enforcement must remain joined to rehabilitation. A student caught with a vape may be addicted, exploited or drawn into distribution. Our sharpest enforcement should target those who profit, while schools retain space to educate, counsel and restore. Success is concrete: fewer sellers reaching our children, fewer teachers diverted from teaching and more young people helped to quit before experimentation becomes dependency. That is what reach looks like on the ground.

Second, Mr Speaker, Sir, reach alone is insufficient. Confidence depends not only on whether a regulator acts, but how. The Bill allows suitably qualified persons outside the Public Service to become auxiliary authorised officers under the HBRA and Healthcare Services Act. This may increase inspection capacity, but unlike full officers, they cannot search premises, inspect medical records, seize items, or test and remove biological samples and specified materials. Their remaining powers are significant: entering premises during business hours, photographing people and activities, operating electronic equipment, copying non-medical data and requiring information.

Under the Healthcare Services Act, non-compliance without reasonable excuse may be an offence. To a clinic operator watching an auxiliary officer access a terminal connected to patient, billing and research information, this may not feel like a limited inspection. Three safeguards are essential.

First, meaningful consent. The Explanatory Statement says auxiliary officers may enter only with consent and that refusing consent is not an offence. Yet proposed sections 45A and 41A say that an officer "may" enter during normal business hours without expressly stating "with consent". If consent is the legal boundary, it should appear in the operative law, not only in explanatory text.

Will the Ministry amend the provisions to state expressly that entry requires consent and that refusing consent is neither an offence nor an act of obstruction? An operator should never be uncertain whether access is consensual, compelled under another statutory provision or undertaken through criminal investigative powers.

Next, digital privacy. One clinic terminal may connect to billing, research, medical records and cloud networks. At the keyboard, the boundary between medical and non-medical information can blur. Digital access should leave a reviewable audit trail, governed by rules on scope, data minimisation, legal privilege, retention and deletion. Accountability is equally important. Auxiliary officers need standards on qualifications, training, confidentiality and conflicts of interest, with sanctions for misuse. Clinics, research subjects and the public need a transparent complaints process and independent review where appropriate.

There must also be rapid escalation. If entry is refused or evidence may be destroyed, a full authorised officer must be able to intervene quickly. Urgency, however, must not blur the line between consent and compulsion. Will HSA publish a clear enforcement code of conduct before auxiliary officers begin work? Such a code should support, not substitute for, clarity in the legislation itself.

Enforcement without sufficient authority invites evasion. Authority without clear boundaries invites fear. A trusted regulator must be effective enough to act and disciplined enough to know where its power ends. That is what restraint requires.

Lastly, Mr Speaker, Sir, readiness turns statutory promise into practical protection. The Explanatory Statement says the Bill involves no additional Government expenditure. Yet HSA will inherit major functions across healthcare services, biomedical research, biological agents and Professional Board administration, alongside its regulation of sophisticated medical products and devices. An enlarged mandate supported only by transferred headcount risks moving responsibility without expanding capability. Readiness requires people, proportionality, access and proof.

It begins with people. Modern regulation spans connected pacemakers, AI diagnostics, cellular and gene therapies, digital evidence and cloud infrastructure. HSA needs biomedical, clinical, forensic, data and cybersecurity specialists whose skills are in intense demand. Will HSA publish a workforce and capacity plan showing how critical gaps will be filled without weakening existing product-safety responsibilities? This must consolidate capability, not queues.

Readiness requires proportionality. Inspections and information requests impose costs on standalone dialysis centres, non-profit nursing homes and medical transport providers. Patients may bear them through higher charges or reduced capacity. Scrutiny should follow risk, not organisational size or ease of inspection. HSA should support smaller providers through model documents, submit-once digital processes and differentiated inspection cycles for providers with strong compliance records.

Clause 7 also permits HSA to waive fees and charges. That flexibility should follow transparent principles, particularly where small or non-profit providers serve vulnerable patients.

Rigorous regulation and proportionate regulation are not opposites. Proportionality directs regulatory attention to where the risk of harm is greatest. Readiness must mean timely access. Regulation should not only keep unsafe products out; it should help safe and valuable innovations reach patients sooner.

HSA already uses early consultation, priority review and regulatory reliance. Consolidation should scale and connect these pathways: give Singapore innovators earlier guidance, avoid duplication where trusted overseas assessments can be relied upon and coordinate regulatory review with health-technology assessment for urgent needs.

Approval, however, is not the same as access. A promising treatment may be registered yet remain beyond a patient's reach because assessment, funding, procurement or clinical adoption takes longer. Will MOH and HSA publish timelines from submission to regulatory decision and from registration to funded clinical adoption? This would promote Singapore's innovation, accelerate responsible adoption of beneficial overseas technologies and reveal where delay occurs.

After HSA's first full year, the public should know whether licensing is faster, high-risk services are inspected, incident responses are quicker and smaller providers face less costs. No inspection, renewal, complaint or disciplinary referral should fall between systems. Will HSA publish a first-year transition audit and dashboard covering turnaround times, risk-based inspection coverage, serious-incident responses, auxiliary-officer complaints and smaller-provider compliance burdens?

What gets consolidated must become accountable. What becomes accountable must become measurable. That is what readiness demands.

In conclusion, Mr Speaker, Sir, the promise of this Bill rests on reach, restraint and readiness. I seek three clear commitments. On reach: publish evidence that consolidation strengthens enforcement where harm occurs, including against those profiting from youth addiction. On restraint: place the consent requirement expressly in the operative legislation and publish clear safeguards for auxiliary officers. On readiness: publish a workforce and transition plan that measures both harm prevented and safe innovation enabled.

Reach without restraint can weaken trust. Restraint without readiness can produce paralysis. Readiness without measurable outcomes can become merely a larger bureaucracy. Residents should not need to see the machinery of regulation. They should simply be able to trust that it works.

Mr Speaker, Sir, let me return to that quiet regulatory decision that I spoke at the beginning of my speech. The medical reviewer was Dr Frances Kelsey. The sedative was thalidomide. Months after she withheld approval, the drug was linked overseas to severe birth defects affecting thousands of babies. Because she insisted on reliable evidence, it was never commercially marketed in the US. America was spared the mass tragedy unfolding elsewhere.

For almost a year, it appeared that nothing was happening. That was the achievement. But Kelsey did not delay for delay's sake. She held the line because the evidence required it. Where evidence is weak, haste can harm. Where evidence is strong, delay can harm too. That is the deeper responsibility we place on HSA: not merely to move quickly or cautiously, but to exercise the judgement to know what the evidence demands.

Our task is to turn individual vigilance into institutional discipline. A regulator's greatest successes are often quiet: (a) the vape that never reaches a child's schoolbag; (b) the data breach that never compromises a patient; (c) the dangerous practice corrected before someone is harmed; (d) the cord blood unit still viable when a family finally needs it; and (e) the breakthrough therapy that reaches a patient in time.

Some victories prevent harm. Others preserve opportunity. If this Bill gives HSA the reach to act, the restraint to remain trusted and the readiness to prevent harm while enabling timely access to beneficial innovation, it will strengthen that invisible contract of trust. Mr Speaker, Sir, I support the Bill.

Mr Sanjeev Kumar Tiwari.

Mr Speaker, I declare my interest as the General Secretary of the Amalgamated Union of Public Employees (AUPE), and I speak on behalf of the Amalgamated Union of Statutory Board Employees, who will represent the officers who will be transferred from MOH to the HSA.

HSA already carries a substantial mandate and this Bill broadens it. It will bring new regulatory functions — Sorry. Mr Speaker, can I just take some time?

Sure. Do you need some time?

Yes.

Okay, let me call on the next speaker first. Dr Hamid Razak.

Mr Speaker, Sir, I rise in support of the Health Sciences Authority (Amendment) and Other Matters Bill.

Firstly, I would like to declare my interest as a practicing orthopedic surgeon in private practice.

In that regard, HSA is never far from my daily practice. Every implant that I fit in, every device that I rely on in the operating theatre has passed through HSA's approval before it reaches my hands and my patient. In fact, many foreign medical device companies aggressively pursue HSA registration because of its maturity level 4 status with WHO and this is something to be proud of. So, obviously when HSA's powers grow, I take a keen interest in how and why.

Our healthcare environment has grown more complex. Regulation today reaches beyond just devices or drugs. We are talking about healthcare services, biomedical research, biological agents and new risks, especially with cybersecurity between connected medical devices, for example. Therefore, there is real merit in building deeper regulatory expertise within one dedicated agency. However, Mr Speaker, Sir, this greater authority to me raises three questions. One, are we clearer about who does what? Two, are policy and practice still aligned? Three, is enforcement ready for what we are asking of it? Let me take each in turn.

My first point is on the balance between MOH and HSA. The Bill transfers real regulatory weight to HSA. Firstly, administration and enforcement of the HBRA and the BATA. Secondly, HSA will also be supporting MOH under a further nine Acts, which includes the Infectious Diseases Act and the MediShield Life Scheme Act. This is not mere re-organisation. It draws a sharper line, MOH as the policy maker and HSA as the regulator.

There is good reason for this. A dedicated regulator builds deeper expertise, professionalises enforcement and can move faster when risks emerge. But healthcare is not like other sectors. Policy, clinical practice and patient safety are tightly bound together. A regulatory decision can change how a doctor practises overnight.

So, I ask the Minister of State these questions: What should stay with MOH and what should sit independently with HSA? In a year or two from now, how would we know that this arrangement produced better regulation and not simply moved it from one organisation to another.

My second point, Mr Speaker, follows from the first. If MOH sets policy while HSA interprets the policy and enforces it, a gap can open between intent and execution. Picture a healthcare provider who believes HSA requirement or regulation sits at odds with an MOH-owned clinical direction. Where does this provider turn to? The Bill already gives the DGH power to issue directions to HSA's officers and requires CE(HSA) to consult the DGH before certain approvals. This is a good start, but is this enough for a provider facing a live, specific dispute? Is there a clear individual channel that can be established to get an authoritative answer, quickly, especially, when patient care is on the line?

For doctors, healthcare institutions and ultimately, patients, the Government must continue to appear as one coherent regulatory system even when different institutions perform different functions. I would therefore suggest establishing a very clear escalation protocol and dispute resolution mechanisms between MOH and HSA together with a straightforward avenue through which licensees and health professionals can obtain clarifications when regulatory interpretation and policy intent appear to diverge.

My third point, Mr Speaker, is on enforcement capability. The Bill lets CE(HSA) appoint auxiliary authorised officers. Under the Healthcare Services Act, they may enter and inspect premises with consent during normal business hours. Their powers are deliberately limited. No search, no testing, no removing of items. There is merit, of course, in getting more manpower, but there is a larger question behind it.

We have already seen HSA take on a more visible frontline role, especially in areas such as vaping as enforcement. As its remits grow across healthcare services, biomedical research and biological agents, is its enforcement keeping pace? Enforcement is not merely administration. It calls for legal grounding, investigative skills specific to the sector, and training to manage a confrontation safely.

Our Customs officers, our Immigration and Checkpoints Authority (ICA) and Central Narcotics Bureau (CNB) officers all have specialised officers because their missions demand it. I ask whether HSA over the long term needs the same. A dedicated trained health enforcement service, clearly identifiable and properly accountable.

And on the auxiliary officers, one more question remains. What happens when consent is refused? Does the matter automatically escalate to an authorised officer with fuller powers? Operators should know their rights, and our officers should know their protocols.

Mr Speaker, Sir, this Bill represents an important evolution in Singapore's healthcare regulatory architecture. Consolidating expertise within HSA can produce a regulator that is more specialised, agile, and capable of responding in an increasingly complex healthcare environment and ecosystem. But greater authority must be accompanied by equally clear accountability, coordination and capability. We should ensure that MOH and HSA continue to speak with one collective voice, that healthcare providers know where to turn to when policy and implementation appear to diverge, and that HSA has the professional enforcement capability necessary to exercise its expanding responsibilities effectively and fairly.

With these observations and clarifications, Mr Speaker, I support the Bill.

Mr Sanjiv, are you ready to make your speech? I will call on you then.

Mr Speaker, apologies for the technical glitch. I will start all over again.

Mr Speaker, I declare my interest as the General Secretary of the Amalgamated Union of Public Employees, and I am speaking on behalf of the Amalgamated Union of Statutory Board Employees (AUSBE) where the officers will be transferred to under HSA.

HSA already carries a substantial mandate, and this Bill broadens it. It will bring new regulatory functions and administrative support for our regulatory bodies for the healthcare profession under one authority. The overarching intent is clear: to strengthen and uplift our national capabilities in public health and safety, so that the whole is more coherent, more responsive to emerging needs, and more effective than its parts.

Mr Speaker, there is a certain fittingness to this Bill. The Health Sciences Authority was itself born of a consolidation. In 2001, five departments of MOH were brought together to form one single authority. The reasoning then was clear: to harness technical synergies, build a larger and stronger core of expertise, and to keep pace with a rapidly changing field.

Mr Speaker, there is a second continuity that deserves mentioning. When HSA was formed in 2001, the law provided that every officer transferred from those five departments would be absorbed on terms no less favourable than they had previously enjoyed. Today, clause 36C of this Bill extends the same assurance to a new generation of officers. The principle is simple: when we recognise and re-organise for the public good, we must not do so at the expense of officers.

Behind every function being transferred are people. Officers who administer those regulatory regimes, they process applications, inspect the laboratories, and maintain the registers on which the integrity of our system depends. They are not merely names or positions on an organisation chart. They are public officers who have built deep expertise over many years. Understandably, some may ask what this re-organisation will mean for their jobs, their employment terms and also their future.

Mr Speaker, I am therefore glad that the Bill provides them with clear statutory protection. I support clause 36C. It provides that, on the transfer date, every transferring employee moves to the service of the authority, and I quote: “on terms no less favourable than those enjoyed by the employee on the eve of the first transfer date." This is an important assurance. It makes clear that transfer will not break the continuity of the years of service the officer has. It will not amount to retrenchment or a redundancy. Nor will it deprive officers of the benefits and the entitlements they may have already earned. This is the right principle and I am heartened to see that it is stated plainly in the law.

I also welcome clause 36D, which provides for the general preservation of the employment terms. This clause protects matters that are important to every affected officer and their family: their accrued leave, their length of service, the continuity of employment, and the employment rights accumulated over the course of their service. These may appear technical when expressed in legislation. But to an officer who has devoted many years of Public Service, they are deeply personal.

Mr Speaker, I would like to focus on subsection (3) of clause 36D. It provides that, until the Authority draws up the new terms and conditions of employment for a transferred employee, that employee will continue on the same terms and conditions as before. This is a fair and necessary transitional safeguard. But it also points to an important next step, and here I would like to highlight to HSA that as it develops the new terms and conditions that will apply to the transferred officers, I hope that it will take into consideration, work strongly with AUSBE, so that they make sure they can come up with a comprehensive, fair and equitable sets of terms and conditions for the officers that are transferred. I also seek that it consults, and continues to work closely with, their union, AUSBE, as it develops these new terms and manages the transfer. Engaging AUSBE early can help surface issues, build trust in the transition, and this is also how the workforce can manage the change successfully, and to ensure that every officer transferred is present, and the decisions taken make sense and is important to them.

Mr Speaker, just want to add two more hopes.

First, I am confident that the HSA and the Ministry will communicate directly and early with each affected officer. And second, I hope that preserving existing terms will be treated as the floor, and not the ceiling. These officers are bringing valuable institutional knowledge and specialised expertise into an authority that will depend on their expertise for years to come. The transition should therefore also be an opportunity to invest in their development, recognise their expertise and provide them with clear pathways to learn, contribute and progress within HSA.

Mr Speaker, this Bill will strengthen the institution entrusted with safeguarding our health sciences. But institutional strength does not come from organisational structure alone. It also comes from the people who carry the work, uphold professional standards and preserve public confidence in our regulatory system.

A stronger authority is our common objective. A well-protected workforce must be our commitment. And close engagement with the union will be one of the best ways we can make sure that every affected worker will be able to continue forward with confidence. As we strengthen the institution, let us also strengthen the people within it. Mr Speaker, I support the Bill.

Ms Kuah Boon Theng.

Mr Speaker, I rise in support of the Health Sciences Authority (Amendment) and Other Matters Bill, and to seek clarifications regarding the operationalisation of the changes envisaged by the Bill.

I wish to declare that I am a lawyer who provides advice and legal services to healthcare institutions and healthcare professionals, as well as to professional bodies within the healthcare ecosystem. I am currently an active member of institutional review boards reviewing biomedical research studies, and as legal counsel, I also handle complaints and disciplinary cases that come before the SMC.

This Bill seeks to consolidate important healthcare regulatory functions within HSA. It will expand HSA’s current remit from primarily product regulation, for example, relating to health products, devices, blood and forensic science, to encompass facility regulation, biomedical research oversight, biological agent control and administrative support for the Professional Boards. This consolidation aims to promote clearer accountability, stronger operational coordination and to maintain more consistent and robust regulatory capability.

These goals are laudable, but for the goals to be achieved, HSA will need to be provided with adequate resources to carry its expanded mandate and detailed planning will need to take place to ensure a seamless transition.

In this regard, I seek the Ministry’s clarifications and assurance on several matters.

First, what steps have been taken and will be taken to ensure a smooth transition of regulatory functions, and to minimise disruptions. The transfer of property, assets, liabilities and employees that is consequential to this Bill will be on a significant scale. I am sure we can all agree that it is essential to preserve legal and administrative continuity in all aspects of the important work that will be affected by this major re-organisation exercise.

The provisions in the Bill that relate to statutory continuity do not automatically translate into operational continuity. A function may legally continue but institutional knowledge can be lost, systems may not be interoperable and responsibilities can become unclear in the midst of a handover, especially one of this scale.

With this in mind, can the Minister of State provide details of the concrete steps that have been taken and will be taken to prepare for this transition?

In particular, has MOH drawn up a detailed function-by-function transition plan and identified the critical processes that will require greater attention during the handover? Can we ensure that system access and contingency arrangements are in place? Will there be a single accountable transition lead, a formal handover protocol, parallel operations where necessary and will there be published service continuity indicators? What safeguards are being put in place to ensure the integrity and confidentiality of regulatory, clinical, investigative and disciplinary records as they move between institutions?

The Minister of State has indicated that the implementation of this transition will be in two stages – November 2026 and, I believe for SPB, it will be next year. Are these intended to be hard deadlines or will there be stipulated readiness criteria that need to be met before effecting the handover of each statutory function?

An example of a critical function that could become vulnerable to disruption is the work of the secretariat that currently supports Professional Boards, handling complaints against healthcare professionals.

Pursuant to the Bill, an entire department presently residing with the SMC will move to the HSA. Of course, the statutory functions of the individual Professional Boards will continue to vest in each statutory body in accordance with the relevant legislation, for example, the Medical Registration Act (MRA).

For this work to continue without disruption, we must ensure that records are kept and handled securely, and the quality of services provided in terms of case administration, legal support, scheduling, correspondence and so on must be maintained. Institutional knowledge must also be preserved. A disruption at the secretariat level can adversely impact the work of the Professional Boards. This in turn will affect the confidence of complainants, practitioners and the public.

In my view, the secretariat that currently supports the Professional Boards already has many pressing needs and priorities to attend to. As of now, there are still old complaint cases that were lodged well before 2020 that have yet to be cleared. There is also a need to keep up with the work of arranging training for those who serve on Inquiry, Complaints and Review Committees as well as those who sit on the Disciplinary Tribunals. As I understand it, it has been some years since such training was arranged.

I also recently called for the Sentencing Guidelines for Singapore Medical Disciplinary Tribunals to be revisited and revised as part of an overall effort to ensure that SMC Disciplinary Tribunals' sentencing decisions continue to be in line with Court decisions.

I seek the Ministry's assurance that this re-organisation is not going to result in any setbacks in clearing the backlog of complaints and that all cases will be handled efficiently and competently. I am sure we can all agree that cases need to be resolved in a timely manner. We must also ensure that the decisions are defensible and well-reasoned.

There are other clarifications I would like to seek regarding specific clauses of the Bill.

May I ask, first of all, what it means to require the CE(HSA) to consult the DGH?

The Bill transfers substantial powers under the Biological Agents and Toxins Act from the DGH to CE(HSA). Clause 19 provides that the CE may grant the specified approval only after consulting the DGH. Clause 22 applies similar language to a range of other provisions under that Act.

Is this consultation process intended to be a mandatory procedural pre-requisite to the lawful exercise of power? To my mind, requiring consultation ordinarily does not mean you need to secure approval or concurrence. The HSA's CE could remain the ultimate decision-maker. Is the wording of the Bill intended to allow CE to proceed so long as DGH has been given a timely opportunity to express a view and that view has been duly considered even if it falls short of an approval?

If consultation is mandatory, what is the consequence of non-compliance? Would the decision be legally vulnerable and liable to be set aside? Will there be a written record of the consultation and the matters considered?

I accept that excessive formalities could slow urgent regulatory decisions, particularly where biological safety is concerned. However, the answer is not to allow uncertainties to remain. The Bill or its implementation framework can provide an expedited consultation process for urgent cases, with clear time limits and documented reasons, all the while preserving the integrity of the process. Legal clarity will protect both public safety and the validity of regulatory action.

Next, I would like to ask about the auxiliary authorised officers who need not be public officers or officers of a public authority but will be entrusted to carry out duties pursuant to the HBRA and the Healthcare Services Act.

The Bill provides that these officers may enter and inspect premises and conveyances with consent during normal business hours, but their powers are limited. For example, they may not search the premises or conveyance. They also do not have the power to inspect, take copies or take extracts from medical records, or to test, examine or remove items, such as equipment, blood sample or products of the human body, that are found on the premises or conveyance.

I agree that limitations on the powers of these auxiliary officers are necessary. The issue is whether the dividing line between entering and inspecting on the one hand and searching on the other is always that clear in practice. I also note that the criterion for appointment is simply to be suitably qualified, but what that means is not clear.

At the end of the day, it will be critically important to ensure that all auxiliary officers employed for such duties are properly trained, including in data governance and medical confidentiality, so that they do not overstep their bounds.

In terms of the resources to be provided, the Bill's Explanatory Statement states that it will not involve the Government in extra financial expenditure. Yet HSA will assume a materially expanded portfolio – additional regulatory, enforcement, research oversight and Professional Board support functions.

Consolidation of functions can produce efficiencies, but sometimes these efficiencies can only be achieved down the road and not immediately. If HSA is expected to do more, it must have the people, systems and funding to do their job properly.

Can the Minister of State clarify how the expanded mandate will be resourced? Was this already accounted for in the MOH Budget? Will the relevant portion of the MOH Budget, headcount and systems simply be transferred? Beyond transferred resources, has there been a workload and capability assessment identifying additional needs and legal services, investigations, scientific expertise, data governance, cybersecurity, case management and even corporate support? Will HSA receive additional manpower and resources if the essential work to ensure a seamless transition makes it necessary?

Finally, I note that the Minister of State will be empowered to assign other functions to HSA by Gazette notification.

This delegation of power is quite a broad one. May I ask the Minister of State if the intention is for this power to be exercised only in respect of other functions that are related or ancillary to the ones already contemplated by this Bill, or could the scope of HSA's regulatory responsibilities potentially be expanded much more than what Parliament is currently being asked to approve?

Mr Speaker, I support the Bill because I believe that a more integrated regulatory structure can in the long run strengthen Singapore's healthcare system. However, implementation of an institutional redesign of this scale must be carried out in a manner that preserves continuity, clarity in terms of legal duties and obligations, professional independence and timely service. I therefore look forward to receiving the requested clarifications and assurances and to hear more about the concrete steps that will be taken to address the issues I have raised. Subject to these assurances, I support the Bill.

Order. We have been in the Chambers for five hours now. I propose to take a break. I suspend the Sitting and will take the Chair at 3.45 pm. Order. Order.

Sitting accordingly suspended

at 3.26 pm until 3.45 pm.

Sitting resumed at 3.45 pm.

[Deputy Speaker (Mr Xie Yao Quan) in the Chair]

Debate resumed.

Dr Haresh Singaraju.

Mr Deputy Speaker, I declare my interest. I am a registered medical practitioner regulated by the SMC and I head a polyclinic licensed under the Healthcare Services Act. I support the Bill.

I start with the consolidation of the professional regulatory system under which every registered healthcare professional in Singapore will practise. The Bill's logic is sound. Seven Professional Boards regulate our doctors, dentists, nurses and midwives, pharmacists, optometrists and opticians, TCM practitioners and allied health professionals. Each runs its own administrative office. The result is duplicated systems, thin capacity and cases that take too long.

Consider what that delay means for the two people inside every case. A patient who complains has usually thought hard before doing so. It takes some courage to question the person who treated you. Having filed a complaint, they may then hear little for years, no clear account of where their case stands, or when it will end. For the professional, an unresolved complaint puts a career on hold and follows them home: practice continues, but under a cloud, whatever the outcome.

Within the professions there is a plain phrase for this: the process itself is the punishment. It falls on complainant and professional alike, and on the deserving and undeserving alike.

The Bill's answer is to consolidate this work into one secretariat within HSA, an agency that already runs regulatory operations at scale. This should shorten proceedings and for both parties in every case, that is the most important reform available.

Capacity, however, is only half of what a disciplinary system requires. The other half is independence. The public accepts judgement by professional peers because that judgement is informed by evidence and clinical reality. In return, the professions hold themselves to a standard higher than the law demands. This arrangement retains legitimacy only if the public can see that complaints are decided independently, neither buried to protect a professional, nor driven by the institution that made them.

The Bill changes the architecture of that independence in three connected ways. The authority's officers will inspect clinics. The authority's officers may file complaints against practitioners of any of the seven professions, exempt from the statutory declaration required of a member of the public. And the secretariat that receives complaints, compiles evidence and administers the Complaints Committees and Disciplinary Tribunals will consist of the authority's staff.

The exemption from the statutory declaration is defensible. An officer referring inspection findings performs a duty and is answerable to the criminal law if the information is false. The oath is replaced by institutional accountability. But institutional accountability is only as strong as the governance behind it. This Bill places complaints, evidence and the administration of judgement in one organisation and is silent on what will separate them. The boards remain the deciders and I do not doubt their integrity. The question is structural, not personal. A sound system does not depend on the good faith of those inside it. It is built so that good faith can be checked from outside.

The design question has been answered before. Australia brought some 15 Professional Boards under one national agency, with functions ring-fenced and oversight made independent. Its regulator publishes how each concern is managed, how long each stage should take and what support exists for the person who complains and for the professional complained about. Consolidation and accountability were designed together. We can do the same.

I therefore make two recommendations.

First, that the separation of the authority's inspection and complaint functions from its secretariat function be set out in a published governance protocol and that the arrangement be subject to periodic independent review. Professionals and patients alike should be able to see the separation, not merely be assured of it.

Second, that the Ministry publish timeliness standards for the new secretariat, in particular, the median time from complaint to Complaints Committee decision, reported regularly, and commit to keeping both parties, complainant and professional, informed of the progress of their case and directed to available support throughout. These are the parts of the system that the people inside it actually feel.

Within this second recommendation, I ask that one word be given a central place in the new secretariat's purpose: education.

Sanction must remain available and must be applied where warranted. But a disciplinary system generates knowledge as well as verdicts. The consolidated secretariat will hold patterns across every complaint in all seven professions: what brings a patient to complain, what is dismissed and why, and where competent professionals err. Returned to the boards and their registrants in aggregated and anonymised form, these patterns would allow every complaint, including those dismissed, to improve practice across the professions.

A system that only punishes produces fear. A system that also teaches produces better professionals and a safer public.

Sir, the principle beneath both recommendations that trust must be designed in from the start, not repaired afterwards applies equally to two further responsibilities this Bill hands the authority.

The first is research. The Bill transfers the administration of the HBRA to the authority. Research misconduct is changing in character: artificial intelligence can now generate plausible data, images, and manuscripts, making fabrication easier to commit and harder to detect. Singapore's standing as a research hub rests on the integrity of its results. The authority should build the capability to detect fabricated and AI-generated research data from the outset of its stewardship, not after the first serious case arises.

The second is inspection. When inspectors arrive at a clinic, patients notice, and a routine visit can create the impression of wrongdoing where there is none. Inspection practice should distinguish clearly between routine assurance and for-cause investigation, so that a visit that finds nothing costs nothing.

I also note the firm line the Bill draws around medical records for the new auxiliary officers. That line protects patient confidentiality and it must hold in practice as it reads in law.

Sir, the interests of the public and the professions converge here. A professional who fears the disciplinary system practises defensively: more tests, more referrals, less candour when things go wrong. A professional who trusts it discloses error earlier, and patients are safer for it. Fair, timely and visibly independent discipline is not protection for the professions. It is a condition of good care.

The Bill consolidates well. My recommendations ask that it separates, reports and teaches equally well. Mr Deputy Speaker, allow me to say a few words in Tamil.

(In Tamil): [Please refer to Vernacular Speech.] Mr Speaker, the central idea of this Bill is very simple. Both the patient who lodges a complaint and the healthcare worker who is the subject of that complaint must receive justice swiftly and fairly.

Thiruvalluvar said this in just two lines: "When investigating a matter, do it thoroughly and impartially; and deliver a verdict that is fair to all, the proper way."

To investigate thoroughly, to stand impartial and to deliver justice: this is the proper way. A system that only punishes will breed fear. A system that whereas teaches from mistakes will create trust. And it is only with trust that good medicine can be practised.

(In English): Sir, I support the Bill.

Dr Choo Pei Ling.

Mr Deputy Speaker, I declare my interest as a registered member of the Allied Health Professions Council and an imaging neuroscientist at the Singapore Institute of Technology researching stroke recovery, work governed in part by the HBRA.

The provisions in this Bill are not abstract to me. This Bill consolidates regulatory functions from the Ministry, the HBRA and the Secretariat of Healthcare Professional Boards under HSA. I accept the Ministry's position that this responds to healthcare regulation becoming genuinely interconnected. AI, new care models and cross-cutting enforcement no longer respect old organisational lines. My key message is that Singapore's regulatory capability can itself become a competitive advantage for our biomedical ecosystem. But that promise must be earned and not assumed.

I want to offer one observation about what this Bill does and does not do. It is structural. It moves functions, offices and enforcement powers into one agency. It does not, on its own, create new rules for the technologies that make this coherence necessary in the first place, such as AI-enabled medical devices. That is not a shortcoming. New rules should follow evidence and not precede it. But it does mean the real test of this restructuring lies ahead, in what HSA does with the structure it has been given, not in the structure itself.

The points I raise today are really one question asked in different ways: how will we know, in practice, that this move has delivered the coherence it promises?

Take an adaptive AI-enabled medical device, of the kind now emerging in rehabilitation and diagnostic settings. Such a device can touch health products regulation, human biomedical research rules during validation and professional practice standards once a clinician is using it. One of the most common frustrations for researchers and innovators working with genuinely novel technology is not the substantive review itself, but simply establishing which regulatory pathway even applies, before review can begin. This is not a criticism of any officer's judgement. It reflects technology moving faster than existing categories. Could the Minister of State share whether HSA intends to commit to a defined turnaround time for classification decisions on genuinely novel products, so that predictability becomes something innovators can plan around and not just a description of intent?

Second, on technical depth: the CE(HSA) will be the single statutory office holder accountable for domains as distinct as human biomedical research, clinical trials, health products and professional practice. No one individual can hold deep expertise across all of these and I do not think anyone expects them to. I accept it would be impractical to legislate rigid criteria for scientific advisory input, since the expertise needed will keep evolving. But could the Minister of State confirm whether, once technical advisory panels for domains like human biomedical research and AI-enabled devices are formed, their composition and areas of expertise will be disclosed to Parliament, even if only after the fact?

Third, on research governance. Administration of the HBRA is moving to HSA, but ethics review of individual protocols still happens at each institution's own institutional review board (IRB). It is a well-recognised feature of research governance in Singapore and internationally that IRB rigour and panel composition can vary between institutions and that reviewers are not always specialists in the particular research area before them. I would ask whether this restructuring includes any parallel effort to harmonise IRB training or competency standards across institutions. And separately, what recourse exists for a principal investigator who believes a review decision was shaped by something other than the merits of their protocol.

Fourth, on oversight. This Bill brings search-and-enforcement powers, research governance and product regulation under one statutory office holder. I accept this is coordination, not concentration for its own sake. But as I understand it, the reporting and escalation protocols meant to preserve oversight are administrative arrangements, not statutory guarantees. I would ask that they be made more transparent.

Fifth, on auxiliary authorised officers. These officers, drawn from outside the public service, bring valuable technical expertise. But the safeguards on paper – consent-based entry, no access to records or biological material – cannot fully remove confidentiality and conflict-of-interest risk, particularly as these officers may move between industry and regulatory roles over time. I would ask that vetting and recusal obligations for these officers be actively monitored and not only assessed once at appointment.

Finally, could the Ministry commit to a defined point at which this restructuring's success will actually be assessed against indicators, like cross-domain processing times and stakeholder experience, rather than leaving the outcome to be judged only in general terms?

Mr Deputy Speaker, I raise these points in support of this Bill, not against it. The direction is right; getting the details right is how we make sure it works as intended, and not just on paper. I support this Bill and I look forward to the Minister of State's response.

Minister of State Rahayu Mahzam.

Mr Deputy Speaker, I thank Members for their support for the Bill and for raising important questions about how this new regulatory architecture will work in practice.

Members have, in different ways, raised the central issue behind this Bill – integration must result in better regulation, not simply a different organisational structure.

I agree. The success of this consolidation will ultimately be judged by whether the system becomes more coherent, responsive and easier for stakeholders to navigate while maintaining strong safeguards for public health, trusted by both the public and those whom we regulate.

Several Members raised questions on the delineation of roles and responsibilities between MOH and HSA, the importance of ensuring close coordination between both agencies, and the scope of functions that HSA may take on in the future.

Dr Hamid Razak asked about the philosophy behind the redistribution of functions between MOH and HSA, and called for clear mechanisms to ensure alignment in regulatory policy and operations and resolve disputes if any. As I shared earlier, this move will house healthcare regulatory operations across products, services, health information and professionals within a single organisation, HSA. This enables HSA to build deeper regulatory, scientific, operational and enforcement expertise across these regulatory operations while ensuring stronger integration and coordination for industry. This Bill thus enables us to strengthen our national regulatory response so that we are better placed to handle emerging issues.

After this move, MOH will remain responsible for the strategic direction for Singapore’s healthcare system to ensure that it remains safe, affordable, accessible and sustainable. MOH will set national healthcare regulatory policies as aligned to the strategic direction. HSA will undertake and execute the regulatory functions within the scope of this Bill in support of MOH’s policies and directions. This Bill does not seek to separate policy from regulation, but rather to better delineate institutional responsibilities. Policy and operations will remain closely intertwined and aligned.

Mr Dennis Tan asked who will be in command during a public health emergency. MOH will continue to lead the overall public health response and national decision-making, including under the Infectious Diseases Act. This Bill does not affect the Government’s arrangements in handling public health emergencies.

As a well-established Statutory Board within the healthcare family, HSA already has regular reporting, escalation protocols, joint review processes and regular meetings with MOH’s senior management and the Minister. With this expanded scope, we will also strengthen collaboration and coordination at the working level with cross-agency project teams, and cross-exposure for both MOH and HSA officers to ensure that policy intent is consistently understood and applied on the ground.

Ms Kuah Boon Theng asked about the consultation process with MOH on specified matters and Dr Choo Pei Ling asked if it would be more transparent to include reporting and escalation protocols into statute. We conducted a thorough review and where such consultations are critical, the relevant provisions have been built into the respective Acts. For instance, under BATA, the CE(HSA) can only approve the possession of certain high-risk biological agents after consulting the DGH. This requires the views of the DGH to be sought and duly considered before a decision is made, even though the ultimate statutory decision remains with the CE(HSA). Appropriate records of such consultations and decisions will be maintained. Restricted human biomedical research will be subject to a similar legislative regime.

For other areas where policy and regulatory authority remain with MOH, such as the HCSA and the Health Information Act, HSA will continue to consult and seek the necessary approvals from MOH senior management in its administration and enforcement. Where a regulatory matter has wider policy implications, MOH and HSA will continue to work through these issues together.

Ms Kuah asked whether the power to assign “other functions” to HSA by Gazette notification could expand HSA’s regulatory responsibilities well beyond what Parliament is currently being asked to approve. I want to assure Members that this is not the intent. Such provisions do not allow the Minister to amend substantive regulatory rights, obligations, offences or requirements within the underlying Acts by administrative order. As with any subsidiary legislation, the functions that may be assigned by the Minister must come within the purposes of the Act, which means that the newly assigned function must relate to the updated functions conferred on HSA in the Act. This provision is not new and already exists in other Acts, such as the Communicable Diseases Agency Act, the Accounting and Corporate Regulatory Authority Act, and the Skills and Workforce Development Agency Act. This provides the legislative flexibility to accommodate further assignments as necessary and ensures the Government is optimally organised to address the evolving healthcare landscape.

Mr Tan asked why the board quorum is being reduced. The revised quorum threshold, set at the higher of one-third of board members or a minimum of three members, is aligned with other Statutory Boards, such as the Energy Market Authority, the Maritime and Port Authority of Singapore, and the Communicable Diseases Agency. More importantly, this amendment should be considered in the broader context of the changes to HSA's board governance. We expect the board size to grow beyond its current 11 members to meet HSA’s expanded mandate. Hence, the board quorum would realistically remain at five or more at the steady state.

Members asked whether HSA’s capacities and capabilities are keeping pace with its expanding responsibilities and how auxiliary authorised officers will fit into the overall enforcement picture.

I note Dr Hamid’s suggestion to establish a dedicated uniformed health enforcement service. I appreciate the need for our enforcement officers to be properly trained and identifiable. I would like to reassure Members that HSA does have a dedicated enforcement unit with officers trained and equipped to conduct surveillance and enforcement operations. With the transfer of functions, the corresponding manpower and resources, including legal, information technology and corporate support within MOH and SMC will be transferred to HSA. MOH and HSA will continue to review the operational capabilities, workloads and systems required to support the expanded mandate. Where further resources or expertise are required to discharge these functions effectively, these needs will be addressed through the appropriate resourcing processes.

Ms Kuah referred to the Explanatory Statement that the Bill does not involve additional Government expenditure, and I would like to clarify that this relates to the legislative changes introduced by the Bill itself. Where additional capacity, expertise or other resources are needed for HSA to discharge these functions effectively, HSA will be adequately resourced.

The different functions, operations and processes will also be integrated and, where necessary, redesigned. For instance, structured training and development programmes for enforcement officers will be strengthened to support HSA’s widening enforcement mandate. Officers will also be supported by technical and subject-matter experts where needed, so that enforcement actions are well-informed and grounded in domain expertise. Where appropriate, HSA will continue to take a whole-of-Government approach and work with other law enforcement agencies to address public health concerns, as we do today for youth vaping.

Mr Yip Hon Weng also raised the need to strengthen mobile enforcement support to the schools while allowing schools to focus on education for the youths who vape. While this Bill does not change the substantive vaping regime under the Tobacco and Vaporisers Control Act, the consolidation can support stronger coordination of HSA’s existing surveillance, investigation and enforcement capabilities, and continue to enhance its existing collaboration with the Ministry of Education to support any further investigative work needed.

Regarding questions on auxiliary authorised officers, Members have rightly observed that enforcement requires different interventions and powers depending on the specific circumstances. The objective should therefore be to ensure that HSA has adequate powers and capacities to perform the full spectrum of enforcement operations, from routine inspections and audits to investigations into serious cases requiring formal enforcement action.

Auxiliary authorised officers are intended to complement HSA officers, so the relevant provisions for them do not replicate the full powers of HSA’s authorised officers. As raised by Ms Kuah, the practical distinction between “entering and inspecting” versus “entering and searching” lies in the circumstances that trigger them. Entering and inspecting is, in most situations, routine and pre-arranged and is about verifying compliance in the ordinary course. Entering and searching, by contrast, occurs when there are reasonable grounds to believe that a breach or patient safety incident has occurred, and more thorough investigation is required. Auxiliary authorised officers cannot exercise the full range of powers available to authorised officers under the relevant legislation, including search, seizure and other investigative powers.

On the issue of entry raised by Mr Yip and Dr Hamid, the policy intent is that entry by auxiliary authorised officers under these provisions is consent-based as routine inspections and audits, where auxiliary authorised officers are likely to be deployed, are generally pre-arranged and scheduled in advance. Refusal to provide such consent does not, by itself, constitute an offence of obstruction. In the unlikely event where consent is not provided, the matter would be escalated to the overseeing HSA officers with the requisite statutory powers and HSA officers will still be deployed. Auxiliary authorised officers will also act under HSA's authority and direction, and their work will be subject to regular review and oversight. The public or healthcare providers can directly reach out to HSA if they have any concerns regarding auxiliary authorised officers or believe that powers have been exercised improperly.

Mr Tan asked how HSA would ensure that access to information, especially confidential information, is segregated, proportionate and limited to relevant information. Today, regulatory officers only have access to IT systems and information on a need-to-know basis as determined by operational needs. This will remain the same, moving ahead. As a Statutory Board, HSA will continue to abide by prevailing public sector data governance requirements, including how HSA manages information, such as data storage, data disposal and sharing with third parties, such as auxiliary authorised officers.

Mr Yip rightly observed that modern health regulation increasingly requires diverse expertise ranging from clinical medicine and biomedical science to AI, cybersecurity, advanced therapies, digital evidence and data. Besides enforcement capabilities, this consolidation is also about building the regulatory expertise Singapore will need for the future.

Dr Choo also asked how the CE(HSA) could personally possess deep expertise across all these areas. The answer is that no single individual can, nor should our system depend on that. The strength of a modern regulator lies not in the expertise of one statutory office holder, but in the collective expertise, systems and governance of the institution. HSA will need to continue developing specialist regulatory teams, strengthening training and career pathways, recruiting new expertise where necessary, and drawing on appropriate external scientific, clinical, legal and technical expertise.

Safeguards will be put in place as part of the recruitment and deployment of suitably qualified private sector individuals or specialist experts. There will be appropriate governance frameworks to establish the scope and requirements for such individuals. These officers will be appointed only where they possess the relevant qualifications, experience and training required for the functions they perform.

For instance, deployments will only be made after clear requirements on qualifications and experience are met, conflicts of interest are properly declared and managed, prescribed procedures are followed, and officers are properly supervised and trained. The statutory powers conferred on these individuals will also be deliberately circumscribed to address our intended needs.

On the concerns raised by Members regarding digital privacy and data safeguards, appropriate requirements and training on confidentiality, information handling and data protection will apply.

Let me address the important points raised by Dr Haresh Singaraju, Ms Kuah and Mr Melvin Yong on healthcare professional regulations. Indeed, behind every professional complaint are at least two people directly affected by the process – the patient who has raised a concern and the healthcare professional whose conduct is being examined. Both deserve a process that is fair, rigorous and timely. Bringing the functions of SPB under HSA will strengthen the administrative capability and consistency of case management.

However, the transfer of functions does not affect the independence and statutory autonomy of the Professional Boards and Councils over healthcare professional matters, for instance, over professional standards and disciplinary decisions. Within the various healthcare professional Acts, there are relevant safeguards to protect the independence of these appointed committees and tribunals that remain external to HSA.

HSA's role is to provide and manage the staff and administrative resources to support the Professional Boards and Councils, such as case preparation and review, conflict-of-interest checks and further investigations. The decision-makers remain independent, regardless of who supports the process. HSA will also ensure external communications are clear on whether they are administrative correspondence on behalf of or a statutory decision of the relevant Professional Board or Council.

Nonetheless, we will ensure that HSA officers who support these committees do not introduce bias or exert undue influence on their decision-making process. Appropriate governance arrangements will preserve the confidentiality of professional regulatory and disciplinary matters, and ensure that access is limited to officers who require it for their work.

For this reason, SPB will be moved to HSA at a later stage, allowing a phased and careful approach to reviewing and finetuning these operational arrangements, including setting out clear governance measures.

For complaints and disciplinary proceedings, Members suggested that the Ministry publish timeliness standards and commit to keeping parties informed of progress.

The various professional Acts already prescribe statutory timelines for the complaints and disciplinary process, although the exact timelines differ by profession and by stage. Importantly, we should be thoughtful about how any additional timeliness standards are framed as, committees and tribunals must be given the space to conduct thorough and fair inquiries, and timeliness should not come at the expense of rigour as disciplinary proceedings carry significant consequences for the professionals involved.

What matters as much as speed is that parties are kept informed and supported throughout. We will look at how this can be strengthened as part of the consolidation. Today, complainants and professionals are kept informed of outcomes at various stages of the inquiry. We will look into strengthening the case management process to provide clearer communication to both complainants and professionals throughout the process and ensure that appropriate support is available to them.

Ms Kuah highlighted if this re-organisation may impact the timelines of ongoing cases. I reiterate that this consolidation is to strengthen administrative capability and case management over time. Ongoing proceedings will continue through the transition, supported by proper handover of records, case information and institutional knowledge.

We agree that beyond deciding cases, a robust professional regulatory system should also allow those who are regulated to learn from it. Analysing the aggregated data and trends of complaints and disciplinary cases can surface recurring issues in clinical practice, communication and professional behaviour that are worth addressing more broadly. This is not something new. We already share learnings from the published grounds of decisions from committees and tribunals. HSA will build on this by sharing lessons drawn not only from disciplinary cases, but also more comprehensively from inspections and audits across healthcare institutions, services, and product manufacturers and dealers, and relevant intelligence from consumer organisations and professional bodies so that the same issues do not arise again.

To build up stronger operational support for the Professional Boards and Councils to carry out the functions as I have outlined above, from case management to data analysis and sharing of lessons learnt, HSA will ensure that skills training and capability development are further strengthened for staff supporting the various complaints committees and disciplinary tribunals.

Mr Yong and Mr Sanjeev Tiwari also asked about the officers affected by this transition and the support for them. Let me assure Members that officers transferred to HSA will do so on terms no less favourable than those they currently enjoy. As shared in my opening speech, the objective of the legislative transfer is to enable a smooth transition while safeguarding affected employees and their existing benefits.

Beyond employment terms, we recognise that officers may have questions about their professional identity, future career opportunities and adapting to a new organisational environment. We have engaged staff, addressed their concerns and will continue to support them through this change. Where job scope changes, officers will be provided with reskilling opportunities and on-the-job training so that officers are equipped with the capabilities needed for their evolving responsibilities. We will also look at opportunities for broader career development pathways, cross-domain learning and stronger multidisciplinary regulatory teams.

As HSA manages this transition, we have and will continue to engage closely with the unions to help surface concerns, strengthen communication and build trust as changes are implemented. This reflects Singapore's tripartite approach, where employers, unions and the Government work together to support workers through change while ensuring that their voices are heard.

Members asked how we will know in practice whether this restructuring delivers more coherent and effective regulation rather than merely shifting responsibilities between organisations. What I have just shared earlier on learning from past lessons across the scope of regulated entities is an area in which we can deliver better value to our stakeholders.

One other measure of success lies in how regulation keeps pace with emerging technologies and innovation. With genuinely novel technologies such as AI-enabled devices, the first challenge is often not whether a particular regulatory requirement is met, but simply determining which requirements apply at all. An integrated health regulatory function should be better placed to resolve such questions, allowing innovators to engage HSA early for timely guidance on whether regulatory requirements apply and if so, which regulatory pathway to pursue. HSA will also be better placed to advise on the governance structures needed to ensure the safe deployment of such AI devices within institutions, including the rollout of regulatory sandboxes where appropriate, and to work with the Professional Boards and Councils on the safe and ethical use of AI devices by healthcare professionals in day-to-day practice.

Another measure of success, as Dr Hamid and Mr Yong rightly pointed out, is the experience of stakeholders. A healthcare provider or professional should not be expected to navigate institutional boundaries to obtain an answer. Similarly, patients and consumers should not need to understand institutional boundaries before knowing where to turn for help, particularly where their concerns span healthcare services, products and professionals.

The Government already adopts a no-wrong-door approach, ensuring that feedback and enquiries are routed to the right agency. This will continue, but we recognise that more can be done to make the experience more seamless for those who need it most. With the transfer of functions to HSA, our aim is for stakeholders to experience one coherent regulatory system, with clear avenues to obtain authoritative guidance and escalate genuinely cross-cutting issues where necessary, and where enquiries and concerns can be received and dealt with more seamlessly.

As with any significant restructuring, there will be a period of adjustment as the new organisation takes shape. Our immediate focus is on ensuring a smooth transition and operational continuity. It is therefore premature to prescribe specific performance indicators at this point as further work is needed to ensure that any adopted indicators truly reflect and drive the organisation towards the outcomes we have described. Notwithstanding, HSA will continue to be accountable to MOH through the established governance arrangements for Statutory Boards, including its annual reporting.

Ms Kuah asked about operational continuity, distinct from statutory continuity. The preparatory work in mapping out the affected functions, critical processes and operational dependencies started ahead of the Bill. Extensive preparatory work was conducted, including consultation with stakeholders, conducting a review with external consultants, and consulting international experts. Extensive preparation has also been undertaken across MOH and HSA, including on IT systems, transfer of records, transfer of budgets, institutional knowledge and operational workflows.

We have also engaged our regulated entities and communicated how they may be affected, if any. We will continue to engage them and ensure that they know who to approach for their respective regulatory matters. This is also why implementation is phased, allowing us to stabilise the first phase, learning from implementation and prepare for the second phase so as to ensure that regulatory services and ongoing cases continue without disruption throughout the transition.

That said, regulatory performance should not be judged simply by whether every process becomes faster. Some of a regulator's most important work involves taking the time required to scrutinise a difficult task properly. Equally, where evidence is strong and a beneficial innovation can safely reach patients, unnecessary delay also has consequences. The objective is therefore not regulation that is invariably faster, but regulation that is timely, evidence-based and proportionate to risk.

It is also worth noting that HSA's regulatory timelines are comparable with those of other established overseas regulatory counterparts, particularly for innovative medicines and medical devices, reflecting a careful balance between efficiency and rigorous assessment. This is aligned with Mr Yip's point on risk proportionality. A risk-based approach directs regulatory attention and resources to where the potential harm is greatest and regulatory requirements, inspections and enforcement should be calibrated accordingly while maintaining the standards necessary to protect patients.

Ultimately, these must translate into value for patients – safe and good quality health innovation and services administered by healthcare professionals who are trusted by the public. These are the broad measures of success of a good regulator.

Finally, I note that Dr Choo asked specifically about the training of IRBs and raising of their competency standards, Mr Yip asked about the adoption of innovations beyond registration, Dr Haresh asked about policing the wider research literature for AI-fabricated data and Mr Tan asked about safeguards to address access to electronic health records, which already exist in legislation such as the HCSA and the Health Information Act. All these responsibilities raised by the various Members span the wider healthcare and research ecosystem and will not be affected by this Bill. They are currently being addressed under separate workstreams. Nonetheless, HSA in its expanded scope will continue to ensure that the regulatory interfaces work coherently with the relevant institutions and agencies so that good research is protected, beneficial innovation can progress responsibly towards patients and emerging risks are addressed collectively.

Mr Deputy Speaker, Members have asked how we can be sure that this consolidation does not simply result in a more unwieldy regulator – one that is larger in structure but no more effective in practice. I will say that this Bill is about building a more integrated, responsive and future-ready healthcare regulatory system to meet emerging challenges. The measure of success will be whether this integrated regulatory system is better able to protect patients and the public, learn from where systems or practice can improve, and enable safe and responsible innovation. Patients experience healthcare as a single, continuous journey; and so, our regulatory system must be capable of seeing that whole journey too.

With the right people, expertise and systems in HSA, clear accountability to MOH, and the statutory roles and independence of our Professional Boards and Councils fully preserved, I am confident that this Bill lays a strong foundation for a regulatory system that is coherent, trusted and fit for the challenges ahead. With that, Sir, I beg to move.

Are there any clarifications for the Minister of State? No?

Question put, and agreed to.

Bill accordingly read a Second time and committed to a Committee of the whole House.

The House immediately resolved itself into a Committee on the Bill. – [Ms Rahayu Mahzam].

Bill considered in Committee; reported without amendment; read a Third time and passed.