HEALTH SCIENCES AUTHORITY (AMENDMENT) AND OTHER MATTERS BILL 2ND READING – CLOSING SPEECH BY MDM RAHAYU MAHZAM, MINISTER OF STATE, MINISTRY OF DIGITAL DEVELOPMENT AND INFORMATION & MINISTRY OF HEALTH

1.         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.

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

3.         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.

MOH-HSA Roles and Coordination

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

5.         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.

6.         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.

7.         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.

8.         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.

9.         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 the Biological Agents and Toxins Act, the Chief Executive, HSA, or CE(HSA), can only approve the possession of certain high-risk biological agents after consulting the Director-General of Health. This requires the views of the Director-General of Health 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.

10.      For other areas where policy and regulatory authority remain with MOH, such as the Healthcare Services Act and 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.

11.      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. 

12.      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, Accounting and Corporate Regulatory Authority Act, and 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.

13.      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, Maritime and Port Authority of Singapore, and Communicable Diseases Agency.

14.      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.

Building Capabilities, Capacities, and Appointment of Auxiliary Authorised Officers

15.      Members asked whether HSA’s capacities and capabilities are keeping pace with its expanding responsibilities, and how Auxiliary Authorised Officers, or AAOs, will fit into the overall enforcement picture.

16.      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.

17.      With the transfer of functions, the corresponding manpower and resources, including legal, information technology (IT), and corporate support within MOH and Singapore Medical Council (SMC) will be transferred to HSA. MOH and HSA will continue to review the operational capabilities, workload, 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.

18.      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.

19.      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.

20.      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 youth 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 (MOE) to support any further investigative work needed.  

21.      Regarding questions on AAOs, 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.

22.      AAOs 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. AAOs cannot exercise the full range of powers available to authorised officers under the relevant legislation, including search, seizure, and other investigative powers.    

23.      On the issue of entry raised by Mr Yip and Dr Hamid, the policy intent is that entry by AAOs under these provisions is consent-based as routine inspections and audits, where AAOs 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 the HSA officers will still be deployed. AAOs 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 AAOs or believe that powers have been exercised improperly.

24.      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 AAOs.

Building Broader Regulatory Expertise

25.      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.

26.      Dr Choo also asked how Chief Executive of 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.

27.      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.

Healthcare Professional Regulations

28.      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 the Secretariat of healthcare Professional Borads (SPB) under HSA will strengthen the administrative capability and consistency of case management.

29.      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. 

30.      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.

31.      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, and we will look at how this can be strengthened as part of this consolidation.

32.      Today, complainants and professionals are kept informed of outcomes at various stages of the inquiry, and 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.

33.      Ms Kuah highlighted if this re-organisation may have impact on the timelines of ongoing cases and 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.

34.      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, and 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.

35.      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.

Staff Transition

36.      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.

37.      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 a 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 multi-disciplinary regulatory teams. 

38.      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.

Measures of Success

39.      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.

40.      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.

41.      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.

42.      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.

43.      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 consultations 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, learn from implementation and prepare for the second, so as to ensure that regulatory services and ongoing cases continue without disruption throughout the transition.

44.      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.

45.      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.

46.      Finally, I note that Dr Choo asked specifically about the training of Institutional Review Boards 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 Healthcare Services Act 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.

Closing

47.      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.

48.      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.

49.      With that, Sir, I beg to move.