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

Introduction

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

2.            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.

3.            But healthcare is evolving rapidly with increasing integration, across new models of care, digital health, genomics and artificial intelligence. 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.

Impetus & Value

4.            Today, our regulatory ecosystem is organised across three agencies: First, the Ministry of Health, or MOH, regulates healthcare services, health information, human biomedical research, and biosafety. Second, the Health Sciences Authority, or HSA, regulates health products such as medicines and medical devices. Third, the Secretariat of healthcare Professional Boards, or 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.

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

a.          HSA is well-regarded, having attained the World Health Organization (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 (WLA) for its medicines regulatory system.

b.          We enabled the regulation of telemedicine and home medical services under a new Healthcare Services Act.

c.           Earlier this year, we enacted the Health Information Act, to govern and safeguard key health information, including in the National Electronic Health Record.

d.          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.

6.            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.

7.            Let me use three examples to illustrate this.

a.            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.

b.            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.

c.            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.

8.            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.

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

a.            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.

b.            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.

c.            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.

10.         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. 

11.         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.

Legislative Amendments

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

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

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

b.            Second, HSA officers will assist the Minister and Director-General of Health, or DGH, in administering or enforcing specified MOH Acts in the First Schedule of the Bill, such as the Healthcare Services Act, or HCSA, 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.

c.            Third, HSA will take on the functions of the Secretariat of healthcare Professional Boards, known as 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.

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

15.         Clause 3 amends section 5 of the HSA 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.

16.         Clauses 9 and 10 provide for the legislative transfer of resources to HSA, covering the relevant assets, liabilities, and employees from MOH and Singapore Medical Council, or 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.                                                                                                    

17.         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 Chief Executive Officer, 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.

18.         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.

19.         Clauses 43 to 59 amend the relevant MOH Acts such as the Allied Health Professions Act, Medical Registration Act, and 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.

20.         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.

Implementation

21.         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.

22.         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.

Conclusion

23.         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.

24.         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.

25.         Mr Speaker, I beg to move.