HEALTH SCIENCES AUTHORITY (AMENDMENT) AND OTHER MATTERS BILL TO CONSOLIDATE HEALTH REGULATORY FUNCTIONS

1.         The Health Sciences Authority (Amendment) and Other Matters Bill, which was tabled for Second Reading in Parliament today, will consolidate and establish an integrated health regulatory function under the Health Sciences Authority (HSA).

2.         The Bill establishes HSA as Singapore’s integrated health regulator to build a more coherent, future-ready system that protects patients, provides clarity and predictability for healthcare industry and professionals, while enabling timely access to beneficial healthcare innovations.

3.         Currently, the regulatory ecosystem is organised across three different agencies:

a)    The Ministry of Health (MOH) regulates healthcare services, health information, human biomedical research and biosafety.

b)    HSA regulates health products such as medicines and medical devices.

c)    The Secretariat of healthcare Professional Boards (SPB) supports the healthcare Professional Boards and Councils that oversee the regulations of doctors, dentists, nurses, pharmacists, and allied health professionals.

4.         This approach has served Singapore well, and we have progressively modernised our regulatory frameworks over time. At the same time, healthcare is evolving rapidly. New models of care and innovative technologies, such as digital health, genomics and artificial intelligence, may span various regulatory domains. Complex cases may also require multiple regulatory touchpoints to address patient safety and access issues. Bringing these regulatory capabilities and expertise closer together will allow us to respond more coherently across the healthcare journey.

5.         The Bill therefore proposes to consolidate health regulatory functions and establish an integrated health regulatory function under HSA. Under the consolidated structure, there will be three key benefits:

a)    Greater clarity and predictability for industry, innovators and healthcare providers – 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)    Greater regulatory alignment across the research and clinical care continuum – Researchers and clinicians across the research and clinical care continuum will experience clearer and more consistent guidance upstream, thereby strengthening protection for research participants while providing a clearer pathway from research to eventual clinical application.

c)    Streamlined interface for the public – Members of the public will have a streamlined interface with the regulator, whether they have concerns about a medicine they have purchased, a medical device used in their care, or the healthcare service provider or professional caring for them.

6.         MOH will continue to be responsible for stewarding Singapore’s healthcare system, including the national healthcare regulatory policies, to ensure that it remains safe, affordable, accessible and sustainable, while HSA will undertake and execute the integrated regulatory functions within the scope of this Bill in support of MOH’s policies and directions.

Legislative Amendments

7.         To achieve these outcomes, the HSA Act will be amended to expand HSA’s functions and enable consolidation across three main areas:

a)    HSA will administer and regulate the Human Biomedical Research Act, and the Biological Agents and Toxins Act, taking over these functions from MOH;

b)    HSA officers will assist the Minister for Health and the Director-General of Health in administering or enforcing specified MOH Acts, such as the Healthcare Services Act, and the Health Information Act when it commences; and

c)    HSA will take on the functions of the SPB to support the Professional Boards and Councils in delivering their regulatory mandate. The Professional Boards and Councils’ existing self-regulatory and disciplinary roles remain unchanged.

Implementation

8.         The consolidation will take place over two phases, so as to support a smooth transition and regulatory continuity. MOH's regulatory functions and manpower will be transferred to HSA in November 2026 in the first phase, while SPB's functions and manpower will be transferred to HSA by end-2027 in the second phase.