HSA's new role allows responsive, future-ready healthcare regulatory system: Rahayu

As new technologies reshape the healthcare scene, Singapore must have a more responsive and coherent regulatory system, said Minister of State for Health Rahayu Mahzam on Wednesday (Sept 9).

The Health Sciences Authority (Amendment) and Other Matters Bill was passed in Parliament, and will consolidate and establish an integrated health regulatory function under the Health Sciences Authority (HSA).

The Ministry of Health's (MOH) regulatory function over healthcare services, health information, human biomedical research and biosafety; and, the Secretariat of Healthcare Professional Boards' (SPB) oversight of regulations of doctors, dentists, nurses, pharmacists, and allied healthcare professionals, will now fall under the Health Sciences Authority's (HSA) remit.

In a media statement, HSA said that the consolidated structure will provide 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," the authority explained.

The consolidation also allows greater regulatory alignment across the research and clinical care continuum, HSA stated, adding that researchers and clinicians can expect clearer and more consistent guidance upstream.

This, in turn, strengthens protection for research participants while providing a clearer pathway from research to eventual clinical application.

Members of the public will also benefit from having a streamlined interface with the regulator.

Illustrating this, HSA said that whether the concern resides with a medicine they have purchased, a medical device used in their care, or the healthcare service provider or professional caring for them, it will be now be the interface for these matters.

Policy and operations remain aligned

Tabling the Bill for Second Reading in Parliament on Wednesday, Rahayu said the Republic's regulatory system must be capable of evolving and responding in an integrated manner.

During the debate, several MPs raised questions on the new regulatory architecture and stressed the need for governance, and clear mechanisms to ensure alignment in regulatory policy and operations.

Rahayu said MOH will continue to be responsible for the strategic direction of Singapore's healthcare system to ensure that it remains safe, affordable, accessible and sustainable.

"HSA will undertake and execute the regulatory functions within the scope of this Bill in support of MOH’s policies and directions," she explained

She emphasised that the 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," she added.

MOH's regulatory functions and manpower will be transferred to HSA this November.

In her closing speech, Rahayu said that the measure of success lie in whether the integrated regulatory system is better able to protect patients and the public.

This includes learning from where systems or practice can improve, and in so doing, enable safe and continuous innovation.

"Patients experience healthcare as a single, continuous journey, and so our regulatory system must be capable of seeing that whole journey too," the minister of state said.

新加坡卫生部政务部长拉哈尤·马赫扎姆周三（9月9日）表示，随着新技术重塑医疗保健格局，新加坡必须建立一个反应更迅速、更协调的监管体系。

《卫生科学局（修订）及其他事项法案》已在议会获得通过，该法案将整合并建立卫生科学局（HSA）下的综合卫生监管职能。

卫生部 (MOH) 对医疗保健服务、健康信息、人类生物医学研究和生物安全的监管职能；以及医疗保健专业人员委员会秘书处 (SPB) 对医生、牙医、护士、药剂师和相关医疗保健专业人员的监管职能，现在将归卫生科学局 (HSA) 管辖。

HSA在一份媒体声明中表示，合并后的结构将为行业、创新者和医疗保健提供者提供更大的清晰度和可预测性。

该机构解释说：“一个综合监管机构将允许由一个机构管理许可申请和查询，从而使利益相关者能够更协调、更清晰地获取信息和答复。”

HSA表示，此次整合还有助于在研究和临床护理连续体中实现更大的监管协调，并补充说，研究人员和临床医生可以期待上游获得更清晰、更一致的指导。

这反过来加强了对研究参与者的保护，同时为从研究到最终临床应用提供了更清晰的途径。

公众也将受益于与监管机构之间简化的沟通渠道。

为了说明这一点，HSA表示，无论他们关注的是购买的药品、护理中使用的医疗器械，还是照顾他们的医疗保健服务提供者或专业人员，HSA现在都将成为处理这些问题的接口。

政策和运营保持一致

拉哈尤周三在议会提交该法案进行二读时表示，共和国的监管体系必须能够以综合的方式发展和应对。

在辩论中，几位议员对新的监管架构提出了疑问，并强调需要建立治理机制和明确的机制，以确保监管政策和运作的一致性。

拉哈尤表示，卫生部将继续负责新加坡医疗保健系统的战略方向，以确保其保持安全、可负担、可及和可持续。

她解释说：“卫生科学局将在本法案的范围内履行监管职能，以支持卫生部的政策和指示。”

她强调，该法案并非旨在将政策与监管分开，而是为了更好地界定机构责任。

她补充说：“政策和行动将继续紧密结合、保持一致。”

卫生部的监管职能和人力资源将于今年11月移交给卫生科学局。

拉哈尤在闭幕致辞中表示，衡量成功的标准在于综合监管体系是否能够更好地保护患者和公众。

这包括从系统或实践中学习可以改进的地方，从而实现安全、持续的创新。

“患者将医疗保健视为一个单一、连续的旅程，因此我们的监管体系也必须能够看到整个旅程，”国务部长说。