SPEECH BY DR JANIL PUTHUCHEARY, SENIOR MINISTER OF STATE, MINISTRY OF DIGITAL DEVELOPMENT AND INFORMATION AND MINISTRY OF HEALTH, AT THE DUKE-NUS CENTRE OF REGULATORY EXCELLENCE’S 10TH ANNIVERSARY SCIENTIFIC CONFERENCE 2024, 14 OCTOBER 2024

      Good morning everybody. Thank you for inviting me to join you here today. It’s great to be back here at the Academia. It is my pleasure to join you for the 10th anniversary celebration of the Duke-NUS Centre of Regulatory Excellence (CoRE).

2.     One of the advantages of having been to many gatherings and meetings, such as scientific meetings, academic meetings, government regulatory meetings, you start to have the ability to have a feel for the community. You have a little bit of a sense, if this is one of those places where tech startups are exchanging cards because everyone's trying to introduce themselves. Or is this community of practice which has been together with deep respect, and a deep understanding of each other's contributions in the academic, scientific, and policy areas. I was asking Professor John Lim earlier this morning: “How long have you all been together?” Because there is a palpable sense of a community of practice, of professionals with deep expertise who have met each other over many meals, over many years, and flown not just halfway around the world, but all the way around the world, to be together. I had that sense of privilege walking in this morning that this is a community of professionals who have been working together for many years and understanding the importance of the work that you do, the effect that you will have on our healthcare systems.

3.     CoRE was established as an academic centre at Duke-NUS Medical School with support from the Singapore Ministry of Health (MOH), Health Sciences Authority (HSA) and Economic Development Board (EDB) to promote regulatory capacity development and innovation in Southeast Asia and the Asia-Pacific. Officially inaugurated in November 2014, this is the first Centre in the region that focuses on promoting regulatory excellence for healthcare regulators and industry. A panel of international regulatory experts forms the CoRE Advisory Board that oversees the governance of the Centre, many of whom are current or former chief officials of their respective regulatory agencies. Some of them in the audience today.

4.     Over the past decade, CoRE has become an important player in Singapore's healthcare landscape. You have made significant strides in advancing regulatory science, not only in Singapore but also across ASEAN and the Asia-Pacific. Through your capacity building, thinktank and advisory initiatives, CoRE has become a trusted partner in a wide collaborative network to actively coordinate and strengthen regulatory systems, comprising international and regional regulatory authorities, industry, non-governmental organisations and academic institutions.

5.     The Centre also supports MOH and HSA in building up the healthcare regulatory ecosystem, and more recently, advocating the convergence of products and services regulation to enhance healthcare systems’ efficiency. By bringing together key stakeholders and fostering collaboration among healthcare regulators, CoRE has created a platform for the exchange of knowledge and best practices.

Future of Health – Digitalisation and Precision Medicine

6.     As we celebrate these achievements, and there are many, we must also anticipate the challenges on the horizon. Singapore’s healthcare landscape is undergoing fundamental changes, driven by demographic shifts and our evolving healthcare needs. To meet these changes, we are embracing digital health and precision medicine technologies. We will innovate to improve population health and ensure the sustainability of our healthcare system. This shift in our healthcare regulations will also be needed to keep pace with innovation and to continue our commitment to patient safety and welfare. Our goal is to create a regulatory framework that acts as a catalyst for progress, not a barrier to it.

7.     The challenges, whether it's our demographic shifts, evolving needs, the tensions and trade-offs within our approach to what we do within the regulatory space, underscores the need for regulators to be innovative and also prudent. We want to maximise the benefits of new technologies and safeguard against the risks. HSA already regulates Artificial Intelligence (AI) in Medical Devices and MOH has issued the national AI in Healthcare guidelines. This is a space where you can see that there are potential significant transformative benefits just around the corner, but there are already extant risks that we need to safeguard against, to shore up public trust and to make sure these tools are deployed in the clinical spaces. And so we publish these guidelines and they lay out good practices for AI developers and influencers, and we're revising this to account for newer technologies such as generative AI. We intend to provide unified guidance for AI developers, service implementers and healthcare professionals on the safe development of AI in healthcare.

8.     With increasing use of precision medicine technologies, we may encounter ethical dilemmas in the potential misuse of genetic test information, for example, in insurance underwriting. To address this, MOH has worked with the Life Insurance Association to put in place a Moratorium on Genetic Testing and Insurance. It sets out specific protections over the use and disclosure of genetic test results, to prevent Singaporeans from being deterred from undergoing genetic testing which can be vital and useful for early detection, prevention and management of genetic conditions.

9      The challenges that I described transcend borders and they make international collaboration amongst regulators essential. Through exchanging best practices and developing partnerships for regulatory harmonisation, we can collectively have regulatory frameworks that are nimble, forward looking, and adaptable to rapid technological advancements.

Nimble and Forward-Thinking Regulatory Framework

10      MOH collaborates with agencies such as the European Partnership for Supervisory Organisations in Health Services and Social Care (EPSO) and HealthAI. We also collaborate with CoRE to strengthen training in healthcare services regulations with ASEAN countries.

11      CoRE is focused on advancing regulatory science and policy in healthcare, both domestically and regionally, through capacity building, thought leadership and fostering collaboration.

12      To grow domestic capability in healthcare regulation, CoRE has launched key educational initiatives, including the flagship Graduate Certificate programme in health products regulation covering pharmaceutical and medical technology regulations. It also supports regional capacity building through the Asian Development Bank Projects in the Greater Mekong Subregion. By identifying regulatory gaps and conducting in-country capacity-building workshops in Laos, Cambodia, Vietnam and Indonesia, CoRE is helping to shape more effective regulatory environments.

13       CoRE also facilitates joint initiatives research projects and roundtables for collaboration between academia, industry and international partners. One example is the CoRE Standards Development Organisation, set up in partnership with Enterprise Singapore, which manages over 60 Singapore Standards and Technical References in the biomedical and healthcare domains, ensuring alignment with global standards.

CoRE’s Role in the Next Decade

14       Regulatory innovation will play a part to shape the future of biomedical science and healthcare and delivery. The diverse topics covered at this conference – ranging from AI and digital health to healthy ageing and disease prevention – highlight the complexity of the challenges that face us. Working together, we can develop regulations that are robust, forward-looking and conducive to both access and innovation.

Closing

15       We have with us regulators from around the world, the Asia-Pacific region and Africa, alongside experts from the Ministry’s Regulatory Advisory Panel. Surely, with this brain trust that you have brought together, and the concentration of capability, expertise and experience, this professional community that has been working together to develop these big relationships, can effectively address these challenges and shape the future of healthcare regulation. Our partnerships will shape the next chapter of healthcare regulation, and so it's my pleasure to declare this conference open.