Speech by Mr Gan Kim Yong, Minister for Health, at Duke-NUS Centre of Regulatory Excellence's Fifth Anniversary Dinner

Professor Thomas Coffman, Dean, Duke-NUS Medical School

Dr Margaret Hamburg, Interim Chairperson, Duke-NUS Centre of Regulatory Excellence (CoRE) Advisory Board

Professor John Lim, Executive Director, Duke-NUS CoRE

Distinguished Guests

Ladies and Gentlemen

1.     Good evening. It is my pleasure to join you at the fifth Anniversary Dinner of the Duke-NUS Medical School Centre of Regulatory Excellence (CoRE) to commemorate the Centre’s five years of advancing scientific and regulatory excellence.

CoRE’s Journey So Far

2.     CoRE was established to promote the strengthening of health product regulatory systems across Asia, build regulatory knowledge and capacity, and provide a neutral academic platform for networking, sharing of knowledge and collaboration among the stakeholders.

3.     Over the past five years, CoRE has grown from strength to strength. Locally, it has worked with the Health Sciences Authority (HSA) to drive capabilities in the regulation of cell and gene therapies and medical devices. Regionally, the Centre supports the APEC Regional Harmonisation Steering Committee and has conducted in-country training for ASEAN member states on pharmacovigilance for post-market drug safety monitoring. Internationally, CoRE is recognised as a Centre of Excellence for Multi-Regional Clinical Trials and new areas such as Advanced Therapies^[1] and Biotherapeutics^[2]. It has also started work to support the drafting of the Guidelines for Good Reliance Practice with the World Health Organisation (WHO). This is but a short list of CoRE’s achievements over the last few years. No small feat, and a testament to the hardwork and dedication of the team.

4.     CoRE’s Advisory Board has also played a significant role in providing strategic guidance and stewardship for the Centre. The Board members are respected international experts in their respective fields, and have been champions for regulatory and healthcare excellence. I would like to thank the Advisory Board members and pay special tribute to Professor Sir Alasdair Breckenridge, CoRE’s inaugural Chairman who is unfortunately not able to be present this evening. His leadership and guidance have been central in bringing CoRE to where it is today. I would like to thank Dr Margaret Hamburg, former United States (US) Food and Drug Administration (FDA) Commissioner and Chair of the American Association for the Advancement of Science for standing in as CoRE’s Interim Chairperson.

Smart Regulation to Support Innovation in Healthcare

5.     Singapore has made substantial strides in enhancing and future proofing our healthcare system to meet the needs of our population. Singaporeans’ life expectancy has improved and we now have the world’s longest life expectancy at 84.8 years, but our years spent in poor health have also increased[3]. Our ageing population and growing chronic disease burden continue to present significant challenges. Hence, we will need to continue to bring in new and innovative products and devices and transform our healthcare service models to bend the curve, while keeping Singaporeans healthy.

6.     Therefore, there is a need for ‘smart regulation’ to support such innovation. For example, HSA offers the Pre-market Consultation Scheme for medical devices, where we engage companies during the early phases of device development. This allows HSA to provide more responsive regulatory advice to the companies to support the registration process of their devices, while ensuring that scientific robustness is not compromised. Likewise, MOH, through its Licensing Experimentation and Adaptation Programme (LEAP) regulatory sandbox, partners with industry to better understand new innovative services, starting with telemedicine and mobile medicine services, to co-develop effective and efficient regulations. I am pleased to note that CoRE is promoting the adoption of similar regulatory innovations regionally and internationally.

7.     ‘Smart regulation’ is also needed to effectively regulate emerging technologies such as Big Data and Artificial Intelligence (AI). These technologies raise difficult and at times intractable issues. As a think tank, CoRE is well placed to convene platforms and develop thought leadership around these issues. A recent example is the conference on Advancing Health in Asia Through Innovation co-organised with US Drug Information Association (DIA), which focused on innovative health technologies, such as AI applications and real-world evidence in regulatory decision-making. While these technologies introduce new risks, they can also be harnessed to enhance our regulatory approach, such as using Big Data for more responsive and more effective post-market product surveillance.

Patient Engagement and Healthcare System Support

8.     Beyond regulation, there is a need to strengthen our healthcare system in two key thrusts. First, we need to start with patients and families. Patient centricity means deriving policies and model innovations from the perspectives of the patients. I am therefore heartened that earlier today, CoRE hosted the inaugural roundtable on patient engagement in Asia together with FasterCures, a centre of the Milken Institute. This collaboration aims to develop methods where patients’ perspectives help shape the discovery, development and delivery of medical products and services.

9.     The second key thrust is value-based healthcare which aims to keep our healthcare system affordable, by looking into treatment protocols that provide the best value for patients. Here, CoRE is collaborating with the Duke Margolis Centre for Health Policy to shape international perspectives on value-based care and supporting the Agency for Care Effectiveness (ACE) to host training in Health Technology Assessments. This will be key in ensuring not only a safe, but sustainable healthcare system for generations to come.

Capability Development to Support Innovation

10.     To support the breadth and depth of transformation I have described, health and regulatory professionals must continue to update their skills and stay relevant. It is therefore important that there are opportunities for Singaporeans to upgrade and develop their potential.CoRE recently launched the Graduate Certificate Programme in Pharmaceutical Regulation, aimed at equipping working professionals with regulatory science expertise. I would like to congratulate the pioneer cohort of graduating students who are here with us tonight. I trust that the knowledge and skills gained from the course will spur you on to advocate for regulatory excellence in your respective vocations.

11.     Going forward, beyond pharmaceuticals and devices, CoRE would also be exploring with MOH to develop educational and training programmes to enhance the regulatory capabilities in healthcare services.

Multi-Stakeholder Partnerships and Collaborations

12.     The healthcare ecosystem is complex, with stakeholders from diverse backgrounds. Therefore, system transformation can only be successful with the support of a strong network of trusted partners. This includes policy makers, regulators, clinicians, researchers, industry players and most importantly, patients. Looking at the audience, I am heartened to see these groups and more, well represented in this room.

13.     The value of collaboration cannot be over-emphasised as we address the challenging tasks ahead of us. As friends and partners of CoRE, every one of you play a key role in contributing to health system transformation. I look forward to the continued growth and strengthening of these partnerships in CoRE’s journey ahead.

14.     I wish you all an enjoyable evening ahead. Thank you.

[1] Advanced Therapies refer to new medical products that use gene therapy, cell therapy and tissue engineering. 

[2] Biotherapeutics, also known as biologics, harness living cells to make or modify protein products to create therapies.

[3] Global Burden of Disease Study 2017 published in April 2019.