From an outsider’s perspective, a career in the regulatory field can seem a daunting one, with its complex mass of rules and regulations governing the minutiae of every product that falls under a regulatory agency’s purview. In many respects, Professor John CW Lim, Executive Director of the Centre of Regulatory Excellence (CoRE) at Duke-NUS Medical School and Policy Core Lead at the SingHealth Duke-NUS Global Health Institute, has helped ‘tame’ the regulatory landscape not only in Singapore but globally through the innovations he has led or contributed to, and the impact they have had on regulatory practice the world over.
Early career
A medical doctor by training, John started his career in health administration with the Ministry of Health (MOH) as the first Administrator at the Singapore national blood bank – which eventually became part of the Health Sciences Authority (HSA). He eventually went on to become the first Special Assistant to the Permanent Secretary for Health and Director of Medical Services, the late Singaporean health pioneer Dr. Kwa Soon Bee, who oversaw the development of most of the major public sector hospitals. John describes Dr. Kwa as a visionary who was looking for someone to support him as he followed up on his many duties and projects – a role that allowed John to learn and grow.
His time under the mentorship of Dr. Kwa saw John develop as a leader in the public healthcare sector, with subsequent appointments as Deputy Medical Director of Woodbridge Hospital and the Institute of Mental Health, as well as a Deputy Director in the Human Resources division of the MOH that included responsibility for deployment of doctors in public sector hospitals and training. During this time, he undertook a fellowship at the Harvard School of Public Health, which added a Master’s in Health Policy and Management from Harvard to his academic credentials, along with the Master’s in Public Health he had received from NUS.
After a stint in the Ministry of Education as Director for Higher Education and Corporate Affairs where he helped launch the Singapore Management University, he came back to the health sector just one year prior to the establishment of the HSA. This was spun off from the MOH in 2001 as a unique statutory board overseeing the regulation of pharmaceuticals, medical devices and other health products, as well as the national blood bank, applied science laboratories, and forensic ‘CSI’ services. John worked for 14 years with HSA, originally as the head of its regulatory arm and then eight years as the agency’s Chief Executive Officer, during a time of rapid growth and expansion, which threw up many challenges for the relatively young agency.
‘First principles’
One of his many achievements while there was streamlining the number of groups it had to the three that form its core services today: health products regulation, blood bank services, and forensics and chemistry testing. Another was ‘internationalising’ the agency, where active engagements with regulatory agencies around the world, particularly the big organisations in the USA, UK, Europe and Australia, and global organisations like the World Health Organisation (WHO) and Interpol were formed.
As Singapore’s economy grew and more products streamed into the country, the responsibilities of regulatory agencies like HSA grew accordingly. John understood early on that HSA – unlike the US Food and Drug Administration with its thousands of employees – needed to “apply first principles in order to enable high quality, innovative, science-based interactions on the world stage without similar headcount.” He became a key champion and advocate for one of HSA’s – indeed Singapore’s – most significant contributions to regulatory innovation: a stratified risk-based approach to regulation that clearly segments product approvals into three distinct routes. Products that have not been licensed elsewhere undergo full review, whereas products previously approved by other National Regulatory Authorities (NRAs) can be evaluated through the faster and less burdensome abridged or verification review routes, leveraging on decisions of other regulatory authorities through information exchange processes and confidentiality agreements.
Collaborating with leading regulatory agencies worldwide and drawing on a wide network of local and global experts, HSA is able to streamline its own work and channel available resources most efficiently, without compromising the scientific quality of decisions. Singapore is today recognised as the first country to introduce this innovative regulatory approach, and HSA is lauded not only by global regulatory organisations for its transparent systems and clear guidance, but also by the companies whose products are subject to its scrutiny and scientifically robust approvals. WHO is currently working with CoRE on a global guidance document on best practices in the regulatory field to support strengthening of regulatory systems in developed and developing countries.
Legacy
John has since received accolades for his contributions to shaping what a 21st century regulatory organisation should be like. In 2018, he received two major global awards honouring his achievements. The first, from the US-based Drug Information Association (DIA) was the Global Connector Award for ‘meritorious services through a leadership role that has advanced the mission of DIA and promoted global collaboration.’ The second was the 2018 Founders Award, the highest honour from the Regulatory Affairs Professionals Society (RAPS), one of the largest global organisations promoting professionalism in the regulation of healthcare and related products, recognising John’s ‘contribution towards driving excellence in the regulatory profession, as well as promoting good regulatory practice and policies in advancing public health.’
Yet, with all his achievements, John remains humble and gives credit to the countless people he has worked with for contributing to these achievements. The learnings from his fruitful career as a leader in the health products regulatory field has shaped the philosophies that underlie CoRE. John sees himself as a regulatory ambassador, “crystallising key issues and systems so they can not only be communicated but also achieve a multiplier effect by others.” And it is through CoRE that the next generation of regulatory innovators and leaders can be groomed to think through first principles and develop new, more efficient ways to meet oncoming challenges.
John lives with his wife, daughter and dog, and enjoys nature and movies. He is active in his church and involved in a project to build an intergenerational care facility integrating a nursing home, senior care centre and a childcare centre based on the belief that interaction between the elderly and the young is beneficial to both groups. Construction is currently ongoing and the facility is expected to be ready by 2021.
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Prof John Lim is also the Lead of the Policy Core at the new SingHealth Duke-NUS Global Health Institute, Chairman of the Singapore Clinical Research Institute and National Health Innovation Centre, and a Senior Advisor at MOH. He is a member of the Executive Board of the APEC Life Sciences Innovation Forum, Advisory Group of the US Pharmacopoeia’s Quality Institute, Scientific Advisory Council of the Centre for Innovation in Regulatory Science, ASEAN Diagnostics Development Initiative Strategic Planning Panel, Board of St Andrew’s Mission Hospital and Advertising Standards Authority of Singapore Council.