Innovation and Regulation: Keeping the Balance in Precision Medicine

From rare diseases to population health, developments in genomics and precision medicine have the potential to change the lives of millions. But given how fast the healthcare landscape is evolving, can regulation safeguard the safety and welfare of our residents without stifling innovation of new healthcare services and technologies?

Staying Ahead of the Curve is Important

Adjunct Associate Professor Raymond Chua, Deputy Director-General of Health (Health Regulation Group), Ministry of Health (MOH), answered, “It’s indeed a challenge trying to balance this. As a regulator, MOH’s main objective is always to ensure that the services and technologies remain safe to be used by the public. However, it is also important to ensure that our regulations do not impede new and innovative healthcare services and technologies which could benefit Singaporeans too.

For example, in precision medicine, such innovations span from technologies like artificial intelligence (AI) to therapies like gene editing, which may potentially transform healthcare. There is often a phrase that ‘regulators lag behind the industry’ and hence if the regulators don’t catch-up, then the industry may not be able to launch the new technologies and services, and the ones to lose out will be the patients. By scanning the horizon proactively and engaging with industry players and professional bodies regularly, we stay plugged in to what is new or in the pipeline. That enables us to get a head start on reviewing our regulatory policies and tools, and in some instances, opportunities to study the relevance of regulatory measures other countries have put in place in our country.”

Safety is the Top Priority—Always

By 2030, around one in four Singaporeans, will be aged 65 and above, according to the Population in Brief 2022. A/Prof Chua pointed out that, as we prepare for a ‘super-aged’ society, we expect the demand for healthcare services to increase. “Against this backdrop, our team at MOH’s Health Regulation Group has to strike a balance among factors like safety, quality, accessibility and affordability. While safety is a starting point, it is important to ensure that healthcare is also accessible and affordable. That calls for streamlining regulations to ensure that efficiency is not compromised, and more importantly, costs are not unnecessarily passed on to care providers or consumers.”

That said, A/Prof Chua emphasised that “there is no question about it. Our population’s safety and welfare come first. Increasingly, these segue into the area of cybersecurity and data governance as digitalisation offers new opportunities for personalised and preventive health. How can we protect data and limit its access to authorised people, while balancing the need to ensure the population can benefit timely from advancements arising from data driven innovation?” He said this is particularly relevant to precision medicine, which involves a lot of individualised data to empower learning and insights, so as to enhance precision and nudge individuals towards healthier lifestyles.

Sandboxing as a Means to Explore Enabling Innovative Services

A/Prof Chua continued, “Slowly but surely, genomic medicine is transforming our healthcare system at different points of the care pathway to enable more personalised healthcare advice and treatment, earlier interventions, better treatment outcomes and cost effectiveness. But first, we need to set up an ecosystem, comprising proper processes manned by trained and competent healthcare professionals, clear governance standards for institutions providing genomic medicine, and strong data and cybersecurity infrastructure to safeguard patient privacy and confidentiality.”

That led to the set-up of a regulatory sandbox in 2022 which Precision Health Research, Singapore (PRECISE),  Trusted Research and Real World-Data Utilisation and Sharing Tech (TRUST) [1], healthcare institutions, insurance companies and genetic testing service providers were a part of.

“It is essential to include all stakeholders in this journey because while we may be regulating the space, we are not the ones offering the services or implementing the model. We need partners like PRECISE to come in and advise us on certain operational issues on the ground and safety gaps in the system, so that we can offer appropriate ‘fit-for-purpose’ regulations. A good example is the Moratorium that bans the use of genetic test results from biomedical research and controls the use of predictive genetic tests from clinical care in insurance underwriting,” said A/Prof Chua.

Although the sandbox has concluded, A/Prof Chua shared that the conversations and MOH’s work are ongoing. “We continue to engage PRECISE to track the effectiveness of regulations and enhance further. We are also analysing findings from the sandbox providers to review how we can translate them into policies, standards, and a set of laws that any clinic or hospital providing genomic medicine will have to come under.”

Balancing Different Forces and Motion

“Nonetheless, we are cognisant that the landscape is fast-changing and what matters to service providers and consumers can be very different. Thus, as much as we try to keep the equilibrium through regular stakeholder engagements and regulatory enhancements. Ultimately, consumers have to be better educated on how they can protect themselves. To help with that, our team puts up knowledge pieces on our Health Watch website,” A/Prof Chua explained.

Referencing the White Paper on Healthier SG released in September 2022, which shared MOH’s multi-year strategy to transform the national healthcare system by shifting the emphasis from reactive to proactive preventive care, A/Prof Chua went on, “To meet the challenges of an ageing population, we need solutions to transform our current healthcare system. Instead of focusing our efforts on treating diseases, which is the most expensive part of the care continuum, can we move into the preventive and early detection spectrum by leveraging precision medicine? And while we are at that, can we also ensure that information shared are secured and used ethically so that people are not unnecessarily discriminated against and disadvantaged when buying insurance or looking for jobs?”

“I believe a good regulatory regime and strong ethical safeguards are what our population needs, coupled with well-educated consumer and competently trained professionals—to benefit from opportunities that new technologies like precision medicine and AI offer,” concluded A/Prof Chua.

1 Trusted Research/Real world-data Utilisation and Sharing Tech (TRUST) is a national platform that enables anonymised health-related research and real-world data to be brought together, accessed and used in an expeditious and secure manner. The platform supports health data analytics and innovation between public institutions, and between the public and private sectors to improve health outcomes. TRUST is co-developed by the Ministry of Health, the Smart Nation and Digital Government Office, the Government Technology Agency and Synapxe (previously Integrated Health Information Systems).