Speech by Dr Lam Pin Min, Minister Of State For Health, at The 2016 Scientific Conference Of Centre Of Regulatory Excellence

Professor Ivy Ng, Group CEO, SingHealth
Professor Thomas Coffman, Dean, Duke-NUS Medical School
Professor Sir Alasdair Breckenridge, Chairman, Advisory Board, Centre of Regulatory Excellence (CoRE)
Associate Professor John Lim, Executive Director, CoRE
Distinguished guests

       I am pleased to be with you this morning at the 2016 Scientific Conference organised by the Duke-NUS Centre of Regulatory Excellence (or CoRE). I would also like to extend a warm welcome to Professor Guido Rasi, Executive Director of the European Medicines Agency, who will be delivering this year’s CoRE Lecture.      

2      I am encouraged to see so many of you gathered here for CoRE’s second Scientific Conference, with a shared goal to enhance access to safe, quality and affordable treatment and medical devices in Asia and the rest of the world. Over the next two days, you will be engaged in talks and discussions on strengthening and promoting best practices in regulatory systems. These are important issues because of the rapid biomedical advances and development of new and innovative therapies.

Challenges in the Health Products Regulatory Landscape

3      The health products regulatory landscape is rapidly evolving even as cutting-edge health products and services are being offered as new healthcare solutions. Three recent examples of major developments include the promising therapies in precision medicine, more personalised healthcare through wearable technology, and new clinical applications in 3D-printing. These non-conventional health products and services are very different from the “traditional” pharmaceutical medicines, and will challenge the way we develop our policies and regulate new products and services.  We have also entered the age of “Big data”, which opens up many possibilities for healthcare but also brings exciting new challenges of how to apply real-world data into our clinical and regulatory decisions.

Roles of Regulatory Systems

4      In this context, we need to ask ourselves whether our healthcare regulatory system is able to fulfil the dual roles of “Protector” and “Enabler”. As Protector, each regulatory system needs to be robust and have the necessary safeguards in place so that patients and consumers can have access to services and products that are safe, of good quality and efficacious. As an Enabler, regulatory systems need to be flexible enough to support a vibrant ecosystem for biomedical R & D and service and technology innovations that can provide our population with potentially better healthcare.

Singapore’s Health Products Regulatory System

5      In Singapore, the regulation of health products is overseen by the Health Sciences Authority (or HSA). Recently, HSA gazetted new subsidiary legislation to regulate Therapeutic Products, conventionally regarded as pharmaceuticals, and clinical trials under the Health Products Act. This omnibus Act was introduced in 2007 to consolidate and streamline regulatory controls of health products which reside in various pieces of older legislation under the Medicines Act and the Poisons Act. The new regulations, which will take effect from 1 November this year, implements an activity-based licensing regime for the registration, manufacture, import and wholesale of therapeutic products in Singapore.

6      A risk-based regulatory framework for clinical trials has also been introduced in the new Regulations. These changes aim to ensure that the controls remain relevant and adequate for different operational and business models, while safeguarding public health and safety. To keep up-to-date with new developments, HSA also stays tuned in by working with stakeholders in its regulatory framework. For example, HSA has begun to consult its stakeholders on the guidance for telehealth products since October this year. And this iterative process will continue, even as we strive to ensure our regulatory environment keeps pace with rapid developments in the healthcare sector.

Ensuring Continued Relevance in Regulation of Healthcare Services and Facilities

7      In addition to keeping our regulatory framework for health products up-to-date, we will need to evolve our regulatory system for healthcare services. Currently, the Private Hospitals and Medical Clinics Act (PHMCA) under MOH is the key piece of legislation for all healthcare services in Singapore utilised by public and private patients. The PHMCA was enacted in 1980 and last amended in 1999. Since then, much has changed in Singapore’s healthcare landscape. And the changes will continue, many of which will benefit our citizens. But even as we encourage the development of new models of care and services appropriate for our population, we also need to safeguard patient safety and welfare. The Enabler and Protector roles played by the regulatory regime remain unchanged. MOH is therefore reviewing the PHMCA to keep pace with the rapid advances in medicine and health technology, new and changing modalities of services, and profile and needs of our population.

8      There are many areas to be reviewed.  For example, the current licensing framework under the PHMCA is premise-based. It works on the assumption that all healthcare services are provided from a physical, brick and mortar location. This needs to change given the increasing prevalence of mobile, online and co-located services. The current PHMCA also does not differentiate appropriately between certain types of healthcare institutions. This has resulted in the force-fitting of some institutions to fit our regulations. For example, community hospitals have historically been subjected to the same requirements as acute hospitals. What would be more appropriate is to tier the PHMCA’s regulatory requirements according to the type and nature of service. MOH will also take the opportunity to strengthen governance systems and improve regulatory clarity. By doing so, providers will be more aware as to their responsibilities, and hence be more accountable to patients.

9      The review of the PHMCA is a significant piece of work.  MOH will involve all stakeholders in assessing the changes needed.  A balance will have to be struck in some areas as the views of stakeholders may differ. In the coming months, MOH will consult widely on where and how the Act should be revised.  Starting next month, we will hold focus group discussions with representatives from both large and small healthcare players, such as clinics, hospitals, clinical labs, nursing homes and many others. Subsequently, we will reach out to patient groups and members of the public. Such feedback on how to improve our regulatory framework for healthcare services will be invaluable to us as we look into revising the regulatory framework to protect the safety and welfare of our people, while enabling the introduction of new and innovative services that will benefit them.

A Platform to Enhance Regulatory Capabilities

10    As we evolve and strengthen our regulatory systems, not just in Singapore but also the region, we will need to ensure a sustainable and steady pipeline of skilled regulatory talent. CoRE was established in 2014 with the mission to address this need by developing programmes that advance regulatory capabilities for health products in the Asia-Pacific, with a special focus on South-East Asia. In this respect, CoRE is developing a curriculum that can meet the needs of working regulatory professionals, both in terms of content and also practical participation. This will impart fundamental technical skills as well as more advanced competencies that are essential for addressing emerging regulatory needs.

11    In addition, through other programmes such as roundtables, workshops and seminars, CoRE serves as a neutral platform to convene key opinion leaders, experts, and stakeholders. This will help build regional networks, facilitate open discussions, and encourage information sharing and collaboration.

12    The Centre also aims to strengthen regulatory systems by promoting innovation in policies and systems, and developing regulatory leadership that is skilled and strategic. All of these initiatives are geared toward creating regulatory systems that are robust and sound, yet collaborative and adaptable.

Conclusion

13    Ladies and Gentlemen, this conference is an excellent opportunity to develop new networks, build on existing ones, and consider practical ways to strengthen regulatory systems in the face of the various scientific and structural challenges. I look forward to the translation of ideas arising from this conference into tangible enhancements in our regional regulatory systems.

14    On that note, I wish you a very fruitful meeting.

Thank you.