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06 Jan 2020

6th Jan 2020

Introduction

Mr Speaker, I beg to move, that the Bill be now read a Second time.

2. Sir, the objectives of the Healthcare Services Bill are to safeguard the safety, welfare, and continuity of care for patients. These are all matters of paramount importance.

3. Today, premises which are used as hospitals, medical clinics, nursing homes and clinical laboratories in Singapore are licensed under the Private Hospitals and Medical Clinics Act (PHMCA). The PHMCA was enacted in 1980 and sets minimum standards for licensees’ premises, personnel as well as processes to safeguard patient safety and welfare. The PHMCA was last amended in 1999 and the regulatory framework needs to be refreshed and updated to address today’s rapidly-evolving healthcare landscape.

4. While Singapore has one of the longest life expectancies in the world, there has also been a rise in the number of unhealthy years lived, because of ageing-related illnesses and also chronic diseases. Hence, to provide more appropriate and accessible healthcare to our ageing population, there needs to be a shift in care models to align ourselves with one of the Ministry’s “3 Beyonds” – “Beyond Hospital to Community”. There will therefore be more vertical and also horizontal integration across traditional healthcare settings. For example, nursing homes may now be able to also provide dementia care and geriatric clinical services within one location, and that is for the better because it puts the related and complementary services under one umbrella.

5. These integrated models of care are difficult to license under the present premises-based licensing framework of the PHMCA, and therefore the licensing framework will need to be reviewed to accommodate such new and also evolving models of care.

6. Secondly, patients, especially the aged sick, may want more convenience and cost savings in their clinical care for some minor ailments or follow-ups to their chronic conditions. This may be possible today when hospitals or medical clinics provide telemedicine or mobile medical services, on top of their premises-based care. There is therefore a need to move beyond just regulating premises, to look at regulating services delivered beyond the premises if we want to ensure the safe delivery of such services into the community or done remotely

7. At the same time we also need to ensure that the welfare and well-being of vulnerable individuals can be enhanced, and that the elderly and frail patients are well looked after. This will include assurance for the continuity of care for patients, and the introduction of additional safeguards to prevent abuse.

8. Finally there are new scientific and technological advancements leading to the emergence of innovative diagnostic methods and also therapies, such as cell, tissue and gene therapy, clinical genomic testing and proton beam therapy. There is therefore a need for an enhanced governance structure to more closely monitor and track the delivery of such services, including the appropriateness of care and information being provided to patients.

9. Taking into consideration the above changes in the evolving healthcare landscape that I have mentioned, it is timely that the Ministry is introducing the Healthcare Services Bill to replace the existing PHMCA, so as to have better lever to regulate the safety and care provided by the existing and also the evolving and newer healthcare services. This Bill will therefore seek to achieve a few objectives:

a. To provide greater flexibility and modularity in licensing, to enable the development of new care models that centre around patient needs;

b. To better protect patient safety and welfare by strengthening licensee governance and also introducing additional safeguards; and

c. To strengthen continuity of care and ensure more appropriate, robust licensee accountability.

10. In putting up this Bill, MOH had conducted extensive public and stakeholder consultations between 2017 and 2018, and also studied developments in the local landscape, as well as the regulatory regime that exists in several overseas jurisdictions. We received much useful feedback from licensees, patients, and the public and some of these ideas have been incorporated into the new regulatory regime.

11. Some examples include the bundling of specific licences for GPs to accommodate their core work, and at the same time allowing licensees to co-locate with certain registered healthcare professionals to facilitate the provision of complementary healthcare services. I would like to take the opportunity here to thank all those who contributed actively throughout this process in the consultation exercises, helping with ideas and suggestions to jointly create the new healthcare services regime.

12. Sir, let me now go through the key features of the Healthcare Services Bill, and highlight the areas of changes from the existing legislation.

Clarifying the scope of the new regulatory regime

13. First, let me start with the scope. We will clearly define the scope of the regulatory regime and the move towards a services-based licensing framework.

14. The scope of the Healthcare Services Bill extends to the regulation of any service by direct providers of ‘healthcare services’ as defined in Clause 3. This includes services that diagnose, assess or treat diseases or illnesses; provide nursing or rehabilitative care; or assess the health of individuals. Services that will require licensing will be set out in the First Schedule.

15. Licensable services are largely similar to the services already provided by the premises-based licensing regime currently under the PHMCA. In addition, the Bill will introduce licensing requirements for certain non-premises based services such as telemedicine and emergency ambulances and new specialised services such as cell, tissue, and gene therapy and also clinical genetic testing.

16. While the scope of the Bill is broad enough to include standalone allied health, nursing, traditional medicine, and complementary and alternative medicine services, we will not at this stage be licensing these services for the time being.

17. However, my Ministry will continue to closely assess these services, particularly from the perspective of risks to patient safety and welfare. If sufficiently serious concerns arise, these services can then be licensed by including them in the First Schedule. In that case, the same regulatory regime as it is now set out in the Bill,would then apply.

18. Government entities such as SAF medical centres and SCDF ambulances are exempted from the Bill. They are bound by internal Government standards and rules, which are generally equivalent to or more stringent than the current licensing standards. There are also staff disciplinary frameworks to deal with errant personnel in the case of such Government entities

19. The Bill’s scope does not include beauty and wellness services as these services do not diagnose, assess or treat diseases or illnesses and are of minimal patient safety risk. Entities that do not provide direct patient care, such as Third Party Agents referring patients to healthcare licensees for their care, will also not be regulated as licensees under the Bill. But this will be an area that we will also review at an appropriate juncture if necessary, and can be included into the Bill.

20. As we transit into Healthcare Services Act, we will move away from the current premises-based licensing framework, which I have mentioned at the outset, is a lot more rigid and inflexible, confined only to one licence per premise and limited to those in physical brick-and-mortar premises.

21. Hence, Part 2 of the Bill introduces a services-based licensing framework which is more flexible and also modular.

22. This approach will better suit the business models of providers, who would just have to take licences based on services that they wish to provide. For example, a provider can decide that he wants to hold a suite of service licences for a nursing home, a clinic, telemedicine, and health screening.

Better safeguards for patient safety and welfare

23. Secondly, as we move towards regulating new services and care models, we will enhance institutional governance and institute additional safeguards to ensure patient safety and welfare. That ultimately is the rationale behind this Bill.

24. The strengthening starts first from our licensing regime and under Clause 11 of the Bill, the Director of Medical Services (‘the Director’) will be required to consider multiple factors in deciding whether to grant or to renew a licence. This includes but is not limited to whether the applicant is a suitable person, and his ability to provide clinically, as well as ethically appropriate patient care.

25. Other factors that may also be considered include the applicant’s conduct when participating in various public schemes, such as the Community Health Assist Scheme or MediSave / Medishield Life schemes, as well as the track record of compliance with regulatory requirements under the Bill, and also under other laws relevant to provision of the healthcare service in a safe or proper manner.

26. Clause 23 also requires key appointment holders of a licensee, such as its governing board or key management to be suitable persons. Key appointment holders must possess the appropriate skills and competencies to carry out effective governance functions.

27. While the licensee is ultimately accountable for overall compliance to the Bill, Clause 24 requires the licensee to appoint a suitably qualified individual as the licensee’s Principal Officer (PO), or the Clinical Governance Officer (CGO), to strengthen accountability as well as clinical oversight at the different layers of its management.

28. However, even as powers and responsibilities are set out under the different layers of governance under the Bill, healthcare professionals will be given autonomy to exercise discretion in the execution of clinical decisions for patient care, to serve the patient’s best interests, and in accordance with professional ethics and considerations. We will therefore introduce provisions in the regulations for due consideration to be given to the views of practising professionals for clinical care matters.

29. Clause 25 of the new Bill will also require certain licensees providing higher patient risk services (e.g. acute hospitals) to set up specific internal committees to monitor the quality as well as the ethics of the service. These specified committees include Quality Assurance Committees, Service Review Committees and Clinical Ethics Committees, each dealing with different aspects of clinical, ethical and quality considerations. Procedural details for these committees will be carried in the Regulations.

30. Stakeholders had raised concerns on whether these governance requirements impose additional burden on smaller licensees, such as the GP clinics. This is a relevant concern, but this will not be the case, as the requirements that are set out are appropriately calibrated to the scale and complexity of the licensee’s operations.

31. In addition to setting up proper governance structures and imposing standards on key appointment holders, we also need to ensure that the employment of healthcare workers, those who work or are employed by the licensees and who deal with patients on a day to day basis, are also properly managed. This is especially so when catering to vulnerable patient groups. Such patients may be at risk of abuse, particularly when they require substantially long term stays at a healthcare institution.

32. Therefore, this Bill introduces safeguards in this area at Clause 28 to impose employment restrictions on certain licensees. Let me explain that. Such licensees will be prohibited from employing any individual convicted of prescribed egregious criminal offences involving violent acts, and must provide the information of all prospective staff to the Ministry for screening with the Criminal Records Office. We understand that we should not treat all past offenders in the same way, or as recalcitrant. Employers who wish to employ past offenders of prescribed offences may seek the approval of the Director, who will consider each such case on its own merits. I will add that this employment restriction is not new – it is similar in nature to the approach taken under the Early Childhood Development Centres Act.

33. Additionally, the employment restrictions will be limited only to settings where patients are at higher risk if they require substantially long term stays or are mentally and physically vulnerable. This would include long term residential care services like nursing homes, inpatient palliative care services, and the Institute of Mental Health.

34. Next, the Bill will also introduce a number of measures to ensure that patients are well informed and are aware, and not misled by errant healthcare providers.

35. Clause 29 will enhance naming restrictions to provide better clarity to patients on the healthcare services provided. Hence, non-licensees will not be able to use names that create a mis-impression of providing licensable healthcare services when they either are not, or should not be doing so. Likewise, licensees will also be prohibited from using names of services that they are not licensed to provide.

36. Clause 30 will disallow unrelated, unlicensed services to co-locate with or within a licensed service, unless MOH approves. The intent behind this is to prevent or mitigate public mis-perception that such unlicensed services, such as wellness and spa services, are endorsed and licensed because of their close physical proximity and association with licensed healthcare services.

37. Clause 31 will also strengthen the advertisement controls under the Bill to prevent non-licensees from advertising licensable healthcare services. Therefore, only licensees and authorised persons appointed by a licensee will be allowed to advertise licensable healthcare services, and in doing so, will have to comply with prescribed requirements to prevent advertisements that are false, misleading or laudatory, and lead to consumption of unwarranted treatments. And also, there is a mismatch of expectation between the advertisement and what the public sees.

38. Besides having levers to regulate the licensees, the Bill will also enhance existing powers in the Ministry carried at Clause 36 to gather data for patient safety, welfare, and public interest purposes.

39. Clause 37 will then empower the Ministry to publish information acquired in the course of administering this Act. In this regard, we intend to publish a list of non-compliant licensees and unlicensed providers. We hope that by making such information available to public, we can help patients make more informed decisions.

Strengthening continuity of care and ensuring accountability

40. Thirdly, we will put in place rules and powers to ensure the safety and continuity of care for patients through the introduction of “step-in” arrangements.

41. Part 4 of the Bill will specifically introduce provisions to achieve this by empowering MOH to directly “step-in” or appoint a “step-in” operator to take over the operations of a licensee who is in serious financial trouble, or is contravening or is not complying with the provisions of the Bill, or is otherwise carrying on its operations in a manner that is detrimental to the interests of patients or customers, but nonetheless wants to, or persist in carrying on operations. The primary purpose is to protect patients’ safety and welfare against a recalcitrant provider endangering patients and also preventing an abrupt discontinuation of residential healthcare services. For this reason, the “step-in” provisions will only apply to a list of designated residential healthcare entities that will be prescribed in the Regulations. These will include nursing homes, hospitals, and inpatient palliative care centres. “Stepping-in” will also be a temporary arrangement until the service has been stabilised, and patient safety and welfare are no longer compromised.

42. I will add that step-in powers are not unique to this Bill. Other regulatory frameworks for essential services, such as those in the financial services or transport sector or the like, also provide similar powers. I would argue the case is perhaps even more compelling in the healthcare setting where lives and the continued delivery of care to patients, whose welfare and interests remain at stake.

43. The Bill will also ensure licensee accountability by broadening our range of regulatory sanctions and strengthening our regulatory toolkit.

44. Clause 39 provides powers to stop the provision of services that are detrimental to patients. While such powers presently exist in the PHMCA, they are limited to cases where the service endangers the health, safety and the welfare of patients. Under the Bill, we will also be able to stop services that go against the rules of professional conduct and ethics. For instance , if a disciplinary tribunal under the Singapore Medical Council has found that a particular treatment should not be provided for specific indications as there is insufficient clinical basis for evidence, MOH can issue stop orders for all licensees to cease any provision of such treatment accordingly.

45. To exercise oversight and control over non-compliant licensees, we will have a wider range of regulatory actions and higher penalties for offences in the Bill. Clause 20 therefore allows various regulatory actions to be taken against non-compliant licensees, as opposed to the PHMCA where we could only revoke or suspend the licence. There is a border range in the tool kit which allows more flexible arrangements given the nature of each particular situation. Penalties for offences have also been updated and aligned with comparable offences under other more recently enacted legislation.

Implementation and impact assessment for PHMCA licensees

46. Next, let me turn to the proposed implementation of this new regime. MOH intends to take a phased approach on the Bill, targeted to be from early 2021 to end 2022; a phased and predated implementation of the regime under this Bill. Regulation of licensable healthcare services will be effected in three phases, so that providers will be given sufficient time to understand the regulations and to ramp up to meet the relevant regulatory requirements. The first phase will bring PHMCA laboratory licensees under the Bill’s regulatory regime, while the second phase will involve medical clinics and other ambulatory care services, as well as ambulance services. In the third and final phase, hospital and long term care services, as well as other new licensable services will be regulated by the Bill.

47. MOH will assist all licensees and ensure a seamless transition to the new licensing regime. We will also continue streamlining our regulatory processes to reduce the burden on licensees as far as possible.

Conclusion

48. Sir, let me conclude by making the point that in implementing the Bill, MOH will continue to engage licensees as it has done to ensure a seamless transition from the PHMCA. We strive to enable new and innovative healthcare service models as well as the use of technology to develop within safe and reasonable boundaries.

49. The Healthcare Services Bill will allow my Ministry to evolve its regulatory framework in tandem with the changing needs of healthcare demands and also the changing healthcare landscape. Together, we can achieve the key objectives of protecting patient safety, welfare, and assuring the continuity of care. My Ministry remains committed to ensure healthcare in Singapore is safe, of good quality, affordable, and accessible.

50. As we continue to build on our regulatory transformation journey to enable new healthcare services and care models to support our ageing population, I would like to urge the Members of the House to give your support to the Healthcare Services Bill. Mr Speaker, I beg to move.