Legal & Regulatory > Singapore > Regulatory Reform

Upcoming regulatory reforms in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.

1. Are there proposals for reform or significant change to the healthcare system?

PROPOSED HEALTHCARE SERVICES BILL

Currently, hospitals and private medical clinics are regulated under the Private Hospitals and Medical Clinics Act (PHMCA), which was first enacted in 1980. Since then, there have been significant changes to the healthcare landscape in Singapore. The Ministry of Health (MOH) has announced plans to replace the PHMCA with a new Healthcare Services Act (HCSA), which will see a move from the current premises-based licensing frame­work to a services-based licensing framework. The HCSA will have a wider regulatory scope than the PHMCA and will include healthcare services, allied health and nursing services, traditional medicine, and complementary and alternative medicine. Other key changes under the HCSA include:

• requiring that the governing body of a healthcare service possess the necessary competence and skills to carry out its role;
• strengthening the governance and oversight of healthcare services by enhancing the role and responsibilities of key personnel;
• introducing a new requirement for Service Review Committees for selected services or programmes that are deemed to be of higher risk, or greater complexity or public interest;
• making Service Ethics Committees mandatory for selected licensees, to ensure that patients are treated in an ethical manner before certain complex and high-risk medical treatment can be conducted;
• empowering the MOH to step in and assist in the operations of failing healthcare services where needed;
• requiring licensees to contribute to the National Electronic Health Record (NEHR), but providing patients with the option to opt-out if they do not wish to have their records accessed on, or uploaded to, the NEHR;
• enhancing the powers of the MOH to gather information for the purposes of patient safety, care and welfare, and public health interest;
• authorising the MOH to publish information concerning non-compliant licensees and unlicensed healthcare providers;
• prohibiting the provision of medical practices and services that have caused harm or may harm patients; and
• implementing measures to minimise public misperception, such as amending existing naming restrictions to allow for greater clarity as to the healthcare services provided.

PROPOSED AMENDMENTS TO THE MEDICAL REGISTRATION ACT

The Ministry of Health (MOH) and the Singapore Medical Council (SMC) have proposed amendments to the Medical Registration Act (Chapter 174) (MRA).

The MRA establishes the regulatory framework governing the practise of medicine and medical practitioners in Singapore. The last major amendments to the MRA were made in 2010.

The proposed amendments to the MRA are aimed at improving the disciplinary proceedings under the MRA for the public as well as medical practitioners, in particular, by: (i) increasing transparency and accountability in the disciplinary and appeals processes; (ii) bringing about better consistency for disciplinary proceedings under the MRA, and aligning them with those of criminal proceedings and other professional boards; and (iii) enhancing efficiency and certainty in respect of timelines.

2. When are they likely to come into force?

PROPOSED DRAFT HEALTHCARE SERVICES BILL

The MOH conducted a public consultation seeking feedback on the draft Healthcare Services Bill (Draft HCS Bill) between 5 January 2018 and 15 February 2018. At the time of this writing, the Draft HCS Bill has yet to be tabled in Parliament.

The MOH has indicated that the new Healthcare Services Act (HCSA), when enacted, will be implemented in three phases:

• Phase 1: medical and dental clinics, and clinical laboratories currently licensed under the PHMCA will be licensed under the HCSA.
• Phase 2: hospitals and nursing homes currently licensed under the PHMCA will be licensed under the HCSA.
• Phase 3: new services currently not licensed under the PHMCA (such as telemedicine services, mobile medical services, and sterile pharmaceutical services) will be licensed under the HCSA.

PROPOSED AMENDMENTS TO THE MEDICAL REGISTRATION ACT

The Ministry of Health and the Singapore Medical Council conducted a public consultation seeking comments on the proposed amendments to the Medical Registration Act (Chapter 174) between 28 September 2018 and 26 October 2018. At the time of this writing, there is no clear indication as to when the proposed amendments to the MRA are slated to come into force.