In singapore, to access medifund benefits, patients must submit an application to whom?

Organisation and financing of healthcare

Organisation

How is healthcare in your jurisdiction organised?

The Ministry of Health (MOH) oversees the regulation of healthcare in Singapore.There are various statutory boards established under the oversight of the MOH, including the Health Sciences Authority (HSA) (established by the Health Sciences Authority Act) and the Health Promotion Board (established by the Health Promotion Board Act).

The HSA was formed on 1 April 2001, and integrated five highly specialised agencies, namely the Centre for Drug Evaluation, Institute of Science and Forensic Medicine, National Pharmaceutical Administration, Product Regulation Department and Singapore Blood Transfusion Service. The HSA has been designated as the authority responsible for the administration of Singapore’s health laws and regulations such as the Health Products Act, Medicines Act, Tobacco (Control of Advertisements and Sale) Act and Poisons Act.

Singapore promulgated the Health Products Act in 2007 with the intention that the Health Products Act (and all subsidiary legislation promulgated thereunder) would consolidate legislation regulating all health products (including medicinal products). Prior to 1 November 2016, the Health Products Act only regulated medical devices and cosmetics. The Medicines Act and other related legislation regulated the manufacturing, sale and distribution of medicinal products. There is also specific legislation regulating the use of radiation-emitting devices, contact lens substances and condoms. However, as part of the HSA’s ongoing initiative to update and streamline the existing regulatory controls for health products and bring them under a single piece of legislation, namely the Health Products Act, so as to ensure that the controls remain relevant and adequate to different operational and business models, with effect from 1 November 2016, pharmaceutical products, conventionally termed as chemical and biological drugs, have been introduced as a new category of health products in the First Schedule of the Health Products Act using the term ‘therapeutic products’. Therefore, controls under the Medicines Act and the Poisons Act no longer apply to pharmaceutical products.

Medical practitioners in Singapore must be registered under the Medical Registration Act (MRA). The Singapore Medical Council (SMC), constituted under the MRA, governs all registered medical practitioners. In September 2016, the SMC issued the 2016 edition of the Ethical Code and Ethical Guidelines (SMC Ethical Code) together with the 2016 Handbook on Medical Ethics, which contains additional materials on the SMC Ethical Code and explains their applications and provides advice on best practices. The SMC Ethical Code came into effect on 1 January 2017 (except Guideline H3(7), which came into force on 1 July 2017). All registered medical practitioners are required to adhere to the SMC Ethical Code. In addition, the Singapore Medical Association (SMA), which is the national medical organisation representing the majority of medical practitioners in both the public and private sectors in Singapore, has published the SMA Ethical Code.

Singapore also established the Allied Health Professions Act 2011 (AHPA), which came into effect on 8 April 2013. The AHPA regulates the allied health professionals listed under Schedule 2 of the AHPA (such as occupational therapists, physiotherapists and speech therapists). The Allied Health Professions Council, which is constituted under the AHPA, is the body that regulates all allied health professionals covered under the AHPA.

Further, private hospitals and medical clinics are regulated under the Private Hospitals and Medical Clinics Act (PHMCA). However, the MOH announced its intention to replace the PHMCA with a new Healthcare Services Act (HCSA). The latter will adopt a services-based regulatory framework rather than the current premises-based regulatory framework. A public consultation on the draft Healthcare Services Bill (Draft HCS Bill) was held from 5 January to 15 February 2018. The Draft HCS Bill’s regulatory scope is broader than that of the PHMCA, and includes healthcare services, nursing and allied health services, traditional medicine, and complementary and alternative medicine.

Financing

How is the healthcare system financed in the outpatient and inpatient sectors?

Singapore adopts a mixed financing system that provides multiple tiers of financing for its citizens’ healthcare expenditure.

There are four main tiers of healthcare financing. The first tier consists of subsidies from the government, which provides a subsidy of up to 80 per cent of the total bill in acute public hospital wards to all Singaporeans.

The second tier is the MediSave scheme. It is a compulsory individual medical savings scheme where all working Singaporeans and their employers contribute a part of the employee’s monthly wages into the account to save for the employee’s future medical needs.

The third tier, MediShield Life (which replaced MediShield from 1 November 2015), is a basic, low-cost catastrophic medical insurance scheme that allows Singaporeans to effectively pool the financial risks of major illnesses. MediShield Life is administered by the Central Provident Fund (CPF) Board. Singaporeans may also supplement their basic MediShield Life coverage by applying for a MediSave-approved Integrated Shield Plan directly from one of the private insurers under the Private Medical Insurance Scheme. The Integrated Shield Plans are made up of two components - MediShield Life and additional private insurance coverage providing additional benefits and coverage (eg, to cover the cost of private hospitals or Class A/B1 wards in the public hospitals).

The fourth tier, MediFund, is a medical endowment fund set up by the government to further assist needy Singaporean patients who cannot afford to pay their medical bills despite utilising the first three tiers.

In addition, ElderShield is a severe disability insurance scheme administered by private insurers that aims to provide basic financial protection to Singaporeans who need longterm care, especially in old age, and is designed to help supplement Singaporeans’ savings in the event of severe disability. The government has announced that an enhanced severe disability scheme, CareShield Life, which offers higher initial cash payouts, will be launched in 2020. ElderShield policyholders will generally have the option of upgrading to CareShield Life. The government has also announced that it will take over the administration of ElderShield from 2021.

Separately, the government also administers other subsidy schemes, such as the Community Health Assist Scheme (CHAS) (formerly known as the Primary Care Partnership Scheme), Interim Disability Assistance Programme for the Elderly (IDAPE) and the Medication Assistance Fund.

Under CHAS, general practitioners and dental clinics that have agreed to partner with the MOH will provide common outpatient medical treatment and basic dental services to needy elderly or disabled patients at subsidised charges. CHAS covers 20 chronic diseases and medical conditions, namely, diabetes mellitus, hypertension (high blood pressure), lipid disorders (eg, high cholesterol), stroke, asthma, chronic obstructive pulmonary disease (COPD), schizophrenia, major depression, dementia, bipolar disorder, osteoarthritis, benign prostate hyperplasia (enlargement of prostate gland), anxiety, Parkinson’s disease and nephritis/nephrosis (chronic kidney disease), epilepsy, osteoporosis, psoriasis, ischaemic heartdisease and rheumatoid arthritis. To make childhood preventive healthcare more affordable and accessible, all vaccinations under the National Childhood Immunisation Schedule will be subsidised at polyclinics and CHAS general practitioners by end of 2020. Singapore citizens whose household monthly income per person is S$1,800 and less, or for households with no income, whose home has an annual value of S$21,000 and less, are eligible to receive subsidies under CHAS.

In addition, the IDAPE scheme provides financial help to elderly Singapore citizens who become disabled but who are not eligible for ElderShield when it was launched in 2002 because they had exceeded the maximum entry age or had pre-existing disabilities.

Basic structures

What are the basic structures of the provision of care to patients in statutory and private care?

Under Singapore’s hybrid delivery healthcare model, healthcare providers in both the public and private sectors offer primary healthcare services, acute hospital services and step-down care services. Private sector providers account for around 80 per cent of the market in the primary care sector, while public sector providers account for around 80 per cent of the market in the acute care sector. Voluntary welfare organisations, which are mostly funded by the government for services provided, account for a majority of the market in the step-down care sector.

Healthcare services

Authorisation

What steps are necessary to authorise the provision of health services, and what law governs this?

Currently, physical premises that are used as a private hospital, medical clinic, clinical laboratory or healthcare establishment are subject to licensing controls under the PHMCA. That said, the MOH has announced its intention to replace the PHMCA with a new HCSA, which will instead adopt a services-based regulatory framework (see question 1). Under the Draft HCS Bill, the following healthcare services are licensable: ambulatory surgical centre service, assisted reproduction service, blood bank service, blood transfusion service, clinical laboratory service, general medical or dental clinic service, proton beam therapy service, radiological service, renal dialysis centre service, specialist medical or dental clinic service and tissue banking service.

An application for a PHMCA licence together with the requisite licence fee must be made to the MOH through its e-Licensing for Healthcare system (eLis) online system no later than two months before the intended practice commencement date. If the application is in order, the MOH will make arrangements for a site inspection. When all licensing requirements are met, the MOH will issue an e-licence on eLis.

Licensees will be notified six months before their current licence expires to submit a renewal application via eLis. E-licences must be renewed no later than two months before their current licence expires.

Additionally, pursuant to the Private Hospitals and Medical Clinics Regulations, the provision of certain specialised or special care procedures, services or tests requires prior approval from the MOH, with applications to be made through eLis.

Structure

Which types of legal entities can offer healthcare services?

PHMCA licensees may be companies, sole proprietors or charitable organisations.

Services of foreign companies

What further steps are necessary for foreign companies to offer health services?

Typically, foreign companies offering healthcare services in Singapore will incorporate a Singapore entity, which will apply for the requisite PHMCA licence.

Advertising

Legislation

Which legislation governs advertising of medicinal products to healthcare professionals?

As of 1 November 2016, the advertisement of medicinal products and therapeutic products is governed by the Medicines Act and the Health Products Act and their subsidiary legislation, including the Medicines (Medical Advertisements) Regulations and the Health Products (Advertisement of Therapeutic Products) Regulations 2016. On the coming into operation of section 76(1) of the amended Medicines Act, the Medicines (Advertisement and Sale) Act and the Sale of Drugs Act are to be repealed and any subsidiary legislation made under those Acts are to be revoked. There will be no changes to the regulatory requirements of advertisement control for other product groups that continue to remain under the Medicines Act, for example, complementary health products, which include Chinese proprietary medicines, traditional medicines, homeopathic medicines and quasi-medicines (vitamin and mineral preparation and medicated plasters, etc). The Singapore Association of Pharmaceutical Industries’ (SAPI) Code of Conduct (SAPI Code of Conduct) further prescribes standards of advertising or promotion that should be adhered to (see question 15). The Singapore Manufacturing Federation’s (SMF) Medical Technology Industry Group’s (MTIG) Code of Ethical Conduct for Interactions with Healthcare Professionals (MTIG Code) in turn sets out principles for ethical collaboration between organisations that develop, manufacture, sell, market or distribute medical technologies (ie, products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities) in Singapore.

Main principles

What are the main rules and principles applying to advertising of medicinal products aimed at healthcare professionals?

In Singapore, advertising of medicinal products directed at healthcare professionals must generally abide by the same rules and principles as those directed at the general public (see question 5).

That said, medical advertisements, sales promotions and representations directed exclusively to a person in his or her business premises who may lawfully sell or supply any medicinal product in the course of his or her trade, business or profession (eg, healthcare professionals) are exempted from the requirement to obtain an advertising permit.

Additionally, reference advertisements and trade advertisements as well as any medical advertisements issued or published by any public authority or any person authorised to issue or publish such advertisement by the Minister for Health are also exempted from the requirement to obtain an advertising permit.

Reference advertisements are advertisements containing a brief description of a medicinal product, its use, any contraindications and warnings relating thereto or of any device, instrument, apparatus or contrivance used or represented to be used for a medicinal purpose appearing without charge in a publication consisting mainly of such advertisements, and where the publication is sent or delivered to practitioners and pharmacists by a person not commercially interested in the product.

Trade advertisements are advertisements relating to a medicinal product or any device, instrument, apparatus or contrivance used or represented to be used for a medicinal purpose that is issued by means of a catalogue, price list or other document for the purpose of a sale by way of wholesale dealing, but that does not contain any recommendation relating to the use of the same other than as part of the name of the medicinal product or device, or as part of any heading or sub-heading indicating a therapeutic classification.

Advertisements made to healthcare professionals must not be false or misleading. Section 50 of the Medicines Act states that an advertisement may be false or misleading if it is made to a practitioner for the purpose of inducing him or her to prescribe or supply medicinal products of that description. A person who makes a false or misleading advertisement is guilty of an offence and may be liable to a fine of up to S$5,000 or imprisonment of up to two years, or both.

Advertising of medical devices

Is the advertising of medical devices to healthcare professionals regulated as rigorously as advertising in the pharmaceuticals sector? What are the main differences?

The advertising of medical devices is regulated under the Health Products (Medical Devices) Regulations 2010.

A ‘medical device’ includes any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of:

• diagnosis, prevention, monitoring, treatment or alleviation of any disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
• investigation, replacement, modification or support of the anatomy or of a physiological process;
• supporting or sustaining life;
• control of conception;
• disinfection of medical devices; or
• providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, and that does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means.

A ‘medical device’ also includes the following articles:

• any implant for the modification or fixation of any body part;
• any injectable dermal filler or mucous membrane filler; and
• any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.

Under regulation 19 of the Health Products (Medical Devices) Regulations 2010, advertisements of medical devices must not contain any statement that expressly or implicitly suggests that the use of the medical device is promoted or endorsed by the HSA. Advertisements for medical devices that are intended for direct delivery to the general public or for direct use by the general public must not contain any statement concerning the intended use and efficacy of the medical device unless such statement has been verified by objective evidence and where the medical device is a registered medical device, such objective evidence has been furnished to the HSA at the time the application to register the medical device was made.

Where the advertisement of a medical device contains any statement, assertion, certification, award or feature of uniqueness or prominence differentiating the medical device from any other competing or similar medical device, the statement, assertion, certification, award or feature must be substantiated by facts or evidence (regulation 20 of the Health Products (Medical Devices) Regulations 2010). For example, the identity of the certifying or awarding body and the date the certification or award was granted should be stated. Where the advertisement makes any claim of historical precedence in the use or administration of the medical device for the purpose of medical treatment, information on the outcome of that use or administration of the medical device should also be stated.

Regulation 21 of the Health Products (Medical Devices) Regulations 2010 states that no person shall advertise any registered ‘professional use only’ medical device or any unregistered ‘professional use only’ medical device that is supplied in accordance with the regulations, unless the advertisement is distributed only to, or is contained in a publication intended for circulation mainly among, qualified practitioners.

Contravention of any of the above provisions is an offence for which an offender may be liable to a fine of up to S$20,000 or imprisonment of up to 12 months, or both. In contrast to the penalties prescribed under the Medicines Act (see question 8), the penalties prescribed under the Health Products Act (under which the Health Products (Advertisement of Therapeutic Products) Regulations 2016 and Health Products (Medical Devices) Regulations 2010 are promulgated) are more stringent.

Data protection, privacy and digitisation in healthcare

Digitisation

What are the legal developments regarding digitisation in the healthcare sector and industrial networks or sales channels?

As mentioned in question 1, the MOH has announced its intention to replace the PHMCA, which adopts a premises-based regulatory framework, with a new HCSA, which adopts a services-based regulatory framework. This was partly prompted by the increasing use of digital healthcare solutions, which may not involve physical premises. Under the Draft HCS Bill, telemedicine services are licensable healthcare services (see question 11).

In this connection, the MOH launched the Licensing Experimentation and Adaptation Programme on 18 April 2018, a regulatory sandbox initiative to facilitate the development of innovative healthcare models in a controlled environment. There are at the time of writing 11 active sandbox providers, which provide either telemedicine or mobile medicine (house call) services.

Additionally, under the Draft HCS Bill, the MOH has the power to mandate that prescribed licensees contribute core patient data to the National Electronic Health Record (NEHR). While all public sector healthcare providers currently contribute patient data to the NEHR, participation by the private sector has been limited. The MOH’s list of proposed contributing licensees is extensive, and will include most private healthcare providers.

Provision of digital health services

Which law regulates the provision of digital health services, and to what extent can such services be provided?

Currently, telemedicine services are not licensable per se under the PHMCA, which adopts a premises-based regulatory framework, and all registered medical practitioners may provide telemedicine services. However, telemedicine services are regulated under the MOH’s 2015 National Telemedicine Guidelines (NTG), as well as the SMC Ethical Code and 2016 Handbook on Medical Ethics. The NTG provides guidance to healthcare providers on clinical standards and outcomes, human resources, organisational issues, and technology and equipment. The SMC Ethical Code, to which all registered medical practitioners are required to adhere, sets out how such services are to be provided responsibly. For instance, it provides that doctors engaging in telemedicine must endeavour to provide the same quality and standard of care as in-person medical care, otherwise they must state the limitations of their opinion.

However, the MOH has announced its intention to replace the PHMCA with a new HCSA (see question 1). Under the Draft HCS Bill, telemedicine services are licensable healthcare services. That said, the MOH has stated that it will adopt a risk-based approach in regulating telemedicine, and that only tele-treatment (and not tele-collaboration, tele-support or tele-monitoring) will be licensable. Regulatory standards will take reference from its existing NTG.

Authorities

Which authorities are responsible for compliance with data protection and privacy, and what is the applicable legislation? Have the authorities issued specific guidance or rules for data protection and privacy in the healthcare sector?

The Personal Data Protection Act (PDPA) is Singapore’s main personal data protection legislation, and is administered and enforced by the Personal Data Protection Commission (PDPC). The PDPA prescribes baseline standards relating to the collection, use, disclosure, access, protection, retention and transfer of personal data to which all organisations must adhere. The PDPC has also issued the Advisory Guidelines for the Healthcare Sector, which aim to address the unique circumstances facing the healthcare sector in complying with the PDPA.

Other regulatory instruments relating to data protection and privacy in the heathcare sector include the following:

• the Medicines Act and the Health Products Act, which contain regulations relating to pharmacovigilance, adverse event reporting and the conduct of clinical trials;
• the PHMCA, which contains provisions relating to the protection of confidential information such as patients’ medical records, diagnosis or treatment;
• the Specific Licensing Terms and Conditions on Medical Records for Healthcare Institutions, to which all healthcare institutions licensed under the PHMCA must adhere;
• the 2015 Guidelines for the Retention Periods of Medical Records issued by the MOH; and
• the SMC Ethical Code and the Allied Health Professions Council’s Code of Professional Conduct, which set out standards of conduct expected of medical practitioners and allied health professionals respectively, such as those relating to patient confidentiality.

Requirements

What basic requirements are placed on healthcare providers when it comes to data protection and privacy? Is there a regular need for qualified personnel?

As mentioned in question 12, the PDPA prescribes baseline standards relating to the collection, use, disclosure, access, protection, retention and transfer of personal data to which all organisations must adhere.

Under the PDPA, organisations are required to protect personal data in their possession or under their control by making reasonable security arrangements to prevent unauthorised access, collection, use, disclosure, copying, modification, disposal or similar risks.

Additionally, the PDPA generally requires organisations to seek consent from an individual before collecting, using, or disclosing his or her personal data. In seeking such consent, the organisation is required to notify the individual of the purposes for such collection, use, or disclosure, which must be what a reasonable person would consider appropriate in the circumstances and cannot go beyond what is reasonably required for the provision of the service.

The PDPA also requires organisations to designate one or more individuals to be responsible for ensuring the organisation’s compliance with the PDPA. These individuals are typically known as data protection officers (DPOs). Key responsibilities of a DPO include the following:

• ensuring compliance with the PDPA when developing and implementing policies and processes for handling personal data;
• fostering a personal data protection culture among employees;
• communicating personal data protection policies to stakeholders;
• handling access and correction requests to personal data;
• managing personal data protection-related queries and complaints;
• alerting management to any risks that might arise with regard to the personal data handled by the organisation; and
• where necessary, liaising with the PDPC on personal data protection matters.

Common infringements

What are the most common data protection and privacy infringements committed by healthcare providers?

As mentioned under question 13, organisations are required to protect personal data in their possession or under their control by making reasonable security arrangements to prevent unauthorised access, collection, use, disclosure, copying, modification, disposal or similar risks, pursuant to the PDPA.

Collaboration

Legislation

Which legislation governs the collaboration of the pharmaceutical industry with healthcare professionals? Do different rules apply regarding physicians in the outpatient and inpatient sectors?

There is no specific legislation governing the collaboration of the pharmaceutical industry with healthcare professionals. However, the SMA and the SAPI have prepared a joint paper (SMA-SAPI Joint Paper), which states that healthcare professionals are expected to place patients’ health and welfare above any financial or commercial gains, whereas the pharmaceutical industry is expected to invest in research and development, to develop new and improved treatment options for the benefit of patients and market them ethically. The relationship between the pharmaceutical industry and healthcare professionals must always be seen to be impartial, honest and in compliance with the ethical codes promulgated by the SMA and the SMC, and the SAPI Code of Conduct.

Further, any advertisements or promotions offered by the pharmaceutical industry to healthcare professionals must comply with the Medicines Act and Health Products Act (and the subsidiary legislation thereunder), the SCAP and any other guidelines issued by the HSA pertaining to the advertising of or supply of health or medicinal products.

The same rules generally apply to physicians in the outpatient and inpatient sectors.

Collaboration with healthcare professionals

What are the main rules and principles applying to the collaboration of the pharmaceutical industry with healthcare professionals?

The pharmaceutical industry must comply with the general principles of advertising as provided for in the Medicines Act and Health Products Act (and the subsidiary legislation thereunder), the SCAP and any other guidelines issued by the HSA pertaining to the advertising of or supply of health or medicinal products, as well as the SMA Ethical Code, SMC Ethical Code and SAPI Code of Conduct.

The SMA-SAPI Joint Paper sets out recommendations in relation to the marketing practices of the pharmaceutical industry including promotions, gifts, symposiums or congresses, sponsorship and the supply of samples, as well as consultancy arrangements between the pharmaceutical industry and healthcare professionals. The SMA and the SAPI maintain a strict oversight of the relationship between individual doctors and the pharmaceutical industry, particularly in relation to the acceptance of gifts, promotional items and educational materials by doctors, the invitations from pharmaceutical companies for doctors to travel overseas to attend medical conferences and travel grants associated therewith. The SMA-SAPI Joint Paper also recommends that continuing medical education programmes provided by pharmaceutical companies must be organised through a registered and recognised academic or professional medical society or institution. Where pharmaceutical companies organise marketing talks about their new products, doctors are encouraged to analyse the information presented at such talks critically.

Further, section 50 of the Medicines Act prohibits advertisements to practitioners that have the purpose of inducing such practitioners to prescribe or supply medicinal products of that description. Contravention of section 50 of the Medicines Act is an offence for which an offender may be liable to a fine of up to S$5,000 or imprisonment of up to two years, or both.

Section 19 of the Health Products Act prohibits the advertisement of any product as a health product (which includes therapeutic products) if it is not a health product within the meaning of section 2 of the Health Products Act. Similarly, advertisements of registered health products that portray that they are usable for any other purpose other than that for which they have been registered are prohibited. In addition, advertisements must not be false or misleading, and must comply with any requirements that may be prescribed by the HSA prior to its approval of the advertisement. A contravention of the above provisions under the Health Products Act is an offence for which an offender may be liable to a fine of up to S$20,000 or to imprisonment of up to 12 months, or both. While there are no rules and principles specific to the collaboration of the pharmaceutical industry with healthcare professionals under the SAPI Code of Conduct, it nonetheless prescribes that, generally, the following standards of promotion should be adhered to:

• data is substantiated;
• false or misleading claims are not allowed;
• unapproved products and indications are not promoted;
• material and data are presented in good taste;
• unqualified superlatives are not allowed;
• new products are clearly identified;
• comparative statements must be used carefully;
• imitation that may give rise to confusion is not allowed;
• medical ethics are adhered to;
• distinction of promotional material is clearly defined;
• products, activities or representatives of other pharmaceutical companies must not be disparaged; and
• medical and scientific opinions of opinion leaders and healthcare professionals must not be disparaged.

The SMC Ethical Code states that doctors should only engage in promotion of food, vitamins, tonics and health and nutrition supplements where there is sufficient scientific basis or if they are generally accepted by the medical profession.

In addition, the SMC Ethical Code does not prohibit doctors from sponsoring, donating, participating or rendering services for any charitable endeavours. However, where a doctor participates in a medical event, conference, talk or publication, or on an educational website sponsored by pharmaceutical companies or any company marketing health or medical products, such a doctor must ensure that his or her participation does not occur in such a way as to appear to endorse such products, or to persuade patients or the general public to use those products. Additionally, the doctor must not permit the publication of any details of services provided by the doctor in relation to such participation. A doctor who is sponsored by a company to participate in an educational event, or who reports research sponsored by a company, must declare all such potential conflicts of interest to the audience.

Collaboration with patient organisations

What are the main rules and principles applying to the collaboration of the pharmaceutical industry with patient organisations?

There is no specific legislation governing the collaboration of the pharmaceutical industry with patient organisations. However, the collaboration of the pharmaceutical industry with patient organisations is indirectly regulated by the Medicines Act and Health Products Act (and the subsidiary legislation thereunder), the SCAP and any other guidelines issued by the HSA pertaining to the advertising of or supply of health or medicinal products, as well as the SAPI Code of Conduct.

The SAPI Code of Conduct prescribes general advertising or promotion principles that the pharmaceutical industry must comply with (see question 15).

Common infringements

What are the most common infringements committed by pharmaceutical manufacturers regarding collaboration with healthcare professionals?

The HSA and government authorities do not make such information publicly available.

Collaboration on medical devices

Is the collaboration of manufacturers of medical devices with healthcare professionals and patient organisations regulated as rigorously as collaboration in the pharmaceuticals sector? What are the main differences?

There is no specific legislation governing the collaboration of manufacturers of medical devices with healthcare professionals. However, manufacturers of medical devices must comply with the general principles of advertising as provided for in the Health Products Act (and the subsidiary legislation thereunder), the SCAP and any other guidelines issued by the HSA pertaining to the advertising of or supply of medical devices, the SMA Ethical Code and SMC Ethical Code (see question 15), as well as the MTIG Code.

The MTIG Code sets out the following general principles to ensure that the medical device industry’s collaborations with healthcare professionals are made in the best interest of consumers and patients as follows:

• advancement: the company’s relationship with healthcare professionals must be for the purpose of advancing medical technology, innovation and patient care;
• integrity: the company must interact with healthcare professionals in an honest, truthful and fair manner;
• independence: the company may not provide anything of value to improperly influence a healthcare professional from making medical decisions that are based on the best interests of patients;
• appropriateness: interactions must be modest or reflect fair market value, and be for legitimate purposes; and
• transparency: the company must be open regarding significant financial relationships with healthcare professionals.

There is no specific legislation governing the collaboration of the medical device industry with patient organisations. However, the collaboration of the medical device industry with patient organisations is indirectly regulated by the Health Products Act (and the subsidiary legislation thereunder), the SCAP and any other guidelines issued by the HSA pertaining to the advertising of or supply of health or medicinal products, as well as the MTIG Code.

Competition law

Authority enforcement

Are infringements of competition law by healthcare providers pursued by national authorities?

Pursuant to the Competition Act, a person who believes that an entity is in breach of competition law may make a complaint to the Competition and Consumer Commission of Singapore (CCCS). The CCCS may also choose to initiate its own investigation into alleged anticompetitive behaviour. The CCCS can take action against healthcare providers that enter into anticompetitive agreements, engage in an abuse of their dominant position or enter into mergers that substantially lessen competition (or is expected to substantially lessen competition) within any market in Singapore. Where the CCCS, upon completion of an investigation, decides that there has been an infringement of competition law, it may, inter alia, impose financial penalties, issue directions or take other appropriate measures to remedy, mitigate or prevent the harmful effect of the infringement, and to prevent recurrence.

Private enforcement

Is follow-on private antitrust litigation against healthcare providers possible?

Only after the CCCS has found a party to be in breach of competition law in Singapore, and after the expiry of any applicable appeal period, can third parties bring actions under section 86 of the Competition Act for loss or damage suffered directly as a result of a healthcare provider’s infringement of competition law. There is a two-year time limit for the commencement of such private actions from the time the CCCS issues the infringement decision or from the determination of the appeal, whichever is later. To date, there have been no instances where a party has brought a follow-on private action against a manufacturer.

Anti-corruption and transparency

What are the main anti-corruption and transparency rules applicable to healthcare providers?

There is no specific legislation in Singapore on the anti-corruption and transparency rules applicable to healthcare providers. However, the Prevention of Corruption Act (PCA) is the primary statute dealing with corruption offences in Singapore. The PCA criminalises corruption in both the public and private sectors and is enforced by the Corrupt Practices Investigation Bureau (CPIB).

Sections 5 and 6 of the PCA prohibit bribery in general. Under section 5 of the PCA, it is an offence for a person (whether by him or herself or in conjunction with any other person) to:

• corruptly solicit, receive, or agree to receive for him or herself or for any other person; or
• corruptly give, promise or offer to any person, whether for the benefit of that person or of another person, any gratification as an inducement to or reward for or otherwise on account of:
• any person doing or forbearing to do anything in respect of any matter or transaction whatsoever, actual or proposed; or
• any member, officer or servant of a public body doing or forbearing to do anything in respect of any matter or transaction whatsoever, actual or proposed, in which such public body is concerned.

Any person convicted of an offence under section 5 of the PCA may be liable to a fine not exceeding S$100,000 or to imprisonment for a term not exceeding five years, or to both.

Section 6 of the PCA sets out the offence of corrupt transactions with agents. It is an offence under section 6 of the PCA for:

• any agent to corruptly accept or obtain any gratification as an inducement or reward for doing or forbearing to do, or for having done or forborne to do, any act in relation to his or her principal’s affairs or business;
• a person to corruptly give or agree to give or offer any gratification to any agent as an inducement or reward for doing or forbearing to do, or for having done or forborne to do any act in relation to his or her principal’s affairs or business; or
• a person to knowingly give to an agent a false or erroneous or defective statement, or an agent to knowingly use such statement, to deceive his or her principal.

Any person who is convicted of an offence under section 6 of the PCA may be liable to a fine not exceeding S$100,000 or to imprisonment for a term not exceeding five years, or to both.

In addition, the ethical codes of the SMA, the SMC, the SAPI as well as the SMF MTIG promulgate the principle that the relationship between the pharmaceutical industry and healthcare professionals must always be seen to be impartial and honest.

Pricing and reimbursement

Price regulation

To what extent is the market price of a medicinal product or medical device governed by law or regulation?

The market price of a medicinal product or a medical device is not generally governed by law or regulation in Singapore. However, the MOH administers several drug subsidy schemes (the Standard Drug List (SDL), Medication Assistance Fund and inpatient drug subsidy, etc).

The SDL, which is modelled on the World Health Organization essential drug lists, consists of drugs assessed to be cost-effective and essential to the provision of medical care to all Singaporeans. Currently, the SDL comprises approx¬imately 1,000 drugs (see www.moh.gov.sg/cost-financing/healthcare-schemes-subsidies/drug-subsidies-schemes).

The Drug Advisory Committee (DAC) is responsible for assessing whether a drug should be included in the SDL. The DAC, with inputs from other clinicians and the Pharmacoeconomics and Drug Utilisation Unit (which operates under the purview of the HSA), reviews the SDL on a yearly basis to take into account changes in clinical practice and advances in medical science. It considers three main factors when determining whether a drug should enter into the SDL:

• whether the drug is essential for the treatment of medical con¬ditions that are important causes of morbidity and mortality in Singapore;
• whether the drug offers a major improvement in terms of efficacy and effectiveness, as compared with existing standard drugs; and
• whether there is sufficient evidence of long-term safety and cost benefits of the drug.

Negotiations between manufacturers and providers

Must pharmaceutical and medical device manufacturers negotiate the prices of their products with public healthcare providers?

Public healthcare providers generally purchase drugs through a tender process, and it may be possible that the terms of the supply (including the prices) would be negotiated between the public healthcare providers and the pharmaceutical and medical device manufacturers.

Reimbursement

In which circumstances will the national health insurance system reimburse the cost of medicines?

As mentioned in question 2, the national health insurance system in Singapore comprises multiple tiers. In general, there is heavy subsidy of services and medicinal products provided by the national healthcare institutions to qualifying Singaporeans. In addition, all Singaporeans must maintain an individual medical savings account scheme, MediSave. A secondary level of medical insurance scheme, MediShield Life (which replaced MediShield from 1 November 2015), allows Singaporeans to pool against the financial risks of major illnesses, whereas ElderShield (and CareShield Life when launched in 2020) allows Singaporeans to pool against the financial risks of suffering a severe disability. Integrated Shield Plans are also available as an additional level of insurance for Singaporeans. Further, MediFund is available as a safety net for those who cannot afford the subsidised bill charges, despite MediSave and MediShield Life coverage. The Medication Assistance Fund (which was implemented in August 2010) also assists patients who require costly medication. Through CHAS, the government has also engaged private general practitioners to provide common outpatient medical services to needy Singapore citizens at subsidised charges. Finally, the government has also introduced the Pioneer Generation Package, whereby Singapore citizens who were aged 16 and above in 1965 and who obtained Singapore citizenship on or before 31 December 1986 are eligible for additional subsidies for their healthcare costs for life.

MediSave, MediShield Life, ElderShield (and CareShield Life when launched in 2020) and any Integrated Shield Plans do not only reimburse the cost of medicines, but also hospitalisation and certain outpatient expenses.

Claims under MediShield Life can be made through the hospital where the patient is being treated. The hospital will inform the CPF Board that the patient is insured under the MediShield Life scheme and submit the claim to the CPF Board. After determining the amount payable from MediShield Life, the CPF Board will make payment directly to the hospital, and the outstanding amount may be settled with the patient’s MediSave or by cash payment, or by a combination of the two. The withdrawal limits for MediSave depend on the type of treatment required by the patient.

MediFund assistance is available to Singapore citizens who are subsidised patients receiving treatment from a MediFund-approved institution. A patient who wishes to apply for MediFund assistance must demonstrate that the patient and family have difficulty affording the medical bill despite the available government subsidies and contributions from MediShield Life and MediSave. Such patients (or their family members) may approach a medical social worker at a MediFund approved institution for assistance. Every MediFund-approved institution has a MediFund committee to consider and approve applications, and decide on the appropriate quantum of assistance to provide. The MediFund committee comprises independent volunteers, most of whom are actively involved in community social work and are familiar with the needs and problems faced by lower-income Singaporeans. The actual amount of assistance provided will depend on the patient’s financial and social circumstances, as well as the size of the medical bill incurred.

The Medication Assistance Fund is available to patients who face difficulties affording their medical bills, after MediShield Life or MediSave claims or deductions. Patients who are prescribed with Medication Assistance Fund-listed drugs can apply for the Medication Assistance Fund by approaching a medical social worker in the restructured hospitals and institutions or polyclinics. At present, only a limited number of drugs are eligible under the Medication Assistance Fund.

Under CHAS, low to middle-low income or disabled Singaporeans with any of the following 20 chronic diseases or medical conditions - diabetes mellitus, hypertension (high blood pressure), lipid disorders (eg, high cholesterol), stroke, asthma, COPD, schizophrenia, major depression, dementia, bipolar disorder, osteoarthritis, benign prostate hyperplasia (enlargement of prostate gland), anxiety, Parkinson’s disease, nephritis/nephrosis (chronic kidney disease) epilepsy, osteoporosis, psoriasis, ischaemic heart disease and rheumatoid arthritis - enjoy subsidised charges when seeking common outpatient medical treatment or basic dental charges at participating clinics.

In addition, the government introduced the Pioneer Generation Package in February 2014 to help more than 450,000 eligible senior citizens with their healthcare costs for life, including the provision of financial subsidies for outpatient treatment (in terms of both services and medications) at polyclinics and specialist outpatient clinics, MediSave top-ups (amount dependent on date of birth) and further subsidies for MediShield Life premiums.

Price adjudication

If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products?

As mentioned in question 22, the Drug Advisory Committee is the competent body for decisions regarding the pricing of certain medicinal products under the SDL.

The reimbursement of medical costs (including hospitalisation costs and costs of medicines) under the MediSave and MediShield Life and ElderShield schemes is decided by the CPF Board. The MediFund Committee determines the reimbursement of medical costs under the MediFund scheme, whereas the MOH is responsible for reimbursements under the Medication Assistance Fund.

Discount

Are manufacturers or distributors of medicinal products statutorily obliged to give a discount to health insurance schemes or third parties?

There are no statutory obligations on manufacturers or distributors of medicinal products to give a discount.

Update and trends

Key developments of the past year

Is there any legislation expected in the near future that will have a major impact on the current legal environment for medicines or medical devices?

Key developments of the past year28 Is there any legislation expected in the near future that will have a major impact on the current legal environment for medicines or medical devices?

There are none at the time of writing.

How do I claim my medifund?

What is medifund Singapore?

How is Singapore's medifund program financed?

What is Medisave MediShield medifund?