Medicinal product regulation and product liability in Singapore: overview

A Q&A guide to medicinal product regulation and product liability law in Singapore.

The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Singapore: overview.

To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool.

The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Contents

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

Drugs are regulated under the Sale of Drugs Act (Chapter 282) and the Medicines Act (Chapter 176). The Sale of Drugs Act sets out regulations relating to the sale of drugs in a pure state, whereas the Medicines Act governs medicinal products. A medicinal product is defined under the Medicines Act as any substance or article to be used for administration to human beings and animals for the diagnosis, prevention or treatment of ailments, including preparations intended for the promotion of health, for anaesthesia or for contraception.

The Poisons Act (Chapter 234) governs substances set out in the Poisons List found in the Schedule to the Poisons Act, many of which are found in drugs and medicinal products.

Biologicals are covered under the Medicines Act, insofar as they serve a medicinal purpose. The Biological Agents and Toxins Act (Chapter 24A) applies to biological agents that can cause death, disease or biological malfunction in humans and to toxins extracted from micro-organisms. The Biological Agents and Toxins Act generally does not apply to the use and possession of finished cosmetic products and finished medicinal products.

Medical devices are regulated under the Health Products Act (Chapter 122D), along with cosmetic products.

These statutes are supplemented by extensive subsidiary legislation and regulatory guidance that are essential to the regulatory framework.

Regulatory authorities

The Ministry of Health oversees the regulation of drugs, medicinal products, biologicals, cosmetic products and medical devices in Singapore. The Health Sciences Authority (HSA), (www.hsa.gov.sg) established by the Health Sciences Authority Act (Chapter 122C) operates under the oversight of the Ministry of Health. The HSA is responsible for the administration of Singapore's health-related laws and regulations and regulates the health products sector. It ensures that drugs, innovative therapeutics, medical devices and health-related products are regulated and meet safety, quality and efficacy standards. The HSA also helps to formulate national drug policies.

 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

Biologicals

The HSA has oversight of the regulation of biological products in Singapore. The sale, manufacture, import and advertisement of biological products is generally regulated in the same way as medicinal products are under the Medicines Act. This means that a valid product licence must be obtained from the HSA for all biological products imported or sold in Singapore.

The HSA has also issued various guidelines that set out additional procedures that have to be followed as part of the registration process for biological products, such as the HSA's:

  • Guideline on the Registration of Human Plasma Derived Medicinal Products.

  • Guideline on the Registration of Human Medicinal Products Containing Materials of Animal Origins.

  • Guidance on the Registration of Similar Biological Products in Singapore.

The HSA can further impose additional requirements on licence holders in relation to the manner in which biological products are to be advertised.

Combination products

Based on the HSA's Guidance on Medical Device Product Registration, combined products are currently regulated under the Health Products Act and the Medicines Act.

The regulatory controls applicable to a particular combined product will, however, depend on the product's primary mode of action (PMOA). The PMOA of a product is defined as the mode of action that makes the greatest contribution to the overall intended therapeutic purpose of the combined product.

If a combined product achieves its PMOA in or on the human body by pharmacological, immunological or metabolic means, it is regulated under the Medicines Act. An application for such combined products must be submitted to the HSA's Therapeutic Products Branch (TPB) for evaluation.

Otherwise, the combined product will be regulated as a medical device under the Health Products Act. This may be the case where, for example, the PMOA of the product is a medical device with the drug having an ancillary function for example, drug eluting stents, dermal fillers incorporating analgesic and antimicrobial silver dressings). An application for such combined products must be submitted to the HSA's Medical Device Branch (MDB).

As a guide, medical devices incorporating registrable medicinal products are classified as Class D medical devices (see Question 3). The product registration applications for such devices will be jointly evaluated by the MDB and the TPB of HSA. If a medical device incorporates a medicinal product exempted from medicinal product registration, the risk classification will follow the medical device risk classification.

 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

Medical devices

The HSA has regulatory oversight of the manufacture, advertising and sale of medical devices in Singapore. Medical devices are regulated under the Health Products Act and its subsidiary legislation, including the Health Products (Medical Devices) Regulations 2010 (Medical Devices Regulations).

A medical device is defined under the Health Products Act as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is both:

  • Intended by its manufacturer to be used, whether alone or in combination, for human beings 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;

    • providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and

  • Which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

All medical devices must be registered with the HSA by a Singapore-based company, before being released on the Singapore market. Such company can be the local office of the product owner or principal manufacturer, or a local company that is authorised by the product owner to submit the product registration application.

The HSA classifies medical devices into four risk groups based on several factors, including:

  • The duration of medical device contact with the body.

  • The degree of invasiveness.

  • Whether the medical device delivers medicinal products or energy to the patient.

  • Whether the device is intended to have a biological effect on the patient.

The following, which is based on guidance developed by the Global Harmonisation Task Force, and adopted by the HSA, are the different risk level classifications for medical devices:

  • Class A. Low risk, for example wheelchairs and tongue depressors.

  • Class B. Low to moderate risk, for example hypodermic needles and suction equipment.

  • Class C. Moderate to high risk, for example lung ventilators and bone fixation plates.

  • Class D. High risk, for example heart valves and implantable defibrillators.

The appropriate product registration route and evaluation route depends on the risk classification of the medical device, whether the medical device has received reference agency approvals (if any) and the prior safe marketing history of the medical device (if applicable). For instance:

  • Currently, all Class A medical devices except for devices supplied in a sterile state are exempted from the registration requirements as they are considered low risk. Sterile devices with the "CE" mark are also typically cleared faster.

  • Medium to high risk medical devices (Classes B, C and D) may have a longer and more complex registration process, especially if the abridged, expedited, or immediate route is not available to it. Any medical device which has not obtained prior approval from any of the HSA's reference agencies at the point of application is subject to a full evaluation. A full evaluation involves the applicant company submitting, among other things, in-depth and detailed pre-clinical studies of design verification and validation, methodology, acceptance criteria, results, and the interpretation of the results, and actual clinical trial data or performance comparison to predicate devices. An abridged evaluation is less costly and time-consuming than a full evaluation.

  • Class B medical devices qualify for immediate registration if the device has been approved by any two of the independent reference agencies specified by the HSA for intended use identical to that submitting for registration in Singapore, and has been marketed for at least three years in two of the independent reference regulatory agencies' jurisdictions without safety concerns.

Once the HSA accepts the application, it registers the medical devices on the Singapore Medical Device Register (SMDR), a public database for approved medical devices, via MEDICS, an online portal. Medical device owners have to pay an annual retention fee for their device to remain on the SMDR.

The classification for medical devices mainly used for an in vitro diagnostic purpose is determined based on a set of rules derived from those features that create risk, including but not limited to:

  • The intended purpose and indications for use of the medical device as specified by the product owner.

  • The technical/scientific/medical expertise of the intended user.

  • The importance of the information to the diagnosis.

  • The impact of the results (true or false) on the individual and/or to public health.

The HSA applies the following risk level classifications for in vitro diagnostic medical devices:

  • A (IVD). Low individual risk and low public health risk, for example, clinical chemistry analysers and prepared selective culture media.

  • B (IVD). Moderate individual risk and/or low public health risk, for example, pregnancy self-tests and urine test strips.

  • C (IVD). High individual risk and/or moderate public health risk is moderate, for example, blood glucose self-tests and rubella tests.

  • D (IVD). High individual risk and high public health risk, for example, HIV blood tests and ABO blood grouping tests.

All medical device advertisements in Singapore must comply with the Singapore Code of Advertising Practice (SCAP) and the Medical Devices Regulations. In particular, under Regulation 21 of the Medical Devices Regulations, advertisements relating to registered "professional use only" medical devices are prohibited unless the advertisement is distributed only to, or is contained in a publication intended for circulation mainly among registered medical practitioners or registered dentists. Contravention of the Medical Devices Regulations is an offence, for which an offender can be liable for a fine of up to S$20,000 or imprisonment of up to 12 months, or both.

The HSA's Guidance on Medical Device Advertisements and Sales Promotion complements the existing legislation relating to the advertisement and sales promotion of medical devices, and also contains general principles to ensure that advertisement claims do not convey misleading messages that could lead to inappropriate use of the medical device or bring undue harm to the public.

For example:

  • Medical device claims presented in advertisements must be truthful and well-supported by scientific evidence.

  • Claims of market prominence or uniqueness must be substantiated with independent third party research data.

  • The use of superlatives or exaggerated claims should be avoided.

  • Advertisements must not contain any statement which expressly or implicitly suggests that the use of the medical device is promoted or endorsed by the HSA.

Generally, advertisements and sales promotion of medical devices do not require prior approval from the HSA and it is the responsibility of the advertiser to ensure compliance with prevailing legislations and guidelines.

Health IT issues and mobile medical applications

Currently, there is no overarching regulation governing health IT issues and mobile medical applications in Singapore. Health IT issues are generally governed under various legislation and regulatory guidelines, such as the Personal Data Protection Act 2012 (No. 26 of 2012) and the National Telemedicine Guidelines (issued by the MOH) in January 2015. Mobile medical applications are generally governed under the existing regulatory framework relating to medical devices and medicinal products.

 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

The national healthcare system in Singapore is funded by a mixed financing system that provides multiple tiers of financing for its citizens' healthcare expenditure.

Broadly, there are four tiers of healthcare funding:

  • Direct subsidies from the Singapore government.

  • Medisave, a compulsory individual medical savings account 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.

  • MediShield Life (which replaced Medishield from 1 November 2015), a low-cost basic health insurance plan for all Singapore Citizens and Permanent Residents, which helps to pay for large hospital bills and selected costly outpatient treatments.

  • Medifund, a medical endowment fund set up by the government for needy Singaporean patients who cannot afford to pay their medical bills despite using the first three tiers of healthcare funding.

The government also administers a number of other subsidy schemes, such as the Community Health Assist Scheme, the Interim Disability Assistance Programme for the Elderly and the Medication Assistance Fund. These three schemes, respectively, subsidise primary healthcare, provide financial assistance to disabled elderly persons, and subsidise certain drugs.

 
5. How are the prices of medicinal products regulated?

The government does not generally regulate the prices of medicinal products. However, public hospitals in Singapore generally purchase medicinal products through centralised Group Procurement Offices (GPOs) by way of tender contracts. This purchasing mechanism operates in some way to regulate the prices of medicinal products.

 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

The tiered system of healthcare funding applies to medical bills in their entirety, including the cost of medication as well as medical treatment and hospitalisation costs. The Ministry of Health also maintains a Standard Drug List (SDL), modelled after the World Health Organisation's essential drug lists, which consists of drugs assessed to be cost-effective and essential to the provision of medical care to all Singaporeans.

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 supervision of the HSA), reviews the SDL on a yearly basis, to take into account changes in clinical practice and advances in medical science. Compensation for provision of dispensing services by pharmacists is not generally regulated.

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

Clinical trials on medicinal products (including both unregistered medicinal products as well as locally registered medicinal products) are governed by the Medicines (Clinical Trials) Regulations (Clinical Trials Regulations), which are supervised by the HSA.

The regulatory framework for clinical trials involving investigational medical devices is currently under development.

Authorisations

All clinical trials of medicinal products require a certificate from the HSA (Regulation 5, Clinical Trials Regulations). As part of the process for applying for a Clinical Trial Certificate (CTC), ethics approval also must be obtained from the hospital's Institutional Review Board. CTCs are specific for each study protocol, and for each institution or site involved in the study. Each CTC is valid for a period of two years. Applications for a CTC must be made by a sponsor, which must be a locally registered company.

Consent

Prior consent is required in respect of all subjects participating in a clinical trial (Regulation 11, Clinical Trials Regulations). Some exceptions apply, and the relevant person(s) from whom consent must be obtained differs depending on various factors such as the age and mental capacity of the subject.

Before a clinical trial is carried out or conducted, the holder of the clinical trial certificate must give the subject, and any person giving consent on behalf of the subject, a full and reasonable explanation of prescribed information on the trial.

Consent must be in a written form approved by the HSA or, if the person is unable to sign the written form, in a form approved by the HSA. The form must be read and explained in the presence of an impartial witness if the person giving consent is unable to read. Persons giving consent on behalf of others must act in the best interests of the person, and have regard to the subject's past and present wishes and feelings and any factors which the subject would consider if he were able to do so.

Trial pre-conditions

The clinical trial certificate holder and any of his assistants must not have any direct or indirect financial interest in the clinical trial (Regulation 20, Clinical Trial Regulations). Typically, the sponsor of the clinical trial is also required to obtain and maintain insurance to provide compensation in the event of injury and loss arising from the conduct of the clinical trial (Regulation 5(3), Clinical Trial Regulations).

Procedural requirements

Only the certificate holder or a person assisting him can treat a subject or administer any test material to a subject (Regulation 15(1), Clinical Trials Regulations).

All test materials used in the clinical trial must adhere to the labelling requirements set out in Regulation 18 of the Clinical Trials Regulations.

Clinical records of each subject must be kept available for inspection by the HSA (Regulation 19, Clinical Trials Regulations). Serious adverse events that are likely to affect the safety or well-being of the subject, including those known in reports of similar clinical trials conducted elsewhere, must be notified to the HSA (Regulation 17, Clinical Trials Regulations).

The HSA can require information from the certificate holder during a clinical trial (Regulation 16(1), Clinical Trials Regulations).

A Final Clinical Study Report must be submitted to the HSA within three months of completion of a clinical trial (Regulation 16(2), Clinical Trials Regulations).

 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?

Application

Manufacturers of medicinal products must obtain a manufacturer's licence from the HSA, under section 6(2) of the Medicines Act.

Conditions

The factors which the HSA takes into consideration in dealing with an application for a manufacturer's licence are the (section 12(3), Medicines Act):

  • Operations proposed to be carried out under the licence.

  • Premises in which those operations are to be carried out.

  • Equipment which is or will be available on those premises for carrying out those operations.

  • Qualifications of the persons under whose supervision those operations will be carried out.

  • Arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products manufactured or assembled in pursuance of the licence.

A manufacturer's licence is only granted when the manufacturing facilities have been assessed, audited and found to comply with the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products.

Restrictions on foreign applicants

Overseas manufacturers who intend to register their medicinal products in Singapore are subject to a GMP Conformity Assessment by the HSA. Overseas manufacturers must comply with PIC/S GMP standard, and can submit a valid GMP certificate or other evidence of GMP compliance from a PIC/S member authority. If such evidence is found to be acceptable, an audit by the HSA would not be necessary. Otherwise, the HSA will conduct an on-site GMP compliance audit of the applicant manufacturer.

Applicants should note the HSA's Regulatory Guidance on GMP Conformity Assessment of an Overseas Manufacturer. In particular, the application must be made by a Singapore-registered company or firm.

Key stages and timing

The target processing timeline stated by the HSA for a manufacturer's licence is ten days from the date of audit close out.

Period of authorisation and renewals

Under Regulation 4 of the Medicines (Licensing, Standard Provisions and Fees) Regulations (Licensing, Standard Provisions and Fees Regulations), each manufacturer's licence is valid for one year. The HSA can renew the licence for periods of one year, with or without modifications, on application for renewal.

GMP Certificates for medicinal products are valid for two years.

Monitoring compliance and imposing penalties

Licensed manufacturers are required under the Fourth Schedule to the Medicines (Licensing, Standard Provisions and Fees) Regulations to notify the HSA of, among others:

  • Changes in the licence holder's details such as name and address.

  • Material alterations to the licensed premises or plant, or to the licensed operations of the licence holder.

  • Proposed changes to personnel named in the licence application as responsible for supervising the production operations or for quality control of the medicinal products being manufactured or assembled.

  • Reports of adverse effects in human beings or animals resulting from the use of any medicinal product to which the licence relates, within seven days of receipt of the report.

The HSA is also statutorily empowered to request information from licence holders (and licence holders have a licence obligation to provide information) about any products being manufactured or assembled under the licence, and of operations relating to the manufacture or assembly. Details of manufacture and assembly of each batch of every medicinal product manufactured or assembled under the licence, and of tests carried out on the products, must also be kept for at least two years after the manufacture of the relevant batch. Such records must be made available to the HSA for inspection.

It is an offence under the Medicines Act to manufacture a medicinal product without a licence and to provide false information to the HSA in a licence application. A breach of any of the standard provisions of a manufacturer's licence is also an offence. These offences carry a fine of up to S$5,000 or imprisonment up to two years, or both.

Under section 16 of the Medicines Act, the HSA has general power to suspend, revoke and vary the provisions of licences. It may do so of its own accord, on the request of the licence holder, or on an application by any interested person. This may be done, for example, when the HSA has determined that a licence would infringe a patent, or when a court has determined that a false declaration about patents relating to the product has been made.

 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?

Application

A product licence or an import licence must be obtained from the Health Products Regulation Group of the HSA to sell or import medicinal products into Singapore.

A product licence must be applied for by a Singapore-registered company responsible for the safety, quality and efficacy of the particular medicinal product.

The HSA's Regulatory Guidance on Medicinal Product Registration in Singapore provides guidance on the application process (see www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Western_Medicines/Overview/Guidelines_on_Drug_Registration.html).

Authorisation conditions

The considerations that the HSA takes into particular consideration in determining whether to grant a product licence are set out in section 12 of the Medicines Act, including:

  • Safety.

  • Efficacy.

  • Quality, according to the specification and method or proposed method of manufacture, and provisions proposed for securing that the products sold or supplied would be of that quality.

  • Whether granting the product licence would be in the public interest.

In respect of new product licences, an application can be in respect of a new drug application (NDA) or a generic drug application (GDA). A generic product is essentially similar to a product currently registered in Singapore (known as the Singapore reference product), but excludes biologics. "Essentially similar" is defined as having the same qualitative and quantitative composition in terms of active substances, having the same pharmaceutical form and being bioequivalent. By extension, the concept of essential similarity also applies to different conventional immediate release oral dosage forms (for example, tablets and capsules) that contain the same active ingredient(s).

Key stages and timing

Application submission. Applications are made in two parts: online submission through the HSA's PRISM web portal and hardcopy submission of the registration dossier (within two working days from the PRISM submission). The registration dossier is in the CTD format, based on the Common Technical Document for Registration of Pharmaceuticals for Human Use (as promulgated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).

Application screening. After submission, the HSA screens the application to ensure that the correct application type has been chosen, and that there are no deficiencies that would delay the process. The HSA uses a stop-clock when it raises any queries in relation to the application. The stop-clock ends when a complete and satisfactory response is received by the HSA.

Application evaluation. Once the application is accepted, evaluation by the HSA commences. A stop-clock is used in respect of any queries raised. Application evaluations take between 60 working days (for verification evaluations) to 270 working days (for full dossier evaluations).

Regulatory decision. Once the application has been evaluated, the HSA will issue one of four possible regulatory decisions (that is, approval, approvable, non-approvable and rejection).

  • Approval and rejection regulatory decisions are final decisions issued by the HSA.

  • If an approvable regulatory decision is issued, the conditions for approval are stated in writing, and the applicant must fulfil these conditions in the stipulated time frame.

  • If a non-approvable regulatory decision is issued, the applicant will be informed of the non-approvable issues in writing, and a reply must be made within the specified time frame if the applicant wishes to continue with the application. The reply should be based on the original data submitted to the HSA. Additional data that require evaluation will not be accepted. No extension of the timeline will be considered, unless mutually agreed between the HSA and the applicant.

An application is considered withdrawn if the applicant fails to reply within the stipulated time frame following an approvable or a non-approvable decision. Once an application is withdrawn, the applicant can submit a new application according to prevailing submission requirements. On an approval decision, a product licence will be issued.

Fee

The fees for a product licence application vary, depending on the level of screening and evaluation required. For more details, see www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Western_Medicines/Application_Registration/Fees.html.

Period of authorisation and renewals

Product licences are generally valid for one year, and can be renewed yearly. At the time of renewal, the HSA can modify the licence conditions.

Monitoring compliance and imposing penalties

The continuing obligations of product licence holders are found in the First Schedule to the Medicines (Licensing, Standard Provisions and Fees) Regulations (see Question 10).

Part VII of the Medicines Act grants the HSA broad powers of investigation and enforcement. These include the right of entry into premises and powers to inspect, take samples and seize goods and documents, among others, to ascertain whether there is, or has been, a breach of the relevant laws regulating medicinal products.

It is an offence to sell, supply or export a medicinal product without a licence and to provide false information to the HSA in a licence application (see Question 8).

 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

Post-marketing commitments and pharmacovigilance obligations

The continuing obligations of product licence holders are listed in the First Schedule to the Medicines (Licensing, Standard Provisions and Fees) Regulations. These obligations include:

  • Reporting to the HSA any change in the licence holder's contact details.

  • Informing the HSA of any prescribed material changes made or proposed in the medicinal product.

  • Informing the HSA of any information received that casts doubt on the continued validity of data submitted with the licence application, for the purpose of assessing the safety, quality or efficacy of any medicinal product to which the licence relates.

  • Informing the HSA of any report, of which he is aware, of any adverse effect in human beings or animals resulting from the use of any medicinal product to which the licence relates, within seven days of receipt of the report.

  • Keeping records available for inspection by the HSA, and not to destroy them for two years from the date when the relevant batch was authorised for import, sale, supply or export.

  • On being directed by the HSA, withholding a batch of medicinal products from sale, supply or exportation, so far as reasonably practicable, for such period as may be specified, and to withdraw the defective products from the market immediately if the HSA requests this.

  • Informing the HSA of any decision to withdraw from sale, supply or exportation any medicinal product to which the licence relates, and to state the reason for such a decision.

  • Stating the licence number on the label and package accompanying the product.

  • Not using the licence for advertising purposes.

  • Undertaking tests and submitting samples requested by the HSA.

Other conditions

All published promotional materials should be dated and updated regularly, and the date of print must be printed on promotional or advertising documents.

As far as possible, the date of first use of all promotional materials on a particular medicinal product circulated to the market should be no more than two years from the date of marketing approval, based on guidance provided by the Singapore Association of Pharmaceutical Industries (SAPI) Code of Marketing Practices. Pharmaceutical companies that are members of the SAPI must seek re-approval from the SAPI in respect of any promotional material used beyond this two-year period. A register, the approval folder and a sample of each approved item must be maintained locally for a minimum of two years.

 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

Abridged evaluations are available for medicinal products which have been approved by foreign drug regulatory agencies. This applies to both NDAs and GDAs.

An abridged evaluation route under an NDA or a GDA is available for medicinal products which have been approved by at least one foreign drug regulatory agency at the time of the NDA/GDA submission.

A verification evaluation route under a GDA or NDA is available for medicinal products approved by at least one or two, respectively, of the HSA's reference drug regulatory agencies, and which meet certain other criteria (see Question 12).

 
12. Are foreign marketing authorisations recognised in your jurisdiction?

This depends on the scope and type of the marketing authorisation granted by the foreign regulator, and which and how many regulatory agencies have given their approval.

Abridged evaluation route

An abridged evaluation route is available for medicinal products that have been evaluated and approved by at least one foreign drug regulatory agency.

The applicant must provide evidence that all aspects (including the quality and direction(s) for use, dosing regimen(s), indication(s) and intended patient group(s)) of the medicinal product are the same as that approved by the drug regulatory agency that issued the initial approval. The following technical documents must also be submitted:

  • Complete quality documents for both the drug substance and drug product.

  • A non-clinical overview.

  • A clinical overview, including:

    • summaries of clinical efficacy and clinical safety;

    • synopses of relevant studies; and

    • a tabular listing of the clinical development programme and study reports of the pivotal studies relevant to the requested indication, dosing and/or patient group (the tables and appendices to the pivotal study reports can be submitted on request by HSA).

Verification evaluation route

Medicinal products with similar indication(s), dosing regimen(s), patient group(s), and/or direction(s) for use, that have been approved by at least two of the HSA's reference drug regulatory agencies and meet certain criteria, are eligible for the verification evaluation route.

The HSA's reference agencies include the Australia Therapeutic Goods Administration, Health Canada, the US Food and Drug Administration, the European Medicines Agency, and the UK Medicines and Healthcare Products Regulatory Agency.

The eligibility criteria include that:

  • The application must be submitted within three years of the approval date by the primary reference agency (which can be chosen by the applicant).

  • The product and its intended use have not been rejected, withdrawn, approved through an appeal process or pending deferral by any regulatory agency for safety or efficacy reasons. A more stringent assessment of the medicinal product due to local disease patterns or medical practices is not necessary.

A complete assessment report and other relevant supporting documents from the chosen primary reference agency must be submitted, and must not be redacted or edited. Reports from the primary reference agency that are obtained from the public domain are not accepted by the HSA.

Information and documents supporting an application, such as certificates, approval letters and approved product labels, must be in English and authenticated.

 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?

Generally, parallel imports are allowed, provided that the importers of medicinal products hold a valid product licence or import licence for the medicinal products imported.

Under section 12A of the Medicines Act, when the HSA is determining whether to grant a licence, it considers:

  • Whether a patent under the Patents Act (Chapter 221) is in force in respect of the medicinal product.

  • If the applicant is the patent proprietor, or has obtained the consent of the patent proprietor.

  • If the patent is invalid or will not be infringed by doing the act for which the licence is sought.

The patent proprietor (if it is not the applicant) can oppose the licence application, by applying for an order or a declaration by a court or the Registrar of Patents.

In addition, importers of medicinal products (or any other person involved in the storage, transportation, and distribution of medicinal products) should comply with the HSA's Guidance Notes on Good Distribution Practice (GDP Guidelines), which seek to ensure the quality of the products during storage, transportation and distribution. For example, the GDP Guidelines require storage conditions for products to be in compliance with instructions on the label. On receipt, each incoming delivery should also be checked for tampering and damage. Further, the GDP Guidelines require a distribution system to be in place to ensure that products that are due to expire first are sold and/or distributed first.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Pharmaceutical IP and Competition Law in Singapore: overview ( www.practicallaw.com/6-567-9006) .

 

Restrictions on dealings with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

The general principles of the following must be adhered to:

  • The Medicines Act and its subsidiary legislation (including the Medicines (Medical Advertisements) Regulations).

  • The HSA Guide on Advertisements and Sales Promotion of Medicinal Products.

  • The Singapore Medical Council Ethical Code and Ethical Guidelines.

Statutory offences under the Medicines Act and the Medicines (Medical Advertisements) Regulations include the offer of any gift or prize to promote the sale of a medicinal product, as well as the issuance of any false or misleading advertisements, and the making of any false or misleading representations to practitioners that have the purpose of inducing such practitioners to prescribe or supply medicinal products.

Members of the Singapore Association of Pharmaceutical Industries (SAPI) must also comply with the SAPI Code of Marketing Practices.

The Singapore Medical Association (SMA) and the SAPI maintain a strict oversight of the relationship between individual doctors and the pharmaceutical industry, particularly in relation to:

  • Acceptance of gifts, promotional items and educational materials by doctors.

  • Invitations from pharmaceutical companies for doctors to travel overseas to attend medical conferences and associated travel grants.

It is an offence for a person to corruptly solicit or receive, or agree to receive for himself or for another person (or corruptly give, promise or offer to a person, for the benefit of that person or another person), any gratification as an inducement to or reward for a person doing or not to do anything in respect of any matter or transaction, actual or proposed (Prevention of Corruption Act (Chapter 241)). This also applies to acts of Singapore citizens outside Singapore.

 

Sales and marketing

15. What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

Any advertisement or sales promotion that relates to or is likely to cause any person to believe that it relates to any medicinal product requires prior approval from the HSA. Aside from certain advertisements relating to medicinal products which are exempted, an application must be made to the HSA for a Medical Advertisement and Sales Promotion Permit. The processing time for each application is 14 working days. Once the application is approved, a permit number will be issued with an endorsed copy of the advertisement or sales promotion. This permit number has to be printed legibly on the advertisement and promotional materials.

Medicines in Singapore are classified as Prescription Only Medicine (POM), Pharmacy only (P) or General Sales List (GSL). POMs can only be supplied by a doctor or by a pharmacist according to a prescription by a doctor. P medicines can be supplied by or under the supervision of a pharmacist without a doctor's prescription, while GSL medicines can be purchased off the shelves. According to the HSA's Guide on Advertisement and Sales Promotion of Medicinal Products, no advertisement or sales promotion is allowed to the general public for POMs. For P medicines, the sales promotion materials are restricted to the pharmacy dispensary only. For P and GSL medicines, the recommendations relating to the use of the product should be consistent with the HSA's approved indications.

Further, the HSA's Guide prohibits certain specified types of sales promotions of medicinal products, including the:

  • Offer of a gift or prize to promote sales of a medicinal product.

  • Use of the word "free" or "complimentary".

  • Use of a money-back guarantee.

  • Offer of a medicine free-of-charge with the purchase of a non-medicinal product.

  • Distribution of samples of medicinal products (for example, P and GSL medicines, Chinese proprietary medicines and traditional medicines) to the general public.

Under section 50 of the Medicines Act, a person is guilty of an offence if he issues or causes another person to issue a false or misleading advertisement relating to medicinal products of any description. It is also an offence for a person to make a false or misleading representation relating to either:

  • A medicinal product, in connection with the sale of that product.

  • Medicinal products of a particular description to a person, for the purpose of inducing him to purchase medicinal products of that description from a person selling them by retail.

Sales promotions of medicinal products on the internet, by e-mail or by mail order are generally governed by the same rules and guidelines that apply to marketing and advertising of medicinal products. However, the sale of medicinal products through the internet is not a well-regulated area in Singapore at present. It would seem that the sale through the internet of medicinal products may need to be linked to a physical pharmacy location, and that physical location would need to be licensed by the relevant authorities.

All advertisements in Singapore should comply with the Singapore Code of Advertising Practice (SCAP). The Advertising Standards Authority of Singapore (ASAS), a self-regulatory body which enforces SCAP, also acknowledges that it may be difficult to ensure compliance with SCAP for advertisements received through the internet, and mail-order brochures from overseas. The Appendices of SCAP contain further guidance in this area, in particular Appendix D on interactive advertisements concerning commercial communications over the Internet and Appendix E on direct marketing of goods sold directly to consumers outside of retail establishments.

 

Advertising

16. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

The advertising of medicinal products is governed by Part VI of the Medicines Act, the Medicines (Advertisement and Sale) Act and their subsidiary legislation, particularly the Medicines (Medical Advertisements) Regulations (Medical Advertisements Regulations). The HSA Guide on Advertisements and Sales Promotion of Medicinal Products (Medical Advertisements Guidelines) sets out guidelines relating to the advertising of medicinal products to the general public. These statutes and guidelines are enforced by the HSA.

The Singapore Code of Advertising Practice (SCAP) is a guidance code promulgated by the Advertising Standards Authority of Singapore (ASAS), a self-regulatory body for the advertising industry under the Consumer Association of Singapore (CASE). The Medical Advertisements Guidelines require compliance with the SCAP. The SAPI prescribes a Code of Marketing Practices and an OTC Medicine Code of Advertising and Promotion Practices as advertising guidelines for the pharmaceutical industry.

Restrictions

In Singapore, an advertising permit from the HSA must be obtained under Regulation 3 of the Medical Advertisements Regulations before any medical advertisement can be issued, or any sales promotion can be conducted in respect of a medicinal product.

A medical advertisement means an advertisement relating or likely to cause any person to believe that it relates to any medicinal product or any device, instrument, apparatus or contrivance used or represented to be used for a medicinal purpose. Labelling on a package and leaflets sold with a product are not considered as medical advertisements under section 49(3) of the Medicines Act.

A sales promotion means any sales campaign (including door-to-door sales), exhibition, competition or any other activity for the purpose of introducing, publicising or promoting the sale or use of any medicinal product or any device, instrument, apparatus or contrivance used or represented to be used for a medicinal purpose.

A person who advertises or promotes medicinal products without a valid permit commits an offence, and can be liable on conviction to a fine of up to S$5,000 or to imprisonment of up to 12 months, or both.

However, there are some exceptions for sales promotions and representations directed exclusively to a person in his business premises who can lawfully sell or supply any medicinal product in the course of his trade, business or profession (for example, healthcare professionals).

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

The following types of sales promotion also do not require an advertising permit from the HSA:

  • Distribution of samples or bonus offers to drug stores, pharmacies, wholesalers and clinics, provided that there is no sales promotion to the general public.

  • Store-wide sales promotion that is not specific to any product by named basis.

Issuing false or misleading advertisements or representations relating to medicinal products is an offence. Further, advertisements that directly or indirectly claim, indicate or suggest that a medicinal product will prevent, alleviate or cure any of the 19 diseases or conditions specified in the First Schedule to the Medicines Act are prohibited.

Part II of the Medical Advertisements Guidelines covers both general and specific principles that apply to medical advertisements and sales promotions, and provides guidance on the types of terms and claims allowed/prohibited in such medical advertisements and sales promotions.

Internet advertising

Internet advertising of medicinal products is generally governed by the same rules and guidelines as advertising of these products through other mediums, as advertisements are broadly defined in section 49 of the Medicines Act as including every form of advertising.

 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

Data protection regulation

Data protection issues in the pharmaceutical sector are currently governed under the Personal Data Protection Act 2012 (PDPA) as well as various pharmaceutical regulatory instruments, including the:

  • Medicines Act and the Health Products Act which contain, among others, regulations governing pharmacovigilance, adverse event reporting and the conduct of clinical trials.

  • Private Hospitals and Medical Clinics Act (Chapter 248) (PHMC Act), which contains provisions relating to the protection of confidential information such as patients' medical records or treatment or diagnosis.

  • Singapore Medical Council Ethical Code and Ethical Guidelines and the Allied Health Professions Council's Code of Professional Conduct, which respectively set out standards of conduct applicable to medical practitioners and allied health professionals, including obligations of patient confidentiality.

  • Advisory Guidelines for the Healthcare Sector issued by the Personal Data Protection Commission.

  • Specific Licensing Terms and Conditions on Medical Records for Healthcare Institutions licensed under the PHMC Act.

  • National Guidelines for Retention Periods of Medical Records issued by the Ministry of Health.

The PDPA contains provisions relating to the protection, collection, use, disclosure, transfer, access and correction, retention, and care of personal data:

  • Personal data is broadly defined under the PDPA as data, whether true or not, about an individual who can be identified from that data or from that data and other information to which the organisation has or is likely to have access.

  • Among other obligations, organisations must obtain the consent of an individual before collecting, using or disclosing his or her personal data.

  • An organisation is defined as any individual, company, association or body of persons, corporate or unincorporated, regardless of whether it is formed or recognised under Singapore laws or is resident or has an office or a place of business in Singapore.

  • Personal data about an individual must only be collected, used or disclosed for purposes that a reasonable person would consider appropriate in the circumstances and only to the extent that it is reasonably required for the provision of the service. Such purposes must generally have been notified to the individual concerned at the time of the collection of his consent for those purposes.

Generally, the provisions under the PDPA will not override existing pharmaceutical regulations on issues relating to personal data protection. Rather, the PDPA provisions are intended to operate as a baseline standard for which all organisations are required to adhere to.

Sensitive patient data

In relation to confidentiality of patient data, the PDPA requires that organisations put in place reasonable security arrangements to prevent unauthorised access, collection, use, disclosure, copying, modification, disposal or similar risks. While the data protection obligations under the PDPA do not distinguish between "personal data" and "sensitive personal data", whether an organisation's security arrangements are reasonable for the purposes of the PDPA would depend on all the circumstances at hand, including the nature of the personal data and the possible impact on the individual concerned if an unauthorised person obtained, modified or disposed of the personal data.

In addition, the director of a private medical clinic is also obliged not to disclose any information in the medical record, or which relates to the condition, treatment or diagnosis, of any person, as may have come to his knowledge while carrying out any investigation or performing any of his statutory duties or functions under the PHMC Act.

Clinical trials

With regard to clinical trials, Regulation 19 of the Medicines (Clinical Trials) Regulations specifies certain minimum retention periods for which all clinical records of a subject must be kept by the clinical trial certificate holder. The PDPA and the Advisory Guidelines for the Healthcare Sector do not specify minimum retention periods but instead provide that organisations are to cease to retain documents containing personal data, or remove the means by which the personal data can be associated with particular individuals, as soon as it is reasonable to assume that both:

  • The purpose for which the personal data was collected is no longer being served by retention of the personal data.

  • Retention of such personal data is no longer necessary for legal or business purposes.

Pharmacovigilance and adverse event reporting

The Medicines Act and the Health Products Act impose pharmacovigilance obligations on licensees, in relation to the monitoring and notification of any adverse event associated with their medicinal products or health products. Healthcare professionals are also encouraged to actively submit adverse event reports to the HSA. These obligations operate alongside the PDPA, which sets out requirements as to obtaining consent from an individual before the individual's personal data can be disclosed or transferred. The PDPA also sets out provisions for cases where an individual is deemed to consent to the collection, use or disclosure of his personal data by an organisation for a particular purpose, where the individual voluntarily provides the personal data to the organisation for that purpose and it is reasonable for the individual to voluntarily provide that data.

National Guidelines for Retention Periods

On 28 January 2015, the Ministry of Health issued the updated National Guidelines for Retention Periods of Medical Records. These updated guidelines seek to standardise best practices and ensure that medical records retention practices meet all current medical and legal requirements. Healthcare institutions are encouraged to develop their own internal processes in tandem with these guidelines.

 

Packaging and labelling

18. Outline the regulation of the packaging and labelling of medicinal products.

Legislation and regulatory authority

The packaging and labelling of medicinal products is governed by Part V of the Medicines Act and the Medicines (Labelling) Regulations (Labelling Regulations).

The HSA is the regulatory authority in charge of packaging and labelling of medicinal products.

Information requirements

Dispensed medicinal products (that is, medicinal products supplied by doctors or dentists to their patients, or dispensed by pharmacists) must contain the following particulars on their containers (Regulation 4, Labelling Regulations):

  • Name of the person to whom the product is to be administered.

  • Name and address of the medical or dental practice, registered pharmacy, hospital or any other institution where the medicinal product is supplied or dispensed, and any other identification number or mark.

  • Date on which the medicinal product is dispensed.

  • Direction for use of the medicinal product.

  • Name of the medicinal product, being either the appropriate non-proprietary name or the proprietary designation.

  • Where the appropriate non-proprietary name is labelled, the appropriate quantitative particulars of the active ingredients of the medicinal product.

The requirements in the last two bullet points above do not apply to medicinal products used in a clinical trial. The expiry date with the words "use by" or similar words must be stamped on packaging for products listed in the Second Schedule to the Labelling Regulations.

Other conditions

The required information (see above, Information requirements) must be printed in letters no less than 1.5 millimetres in height, and clearly legible and appear conspicuously in a prominent position on the label, so as to be easily read by an intending buyer or user of the medicinal product under normal conditions of purchase or use (Regulation 9, Labelling Regulations). The size of the particulars can be smaller (but must still be clearly legible) if the package is too small to allow the required size.

The information can be displayed at frequent intervals if the container is a bubble, blister or sealed unit that is part of a continuous series of a sheet or strip of similar containers. All labelling of medicinal products must be in an indelible manner (Regulation 10, Labelling Regulations).

 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.

The principal regulator in relation to medicinal product liability is the Health Sciences Authority (HSA). The key legislation on medicinal product liability is the Medicines Act, which governs all aspects of dealing in medicines and its related products, including Western medicines, Chinese medicines and cosmetic products.

The HSA administers the legal requirements governing medicinal products. The HSA also constantly monitors the product market to ensure the safety, efficacy and quality of the import, distribution and use of medicinal products. More specifically, the HSA's Health Products Regulation Group (HPRG) (consisting of the Pre-marketing Division (Western Medicine, Medical Devices, Complementary Health Products and Cosmetic Products branches), the Post-marketing Division (Vigilance, Compliance and Medical Advertisement branches) and the Audit and Licensing branch) is responsible for ensuring that drugs, innovative therapeutics, medical devices and health-related products in Singapore are properly regulated, to meet appropriate standards of safety, quality and efficacy.

Where medicinal products do not comply with the legal requirements they are subject to, the HSA has wide-ranging powers to enforce these regulations:

  • Most significantly, the HSA has the power to order a recall of a particular batch of product, or to recall the product entirely from the market, if the product is found to be of defective quality or is a non-compliant product (Medicines (Licensing, Standard Provisions and Fees) Regulations). A recall can be a permanent removal of the affected product from the market or a temporary removal for product correction, after which the corrected product is returned to the market.

  • The HSA also has power to enter premises as well as to inspect, take samples of, and seize non-compliant medicinal products, such as medicinal products imported without a valid licence and illegal products (section 57, Medicines Act). This can include taking samples of medicinal products at different stages of the supply and distribution chain (for example, for testing, examination or analysis) and any substance or article used or intended to be used in the manufacture of a medicinal product, including the containers and packaging, and the plant or equipment used in connection with the manufacture or assembly of any medicinal product. Thereafter, a court can order forfeiture of any goods which have been seized by the HSA (section 60, Medicines Act).

Any wilful obstruction of the HSA, or any failure to render assistance or information as may be reasonably required by the HSA, is an offence. A person committing such an offence can be liable on conviction to a fine of up to S$2,000. Additionally, a person who knowingly gives any false information or statements to the HSA commits an offence, and can be liable on conviction to a fine of up to S$5,000 and/or to imprisonment for a term up to two years.

The Singapore Customs and the Singapore Police Force are empowered to seize and detain any medicinal products that may be imported contrary to a prohibition or restriction under the Medicines Act. A court may order the forfeiture of the medicinal products seized if it is satisfied that the goods were the subject matter of or were used in the commission of an offence under the Medicines Act. Thereafter, the HSA may dispose of the forfeited goods in such manner as it thinks fit.

 
20. Are there any mandatory requirements relating to medicinal product safety?

Licence requirements

Licences granted by the HSA to product manufacturers and suppliers are issued on certain standard terms, according to Regulation 3 of the Medicines (Licensing, Standard Provisions and Fees) Regulations.

Under these licences, the product manufacturer and/or supplier are subject to the following mandatory requirements, including:

  • The product manufacturer and/or supplier must inform the HSA within seven days of receipt of any report of adverse effects resulting from the use of the product to which the licence relates.

  • Where a recall of the product is initiated by the HSA following receipt of such information, the manufacturer and/or importer must withdraw the defective products from the market immediately.

  • All manufacturers and/or suppliers also have a continuing duty to keep and maintain proper sales records for each product, for a minimum period of two years from the date of last entry, so as to effectively implement a recall when necessary.

If the product manufacturer and/or supplier fails to comply with any of the mandatory requirements, it is guilty of an offence and can be liable on conviction to a fine up to S$5,000 or to imprisonment for a term up to two years or both (Regulation 6, Medicines (Licensing, Standard Provisions and Fees) Regulations).

Adverse event reporting

Adverse event reports must be submitted to the HSA's Vigilance and Compliance Branch. Such reports must contain, at minimum, the following information:

  • An identifiable patient, an identifiable reporting source, one or more adverse reaction(s), and one or more suspected medicinal product(s).

  • The name, profession and place of practice of the person making the report.

  • An assessment by the product licence holder on whether there is a causal association between the suspected product(s) and adverse reaction(s) and an explanation of how such causality assessment is made.

The following prescribed time limits apply for submitting adverse reaction reports:

  • All fatal or life-threatening spontaneous adverse reactions occurring in Singapore should be reported as soon as possible but no later than seven calendar days after first knowledge by the product licence holder, followed by as complete a report as possible within eight additional calendar days.

  • All other serious spontaneous adverse reactions occurring in Singapore should be reported as soon as possible but no later than 15 calendar days after first knowledge by the product licence holder.

Product licence holders are also required to develop proper systems and processes to take appropriate action in respect of its products on the market when necessary, and designate a person responsible for matters relating to product safety. The appointed person must report all safety information to the HSA, and respond promptly to any request for information necessary for the evaluation of the benefits and risks of a medical product, which includes sales figures and a list of buyers.

Periodic safety update reports (PSURs)

In certain cases, the HSA may also require product licence holders of particular registered medicinal products to submit PSURs to the HSA's Vigilance and Compliance Branch. Where required, the PSURs typically need to be submitted once every six months for the first two years after marketing approval, and then once a year for the subsequent three years. This reporting timeframe may be varied by the HSA to harmonise periodic safety updates internationally.

Notification of actions by regulatory agencies or by the company

If a product licence holder becomes aware of any regulatory actions taken by other regulatory authorities, or if the product licence holder takes any action arising from significant safety issues (for example, product withdrawal/recall and product defects, removal of approved indications by regulatory agencies, failure to obtain a product licence renewal due to safety reasons, and dissemination of "Dear Healthcare Professional Letter" related to safety issues) in relation to the medicinal product, the product licence holder must promptly inform the HSA's Vigilance and Compliance Branch.

Product withdrawal/recall and product defects must be reported within 24 hours after first knowledge by the product licence holder.

Product recalls

The HSA can require a product licence holder to withhold or withdraw, as far as reasonably practicable, the sale, supply or exportation of any batch of any medicinal product to which the product licence relates, for such period as may be specified by the HSA (see Question 19).

Product recalls can be permanent or temporary. The extent of the product recall is usually determined after consultation between the product licence holder and the HSA.

The HSA needs to determine the classification of the recall (Class 1 or Class 2) depending on the potential hazard of the defective product:

  • Class 1 recalls can be initiated when the product defect poses a life-threatening situation to users (for example, non-sterile injections, contamination with toxic substances and products with major labelling errors).

  • Class 2 recalls can be initiated when the problem or defect is unlikely to cause serious harm to users (for example, products with minor labelling errors or products which fail to meet product specification or pharmacopoeia standards but are likely to cause minimal hazard to users).

The HSA also determines the level of recall (at wholesale, retail or consumer level) depending on the nature of the defect, the distribution networks of the product and the extent of distribution.

  • Recall to wholesale level includes all parties involved in wholesale sale and may include wholesalers and retail pharmacies.

  • Recall to retail level includes:

    • all restructured and private hospital pharmacies;

    • retail pharmacies;

    • medical, dental and other healthcare practitioners' establishments;

    • nursing homes and other related institutions;

    • clinical trial centres;

    • other retail outlets (for example, health food stores and supermarkets);

    • wholesale level.

  • Recall to consumer level includes:

    • patients;

    • other consumers;

    • wholesale and retail levels.

 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.

Legal provisions

Medicinal product liability can arise under an action in tort, contract and/or breach of relevant statutory provisions.

An action in tort can arise where the manufacturer, importer and/or distributor has breached its duty of care, such as its duty to ensure adequate quality control measures for medicinal products, or to exercise reasonable care in the marketing and advertisement of products.

An action for a breach of contract can arise from a breach of express or implied contractual terms, most commonly of an implied term that goods supplied are of satisfactory quality, as supported by section 14 of the Sale of Goods Act (Chapter 393).

Criminal liability can also arise under the Medicines Act. For example, a person who sells medicinal products that can only be dispensed on prescription, without a prescription given by an appropriate practitioner, commits an offence (sections 29 and 35, Medicines Act). The issue of a false or misleading advertisement relating to medicinal products is also an offence (section 50, Medicines Act).

Substantive test

To establish the tort of negligence, it must be shown that:

  • There was a duty of care owed by the person committing the tort to the consumer.

  • The person committing the tort did not meet a reasonable standard of care, as determined by the court.

  • The injury to the consumer is causally linked to the person committing the tort's act and the injury was reasonably foreseeable, as determined by the court.

To establish a breach of contract, certain elements will have to be proved, such as the existence of a contract and a breach of its terms.

Liability for statutory offences differs, depending on the conditions in the relevant statute.

 
22. Who is potentially liable for defective medicinal products?

The parties involved in a chain of distribution of the defective medicinal product may potentially be liable for the defects in the medicinal products.

Importers, retailers and manufacturers can be liable for trading a defective product. Officers of such companies can also be personally liable if they authorised, directed or procured the commission of the tort.

A Singapore Court of Appeal case illustrates how an importer and a sole distributor were both found negligent (for trading in defective slimming pills). The director and principal shareholder of the importer was also found liable for his involvement in procuring, directing and authorising the negligence of his company (TV Media Pte Ltd v De Cruz Andrea Heidi and another [2004] 3 SLR(R) 543).

Product licence holders are generally responsible for ensuring that the statutory packaging and labelling requirements in respect of their registered medicinal products are complied with. In the event of a medicinal product labelling error, the HSA can initiate a product recall (see Question 20). In such a case, the product licence holder may also have committed an offence under the Sale of Drugs Act (Chapter 282). This prohibits the sale of any drug in any package that contains any false or misleading statement, word, brand, label or mark purporting to indicate the nature, quality, strength, purity, composition, weight, origin, age or proportion of the article contained in the package or of any ingredient. This offence carries a penalty on conviction of up to S$1,000 for first-time offenders and up to S$4,000 for subsequent offenders. If an offence is committed by the personal act, default or culpable negligence of the offender, the offender can be liable for a fine up to S$4,000 or up to three months of imprisonment, even if it is the first offence.

Any person making an advertisement that consists of or includes unauthorised recommendations (such as off-label use) in relation to a registered medicinal product can also be liable to an offence under the Medicines Act. The penalty on conviction of such an offence is a fine of up to S$5,000 and/or imprisonment of a term of up to two years.

While there is currently no specific legislation in Singapore that prohibits the off-label use of medicinal products, medical practitioners (doctors) are generally required, under the Singapore Medical Council's Ethical Code and Ethical Guidelines, to treat their patients according to generally accepted methods and use only licensed drugs for appropriate indications (that is, no treatment of patients using off-label indications). A medical practitioner who fails to comply with these guidelines can be subject to disciplinary proceedings.

 
23. What defences are available to product liability claims?

Possible defences include:

  • The elements of the tort of negligence are not made out (for example, that the duty of care was not owed, or the standard of care was not breached).

  • Contributory negligence or voluntary assumption of risk.

  • For breach of contract cases, certain vitiating factors such as frustration, mistake, misrepresentation, illegality and unfairness.

  • Statutory defences may be available in respect of offences under the Medicines Act.

 
24. How can a product liability claim be brought?

Limitation periods

The limitation period for bringing a product liability claim in contract or tort is six years from the date on which the cause of action accrued (section 6, Limitation Act, Chapter 163).

Class actions

Class action suits can be brought under Order 15, Rule 12 of the Rules of Court. This is a form of group litigation where proceedings are brought by or against one or more of a group of numerous persons who have the same interest in the proceedings. However, class action suits are generally uncommon in Singapore. To the best of the authors' knowledge, we have not come across a class action suit brought for product liability claims in Singapore for medicinal products.

 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

A claimant can obtain damages and/or an injunction if he succeeds in a claim of negligence.

In a claim for breach of contract, the claimant can be awarded damages or specific performance. He may also be entitled to terminate the contract in certain circumstances. To date, the authors have not come across a case involving a product liability claim where punitive damages have been awarded.

The Singapore High Court has not had the opportunity to decide whether it is possible for aggravated damages to be awarded for negligence in general. The closest the High Court has come to deciding this issue was a case concerning professional negligence of an anaesthetist (not product liability) (Tan Harry and another v Teo Chee Yeow Aloysius and another [2004] 1 SLR(R) 513). It was suggested that aggravated damages could be awarded if there was exceptional or contumelious conduct or motive on the part of the wrongdoer. However, the court did not decide this issue conclusively. More recently, in the case of AYW v AYX [2015] SGHC 312, the High Court once again declined to make a determination on whether aggravated damages could ever be awarded for negligence.

 

Reform

26. Are there proposals for reform and when are they likely to come into force?

Currently, the regulatory controls for Western medicines are contained in both the Medicines Act and Poisons Act.

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 legislation, the HSA has indicated that it will be carrying out a series of public consultations on the subsidiary legislation for the transfer of the controls of pharmaceutical products to the Health Products Act.

The first public consultation was conducted between 27 October 2014 and 23 November 2014 on the proposed Health Products (Advertisement of Therapeutic Products) Regulations 2015 and the proposed Health Products (Licensing of Retail Pharmacies) Regulations 2015. The former concerns controls on advertisements, and the latter concerns the licensing of the retail sale of therapeutic products in pharmacies. Some key proposed changes include:

  • The removal of the existing permit system for advertisements of therapeutic products so that advertisers will self-regulate on broad principles and requirements prescribed in the Regulations.

  • All direct-to-consumer advertisements of Pharmacy Only Medicines to carry advisories/warnings as required by HSA.

  • The inclusion of provisions on telepharmacy by licensed retail pharmacies into the Health Products Act.

In addition, the HSA has issued an explanatory guidance to the Proposed Health Products (Advertisement of Therapeutic Products) Regulations 2015 which contains the general rules and principles relating to the content and manner of advertisements for therapeutic products. This also includes guidance on advertising to children, advertising on the internet, and sales promotion activities.

Between 15 December 2015 and 15 January 2016, the HSA conducted its second round of consultations, on the following proposed subsidiary legislation:

  • Health Products Act (Amendment of First Schedule) Order 2015.

  • Health Products (Therapeutic Products) Regulations 2015.

  • Health Products (Clinical Trials) Regulations 2015.

  • Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2015.

  • Health Products (Medical Devices) (Amendment) Regulations 2015.

Some key changes proposed under the second consultation include:

  • A definition of "therapeutic products" to refer to both the purpose and the active ingredients of such products.

  • Subsuming the existing licensing regime for pharmaceuticals to the activity-based licensing regime under the Health Products Act, and streamlining the licence application process by merging existing application forms and bundling licence fees.

  • Additional measures to enhance the post-market surveillance and safety of therapeutic products, including requirements to implement risk management plans, submit benefit-risk evaluation reports, maintain records of events or occurrences revealing defects, and report product defects and serious adverse reactions.

  • Introduction of a risk-based approach to the regulation of clinical trials for therapeutic products.

  • Simplification and harmonisation of current import approval system for medicinal products, therapeutic products or medical devices which are intended to be administered or used for clinical trials (that is, clinical research materials).

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Pharmaceutical IP and Competition Law in Singapore: overview ( www.practicallaw.com/6-567-9006) .

 

Online resources

Singapore statutes online

W http://statutes.agc.gov.sg/aol/home

Description. The official website for online publication of Singapore legislation, maintained by the Attorney-General's Chambers. The website contains current versions of Singapore legislation as well as subsidiary legislation.

W www.hsa.gov.sg

Description. The official website of the HSA. The website contains updates and press releases issued by the HSA, as well as other useful information on health product regulation in Singapore.



Contributor profiles

Tony Yeo, Director

Drew & Napier LLC

T +65 6531 2512
F +65 6535 4906
E tony.yeo@drewnapier.com
W www.drewnapier.com

Professional qualifications. LLB (Hons), National University of Singapore; Admitted to the Singapore Bar 1992

Areas of practice. Administrative and public law; commercial litigation; healthcare and life sciences; intellectual property.

Recent transactions

  • Representing a client in a suit concerning disputes over defamation and shareholdings in an Indonesian listed company.
  • Acting as lead counsel in a patent infringement action involving an invention relating to drugs for breast cancer treatments. Representing the patent proprietor, Aventis Pharma S.A., and Sanofi-Aventis Singapore Pte Ltd, subsidiaries of the Sanofi-Aventis Group.
  • Acting as lead counsel for Novartis AG and its subsidiary Novartis (Singapore) Pte Ltd in a patent infringement action over a pharmaceutical invention for hypertension treatment.

Languages. English

Professional associations/memberships

  • President, International Association for the Protection of Intellectual Property, Singapore Group.
  • Honorary legal counsel, ORBA (Orchard Road Business Association).
  • Honorary legal counsel, Singapore Advertisers Association (in May 2012).
  • Examinations Committee at the Intellectual Property Office of Singapore.
  • Asian Patent Attorneys Association.
  • International Trademark Association.
  • Law Society's Inquiry Panel and Disciplinary Tribunal.

Publications

  • Singapore chapter of Global Pharmacovigilance Laws & Regulations: The Essential Reference, published by the Food & Drug Law Institute.
  • Legislating medical devices in Singapore, in Financier Worldwide: Biotechnology & Life Sciences e-Book 2010.

Lim Chong Kin, Director

Drew & Napier LLC

T +65 6531 4110
F +65 6535 4864
E chongkin.lim@drewnapier.com
W www.drewnapier.com

Professional qualifications. LLB (Hons), National University of Singapore 1995;

Admitted to the Singapore Bar 1996; LLM, National University of Singapore 1997, Admitted to the Roll of Solicitors of the Supreme Court of England and Wales.

Areas of practice. Competition/antitrust and regulatory law; telecommunications, media and technology law; corporate commercial law

Recent transactions

  • Assisting Pacnet in its joint notification with Telstra to IDA in respect of the acquisition of Pacnet by Telstra.
  • Assisted Airbus and Singapore International Airlines in obtaining a merger clearance decision from the Competition Commission of Singapore (CCS) in respect of their joint venture to establish a flight training facility in Singapore.
  • Led a team appointed by CCS as part of a consortium to assist the CCS with its review of the Block Exemption Order for Liner Shipping Agreements in Singapore.
  • Represented a large international MNC in the financial services sector in respect of an on-going cartel investigation by the CCS.
  • Represented a large international bearing manufacturer and distributor in respect of a cartel investigation by the CCS.
  • Successfully assisted Visa in obtaining competition law clearance from the CCS for Visa's Multilateral Interchange Fee system.
  • Successfully represented and advised All Nippon Airways, Continental and United Airlines in their notification for decision to CCS in relation to their joint venture agreement.
  • Successfully filed and obtained merger approval from the CCS for Seagate's proposed acquisition of Samsung's hard disk drive business.

Languages. English

Professional associations/memberships

  • Member of the Law Society of Singapore.
  • Member of the Singapore Academy of Law.
  • Member of the Law Society of England and Wales.
  • Member of the Pacific Telecommunications Council.
  • Associate member of the American Bar Association.

Publications Including:

  • Bull, Lim and Whish, Competition Law and Policy in Singapore (Academy Publishing, 2009).
  • Hwang and Yeo, Law Relating to Specific Contracts in Singapore, (Thomson Reuters, Sweet & Maxwell, 2008), Chapter 5.
  • All Things Not Being Equal, Asian MENA Counsel Vol 9 Issue 7 2011.
  • Singapore Chapter of the American Bar Association International Antitrust Law.
  • Committee Year-in-Review 2009 and 2010.
  • Counting on Competition, Asian Counsel Vol 7 Issue 9 November 2009 – In Antitrust we trust?
  • Lim and Ng, Your Country Guide to ASEAN Competition Law (Drew & Napier LLC, 1st edition 2008; 2nd edition 2010; 3rd edition 2012) .
  • Singapore Chapter on Merger Control 2011, The European Lawyer Reference Series - Jurisdictional Comparisons (The European Lawyer) .
  • Merger Notifications in Singapore: Information Requirements, International Antitrust Committee: The Newsletter, Summer 2013.
  • Lim and Ng, The International Encyclopaedia of Laws, Competition Law - Singapore (Kluwer Law International, 2013).

Benjamin Gaw, Director

Drew & Napier LLC

T +65 6531 2393
F +65 6535 4906
E benjamin.gaw@drewnapier.com
W www.drewnapier.com

Professional qualifications. LLB (Hons), National University of Singapore (2002);

Admitted to the Singapore Bar 2003; Specialist Diploma in Molecular Biotechnology, Ngee Ann Polytechnic 2007; Admitted to the Roll of Solicitors of the Supreme Court of England and Wales 2009

Areas of practice. Administrative and public law; banking and finance; corporate restructuring; corporate/M&A; employment; healthcare and life sciences; information technology; intellectual property.

Recent transactions

  • Advised a healthcare institution on medical laws and regulations compliance.
  • Advised a pharmaceutical company on various matters of medical confidentiality and data protection.
  • Acted for a liquefied natural gas terminal operator in its procurement of software systems and hardware for all of its business operations.
  • Advised the Singapore subsidiaries of a German speciality chemicals company in its worldwide amalgamation process, arising from its acquisition of an international catalysts manufacturer.
  • Advised and assisted a NYSE-listed asset management related company, in its acquisition of a global relocation and real estate brokerage, and worldwide reorganisation exercise.

Languages. English

Professional associations/memberships

  • Singapore Academy of Law's Committee on Legal Education and Studies.
  • Law Society of Singapore.
  • Singapore Academy of Law.

Publications

  • Singapore chapter of Global Pharmacovigilance Laws & Regulations: The Essential Reference, published by the Food & Drug Law Institute.
  • Legislating medical devices in Singapore, in Financier Worldwide: Biotechnology & Life Sciences e-Book 2010.
  • Employment Contracts – Safeguard Your Intellectual Property Rights, Singapore Biotech Guide 2007/2008.
  • Legislating the Fruits of Biotechnology: Suggestions for Regulating Bio-engineered Food, Singapore Law Review.

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