Life Sciences 2021

Last Updated March 22, 2021

Singapore

Law and Practice

Authors



Drew & Napier LLC has been providing exceptional legal service since 1889 and is one of the largest full-service law firms in Singapore. The firm has three senior counsel. It is pre-eminent in dispute resolution, international arbitration, competition and antitrust, corporate insolvency and restructuring, IP (patents and trade marks), tax, and telecommunications, media and technology, and has market-leading practices in M&A, banking and finance, and capital markets. Drew & Napier has represented Singapore’s leaders, top government agencies and foreign governments in landmark, high-profile cases. It is also appointed by Fortune 500 companies, multinational corporations, and local organisations. The firm is experienced in international disputes before the Singapore International Commercial Court and covers the full range of commercial litigation matters, including building and construction, constitutional law, debt recovery, defamation, fraud, and white-collar crime.

The Health Products Act (Cap. 122D) is the main legislation governing pharmaceuticals, which are referred to as “therapeutic products”, and medical devices.

Therapeutic products and medical devices are also regulated under the following legislation and regulations:

  • the Health Products (Advertisement of Therapeutic Products) Regulations 2016;
  • the Health Products (Medical Devices) Regulations 2010;
  • the Health Products (Therapeutic Products) Regulations 2016;
  • the Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016;
  • the Poisons Act (Cap. 234) and its subsidiary legislation;
  • the Sale of Drugs Act (Cap. 282) and its subsidiary legislation.

The Health Sciences Authority (HSA), a statutory body under the Ministry of Health (MOH), is the main regulatory body which administers, applies and enforces the aforementioned legislation and regulations. The HSA also publishes guidelines in its administration of the legislation and regulations. As a statutory body, the HSA has substantial independence and autonomy over its operations. Nevertheless, it generally operates in line with the policy directions set by the government.

An appeal can be made in respect of any of the following decisions made by the HSA:

  • refusal of the HSA to register a health product;
  • attachment of any condition to the registration of a health product;
  • decision to re-categorise or reclassify a health product;
  • decision to suspend or cancel the registration of a health product.

Any person aggrieved by the decision can make an appeal in writing within the time specified in the decision notice to the Minister of Health, whose decision is final. The Minister may choose to refer the appeal to an Appeal Advisory Committee before making a decision and will have to take into consideration any report made to him or her by the Appeal Advisory Committee in making the decision.

This challenge procedure is specific to health products.

Therapeutic Products

Therapeutic products in Singapore are classified as Prescription-Only Medicines, Pharmacy-Only Medicines and General Sale List medicines. These categories of therapeutic products are regulated differently on the basis of the types of marketing authorisation required.

Medical Devices

The appropriate product registration requirements and evaluation route depends on the risk classification of the medical device.

Medical devices are classified into the following risk groups, based on guidance developed by the Global Harmonisation Task Force:

  • Class A – low risk, (eg, wheelchairs and tongue-depressors);
  • Class B – low to moderate risk (eg, hypodermic needles and suction equipment);
  • Class C – moderate to high risk (eg, lung ventilators and bone-fixation plates);
  • Class D – high risk (eg, heart valves and implantable defibrillators).

Medical devices mainly used for in vitro diagnostic purposes are also separately classified on the basis of their risk levels:

  • A (IVD) – low individual risk and low public-health risk (eg, specimen receptacles);
  • B (IVD) – moderate individual risk and/or low public-health risk (eg, vitamin B12 and pregnancy self-tests);
  • C (IVD) – high individual risk and/or moderate public-health risk (eg, blood glucose self-tests and rubella tests);
  • D (IVD) – high individual risk and high public-health risk (eg, HIV blood-donor screening and HIV diagnostic kits).

Clinical trials of therapeutic products are specifically regulated by the HSA under the Health Products (Clinical Trials) Regulations 2016.

At this point in time, clinical trials of medical devices are not specifically regulated under any legislation. Where clinical trials of medical devices involve human biomedical research, such trials are required to comply with the requirements of the Human Biomedical Research Act 2015 (No 29 of 2015), which is administered by the MOH. Clinical trials of medical devices which do not involve human biomedical research are currently unregulated in Singapore.

Therapeutic Products

In order to undertake a clinical trial of a therapeutic product, regulatory approval from the HSA and ethics approval from the relevant Institutional Review Board (IRB) are required to be obtained.

Applicants must first determine whether the clinical trial is subject to the requirements of a Clinical Trial Authorisation (CTA) or Clinical Trial Notification (CTN). CTAs are required for higher-risk clinical trials involving therapeutic products unregistered in Singapore or uses of registered therapeutic products which are unapproved. Low-risk clinical trials involving only therapeutic products used in accordance with their approved labels may make a CTN submission.

The clinical trial application, together with the relevant supporting documents, should be submitted by the sponsor to the HSA via its online platform PRISM. The study may be initiated after the HSA accepts the notification of clinical trial or authorises the clinical trial.

Medical Devices

Authorisation is generally not required for clinical trials of medical devices. However, a notification must first be submitted to the Director of Medical Services before the commencement of any clinical trial of medical devices involving human biomedical research.

Particulars of any application for authorisation or a notification received by the HSA for clinical trials of therapeutic products are made publicly available online on the Clinical Trial Registry. The results of the trials are not made publicly available.

There are no restrictions for using online tools to support clinical trials, as long as the use complies with the International Council for Harmonisation (ICH) E6 (R2) Good Clinical Practice Guidelines.

Data from clinical trials are considered as personal data as there is no express categorisation of sensitive data in Singapore. However, the Personal Data Protection Commission (PDPC), which administers the Personal Data Protection Act 2012 (No 26 of 2012) (PDPA), Singapore’s primary data protection legislation, has taken the position in several enforcement decisions that medical data are more sensitive in nature and require a higher standard of protection.

Resulting data may be transferred to a third party or an affiliate if consent has been obtained from individuals involved in the clinical trials. Data transfers are required to comply with the requirements of the PDPA.

The creation of a database containing personal or sensitive data would not be subject to requirements beyond that which is already required in the PDPA.

The classification of the health product is assessed when an application for registration is screened to determine whether it should be accepted for evaluation.

Therapeutic Products

A therapeutic product is any substance that has certain active ingredients as a constituent, is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes:

  • preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or any symptom thereof;
  • investigating, modifying or replacing any physiological process;
  • influencing, controlling or preventing conception; or
  • inducing anaesthesia;

and which exerts an inherent effect, either pharmacologically, chemically or by other physiological means, leading to its use for a therapeutic, preventive, palliative or diagnostic purpose.

Medical Device

A medical device is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, 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 disease;
  • diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;
  • investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;
  • supporting or sustaining life;
  • control of conception;
  • disinfection of medical devices; or
  • providing information by means of in vitro examination of specimens derived from the human body, for medical or diagnostic purposes;

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 intended function by such means.

Medical devices also include the following:

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

Biologic medicinal products are generally classified as therapeutic products and are not subject to any specific obligations in relation to the granting of a marketing authorisation. However, the registration requirements for biosimilar product applications differ from those of generic drug applications, as the registration of biosimilar products additionally involve step-wise comparability exercises, such as the comparison of the quality characteristics of the biosimilar product and the reference biological product.

Additional guidance relevant to biological therapeutic products include the:

  • Guidance on Registration of Biosimilar Products;
  • Guideline on Minor Variation (MIV) Applications for Biological Therapeutic Products;
  • Guideline on the Registration of Human Therapeutic Products Containing Materials of Animal Origin; and
  • Guideline on the Registration of Human Plasma-derived Therapeutic Products.

Registrations of therapeutic products and medical devices generally remain valid for a year and may be renewed by paying an annual retention fee, unless the registration is suspended by the HSA or cancelled by either the HSA or the product registrant. There is no requirement to market the health product once it is registered by the HSA. However, under the Singapore Association of Pharmaceutical Industries Code of Conduct, the first use of all promotional materials circulated to the market may not be more than two years from the date of approval. Materials used beyond this time-period are required to be re-approved.

The registration of a health product may be suspended or cancelled by the HSA on the following grounds:

  • the registration has been obtained by fraud or misrepresentation;
  • the registrant of the health product has contravened or is contravening any provision of the Health Products Act, any condition attached to the registration, or any other prescribed requirement;
  • the formulation, composition, design specification, quality, safety or presentation of the health product has changed in such a way as to render it unsuitable to continue to be registered;
  • the health product no longer complies with a prescribed requirement; or
  • it is in the public interest to do so.

The HSA may also re-categorise or reclassify a registered health product if it receives information in respect of the health product that it should be transferred from the category or class under which it has been registered.

Therapeutic Products

Registration procedure

Application submission: submission of the application form online via the HSA’s portal, PRISM and submission of technical dossier accompanying the application within two working days of the PRISM application submission must be made.

Application screening: the application is screened to ensure that the application type is correct and the technical dossier is complete. Where any changes are required or where there are deficiencies in the application, the HSA will request the applicant to take the necessary action via an Input Request. In the case of certain major deficiencies, applicants will be requested to withdraw the application.

Application evaluation: the evaluation stage begins when the application is accepted. Evaluation queries may be issued to the applicant if clarification or additional information is required. The evaluation route applicable depends on whether the therapeutic product has received reference agency approvals.

Regulatory decision: the HSA will notify the applicant of one of the following outcomes after the application has been evaluated: approval, approvable, non-approvable or rejection.

Where the applicant receives an approvable regulatory decision, the applicant will be informed of the conditions for approval and will receive a grant of a final approval if the conditions are fulfilled within a stipulated timeframe.

Where the applicant receives a non-approvable regulatory decision, the applicant will be informed of the deficiencies leading to the non-approvable decision. The applicant may address the specified deficiencies by furnishing a response based on the original data set submitted to the HSA within the stipulated timeframe to continue with the application.

Variation procedure

Variation applications of registered therapeutic products are split into major variation applications (MAV) and minor variation applications (MIV). Each application type may be subject to different evaluation routes and different variation procedures.

As a whole, the procedure to vary a therapeutic product registration is largely similar to the registration procedure. The differences between the procedures are as follows:

  • at the pre-submission stage, applicants may submit a pre-submission enquiry to the HSA for any clarification and also request a pre-submission meeting with the HSA where necessary to address specific submission issues;
  • only MAV applications will be screened to ensure the correctness of the application type and completeness of the technical dossier;
  • during the evaluation stage, applicants who have incorrectly selected an application type or evaluation route will be requested to make the appropriate changes. In such cases, the applicant will be required to withdraw and resubmit the application if the applicant intends to pursue the application.

Transfer procedure

A registrant for a registered therapeutic product may be changed from one company to another.

Before the submission of a transfer application, the existing registrant should conclude all pending variation applications and payment of the annual retention fee. To make a transfer application, the existing registrant first initiates the application via the HSA’s portal, transfer@prism. The new registrant will then receive an e-mail notice with a PRISM transaction number. The new registrant is then required to retrieve the draft application on transfer@prism using the transaction number and submit the completed application in PRISM within 30 calendar days of receiving the email notice.

Medical Devices

Registration procedure

The registration requirements and evaluation route for medical devices depend on their risk classification, whether they have received reference agency approvals, and their prior safe marketing history. Generally, medical devices which have not received prior reference agency approvals will have to undergo the full evaluation route.

Medical device registration applications are submitted online via the HSA’s portal, MEDICS. For applications under the full or abridged evaluation routes, the application will first be verified for eligibility and completeness before it is accepted for evaluation. In the event that the application does not qualify for the selected evaluation route, it will be re-routed accordingly. A regulatory decision is made after the HSA’s evaluation of the application. Only applications that satisfy the registration requirements will be registered. For applications under the immediate evaluation route, the medical device is registered immediately and listed on the Singapore Medical Device Register within an hour.

Variation procedure

Registrants may be required to submit a “Change Notification” application to the HSA upon changes to the medical device registrations. Changes which require the submission of a Change Notification to the HSA can be categorised into Notification, Administrative, Technical and Review changes.

Some changes may not qualify for a Change Notification and require the submission of a new registration. These changes include:

  • a change to the intended purpose of the registered medical device;
  • a change to the risk classification of a registered medical device; and
  • a change to the medicinal substance in a device that incorporates a medicinal product in an ancillary role

A Change Notification application is submitted to the HSA via MEDICS. Applications for changes categorised as Technical or Review will be evaluated by the HSA. Where the HSA determines that the Change Notification is approvable, the change to the registered device may be implemented. Applications for changes categorised as Administrative and Notification may be implemented immediately upon the receipt of the acknowledgement email from HSA after the submission of the application and the verification of the documentation.

Transfer procedure

A transfer application can only be made to the HSA after the medical device is listed on the Singapore Medical Device Register and there are no pending applications in the HSA’s system in relation to the device.

The new registrant is responsible for making the transfer application, by emailing the application form and required supporting documents to the HSA. The new and existing registrants will then be notified of the outcome of the application for the change in registrant.

Unregistered therapeutic products may be supplied to patients under a number of exceptions, including the following:

  • where the therapeutic product is compounded at a private hospital or medical clinic and supplied to a patient of any private hospital or medical clinic; or
  • where the therapeutic product is supplied by a medical practitioner to the medical practitioner’s patient.

Unregistered therapeutic products and medical devices can also be supplied to patients on a named-patient basis. This may be done as part of compassionate-use programmes.

In general, health products may be registered subject to post-approval commitments.

Therapeutic Products

Ongoing obligations of registrants of therapeutic products include:

  • maintaining records of every receipt and supply of the therapeutic product;
  • maintaining records of defects and adverse effects and reporting them to the HSA within certain timeframes;
  • notifying the HSA before any intended recall;
  • informing the HSA of any information that adversely affects the validity of any data furnished to the HSA;
  • submitting benefit-risk evaluation reports periodically to the HSA; and
  • implementing risk-management plans.

The Regulatory Guidance on Post-Marketing Vigilance Requirements for Therapeutic Products, published by the HSA in November 2016, sets out further guidance relating to the submission of relevant safety information during the post-marketing phase.

Medical Devices

Ongoing obligations of registrants of medical devices include:

  • ensuring and maintaining objective evidence to establish that the medical device complies with safety and performance requirements;
  • maintaining records of every supply of the medical device;
  • maintaining records of every complaint received pertaining to the medical device;
  • reporting defects in the medical device or adverse effects arising from the use thereof;
  • reporting information that adversely affects the validity of any data furnished to the HSA relating to the quality, safety or efficacy of the medical device;
  • notifying the HSA prior to any intended recall and furnishing a report of that recall; and
  • notifying the HSA prior to carrying out any field-safety correction in relation to a medical device and furnishing a report thereof.

The Health Products (Medical Devices) Regulations and Health Products (Therapeutic Products) Regulations allow the disclosure of information relating to applications for registration. Trade secrets and information of commercial value that would be, or would be likely to be, diminished by disclosure are excluded from any such disclosure.

The HSA makes publicly available, on an online database, information submitted to the HSA in support of health-product registration applications for registered health products. Information relating to pending applications is currently not publicly available.

Confidentiality

The Health Products Act generally does not allow the disclosure of confidential information obtained in the administration of the Act except with the consent of the person from whom the information was obtained.

Additionally, confidentiality of confidential supporting information given in relation to an innovative therapeutic product application is protected by the HSA for a period of five years after it receives the innovative therapeutic product application, subject to exceptions. An innovative therapeutic product application is defined as a therapeutic product registration application that refers to a substance that is an ingredient in the manufacture or preparation of the therapeutic product to which the application relates that has not been referred to as an ingredient in the manufacture or preparation of any other therapeutic product in any previous application.

It is an offence under the Health Products Act to manufacture, supply or import a counterfeit product in Singapore and offenders may be subject to a fine not exceeding SGD100,000 and/or imprisonment for up to three years.

The registration of all health products before they are marketed and sold in Singapore allows the HSA to detect better any adulterated, counterfeit or illegal products. The HSA has also compiled a public database of detected and tested illegal health products in Singapore.

Border measures are available under intellectual property law for proprietors or licensees of registered trade marks. See 10.1 Counterfeit Pharmaceuticals and Medical Devices for more information.

Manufacturers of therapeutic products and medical devices are generally required to obtain a manufacturer’s licence from the HSA. The manufacture of a health product means to make, fabricate, produce or process the health product, and includes:

  • any process carried out in the course of so making, fabricating, producing or processing the health product; and
  • the packaging and labelling of the health product before it is supplied.

Manufacture of Therapeutic Products

To obtain a manufacturer’s licence, the HSA must be satisfied that the applicant is able to comply with the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products in relation to the manufacture of the therapeutic product in question. The HSA enforces these standards by conducting pre-approval and routine GMP audits to ensure conformance to the standards. The details of the audit process may be found in the Regulatory Guidance published by the HSA on Audit and Licensing of Pharmaceutical Manufacturers in December 2017. Establishments will be given an opportunity to rectify any non-conformities raised during the audit within a prescribed timeframe.

Manufacture of Medical Devices

Applicants for a manufacturer’s licence are required to provide information on their Quality Management System through the submission of an ISO 13485 certificate, the scope of which must include import, storage and/or distribution of medical devices, or a declaration of conformity to a Quality Management System.

A manufacturer’s licence is not required for certain activities, including:

  • manufacture by way of fitting or adjusting the medical device to meet the requirements of the end user;
  • manufacture to enable the continued used of the medical device by the end user;
  • secondary assembly where the company holds an importer’s licence or wholesaler’s licence;
  • manufacture for use in clinical research; or
  • manufacture of Class A medical devices for a charitable purpose.

The period of validity of a wholesaler’s licence depends on the respective terms and conditions of the licence.

Establishments are generally required to obtain a wholesaler’s licence from the HSA in order to engage in the wholesale of therapeutic products and medical devices. The wholesale of a health product includes the supply of the product:

  • to a person who obtains the product for the purposes of supplying it to another person;
  • to a person as a commercial sample in the normal course of a lawful trade;
  • to the Singapore government where it is required for the purposes of public service or use in connection with the exercise of any statutory power;
  • to a person or an institution concerned with scientific education or research requiring the health product for such a purpose; or
  • by export to a party outside Singapore.

To obtain a wholesaler’s licence for therapeutic products, the establishment must first be audited to comply with the HSA’s Good Distribution Practice standards, which are set out in the HSA’s Guidance Notes on Good Distribution Practice, published in August 2015.

Additionally, where the establishment intends to supply by wholesale codeine cough preparations or therapeutic products containing psychotropic substances, additional approval must first be obtained from the HSA. Certain activities may not require a licence if the exceptions available in the Health Products (Therapeutic Products) Regulations apply, such as if the wholesaler holds a manufacturer’s licence.

To be granted a wholesaler’s licence for medical devices, the establishment is generally required to submit to the HSA any of the following:

  • an ISO 13485 certificate, the scope of which must include import, storage and/or distribution of medical devices, where applicable;
  • a declaration of conformity to a Quality Management System; or
  • a Good Distribution Practice Standard for Medical Devices certificate issued by a certification body accredited by the Singapore Accreditation Council or a declaration of exemption thereof.

A wholesaler’s licence is not required if the wholesaling is for a clinical purpose in clinical research.

The period of validity of a wholesaler’s licence depends on the respective terms and conditions of the licence.

Therapeutic products in Singapore are classified as Prescription-Only Medicines and Pharmacy-Only Medicines. Prescription Pharmacy-Only Medicines may only be supplied by a registered medical practitioner or pharmacist in accordance with a prescription. Pharmacy medicines may be supplied by a pharmacist without a prescription.

The import and export of therapeutic products and medical devices are governed by the Health Products (Therapeutic Products) Regulations 2016 and the Health Products (Medical Devices) Regulations 2010 respectively. Additionally, all goods imported into Singapore are regulated under the Customs Act (Cap. 70), the Goods and Services Tax Act (Cap. 117A) and the Regulation of Imports and Exports Act (Cap. 272A).

The Singapore Customs applies and enforces import regulations at the point of entry and thereafter, the regulations are applied and enforced by the HSA.

Only a qualified pharmacist or a person approved by the HSA may act as the importer of record of therapeutic products. There are no specific requirements regarding the importer of record of medical devices.

An importer’s licence is required in order to import therapeutic products and medical devices. In general, only registered therapeutic products and medical devices may be imported.

The exemptions to the above include the following:

  • a healthcare institution may import a therapeutic product without a licence on a named-patient basis with the prior approval of the HSA;
  • a person may import a therapeutic product that does not contain psychotropic substances or amounts of codeine and dextromethorphan greater than that specified by the HSA without a licence for personal use with the prior approval of the HSA;
  • a licensed manufacturer may import any therapeutic product or medical device if required for the purpose of carrying out the licensed manufacture of a therapeutic product;
  • medical devices may be imported without a licence for personal use subject to conditions set out by the HSA or for use in a clinical purpose in any clinical research; and
  • in light of the COVID-19 situation, the HSA announced that surgical masks, particulate respirators, thermometers and protective gear for medical professionals may be imported without a licence (see 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices).

Harmonised System (HS) codes are required in Singapore in the permit declaration of goods. They are used to determine the tariffs, controls and rule of origin applicable to the relevant goods. The HS code of goods used in Singapore is an eight-digit code known as the ASEAN Harmonised Tariff Nomenclature code and it is harmonised at the eight-digit level across the ASEAN member countries. The HS codes are listed in the Singapore Trade Classification, Customs and Excise Duties published by the Singapore Customs.

Singapore is part of the ASEAN trade bloc and is a party to Free Trade Agreements with numerous jurisdictions containing provisions on trade/regulatory facilitation, including the European Union, China and New Zealand.

In general, prices for therapeutic products and medical devices are not regulated in Singapore. However, it should be noted that public healthcare institutions in Singapore procure medicinal products in bulk by way of tender contracts through Group Procurement Offices to achieve economies of scale.

Price levels of therapeutic products and medical devices generally do not depend on the prices for the same product in other countries, as prices are generally not regulated in Singapore. However, this may be a factor that can be taken into account in negotiations with drug companies.

The Singapore government provides direct subsidies of up to 75% for subsidised medications for subsidised patients at specialist outpatient clinics and all patients at polyclinics. The Singapore government has also implemented the Seniors’ Mobility and Enabling Fund, which provides subsidies to offset the costs of assistive devices and home healthcare items. Drugs are only subsidised if they fall under the Standard Drug List maintained by the MOH, or fall within the government’s subsidy schemes.

Additionally, the government provides multiple tiers of financing for Singapore citizens and permanent residents for their healthcare expenditure, which includes a basic health insurance plan and a medical endowment fund. These tiers of funding apply to medical bills as a whole, including the cost of medication.

The Agency for Care Effectiveness (ACE) under the purview of the MOH is the national health technology assessment agency in Singapore. The ACE works to lower prices of health technologies, including drugs, medical devices and medical services, by evaluating their clinical and cost-effectiveness and negotiating with companies based on their proven outcomes. The evaluations made by the ACE also guide policy-makers in making subsidy decisions. Summaries of the rationale for subsidy decisions, as well as the key clinical and economic evidence supporting such recommendations, are published by the ACE to increase the level of transparency in decision-making.

There are generally no regulations restricting pharmaceutical spending with regard to prescriptions by physicians and dispensing by pharmacies. However, medical practitioners are increasingly reminded to prescribe medications which are the most cost-effective for patients, where available.

There is currently no specific legislation or guidelines governing mobile medical applications in Singapore. Standalone mobile medical applications are classified as telehealth products under the HSA Regulatory Guideline for Telehealth Products and may be considered medical devices if they are intended to be used for medical purposes such as investigation, detection, diagnosis, monitoring, treatment or management of any medical condition, disease, anatomy or physiological process.

While there is no legislation governing telemedicine, the policy stance taken in Singapore is reflected in the National Telemedicine Guidelines issued by the MOH in January 2015 and the HSA Regulatory Guidelines for Telehealth Products, which were revised in April 2019.

Registered medical practitioners may provide medical attention through a mobile device in Singapore. Such services are currently regulated under the Licensing Experimentation and Adaptation Programme (LEAP), a regulatory sandbox initiative launched by the MOH in April 2018 to enable new and innovative models and services to be developed in a safe and controlled environment.

There are no special rules governing the promotion and advertisement of therapeutic products and medical devices online. The general rules regarding the advertisement of therapeutic products and medical devices apply.

Electronic prescriptions are allowed and used in Singapore by both public and private healthcare providers. Electronic prescriptions are not specifically regulated and are subject to the general legislation governing the collection of personal data and medical records under the PDPA and various healthcare-related legislation.

Medicines in Singapore are classified as Prescription Only Medicines, Pharmacy Only Medicines and General Sale List medicines may be sold online. General Sale List medicines may be sold online, subject to certain regulatory requirements. Medicines categorised as General Sale List medicines are set out in the Medicines (General Sale List) Order 2016, and are comprised of the following:

  • Chinese proprietary medicine;
  • homeopathic medicine;
  • medicated oil and balm;
  • quasi-medicinal products; and
  • traditional medicine.

In general, Class A medical devices and selected categories of unregistered Class B, C and D medical devices may be sold online.

Electronic health records are currently not specifically regulated in Singapore and are subject to the general legislation governing the collection of personal data and medical records under the PDPA and various healthcare-related legislation.

Health-related information is not regulated as sensitive data, although the PDPC, which administers the PDPA, has taken the position in several enforcement decisions that medical data are more sensitive in nature and require a higher standard of protection.

Cloud Platforms

While there are no specific requirements for the storage of information on cloud platforms, the PDPC has published the Guide to Securing Personal Data in Electronic Medium to provide guidance for organisations using cloud platforms. Sensitive data of patients may be transferred and stored on cloud platforms. However, where the cloud platforms are based outside Singapore, the PDPA requires organisations to ensure that the transferred personal data are accorded a standard of protection that is comparable with that of the PDPA.

In Singapore, patents are regulated under the Patents Act (Cap. 221) and its various subsidiary legislation, which include the Patents Rules. Therapeutic products are commonly patented in Singapore and there are generally no patentability requirements specific to therapeutic products or medical devices.

Issues

The Court of Appeal in Warner-Lambert v Novartis [2017] SGCA 45 has recently called into question whether Swiss-type claims should be valid in Singapore to frame second and subsequent medical-use claims, given that purpose-limited product claims may be sufficient to protect such claims. While the Intellectual Property Office of Singapore continues to take the approach that Swiss-type claims are valid, it is not certain if this approach will change in the future to reflect the Court of Appeal’s position.

As software is not patentable under the Singapore patent regime, medical devices consisting exclusively of software may not receive patent protection.

Second and subsequent medical uses of a known product are patentable insofar as they are claimed in the form of “Swiss-type” claims. Additionally, second medical-use claims can only derive novelty from their intended use where the use is a method of treatment of the human or animal body by surgery or therapy or a method of diagnosis practised on the human or animal body. It should be noted that the Singapore patents' registry practice for using the Swiss-type claim format differs from that of the United Kingdom and Europe, which are contracting members of the Europe Patent Convention 2000.

Patentability of Claims

Second medical-use claims are typically used to protect the use of a substance or composition in the treatment of a different disease.

Second medical-use claims are also allowable for new dosage regimes, on the condition that the claimed dosage regime is novel and inventive. However, the patents' registry recognises that, in most cases, it is generally presumed that new dosage regimes lack inventiveness, unless there is a clear technical prejudice pointing away from the claimed dosage regime.

Additionally, depending on the factual scenario, second medical-use claims may rely solely on the patient population to be treated to fulfil the requirements of novelty and inventive step, despite known associations of the claimed product and the disease to be treated. For such claims to be patentable, the new patient group must consist of a distinctly different patient population from those treated in the prior art.

Infringement

It is uncertain how the Singapore courts will apply the legislation on infringement to second and subsequent patents as, at the time of writing, there are no cases in Singapore on the infringement of second and subsequent patents of pharmaceutical products.

Under the Patents Act, the proprietor of a patent can make an application to the patents' registry to extend the terms of the patent on any of the following grounds:

  • where there was an unreasonable delay by the patents' registry in granting the patent;
  • where the patent was granted on the basis of any prescribed documents relating to a corresponding application, and there was an unreasonable delay in the issue of the corresponding patent, and the patent office that granted the corresponding patent has extended the term of the corresponding patent on the basis of that delay; or
  • where the subject of the patent includes any substance which is an active ingredient of any pharmaceutical product, and there was an unreasonable curtailment of the opportunity to exploit the patent, due to the process of obtaining marketing approval for the first pharmaceutical product, which uses the substance as an active ingredient, and the patent term has not previously been extended on this ground.

Further guidance on how the above grounds are applied is set out in the Patent Rules. In the case of the first ground, a delay by the patents' registry will not be treated as an unreasonable delay unless:

  • the interval between the date of filing of the application for the patent and the date of issue of the certificate of grant, excluding any period attributable to an act or omission of the applicant, exceeds four years; or
  • the interval between the date on which the applicant filed a request for a search and examination report, or an examination report, and the date of issue of the certificate of grant, excluding any period attributable to an act or omission of the applicant, exceeds two years.

In the case of the third ground, a curtailment of an opportunity to exploit a patent will not be considered an unreasonable curtailment unless the marketing approval was obtained after the date of issue of the certificate of grant, and the interval between the date the application for marketing approval was filed and the date marketing approval was obtained, excluding any period attributable to an act or omission of the applicant for marketing approval, exceeds two years.

Patent-term extensions may not be challenged by third parties. 

When a person carries out any of the following acts in Singapore in relation to the invention of a patent without the consent of the proprietor’s consent, it will constitute a patent infringement:

  • where the invention is a product, the person makes, disposes of, offers to dispose of, uses or imports the product or keeps it, whether for disposal or otherwise;
  • where the invention is a process, he or she uses the process or offers it for use in Singapore when he or she knows, or it is obvious to a reasonable person in the circumstances, that its use without the consent of the proprietor would be an infringement of the patent; and
  • where the invention is a process, he or she disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product, whether for disposal or otherwise.

An application for marketing authorisation will not infringe a patent. However, the HSA may refuse the application if it is of the opinion that the doing of the act for which the marketing authorisation is sought for will infringe on an existing patent.

Only actual infringement is actionable and a person aggrieved by groundless threats of infringement proceedings may bring an action against the person making the threats.

The defences to patent infringement relevant to pharmaceuticals and medical devices are as follows:

  • if the act is done for experimental purposes relating to the subject-matter of the invention;
  • if the act consists of the extemporaneous preparation of a medicine for an individual in accordance with a prescription given by a registered medical or dental practitioner or consists of dealing with a medicine so prepared;
  • if the act consists of the doing of any infringing act in relation to the subject matter of the patent to support any application for marketing approval for a pharmaceutical product, provided that anything produced to support the application is not made, used or sold in Singapore or exported outside Singapore, other than for purposes related to meeting the requirements for marketing approval for that pharmaceutical product; or
  • if the act consists of the import, disposal or offer to dispose of a patented pharmaceutical product for use by or on a specific patient in Singapore, or the use of that product by or on that patient, where that product is required for use by or on that patient, the relevant authority has granted approval specifically for the import of that product for use by or on that patient; and that product was produced by or with the consent (conditional or otherwise) of the proprietor of the patent or any person licensed by him or her.

Compulsory Licence

An interested person may apply to the court for the grant of a licence under a patent on the ground that the grant of the licence is necessary to remedy an anti-competitive practice. The court may grant the licence if:

  • there is a market for the patented invention in Singapore;
  • that market is not being supplied on reasonable terms; and
  • the court is of the view that the proprietor of the patent has no valid reason for failing to supply that market with the patented invention, whether directly or through a licensee, on reasonable terms.

The proprietor of the patent may bring proceedings for patent infringement in court and make a claim for any of the following remedies:

  • an injunction restraining the defendant from any apprehended act of infringement;
  • an order for the defendant to deliver up or destroy any patented product in relation to which the patent is infringed or any article in which that product is inextricably comprised or any material and implement the predominant use of which has been in the creation of the infringing product;
  • damages in respect of the infringement;
  • an account of the profits derived by the defendant from the infringement; or
  • a declaration that the patent is valid and has been infringed by the defendant.

The proprietor of a patent and any other person may choose to refer to the Registrar of Patents to determine whether the other person has infringed the patent, upon mutual agreement.

The procedure for regular court proceedings apply to a patent infringement action in court. Typically, the plaintiff commences an action by serving on the defendant a writ of summons. Parties will then file their respective pleadings and exchange their affidavits before setting down for trial. Patent infringement actions are heard in the General Division of the High Court and parties have an opportunity to appeal the decision at the Court of Appeal. Separate procedures apply for references to the Registrar of Patents.

Invalidity is an available defence to patent infringement and can be invoked during the infringement proceedings at the pleadings stage.

In general, when processing applications for therapeutic product registration, the HSA will take into account patent protection.

Before making an application for a generic market entry, the applicant must first declare the existence of any patent in force in respect of the therapeutic product, and whether the applicant is the proprietor of the patent. Where a patent is in force in respect of the therapeutic product and the potential applicant is not the proprietor, the potential applicant should first obtain the consent of the patent proprietor to make the application.

Where the patent is invalid or will not be infringed by the generic market entry, the HSA may require the applicants to serve on the proprietor a notice in the form specified by the HSA declaring that the applicant has made an application in respect of the proprietor’s patent. If the proprietor does not make a court application to restrain the generic market entry or seek a declaration that the patent is valid or will be infringed by the generic market entry within 45 days of receiving the notice, the HSA may proceed with the generic market entry application. If the proprietor is successful in its court application, a 30-month moratorium will be granted, during which the HSA will not grant marketing approval for the generic market entry.

In the event that the patent proprietor misses the deadline to make a court application and the applicant successfully registers the therapeutic product, the proprietor may still make an application to the HSA to cancel the registration if the proprietor has obtained a determination that:

  • the doing of an act authorised by the registration infringes a patent; or
  • the initial declaration made by the applicant contains a statement that is false or misleading in a material particular or omits to disclose any matter that is material to the application.

This was confirmed in the recent Court of Appeal case Millennium Pharmaceuticals, Inc v Drug Houses of Australia Pte Ltd [2019] SGCA 31.

It is an offence under the Trade Marks Act (Cap. 332) to counterfeit a trade mark, falsely apply a registered trade mark to goods or services, or do any of the following in relation to goods to which a registered trade mark is falsely applied:

  • import into Singapore for the purpose of trade or manufacture;
  • sell or offer or expose for sale; or
  • possess for the purposes of trade or manufacture.

Seizure of Infringing Goods

The proprietor or licensee of a registered trade mark in Singapore who expects infringing goods to be imported or exported may request for the Singapore Customs to seize the goods by giving written notice and sufficient information to identify the goods, enable the Singapore Customs to ascertain when and where the goods are expected to be imported or exported, and satisfy the Singapore Customs that the goods are infringing goods. The requestor may also be required to provide security for the liability or expense of seizing the goods, and their subsequent storage and disposal.

At any time after the goods have been seized, the Singapore Customs may give the requestor the name and contact details of any person connected with the import or proposed export of the seized goods and permit the requestor to inspect the seized goods. The seized goods will be released to the importer or exporter if the requestor has not instituted an infringement action in relation to the goods before the expiry of the retention period.

Trade marks used for therapeutic products and medical devices will not be registered if they contain or consist of their international non-proprietary name without being accompanied by any other distinctive matter due to their descriptiveness and lack of distinctive character. There are no restrictions under trade-mark law to import and distribute non-counterfeit, genuine pharmaceutical or medical device products.

While the concept of trade dress is not expressly recognised in Singapore, it is possible to register the design of therapeutic products and medical devices and their packaging and any such registered designs can receive protection for up to 15 years. Registrable designs generally refer to the features of shape, configuration, colours, pattern or ornament applied to any article or non-physical product that give that article or non-physical product its appearance but do not include methods or principles of construction and designs that are solely functional.

The design and packaging of therapeutic products and medical devices, including their three-dimensional shape, may also be registered as trade marks or receive protection under the common law tort of passing off.

Safety and efficacy data generated in support of a therapeutic product registration cannot be relied on by a subsequent similar therapeutic product to obtain registration unless consented to by the registrant of the earlier registration. This exclusivity lasts for a period of five years after the date of the registration of the therapeutic product. Chemical drugs and biologics are not treated differently.

Waiver of Import Licence Requirements for Masks, Thermometers, Etc

Effective from 31 January 2020, the HSA waived the requirement for import licences for surgical masks, particulate respirators (eg, N95 masks), thermometers and protective gear for medical professionals such as gloves. Commercial importers are still required to file online notifications.

Provisional Authorisations for COVID-19 Diagnostic Tests

To address the need for diagnostic tests, the HSA set up an expedited provisional authorisation process and provisionally authorised over a hundred COVID-19 tests. The HSA requires periodic reports on safety and performance to be submitted post authorisation. Applicants intending to supply tests in the long term must still register the device.

Regulatory Flexibility in Relation to Respiratory Devices

On 1 April 2020, the HSA announced a position of regulatory flexibility towards respiratory devices which will remain in effect during the COVID-19 period. The HSA stated that:

  • it would allow the safe use of HSA-registered anaesthesia machines and positive airway pressure devices as emergency ventilators without approval;
  • it would allow upgrades or modifications to HSA-registered ventilators without approval as long as the changes do not affect registered performance specifications, the devices continue to meet the safety and performance requirements and the changes are notified on a six-monthly basis;
  • it would advise companies seeking to supply unregistered ventilators; and
  • it would allow remote inspections of facilities not yet audited or certified to the ISO 13485 standard in order for the companies to obtain manufacturing licences for surgical masks in Singapore.

Provisional Authorisations for Respirator Decontamination Devices

On 11 June 2020, the HSA announced a provisional authorisation pathway for medical devices intended for decontaminating used respirators.

As of January 2021, the HSA has not issued any special regulations in relation to clinical trials of COVID-19 treatments and vaccines specifically.

HSA Guidance on the Conduct of Clinical Trials

On 27 March 2020, the HSA issued a guidance on the conduct of clinical trials during the COVID-19 situation. The guidance describes considerations surrounding the implementation of any contingency measures during clinical trials. The potential contingency measures discussed include:

  • remote study visits;
  • direct-to-patient services for investigational product supply;
  • obtaining informed consent remotely; and
  • remote monitoring.

The recommendations include:

  • ensuring proper documentation of reasons for implementing any contingency measure;
  • engaging in early consultations with sponsors, investigators, institutional review boards (IRBs) and the HSA; and
  • including in study reports the impact of COVID-19 and contingency measures on the safety and efficacy data.

New Pandemic Special Access Route (PSAR)

In 2020, the HSA introduced the Pandemic Special Access Route (PSAR). The PSAR facilitates early access to novel vaccines, medicines and medical devices which the government designates as being required for a pandemic by granting such products an interim authorisation, exempting them from the registration and licensing requirements.

The HSA will consider interim authorisation if there is reasonable quality, safety and efficacy (QSE) data suggesting that the potential benefits outweigh the known risks and there is continuing QSE data generated from ongoing studies to support the eventual transition of the interim authorisation to full registration. The HSA may cancel an interim authorisation if the evolving data suggests that the benefits no longer outweigh the risks or if the emergency ceases.

The PSAR allows vaccines, medicines and medical devices to be evaluated based on data submitted on a rolling basis instead of full data sets, giving the HSA more time to review submitted data and allowing companies to continue with clinical trials and development.

Other than the measures targeted at medical devices (such as diagnostic tests) for addressing COVID-19 specifically (discussed in 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices), no other simplifications or flexibilities in certification requirements were formally introduced by the HSA as a result of COVID-19.

Waivers were granted for import licences on masks, respirators, thermometers and protective gear (discussed in 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices).

The PSAR (discussed in 11.3 Emergency Approvals of Pharmaceuticals and Medical Devices) allows, subject to conditions, the interim authorisation of vaccines, medicines and medical devices designated by the government to be exempt from the prohibition against importation without the required importer’s licences and product registrations.

Financial Support for Telemedicine

On 3 April 2020, to support the safe-distancing measures to minimise activities and to reduce the risk of local transmission of COVID-19, the Ministry of Health introduced for a limited time an initiative to allow the tapping of funds from the Community Health Assist Scheme (a government scheme which provides subsidies for medical care at general practitioner clinics) and Medisave accounts (the national savings scheme which sets aside part of a person’s income for medical expenses) for follow-up video consultations by approved healthcare institutions for certain chronic conditions. The list of eligible chronic conditions under the time-limited initiative was subsequently expanded from seven to 20 on 9 October 2020.

Power to Issue Compulsory Licences

There have been no announcements by the government regarding compulsory licensing of COVID-19 treatments or vaccines. The power of the government to issue such licences can be found in the Patents Act. To the best of the available knowledge, the government has never exercised these powers.

Under the Patents Act, the government (and any authorised party) may do anything in relation to a patented invention for a public non-commercial purpose or, for or during a national emergency or other circumstances of extreme urgency, without amounting to an infringement of the patent.

The government may also import pharmaceutical products upon giving the Council for the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) the required notification.

Restrictions and Obligations of the Power to Issue a Compulsory Licence

The government can only issue licences which are non-exclusive and limited to the supply of the patented invention predominantly in Singapore. Further, a pharmaceutical product imported under the government’s powers to import patented pharmaceutical products cannot be re-exported.

The government must inform the patentee promptly of its use of the patented invention and must pay the remuneration that has been agreed, or in default of agreement, remuneration as determined by the Singapore courts. There is no requirement to pay remuneration if the patentee has already received or will receive some other remuneration.

As far as is known, no information is publicly available as to whether liability exemptions or indemnities are applicable for COVID-19 vaccines or treatments.

As far as is known, no manufacturing sites were requisitioned or converted due to COVID-19.

Although new legislation was introduced to allow the Minister of Health to requisition land, undertakings and resources, the provisions relate to requisitions necessary for measures to control the spread of COVID-19, such as a requisition of land to ensure sufficient accommodation for quarantine purposes.

No systemic changes were made to the system of public procurement of medicines and medical devices due to COVID-19. However, according to a statement released by the Second Minister for Finance, emergency procurement procedures were invoked at the early stages of the pandemic to allow the government to source and secure essential medical supplies quickly. Instead of open sourcing, the government directly contracted with suppliers with the necessary expertise and resources and who were best able to meet the requirements within the shortest timeframe possible.

The Minister signalled that, as the situation improves and the time urgency abates, a larger proportion of procurement will be done through the default process of open sourcing.

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Drew & Napier LLC has been providing exceptional legal service since 1889 and is one of the largest full-service law firms in Singapore. The firm has three senior counsel. It is pre-eminent in dispute resolution, international arbitration, competition and antitrust, corporate insolvency and restructuring, IP (patents and trade marks), tax, and telecommunications, media and technology, and has market-leading practices in M&A, banking and finance, and capital markets. Drew & Napier has represented Singapore’s leaders, top government agencies and foreign governments in landmark, high-profile cases. It is also appointed by Fortune 500 companies, multinational corporations, and local organisations. The firm is experienced in international disputes before the Singapore International Commercial Court and covers the full range of commercial litigation matters, including building and construction, constitutional law, debt recovery, defamation, fraud, and white-collar crime.

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