The Pharma Legal Handbook: Singapore
The Pharma Legal Handbook: Singapore answers essential questions about the legal and regulatory environment for pharmaceuticals in Singapore. It is a must-have for any company operating in the country or looking to enter the market.
Prepared in association with Drew & Napier LLC, one of Singapore’s leading law firms, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
March 2019
1. Biosimilars & Biologics: Singapore
A brief overview of the situation regarding biosimilars & biologics in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.
1. Are biosimilar medicines considered the same as generic medicines in your country?
Biosimilar medicines are not considered the same as generic medicines. According to the Health Sciences Authority of Singapore (“HSA”), biologics are medicinal products with large complex molecules produced by living cells through highly specific processes. Even a slight change in the manufacturing process can vary the structure of the biologic compound and consequently impact the efficacy, safety and quality of the biologic medicine. Biosimilars are then ‘follow-on’ versions of biologic medicines, which are required to show similarity in physical and chemical characteristics, biological activity, safety and efficacy to the first approved biologic medicine.
On the other hand, generic medicines are small molecule chemical medicines such as paracetamol, for which the manufacturing process can be replicated to produce an identical copy.
Accordingly, different application and processes are required depending on whether the medicine is a biosimilar or a generic drug. Biosimilars are required to be submitted as new drugs under the new drug application (NDA) via NDA-2 or NDA-3. They are not eligible for a generic drug application (GDA) for which only therapeutic products that contain one or more chemical entities and is essentially the same as a current registered product (Singapore Reference Product) in terms of its qualitative and quantitative composition of active ingredients.
2. Are all biologic medicines, including biosimilar medicines patentable in your country?
Yes, subject to requirements for patentability under the Patents Act (Cap. 221) of Singapore (“Patents Act”).
3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?
The biosimilar medicine is subject to the same regulatory framework as all other therapeutic products in Singapore, i.e. the Health Products Act 2016 and the Health Products (Therapeutic Products) Regulations 2016 (Cap 122D). Companies are required to obtain a dealer’s licence before manufacturing, importing or supplying therapeutic products, and all therapeutic products must be registered with the HSA before they can be supplied in Singapore.
However, the application for a biosimilar product differs from that of other therapeutic products as it can only be registered for as a biosimilar if it is similar to an existing biological product registered in Singapore in terms of physicochemical characteristics, biological activity, safety and efficacy. It is to be submitted as a new drug application (NDA) via the abridged evaluation route, either through NDA-2, for the first strength of a biosimilar product with the same dosage form and route of administration as the Singapore reference biological product, or NDA-3, for subsequent strengths of a biosimilar product that has been registered or submitted as an NDA-2. The administrative requirements are as per those required for an NDA via the abridged evaluation route. There must also have been a comprehensive comparability exercise done with the reference product.
Further, Singapore’s patent linkage system links the marketing approval of drugs to whether there is a relevant patent in force corresponding to the originator’s drug. If there is a relevant patent, applicants have to declare it to the HSA.
4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?
All therapeutic drugs including both the biosimilar and the original biologics drugs require their application to be approved by the HSA. However, if the original biologics drug contains a new biological entity, an application under NDA-1 is required, while a biosimilar, which contains no new biological entity from its reference product, can apply as either NDA-2 or NDA-3. For an NDA-1 application, it must go through the full evaluation route, which requires
- Administrative documents,
- common technical documents,
- quality documents,
- non-clinical documents and
- clinical documents to be provided.
For an NDA-2 or NDA-3 application, while administrative, common technical and quality documents are required, only an overview of non-clinical documents need to be provided if organized in the ASEAN Common Technical Document (CTD) format, and not at all if organized in the International Council for Harmonisation CTD. However, non-clinical studies should have been performed before initial clinical development, and the studies should be comparative in nature and designed to detect differences in response between the biosimilar product and reference biological products.
As for clinical reports, the requirements depend on the existing knowledge of the reference biological therapeutic product and the claimed therapeutic indication(s). Available product/disease specific guidelines should be followed when appropriate and relevant international guidelines should be referred to in the design of an appropriate clinical study programme for biosimilar products.
5. What are the requirements for the choice of the reference comparator product?
The reference comparator product must be a Singapore Reference Biological Product (SRBP). A registered biosimilar product cannot be used as a reference product. A biological product with no suitable SRBP will not qualify for registration as a biosimilar product in Singapore.
Similarity to the Singapore reference biological product (SRBP) needs to be established using a comprehensive comparability exercise based on:
- Quality characteristics
- Biological activity
- Safety
- Efficacy
The same chosen reference product should be used throughout the comparability assessment for quality, safety and efficacy studies during the development of a biosimilar product in order to allow the generation of coherent data and conclusions.
The chosen reference product used should be of the corresponding strength and from the Singapore registered drug product manufacturing source.
The active substance of a similar biological medicinal product must be similar, in molecular and biological terms, to the active substance of the reference medicinal product.
The pharmaceutical form, strength, and route of administration of the similar biological medicinal product should be the same as that of the reference medicinal product.
When the pharmaceutical form, the strength or the route of administration is not the same, additional data in the context of the comparability exercise should be provided.
Any differences between the similar biological medicinal product and the reference medicinal product will have to be justified by appropriate studies on a case-by-case basis
The conditions of use for the biosimilar product must fall within the directions for use including indication(s), dosing regimen(s) and patient group(s) for the Singapore registered reference product.
6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
The chosen reference medicinal product must be a medicinal product registered in Singapore. Data generated from comparability studies with medicinal products registered in other countries may only provide supportive information.
If comparative studies are performed with a reference biological product from a non-Singapore registered manufacturing source, the manufacturer needs to demonstrate that the reference biological product (“RBP”) is comparable to the Singapore reference biological product (“SRBP”) and hence suitable to support the application for marketing authorisation of a biosimilar product by providing an additional bridging study. The type of bridging data needed will typically include data from analytical studies (e.g. structural and functional data) that compare all three products (the proposed biosimilar product, the SRBP and the RBP), and may also include clinical pharmacokinetics (“PK”) and/or pharmacodynamics (“PD”) bridging studies data for all three products. All comparisons should meet the target acceptance criteria for analytical and PK/PD similarity which will be determined on a case-by-case/product-type basis. A final determination regarding the adequacy of the scientific justification and bridging data will be made during the evaluation of the application.
7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?
The prices of therapeutic products (which include biological and biosimilar products) and medical devices are generally not regulated by the Singapore government. However, public sector hospitals in Singapore generally purchase medicinal products through centralised Group Procurement Offices by way of tender contracts, and this operates in some way to regulate the prices of therapeutic products and medical devices.
8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?
There is no specific reimbursement policy for biosimilar medicine or biologics drugs. However, the Ministry of Health provides subsidies for drugs at its public hospitals, specialist outpatient clinics and polyclinics. Patients receive drug subsidies and assistance based on their subsidy and means-test status, and the scheme under which the drug is covered. Various schemes cover different drugs and their active ingredients, including the Standard Drug List (SDL) and the Medication Assistance Fund (MAF).
Further, the national healthcare system in Singapore is funded by a mixed financing system that provides multiple tiers of financing for its citizens’ healthcare expenditure. The four tiers of healthcare funding are direct subsidies from the government, Medisave, Medishield Life and Medifund.
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.
9. Does biosimilar competition impact the reimbursement policy of the originator reference products?
The subsidy scheme in Singapore is based on the active ingredient of the drug. If the active ingredients are those listed in the register under the Ministry of Health, the drug is available for a subsidy regardless of whether it is a biosimilar or the original reference product.
10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?
The Health Products (Therapeutic Products) Regulations 2016 (Cap. 122D) (“TPR”) deals with the prescribing and dispensing of therapeutic products, including biosimilars and biologics. There is no difference between the requirements for the two types of drugs.
Prescription
Section 12(a) of the TPR requires a person to be a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner to administer prescription-only medicine. Exceptions under section 12(b) of the TPR are listed in the first column of the Third Schedule, which includes persons requiring prescription-only medicines in order to comply with any requirements made by written law with respect to the medical treatment of their employees.
Dispensation
Section 11 of the TPR prevents a person from supplying prescription-only medicine by retail sale unless the supply is made at or from a licensed healthcare institution supplying the prescription‑only medicine to a patient of that healthcare institution, and in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner practising in that healthcare institution. The person supplying the medicine must be a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner, and the supply must be made to a patient under the care of the qualified practitioner or collaborative prescribing practitioner.
Section 2 of the TPR defines a licensed healthcare institution as a healthcare institution that is licensed under the Private Hospitals and Medical Clinics Act (Cap. 248) of Singapore.
A retail pharmacy must obtain a license from the Health Sciences Authority before they can retail therapeutic products classified as prescription-only medicines or pharmacy-only medicines, as prescribed by the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (Cap. 122D).
11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?
As at the date hereof, there is no such publicly available information.
12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?
Pharmacovigilance
At the time of market approval for a medicinal product, information on the safety of the product is relatively limited, and there are some potential risks which may not have been identified. For biosimilar products, there is also the concern on potential immunogenicity issues. Therefore, post-market monitoring of clinical safety for biosimilar products is necessary as with all medicinal products, with focus on the specific concerns for biosimilar products.
Risk Management Plans (RMP)
RMP documents in support of NDA-1 original biologic product applications and all biosimilar product applications should be provided as part of the application dossier at the point of application submission, and not as part of the post-authorisation measure.
The RMP documents should include the following:
- Singapore-Specific Annex (SSA);
- Latest version of the approved EU-RMP and/or US REMS (where available); and
- Proposed local RMP materials (e.g. draft educational materials, if any).
If the original biologics drug is going through an NDA-2 application, RMP documents may be requested by the HSA on a case-by-case basis, but need not be part of the application dossier. The request for RMPs may be in response to a new safety concern arising from a new route of administration.
Post Approval Studies
Biosimilar products are subjected to a risk-based post-approval batch release programme. The product licence holder would be required to submit batch quality documents prior to import and sale of each batch of biosimilar product for evaluation. The batch release documents are to include the manufacturer’s batch release data and certificate of analysis. The licence holder is also required to update HSA on the stability data of the batch of product selected each year to be part of the stability study program for the drug product. HSA may choose to request additional documents or to carry out independent batch testing of selected batches, if deemed necessary.
Other Post-authorisation Measures
The current post-market vigilance systems for detecting safety issues relating to RBPs are applicable to biosimilars. These may include:
- Reporting of serious adverse events associated with biosimilars to HSA by product registrants or healthcare professionals;
- Timely update by product registrants on significant safety issues and safety-related regulatory actions taken by overseas agencies;
- Submission of benefit-risk evaluation reports relating to the biosimilar by product registrants (when required);
- Conduct of post-marketing safety studies by product registrants (when required).
Risk minimisation activities to mitigate the risks known to be associated with RBPs will generally be adopted for biosimilars. These may include:
- Warnings and precautions in package inserts (e.g. warning statement on the risks associated with switching of products during treatment);
- Provision of educational materials for physicians and/or patients (when required).
13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?
Section 14(7) of the Patents Act provides that where an invention consists of a substance for use in a method of treatment of the human body by therapy, the fact that the substance forms part of the state of the art does not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.
Since the Patents Act governs second medical use patents, the new biosimilar medicines, when labelling, must not infringe the patent rights of the originator company and their drug.
14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)
As at the date hereof, there is no such publicly available information.
15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?
As at the date hereof, there is no such publicly available information.
Also from this Legal Handbook
2. Orphan Drugs & Rare Diseases: Singapore
The ins and outs of orphan drugs & rare diseases in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.
1. What is the definition of Rare Diseases in your country?
As at the date hereof, there is no legal definition of rare diseases in Singapore.
In a press release dated 2 July 2019, the Ministry of Health of Singapore (“MOH”) defined a rare disease as a condition that affects fewer than 1 in 2,000 people.
2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)
As at the date hereof, there is no publicly available designation of “orphan drug” in Singapore.
3. What is the regulatory framework for the authorisation of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)
Prior to 1 November 2016, orphan drugs were regulated under the Medicines Act (Chapter 176) of Singapore. Specifically, the regulations relating to orphan drugs were contained in the Medicines (Orphan Drugs) (Exemption) Order (“Orphan Drugs Order”).
However, as part of the Health Sciences Authority of Singapore’s (“HSA”) efforts to consolidate the existing regulatory controls under a single legislation, namely, the Health Products Act (CHP of Singapore) (“HPA”), the Orphan Drugs Order was repealed.
The HPA does not contain any specific reference in relation to orphan drugs or rare diseases. However, the HPA would govern orphan drugs in the same manner in which other therapeutic products are governed under the HPA.
4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?
As at the date hereof, there are no publicly available provisions for relaxed clinical trial / scientific evidence requirements in respect of orphan drugs as compared to other drugs in Singapore.
5. Is there an expedited pathway for Orphan Drugs?
As at the date hereof, there is no publicly available information relating to expedited pathways for orphan drugs, if any.
However, in general, there are four types of evaluation routes for registering a new therapeutic product, namely (i) the full route, (ii) the abridged route, (iii) the verification route and (iv) the verification-CECA route. The full route has the longest turnaround time, followed by the abridged route and the verification route.
The full route applies to any new product that has not been approved by any drug regulatory agency. The abridged route applies to any new or generic product that has been evaluated by at least one drug regulatory agency. The verification route applies to a new or generic product that has been evaluated and approved by one of the HSA’s reference drug regulation agencies. The verification-CECA route applies to any new or generic product manufactured in India that has been evaluated and approved by one of the HSA’s reference drug regulation agencies.
HSA’s reference drug regulatory agencies include Australia’s Therapeutics Goods Administration, the European Medicines Agency, Health Canada, the UK Medicines and Healthcare Products Regulatory Agency and the USA Food and Drug Administration.
The Therapeutic Products Guidance provides that where a product has been designated as an Orphan Drug by at least one reference drug regulatory agency, or has been approved by at least one reference drug regulatory agency via an accelerated approval, approval under exceptional circumstances or equivalent approval process, the applicant should consult the HSA on the eligibility for the verification route. It thus appears that the HSA would determine whether the shorter verification route can be taken to register the Orphan Drug.
6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?
There are no specific foreign marketing organisations recognized in Singapore for orphan drugs.
7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?
No specific procedures. The market price of a medicinal product is not generally governed by law or regulation in Singapore. However, the MOH administers several drug subsidy schemes (the Standard Drug List (SDL), Medication Assistance Fund, inpatient drug subsidy, etc).
8. How are the prices of Orphan Drugs regulated?
As at the date hereof, there is no publicly available information on the regulation of Orphan Drug prices.
The MOH and SingHealth Fund have jointly established the Rare Disease Fund (“RDF”) in 2019. The RDF is a charity fund that combines community donations and government matching contribution to support Singapore citizens with specific rare diseases. This initiative aims to support patients whose treatment costs remain unaffordable even after government subsidies, insurance and financial assistance.
9. In case of reference price based on a basket of countries, what countries are included?
As at the date hereof, there is no such publicly available information.
10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?
As at the date hereof, there is no such publicly available information.
11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?
As at the date hereof, there is no such publicly available information.
Also from this Legal Handbook
3. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Singapore
Cannabinoid drugs, medicinal cannabis and opioid drugs in Singaporean Pharma – a legal guide. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
In general, Cannabinoid Drugs are not authorised in Singapore. The Misuse of Drugs Act (Chapter 185) of Singapore (“MDA”) prescribes that it shall be an offence to traffic, manufacture, import or export, or possess or consume a “controlled drug”.
The term “controlled drug” is defined in section 2 of the MDA as “any substance or product which is for the time being specified in Part I, II or III of the First Schedule or anything that contains any such substance or product”.
Part 1 of the First Schedule of the MDA specifies cannabis and cannabis resin, cannabinol and cannabinol derivatives as controlled drugs, among others. As regards each of these substances:
- The term “cannabis” is broadly defined as “any part of a plant of the genus Cannabis, or any part of such plant, by whatever name it is called” (section 2 of the MDA).
- The term “cannabis resin” is defined as “any substance containing resinous material and in which is found tetrahydrocannabinol and cannabinol in any quantity” (section 2 of the MDA).
- The term “cannabinol derivatives” refers to tetrahydro derivatives of cannabinol and their carboxylic acid derivatives, and 3-alkyl homologues of cannabinol or its tetrahydro derivatives (Part IV, First Schedule of the MDA).
Assuming that Cannabinoid Drugs contain cannabis, cannabis resin and/or cannabinol derivatives as defined under the MDA, such Cannabinoid Drugs will fall under the definition of a “controlled drug” under the MDA.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The MDA confers enforcement powers to the Central Narcotics Bureau of Singapore (“CNB”).
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
As at the date hereof, there is no specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs.
4. Which are the cannabinoid drugs that have received market approval to date?
As at the date hereof, there is no such publicly available information.
5. Who can prescribe Cannabinoid Drugs?
In general, it is an offence under the MDA to traffic in Cannabinoid Drugs. The MDA defines “traffic” as (a) to sell, give, administer, transport, send, deliver or distribute; or (b) offer to do anything mentioned in (a).
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
As at the date hereof, there is no such publicly available information.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
The Misuse of Drugs Regulations provides certain exemptions to the prohibitions set out in the MDA.
In general, the cannabinoid drug is subject to the same regulatory framework as all other therapeutic products in Singapore, i.e. the Health Products Act 2016 and the Health Products (Therapeutic Products) Regulations 2016 (Cap 122D). Companies are required to obtain a dealer’s licence before manufacturing, importing or supplying therapeutic products, and all therapeutic products must be registered with the HSA before they can be supplied in Singapore.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
As at the date hereof, there is no such publicly available information.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
As at the date hereof, there is no such publicly available information.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
In 2018, the National Research Foundation (NRF) announced the Synthetic Cannabinoid Biology Programme, which is part of a $25-million Synthetic Biology Research and Development (R&D) programme. The R& D program will span five years, and seeks to help boost Singapore’s research into synthetic biology. This refers to the science behind the production of natural products through engineering biological systems.
11. When are they likely to come into force?
As at the date hereof, there is no such publicly available information.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
The MDA prescribes that it shall be an offence to traffic, manufacture, import or export, or possess or consume a “controlled drug”.
Part 1 of the First Schedule of the MDA specifies cannabis as a controlled drug.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The MDA confers enforcement powers to the CNB.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
As at the date hereof, there is no specific regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
The production and import of Medical Cannabis is regulated under the MDA, which grants enforcement powers to the CNB.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
The Misuse of Drugs Regulations provides certain exemptions to the prohibitions set out in the MDA.
In general, the Medicinal Cannabis is subject to the same regulatory framework as all other therapeutic products in Singapore, i.e. the Health Products Act 2016 (“HPA”) and the Health Products (Therapeutic Products) Regulations 2016 (Cap 122D). Companies are required to obtain a dealer’s licence before manufacturing, importing or supplying therapeutic products, and all therapeutic products must be registered with the HSA before they can be supplied in Singapore.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
In general, it is an offence under the MDA to traffic in Medicinal Cannabis. The MDA defines “traffic” as (a) to sell, give, administer, transport, send, deliver or distribute; or (b) offer to do anything mentioned in (a).
18. How can patients obtain Medicinal Cannabis?
Please refer to the response to question 16 above.
19. Who can prescribe Medicinal Cannabis?
In general, it is an offence under the MDA to traffic in Medicinal Cannabis. The MDA defines “traffic” as (a) to sell, give, administer, transport, send, deliver or distribute; or (b) offer to do anything mentioned in (a).
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
As at the date hereof, there is no such publicly available information.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
Please refer to the response in question 16 above.
22. Where is Medicinal Cannabis available?
As at the date hereof, there is no such publicly available information.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
As at the date hereof, there is no such publicly available information.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
As at the date hereof, there is no such publicly available information.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
To the extent such Opioid Drugs fall within the definition of “health products” under the Health Products Act (Chapter 122D) of Singapore (the “HPA”), the HPA prescribes that it shall be an offence to supply any health product unless the health product is a registered under the HPA.
Certain Opioid Drugs may also fall within the definition of a “controlled drug” under the MDA. The MDA prescribes that it shall be an offence to traffic, manufacture, import or export, or possess or consume a “controlled drug”.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
Assuming that the Opioid Drugs fall within the definition of “health products” under the HPA, the Health Sciences Authority of Singapore (“HSA”) shall have jurisdiction over Opioid Drugs.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Assuming that the Opioid Drugs fall within the definition of “health products” under the HPA, the HPA regulates the authorisation of Opioid Drugs.
The prices of health products, (including therapeutic products) are generally not regulated by the Singapore government. However, public sector hospitals in Singapore generally purchase medicinal products through centralised Group Procurement Offices by way of tender contracts, and this operates in some way to regulate the prices of health products.
The national healthcare system in Singapore operates on mixed financing systems that provides multiple tiers of financing for its citizens and residents. Apart from direct subsidies for services and drugs at public healthcare institutions, the Singapore government also administers a number of drug subsidy schemes.
28. Which are the Opioid drugs that have received market approval to date?
The HSA maintains a register of health products registered under the HPA.
29. Who can prescribe Opioid Drugs?
The persons who can dispense drugs and sell medical devices to patients depends on the relevant classification of the drug or device.
Prescription-only medicines can only be supplied by a doctor or dentist, or by a pharmacist at a retail pharmacy according to a prescription by a doctor or a dentist, pharmacy-only medicines can be supplied by or under the supervision of a pharmacist without a prescription and general sales list medicines can be purchased from any retailer.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
As at the date hereof, there is no such publicly available information.
31. What approvals or notifications are required to prescribe Opioid Drugs?
Assuming that the Opioid Drugs fall within the definition of “health products” under the HPA, the HPA regulates the authorisation of Opioid Drugs.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Please refer to the response in question 29 above.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
As at the date hereof, there is no such publicly available information.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
As at the date hereof, there is no such publicly available information.
35. When are they likely to come into force?
Not applicable.
Also from this Legal Handbook
4. Regulatory Reform: Singapore
Upcoming regulatory reforms in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
PROPOSED HEALTHCARE SERVICES BILL
Currently, hospitals and private medical clinics are regulated under the Private Hospitals and Medical Clinics Act (PHMCA), which was first enacted in 1980. Since then, there have been significant changes to the healthcare landscape in Singapore. The Ministry of Health (MOH) has announced plans to replace the PHMCA with a new Healthcare Services Act (HCSA), which will see a move from the current premises-based licensing framework to a services-based licensing framework. The HCSA will have a wider regulatory scope than the PHMCA and will include healthcare services, allied health and nursing services, traditional medicine, and complementary and alternative medicine. Other key changes under the HCSA include:
- requiring that the governing body of a healthcare service possess the necessary competence and skills to carry out its role;
- strengthening the governance and oversight of healthcare services by enhancing the role and responsibilities of key personnel;
- introducing a new requirement for Service Review Committees for selected services or programmes that are deemed to be of higher risk, or greater complexity or public interest;
- making Service Ethics Committees mandatory for selected licensees, to ensure that patients are treated in an ethical manner before certain complex and high-risk medical treatment can be conducted;
- empowering the MOH to step in and assist in the operations of failing healthcare services where needed;
- requiring licensees to contribute to the National Electronic Health Record (NEHR), but providing patients with the option to opt-out if they do not wish to have their records accessed on, or uploaded to, the NEHR;
- enhancing the powers of the MOH to gather information for the purposes of patient safety, care and welfare, and public health interest;
- authorising the MOH to publish information concerning non-compliant licensees and unlicensed healthcare providers;
- prohibiting the provision of medical practices and services that have caused harm or may harm patients; and
- implementing measures to minimise public misperception, such as amending existing naming restrictions to allow for greater clarity as to the healthcare services provided.
PROPOSED AMENDMENTS TO THE MEDICAL REGISTRATION ACT
The Ministry of Health (MOH) and the Singapore Medical Council (SMC) have proposed amendments to the Medical Registration Act (Chapter 174) (MRA).
The MRA establishes the regulatory framework governing the practise of medicine and medical practitioners in Singapore. The last major amendments to the MRA were made in 2010.
The proposed amendments to the MRA are aimed at improving the disciplinary proceedings under the MRA for the public as well as medical practitioners, in particular, by: (i) increasing transparency and accountability in the disciplinary and appeals processes; (ii) bringing about better consistency for disciplinary proceedings under the MRA, and aligning them with those of criminal proceedings and other professional boards; and (iii) enhancing efficiency and certainty in respect of timelines.
2. When are they likely to come into force?
PROPOSED DRAFT HEALTHCARE SERVICES BILL
The MOH conducted a public consultation seeking feedback on the draft Healthcare Services Bill (Draft HCS Bill) between 5 January 2018 and 15 February 2018. At the time of this writing, the Draft HCS Bill has yet to be tabled in Parliament.
The MOH has indicated that the new Healthcare Services Act (HCSA), when enacted, will be implemented in three phases:
- Phase 1: medical and dental clinics, and clinical laboratories currently licensed under the PHMCA will be licensed under the HCSA.
- Phase 2: hospitals and nursing homes currently licensed under the PHMCA will be licensed under the HCSA.
- Phase 3: new services currently not licensed under the PHMCA (such as telemedicine services, mobile medical services, and sterile pharmaceutical services) will be licensed under the HCSA.
PROPOSED AMENDMENTS TO THE MEDICAL REGISTRATION ACT
The Ministry of Health and the Singapore Medical Council conducted a public consultation seeking comments on the proposed amendments to the Medical Registration Act (Chapter 174) between 28 September 2018 and 26 October 2018. At the time of this writing, there is no clear indication as to when the proposed amendments to the MRA are slated to come into force.
Also from this Legal Handbook
5. Patents and Trademarks: Singapore
What you need to know about patents and trademarks in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
The relevant applications must be filed with the Intellectual Property Office of Singapore (IPOS) in order to obtain protection for patents in Singapore.
It is not compulsory to register a trade mark in Singapore. An individual, firm or company, who owns a trade mark and uses it in connection with his goods or services, acquires common law rights in that mark by virtue of the use and reputation of the mark. For instance, the proprietor can rely on the tort of passing off at common law to protect his mark against unauthorised use. Trade mark registration can be obtained by filing the relevant applications with the IPOS. Registration of a trade mark under the Trade Marks Act grants the owner a statutory monopoly of the trade mark in Singapore.
2. What agencies or bodies regulate patents and trademarks?
The Intellectual Property Office of Singapore (IPOS) administers the patents and trade marks regime in Singapore.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
PATENTS
Generally, a patentable invention is one that is new (i.e., the invention does not form part of the state of the art), involves an inventive step (i.e., the invention is not obvious to a person skilled in the art), and is capable of industrial application (i.e., the invention can be made or used in any kind of industry, including agriculture).
However, certain types of inventions cannot be patented. For instance: (i) inventions which, if published or exploited, would generally be expected to encourage offensive, immoral or anti-social behaviour; and (ii) methods of treatment of the human or animal body by surgery, therapy or diagnosis practised on the human or animal body, on the basis that they are not regarded as capable of industrial application.
TRADEMARKS
In order to register a trade mark, it: (i) has to be a sign that is capable of graphical representation; (ii) must be distinctive; (iii) must not conflict with an earlier trade mark; and (iv) must be used in the course of trade, or there must be a bona fide intention that the mark should be so used.
However, certain signs cannot be registered as trademarks. For instance: (i) signs which are contrary to public policy or to morality; and (ii) signs which are of such a nature as to deceive the public (for instance as to the nature, quality or geographical origin of the goods or service).
4. How can patents and trademarks be revoked?
PATENTS
Section 80 of the Patents Act (Chapter 221) sets out an exhaustive list of grounds on which the Registrar of Patents may, on the application of any person, order a patent to be revoked:
- the invention is not patentable;
- the patent was granted to a person who was not entitled to be granted that patent;
- the patent specification does not disclose the invention clearly and completely for it to be performed by a person skilled in the art;
- the matter disclosed in the patent specification extends beyond that disclosed in the patent application;
- an amendment or correction has been made to the patent specification or application, and such amendment or correction should not have been allowed;
- the patent was obtained fraudulently, on any misrepresentation, or on any non-disclosure or inaccurate disclosure of prescribed material information; or
- the patent is one of two or more patents for the same invention which have the same priority date, and filed by the same party or the successor in title to that party.
TRADEMARKS
Pursuant to section 22 of the Trade Marks Act, the Registrar of Patents or the Singapore High Court may, on the application of any person, order the registration of a trade mark to be revoked on any of the following grounds:
- the mark has not been put to genuine use in the course of trade in Singapore within five years from the date of completion of the registration procedure, by the proprietor or with his consent, in relation to the goods or services for which it is registered, and there are no proper reasons for non-use;
- such use has been suspended for an uninterrupted period of five years, and there are no proper reasons for non-use;
- the mark has become the common name in the trade for the product or service for which it is registered, as a result of the proprietor’s acts or inactivity; or
- the mark is liable to mislead the public, in particular as to the nature, quality or geographical origin of those goods or services, as a result of the use made of it by the proprietor or with his consent in relation to the goods or services for which it is registered.
5. Are foreign patents and trademarks recognized and under what circumstances?
PATENTS
A person intending to register a patent in Singapore who has a corresponding application filed earlier in a Paris Convention country or a World Trade Organisation member country (other than Singapore) may claim priority over that patent from the first-filed application, if the Singapore application is filed within 12 months from the date of the first filing. There are limited circumstances under which an applicant may be able to apply to restore a declaration of priority of an earlier relevant application even though they had failed to file a subsequent patent application within 12 months from the date of the earlier application, e.g. where the failure to file within the 12-month period was unintentional, or occurred in spite of due care required by the circumstances having been taken.
TRADEMARKS
A person intending to register a trade mark in Singapore who has a corresponding application filed earlier in a Paris Convention country or a World Trade Organisation member country (other than Singapore) may claim priority from the first-filed application, if the Singapore application is filed within 6 months from the date of the first filing. When a priority is claimed, the filing date in Singapore dates back to the date of the first filing.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
THERAPEUTIC PRODUCTS
Where an applicant has provided to the HSA information relating to the safety or efficacy of a therapeutic product in support of an application for product registration, and the HSA has registered that therapeutic product, the HSA may not, for 5 years after the date of that earlier registration, register a similar therapeutic product on the application of another person on the basis of the earlier registration, unless the registrant of the earlier registration has so consented.
In respect of innovative therapeutic product applications, there is additional protection for confidential supporting information, subject to certain exceptions. An innovative therapeutic product application is an application to register a therapeutic product that refers to a substance that is an ingredient in the manufacture or preparation of the therapeutic product to which the application relates, and that has not, before that application is received by the HSA, been referred to as an ingredient in the manufacture or preparation of any other therapeutic product in any previous application.
MEDICAL DEVICES
There is no equivalent protection in respect of medical devices.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
See Question 3 above.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
It is not mandatory to record a trade mark or patent license with the IPOS, or for the terms of the license agreement to be approved or accepted by the IPOS.
There are, however, benefits to registering transactions, instruments or events affecting the rights in respect of patents or registered trademarks, such as licence agreements and assignment agreements, upon their execution. Where a dispute relating to such rights arises, the registration would serve as prima facie evidence of the parties’ rights. Further, the entry of a transaction, instrument or event in the IPOS’s register(s) affects the right of the proprietor or licensee to claim certain remedies for infringement.