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:

1. 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).
2. 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).
3. 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.