Cannabinoid drugs, medicinal cannabis and opioid drugs in Czech Republic – a legal guide. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for USD 99.

CANNABINOID DRUGS

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoid Drugs, i.e. drugs containing active compounds of cannabis, such as tetrahydrocannabinol (THC) or cannabidiol (CBD), can be authorized in the Czech Republic under the general legal framework for authorization of drugs. Cannabinoid Drugs must be differentiated from Medicinal Cannabis (dried female flowers of the plant Cannabis sativa L. or Cannabis indica L.), which is subject to a specific legal framework.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The regulatory authorities with jurisdiction over all drugs, i.e. Cannabinoid Drugs as well as other drugs, are the State Institute for Drug Control and the Ministry of Health.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

No. Authorization, pricing and reimbursement of Cannabinoid Drugs are regulated by the same legislation as the authorization, pricing and reimbursement of other drugs (please refer to Answer No. 2 of Regulatory, Pricing, and Reimbursement Overview).

4. Which are the cannabinoid drugs that have received market approval to date?

The only drug containing cannabinoids which has been authorized in the Czech Republic so far is Sativex (registration No. 63/ 256/11-C, marketing authorization holder: GW Pharma (International) B.V., Netherlands, type of registration procedure: mutual recognition procedure). While Sativex has authorization, it hasn’t been available on the Czech market for some time.

Sativex contains THC and CBD; each 100 microliters of spray contains 2.7 milligrams of delta-9-tetrahydrocannabinolum (THC) and 2.5 milligrams of cannabidiolum (CBD). Sativex is used in the treatment of multiple sclerosis, specifically to treat symptoms related to muscular stiffness (spasticity). Sativex can be prescribed only after other drugs for muscular stiffness proved ineffective.

5. Who can prescribe Cannabinoid Drugs?

Drugs containing cannabinoids (such as Sativex) can be prescribed by any medical doctor authorized to provide healthcare services.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No. Cannabinoid Drugs can be prescribed by any doctor authorized to provide healthcare services.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Cannabinoid Drugs containing substances classified as narcotic substances (such as Sativex which contains THC) can only be prescribed using a specific type of prescription in paper form with a diagonal blue stripe or, under certain circumstances, within the electronic prescription system. The distribution, use and liquidation of paper prescriptions with a diagonal blue stripe are strictly regulated. Municipal offices are responsible for the distribution of prescriptions and for keeping records of such distribution.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Drug manufacturers, wholesalers and distributors wishing to sell/distribute authorized Cannabinoid Drugs must obtain the following authorizations: (i) authorization from the Ministry of Health for handling narcotic and psychotropic substances under the Narcotic Substances Act and (ii) authorization from the State Institute for Drug Control for manufacturing and/or distributing drugs under the Act on Drugs.

As regards selling Cannabinoid Drugs to the public, the only organizations authorized to do so are pharmacies, upon a prescription issued by a medical doctor. For details regarding prescriptions, please refer to Answer No. 7 above.

9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?

A database of pharmacies is available at the website of the State Institute for Drug Control under the following link: http://www.sukl.eu/modules/apotheke/index.php?rewrite=modules%2Fapo theke&lang=2

Any pharmacy in the database is authorized to sell (dispense) Cannabinoid Drugs upon presentation of a prescription with a blue stripe issued by a medical doctor. Pharmacies do not need any special permission to sell Cannabinoid Drugs since they are exempt from the requirement to hold an authorization for handling narcotic and psychotropic substances issued by the Ministry of Health under the Narcotic Substances Act.

A database of distributors is available at the website of the State Institute for Drug Control under the following link: http://www.sukl.eu/modules/distributors/index.php?lang=2

In this database, there is no information about whether the distributor is authorized to distribute Cannabinoid Drugs, i.e. whether it holds an authorization for handling narcotic and psychotropic substances issued by the Ministry of Health under the Narcotic Substances Act. Moreover, the only Cannabinoid Drug authorized in the Czech Republic, Sativex, has not been available on the Czech market for some time.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

No, there is no proposal for reform of the regulation of Cannabinoid Drugs.

11. When are they likely to come into force?

Not applicable.

MEDICINAL CANNABIS

12. Is Medicinal Cannabis authorized in the country?

Yes, Medicinal Cannabis has been authorized in the Czech Republic since 2013; however, in practice Medicinal Cannabis has only been available to patients since 2015.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Medicinal Cannabis falls under the jurisdiction of the State Agency for Medical Cannabis (whose tasks are performed by the State Institute for Drug Control) and of the Ministry of Health.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Medicinal Cannabis is defined as dried female flowers of the plant Cannabis sativa L. or Cannabis indica L. whose levels of THC (tetrahydrocannabinol) and CBD (cannabidiol) fall within 0.3 percent to 21.0 percent for THC and from 0.1 percent to 19.0 percent for CBD. Medicinal Cannabis can only be prescribed by doctors with the appropriate specialization and only for the health indications listed in the Cannabis Regulation (Regulation No. 236/2015 Coll.).

The State Agency for Medical Cannabis organizes public tenders to select a supplier from whom it will purchase Medicinal Cannabis for the Czech market. The tender participants submit their price offers in the tender. The supplier selected in the public tender concludes a framework agreement with the State Agency for Medical Cannabis. The State Agency for Medical Cannabis purchases Medicinal Cannabis from the successful participant and resells it to pharmacies on a not-for-profit basis. The current price for Medicinal Cannabis in pharmacies is approx. CZK 180 per gram (EUR 7 per gram).

Generally, public health insurance does not cover prescriptions of Medicinal Cannabis. The law provides for an exceptional reimbursement in special situations, where the medicinal product in question is the only suitable treatment for the patient with respect to the patient’s condition. So far, there has only been one case where, after a court action, reimbursement of Medical Cannabis was provided by the General Health Insurance Company (the largest, state-owned insurer) to the patient, who suffered from multiple sclerosis.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Production and import of Medicinal Cannabis are primarily regulated by the Narcotic Substances Act and the Act on Drugs and their implementing regulations, the most relevant of them being the Cannabis Regulation (Regulation No. 236/2015 Coll.). The authorities responsible for regulation of the import and production of Medicinal Cannabis are the Ministry of Health (its Inspectorate of Narcotic Drugs and Psychotropic Substances), and the State Agency for Medical Cannabis, whose tasks are carried out by the State Institute for Drug Control. Certain powers related to the import of Medicinal Cannabis are vested in the Customs Administration.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Suppliers intending to supply Medicinal Cannabis to the Czech Market must take part in a public tender organized by the State Agency for Medical Cannabis. If successful in the public tender, the suppliers intending to grow Medicinal Cannabis in the Czech Republic are required to obtain (i) a license for growing Medicinal Cannabis issued by the State Agency for Medical Cannabis and (ii) an authorization for handling narcotic and psychotropic substances issued by the Ministry of Health under the Narcotic Substances Act. Medicinal Cannabis can only be grown in indoor and secured premises. All produced Medicinal Cannabis must be sold to the State Agency for Medical Cannabis.

Suppliers intending to import Medicinal Cannabis from abroad are required to obtain (i) authorization to distribute medicinal products, extended by the distribution of medicinal and auxiliary substances to persons authorized to prepare medicinal products, issued by the State Institute for Drug Control under the Act on Drugs and (ii) authorization for handling narcotic and psychotropic substances as well as authorization to import each respective supply of Medicinal Cannabis, both issued by the Ministry of Health under the Narcotic Substances Act.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Advertising Medicinal Cannabis is subject to general advertising restrictions as set out by the Act on Advertising. For further information thereon please refer to Answer No. 17 of Marketing, Manufacturing, Packaging & Labeling, Advertising. In addition, advertising Medicinal Cannabis to the general public is prohibited. Advertisements of Medicinal Cannabis targeting experts (i.e. doctors and pharmacists) may only be distributed through communication channels designated for these experts; the information contained in it must be precise, current and verifiable.

Medicinal Cannabis can only be sold to patients by pharmacies as an individually prepared medicinal product. Pharmacies purchase Medicinal Cannabis from the State Agency for Medical Cannabis. Suppliers of Medicinal Cannabis to the State Agency for Medical Cannabis are selected in a public tender.

18. How can patients obtain Medicinal Cannabis?

Medicinal Cannabis can be obtained by patients as an individually prepared medicinal product for medicinal use upon a doctor’s prescription in the maximum quantity of 180 grams per month and only by patients who are at least 18 years old. Medicinal Cannabis can only be prescribed by doctors authorized to provide healthcare services with the appropriate specialization and only for the health indications listed in the Cannabis Regulation. For example, specialists in neurology and geriatrics are allowed to prescribe Medicinal Cannabis for a wide range of health conditions, including spasticity and pain associated with multiple sclerosis.

Medicinal Cannabis can only be prescribed through an electronic prescription system for individually prepared medicinal products containing cannabis for medicinal use that is linked to the Central Database of Electronic Prescriptions and ensures compliance with restrictions on the prescription of Medicinal Cannabis. The electronic prescription system is operated by the State Institute for Drug Control.

The electronic prescription for Medicinal Cannabis must include the following information: type of the Medicinal Cannabis, the amount of THC and CBD (indicated as a percentage), the dosage and route of administration of the medicinal product, and the amount of the product, not exceeding the monthly maximum of 180 grams. Based on such prescription, Medicinal Cannabis is dispensed in pharmacies that have concluded a framework agreement with the State Agency for Medical Cannabis.

19. Who can prescribe Medicinal Cannabis?

Medicinal Cannabis can only be prescribed by a specialist doctor with expertise in a field listed in the Cannabis Regulation, for example a neurologist, oncologist or psychiatrist.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

A list of doctors authorized to prescribe Medicinal Cannabis is available at the website of the State Agency for Medical Cannabis: http://www.sakl.cz/en/patients/list-of-prescribing-medical-doctors

However, as the doctor must give her/his consent to be included in the list, the list does not necessarily include all the doctors authorized to prescribe Medicinal Cannabis.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

In order to prescribe Medicinal Cannabis the specialist doctor must obtain access to the Central Database of Electronic Prescriptions and to the electronic system for the prescription of individually prepared medicinal products containing cannabis for medicinal use. Furthermore, Medicinal Cannabis can only be prescribed by doctors authorized to provide healthcare services within the appropriate specialization and only for the health indications listed in the Cannabis Regulation.

22. Where is Medicinal Cannabis available?

Medicinal Cannabis is available through pharmacies that have concluded a framework agreement with the State Institute for Drug Control.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

The list of pharmacies authorized to sell Medicinal Cannabis can be found on the State Institute for Drug Control’s website: http://www.sakl.cz/en/patients/list-of-pharmacies (in Czech only).

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

A bill introducing insurance coverage of Medicinal Cannabis is currently under debate in Parliament. According to the bill, insurance would cover 90 percent of the price of up to 30 grams of Medicinal Cannabis per month. If approved by the insurance company’s doctor, this could be increased to 180 grams per month (i.e. the total quantity limit). The bill also introduces a new duty on doctors prescribing Medicinal Cannabis. Doctors would be required to inform the regulator about the method and results of treatment for each patient being prescribed Medicinal Cannabis.

A proposal to legalize cultivation and use of small amounts of cannabis for medicinal and recreational purposes was introduced in the Parliament by the Pirate Party in 2018. The proposal suggests that an adult could possess up to 1.25 kilograms of dried cannabis at home and carry up to 30 grams in public. It was also proposed that an individual could grow up to 5 plants of cannabis at home. The proposal has been rejected by the government; however, it is likely that the initiative to legalize cannabis for recreational use or at least home cultivation for medical purposes will continue.

OPIOID DRUGS

25. Are Opioid Drugs authorized in your country?

Yes, Opioid Drugs are authorized in the Czech Republic under the general legal framework for authorization of drugs.

26. Yes, Opioid Drugs are authorized in the Czech Republic under the general legal framework for authorization of drugs.

The regulatory authorities overseeing drugs, including Opioid Drugs, are the Ministry of Health and the State Institute for Drug Control.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

No. Authorization, pricing and reimbursement of Opioid Drugs are regulated by the same legislation as the authorization, pricing and reimbursement of other drugs (please refer to Answer No. 2 of Regulatory, Pricing, and Reimbursement Overview).

28. Which are the Opioid drugs that have received market approval to date?

According to the State Institute for Drug Control’s drug database there is a number of drugs containing opioids that have received market approval and are available with a doctor’s prescription. For example: Morphine (Morphine Kalceks), Oxycodone (Dolocodon, Dyxal, Oxycontin), Hydromorphone (Palladone-SR), Fentanyl (Adolor), etc.

29. Who can prescribe Opioid Drugs?

Any medical doctor authorized to provide healthcare services can prescribe Opioid Drugs.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

Since any medical doctor authorized to provide healthcare services can prescribe Opioid Drugs, there is no special list; however, there are general online tools / websites for searching medical doctors.

31. What approvals or notifications are required to prescribe Opioid Drugs?

Opioid Drugs can be prescribed by a medical doctor authorized to provide healthcare services, either with a regular prescription or on a prescription with a blue stripe, depending on the type of the opioid substance contained in the prescribed medicinal product. Distribution, use and liquidation of prescriptions with a blue stripe are strictly regulated. Municipal offices are responsible for distribution of the prescriptions and for keeping records of such distribution.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Drug wholesalers and distributors wishing to sell/distribute authorized Opioid Drugs must obtain the following authorizations: (i) authorization from the Ministry of Health for handling narcotic and psychotropic substances under the Narcotic Substances Act and (ii) authorization from the State Institute for Drug Control for distribution of drugs under the Act on Drugs.

Drugs containing opioids are dispensed in pharmacies upon doctor’s prescription (either upon regular prescription or upon a prescription with a blue stripe). Any pharmacy may dispense Opioid Drugs, they do not need any special permission to handle opioids since they are exempt from the requirement for an authorization from the Ministry of Health for handling narcotic and psychotropic substances under the Narcotic Substances Act.

33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?

There is no special list of pharmacies/distributors that sell Opioid Drugs. However, the State Institute for Drug Control provides a general search tool of all pharmacies in the Czech Republic on its website: http://www.sukl.eu/modules/apotheke/search.php?lang=2

The State Institute for Drug Control provides a similar general search tool of distributors: http://www.sukl.cz/modules/distributors/

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There are currently no proposals for reform or change to the regulations of Opioid Drugs.

35. When are they likely to come into force?

Not applicable.