Legal & Regulatory > Czech Republic > Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

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 GBP 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., the Netherlands, type of registration procedure: mutual recognition procedure).

Sativex contains THC and CBD; each 100 microliters of spray contains 2.7 milligrams of tetrahydrocannabinol (THC) and 2.5 milligrams of cannabidiol (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; although a specific type of prescription is required.

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

No, there is no such list.

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 of this Chapter.

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%2Fapotheke&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.

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

There are no proposals for any significant reform of the regulation of Cannabinoid Drugs. However, there are, for example, proposals to allow the use of the Czech electronic prescription system (eRecept) for the prescription of narcotic drugs and proposals to allow for multiple local growers of locally produced Medicinal Cannabis (please see also response to question No. 12).

11. When are they likely to come into force?

Unclear at present.

MEDICINAL CANNABIS

12. Is Medicinal Cannabis authorized in the country?

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

Both locally produced and imported Medicinal Cannabis are available in the Czech Republic; however, local production is currently limited to a single grower, which is selected through a public tender. A change in legislation to allow for multiple local growers is under consideration.

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

Medicinal Cannabis falls under the jurisdiction of the State Agency for Medi-cal Cannabis (SAKL) and the Ministry of Health.

Technically, the SAKL is only a subdivision of the State Institute for Drug Control, as one of the tasks of the State Institute for Drug Control is to serve as an agency pursuant to the Single Convention on Narcotic Drugs (1961).

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) fall within 0.3 percent to 25.0 percent and whose levels of CBD (cannabidiol) do not exceed 23.0 percent. 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.). This applies to both locally produced and imported Medicinal Cannabis.

Concerning local production, currently, the State Institute for Drug Control 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 their bid. The successful tender participant concludes a framework agreement with the State Institute for Drug Control. The State Institute for Drug Control subsequently purchases the Medicinal Cannabis from the successful participant and resells it to pharmacies on a not-for-profit basis. Currently, the locally produced Medicinal Cannabis is sold to pharmacies at approx. CZK 165 per gram (EUR 6.5 per gram) incl. VAT. In the case of imported Medicinal Cannabis the price is determined contractually and varies accordingly.

On 1 January 2020 Medicinal Cannabis finally became reimbursable. The public health insurance currently covers 90% of the price of up to 30 grams of Medicinal Cannabis per month per patient. If approved by the insurance company doctor, this amount can be increased to 180 grams per month per patient.

To be precise, reimbursement covers 90% of the price of an individually prepared medicinal product (IPMP), i.e. a medicinal product which is individually prepared for a patient by a pharmacy based on a doctor’s prescription. The maximum possible price of all IPMPs (whether reimbursed or not) is set in a price regulation of the Ministry of Health. The maximum price varies based on the amounts of Medicinal Cannabis used and the size of the packaging, but in general it is calculated with a price similar to the price of the locally produced Medicinal Cannabis and the materials and pharmacy work used. Given that currently, the price of imported Medicinal Cannabis is well below the maximum price, the regulation does not represent any barrier for imported Medicinal Cannabis.

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?

Local production of Medicinal Cannabis in the Czech Republic is considerably limited. Suppliers intending to produce Medicinal Cannabis in the Czech Republic must take part in a public tender organized by the State Institute for Drug Control, which currently selects only a single winner. If successful in the public tender, the winner must then obtain (i) a cultivation license issued by the State Institute for Drug Control 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 Institute for Drug Control. A change of legislation aiming to relax the limited local production is under consideration.

On the other hand, import of Medicinal Cannabis to the Czech Republic is more flexible. Suppliers intending to import Medicinal Cannabis from abroad are required to obtain (i) an authorization to distribute medicinal products with an extended scope encompassing distribution to persons authorized to prepare medicinal products (i.e. pharmacies), issued by the State Institute for Drug Control under the Act on Drugs and, (ii) an authorization for handling narcotic and psychotropic substances issued by the Ministry of Health under the Narcotic Substances Act. On top of that, the importer has to secure individual import licenses for each individual supply of Medicinal Cannabis, which are also issued by the Ministry of Health. The import licenses are under the discretion of the Ministry of Health, which has no obligation to issue an individual import license, even if all statutory requirements are met.

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 Chapter: 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 be distributed by any legal entity or individual carrying out business who meets the statutory criteria. In particular such person must obtain an authorization to distribute medicinal products with an extended scope encompassing distribution to persons authorized to prepare medicinal products, i.e. pharmacies. Medicinal Cannabis can then be sold to patients only by pharmacies as an individually prepared medicinal product.

18. How can patients obtain Medicinal Cannabis?

Medicinal Cannabis can be obtained by patients as an individually prepared medicinal product (IPMP) 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 through an electronic prescription system (eRecept) operated by the State Institute for Drug Control. The electronic prescription system includes a Register of Restricted Medicinal Products. One of the purposes of the register is to provide the prescribing doctor and dispensing pharmacist with a tool to check and ensure the compliance with the relevant statutory criteria with respect to a specific patient.

The electronic prescription for Medicinal Cannabis must, in particular, include a specific code. The code is used to divide the Medicinal Cannabis into individual groups based on its species (indica or sativa) and its THC and CBD content (percentage-based) and can be found in Annex 1 to the Cannabis Decree. Furthermore, the prescription must include the dosage and route of administration of the medicinal product.

19. Who can prescribe Medicinal Cannabis?

Only doctors with a specific specialization may prescribe Medicinal Cannabis, and only for specific health indications according to the doctor’s specialization. Both the allowed specializations and corresponding health indications are listed in Annex 3 of the Cannabis Regulation.

For example, doctor specializations include clinical and radiation oncology, rheumatology, neurology, psychiatry, etc. and Medicinal Cannabis can be used as an auxiliary treatment to alleviate symptoms accompanying such indications as chronic constant pain, spasticity and related pain from multiple sclerosis, nausea or vomiting in association with cancer or HIV treatment, Tourette syndrome and surface treatment of dermatoses and mucosal lesions.

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, the doctor must give her/his consent to be included in the list; therefore, the list does not necessarily include all 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 apply to the State Institute for Drug Control for authorization to prescribe. The application is filed via a simple electronic form and merely the doctor’s specialization is verified without the need to provide any documentation. Based on the application, the doctor is granted an access to the Register of Restricted Medicinal Products and may start prescribing Medicinal Cannabis.

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 Annex 3 of the Cannabis Regulation.

22. Where is Medicinal Cannabis available?

Due to statutory limitations, locally produced Medicinal Cannabis is only available through pharmacies that have concluded a framework agreement with the State Institute for Drug Control. On the other hand, pharmacies are free to purchase imported Medicinal Cannabis from a distributor of their choice.

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

The list of pharmacies authorized to sell locally produced Medicinal Cannabis can be found on the State Institute for Drug Control’s website available through: http://www.sakl.cz/en/patients/list-of-pharmacies (in Czech only). Any pharmacy authorized to dispense restricted medicinal products may dispense imported Medicinal Cannabis.

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

The current regulation only allows for the existence of a single local producer of Medicinal Cannabis selected through a public tender. This system has been heavily criticized for causing supply outages of locally produced Medicinal Cannabis. Furthermore, practice has shown that the system leads to the price of locally produced Medicinal Cannabis being relatively high (in particular due to lack of flexibility in the tenders, which are for five-year periods) while also generating excess costs for the state.

Another issue of the current regulation is that Medicinal Cannabis cannot be legally exported from the Czech Republic. This includes both the locally produced and imported Medicinal Cannabis. Apart from obvious effects on price, this also forces importers to import only as much Medicinal Cannabis that they can be certain to sell in the Czech Republic.

Since the Czech government recognizes both issues (it even declared the current system to be unsustainable), it introduced an amendment to the relevant regulation. If passed, it would make possible to export Medicinal Cannabis and introduce a broader license-based system for local production.

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. What are the regulatory authorities with jurisdiction over Opioid 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 Chapter: 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 are a number of drugs containing opioids that have received market approval and are available with a doctor’s prescription. For example: Morphine (Sevredol, Morphine Kalceks), Oxycodone (Oxycontin), Hydromorphone (Palladone SR), Fentanyl (Adolor, Breakyl), etc.

29. Who can prescribe Opioid Drugs?

Any medical doctor authorized to provide healthcare services can prescribe Opioid Drugs; although a specific type of prescription may be required.

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

No, there is no such list.

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 a 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.