Legal & Regulatory > Germany > Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Want to know more about cannabinoid drugs, medicinal cannabis and opioid drugs in Germany? Read on! Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

There is no uniform answer to this question.

In Germany, some Cannabinoid Drugs are subject to restrictions under the Narcotic Drugs Act (“BtMG”) or the New Psychoactive Substances Act (“NpSG”).

Tetrahydrocannabinol, for example, is classified in Germany as a marketable but non-prescription narcotic drug; Annex II to the Narcotic Drugs Act. On the other hand, Tetrahydrocannabinol (Dronabinol) used for medical purposes is marketable and a prescription drug under Annex III to the Narcotic Drugs Act. In turn, isomers of Tetrahydrocannabinol such as delta6a(10a)-THC are not marketable according to Annex I to the Narcotic Drugs Act.

Nabilone is marketable and a prescription drug in accordance with Annex III to the Narcotic Drugs Act.

On the other hand, products used as medicinal products and containing cannabidiol and having a THC content of less than 0.2% are classified as prescription drugs in Germany; Ordinance on the Prescription of Medicinal Products (“AMVV”), Annex 1 (to section 1(1) and section 5) Substances and preparations pursuant to section 1(1) intended for medical purposes. In addition, cannabidiol was granted the orphan drug status by the EU for the treatment of special forms of epilepsy; cf. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. In Germany, medicinal products may in general only be placed on the market if previously authorized or registered as such or if they have an appropriate authorization from the European Commission in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

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

Pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, the European Medicines Agency (“EMA”) is the competent body for the marketing authorization of medicinal products in the European Union and the EEA States on the basis of a centralized procedure. Orphan drugs, therefore, require mandatory authorization by the EMA in the centralized procedure.

In addition, solely national authorization in only one EU Member State is generally feasible unless – as is the case with orphan drugs – EMA’s exclusive competence is stipulated for. Moreover, national applications for authorization of the same product in more than one EU Member State are not admissible. In Germany, the Federal Institute for Drugs and Medical Devices (“BfArM”) is responsible for the approval of “normal” drugs. BfArM also performs the tasks of the Federal Opium Agency. The agency’s major tasks are the following:

• granting general licenses to trade in narcotic drugs, psychotropic substances and precursors,
• supervising the trade in narcotic drugs, psychotropic substances and precursors among license holders (manufacturers, traders, importers, exporters, cultivators and scientific institutions) by checking the reports submitted under Section 18 Narcotic Drugs Act and Article 9 of Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 and Article 10 of Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors as well as inspecting manufacturing sites, trading enterprises, and storage facilities,
• issuing import and export authorizations for narcotic drugs and psychotropic substances
• granting import and export authorizations for precursors
• preparing and distributing special prescription forms for narcotic drugs.

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

There is no specific legal framework for and limited to Cannabinoid Drugs.

If Sativex® or Canemes® are prescribed in Germany within the approved indication areas (“in label”), the health insurance is obliged to cover the costs. If the physician prescribes one of the preparations in an indication that is not covered by the existing authorization (“off label”), however, patients must have their health insurance individually confirm in advance that the costs will be borne by the health insurance.

The situation is different for Dronabinol and Cannabidiol, however, which must also be prescribed by a physician, but the fact that these may or must be prescribed does not constitute a fundamental obligation for health insurance to bear the costs of the preparations. In these cases, separate declaration of coverage of the related costs by the health insurance is always required. It is thus at the discretion of the health insurance whether or not these costs will be covered. They may be obligated to bear the costs, however, if the patient suffers from a life-threatening or regularly fatal illness, if no other generally recognized treatment in accordance with the standard of care is available, and if there is a not entirely remote prospect of a cure or a noticeable positive effect on the course of the illness; cf. Federal Constitutional Court, December 6, 2005 – 1 BvR 347/98, NJW 2006, 891.

In order for Dronabinol or Cannabidiol to be included as a standard therapeutic agent in the health insurance’ catalogue of services, a recommendation of the Joint Federal Committee is required pursuant to Section 135 Social Code Book Five – Statutory Health Insurance, at the request of the Federal Association of Statutory Health Insurance Physicians, a Statutory Health Insurance Physicians’ Association, or of a Central Association of Statutory Health Insurances. To the best of our knowledge, neither Dronabinol nor Cannabidiol are currently the subject of any such request or recommendation.

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

As narcotic drugs, Dronabinol and Nabilone are marketable and classified as prescription drugs in Germany. Cannabidiol is available as a prescription drug in Germany.

Sativex® Spray (Nabiximols: THC and CBD from Cannabis sativa extract) and Canemes® Capsules (Nabilone) have received market approval as proprietary medicinal products. Epidiolex® (Cannabidiol) has been submitted for market authorization. Pharmacies may also apply to BfArM for permission to import Marinol® (Dronabinol) or contact one of the importers who already hold an import license for this product.

5. Who can prescribe Cannabinoid Drugs?

Generally, licensed physicians of any specialty; for Dronabinol, this applies with the exception of dentists and veterinarians; cf. sections 2 et seqq. Ordinance on the Prescription, Dispensing, and Verification of Dispensing of Narcotic Drugs (Narcotic Drugs Prescription Ordinance – “BtMVV”).

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

A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.

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

In cases of sufficient medical indication, there are no specific restrictions.

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

Sale is only possible through drug wholesalers and pharmacies.

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

The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.

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

No.

11. When are they likely to come into force?

Not applicable.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medicinal Cannabis is authorized in Germany.

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

In Germany, a government agency, the Cannabis Agency, has been established at the Federal Institute for Drugs and Medical Devices, which controls and monitors the cultivation of Medicinal Cannabis in Germany.

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

The quantities of Medicinal Cannabis that may be prescribed are governed by law. In accordance with section 2(1) Narcotic Drugs Prescription Ordinance, physicians must comply with the stipulated maximum quantities: within 30 days, they may prescribe up to 100,000 milligrams of Cannabis in the form of dried flowers or alternatively up to 1,000 milligrams of Cannabis extract (based on delta 9 THC content) per patient. Exceptions are possible in justified individual cases, if a patient is under permanent treatment and the necessary safety of narcotics trading is observed and maintained. The law does not govern the maximum active substance content in this respect, however.

Prior to starting a Cannabis therapy, the health insurance must approve the coverage of the related costs. In these cases, the health insurance usually consults the Medical Service of the Health Insurance Funds to obtain a professional assessment of the indication. A decision must be made within three weeks, and if an assessment is made by the Medical Service of the Health Insurance Funds, within five weeks. Health insurance may only reject an application in exceptional cases. If Cannabis therapy is to be carried out as part of specialized outpatient palliative care, the approval period is only three days.

Any therapy with Medicinal Cannabis must be documented for an accompanying study, which serves scientific purposes only. The physician transmits anonymized treatment data to BfArM. Without participation in the accompanying study, the costs will not be covered by the respective health insurance. The accompanying survey is intended to run until 2022.

Dried Cannabis flowers are about EUR 22.00 per gram. Costs of a therapy with Medicinal Cannabis are therefore in a range between EUR 300.00 and EUR 2,200.00 per month.

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

In the future, Cannabis will be grown in Germany exclusively for medical purposes. Cannabis is therefore a medicinal product. Consequently, only Cannabis grown in accordance with the Good Agricultural and Collection Practice (GACP) which specifically meets the requirements of the “Cannabis Flowers” monograph and also meets the requirements of the other relevant monographs and guidelines may be used. This is intended to ensure the availability of Cannabis in Germany for medical purposes in reproducible quality in accordance with any applicable drug law requirements. Medicinal Cannabis is therefore also subject to the statutory provisions of the Narcotic Drugs Act.

a) Demand is covered by imports, for which the Cannabis Agency as such is not responsible, but only until Medicinal Cannabis is available from German cultivation. The Federal Opium Agency at the Federal Institute for Drugs and Medical Devices issues the relevant authorizations.

b) The Cannabis Agency’s first cannabis tender process for cultivation of Cannabis in Germany was canceled by a court in March 2018. In July 2018, however, a new tender process was launched for the cultivation and harvesting of Medicinal Cannabis with a deadline for submission of bids at December 11, 2018. In April 2019, the first contracts were awarded for cultivation and harvesting for a total of 7,200 kg of Cannabis for a period of four years. BfArM expects that cannabis from cultivation in Germany will be available from 2020.

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

a) Anyone wishing to participate in trading, here the import of narcotic drugs, requires the general license of BfArM – Federal Opium Agency – in accordance with section 3 Narcotic Drugs Act. In addition, for each individual import transaction, the licensee will require a separate import permit from BfArM – Federal Opium Agency.

b) Anyone wishing to grow Cannabis in Germany in the future must take part in any future tender process initiated by BfArM – Cannabis Agency – and be awarded the relevant contract. Future tender offers will be published in the Official Journal of the European Union.

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

Trading in narcotics and psychotropics and precursors is comprehensively governed by the Narcotic Drugs Act and the relevant ordinances – Foreign Trade Ordinance on Narcotic Drugs, Internal Trade Ordinance on Narcotic Drugs, Prescription Ordinance on Narcotic Drugs – and by Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors and by Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 and Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors and the Precursors Monitoring Act supplementing it.

In certain cases, physicians may prescribe pharmaceutical-quality Medicinal Cannabis on a narcotic drug prescription to patients with serious illnesses with the appropriate indication and in the absence of alternative therapies. According to Annex III to the Narcotic Drugs Act, Cannabis (marijuana, plants, and parts of plants belonging to the genus Cannabis) is only considered as marketable and prescription narcotic drug in Germany if grown for medical purposes under State control in accordance with Articles 23 and 28(1) of the Single Convention on Narcotic Drugs of 1961 and in preparations authorized as finished medicinal products.

18. How can patients obtain Medicinal Cannabis?

Patients need a narcotic drug prescription with which they may obtain Medicinal Cannabis in a pharmacy.

19. Who can prescribe Medicinal Cannabis?

Generally, licensed physicians of any specialty, with the exception of dentists and veterinarians; cf. sections 2 et seqq. Narcotic Drugs Prescription Ordinance.

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

A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.

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

In cases of a sufficient medical indication, there are no specific restrictions. It must be a serious disease with a corresponding indication and with no alternative therapies.

22. Where is Medicinal Cannabis available?

Sale is only possible through drug wholesalers and pharmacies.

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

The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.

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

No.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

There is no uniform answer to this question, as well. There are Opioid Drugs listed in Annex III to the Narcotic Drugs Act and therefore classified as marketable and prescription drug narcotics in Germany, such as Morphine, Sufentanil, Remifentanil, Fentanyl, Alfentanil. There are, however, also Opioid Drugs listed in Annex I to the Narcotic Drugs Act and therefore not marketable in Germany, such as Ohmefentanyl. There are also Opioid Drugs that are not relevant under the narcotic drugs laws, but are prescription drugs in Germany, such as Nalbuphin.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Where Opioid Drugs are medicinal products, the EMA and BfArM are the competent bodies. If the Opioid Drugs are narcotic drugs, the Federal Opium Agency of BfArM is competent.

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

Compared to other drugs, there are no specific rules for authorization, pricing, and reimbursement of Opioid Drugs. It is a condition precedent to reimbursement that the drug is a prescription-only drug. Most of the Opioid Drugs used are standard therapeutics which are included in the service catalogue of the health insurance.

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

A large number of Opioid Drugs have received market approval, including, but not limited to Codeine, Tilidine, Sufentanil, Remifentanil, Fentanyl, Alfentanil, Buprenorphine, Hydromorphone, Methadone, Oxycodone, Morphinesulphate-Pentahydrate or Morphinehydrochloride_Trihydrate (“morphine”), Piritramide, Tapentadol, Dihydrocodeine, Tramadol.

29. Who can prescribe Opioid Drugs?

Generally, any licensed physician. Special provisions are contained in sections 2 et seqq. Narcotic Drugs Prescription Ordinance. There is another restriction relating to Diacetylmorphine: prescribing physicians must be physicians qualified in addiction medicine and their qualification must extend to treatment with Diamorphine or they must have worked as physicians for at least six months as part of the “heroin-assisted treatment of opiate addicts” model project; section 5a Narcotic Drugs Prescription Ordinance.

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

A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.

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

See above under item 29.

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

Sale is only permitted via the wholesale trade in drugs and pharmacies.

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

The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.

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

No.

35. When are they likely to come into force?

Not applicable.