Overview – German Legal Regime Concerning Cannabis for Medical Use

I. Introduction

In 1999, the German Constitutional Court (Bundesverfassungsgericht, BVerfG) first suggested the possibility that patients could legally receive cannabis for medical purposes. The BVerfG pronounced in an obiter dictum of a constitutional complaint procedure that under certain circumstances, an exceptional permission on cannabis for personal medical use should be granted to patients. This suggestion of the BVerfG had no concrete impact, save for the German Highest Federal Administrative Court (Bundesverwaltungsgericht, BVerwG) decision in 2005. The BVerwG decided in this proceeding that a person suffering from a serious disease or serious symptoms must be able to apply successfully for an exceptional permission to cultivate and possess cannabis for personal medical use, according to Sec. 3 para. 2 German Code on Drugs (Betäubungsmittelgesetz, BtMG). Back in 2005, German law did not yet specifically regulate the prescription of cannabis for medical use.

Over a decade later, the German Parliament in March 2017 legalized pharmaceutical-grade cannabis on prescription. The Parliament amended the Social Security Code n. 5 on Statutory Health Care Insurance (Sozialgesetzbuch V – gesetzliche Krankenversicherung, SGB V) and introduced Sec. 31 para. 6 SGB V, which dictates the legal requirements for physicians to prescribe cannabis for medical use. In the context of the amendment, the Parliament created within the Federal Authority for Medicine and Medical Devices (Bundesanstalt für Arzneimittel und Medizinprodukte, BfArM) the sub-unit Cannabis Agency (Cannabisagentur). While the Cannabis Agency is competent to regulate the domestic cultivation and production of pharmaceutical-grade cannabis, the sub-unit Federal Opium Authority (Bundesopiumstelle) remains competent to approve the import and trade of narcotic drugs in general, including pharmaceutical-grade cannabis.

II. Prescription of medical cannabis

Under the new provision (Sec. 31 para. 6 SGB V), any physician (GP and specialist) can diagnose at their professional discretion the patients’ need for pharmaceutical-grade cannabis and prescribe cannabis in the form of dried flowers or extracts of standardized quality and licensed drugs containing the active substances dronabinol or nabilone. If the legal requirements according to Sec. 31 para. 6 SGC V are met, physicians may prescribe cannabis—but it must be pharmaceutical grade only. To meet the legal requirements, the patient must suffer of a serious disease for which there is no other equal option for medical treatment.

Besides dried cannabis flowers and cannabis extracts, the approved and licensed pharmaceutical manufactured drugs Sativex® and Canemes® are permitted on the German market. The new provision does not affect the option to prescribe and use these manufactured drugs.

The costs for prescribed medical cannabis are reimbursed to patients insured in the Statutory Health Care Insurance (SHI)—around 90 % of the German population—subject to the condition that SHI has given its approval before the first prescription and start of the medication. The SHI shall refuse the approval only in justified exceptional cases. There are no specific reimbursement rules in Germany for patients privately insured. Private health care insurance funds reimburse the costs of medical cannabis on prescription according to the general rules—i.e., if pharmaceutical-grade cannabis is required for an effective curable treatment.

Beside dronabinol products, pharmacists in Germany may prepare an individual drug on prescription with cannabidiol. Cannabidiol is not considered a narcotic drug under the BtMG; nevertheless, cannabidiol is available for medical use only on prescription. The SHI does not reimburse the costs for products prepared on prescription with cannabidiol.

SHI-insured patients with a life-threatening or regularly fatal illness or an illness at least comparable in severity—for which a generally recognized treatment corresponding to the medical standard is not available—may also apply for a non-standardized treatment pursuant to Sec. 2 para. 1a SGB V, as long as there is a not entirely remote chance of cure or a noticeable positive effect upon the illness. In case of application by the insured person or the treating doctor, the SHI must issue a declaration of reimbursement before the start of treatment.

Patients can generally fill prescriptions at any pharmacy that is registered with BfArM (notice obligation) regarding the trade with drugs pursuant to BtMG, including pharmaceutical-grade cannabis.

III. Cultivation of medical cannabis in Germany

According to Sec. 19 para. 2a BtMG, the cultivation and production of cannabis for medical use in Germany take place under the surveillance of BfArM (Cannabis Agency). Only companies that were licensed by a public tender proceeding and entered into a contract with BfArM may cultivate and produce cannabis for medical use in Germany. The domestically cultivated cannabis is centrally collected and then put on the market by the Cannabis Agency.

The first public tender proceeding for licenses on domestic cultivation and production of pharmaceutical-grade cannabis in Germany ended in May 2019. BfArM adjudicated all 13 lots to Canadian companies (one of which has a German-based affiliate). The winning companies are allowed—and obliged—to cultivate in the next four years cannabis for medical use in amount of 10,400 kilogram (2,600 kilogram per year) under public surveillance. The first German harvest is expected in 2020.

IV.Import and trade of medical cannabis

Until the first harvest of pharmaceutical-grade cannabis cultivated in Germany is ready to be used, medical cannabis available on prescription is manufactured outside of Germany. The fact that BfArM has authorized the domestic cultivation and production of cannabis for medical purpose will not exclude the import of pharmaceutical-grade cannabis to Germany in the future.

Germany permits the import of cannabis plants and plant parts for medicinal purposes under State control, subject to the condition that the requirements under the United Nations Single Convention on Narcotic Drugs of 1961 (UN Single Convention) and the Good Agricultural and Collection Practice (GACP), an annex to the European Union – Good Manufacturing Practices (EU-GMP), are met. Current German legislation does not establish quantitative restrictions on imports, but requires importers, exporters, traders and others who put cannabis products on the German market to apply for a license under the BtMG. In other words, any person wishing to supply, sell or otherwise place drugs on the German market (including import and export) or acquire narcotic drugs there, requires a license issued by Federal Opium Authority, a sub-unit of BfArM. The Federal Opium Authority may restrict the permissions under this license, inter alia, in relation to the

1. Kind of narcotic drugs and the trade in narcotic drugs;
2. Annual quantity and the stock of narcotic drugs; and
3. Location of the sites.

In addition to a narcotic trade license, each import or export of narcotic drugs with a starting point or end point in Germany must be additionally authorized by the Federal Opium Authority. For this purpose, importers and exporters are required to submit an application for an import/export authorization to BfArM for in any single case. Import permits are issued on a shipment-specific basis and have generally a three-month validity period. The import permit, once granted, will specify for each shipment, inter alia, the importer, exporter and product-specific details on the narcotic drug imported.