Throughout Europe, cannabis remains broadly illegal and, in most European countries, selling the plant is a criminal offense. However, many countries have adopted their own laws to permit cannabis purchases, sales, and use for medicinal purposes. The current state of European law is similar to the United States – each country (state) has taken its own path to legalize aspects of cannabis, resulting in a complex regional set of laws and rules that apply to the cannabis business. Fortunately for companies doing business in Europe, unlike in the United States, there is no overarching federal criminalization of cannabis that creates federal-local law conflicts.
Throughout Europe, cannabis remains broadly illegal and, in most European countries, selling the plant is a criminal offense. However, many countries have adopted their own laws to permit cannabis purchases, sales, and use for medicinal purposes. The current state of European law is similar to the United States – each country (state) has taken its own path to legalize aspects of cannabis, resulting in a complex regional set of laws and rules that apply to the cannabis business. Fortunately for companies doing business in Europe, unlike in the United States, there is no overarching federal criminalization of cannabis that creates federal-local law conflicts.
Brief updates from a selection of countries illustrate the varying systems European countries have in place to permit medicinal cannabis while keeping non-medicinal sales illegal. Companies and individuals will need to keep each jurisdiction’s rules in mind if they seek to do business in Europe – there is no continent-wide cannabis regime.
1. United Kingdom
(by Charles Thomson and Kate Geale)
As of November 1, 2018, “cannabis-based products for medicinal use in humans” (“CBPMs”) have been rescheduled in the UK, permitting their use for medicinal purposes. Specialist physicians can now prescribe CBPMs to patients without requiring a Home Office license to lawfully write a prescription.
Companies wishing to possess, supply, produce and/or manufacture CBPMs require a Home Office license, unless a limited exemption applies. A Home Office license will also be required to import and export these drugs. Any proposal to cultivate cannabis materials to produce CBPMs will be individually considered on its merits in accordance with the general drug licensing risk assessment process and other applicable regulatory considerations.
2. Poland
(by Radoslaw Nozykowski and Marcin Fiałka)
Poland authorized the use of cannabis for medicinal purposes through the Act of 7 July 2017. Physicians now possess the discretion to prescribe drugs made of cannabis for any condition, as long as the treatment is in accordance with current medical practices.
Polish pharmacies are allowed to prepare medicines from imported cannabis plants, under the condition that the imported material has been granted a license by the Polish Office for the Registration of Medical Products. On October 24, 2018, the Office issued a license to Spectrum Cannabis, part of the Canadian capital group Canopy Growth Corp., for the first, and so far only, imported cannabis pharmaceutical raw material.
3. Italy
(by Aurelio Giovannelli and Ludovica Veltri)
Italy first authorized the use of medicinal cannabis through a January 23, 2013 Ministerial Decree of the Ministry of Health. Italy later modified those regulations through a November 9, 2015 decree from the same Ministry.
A physician can prescribe medicinal products originating from cannabis. Any licensed physician enrolled with the General Medical Council can issue a one-time prescription pursuant to Law No. 94/1998. Medicinal cannabis in Italy cannot be broadly prescribed. It can only be used as symptomatic treatment in support of standard treatments when the latter have not produced the desired effects, when they have caused unbearable secondary effects, or when the patient needs a dosage increase on standard treatments that might lead to the development of side effects.
The November 9, 2015 decree also specifies that the cultivation, for medicinal purposes, of cannabis plants containing more than 0.2% of tetrahydrocannabinol must be authorized by the Ministry of Health. The Ministry also authorizes the importation, exportation, and distribution of cannabis plants and vegetal material. It further collects the products and vegetal materials cultivated by the authorized producers and transfers the material to the pharmacies for their use in filling prescriptions
4. Germany
(by Dr. Thilo Räpple)
Historically, medical cannabis in Germany was only available to seriously ill patients with a special permit from the Federal Institute for Drugs and Medical Devices. However in March 2017, Germany broadened legalized the use of medicinal cannabis. Although patients must still be seriously ill to receive medicinal cannabis, physicians can now prescribe it even if other treatment options are available. Additionally, patients no longer need to obtain a special permit.
German law limits medicinal cannabis products to those produced under governmental control for medical purposes and preparations that are approved as finished medical products. Pharmacies carry out the distribution to individual patients. The Federal Institute for Drugs and Medical Devices is in charge of controlling and coordinating the cultivation and distribution of the marijuana to the pharmacies.
Individuals or companies that want to manufacture, trade, import, export, supply, sell or place narcotics on the market require a special permit.
5. Spain
(by Victor Mercedes and Samantha Salsench)
Although medicinal cannabis is legal in Spain, the prescription and use of it are restricted. Prescriptions can only be issued by medical practitioners. Selling or dispensing preparations containing medicinal cannabis must be carried out through legally established pharmacies. In any other circumstances, selling cannabis would be considered illegal trafficking.
Pursuant to Article 8 of the Decree 1/2015, the Spanish Medicines and Health Products Agency is the sole body allowed to deem a product “medicinal.” The Ministry of Health is in charge of establishing the minimum requirements, characteristics, and duration of medical prescriptions concerning medicines with psychoactive substances like medicinal cannabis, as well as the special requirements for their prescription and dispensing. Currently, there are four medicines derived from cannabis that are used in Spain – Sativex, Epidiolex, Nabilona and Dronabinol.
Small amounts of cannabis can also be cultivated and consumed for personal use pursuant to Article 368 the Spanish Penal Code and Law 4/2015 on the Protection of Citizen Security. Providing cannabis to others remains a crime.
6. France
(by Eric Lasry)
In France, companies can obtain marketing authorizations to create and sell medicinal products that contain either cannabis or tetrahydrocannabinol. Marketing authorizations are similar to U.S. Food & Drug Administration approvals.
French authorities are also currently discussing the potential authorization of cannabis for medicinal purposes without the requirement of a marketing authorization. In September 2018, the French National Agency for the Safety of Medicines and Health Products (“ANSM”) set up a temporary scientific committee to assess the feasibility of making cannabis available in France for medicinal uses. On December 27, 2018, based on the committee’s recommendation, ANSM published a note endorsing the use of cannabis for certain medical conditions.
The ANSM committee will hold meetings in 2019 to analyze the practical framework for providing access to medicinal cannabis. The meetings will discuss issues including how to administer the medicinal cannabis to patients and how to properly distribute it.
