Features International Medical Regulations
Principles of Clinical Cannabiology, Chapter 4: Medical cannabis regulations, access and products in Europe

4.1 Foreword

The therapeutic properties of cannabis have been widely recognised by the international scientific community for decades now. However, the illegal status of cannabis, especially of its active ingredient THC, has made its use in the therapeutic field particularly difficult. For this reason, in many European states and beyond, a debate has been going on for years about the possibility of using cannabis for medicinal purposes, involving governments, regulators and law enforcement on the one hand, and doctors and patients on the other.

As a result, several states in Europe have introduced specific laws and programmes to allow patients to use cannabis preparations in various forms to alleviate the symptoms of a range of pathological conditions. In the absence of a European Union framework law, each individual state has its own laws regulating the use of Medical Cannabis, some more restrictive, some more permissive.

In order to get a complete picture of the legal status of Medical Cannabis access in various European states, the following sections will consider the legislation of those states that have opened up to its use, in particular:

⁕ Belgium,

⁕ Czech Republic,

⁕ Denmark,

⁕ Germany,

⁕ Ireland,

⁕ Italy,

⁕ Malta,

⁕ Poland,

⁕ Portugal,

⁕ Sweden,

⁕ Switzerland,

⁕ U.K.

Currently, the therapeutic use of cannabis and/or cannabinoids in Europe is regulated in the countries described in this guide, each with a different modality, as well as in others, whereas pilots or very tight Government control are applied, such as:

⁕ France: The Medical Cannabis program is operational until March 26, 2024, and has successfully treated around 2,200 patients over the past two years. Six producers have gained approval for nine products, which are being provided to the program at no cost by the producers. Presently, a tender process is underway to obtain additional supply for the final year of the program, and the producers will be paid for the products delivered.

⁕ Luxembourg: The initial Medical Cannabis program came to a close in 2021, followed by an extensive evaluation of its effective-ness. The launch of a second pilot program is anticipated shortly, with an estimated 1,000 patients served annually. The supply of Medical Cannabis products is limited, sourced from only three suppliers.

⁕ The Netherlands: The market for Medical Cannabis is solely sup-plied by one local producer, under a meticulously controlled sup-ply arrangement, with government monitored distribution. There is no provision for market entry except through direct negotiations with the government. Currently, the country caters to roughly 13,000 patients each year.

⁕ Cyprus, Finland, Greece, North Macedonia, Norway: In these Countries Medical Cannabis treatment is legal, but the low patient count is due to an underdeveloped infrastructure for treatment. This is attributed to various factors such as a scarcity of prescribing doctors, limiting conditions for prescribing, an incomplete regulatory framework for Medical Cannabis treatment, unavailability of products, inadequate awareness of structures and processes for medical cannabis treatment, and so on. In these markets, Medical Cannabis is only accessible under exceptional circumstances, with individual patients granted authorization for its use. Importation of products occurs in minimal quantities on their behalf.

The laws of the various states are updated to September 2022. As the legal situation of cannabis in Europe is constantly evolving, in some cases the current legislation, as well as the type and prices of products that can be purchased, may not be in line with this text. However this manuscript is subject to early review for both the science and the new regulatory and product frameworks.

Law references that regulate prescription

The law regulating the use of cannabis and its derivatives in Germany is the German Narcotic Drugs Act (Betäubungsmittelgesetz). Originally, cannabis was one of the narcotic substances that could not be marketed except under special conditions (Section 1, Annex 1).

As of 2017, cannabis was moved to Schedule 3. As an effect of this, the possibility of dispensing cannabis for medical purposes has been increased. In accordance with the new indications, since 2017 the use of Medical Cannabis is only permissible if it originates from a cultivation under state control, in accordance with the UN Single Convention on Narcotic Drugs and in preparations authorised as finished medicinal products. However, as the growth in demand cannot be met by local cultivation, the import of Medical Cannabis is becoming increasingly important.

Differences on private and public healthcare system/insurance system

The German Social Security Code, Vol. 5 of 20 December 1988, sets out the conditions for reimbursement by public health insurance.

Patients suffering from serious illnesses may, under certain circumstances, be reimbursed by public health insurance. The basic reimbursement price is set at EUR 4.30/gram. Patients with private insurance will have to pay the full cost in advance and request reimbursement through the insurer.

Who can prescribe Medical Cannabis and on what situation?

In Germany, as of Q1 2023, any doctor can prescribe Medical Cannabis, but under certain conditions. In fact, patients may receive a prescription for Medical Cannabis from a doctor if:

⁕ there is no general standard therapy for the patient’s illness;

⁕ first line therapy is not applicable according to the treating physician’s justified assessment, taking into account the side effects and the patient’s state of illness;

⁕ there is a reasonable possibility that Medical Cannabis will have a positive effect on the disease process or symptoms.

If the above requirements are met, health insurers must reimburse the costs of cannabis-based therapies, except in exceptional circumstances. Since ‘exceptional circumstances’ are not well defined in the law, this has allowed insurers to reject most claims for reimbursement.

Pathologies for which cannabis can be prescribed

In Germany, technically any disease can be treated if it meets the above requirements. The most commonly treated conditions are:

⁕ pain,

⁕ spasticity,

⁕ anorexia,

⁕ epilepsy,

⁕ ADHD,

⁕ Gilles de la Tourettes syndrome.

Medical products/varieties available for prescription and routes of administration allowed

The following products are available in Germany:

⁕ Sativex®

⁕ Epidolex®

⁕ Canemes ® (Nabilone),

⁕ Cannabis inflorescences,

⁕ Preparations with inflorescences: they can be ground, used in an oil tincture

⁕ Extracts prepared in pharmacies.

The routes of administration allowed are:

⁕ Oral (oil, capsule, extract, tincture),

⁕ Inhalation,

⁕ Topical.

How does a prescription look like?

In Germany, prescriptions containing narcotics must include:

⁕ Name of active ingredient and manufacturer,

⁕ Quantity and dosage,

⁕ Insurance number,

⁕ Patient’s name and address.

How patients get their medicine

When a patient receives a prescription for cannabis or its derivatives for the first time, he or she must obtain approval from his or her health insurance company (it can only be refused in special cases).

Afterwards, the patient must go to an authorised pharmacy. Currently, not many pharmacies stock Medical Cannabis and are sufficiently trained in this field. Customers often have to contact many local pharmacies before they can receive the prescribed cannabis therapy. Home delivery or pick-up is common as far as private clinics are concerned.

 Medical Cannabis treatment average prices

In Germany, the price of cannabis sold on public prescription is set by the government (see table above). Patients with public insurance can purchase unprocessed cannabis flow-ers at a fixed cost of EUR 4.26/gram, plus a fixed surcharge of between 90% and 100%, depending on the size of the prescription. Patients may receive insurance reimbursement if they fall within the parameters.

Cannabiscientia Website: cannabiscientia.com/