Medical cannabis: uses and regulation in Europe

Medical cannabis is a therapy that causes quite a lot of confusion. There is a great deal of information going around about the potential benefits of cannabis or some of its components, but not all of it is backed by enough therapeutic evidence, or is legal yet.

In this Cannactiva post, we explain what medical cannabis is, its accepted therapeutic uses and side effects, and we look at some European examples of how medical cannabis therapies are regulated and how to access them.

Uses of medical cannabis

What is medical cannabis?

In general, medical cannabis refers to the use of components obtained from the cannabis plant or its active ingredients (cannabinoids) in order to treat a disease or relieve a particular symptom.

Has medical cannabis been used throughout history?

In the ancient world, several cultures used cannabis as a medicine. From the “Ebers Papyrus” of Egypt, written more than 3,500 years ago, to the “Atharva Veda” of India’s Ayurvedic medicine (1500 BC), the 1st-century Greek treatise by Dioscorides, which mentions the use of medical cannabis, or the Treatise on Botany by Ibn al-Baytar al-Malaqi (Islamic Empire, 13th century).

Even in more modern times, cannabis held a prominent place in the prestigious Merck Manual. In its 1889 edition, it was recommended for treating ailments such as hysteria, delirium, epilepsy, nervous insomnia, migraine, dysmenorrhoea and chronic pain.

It is also said that Queen Victoria of England used therapeutic cannabis to relieve her period pain. Although there is no proof of this, we do know that her personal physician was a fervent advocate of therapeutic cannabis (1).

Medicinal uses of cannabis through history

Why is medical cannabis such a controversial issue?

The UN Drug Conventions (1961, 1971, 1988) determined that cannabis was a dangerous substance with no therapeutic uses. On the other hand, however, the therapeutic properties of cannabinoids are undeniable.

The irrationality of drug policies and the interference between science and morality (2) lead to surreal situations. In Spain, you can carry a pharmaceutical-grade cannabinoid spray in your pocket, but carrying cannabis buds means a minimum fine of €600. In other countries, this difference can mean going to prison.

History of cannabis: from 4% to 35% THC in less than 30 years

Is there evidence that medical cannabis works?

In the mid-20th century, clinical trials became the standard way of determining whether medicines were effective. This coincided with the legal restrictions on cannabis. For this reason, research into therapeutic cannabis was held back.

However, there are now enough scientific studies to state beyond any doubt that some cannabinoids, above all THC or tetrahydrocannabinol and CBD or cannabidiol, are safe and effective for certain symptoms or diseases. In fact, both in Europe and in the United States, the official medicines agencies have approved cannabis extracts for the treatment of various conditions.

Differences between “medical cannabis” and “the use of cannabinoids” in medicine

From a medical and pharmacological point of view, it is preferable to use isolated active ingredients rather than plant extracts of variable composition. Plant extracts make it harder to control the dose and to obtain products of consistent potency, and they are less effective and less safe. In this sense, on the one hand we could consider the therapeutic properties of THC and CBD. However, in the case of cannabis, many of its therapeutic effects are thought to depend on the interaction of the different cannabinoids with each other and with other compounds in the plant, such as terpenes.

This gives rise to synergistic effects between cannabinoids and terpenes (3): the effect of two or more components together is stronger than the sum of their individual effects. This is what is known as the entourage effect of cannabis (efecto séquito, in Spanish). Nevertheless, most countries still use medicinal preparations made from pure cannabinoids, or combinations of pure cannabinoids.

Which diseases is medical cannabis used for?

Medical cannabis has been used to treat a variety of diseases and symptoms. The clearest indications for medical cannabis are:

• Spasticity (muscle stiffness) and other symptoms associated with multiple sclerosis (4)
• Chemotherapy-induced nausea and vomiting (5)
• Chronic pain: especially neuropathic pain (pain caused by direct damage to the fibres of the nervous system) (6)
• Pain associated with diseases such as fibromyalgia (7) and arthritis (8).
• Sleep disorders and anxiety: only in some patients (9). In others, cannabis can make anxiety symptoms worse (10).

In addition, certain cannabinoids have specific applications, such as CBD in neurological diseases and CBD in psychiatric disorders.

CBD for anxiety: research

Other possible future therapeutic uses of medical cannabis

Therapeutic cannabis is also being tested experimentally in other medical applications:

• Parkinson’s disease (11)
• Alzheimer’s disease (12)
• Post-traumatic stress disorder (13)
• Rheumatoid arthritis (14, 15)
• Systemic lupus erythematosus (16)
• Inflammatory bowel disease (Crohn’s disease and ulcerative colitis) (17, 18)
• Cancer-related symptoms and palliative care (19)
• Treatment of some brain tumours (20)
• Anorexia nervosa (21)
• Amyotrophic lateral sclerosis (22)
• Tourette syndrome (23, 24)

Medical cannabis medicines

Which medical cannabis medicines are available?

To date, no medical cannabis drug containing the plant in its natural form has been approved in Europe. However, there are some approved medicines that contain synthetic cannabis derivatives or components isolated from the plant. The two medical cannabis medicines approved by the European Medicines Agency (EMA) are:

• Sativex: an oral spray for sublingual use with fixed concentrations of THC and CBD in a 1:1 ratio. It is approved for the treatment of spasticity related to multiple sclerosis.
• Epidiolex: a medicine containing a cannabidiol-based oral solution, used to treat Lennox-Gastaut syndrome and Dravet syndrome, two rare forms of epilepsy that are difficult to treat with other medicines.

There are other existing drugs based on synthetic cannabinoids: Marinol (dronabinol, synthetic delta-9-THC) for nausea and vomiting; and Cesamet (nabilone, a synthetic cannabinoid that mimics the effects of THC), for nausea and vomiting and appetite stimulation.

Each country has its own laws and regulations on the use of medical cannabis, and access to these treatments can vary depending on where the patient is.

How medical cannabis prescription works in European countries

How can you access medical cannabis?

Access to and prescription of medical cannabis vary from one European country to another, and are often subject to national regulations. In general, in most cases doctors need special or specific authorisation to prescribe medical cannabis, and patients must meet certain medical criteria to receive this type of treatment.

Below are some examples of how medical cannabis prescription works in a number of European countries:

Spain and medical cannabis

In Spain, any registered doctor can prescribe either of the two medicines available. As well as the usual prescription, an official narcotics prescription has to be presented at the pharmacy. Both medicines are classified as hospital diagnosis medicines. However, they can be obtained from any pharmacy in Spain through a special supply procedure.

All medicines authorised in Spain have indications listed in their summary of product characteristics, which are the uses they are formally indicated for. In the case of Sativex, the indication is “treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy”. But the law also allows a doctor to prescribe a medicine for an “off-label” indication if they consider it appropriate, with reasons, based on their own clinical judgement.

The price of both medicines is high. Spain’s National Health System funds them provided they have the approval of a specialist doctor, usually a neurologist or oncologist. Difficulties in access, moral prejudice or the differing clinical judgement of each specialist mean that, in practice, many people turn to home growing, supply through cannabis social clubs or the black market. These are not appropriate routes although, realistically, the difficulties in accessing treatment through the health system force patients to use these resources.

The United Kingdom and medical cannabis

In England, medical cannabis was legalised in 2018 and can be prescribed for a wide range of medical conditions, such as epilepsy, chemotherapy-related nausea and vomiting, and chronic pain; but also for other conditions not covered in other countries, such as anxiety or endometriosis. You can see the full list of conditions it can be prescribed for here.

English doctors must obtain special authorisation from the UK regulator, the Medicines & Healthcare products Regulatory Agency, to prescribe medical cannabis, and only products approved by it may be used.

On the other hand, possession of cannabis for personal and recreational use in this country can lead to a prison sentence. If you are interested in the subject, we recommend our post on Cannabis and CBD in the UK.

The Netherlands and medical cannabis

Prescription of and access to medical cannabis in the Netherlands, on the other hand, is quite different from other European countries. In the Netherlands, the government itself is in charge of controlling the production and distribution of medical cannabis to pharmacies authorised throughout the country, through the Bureau of Medicinal Cannabis (BMC) programme.

The BMC produces a range of medical cannabis products, which include cannabis flower (buds), cannabis oil and capsules.

To receive medical cannabis treatment, people in the Netherlands must obtain a prescription from a doctor authorised to issue such prescriptions. As in other countries, access to medical cannabis is restricted to patients with certain medical conditions, such as chronic illnesses and chronic pain.

Patients can go to an authorised pharmacy and choose the cannabis strain that best suits their needs and preferences, based on the specific cannabinoid profiles on offer.

Germany and medical cannabis

In Germany, medical cannabis was legalised in 2017 following the “Cannabis as Medicine Act”, and it can be prescribed for a range of medical conditions, such as those mentioned in the examples above.

Doctors must obtain special authorisation to prescribe medical cannabis, and only products approved by Germany’s Federal Institute for Drugs and Medical Devices may be used.

How medical cannabis is taken

By which routes can medical cannabis be used?

For therapeutic use, most clinical trials have used preparations taken sublingually. This route of administration allows cannabinoids to pass directly into the bloodstream through the veins under the tongue.

This avoids the drawbacks of the oral route, in which cannabinoids are absorbed somewhat more unpredictably, depending on how they are ingested. In other words, depending on what is in the stomach and on other individual factors, the amount of cannabinoids taken up via the digestive tract varies (25).

How does vaporising medical cannabis work?

Using vaporizers avoids the problems of combustion, such as the formation of toxic and carcinogenic particles. There are studies showing that cannabis can be administered in this way, achieving stable levels of cannabinoids in the body (26).

However, in many countries the use of cannabis (the plant) for vaporising for medical purposes is not provided for. In Spain, for example, the ways to obtain it are home growing, cannabis social clubs or the black market.

What side effects can medical cannabis have?

In clinical trials, most of the adverse effects of medical cannabis are mild or moderate, and well tolerated by most patients (27, 28, 29):

• Mouth pain
• Changes in taste
• Tooth discolouration
• Dizziness
• Diarrhoea

Some studies have found memory and attention problems (27, 28) in users of therapeutic cannabis. But a systematic review (29) concludes that, given the doses used therapeutically, the size of this effect is small for most patients.

Can medical cannabis cause dependence?

8-10% of patients reported mild symptoms (difficulty sleeping, irritability, tiredness) when stopping treatment abruptly (30). These effects disappear within a few days of stopping treatment.

In conclusion…

In conclusion, the medicinal properties of cannabinoids have now been proven and are backed by solid scientific evidence, which supports their effective and safe therapeutic use to treat various symptoms and diseases. As research advances, medical cannabis is likely to become an even more widely available and accepted treatment option in the future.

Some European countries have legalised medical cannabis, although most of them use it in the form of extracts rather than as buds.

It is important to stress that, like any medical treatment, the use of medical cannabis must be prescribed and supervised by a doctor and must comply with local laws and regulations.

Please remember that this is an informative article that is not intended to prevent, diagnose or treat any disease. Its content may complement, but never replace, the diagnosis or treatment of any disease or symptom. Consult your doctor if you have any questions or concerns about this. Cannactiva products are not medicines. The regulation of medical cannabis may have changed since this post was published.