Medical cannabis: uses and regulation in Europe

Medical cannabis is a therapy that generates a lot of confusion. There is a lot of information circulating about the potential benefits of cannabis or some of its components, but not all of it has sufficient therapeutic evidence, or is legal yet.

In this post, we define what medical cannabis is, its accepted therapeutic uses and side effects, as well as look at some European examples in the regulation of medical marijuana therapies 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. cannabis plant or its active ingredients(cannabinoids) in order to treat a disease or alleviate a specific 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 3500 years ago, to the “Atharva Veda” of the Ayurvedic medicine of India (1500 B.C.), the Greek treatise of Dioscorides of the 1st century, where the use of medicinal marijuana is mentioned, or the Botanical Treatise of Ibn al Baytär al Malaqi (Islamic Empire, 13th century).

Even in more modern times, cannabis figured prominently in the prestigious Merck Manual of Medicine. In its 1889 edition, it was recommended to treat ailments such as hysteria, delirium, epilepsy, nervous insomnia, migraine, dysmenorrhea and chronic pain.

It is also said that Queen Victoria of England used therapeutic marijuana to relieve her menstrual cramps. Although there is no evidence, we do know that his personal physician was a fervent advocate of therapeutic cannabis (1).

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 use. But, on the other hand, 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, it is possible to carry a pharmaceutical grade cannabinoid spray in your pocket, but carrying marijuana buds carries a minimum fine of 600 €. In other countries, this difference can lead to imprisonment.

Is there evidence on the efficacy of medical cannabis?

In the mid-20th century, the use of clinical trials became widespread as a test to determine the efficacy of drugs. This coincided with the legal restrictions on cannabis. As a result, research on medical cannabis has been delayed.

However, at the present time, there are already enough scientific studies to affirm without any doubt that some cannabinoids, especially THC or tetrahydrocannabinol 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 different pathologies.

Differences between “medical marijuana” and “cannabinoid use” in medicine”.

From a medical and pharmacological point of view, it is preferable to use isolated active ingredients rather than plant extracts of varying composition. Plant extracts make it more difficult to control dosage, to achieve products with homogeneous potency, and 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 have to do with the interaction between the different cannabinoids with each other and with other compounds in the plant, such as the terpenes .

Thus, synergistic effects appear between cannabinoids and terpenes (3): The effect of two or more components together is stronger than the sum of their individual effects. This is known as the “ entourage effect entourage effect” of cannabis. However, most countries continue to use medicinal preparations based on pure cannabinoids, or combinations of pure cannabinoids.

In which diseases is medical cannabis used?

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)
  • Nausea and vomiting associated with chemotherapy (5)
  • Chronic pain: Especially neuropathic pain (pain caused by direct injury to the fibers 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 may worsen anxiety symptoms (10).

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

Other possible therapeutic uses of medical cannabis in the future

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-associated symptoms and palliative care (19)
  • Treatment of some brain tumors (20)
  • Anorexia nervosa (21)
  • Amyotrophic Lateral Sclerosis (22)
  • Tourette Syndrome (23, 24)

Medicines with medical cannabis

What medicines are available with medical cannabis?

To date, there are no approved medical marijuana drugs in Europe that contain the plant in its natural form. However, there are some approved medications that contain synthetic derivatives of cannabis or isolated components of the plant. The two medicinal cannabis drugs that have been approved by the European Medicines Agency (EMA) are:

  • Sativex: It is an oral spray for sublingual administration 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 drug containing an oral solution based on cannabidiol, Epidiolex is used to treat Lennox-Gastaut syndrome and Dravet syndrome, two rare forms of epilepsy that are difficult to treat with other drugs.

There are other existing drugs based on synthetic cannabinoids Marinol (dronabinol, synthetic delta-9-THC) for nausea and vomiting; and Cesamet (nabilone, 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 may vary depending on where the patient is located.

How the prescription of medical cannabis works in European countries

How to access medical cannabis?

Access to and prescription of medical cannabis varies from one European country to another, and is often subject to national regulations. In general, in most cases, physicians are required to have special or specific authorization to prescribe medical cannabis, and patients must meet certain medical criteria to receive this type of treatment.

The following are examples of how medical cannabis prescription works in some European countries:

Spain and medical cannabis

In Spain, any licensed physician can prescribe either of the two available drugs. In addition to the usual medical prescription, an official prescription for narcotic drugs must be presented at the pharmacy. Both drugs are classified as hospital diagnostic. However, they can be obtained from any pharmacy in Spain through a special supply procedure.

All drugs authorized in Spain have indications in the technical data sheet, which are those uses for which they are formally indicated. For 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 medications and who have shown clinically significant improvement in spasticity-related symptoms during an initial treatment trial period.” However, the legislation also contemplates that a physician may prescribe a drug for an indication “outside the technical file” if he/she deems it appropriate, based on his/her own clinical criteria.

The price of both drugs is high. The National Health System finances them as long as they have the approval of a specialist physician, usually a neurologist or oncologist. Difficulties in access, moral prejudices or the different clinical criteria of each specialist mean that, in practice, many people resort to self-cultivation, supply in cannabis associations or the black market. These are not adequate, although, realistically, the difficulties of access through the health system force the patient to use these resources.

United Kingdom and medical cannabis

In England, medical cannabis was legalized 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 by other countries, such as anxiety or endometriosis. You can see the full list of conditions for which it can be prescribed here.

English doctors must obtain special authorization from the UK regulatory authority, the Medicines & Healthcare Products Regulatory Agency, to prescribe medical cannabis, and only products approved by it are allowed for use.

Moreover, possession of cannabis for personal and recreational use in this country can lead to imprisonment. If you are interested in the subject, we recommend the post on. Cannabis and CBD in the UK .

The Netherlands and medical cannabis

On the other hand, prescription and access to medical cannabis in the Netherlands is quite different from other European countries. In the Netherlands, the government itself is responsible for controlling the production and distribution of medical marijuana in licensed pharmacies throughout the country, through the Bureau of Medicinal Cannabis (BMC) program.

BMC produces a variety of medical cannabis products, including cannabis flowers (buds), cannabis oil and capsules.

In order to receive treatment with medical cannabis, Dutch nationals must obtain a prescription from a physician authorized to write such prescriptions. As in other countries, access to medical cannabis is restricted to patients with certain medical conditions, such as chronic diseases and chronic pain.

Patients can go to an authorized pharmacy and choose the cannabis strain that best suits their needs and preferences, taking into account the different specific cannabinoid compositions offered.

Germany and medical cannabis

In Germany, medical cannabis was legalized in 2017 following the “Cannabis as Medicine Act”, and can be prescribed for a variety of medical conditions, as in the cases mentioned in the examples above.

Physicians must obtain special authorization to prescribe medical cannabis, and only products approved by the German Federal Agency for Medicines and Medical Devices are allowed for use.

How to take medical cannabis

Through which routes can medical cannabis be used?

For therapeutic use, most clinical trials have used sublingual preparations. This form of administration causes the cannabinoids to pass directly into the bloodstream through the veins under the tongue.

This avoids the disadvantages associated with the oral route, in which cannabinoids are absorbed somewhat more unpredictably, depending on the form of ingestion. That is, depending on the contents of the stomach and other individual factors, the amount of cannabinoids that are taken up by the digestive tract varies (25).

How do medical marijuana vaporizations work?

The use of vaporizers avoids combustion problems, such as the formation of toxic and carcinogenic particles. There are studies that show that it is possible to administer cannabis in this way, achieving stable levels of cannabinoids in the body (26).

However, in many countries the use of marijuana (the plant) for medical vaporizations is not contemplated. In Spain, for example, the resources to supply yourself are self-cultivation, cannabis associations, or the black market.

What side effects can medical cannabis have?

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

  • Mouth pain
  • Flavor alterations
  • Dental discoloration changes
  • Dizziness
  • Diarrhea

Some studies have found memory and attention problems (27, 28) in therapeutic cannabis users. But a systematic review (29) considers that, taking into account the doses used at the therapeutic level, the magnitude of this effect is small for most patients.

Can medical cannabis produce dependence?

Mild symptoms (difficulty sleeping, irritability, tiredness) were reported in 8-10% of patients when treatment was abruptly discontinued (30). These effects disappear a few days after discontinuation of treatment.

In conclusion…

In conclusion, nowadays the medicinal properties of cannabinoids have been proven and there is solid scientific evidence supporting their effective and safe therapeutic use to treat various symptoms and diseases. With advances in research, medical cannabis is likely to become an even more widely available and accepted treatment option in the future.

Some European countries have legalized medical cannabis, although most of them use it in the form of extracts, not as buds.

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

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

Referencias
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  10. Sharpe L, Sinclair J, Kramer A, de Manincor M, Sarris J. Cannabis, a cause for anxiety? A critical appraisal of the anxiogenic and anxiolytic properties. J Transl Med. 2020 Oct 2;18(1):374. doi: 10.1186/s12967-020-02518-2. PMID: 33008420; PMCID: PMC7531079.
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  12. Farkhondeh T, Khan H, Aschner M, Samini F, Pourbagher-Shahri AM, Aramjoo H, Roshanravan B, Hoyte C, Mehrpour O, Samarghandian S. Impact of Cannabis-Based Medicine on Alzheimer’s Disease by Focusing on the Amyloid β-Modifications: A Systematic Study. CNS Neurol Disord Drug Targets. 2020;19(5):334-343. doi: 10.2174/1871527319666200708130745. PMID: 32640965.
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  16. Rodríguez Mesa XM, Moreno Vergara AF, Contreras Bolaños LA, Guevara Moriones N, Mejía Piñeros AL, Santander González SP. Therapeutic Prospects of Cannabinoids in the Immunomodulation of Prevalent Autoimmune Diseases. Cannabis Cannabinoid Res. 2021 Jun;6(3):196-210. doi: 10.1089/can.2020.0183. Epub 2021 May 24. PMID: 34030476; PMCID: PMC8266560.
  17. Naftali T. An overview of cannabis based treatment in Crohn’s disease. Expert Rev Gastroenterol Hepatol. 2020 Apr;14(4):253-257. doi: 10.1080/17474124.2020.1740590. Epub 2020 Mar 12. PMID: 32149543.
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Can medical marijuana be prescribed in Spain?

From an exclusively theoretical point of view, a drug of these characteristics (therapeutic marijuana, weed) could be requested from an EU member country that has approved it. But the bureaucracy is complex, full of obstacles and, as far as I know, no one has successfully navigated this process. A specialist physician should make a request for foreign medication, justifying why he/she is requesting precisely that form of presentation, explaining in a reasoned manner the arguments that support it and, specifically, the quality scientific studies that support its efficacy and safety. Afterwards, it has to pass the evaluation of an Ethics Committee of the Area Hospital. These committees do not decide capriciously or at the personal discretion of the members. Objectively, there are few quality studies to justify the use of marijuana (precisely because marijuana research is extraordinarily complex to conduct, given its legal status). In short, it is practically impossible.

Can medical cannabis be smoked?

Smoking marijuana joints, the most commonly used recreational method, is a form of administration that allows cannabinoids to be incorporated into the body quickly and efficiently. The toxic substances generated as a result of combustion mean that, in practice, this is not an acceptable route for therapeutic cannabis.

Dr. Fernando Caudevilla
Family Physician | Expert in Drug Addictions. He works in different assistance, research and training projects related to drugs, including therapeutic cannabis.

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