Medicinal Cannabis in Europe
Cannabis has a wide range of applications in the textiles, recreation, health and beauty, as well as healthcare industry. This has resulted in a worldwide surge in cannabis cultivation, with the global market expected to be worth over USD$ 57Bn by 2026.
In fact, Europe is set to become the world’s largest cannabis market, with over 15 countries legalising the use of medicinal cannabis. However, it is important to bear in mind that the legality varies between countries.
What is medicinal cannabis?
Medical cannabis is a plant-based medicine derived from the Cannabis plant. It is usually prescribed by a medical practitioner, whereby it is used for pain relief, treating symptoms of depression, or reducing acne (to name a few). Medical cannabis contains molecules known as cannabinoids, which can interact with our body to treat illnesses. With over 113 different types of cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD) are the most well-known ones. It is also worth noting that CBD products are not regulated as medicines, but medical cannabis would typically contain high levels of CBD.
Pharmaceutical cannabis is a subset of medical cannabis. It involves designing analogues of cannabinoids with improved pharmacokinetic and pharmacodynamic profiles to treat disease symptoms. Analogues are essentially defined as the different forms of a molecule, which is produced by introducing new functional groups to its structure in order to help a drug enter our body. This modification can thereby help to lower the drug dosage through improving its potency and reducing the presence of toxic metabolites.
Moreover, there are three different cannabis species, but only C. indica and C. sativa are used for medicinal reasons. Using those species, the plant extracts can be consumed in an array of methods such as sprays, smoking, edibles, and capsules. Also, it is essential to note the difference between recreational and medicinal, whereby the recreational use of cannabis is illegal in almost all countries in Europe as this consists of cannabis with high levels of THC. Specifically, THC is a cannabinoid that can lead to psychoactive effects, which is commonly referred to as getting “high”. In contrast, medical cannabis contains high levels of CBD and low levels of THC, in which consuming CBD does not make you “high” as opposed to THC.
Good manufacturing practises
All medical cannabis-based products must adhere to strict control testing known as the Good Manufacturing Process (GMP), with their market retail also being strictly regulated. The presence of such regulations ensures controlled testing of the active pharmaceutical ingredient (API) which is to be consumed by a patient, and they also help in the prevention of substance abuse. The API is a term used to define an extractive component of the cannabis plant or a specific part of the plant. On the other hand, recreational cannabis does not undergo such stringent control measures and so may present some notable risks to a consumer’s health.
Good Manufacturing Process (GMP)
GMP is a series of compliance and control measures that are put in place to ensure all API are of consistent quality and high in purity. These control measures involve employing testing facilities to measure cannabinoid levels and detect traces of contaminants such as heavy metals and potency testing, and ensuring that all technicians are certified as qualified for work. In addition, GMP ensures that testing facilities are equipped with the state-of-the-art equipment that will permit the safest and most environmentally friendly testing procedure.
Uses of Medical Cannabis
Medicinal cannabis opens doors to treating illnesses and diseases. Although it has yet to be fully explored, medicinal cannabis is known to help alleviate the symptoms of appetite loss, Alzheimer’s disease, cancer, mental health conditions, multiple sclerosis, and pain. THC and CBD are used for medicinal purposes because of their different activities with the endocannabinoid system (ECS) and the receptors in which they target.
Cannabinoid receptors are widespread within our body via the ECS, and they are involved in regulating cognition, pain sensation, memory, and even sleep. The key receptors involved are called CB1 and CB2 receptors, which are located in the brain and spinal cord, respectively. THC is an agonist of the CB1 receptor (i.e. THC increases its activity), while CBD is an antagonist of the CB1 (i.e CBD decreases its activity).
The exact mode of action (MOA) by which medical cannabis adopts to relieve symptoms of cancer, Alzheimer’s disease, and multiple sclerosis are discussed below:
Cancer is described to be cells possessing six “hallmarks”, which involves having uncontrolled cell proliferation, skipping signalling pathways, and possessing metastatic capabilities. It is one of the most complex diseases due to its genetic and epigenetic changes. Thus, for this reason, there is no single appropriate treatment. There are over 200 different types of cancer, and every kind of treatment leads to some kind of side effect. For example, cisplatin is a drug used for testicular cancer, but it can cause serious side effects such as kidney loss.
Preclinical studies have indicated that cannabinoids can control cell proliferation and stimulate apoptosis (meaning cell death). It has been shown that the absence of the CB1 and CB2 receptor leads to a decreased cancer formation as agonists (such as THC) stimulate apoptosis. However, these studies are still in their preclinical trials, and more information is needed before the scientist can elucidate its mode of action.
On the other hand, scientists have extensively examined the effect of cannabinoids in upregulating the immune cells, specifically T cells, and their inhibition of angiogenesis (i.e. blood vessel formation around cancer cells). T cell proliferation is affected by cytokines (which are proteins that stimulate a humoral and clonal response), and increased levels of cytokines can help activate the immune system to destroy cancerous tissue. Moreover, as cannabinoids downregulate vascular endothelial growth, they can help lower the rapid growth of cancer and the risk of secondary tumours.
In the USA, there are already two cannabinoid drugs, namely Nabilone and Dronabinol, which are used to treat the symptoms of cancer found amongst chemotherapy patients.
Multiple Sclerosis (MS)
MS is a neuroinflammatory disease which can lead to mood changes, muscle spasms and pain. Neurons in your brain contain an axon (which are strong fibres in which electrical impulses travel along) that is coated by an insulating layer of myelin. Over time, some axons can become demyelinated and/or experience inflammation. If they are not repaired, these axons will eventually degrade. Hence, patients who suffer from MS will experience an imbalance between their anti-inflammatory response and immune response, which will damage neurons. In MS, the immune cells become over-activated and start to destroy all neurons. This results in a cascade of proinflammatory cells, bringing damage to the blood-brain barrier and causes the person to exhibit a range of uncontrolled symptoms such as spasms.
A recent study established that cannabinoids can be used to alleviate the symptoms of chronic pain, especially for those who suffer from MS. In a randomised trial, over 80% exhibited a significant pain-relieving effect. In addition, a new cannabinoid drug, Sativex, has already been approved by multiple countries in Europe to help treat MS.
Alzheimer’s disease (AD)
AD is characterised by the presence of amyloids (plaques) in the brain. These insoluble fibrous proteins can cause cerebral shrinkage and neuron death. Further, there is a reduction in the neurotransmitter acetylcholine, which is essential for cognitive and memory functions. This gradual degeneration of cerebral cells is due to the build-up of a protein, amyloid. The main symptoms include memory loss, behavioural disorders, and cognitive decline.
Research and clinical trials have shown that the ECS is involved in the development of AD and that cannabinoids, such as THC, can reduce neuroinflammation and neuron death due to their ability to breakdown amylin. Furthermore, trials have also found that medical cannabis resulted in “significant improvements” in a range of neuropsychiatric symptoms. Nabilone is a newly developed pharmaceutical drug derived from cannabis that has been legalised to treat AD as well as other diseases in the U.S and Europe.
Available cannabis drugs for purchase
The limited scientific evidence around medicinal cannabis means its availability is limited, and a doctor’s prescription is required to get access to it. However, there are a few licensed pharmaceutical products derived from cannabis that have passed clinical trials and safety testing and are available for consumption.
A highly purified CBD oil made by GW Pharmaceuticals that is used to treat epilepsy and multiple sclerosis (MS). This product does not lead to any psychoactive effects and can be prescribed by doctors in the U.K. for patients with Dravet syndrome and Lennox-Gastaut, which are rare forms of epilepsy. Legalising Epidiolex is a significant milestone in offering patients a new line of treatment to debilitating and rare diseases. This pharmaceutical drug was recently approved by the European Commission for all 28 European countries.
Nabilone is a synthetic version of THC, meaning that it is not derived from the plant but made artificially instead. By mimicking THC’s structure and pharmacological profile, it can alter one’s mood and pain sensations by binding to the CB receptors in the ECS. Nabilone is prescribed to treat chemotherapy side effects, such as vomiting. However, it is not licensed for children under the age of 18 years as potential side effects include having dry mouth, euphoric mood, and decreased appetite.
The first cannabis-based medicine to be licensed in the U.K., and it is classified as a Class B controlled drug. This drug, which contains a mixture of THC and CBD, administered in the form of a mouth spray for 4 weeks. Sativex is prescribed to treat the symptoms of muscle spasms, and stuffiness which are caused by MS. Side effects include dizziness, hallucinations, and psychoactive effects. For this reason, Sativex is only prescribed if a positive response to treatment is observed.
This orally administered drug, made by Solvay Pharmaceuticals, is used to relieve the symptoms of nausea, vomiting, and weight loss. This synthetic form of THC can only be prescribed by a doctor, and it acts as a stimulant. Marinol is commonly prescribed to patients undergoing cancer therapy as it also stimulates appetitive and prevents significant weight loss during treatment. In fact, the National Cancer Institute supports the research and development of Marinol for use in alleviating the symptoms experienced by patients undergoing cancer chemotherapy. Side effects include feeling elated, lightheadedness, and abdominal pain. Marinol is permitted for use in the U.S, South Africa, Germany, and Australia.
Side effects of medical cannabis
There are many reports stating the beneficial nature of CBD oils. Although this cannabinoid is the main ingredient in medical cannabis, THC can also be present. Therefore, the risk of using THC containing cannabis is not known. Cannabis products containing only CBD, such as Epidiolex, are not known to cause any serious side effects aside from a dry mouth. However, THC presents a few risks:
There is evidence to suggest that regular cannabis consumption that contains high levels of THC, can lead to psychotic illnesses such as schizophrenia. In addition, patients with pre-existing schizophrenia can also suffer from paranoia and delusions.
Studies indicate that 10% of regular cannabis users become dependent on these substances. As with other addictive drugs, a regular user will require eventually more in order to feel the same effects. The risk of developing these symptoms is higher if you are young, smoke regularly, and use it for a long time. Therefore, cannabis can also act as a gateway drug.
Lung and brain damage
As with anything that is smoked, excessive use can damage the lungs. More specifically, a user can become more prone to lung infections as the heat damages the cilia cells in their airways and they may experience an increased amount of mucus in their throat. If tobacco is present, this can lead to other lung diseases such as cancer. However, the use of a “bong” or filter can lower the temperature of smoke inhaled and thereby reduce the damage to your lungs.
Further, THC can lead to neural damage in adolescence, memory, and learning problems. As medicinal cannabis can contain THC, a medical prescription is thereby required for use.
Is medical cannabis legal?
The regulation of cannabis therapy is complex and continuously changing worldwide. In the U.S, Canada, and several European countries, a person can only buy medical cannabis provided they have a doctor’s prescription. In fact, it was only until 2018 that the U.K government allowed medical cannabis to be prescribed for the first time by doctors on the General Medical Council Specialist Register. Marijuana Business Daily estimates that the total sales of medical cannabis within the EU were USD$ 83.8mn in 2018.
Medical cannabis was only recently legalised by 22 European countries, and it has attracted national attention due to the surrounding controversies from a legal, societal, and ethical perspective. However, cannabis is increasingly recognised as a valid medicine to fight pain by the scientific community, and the European Monitoring Centre for Drug and Addiction (EMCDDA) authorised the use of cannabis extracts in drugs in 2017. The EU directive defines medical cannabis as “any substance or combination of substances presented for treating or preventing disease in human beings”.
With the limited research available, most associate the plant with its adverse side effects. However, research has shown that this is not the case, and most countries in Europe have decriminalised medical cannabis in some way or another. There is now an increasing number of trials being conducted in EU different countries.
Under the Narcotics Act s.3.2, cannabis can only be used under the authorisation that it is for scientific research, which will lead to a public benefit. In 2017, Germany legalised medical cannabis.
Cannabis is legal and readily available in Switzerland if the strain contains less than 0.1% THC.
All cannabis for recreational use, even with THC levels below 0.2%, is entirely illegal, in which fines and imprisonment are possible consequences. However, in 2002, clinical trials for the medical cannabis Marinol began and later in 2014, France legalised a medicinal cannabis program.
Public consumption of cannabis is an offence. However, its recreational use at home is legal and cannabis social clubs are also allowed. Moreover, a limited list of cannabis-derived pharmaceutical products is licensed for usage.
All narcotics in Portugal, including cannabis, are legal.
Known for attracting tourists into its rich canals and local coffee shops, individuals can buy cannabis, provided it is a maximum of 5 grams per person. Furthermore, under the Opium Act in 1999, the Netherlands began planning clinical trials to test the efficacy of medical cannabis.
A medical cannabis programme began in 2003, and over 2,000 pharmacies sell this as a new product. Medical cannabis can be expensive, and this has unfortunately meant it is harder to acquire. Patients have resorted to local coffee shops to buy standard cannabis at discounted prices.
Recreational cannabis is legal provided that it contains less than 0.1% THC content. Moreover, medical cannabis is entirely legal.
Cannabis is a class B drug, meaning that its recreational use is illegal, and if caught, an initial warning will be given on possession. However, in 2018, medical cannabis was legalised. Due to the high costs, it is hard for patients to be granted a prescription by the NHS and to have their treatment covered. However, private retailers of cannabis licensed by the Home Office, can be obtained by individuals; however, the private costs can be in the thousands.
Home cultivation is legal, and so is recreational use provided that an individual’s possession contains less than 0.2% THC content. Under the Venice 2002 court ruling, private cannabis can be grown at home, and the Regional Health System will cover the costs of medical cannabis. Italian doctors have been able to prescribe medicinal cannabis since 1990, and in 2014, domestic cultivation began.
The pharmaceutical drug Marinol can be prescribed. However, THC or cannabis alone cannot be prescribed for medication, and it is prohibited under the Austrian Narcotic Drug Ordinance.
As of 2002, Belgium gratified clinical trials on medical cannabis in 2002 that was conducted by GW Pharmaceuticals and later legalised pharmacists and practitioners to provide medical cannabis in 2015. Recreational use is also decriminalised.
In 2017 the Greek government declared that the medical use of cannabis was allowed provided a doctor’s prescription was given.
Recreational cultivation and possession up to 10 grams are legal. In 2012, the prescription of medical cannabis in pharmacies as medicine was legalised, and in 2013 up to 90% of treatment costs were covered by private insurance. Further, medical cannabis is also price restricted at €7/gram.
Poland legalised the medical use of cannabis in 2017. Recreational use and personal possession are illegal, but if small quantities are in possession, prosecutors can drop the charges.
Cannabis is illegal for recreational use, and it is only allowed for medical purposes on a case-by-case approval by the Minister for Health.
Cannabis possession and consumption are legal.
In 2019 Cyrpus legalised the cultivation and medical use of cannabis. Recreational use is illegal.
In Croatia, only medical cannabis is allowed.
Cannabis was decriminalised; up to 7.5 grams can be carried but is punishable by a fine. Although medical cannabis has been legal since 2005, it is extremely hard to obtain.
Recreational use of cannabis is illegal; however, three medical drugs: Sativex, Nabilone, and Marinol were approved by the Danish Medicines Agency in 2011 (with a prescription). In 2017, Denmark also approved the domestic cultivation by licensed farmers.
Cannabis is illegal; however, it can be obtained for medical reasons but under strict conditions. A limited number of users can obtain Sativex from one of the apothecaries that have a permit to retail medical cannabis.
Although cannabis is illegal, it is partly decriminalised, and in 2018, Malta legalised the use of medical cannabis.
Although recreational use is illegal, some cannabis products are allowed for medical reasons. Sativex can also be prescribed at no cost to a patient.
Cannabis is decriminalised for recreational use and legalised for medical use.
Recreational use is illegal. However, legislation in 2018 allowed its medical use. Further, in 2013, the cultivation of industrial hemp was also legalised.
How to get a prescription
Medical cannabis in Europe is mostly obtainable through a prescription. In the U.K., an underlying medical condition that involves epilepsy, multiple sclerosis or pain relief from chemotherapy is the only way one can obtain a prescription. Medicinal cannabis products require a doctor’s prescription as it can contain elevated levels of THC. In addition, NICE guidelines state that licensed cannabis-derived medicines, for certain underlying conditions, are covered by the NHS service in the U.K. Still they will run the risk of spending 100s to 1,000s on non-subsidised medication.
Furthermore, cannabis-based products, including CBD oils, can be bought online. Online products should be third-party tested. The reason is that the concentration of THC must be below 0.1 mg (0.3%) in any sample by law. This means that any beauty product, pain relief, or food supplement could be illegal unless adequately vetted by a certified third-party lab. Also, a consumer will be made aware of all ingredients present in the sample that they buy as well as any possible contaminants.
Subsequently, it is also worth noting that the regulatory backdrop has made medical cannabis very expensive for consumers. Although public health services in several countries, such as the NHS, do cover the cost of treatment, not all of them do. It goes without saying that medical cannabis, distributed by the European Healthcare system, can also be costly and can result in consumers cultivating their own, potentially unsafe, the cannabis plant.
Medical cannabis is an emerging topic in Europe and around the world, with research pointing out uncovered benefits of medical cannabis for treating a range of symptoms. Thus, it may provide an alternative form of treatment to conventional medicine. In general, scientific research and evidence are crucial to inform governments and allow appropriate regulations surrounding cannabis. The use of cannabis derivatives for medical purposes is permitted by the international legal framework. However, it is clear that one must understand the legality of cannabis in their country before they attempt to use it. In some countries, only under strict conditions can you obtain a doctor’s prescription for its use.
However, shortly, the European Commission could impose new legislation that restricts the retail of cannabis products, which are authorised. Although this would lead to a greater emphasis on GMP and API control, it could further slow the progress and development of this market as all products would be required to pass clinical trials before entering the market.