Questions and answers on medicinal cannabis
Is it legal to obtain medicinal cannabis in Denmark?
What types of cannabis products are available in Denmark?
Doctors have four possibilities of prescribing cannabis-based products:
Authorised medicinesThere are currently two authorised cannabinoid-/cannabidiol-containing medicines in Denmark, Sativex and Epidyolex. Sativex is an oromucosal spray for the treatment of spasms in multiple sclerosis. Sativex can be prescribed by medical specialists in neurology to patients with multiple sclerosis. Epidyolex is an oral solution for the treatment of the rare forms of epilepsy called Dravet syndrome and Lennox-Gastaut syndrome. Epidyolex can be prescribed by medical specialists in neurology and/or paediatrics.
Medicines prescribed via compassionate use permitThis is relevant for the medicines Marinol and Nabilone, which contain synthetically-produced cannabinoids. The manufacturers of Marinol and Nabilone have not applied for authorisation in Denmark. However, doctors can apply to the Danish Medicines Agency for a compassionate use permit for medicines that are not authorised or marketed in Denmark. If the Danish Medicines Agency accepts the doctor’s application to prescribe either Marinol or Nabilone to a specific patient, the product concerned can be imported from, for example, the USA.
Magistral preparations of medicinesDoctors can prescribe magistral preparations with active substances of cannabis in the form of capsules or oils for example. Magistral preparations are prepared by a pharmacy for an individual patient according to a doctor’s prescription.
Products admitted to the medicinal cannabis pilot programmeOn 1 January 2018, the act on a Medicinal Cannabis Pilot Programme entered into force. It gave doctors a fourth possibility to prescribe other types of cannabis products for medicinal use such as herbal tea and cannabis oils. The pilot programme launched on 1 January 2018 and will run until 31 December 2025.
Why hasn’t the Danish Medicines Agency authorised more cannabis-based medicines?
We can only assess and potentially authorise more cannabis-based medicines if more companies apply for authorisation of their products. It is not our responsibility to request companies to apply for authorisation of medicines; the initiative has to come from the companies. The Danish Medicines Agency has authorised two cannabis-containing medicines; Sativex for the treatment of multiple sclerosis and Epidyolex for the treatment of the rare forms of epilepsy called Lennox-Gastaut syndrome and Dravet syndrome.
We have not turned down any applications for authorisation of cannabis-containing medicines, but we have explained the procedure to several companies.
Why hasn’t the Danish Medicines Agency admitted more products to the medicinal cannabis pilot programme?
We can only accept cannabis products to the pilot programme when companies submit requests to include specific products in the programme. The programme is based on the initiative of companies in the private sector.
We review applications for admission of cannabis products on receipt, and we admit all products whenever the companies and products meet the requirements set out in legislation.
The products currently available in the pilot programme are listed on medicinpriser.dk.
Which doctors can prescribe medicinal cannabis in Denmark?
All doctors can prescribe the products in the medicinal cannabis pilot programme, but they have no obligation to do so.
All doctors can prescribe magistral preparations with cannabis, but they have no obligation to do so.
Only medical specialists in neurology are allowed to prescribe Sativex.
Epidyolex can only be prescribed by medical specialists in neurology and/or paediatrics.
In case a doctor applies for a compassionate use permit for Marinol or Nabilone, the Danish Medicines Agency will decide for each specific application.
Is reimbursement available for medicinal cannabis?
Products under the pilot programme can be reimbursed under a special programme.
Terminally ill patients receive full reimbursement for cannabis products in the pilot programme. Other patients receive a 50% subsidy amounting to up to DKK 10,000 a year.
Is single reimbursement available for other cannabis-containing medicines?
Doctors in Denmark can apply to the Danish Medicines Agency for single reimbursement of cannabis-containing medicines not included in the medicinal cannabis pilot programme. Single reimbursement is granted individually to the person who buys the medicine.
Single reimbursement is available for Sativex, Epidyolex, magistral preparations with cannabis, or cannabis-containing medicines prescribed via compassionate use permit (Marinol and Nabilone).
Applications are individually assessed based on the criteria of the Danish executive order on reimbursement. The Danish Medicines Agency grants single reimbursement to patients suffering from disease if assessing that the medicine will work or considering it highly likely that the cannabis-based medicine will work. This assessment is based on treatment guidelines for the diseases in question issued by relevant medical societies. As with any other unmarketed medicine, single reimbursement is not granted before all other treatments with authorised medicines have been tried for the disease in question.
Can I drive while taking THC medicine?
If you feel sleepy, drowsy or dizzy, you should never drive, operate machinery or participate in dangerous activities. If a doctor prescribes THC-containing medicine to you, they should discuss safe driving with you. In this connection, you may be told not to drive through the issue of a so-called medical driving ban.
The Danish Patient Safety Authority presently recommends doctors who prescribe treatment with products in the medicinal cannabis pilot programme to issue a medical driving ban throughout the treatment period. See more information on driving and cannabis treatment on the website of the Danish Patient Safety Authority.
Do other countries have more evidence of the beneficial effects of cannabis?
No. Evidence does not belong to specific countries. The results of scientific studies are published in international journals in English.
Globally, only a limited number of high-quality studies have investigated the effects or side effects of cannabis in humans. So, the evidence-based knowledge available on medicinal cannabis is very limited in Denmark and elsewhere.
The Danish Medicines Agency’s guidelines on the medicinal cannabis pilot programme are based partly on international scientific literature on cannabis and experience from Holland, Canada and Israel.
Is it possible to buy legal cannabis oils in Danish shops and online shops that are not pharmacies?
The cannabis oils sold online can have many different strengths, and they usually contain both THC and CBD. The oils are sold as food, medicines and cosmetics; three areas governed by separate legislation.
In the case of cannabis oil for medicinal use, the answer is no. Cannabis oil for medicinal use can only be sold legally from a pharmacy and only to patients with a prescription from a doctor.
For information about the rules applicable to cannabis oils such as in the form of food supplements or cosmetics, we refer to the Danish Veterinary and Food Administration or the Danish Environmental Protection Agency.
Who determines if a cannabis oil is a medicine?
This is determined by the Danish Medicines Agency based on an assessment of each individual product. If the oil contains active substances like THC and CBD in quantities producing an effect in the body, or if the oil intends to treat a disease, then we will most likely classify it as a medicine. If we classify the oil as a medicine, it must be authorised or admitted to the pilot programme before pharmacies may sell it.
Many websites claim that it has become legal to sell cannabis oil if the THC content is less than 0.2%. Is this true?
After 1 July 2018, cannabis products with a content of up to 0.2% THC are no longer comprised by the rules on euphoriant substances. But there may be other rules to observe depending on the individual type of product, e.g. medicine, food supplement (or other food products) and cosmetics. It is difficult to say in general whether or not cannabis products sold in shops or online are now legal. It would depend on a specific assessment of the individual product, for example of its actual content, use, country of origin, manufacturing conditions and so on.
If the product is a food supplement or a cosmetic product, either the rules on food supplements (food products) or cosmetics must be followed.
If the cannabis product is a medicine, it must either fulfil the rules of the Danish Medicines Act or the rules of the Act on a Medicinal Cannabis Pilot Programme. Many of the cannabis oils that are sold online contain CBD in quantities that produce an effect in the body. As a result, a cannabis oil could be classified as a medicine – even if it contains less than 0.2% THC.
In our experience, the cannabis oils containing CBD and marketed online can be illegal – even if the oil contains less than 0.2% THC, the reason being that the oil fails to meet other rules regulating that specific product.
What are the risks involved for you or your child if you self-medicate with cannabis oil bought illegally?
This can be dangerous for several reasons:
Firstly, there is no way to be certain of the content of THC and CBD contained in products that you buy on the illicit market. The strength could be way too high, exposing you to the risk of serious side effects.
Secondly, even at ‘right’ doses, there could be side effects requiring medical supervision and possibly intervention.
Thirdly, illegal medicines are not controlled by the authorities. Sadly, there are many examples of illegal medicines being manufactured under unhygienic conditions and containing anything but what is on the label. Taking unknown substances is dangerous, especially if you are ill since neither you or a doctor has any way of predicting how the unknown substances will affect your disease or interact with any other medicines you take. You might end up getting sicker than you were.
Is it dangerous to give children with epilepsy illegal cannabis oil?
Yes. Children must under no circumstances be exposed to uncontrolled medicines. When it comes to CBD, specific research has investigated how legally manufactured CBD-containing medicines affect children and young people who suffer from the rare form of epilepsy called “Dravet syndrome”.
Although this research showed that perhaps there was a moderately positive effect on the number of seizures, it also showed serious side effects in the form of sleepiness, diarrhoea and elevated liver counts, which could be a sign of toxic effect on the liver in one fifth of the children receiving CBD. The Danish Medicines Agency therefore strongly advises against treating children with cannabis oil without medical supervision.
The medicine Epidyolex is authorised for the treatment of the rare forms of epilepsy called Lennox-Gastaut syndrome and Dravet syndrome.
Is it a criminal offence to buy CBD products by bypassing the doctor and pharmacy?
From a legal point of view, it is generally not a criminal offence to buy illegal medicines in Denmark for personal use. We enforce the rules on the companies – not the individual person buying products in Denmark.
However, you should be aware that if you buy and possess CBD oils or other cannabis products containing more than 0.2% TCH, possession thereof is a criminal offence.
There is a risk that illegal medicines are impure, incorrectly dosed and incorrectly labelled. Medicines that you buy on the illegal market are not safe, and we therefore advise strongly against buying illegal medicines.
In case of goods sold from foreign companies, attention should also be paid to any import rules.
See more information about medicines imported from abroad.
Is medicinal cannabis available for animals in Denmark?
No. In Denmark, no cannabis products have been authorised for horses, dogs, cats or any other animal.
Animals are not comprised by the medicinal cannabis pilot programme, and it is not possible to obtain cannabis-based medicines for animals via the exemptions in the Danish Medicines Act, neither through the issue of a compassionate use permit nor the dispensing of a magistral preparation.
The sale of products intended for animals by foreign companies could also be subject to import rules. See more information about medicines imported from another country.
If your dog, cat or any other animal becomes ill, you should ask a veterinarian for advice about the proper treatment.
Some products are declared as being “animal feed”. The Danish Veterinary and Food Administration has issued guidelines in Danish on cannabis-containing products for animals.
Cannabis and synthetic cannabinoids are furthermore on the list of prohibited substances in, for example, horse racing.