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:
The medicine Sativex is an oromucosal spray for treatment of spasms in multiple sclerosis. Sativex contains cannabis extracts and is an authorised medicine in Denmark. It can be prescribed by neurologists to patients with multiple sclerosis.
Medicines dispensed according to a compassionate use permit
This is relevant for the medicines Marinol and Nabilone containing synthetically-produced cannabinoids. The manufacturers of Marinol and Nabilone have not applied for authorisation in Denmark, but doctors can apply for a compassionate use permit for medicines that are not authorised or sold in Denmark. Marinol or Nabilone can be imported from for example the USA provided the Danish Medicines Agency accepts a doctor’s application to prescribe one of the products to a specific patient.
Doctors can prescribe magistral preparations of active substances from cannabis such as in the form of capsules or oils. Magistral preparations are prepared at the pharmacy for an individual patient according to a doctor’s prescription.
Products admitted to the medicinal cannabis pilot programme
On 1 January 2018, the Act on a Medicinal Cannabis Pilot Programme was introduced. 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 started on 1 January 2018 and runs for a period of four years.
Why hasn’t the Danish Medicines Agency authorised more cannabis-based medicines?
The Danish Medicines Agency can only assess and authorise, if relevant, more cannabis-based medicines if companies apply to have their products authorised. It is not for us to ask companies to apply for the authorisation of medicines. The initiative has to come from the companies. In 2011, the Danish Medicines Agency authorised one cannabis medicine. The application came from GW Pharmaceuticals, which applied to have Sativex approved as a medicine for treatment of multiple sclerosis.
The Danish Medicines Agency has not turned down any applications for authorisation of cannabis-containing medicines, but we have indeed told several companies about the procedure.
What will it take for more cannabis products to be authorised as medicines?
Simply put, someone first has to apply to have a cannabis product authorised as a medicine. For it to happen, a company with permission to manufacture medicines has to develop a cannabis product and then apply to have the products authorised for marketing in Denmark.
The company must submit evidence of the medicine’s effect and side effects and provide evidence that the medicine will be manufactured according to approved standards. The authorisation procedure is to ensure that patients do not get ineffective or harmful medicines.
Why hasn’t the Danish Medicines Agency admitted more products to the medicinal cannabis pilot programme?
The Danish Medicines Agency 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 private companies.
We review applications for admission of cannabis products as soon as we receive them, and we admit all products, provided the companies and products meet the requirements.
The act on the medicinal cannabis pilot programme entered into force on 1 January 2018, and several companies have told us that they are currently working on applications for new products. We expect to include more products in the pilot programme regularly.
The products currently available in the pilot programme are listed on medicinpriser.dk.
What doctors have permission to prescribe medicinal cannabis?
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 of cannabis, but they have no obligation to do so.
Only neurologists are allowed to prescribe Sativex.
In case a doctor applies for a compassionate use permit for Marinol or Nabilone, the Danish Medicines Agency will make a decision for each specific application.
Can medicinal cannabis be reimbursed?
A political agreement has made cannabis products in the pilot programme eligible for reimbursement from 1 January 2019.
Under the agreement, terminally ill patients will be reimbursed at 100% when buying cannabis products in the pilot programme whereas other patients will be reimbursed at 50% up to an annual reimbursement amount of DKK 10,000. The parties have agreed that the reimbursement will be retroactive, allowing for reimbursement of cannabis products bought in 2018. The reimbursement will be paid on a current basis to terminally ill patients from 1 September 2018 and to other patients from the 1st quarter of 2019.
Single reimbursement for other cannabis-containing medicine
If a doctor prescribes Sativex, a magistral preparation of cannabis or cannabis-containing medicines pursuant to a compassionate use permit (relevant for Marinol and Nabilone), then the doctor can apply for single reimbursement on behalf of individual patients.
The Danish Medicines Agency may grant single reimbursement to patients with diseases where cannabis-based medicine is presumed to work. However, single reimbursement can only be granted if all other treatments with authorised medicines intended for the concerned disease have been tried with no sufficient effect. This applies to any medicine that is not marketed.
The applications are reviewed individually according to treatment guides from relevant scientific societies.
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, he or she should discuss safe driving with you and in this connection you may be told not to drive by 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. The Danish Patient Safety Authority provides more information in Danish about driving and cannabis treatment on its website.
Have other countries found more evidence of the beneficial effects of cannabis?
No. Evidence does not belong to individual countries. The results of scientific studies are published in international journals in English and shared in scientific communities and among authorities across borders.
Globally there have not been that many scientific studies of a high quality that have looked at the effects or side effects of cannabis in human beings. So, the evidence-based knowledge available on medicinal cannabis is very limited in Denmark and abroad.
The Danish Medicines Agency’s guidelines on the medicinal cannabis pilot programme is, among other things, based 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. These three areas are governed by different legislation.
If the question concerns cannabis oil for medicinal use, then the answer is no. Cannabis oil for medicinal use can only be sold legally from a pharmacy and only to a patient who has been issued 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 that will produce an effect in the body, or if it is to be used for the treatment of a disease, then it will most likely be determined to be a medicine. If it is determined that the oil is a medicine, it must be authorised or admitted to the pilot programme before it can be sold by pharmacies.
Many websites claim that it is now legal to sell cannabis oil if the THC content is less than 0.2 %. Is that 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 the rules on medicines, food products, including food supplements, must still be observed.
It is difficult to say in general if cannabis products sold in shops or online are now legal. It would depend on a specific assessment of the individual product, for example of the product’s actual content, application, country of origin, production conditions and so on.
If the product is a food product, food supplements included, it must live up to the rules on food products and food supplements. You can read more about this on the website of the Danish Veterinary and Food Administration and about the rules on the CBD and THC content in food (some information may only be available in Danish).
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, and a cannabis oil could therefore be classified as a medicine – even if it contains less than 0.2% THC.
In our experience, most of the cannabis oils which contain CBD and are sold online are illegal – even if the oil in question contains less than 0.2% THC, the reason being that the oil fails to meet the other rules that apply to it.
What are the risks involved for you or your child if you self-medicate with THC or CBD oil that you have bought illegally?
There are several reasons why it could be dangerous:
Firstly, there is no way of telling how much THC and CBD is in the products when you buy products 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, side effects requiring medical supervision and possibly intervention could occur.
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 the disease or interact with other medicines that you take. You might end up getting sicker than you were.
Is it dangerous to give children with epilepsy illegal CBD oil?
Yes. Children must under no conditions 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 epileptic disorder known as "Dravet syndrome".
Although the 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.
Are CBD oils regarded as food supplements by other EU countries?
The Danish Medicines Agency does not know of any EU country which generally considers cannabis oils to be food supplements. Like Denmark, many countries believe that CBD is a pharmaceutical substance.
It is possible that specific oils with a very low content of THC and CBD have been classified in certain countries as food supplements by authorities in that specific country.
In the Danish Medicines Agency’s assessment, it is most likely that the vast majority of products imported by private individuals as cannabis oils, THC oils or CBD oils are most likely illegal in the countries they are sold in.
What will it take for a cannabis oil to be registered as a food supplement in Denmark?
Is it punishable to buy CBD-containing products by bypassing the doctor and pharmacy?
From a legal point of view, it is generally not a punishable act to buy illegal medicines in Denmark for your own consumption. We enforce the rules on the companies – not the citizens who buy the products in Denmark.
But you should be aware that if you buy and possess CBD oils or other cannabis products that might possibly contain more than 0.2 % TCH, it will also be punishable to possess it.
In any case, illegal medicines can be impure, incorrectly dosed and incorrectly labelled. Medicines that you buy on the illegal market are not safe, and therefore the Danish Medicines Agency advises strongly against buying illegal medicines.
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 as a magistral preparation. In other words, there are no lawful ways in Denmark to give cannabis-based medicines to animals.
You are not allowed to import medicines for animal use, and it makes no difference if the product is legal or illegal. Animals should not be exposed to illegal medicines. If your dog, cat or any other animal becomes ill, you should ask a veterinarian for advice about the proper treatment.
Cannabis and synthetic cannabinoids are furthermore on the list of prohibited substances in for example horse racing.