Questions and answers about medicinal cannabis: What does the law say?
Can I get medicines containing cannabis legally in Denmark today?
Yes, but only if you have a prescription from a doctor and the medicine is dispensed by a pharmacy.
What types of cannabis-based medicines are available in Denmark?
Today, doctors have three possibilities of prescribing medicinal products based on cannabis:
- The medicinal product Sativex, which is an oromucosal spray for the treatment of spasms associated with multiple sclerosis. Sativex contains cannabis extracts and is an authorised medicinal product in Denmark. The product can be prescribed by specialists in neurology to patients with multiple sclerosis.
- The medicinal products Marinol and Nabilone, which contain synthetic cannabinoids. The manufacturers of Marinol and Nabilone have not applied for authorisation in Denmark. However, doctors can apply for compassionate use permits for medicines that are not authorised or sold in Denmark. Marinol and Nabilone can be imported from for instance the USA if the Danish Medicines Agency grants a Danish doctor permission to prescribe the product to specific patients.
- Doctors can prescribe magistral medicinal products, for example capsules or oils containing substances from cannabis. Magistral medicinal products are medicinal products prepared by a pharmacy for an individual patient in accordance with a prescription from a doctor.
On 8 November 2016, a political agreement was entered into on the establishment of a pilot project on medicinal cannabis, which will give doctors a fourth possibility of prescribing other types of cannabis-based products for medicinal use. The pilot project will start in 2018 and run for a period of four years.
Why has the Danish Medicines Agency not authorised more cannabis-based medicinal products?
We have authorised one medicinal product containing cannabis. The application was filed by GW Pharmaceuticals that wanted an authorisation of the medicinal product Sativex for the treatment of multiple sclerosis. We authorised Sativex in 2011. We can only assess and perhaps authorise more cannabis-based medicinal products if companies apply for authorisation of their medicinal products. We cannot encourage companies to apply for authorisation of medicines. Companies must take the initiative. We have not refused any applications for the authorisation of medicinal products containing cannabis, but we have informed several companies about the authorisation procedure.
Why can the Danish pharmacy Glostrup Apotek legally sell medicine containing cannabis that is not authorised by the Danish Medicines Agency?
Some pharmacies, including Glostrup Apotek, prepare magistral medicinal products. Magistral medicinal products are medicinal products prepared by a pharmacy for an individual patient in accordance with a prescription from a doctor. The doctor who prescribes the medicine must take full responsibility for the prescription because the medicine has not been authorised by the Danish Medicines Agency. Consequently, the efficacy and adverse reactions of the medicine have not been tested to the same extent as authorised medicines.
How can Marinol or Nabilone be purchased legally?
Doctors can apply to the Danish Medicines Agency for a compassionate use permit for the medicinal products Marinol and Nabilone. With a compassionate use permit, doctors can prescribe medicine that is not sold in Denmark. The manufacturers of the medicinal products Marinol and Nabilone have not applied to the Danish Medicines Agency for an authorisation to sell their products in Denmark. If doctors want to prescribe Marinol or Nabilone to specific patients, they have to apply to the Danish Medicines Agency for a compassionate use permit so that the products can be purchased abroad.
Is it legal to sell cannabis oil from shops or webshops that are not a pharmacy?
No. Only pharmacies have permission to sell medicine based on cannabis. And they are only allowed to sell such medicine to people who have a prescription for the medicine from a doctor.
Unfortunately, some webshops write on their websites that they have permission to sell cannabis oil in Denmark. This is not correct. No permissions have been granted for the sale of cannabis oil from ordinary shops or webshops.
Is it legal to buy or sell THC oil from shops or webshops that are not a pharmacy?
THC is an active substance extracted from the cannabis plant. The substance is classified as a euphoriant substance and covered by the drug laws. It is illegal to buy and sell THC in ordinary Danish shops and webshops.
Only pharmacies are allowed to sell medicine containing THC – and only to patients who have a prescription for the medicine from a doctor.
It is also illegal to buy or possess medicine containing THC, unless you have a personal prescription for the relevant medicine and you bought the medicine at a pharmacy.
Many websites claim that it is legal to buy and sell cannabis oil if the THC content is less than 0.2%. Is that true?
No. The information about the 0.2% is incorrect, even though you can find it on many websites. It is illegal to buy and sell cannabis oil containing THC in ordinary shops and webshops. Only pharmacies are allowed to sell medicine containing THC – and only to patients who have a personal prescription for the medicine from a doctor.
Is it legal to buy or sell CBD oil from shops or webshops that are not a pharmacy?
CBD is an active substance extracted from the cannabis plant. Products containing CBD can be medicine if they have an effect on the body. It is illegal to sell medicine without permission from the Danish Medicines Agency. In the opinion of the Danish Medicines Agency, many CBD oils are medicines, and consequently it is illegal to sell them in ordinary shops or webshops.
Only pharmacies are allowed to sell medicine containing CBD – and only to patients who have a personal prescription for the medicine from a doctor. In our experience, the illegal CBD oils contain THC – even though it appears from the bottle that the oil does not contain THC. If the oil contains THC, it is illegal to buy and possess the oil.
Are CBD oils considered to be food supplements in other EU countries?
The Danish Medicines Agency has no knowledge of other EU countries that consider CBD oils to be food supplements. We assess that by far the majority of the products that are imported as cannabis oils, THC oils or CBD oils are most likely illegal in the countries from which they are sold. They are manufactured and sold without any kind of control – and it is therefore very uncertain what these products actually contain.
What are the risks of medicating yourself or your children with THC oil or CBD oil that you have bought illegally?
It may be associated with the following three risks:
First, there may be uncertainty as to the content of the substances THC and CBD. The strength may be far too high which may be associated with a risk of serious adverse reactions.
Second, even the 'right' doses may cause adverse reactions that require medical supervision and intervention.
Third, illegal medicines are not monitored, and there are several examples that illegal medicines are prepared under unhygienic conditions and contain other substances than those mentioned on the label. It is dangerous, especially for ill people, to take unknown substances, because neither the doctor nor the patient can predict how the unknown substances will affect the disease and other medicines that the patient is taking. Ultimately, the patient has a risk of getting more ill.
Is it dangerous to give illegal CBD oil to children suffering from epilepsy?
Yes. Under no circumstances should children be given uncontrolled medicines. Particularly in relation to CBD, research has been made into how legally manufactured medicines containing CBD affect children and young people suffering from the rare Dravet syndrome
The research showed a moderately positive effect on the number of seizures, but also showed serious adverse reactions such as pronounced tiredness, diarrhoea and abnormal results on liver-function tests, which may be a sign of a toxic effect on the liver in one fifth of the children who were given CBD. Consequently, the Danish Medicines Agency strongly advises against treating children with CBD oil without medical supervision.
What will be required to have more cannabis-based medicinal products authorised as medicinal products?
In brief, companies have to apply to us to have their cannabis-bases products authorised as a medicinal product. For example, a company authorised to manufacture medicinal products can develop a cannabis-based product and apply for authorisation of the product for the Danish market.
The company has to submit documentation for the efficacy and adverse reactions of the medicinal product and must be able to document that the medicinal product is manufactured under approved conditions. The purpose of the authorisation procedure is to ensure that patients are not given inactive or dangerous medicines.
Is more evidence about any beneficial effects of cannabis available abroad?
No. Evidence is not related to individual countries. The results of scientific studies are published in English in international journals and shared in the scientific establishment and between authorities across borders.
Globally, not many scientific studies of a high quality have been conducted in humans to investigate the effect or any adverse reactions of cannabis. So the evidence-based knowledge about medicinal use of cannabis is very limited. This is the case both in Denmark and abroad.
Is it possible to get reimbursement for medicinal products containing cannabis?
If a doctor prescribes cannabis-based medicine, the doctor can apply to the Danish Medicines Agency for single reimbursement to the specific patient.
The Danish Medicines Agency may grant single reimbursement to patients suffering from diseases where it seems probable that cannabis-based medicine works. As is the case for other non-marketed medicinal products, it is a requirement that any other treatment with authorised medicinal products for the relevant disease has been tested and had insufficient effect.
The applications are processed individually in accordance with treatment guides from relevant scientific societies.
It has not yet been decided whether reimbursement will be granted to the cannabis-based products that will form part of the pilot project starting in 2018.
Consequently, the Danish Medicines Agency always advises against buying medicines illegally.
Can I drive a car if I have taken medicine containing THC?
If you feel sleepy, drowsy or dizzy, you should never drive a car, operate machines or participate in dangerous activities. If your doctor prescribes medicine containing THC to you, your doctor should inform you that the medicine may affect your driving ability, and the doctor may decide to impose a driving ban. The reason is that it is very individual how patients are affected by this type of medicine. Even if you have a driving ban, you should consult your doctor if you are unsure whether it is safe to drive a car.
The Danish Road Traffic Act lays down the rules on driving, including rules on when driving under the influence of medicine, e.g. THC, is illegal.
The Danish Patient Safety Authority is preparing guidelines for doctors on health requirements to drivers. They will come into force on 1 August 2017.