Medicinal cannabis pilot programme
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On 1 January 2018, a medicinal cannabis pilot programme entered into force. The programme allows doctors to prescribe new types of cannabis products that were not legal in Denmark before. The pilot programme runs until 31 December 2025.
The purpose of the pilot programme is to offer patients a lawful way of testing treatment with medicinal cannabis if they have experienced no benefits from authorised medicines. That is the intention with the programme.
The products available in the pilot programme depend on the manufacturers of cannabis products. They apply for admission of cannabis products to the programme with the aim of making these products available for prescribers. The available cannabis products are therefore likely to change during the course of the pilot programme.
The currently available cannabis products can be seen on Medicine Prices, www.medicinpriser.dk.
The cannabis products included in the pilot programme are not authorised medicines – not in Denmark or any other country. Usually, the products are not tested in clinical trials like authorised medicines. So compared to authorised medicines, doctors have limited evidence of the effects and side effects. One of the implications thereof is that doctors must accept full responsibility for the prescription of a product, e.g. by determining the dose for the individual patient. They can neither consult a package leaflet nor a summary of product characteristics to assess what beneficial effects or side effects the individual patient is likely to expect.
The Danish Medicines Agency has issued a guideline for doctors who consider prescribing medicinal cannabis to their patients. The guideline is based on extensive and ongoing literature searches, evaluation of cannabis schemes in Holland, Canada and Israel, and an evaluation of the background leading to previous licensing of cannabis-containing medicines in Europe and the USA as well as assessments of the thorough review of the scientific evidence from the National Academy of Sciences (USA, 2017).
In summary, the Danish Medicines Agency assesses that medicinal cannabis should be considered only for the following indications for which there is some supporting evidence of the effect of medicinal cannabis.
Relevant indications for consideration:
- Painful spasms caused by multiple sclerosis
- Painful spasms caused by spinal cord damage
- Nausea after chemotherapy
- Neuropathic pain, i.e. pain due to a disease of the brain, spinal cord or nerves
The Danish Medicines Agency has selected these indications after studying and assessing the relevant scientific studies conducted worldwide to investigate the effect of medicinal cannabis. The actual products comprised by the pilot programme have not necessarily been investigated; nor have the possible side effects in the short and long term been sufficiently identified. It is important that prescribers and patients know and accept this.
Doctors are permitted to prescribe the products of their choice, which basically means that all doctors can prescribe the products of the pilot programme to their patients. Neither the law nor the pilot programme’s guideline prevents doctors from prescribing medicinal cannabis to patients with other illnesses than those mentioned in the guideline.
However, doctors must, as always, exhibit diligence and conscientiousness in the performance of their duties. It implies, among other things, that doctors must base their therapeutic decisions on the extent to which there is scientific evidence for the treatment and on their experience with the individual patient and that patient’s requests.
Doctors in Denmark have no obligation to prescribe medicinal cannabis.
Treatment with medicinal cannabis should only be considered when other authorised medicines have proved insufficient.
The Danish Medicines Agency strongly recommends not to treat children and young people under the age of 18 with medicinal cannabis. This is because there is limited evidence of long-term effects, including how medicinal cannabis affects the brain.
Talk to your doctor to find the treatment most suitable for you.