Medicinal cannabis pilot programme
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On 1 January 2018, the act on the medicinal cannabis pilot programme will enter into force. The programme will allow doctors to prescribe a new type of cannabis product which, until now, was not legal in Denmark.
The purpose of the pilot programme is to offer patients a lawful way of testing treatment with medicinal cannabis if they have not benefitted from authorised medicines. The pilot programme is intended to provide a better basis to assess the use of medicinal cannabis at the end of the trial period.
Precisely which products will be available in the pilot programme will depend on the manufacturers of cannabis products. It is the manufacturers who will decide which cannabis products they want to import to Denmark and hence which products doctors can prescribe. So, the cannabis products available may change during the course of the four-year pilot programme.
The cannabis products available from 1 January 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 other countries. The products have rarely been tested in clinical trials, which means doctors do not have the same knowledge of effects and side effects compared to authorised medicines. As part of the programme, doctors must take full responsibility for the product they prescribe and determine the dose given to the individual patient. There is no package leaflet or a summary of product characteristics for them to consult to assess the possibilities of beneficial effects or the risk of side effects for the patient in front of them.
The Danish Medicines Agency has written guidelines for doctors to consult if they are considering to prescribe medicinal cannabis. The guidelines are based on extensive literature searches, evaluation of cannabis schemes in Holland, Canada and Israel, and 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 brief, the Danish Medicines Agency assesses that medicinal cannabis should be considered only for the following indications that are supported by some evidence that medicinal cannabis could have an effect.
The relevant indications are:
- 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 the indications after studying and assessing the relevant scientific studies conducted worldwide to investigate the effect of medicinal cannabis. The specific products comprised by the pilot programme have not necessarily been investigated. Nor have the possible side effects in the short and long term been identified sufficiently, which is something doctors and patients must pay attention to and accept.
Doctors may prescribe the products of their choice, which means that all doctors may prescribe the products comprised by the pilot programme to their patients. Neither the law nor the pilot programme’s guidelines prevent doctors from prescribing medicinal cannabis to patients with other illnesses than those appearing from the guidelines.
Doctors must always exhibit diligence and conscientiousness when they carry out their duties. It implies, among other things, that doctors must base their therapeutic decisions on whether there is scientific evidence to support the treatment and their experience with the individual patient and his or her wishes.
No doctor has a duty to prescribe medicinal cannabis.
Treatment with medicinal cannabis should not be tried before the patient has first tested relevant authorised medicine with an insufficient result.
The Danish Medicines Agency clearly recommends not to treat children and young people under the age of 18 with medicinal cannabis. One of the reasons is that we lack knowledge about the long-term effects, including how medicinal cannabis affects the brain.
Talk to your doctor to find the treatment that is best for you.