Minister of Health, Ellen Trane Nørby, provides insight into the recently introduced Danish medical cannabis pilot programme and its implications.
What does the Danish medical cannabis pilot programme mean for patients, producers and healthcare professionals? How will its success be measured? And what safeguards are in place to ensure the quality of the medicines manufactured? Health Europa explores with Minister of Health Ellen Trane Nørby to find out more.
What was behind the decision to begin a medical cannabis pilot programme, and how will you judge its success?
In 2018, the four-year pilot programme on medical cannabis began. The purpose of the pilot programme is to help some of those patients who have tried every possible treatment without effect. If we can help this group of patients – if these people find that their lives are just a bit better with the use of medical cannabis – that will measure the success.
We’ve initiated research projects focusing on not only the clinical effects but also the quality of life for the patients during the pilot programme.
Are you pleased with the number of patients who have been prescribed medical cannabis so far?
Yes. By the end of August 628 patients had been prescribed medical cannabis. This is positive, as we expected around 500 patients to receive treatment in the first year.
Some doctors are reportedly still reluctant to prescribe medical cannabis – how can this challenge be overcome?
The number of doctors prescribing medical cannabis increases month by month. By the
end of August 186 doctors had prescribed medical cannabis.
But there is a challenge of course and we hope to overcome this challenge with information and gradually more research. Therefore, we have invested a substantial amount into research regarding medical cannabis and we also follow the clinical trials conducted around the world in order to ensure that new medical results are transmitted to the doctors in Denmark.
How will the development programme ensure the safety and quality of domestically produced medical cannabis? Do you envision home-grown cannabis to be sufficient to meet demand?
The requirements are set out in the order on the cultivation, manufacture and distribution of cannabis bulk. The production of cannabis products must ensure that the products have the required quality, so it is safe to deliver to the patients.
Examples of requirements:
- The production of cannabis should be done in accordance with the European Medicines Agency’s Guidelines for Good Agricultural Practices (GACP) and without the use of pesticides.
- In addition, the principles of the Good Manufacturing Guidelines (GMP) of active drug substances should be followed.
- The manufacturer must document the quality determination with information on manufacturing processes and the analytical methods used and durability. The analysis methods must be validated and described in detail, as well as system suitability requirements, so that they can be transferred and repeated in control analyses carried out at the request of the Danish Medicines Agency.
It is our hope that the Danish production, hopefully soon, will be large enough to satisfy domestic demand and to export cannabis to other countries. The Danish Medical Agency closely follows the production and set-up.
Ellen Trane Nørby
Minister of Health
This article will appear in issue 7 of Health Europa Quarterly, which will be published in November 2018.