Licensing of medical cannabis is increasing
The Swedish Medicines Agency is receiving more and more license applications for medical cannabis, and most are approved.
The largest meta-analysis of cannabis and cannabinoids for non-cancer-related chronic pain was published in the Scientific Journal for Pain in October last year and covers over 100 studies and nearly 10,000 patients. It does show a significant effect, but it is not large. Of the pain patients treated with cannabis, 29 percent experienced a moderate (30 percent) reduction in pain compared to 25.9 percent of those receiving placebo. In pain intensity, the authors state that the effect corresponds to a decrease of 3 millimeters on a 100-millimeter VAS scale.
Last year, 86 applications for licensing of cannabis-based drugs and products were submitted to the Swedish Medicines Agency, showing figures requested by the World of Medicines. This is 29 more than the year before when 57 applications were submitted.
Most applications, 42 percent, concerned the product Bediol, which is the dried material of the plant Cannabis Sativa.
The first time the Swedish Medicines Agency granted a license application for Bediol, which is not classified as a drug, was two years ago, something that the Swedish Medicines World reported.
At that time, 15 license applications were granted . Last year, 27 applications were granted, which represents an increase of 80 percent. But even though the increase is significant in percentage terms, few patients are treated with the licensed cannabis product, points out Karl Mikael Kälkner, a clinical investigator at the Swedish Medicines Agency.
– If we grant a first-time application, we do so for three months. The effect is then evaluated, and if it is sufficiently good and the prescriber applies again, we grant a license for one year. Each application is counted in the statistics.
Bediol is, as I said, dried cannabis, and according to the Dutch company Bedrocan that manufactures the product, it contains a controlled amount of the cannabinoids THC and CBD.
Exactly how many Swedish patients treated with Bediol cannot Karl Mikael Kälkner answer, but estimates the number to 15-20, where the main reason is neuropathic pain.
Of the license applications for Bediol that came to the Swedish Medicines Agency last year, three quarters were granted. It is the treating physician who applies for the license, and when assessing the applications, the Medical Products Agency looks at how well they argue for their case.
– It is about describing the benefit of the current condition and how other approved drugs have been used previously in the treatment. It is also about being able to secure follow-up in a way that the patient does not get into difficulties, says Karl Mikael Kälkner.
Unlike registered drugs, for which the Swedish Medicines Agency has supervisory responsibility, in this case, the responsibility falls on the treating physician. It is for them, for example, to report any possible side effects and develop evidence to show the effects and risks.
– Cannabis is a drug class, and the only way you can use it legally is if you get it on a medical license and use it within the prescription. If you use it in a different way than prescribed, for example, it smokes instead of taking it orally, which is the prevailing treatment principle, then another legislation will be adopted.
Since last year, Denmark has been conducting a four-year trial with prescribing cannabis products for medical use, as reported by the World of Medicines. Recently, the Danish counterpart to the Swedish Medicines Agency, Laegemiddelstyrelsen, presented a summary of, among other side effects, reported in the first year.
More than 1,200 patients obtained at least one prescription for medical cannabis in 2018, and the National Board of Medicines has received 21 adverse reaction reports that can be linked to the use. Among the side effects that were classified as severe were fainting, nausea and disorientation. Among less serious side effects were reported, among other things, confusion, depression, and headaches.
The Swedish Medicines Agency has so far not received any adverse reaction reports for the medical cannabis prescribed under license in Sweden, says Karl Mikael Kälkner.
What do you think about increasing the medical prescription of medical cannabis?
– The Swedish Medicines Agency has no opinion and does not run a line regarding marijuana and whether it is useful as a drug or not. We are a regulatory authority that must be passed if you want to seek approval for a prescription, and then we evaluate the application ourselves in terms of benefit and risk.
However, the Dutch company that manufactures Bediol and other medical cannabis have not applied for approval of its products as pharmaceuticals in either the EU or Sweden.
The scientific basis for dried cannabis as a medicine is still scant. More research among Swedish doctors and dependents is also called for, which emerged at a meeting on cannabis as medicine that the Medicines World arranged earlier. It also highlighted a potential benefit of medical marijuana for, for example, patients with severe and long-term pain who have not been helped by other treatments.