Licensed Medicinal Products instead of individual therapy – a step backwards for cannabis medicine
Germany was a pioneer in cannabis medicine
With the enactment of the "Cannabis as Medicine" law on March 10, 2017, Germany set an important precedent for seriously ill people. Doctors could prescribe medical cannabis – especially cannabis flowers and cannabis extracts – when conventional therapies were ineffective or caused excessively severe side effects. Under certain conditions, statutory health insurance companies even covered the treatment costs. For many years, Germany was considered one of the most progressive countries in Europe in the field of medical cannabis provision and became a model for many other nations.
New legal amendment makes access more difficult
With the German Bundestag's recently passed Act on the Stabilization of Statutory Health Insurance Contribution Rates, this approach is partially reversed. In the future, patients with statutory health insurance must, as a general rule, first undergo treatment with an approved cannabis-based Licensed Medicinal Products for at least six months. Only if this therapy demonstrably proves insufficiently effective can cannabis extracts be covered by health insurance. Cannabis flowers will be excluded from reimbursement in the future.
While medical prescriptions for cannabis remain possible, for many patients, access to the therapy that actually helps them is unnecessarily delayed and made more difficult.
Cannabis medicine has evolved in recent years
The medical use of cannabis has made enormous progress in recent years. Doctors, pharmacists, and researchers now possess significantly more knowledge and practical experience than just a few years ago. It is now understood that cannabis cannot be treated like a conventional drug. The various cannabis strains differ in their composition of cannabinoids and terpenes and can therefore have very different therapeutic effects. The method of administration also plays a crucial role. Cannabis flowers, full-spectrum extracts, and standardized preparations do not have identical effects and are suited to different conditions and individual circumstances. This individualization is now one of the most important principles of modern cannabis medicine.
Cannabis is far more than a Licensed Medicinal Products
The currently preferred Licensed Medicinal Products represent only a small portion of the therapeutic possibilities. Many patients report significantly better treatment outcomes by inhaling cannabis flowers or taking full-spectrum extracts than with standardized Licensed Medicinal Products . Flowers and full-spectrum extracts contain the natural diversity of cannabinoids and terpenes found in the cannabis plant. The interplay of these constituents can have a decisive influence on the therapeutic effect and often cannot be replicated as effectively with a Licensed Medicinal Products .
A well-known example is the oral spray Sativex. It is based on a standardized cannabis extract and contains alcohol. Many users report irritation of the oral mucosa or find its use unpleasant. They often do not achieve the same effect as with individually tailored cannabis flowers or full-spectrum extracts.
The freedom to choose therapy must be preserved
Which cannabis therapy is suitable for a person should be decided based on medical criteria – and not on a legally prescribed order imposed by politicians. If doctors are required to prescribe a specific Licensed Medicinal Products first, even though they know from experience that another cannabis preparation would be more suitable, their freedom to choose the right therapy is restricted. This causes patients to lose valuable time and potentially have to try a therapy for months that is not even the best option for their condition.
It is particularly incomprehensible that this regulation largely disregards the findings of recent years. Modern cannabis medicine has long since abandoned the notion that a single preparation is suitable for all patients. Today, we know that the choice of cannabis strain, the composition of its ingredients, and the method of administration can significantly contribute to the success of the therapy. A legally prescribed sequence contradicts this individualized therapeutic approach and, in our view, represents a clear step backward. Modern medicine should always be geared toward the individual needs of the patient.
Switzerland should closely monitor this development
Although the change in the law affects Germany, we at MEDCAN are following it with great concern. Since the legal amendment in 2022, the supply of medical cannabis has also improved significantly in Switzerland. More and more doctors are gaining experience with cannabis flowers, full-spectrum extracts, and various methods of administration. This knowledge is constantly growing and enabling increasingly successful therapies. In our view, it would be a mistake to restrict this progress again and reduce modern cannabis medicine to a few standardized Licensed Medicinal Products .
Our conclusion
MEDCAN advocates for scientifically sound, patient-centered, and individualized cannabis medicine. In our view, the new regulations in Germany represent a step backward. They hinder access to proven therapies and do not reflect current knowledge in cannabis medicine.
We hope that the effects of this legislative change will be carefully monitored and, if necessary, corrected. At the same time, we appeal to the political decision-makers in Switzerland to consistently pursue the path they have embarked upon towards modern, patient-centered cannabis medicine.
What is the difference between a Cannabis Licensed Medicinal Products and a full-spectrum extract?
Cannabis- Licensed Medicinal Products are industrially manufactured and officially approved medications. They are produced with a standardized composition and are approved for specific, clearly defined medical conditions.
The best-known cannabis-based Licensed Medicinal Products include:
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Sativex® – an oral spray with THC and CBD for the treatment of moderate to severe spasticity in multiple sclerosis.
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Epidyolex® – an oral CBD solution for the treatment of certain rare forms of epilepsy such as Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis.
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Canemes® – contains the synthetically produced active ingredient nabilone and is primarily used to treat nausea and vomiting during chemotherapy.
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Exilby® – a newly approved cannabis-based medicine for the treatment of chronic back pain with a neuropathic component. It is based on a standardized full-spectrum extract.
What are full-spectrum extracts?
Full-spectrum extracts are made from the entire cannabis plant. They contain not only THC or CBD, but ideally the plant's natural spectrum – including various cannabinoids, terpenes, and other bioactive compounds. Depending on the cannabis strain used, these constituents can vary considerably. This can also lead to differences in therapeutic effects. It is precisely this natural diversity that allows for more individualized therapy and is a key reason why full-spectrum extracts are so important.
The entourage effect
A key principle of modern cannabis medicine is the so-called entourage effect. This refers to the interplay of the various components of the cannabis plant. Cannabinoids such as THC and CBD can influence each other. Terpenes and other plant compounds also appear to contribute to the overall effect. Many professionals and patients are familiar with the entourage effect from their experience. Scientific evidence supporting its significance is steadily increasing. At the same time, its precise mechanisms of action continue to be intensively researched.
Why these differences are important
While Licensed Medicinal Products represent a standardized therapy approved for specific conditions, cannabis flowers and full-spectrum extracts allow for more individualized treatment. Depending on the symptoms, tolerability, and desired effect, a different cannabis strain or method of administration may be appropriate. This very therapeutic diversity has significantly contributed to the development of cannabis medicine in recent years. Therefore, many professionals and patients fear that a preference for Licensed Medicinal Products could restrict individualized treatment approaches and thus negatively impact treatment success.
The regulation also raises economic questions
Licensed Medicinal Products of cannabis can incur very high treatment costs, depending on the specific product and dosage. Preparations like Sativex, in particular, are among the most expensive treatments. If physicians are legally obligated to prescribe such a Licensed Medicinal Products even when their experience suggests that treatment with cannabis flowers or a full-spectrum extract would be more appropriate, the question of the benefit of such a regulation arises, not only from a medical but also from an economic perspective.
From MEDCAN's perspective, both medical efficacy and cost-effectiveness should therefore be considered. The goal should be to ensure that patients receive the therapy best suited to their individual situation from the outset.