Medical Cannabis in Germany

Medical cannabis is one of the most dynamic fields of modern pharmacotherapy in Germany. It has undergone rapid development since the legislative change of 10 March 2017. What was previously accessible only to a small number of seriously ill patients with a special permit from the Federal Institute for Drugs and Medical Devices (BfArM) has since been available in principle to all patients with a serious condition for whom conventional therapies are insufficiently effective or not tolerated. This article examines the legal framework, prescribing practice, key indications and practical aspects of accessing medical cannabis.

## Legal Framework Since 2017

The Act Amending Narcotics Law and Other Provisions came into force on 10 March 2017 and created the legal basis for prescribing cannabis on health insurance prescription. The Bundestag passed the law unanimously – a rare cross-party consensus underscoring the medical necessity. The key provisions are:

**Prescription on narcotics prescription (BtM-Rezept):** Cannabis-based medicines and cannabis flowers may be prescribed by any licensed physician on a narcotics prescription. There is no specialist physician requirement – theoretically, any general practitioner can prescribe cannabis. In practice, however, many GPs refer to specialized pain clinics or cannabis-experienced physicians.

**Health insurance coverage:** Statutory health insurance members have a right to coverage under certain conditions. The insurer must decide on the application within three to five weeks. Rejection is only permissible in justified exceptional cases. For first prescriptions in the context of specialized outpatient palliative care (SAPV), the insurer may not reject the application.

**Accompanying survey:** For the first five years, a mandatory accompanying survey by BfArM required prescribing physicians to report anonymized data on diagnoses, treatment courses and side effects. The results, published in 2022, confirmed efficacy and tolerability in the majority of patients.

## Indications: When Is Cannabis Prescribed?

The law does not specify an exhaustive list of diagnoses for which cannabis may be prescribed. Instead, an open indication model applies: cannabis may be prescribed for any serious illness if there is a not entirely remote prospect of a noticeable positive impact on the course of disease or on severe symptoms. In practice, the following main indications have become established:

### Before 2017: The Special Permit

Prior to the legislative change, seriously ill patients could apply for a special permit from BfArM allowing them to purchase cannabis from pharmacies. This procedure was cumbersome, lengthy and inaccessible to most patients. In 2016, only around 1,000 patients in Germany held such a permit. Costs had to be borne entirely by the patients themselves, making therapy unaffordable for many. The average monthly expenditure ranged from 500 to 1,500 euros – a sum that represented a considerable financial burden, particularly for chronically ill individuals with limited earning capacity.

### Chronic Pain

Chronic pain is by far the most common indication for medical cannabis in Germany. The BfArM accompanying survey showed that approximately 76 percent of all cannabis prescriptions were for pain conditions. These include neuropathic pain (nerve pain), which often responds inadequately to conventional analgesics, chronic back pain, fibromyalgia-related pain, tumour-related pain and pain from rheumatic diseases.

Cannabis acts on pain through multiple mechanisms: THC activates CB1 receptors in the central nervous system, thereby modulating pain signalling. CBD has anti-inflammatory and anxiolytic properties that provide complementary effects. The combination of both active substances – often referred to as the entourage effect – can offer better pain relief than the isolated individual substances.

### Spasticity in Multiple Sclerosis

Spastic symptoms in multiple sclerosis (MS) are among the best-studied indications for cannabis. The oromucosal spray nabiximols (Sativex), containing THC and CBD in a 1:1 ratio, has been approved in Germany as a finished pharmaceutical product since 2011. Studies show that approximately one-third of MS patients experience a clinically relevant improvement in spasticity under nabiximols therapy.

### Nausea and Vomiting During Chemotherapy

Cannabis has a long history as an antiemetic. In oncology, it is used particularly for chemotherapy-induced nausea that does not respond adequately to conventional antiemetics. Nabilone (Canemes), a synthetic THC analogue, is approved for this purpose as a finished pharmaceutical product.

### Appetite Loss and Weight Loss

In severe conditions such as HIV/AIDS, advanced cancers or chronic bowel diseases, cannabis can stimulate appetite and counteract disease-related weight loss (cachexia). THC stimulates appetite via CB1 receptors in the hypothalamus and the brain's reward system.

### Further Indications

Cannabis is also used for a range of additional conditions:

**Epilepsy:** Cannabidiol (CBD) is approved under the trade name Epidiolex for treating rare, treatment-resistant forms of epilepsy (Dravet syndrome, Lennox-Gastaut syndrome). The approval is based on several randomized controlled trials demonstrating a significant reduction in seizure frequency.

**Tourette syndrome:** Several studies and clinical observations show that THC can reduce the frequency and intensity of tics in Tourette patients.

**Anxiety disorders and PTSD:** The anxiolytic effect of CBD is increasingly being researched for anxiety disorders and post-traumatic stress disorder. Initial clinical studies show positive effects, particularly in patients who do not respond adequately to conventional anxiolytics.

**Sleep disorders:** Cannabis, particularly THC-dominant preparations, can shorten sleep onset time and improve sleep quality. In clinical practice, cannabis is frequently used in patients whose sleep disorders are secondary to chronic pain or anxiety – here cannabis simultaneously addresses the underlying condition and the sleep problem.

**Chronic inflammatory bowel diseases:** In Crohn's disease and ulcerative colitis, there is evidence of anti-inflammatory and symptom-improving effects of cannabis, though the data remain inconsistent.

**ADHD:** Although the evidence base is limited, many patients with attention deficit hyperactivity disorder (ADHD) report improved concentration and reduced inner restlessness under cannabis medication. A small randomized study (2017) showed a trend toward improved cognitive performance under nabiximols in ADHD patients but failed to reach statistical significance. Cannabis prescription for ADHD is considered an off-label use and requires particularly careful consideration.

**Chronic headaches and migraine:** The use of cannabis for migraine has historical tradition – in the 19th century, cannabis was one of the most commonly prescribed migraine remedies. Current observational studies show that cannabis can reduce the frequency and intensity of migraine attacks. A prospective study at the University of Haifa found an average 42 percent reduction in monthly migraine days under cannabis therapy.

## Dosage Forms: Flowers, Extracts and Finished Medicines

Medical cannabis is available in Germany in various dosage forms:

### Cannabis Flowers

Dried cannabis flowers are weighed out at the pharmacy and can be vaporized or prepared as tea by the patient. Smoking is not recommended from a medical perspective as combustion produces harmful by-products. Temperatures between 180 and 210 degrees Celsius are optimal for vaporization.

Numerous cannabis flower strains from various manufacturers are now available in Germany, differing in THC and CBD content as well as terpene profile. Common strains include Bedrocan (THC approx. 22%, CBD <1%), Bedica (THC approx. 14%, CBD <1%), and Bediol (THC approx. 6%, CBD approx. 8%).

### Dronabinol (Synthetic THC)

Dronabinol is the international non-proprietary name for synthetic or cannabis-extracted THC. In Germany, it is prepared as a compounding prescription in pharmacies as an oil solution (drops) or capsules. Dosing can be very precisely titrated, which is particularly advantageous for THC-naive patients. The advantage over cannabis flowers lies in the exact dosability and simple handling – particularly for older patients who may have difficulty vaporizing flowers. A disadvantage is the absence of the entourage effect, as dronabinol contains only THC and no other cannabinoids or terpenes.

### Nabiximols (Sativex)

Nabiximols is an oromucosal spray containing THC and CBD in a 1:1 ratio. Each spray delivers 2.7 mg THC and 2.5 mg CBD. It is applied by spraying into the oral cavity.

### Nabilone (Canemes)

Nabilone is a fully synthetic THC analogue available as a finished pharmaceutical product in capsule form, approved for treating chemotherapy-induced nausea.

### Cannabidiol (Epidiolex)

Pure CBD in the form of the finished medicine Epidiolex is approved for treating certain forms of epilepsy.

## Prescribing Practice in Detail

The path to medical cannabis typically begins with a detailed physician consultation. The physician assesses whether a serious condition exists, whether conventional therapies have been exhausted or are not tolerated, and whether there is a not entirely remote prospect of improvement through cannabis.

**Initial prescription:** The physician issues a BtM prescription. Simultaneously, an application for cost coverage must generally be submitted to the health insurer. The physician prepares a justification outlining the diagnosis, previous treatment course and reasons for cannabis prescription.

**Dosing:** The dosage is determined individually and increased gradually (titration). The basic rule is: "Start low, go slow." With dronabinol, treatment typically begins with 2.5 mg THC (one to two drops) in the evening, increasing by 2.5 mg every three to seven days. For cannabis flowers, the starting dose is approximately 0.05–0.1 grams per single dose.

**Follow-up prescriptions:** Follow-up prescriptions can be issued without a new insurance application as long as therapy continues. The BtM prescription must be renewed every 30 days.

## Health Insurance Coverage

Cost coverage is a central and often contentious aspect of medical cannabis therapy. Costs can be substantial: cannabis flowers cost between 8 and 25 euros per gram at the pharmacy, and a patient with a monthly requirement of 30–60 grams can incur costs of 300–1,500 euros per month.

**Approval process:** The insurer must decide within three weeks – or five weeks if the Medical Service (MD) is consulted. If the deadline passes without a decision, the application is deemed approved (approval fiction under Section 13(3a) SGB V).

**Grounds for rejection:** The insurer may only reject coverage in justified exceptional cases. In practice, many applications were rejected in the early years after 2017, with a rejection rate temporarily around 40 percent, though this has since declined.

**Appeal:** An appeal may be lodged within one month against a rejection. Many rejections are reversed on appeal. If the appeal is also rejected, legal action before the Social Court remains.

## Pharmacies and Supply Security

Medical cannabis in Germany is dispensed exclusively through pharmacies. Since the entry into force of the KCanG in 2024, the supply situation has improved significantly, with more approved manufacturers and importers and fewer supply shortages.

## Patient Rights and Practical Information

Patients using medical cannabis should be aware of the following rights and obligations:

**Driving licence:** Patients prescribed cannabis may generally participate in road traffic provided they are fit to drive. The mere presence of THC in the blood does not constitute an administrative offence when there is a medical prescription. However, the patient must ensure that driving ability is not impaired.

**Travel:** Carrying medical cannabis abroad requires special preparations. Within the Schengen area, patients need a certificate under Article 75 of the Schengen Convention. For travel outside the Schengen area, the respective national regulations apply.

**Workplace:** Handling medical cannabis in the workplace is legally complex. In principle, patients may not be discriminated against for their prescribed medication. However, in safety-critical professions, employment under cannabis medication may be excluded.

**Storage:** Medical cannabis must be stored securely, particularly when children or adolescents live in the household.

## Medical Cannabis and the KCanG

The entry into force of the Cannabis Consumption Act (KCanG) on 1 April 2024 also had implications for medical cannabis prescribing. The most important change: cannabis no longer falls under the Narcotics Act. This eliminates the need for a narcotics prescription – physicians can now prescribe cannabis on a standard prescription. This considerably simplifies prescribing: the special documentation requirements of the narcotics prescription are eliminated, the prescription's validity period is extended, and the bureaucratic barrier for prescribing physicians is lowered.

At the same time, the removal from the BtMG has caused some uncertainty. Some health insurers have used the transition as an occasion to review existing approvals, which led to temporary supply interruptions for some patients. The regional associations of statutory health insurance physicians have clarified that the legal basis for cost coverage is not affected by the new regulation.

For patients using medical cannabis, the distinction from recreational use under the KCanG is relevant. Medical patients are not subject to the KCanG possession limits (25 grams public, 50 grams private) but may possess and carry the physician-prescribed quantity. They should always carry the medical prescription or a patient certificate to demonstrate medical use in case of checks.

## Research and Future Perspectives

Research into medical cannabis in Germany has gained significant momentum since 2017.

## Side Effects and Contraindications

Like any medicine, medical cannabis has side effects that patients should be aware of. The most common include fatigue and drowsiness (particularly at the start of therapy), dizziness and orthostatic hypotension, dry mouth, tachycardia, nausea and cognitive impairments such as concentration difficulties and slowed reaction time.

Most of these side effects are dose-dependent and subside with slow titration. The "start low, go slow" principle is therefore not only a therapeutic imperative but also the best protection against adverse effects.

**Contraindications** include severe cardiovascular diseases (particularly unstable angina pectoris and recent myocardial infarction), acute psychotic disorders or a history of schizophrenia, severe personality disorders, pregnancy and breastfeeding, and known hypersensitivity to cannabinoids. Patients with a family history of psychotic illness require particular caution and close psychiatric monitoring.

## The Doctor-Patient Relationship

Medical cannabis therapy requires a particularly trusting doctor-patient relationship. Many patients report having to consult multiple physicians before finding one willing to prescribe cannabis. Reasons for physician reluctance include insufficient training in cannabinoid medicine, concerns about misuse, the bureaucratic burden of narcotics prescribing and fears of recourse from health insurers.

Since 2017, however, the situation has improved significantly. Continuing education offerings from medical chambers, specialized cannabis consultations at university hospitals and the growing evidence base have contributed to more physicians regarding cannabis as a legitimate therapeutic option. The German Pain Society (DGS) published its first guideline on cannabinoid therapy in 2019.

## Cannabis and Other Therapies

Medical cannabis is typically not used as monotherapy but as part of a multimodal treatment concept. In pain medicine, it often complements existing therapy with conventional analgesics, physiotherapy and psychological pain therapy. In some patients, cannabis enables a reduction of opioid medication – an effect that is particularly valuable given the risks of long-term opioid therapy.

In palliative medicine, cannabis holds a special position as it simultaneously addresses multiple distressing symptoms: pain, nausea, appetite loss and sleep disturbances. The ability to treat several symptoms with one substance reduces polypharmacy, which can be particularly problematic in seriously ill patients.

## Facts and Figures

Since 2017, the number of cannabis prescriptions in Germany has steadily increased. According to data from the GKV-Spitzenverband, approximately 370,000 prescriptions for cannabis-based medicines were issued in 2023. Total statutory health insurance expenditure on medical cannabis amounted to approximately 230 million euros. The number of patients receiving cannabis on prescription is estimated at 150,000 to 200,000, with the actual figure likely higher due to private prescriptions.

The most frequently prescribed products are cannabis flowers (approximately 60 percent of all prescriptions), followed by dronabinol drops (approximately 25 percent) and finished medicines such as Sativex and Epidiolex (approximately 15 percent).

Future developments include research into specific cannabis chemotypes for particular indications, development of standardized finished medicines, exploration of the therapeutic potential of rare cannabinoids (CBG, CBC, THCV), and integration of cannabis into multimodal pain therapy concepts.

## International Comparison

Germany's approach to medical cannabis differs from that of other countries. Canada, which legalized medical cannabis in 2001 and recreational cannabis in 2018, has a more developed infrastructure with dedicated cannabis clinics and a wide range of available products. Israel, often considered a global leader in cannabis research, has a highly structured medical cannabis programme with over 100,000 registered patients and a robust research ecosystem. The Netherlands offers medical cannabis through its Office of Medicinal Cannabis (Bureau voor Medicinale Cannabis), which supplies standardized cannabis products through pharmacies.

In the United States, medical cannabis is legal in 38 states but remains illegal at the federal level – creating a patchwork of regulations and significant barriers to research. The US Food and Drug Administration (FDA) has approved only a handful of cannabinoid-based medicines, while the broader medical cannabis market operates largely outside conventional pharmaceutical regulation.

Germany's model occupies a middle ground: cannabis can be prescribed by any physician for any serious condition, but the health insurance system provides a mechanism for cost coverage that is absent in many other countries. The German approach of integrating medical cannabis into the existing healthcare and insurance framework, rather than creating a parallel system, may serve as a model for other European countries considering similar reforms.