German medical cannabis associations call for wider regulatory reform

German associations have called for wider reforms to medical cannabis regulations to ‘reduce bureaucracy’ and open up access for patients. 

In July 2023, Germany’s federal government commissioned the Federal Joint Committee (G-BA) – the body responsible for determining which medical treatments are covered by the country’s statutory health insurance – to amend the current regulations around medical cannabis prescriptions.

The G-BA is in the process of deciding four specialist areas for which the current approval requirement should no longer apply, making it easier to obtain insurance coverage for the medicine.

However, the country’s medical cannabis associations say this does not go far enough and have called for the approval requirement to be removed for all conditions in which cannabis has shown medical efficacy. 

Medical cannabis has been legal in Germany since 2017 and can be prescribed by any doctor for patients with serious medical conditions. It is one of the few countries globally where the treatment can be covered under the public health insurance system in certain cases.

But currently, for patients with statutory health insurance, the costs of medical cannabis are only covered if previously approved by the insurance company. 

This application process is said to be ‘daunting, lengthy and bureaucratic’ for doctors and patients, with 30-40% of applications being rejected.

Previous amendments to the regulations 

The regulations around the prescription of medical cannabis and its reimbursement under the public health insurance system have been in the spotlight for some time.

In March 2023 the G-BA announced that only the initial prescription of cannabis and a ‘fundamental change in therapy’ would require the approval of health insurance companies, and could only be refused in ‘justified exceptional cases’. 

Subsequent prescriptions, changes to dosage or switching other standardised extracts or flower-based products, would no longer require re-approval in order to be covered by statutory health insurance. 

While this was largely welcomed, the Industry Association Cannabis Industry eV (BvCW) expressed concern that this may cause ‘additional uncertainty’ for patients and doctors and has been pushing for broader changes. 

Calls for the approval requirement to be abolished 

The BvCW, along with several other medical cannabis and patient advocacy organisations has now called on the G-BA to remove the approval requirement for all conditions in which cannabis-based medicines have been found to be effective. 

In a joint press release issued earlier this month, they urged the body to make the ‘necessary adjustments’ to abolish the approval requirement outlined in the Medical Cannabis Act (MedCanG), in the upcoming regulations.

This reduction in bureaucracy would not only lead to cost savings for the health insurance companies but also to better treatment for patients, they say. 

They add: “An optimal supply situation for patients can only be guaranteed if the approval requirement is completely abolished in order to give patients access to the therapy they need, regardless of their financial possibilities. At the same time, prescribing doctors must be protected from recourse. 

“The signatory associations are therefore calling on the legislature to make the necessary adjustments within the framework of the upcoming regulations, within the framework of the Medical Cannabis Act (MedCanG), or within the framework of reducing bureaucracy in the healthcare system.”

According to local media reports, 17 written statements have been submitted to the G-BA, with those entitled to comment, including BvCW, invited to an oral hearing with the Subcommittee on Medicines. This is expected to be held in the coming months, following which the G-BA will make a final decision at a future meeting. 

The statement is issued on behalf of the following organisations: Working Group Cannabis as Medicine eV (ACM), Association of German Cannabis Patients (BDCan), Industry Association Cannabis Industry eV (BvCW), Federal Association of Pharmaceutical Cannabinoid Companies (BPC), German Medical Cannabis Society eV (DMCG), Interdisciplinary Working Group of Brandenburg Pain Therapists and Palliative Medicine Specialists (IABSP), Patient Association Self-Help Network Cannabis Medicine (SCM), Association of Cannabis Supplying Pharmacies (VCA).