New regulations for the prescription of medical cannabis in Germany are set to make it easier for to access the treatment under the public health insurance system. We take a look at the decision and what it means for patients.
On Thursday 16 March, the Federal Joint Committee (G-BA), which is responsible for determining which medical treatments are covered by the country’s statutory health insurance, decided on new regulations for the prescribing of medicinal cannabis.
The changes are expected to make it easier for patients to access the treatment in a ‘timely’ and ‘needs-based manner’, providing ‘security’ and ‘certainty’ around their care.
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 in some cases the treatment can be covered under the public health insurance system.
However, the process for approval can be lengthy and complex, with a rejection rate of approximately 30%, despite the law stating that rejections are only permitted in exceptional cases.
Under the new regulations, announced in a press release on behalf of the G-BA, medical cannabis will be treated more in line with other medicines, with no additional requirements for the approval of dried flowers and extracts beyond the mandatory prescription requirements set out by the G-BA.
What do the new regulations say?
The new regulations have been set out with a view to making the process of obtaining a prescription for medicinal cannabis as ‘unbureaucratic as possible’ while operating within the legal framework to ensure patient safety.
Under the proposals, only the initial prescription of cannabis and a ‘fundamental change in therapy’ will require the approval of health insurance companies, and companies can only refuse initial approval in ‘justified exceptional cases’.
Subsequent prescriptions, changes to dosage or switching other standardised extracts or flower-based products, will not require re-approval in order to be covered by statutory health insurance.
Additional changes will also be implemented with the aim of improving access to cannabis treatment for palliative care patients.
Cannabis prescriptions for patients receiving ‘specialised outpatient palliative care’ will not require approval from health insurance companies. Those under ‘general outpatient palliative care’, or when starting cannabis treatment as an inpatient, will need to have their prescription approved, but this must be done within three days.
The regulations also stipulate that all doctors are still authorised to prescribe cannabis.
What do these changes mean for patients?
The G-BA announcement has been largely welcomed by organisations representing patients, health professionals and stakeholders in Germany’s medical cannabis sector.
A spokesperson for the Deutsche Medizinal-Cannabis Gesellschaft e. V. (DMCG) told Cannabis Health that the decision represents ‘progress in cannabis-based therapy’.
The changes are expected to enable patients to access medical cannabis in a ‘timely manner and in line with their needs’, as well as providing ‘security of care’.
The ‘clear guidance’ and ‘legal certainty’ for the companies which provide statutory health insurance is also an important development, the DMCG said.
“This is of crucial importance for the prescribing practice of physicians in private practice in the Federal Republic of Germany, because only in this way can the care of patients with statutory health insurance – who make up the majority of the population – be maintained at all,” a spokesperson said of the decision.
“In case of need, it now no longer appears impossible to provide patients with medical cannabis in a timely manner and in line with their needs.”
They continued: “As a medical society, the DMCG welcomes any patient-centred and professionally defensible developments in the field of medical cannabis. At the end of the day, we are talking about patients with serious illnesses who can be shown to have relief. Neither the legislature nor the executive branch bodies can ignore this.”
But the effect on everyday prescribing remains to be seen
The real impact of the new regulations will only be seen once the changes are implemented into everyday practice, with some concern expressed around whether the changes will be sufficient.
In a statement, the Branchenverband Cannabiswirtschaft e.V. (BvCW), an association which represents a variety of organisations across the cannabis sector, expressed concern that the new regulations may actually increase bureaucracy for patients and doctors, creating ‘additional uncertainty’.
“Above all, it is to be welcomed that the care of the patients has always been the focus of the discussion and that a regulation that corresponds to the law has been found here,” the BvCW said.
“At the same time, it became clear again in this process that after six years of ‘cannabis as medicine’ in Germany, the legal regulations show a great need for optimisation. The reservation of approval continues to lead to rejection rates of 30 – 40%, although the law only provides for rejection in exceptional cases.
“We fear that the drug directive that has now been presented will not lead to a reduction in bureaucracy for patients and doctors, but will also run counter to this due to the additional uncertainties created.”
The key associations which make up the BvCW were involved in talks with the G-BA prior to the decision and are said to be working on a joint position paper, which is expected to be published in the coming weeks.
The BvCW added: “We have achieved a lot for seriously ill patients in Germany over the past six years and have created an exemplary legal framework for access to medical cannabis that is a role model worldwide.
“Developing this further must be the common goal of politics, patients, doctors, pharmacists, science and industry.”
What happens now?
Subject to the approval of the G-BA proposals by the Ministry of Health, the regulations will be passed into official German law, with a revision of the 2017 Cannabis as Medicine Act.
Making the announcement, Professor Josef Hecken, impartial chairman of the G-BA said: “Today we passed regulations that do not place any additional requirements on the prescription of medicinal cannabis in the form of dried flowers or extracts that go beyond the legally mandatory and binding for the G-BA go beyond statutory requirements.
“In doing so, we want to ensure patient care with this additional therapy option for serious illnesses if necessary… The Federal Joint Committee had to weigh up the efforts to help seriously ill people with an additional therapy option and the necessary drug therapy safety.”
He added: “Overall, the regulation found is a solution with little bureaucracy within the legal framework, because it enables a good supply of medical cannabis as an additional therapy option in the treatment of patients with serious illnesses.”
