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Proposed Changes To Germany’s Medical Cannabis Framework Would ‘Seriously Impact Both Patients And Industry’ If Brought In Tomorrow

TOMORROW, Germany’s Federal Joint Committee (G-BA) is expected to announce major changes to the country’s medical cannabis framework.

These could have a significant impact on the growth rate of Europe’s largest medical cannabis market, which has expanded in double-digits consistently since legalisation in 2017.

By potentially making it far more difficult for patients to have their prescriptions reimbursed, overall growth is expected to slow, but the private prescription market is likely to experience dramatic growth.

The controversial move has been criticised by patients, doctors and businesses alike, who argue that ‘many seriously ill patients will soon be forced back into the black market’.

What is being proposed?

In late October, 2022, the G-BA’s Subcommittee on Drugs published its proposals for an amendment to its ‘drugs directive’, giving industry stakeholders until the end of November to submit their comments.

Tomorrow (March 16) the G-BA, responsible for defining guidelines and rules for the healthcare system, will announce their final decision on the amendment, which will be available to live stream here.

The committee has proposed a number of significant changes to how medical cannabis is both prescribed and reimbursed under the country’s public statutory health insurance, which currently covers around 88% of the population.

Should the G-BA’s proposals be implemented, the approval process for patients undertaken by health insurance companies will be significantly stricter, despite around 64% of cost coverage applications already being rejected.

Medical cannabis will become the very last option for patients, who will need to prove that they have tried and failed to be treated with alternative medicines.

Furthermore, extracts will be heavily favoured, with the prescription of cannabis flowers needing to be specially justified, and only necessary if the inhalative application of extracts is not sufficient.

Niklas Kouparanis, CEO and Co-Founder of Bloomwell Group, one of Germany’s largest cannabis businesses, explained to BusinessCann: “The first medication they (patients) can choose will not be flowers anymore, it will start with extracts. Most patients are using flowers, they are by far the most important part of the medication programme right now in Germany”.

Perhaps more crucially, general practitioners without additional qualifications would only be able to prescribe medical cannabis in exceptional cases, further reducing access.

Only doctors with specialisms in gastroenterology, neurology, psychiatry, psychotherapy would be allowed to prescribe medical cannabis under the new proposed system.

Specialists in anaesthesiology and neurology or those with a corresponding additional qualification in pain or palliative medicine would also be allowed to initiate cannabis therapy as the treatment would have a focus on pain.

A joint statement from the German Cannabis Industry Association (BvCW) and seven other cannabis associations, suggested this was a ‘slap in the face for patients who have been successfully treated with cannabis-based medicines for years.’

“Furthermore, parts of the G-BA draft guidelines are a direct attack on the freedom of therapy for doctors. While the current legal framework already sets major hurdles for prescribing cannabis as medicine, even fewer doctors will be able to decide on the right treatment method for their patients in the future.”

The move has reportedly been made in response to an ‘accompanying survey’ conducted by the Federal Institute for Drugs and Medical Devices (BfArM) sent to the G-BA on July 6 2022.

According to the G-BA, the companion survey suggested that the ‘THC dose when using cannabis flowers was several times higher than when using all other cannabis medicinal products’, with a mean daily dose ‘far above any dosage recommendation for therapeutic purposes that has been scientifically examined’.

While this justifies the restriction of flower prescriptions in the eyes of the G-BA, who also highlight the relatively young average age of the patient as a concern, the results have been criticised by the aforementioned consortium of industry associations.

The group suggests the survey ‘on the one hand must not be understood as a scientific study and on the other hand only depicts a fraction of the patients and is therefore not representative.’

“Despite this methodological limitation, the authors of the accompanying survey conclude, among other things, that in almost 75% of the cases an improvement in the symptoms was achieved through the use of cannabis medicinal products.

“Reported side effects were common but usually not serious. It is therefore very surprising that the drafts of the new G-BA guideline that are now available would significantly restrict access to cannabis-based medication, especially for statutory health insurance patients.”

Private market could see ‘drastic increase’ in patients 

Should the proposals be implemented as they stand, patients who are already reimbursed for medical cannabis via statutory health insurance will not be affected, meaning that the market is unlikely to shrink. However, the market will likely struggle to maintain the growth rates which have made Germany the most attractive country in Europe for medical cannabis businesses for half a decade.

Throughout 2021, exports to Germany topped 20,566kg in total including 5678kg in Q4. Recently published data suggests that this number rose to nearly 25,000kg in 2022, an increase of around 20%.

According to the latest figures from Prohibition Partners, without the proposed changes the market is due to almost double in value between 2022 and 2024.

However, with the proposed changes, the growth is expected to be heavily weighted towards those paying privately.

Mr Kouparanis suggested that while there is little data available on how many privately paying medical cannabis patients there were, the industry is currently roughly split 50-50 between private and publicly reimbursed patients.

“What will happen is that we will have a huge shift to the private payer market because patients want flowers. Patients won’t have to look for a specialised doctor, have a huge treatment plan or have to show the entire background of their treatments.

“Privately insured patients and especially the private payer market will grow substantially.”

In turn, this potential boom in privately paying patients will lead to significant cost pressures, as those paying out of their own pocket will be much more sensitive to price.

Considering patients, doctors, many businesses and even the anti-legalisation CDU/CSU party are largely against the proposals, the motivations behind the potential changes are somewhat unclear.

While the costs associated with cannabis flower may be a factor, Mr Kouparanis believes this could have more to do with Germany’s upcoming adult-use legalisation.

When legalisation eventually comes, it is expected that in principle cannabis would no longer be legally classified as a narcotic, meaning that the much higher barrier to prescribing would no longer be an issue for doctors.

This lower barrier of entry would likely lead to a spike in both applications and prescriptions for medical cannabis through public health insurance.

“I think maybe that is the first step to prepare for the reclassification of cannabis as a substance, in order to deal with the risks associated with reclassification when it comes to public costs.”

Prohibition Partners’ Lead Analyst Lawrence Purkiss concluded: “There is still a wide range of possibilities regarding the details of the new regulations.

“Based on the initial proposals however, there is a significant risk that patient access and ease of prescription will be reduced, which will seriously impact both patients and industry. Whatever decisions are ultimately taken, the regulators should be clear about what they hope to achieve, because transparency in this is currently lacking.”

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