Experts expect to see a rise in the number of patients self-medicating unless ‘urgent’ reforms are made to medical cannabis regulations.
Last week Germany announced its revised approach to cannabis reform, including the legalisation of possession of up to 25g, self-cultivation for up to three plants and the establishment of non-profit cannabis social clubs, expected by the end of 2023.
The plans have been significantly scaled back from the full-scale nationwide legalisation initially proposed, with the new two-pillar approach instead seeing regional experiments where commercial supply of regulated cannabis products will be permitted in certain districts.
Read our full coverage on the proposals here
Following the announcement by Health Minister Karl Lauterbach on Wednesday 12 April, experts at BvCW [Branchenverband Cannabiswirtschaft e.V] an association of German cannabis organisations, called for ‘significant amendments’ to the laws around the medicinal use of cannabis.
The call stems from fears that the legalisation of recreational cannabis could lead to more patients choosing to self-medicate rather than accessing the treatment on prescription and under clinical guidance.
“In order to prevent self-paying patients from migrating to the cultivation clubs, cannabis as a medicine law must be significantly amended,” said Dirk Heitepriem, vice-president and departmental coordinator for the regulation of luxury goods in the BvCW.
“Medically necessary therapies should always be accompanied by a doctor and the costs of the medication should be reimbursed.”
The current state of the medical cannabis system
Since 2017, Germany has had one of the world’s most progressive frameworks for accessing medical cannabis legally, with around 100,000 patients now holding prescriptions.
It is one of the few countries where the costs of cannabis medication can be covered or reimbursed by health insurance companies, in some cases.
However, patients who only have access to statutory insurance must apply to have the treatment covered, with figures showing around 30-40% of cases are rejected.
In 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 cannabis medicines.
Under the proposals, only the initial prescription of cannabis and a ‘fundamental change in therapy’ will require the approval of health insurance companies. But many believe this doesn’t go far enough.
Following the announcement, the BvCW said: “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.”
Reluctance from insurance companies and doctors
Gero Kohlhaas, is a German cannabis patient, speaker of the support network SCM [Selbsthilfenetzwerk-cannabis-medizin] and member of the patient council of the International Alliance of Cannabinoid Medicines (IACM). He told Cannabis Health that statutory health insurance providers have generally been reluctant to cover cannabis medicines, citing fears over high patient numbers and prices.
Gero Kohlhaas, German cannabis patient.
They have been known to deny medical evidence in complex conditions such as ADHD and some claims have been rejected on the basis of ‘drug addiction’.
Many doctors in Germany are still reluctant to prescribe cannabis, as a result of stigma, lack of education and the bureaucracy which is currently involved in making applications to insurance companies.
Following the legalisation in 2017, statutory insurance companies were accused of ‘trying to scare’ doctors with a statement putting them ‘under pressure’ not to prescribe whilst further stigmatising patients.
The use of cannabis for the treatment of mental health conditions is not widely accepted, with the number of prescribing psychiatrists and neurologists reportedly very low. The majority of prescriptions are for cancer and chronic pain.
“There is an urgent need for changes regarding the medical cannabis law,” agrees Kohlhaas.
“As it stands patients with statutory health insurance have to apply for their medicine, and it’s hard work for the doctor too, and in 40% of cases the applications are denied. If that would change, the number of doctors who prescribe cannabis would increase and the need for patients to supply themselves would not be as high as it is now.”
An increase in patients self-medicating
If German officials move forward with the plans to legalise self-cultivation and possession, Kohlhaas also expects that many existing and future patients will choose to access their medication this way, rather than face the barriers on the prescription pathway.
“The amount of patients who medicate themselves without trying to find a prescribing doctor is very high today and it will increase in the future,” he said.
“The number of patients treated with cannabinoids is much higher in other countries, for example 10 times higher in Israel.
“The number of patients who baulk to fight for finding a doctor and getting costs covered by their statutory health insurance is again very high.
“We also expect an increase in the amount of people who want to treat their conditions with cannabis. As we know, there’s an underreporting regarding the need of treatment with cannabinoid medicine, the estimated number of unreported cases is very high.”
The changes could also potentially prevent some doctors from prescribing, with the knowledge that patients at least have legal access to cannabis.
“In the future, it could be that more doctors, who do not want to prescribe cannabis, will point out that patients can grow for themselves or go anywhere to buy their medicine,” Kohlhaas adds.
“We think that a high number of patients, depending on their disease, could grow their medicine by themselves, but surely it would be better, if they could find a prescribing doctor more easily – and if there would be a cost-takeover by their health insurance.”
Some patients prefer to grow their own medicine. In Canada and Isreal where there are established medical cannabis markets, there is a growing patient base which is opting for home growing over prescription products.
But if this is to be the case in Germany, there will need to be a push for more education and around harm reduction and cultivation.
“We do think that knowledge about consuming, growing and processing must be spread,” Kohlhaas says.
“There will be a lot of work regarding harm reduction amongst patients, but also in explaining growing techniques.”
Limitations and a potential post code lottery
There are also concerns around the proposed limits on how much consumers will be able to grow and carry, with patients often needing to consume higher doses of cannabis than recreational consumers.
“I think the limitation of the amount that can be possessed is much too low, as is the foreseen amount that could be sold in a month,” says Kohlhaas.
“Limitation on the number of flowering plants seems not very practical to us, as patients. But it’s a result of the fact that the pronounced basic points of the new law focuses not on medical but recreational use. It makes clear that wished separation between medical and recreational use can be difficult. Especially with the absence of urgent needed improvements on the medical sector.”
The aspect of the Health Minister’s approach to the legislation which has seen the most criticism from consumers is the second pillar, for adult residents in certain districts across several federal states to be permitted to buy cannabis from specialty stores.
There are concerns that those living in more ‘conservative’ regions will not have the opportunity to participate in these experiments. Meanwhile the approval and monitoring of cannabis social clubs will also be carried out by state authorities, which could be ‘problematic’.
“There are already conservative voices who want to ban growing associations in their town or region,” says Kohlhaas.
Further clarity needed on driving
Further clarity is also needed on regulations around cannabis consumption and driving.
Even though medical cannabis is legal, under road traffic laws cannabis is still treated as an illegal drug, with patients required to prove they are fit to drive.
“One of the biggest problems that exists is around driver’s licences,” Kohlhaas says.
“Today, the licences of consumers and patients are often retracted. It is pronounced that changes towards the upper THC-blood-ratio-limit will be made around the legalisation of cannabis, but when the new law becomes legal, existing upper-limits will still be in force. This will be a danger for cannabis patients and consumers.”
Freedom from stigma and criminalisation
While many hoped for more, the proposals have been largely welcomed with the promise that soon those who use cannabis for any reason will no longer face stigma and criminalisation.
In Germany there are still reports of patients being harassed and searched by police, confiscations of verified medical cannabis products and even cases of police brutality against legal patients.
“On one side most patients and consumers hoped for more, but it will still be a big step,” says Kohlhaas of the government’s plans.
“Cannabis will hopefully lose its forbidden status in future and patients will no longer be stigmatised. No one will have to be fearful of unheralded visitings by the police, like today.”
The post What do Germany’s plans for cannabis reform mean for patients? appeared first on Cannabis Health News.
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Author: Sarah Sinclair
