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Four years of cannabis as medicine – good approaches, but still room for improvement – the big analysis

Four years ago today, the “Cannabis as Medicine” law came into force, giving chronically ill patients access to medical cannabis and reimbursement from their health insurers. The joy and the expectations were great. Experts assumed that there would be 800,000 patients, analogous to the North American situation. We asked doctors, entrepreneurs, lawyers and consultants, pharmacists, patients, associations and politicians: Did the law deliver what it promised?

Lisa Haag and Moritz Förster

Authorization requirement prevents access

In many places, there is disillusionment: “The negative developments feared in advance have occurred more strongly,” looks back Burkhard Blienert, who, as drug policy spokesman for the SPD parliamentary group for four years, was directly involved in the law. The “bottleneck – prescription subject to the reservation of the MDK and thus of the health insurance funds” had turned out to be an “aggravation”. With this opinion Blienert is by far not alone. Georg Wurth for years with the hemp federation in leading position active: “At all the health insurance companies should be able to reject the therapy only in individual cases. Unfortunately, that turned out quite differently.” Jürgen Neumeyer, managing director of the industry association Cannabiswirtschaft (BvCW), assumes a surprisingly high “rejection rate of about 40 percent by the statutory health insurance companies.” Dennis Stracke, head of neurology at Medios Apotheke, also sees the high bureaucratic hurdles as a major reason why “many patients are still denied a highly effective alternative therapy to improve their symptoms of illness.”

With Dr. Franjo Grotenhermen, one of the leading physicians for cannabinoid-based medicine also criticizes the current situation quite clearly: “For several reasons, which are primarily related to the financial effects of the law, many affected persons, who according to medical opinion need an appropriate therapy, continue to be excluded from it. Even of those patients who had an exemption permit according to §3 paragraph 2 BtMG before the law was changed, not even half have received cost coverage from the health insurance company so far.”

What have been the disappointments in the last four years of CAM?

Too few physicians who rely on medical cannabis

“The fact that it’s still so difficult to find a prescribing physician after years is disillusioning,” Wurth notes. Axel Gille, President Aurora Europe speaks of still existing “direct and indirect access barriers for patients”. Pharmacist Stracke on this: “In my view, cannabis-based medicines are also still too little included in medical therapy decisions – often due to lack of knowledge and uncertainty. Therefore, we must continue to work meticulously on knowledge transfer – interdisciplinary and multiprofessional.”

Deficient information situation, recourse costs, bureaucratic effort and reservations

Jens Iwer, executive committee and initial member federation of German Cannabis patients registered association agrees with the words of the pharmacist and speaks of a “deficient information situation of the medical profession” in addition always “recourse costs for the prescribing physicians” would threaten. According to Wurth the “health insurance companies would steer the prescriptions toward pain means”, even “appropriate self censorship” with private prescriptions would operate.

Dr. Julian Wichmann, medical specialist and founder and CEO of Algea Care, provides complementary explanations: “Even four years after the amendment, many doctors still have reservations about medical cannabis.” With Algea Care, Wichman now cares for well over a thousand patients:inside each month. The tenor: Due to the “complex issue of cost coverage, access to this therapy continues to be unnecessarily impeded or even blocked”. Alexander Rieg, who founded the wholesaler Geca Pharma back in 2017, agrees: “The bureaucratic hurdles to getting the costs covered by health insurance are already enormously high.” The German Association of Pharmaceutical Cannabinoid Companies also criticizes the “high administrative effort for applying for a therapy with cannabis.”

Lack of expertise and need for research

Neumeyer sees not only the “great need for further training in the medical profession”, which is evident in several places, but also a “great need for research into evidence-based applications”. He is surprised “that the German government has financially supported only one clinical cannabis study since 2013.”

Little progress in Europe

The German law has not sufficiently fulfilled the hoped-for role model function. “I would have liked to see more states come up with reimbursement already in recent years,” regrets Jakob Sons, co-founder of the company Cansativa. Moreover, even at the European level, there is not yet a harmonized legal situation that allows for the smooth international trade of medical cannabis within the EU.” ICBC founder Alex Rogers sees the EU – albeit in terms of the “war on drugs” – more as a brake and believes “each state or EU country should be able to determine its own drug policy.” Stephen Murphy of Prohibition Partners questions the role of lobbyists “trying to limit access to a few.” He says this has been seen to have a negative impact on health care.

Regulatory ambiguity and regional differences

Jakob Sons, a lawyer by training, would have liked to see “a uniform regulatory approach to cannabis flowering at the wholesale level.” Peter Homberg, a lawyer at Dentons, also regrets that after four years, Germany has not yet succeeded in “implementing a uniform nationwide handling of regulations with regard to medical cannabis.” Says Homberg, “For example, views on the classification of medical cannabis as an active ingredient or medicinal product, on the requirement for release, and on GMP-related issues vary from federal state to federal state.” The Bundesverband Pharmazeutischer Cannabinoidunternehmen e.V. (BPC) also observes varying evaluation, interpretation and processing of applications in the 16 federal states. It says the “inconsistent handling of medical cannabis products among the regulatory authorities involved leads to massive uncertainty among physicians, pharmacists and pharmaceutical cannabinoid companies.” Rieg confirms “ambiguity and confusion” for companies. But that’s not all: “In principle, the question of whether a patient can be treated with cannabis is thus also a question of where he or she lives. So here we have to come to uniform standards and procedures,” demands Sebastian Schütze, member of the management and Director Policy at the German Pharmaceutical Industry Association (BPI) and head of the industry working group on cannabis. In his opinion, the discretionary scope of the health insurance funds should be linked to clearer guidelines and a rejection should really only be possible in very justified exceptions.

Market falls short of expectations – high prices for flowers

Lana Korneva, managing director at Drapalin Pharmaceuticals speaks of a “slower market development than expected.” The BPC would have liked to avoid the restriction of cannabis imports and the monopolization caused by the BfArM tender. Georg Wurth still remembers the years of severe supply bottlenecks and is also surprised that “the prices for hemp flowers from the pharmacy have gone up so much.” Homberg would have liked to see the “faster provision” of medical cannabis from a cultivation facility in Germany. Demecan’s Dr. Adrian Fischer would have expected “Germany to react more quickly to the rising import figures for cannabis products.”

Despite all the criticism, the vast majority of people welcome the law itself. Some developments also came as a positive surprise.

Things are going well!

Patients benefit

The major advantage of the law has remained since it came into force: “Since then, seriously ill patients with statutory health insurance have been able to obtain cannabis on prescription on a regular basis, and the more complex procedure of exceptional approvals has been eliminated,” says Neumeyer. The number of patients benefiting from medical cannabis is constantly increasing, he added. SPD politician Blienert accordingly observes an “enormous increase” in the acceptance of cannabis among people: “For many, treatment is now an option.” Jens Iwer, as a spokesman for cannabis patients, sees little abuse and welcomes the variety of strains, which made a targeted treatment possible. One of the very first cannabis patients in Germany, Maximilian Plenert, is also pleased that “people are starting to realize what potential is opening up.” Doctors and pharmacists can no longer ignore the legal phenomenon of cannabis as medicine. BPI expert Sebastian Schütze is therefore in good spirits for the future: “The experiences of many patients and doctors give reason to hope that research and development in this long-punished sector will also make progress.”

Open interpretation proves its worth

“The wording of the law was very forward-looking at the time and deliberately did not define a catalog of possible indications for cannabis therapy,” explains Dr. Julian Wichmann. An approach that has proven its worth. Doctors could thus prescribe medical cannabis for a variety of serious illnesses, which “ultimately promotes medical knowledge as well as acceptance in general,” according to the specialist. Association spokesman Wurth agrees with this finding and welcomes the “quite open interpretation for the treatment of many different diseases and that access has also been opened to flowers, not just pure THC preparations.

Professional discussions and destigmatization

Overall, many experts observe an objectification of the discussion. According to Cansativa’s Jakob Sons and Drapalin’s Lana Korneva, more physicians and more pharmacists are becoming involved with cannabinoids. “I wouldn’t have thought four years ago that cannabis would be discussed so extensively and in such a technically concrete way. Cannabis has been a perennial topic at pain management symposia over the past few years,” Sons said. Korneva welcomes the fact that more and more webinars and continuing education courses with CME certification are being offered to professionals. Alexander Rieg also observes a growing acceptance in the population. Blienert comments, “The view of cannabis as a whole has become more sober, factual, and enlightened.”

Improved evidence base

The BPC speaks of the “development of demonstrable medical evidence for cannabis in the treatment of various symptoms” and is pleased about the entry of the “therapy into practice recommendations and guidelines.” Probably also a reason why, according to Fischer, “acceptance among physicians and pharmacists has risen sharply, especially in the last two years.”

More product variety and no supply bottlenecks despite Corona

Supply bottlenecks accompanied the industry for a while. In the meantime, however, these seem to have been finally overcome: Despite the Corona pandemic, product supply to patients has been ensured, according to Aurora’s Axel Gille. So there was no relapse. On the contrary: “The variety of products is becoming more and more extensive, and new dosage forms based on prescriptions are also becoming established,” explains pharmacist Dennis Stracke. Dr. Franjo Grotenhermen also welcomes the fact that “today we have a large selection of different preparations.”

So now it’s a matter of expanding what’s already going well and improving what’s still lacking. How exactly this can look like we describe in the coming days in our second part: The wishes and suggestions of the important stakeholders four years after the law “Cannabis as Medicine”.

Based on the materials

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Seit dem Inkrafttreten des „Cannabis als Medizin” Gesetzes am 10. März 2017 ist die Verschreibung von Cannabis in Deutschland zu therapeutischen Zwecken legal. Unter ärztlicher Anleitung können Patienten ein Rezept für medizinisches Cannabis erhalten und damit medizinisches Cannabis in verschiedenen Formen erhalten und anwenden.