Tag: Germany

After a brew ha ha over hemp tea that made its way to federal court, there is a renewed call domestically to homogenize German law with European ruling. Is “Trickle Down Reform” from the EU a better way to handle cannabis reform?

In an indeterminate case in March, a case involving hemp tea made its way to the German federal court but the ruling did not clear up the status of hemp in the country. It is still considered a “narcotic” under German law (even though on a European level this has now been cleared up).

The case however is indicative of a larger problem that exists across Europe. The first is that the status of cannabis generally has not been determined across the region. The ruling on CBD by the European Commission last fall may have given the EU its “2018 Farm Bill” but there are much bigger issues to deal with still in the room. Think, for example, how largely ineffective the U.S. legislation has been with dealing with the vast majority of problems facing just the American industry.

This is why the European Cannabis Association was formed (to begin to move the bigger ticket items forward from cultivation through end distribution). There is an urgent need to do the same as even the Spanish government is finally moving (as the last larger economy in Europe) to recognize the medical efficacy of the plant.

Beyond that, however, there is then the problem of adoption of sovereign states of any European-wide decision on cannabis. In this case, the cry has been taken up by the hemp company involved in the German case as well as the German Cannabis Industry Association.

It is clear that it is critical that German law be in alignment with EU-wide decrees on cannabis – but what is the best approach to make this happen? Is hemp the real door opener, or rather cannabis generally? And further, now that EU policy has been set on the same, why focus on anything other than comprehensive reform and policies?

If the US is any indication, it is discussions about the entire plant which make a real difference. Without regulation on a federal level, the U.S. states are proceeding on policies that themselves will have to be changed again with a national policy change. The “hemp exception” made zero difference in any state in the U.S. when it has come to actual reform. Indeed, this has been used as window dressing to stave off the larger discussions – namely all of the ones involved in comprehensive regulation except for the level of THC allowed in hemp.

This means that in Europe, it is critical for sovereign organizations and groups to begin to unite under a single umbrella to push reform at a regional level, and in Brussels. And for the whole plant, not just part of it.

Indeed, in the recent tea case, it was the EU decision that was the deciding case law, not the German Narcotics Act. While it is painful for individual members of the industry to get caught in changing gears of regulatory requirements, it is also critical for the companies within it to realize that organization in Europe must happen regionally first, not locally, for real change to come at a legislative and legal level now.

Be sure to book your tickets now to the International Cannabis Business Conference when it returns to Europe this summer.

Without a doubt, Germany is the largest medical cannabis market in Europe (so far). There have been approximately 100,000 applications so far to the public health insurers. And there are, depending on whose estimate you are using, about 60,000 “legitimate” patients. But again, nobody is sure.

Here is what it is much easier to understand. Patients are still going through huge amounts of paperwork, stress and multiple rejections to obtain government/public health insurer-reimbursed cannabis. So much so that they are still suing (and winning). And further – many of the cases now expected to come to fruition were in fact launched almost immediately after Germany changed the law.

Two and a half years into the “German cannabis experiment” and some of these cases are now seeing their day in court if not the appeals process – which are (no surprise) coming down on the side of the patients who are bringing them.

The latest case to make the news is a Gen X woman, born in 1974. She is both on reduced earning capacity and was prescribed not even bud cannabis but dronabinol by her physician two years ago. Coverage of the same, however, has been repeatedly denied by her insurer in no small part by the botched oversight and review of the regional approver (known as the Medizinische Dienst der Krankenversicherung or MDK). All public health insurers send cannabis prescriptions to the MDK, which is why this case is also so impactful.

Initially, when the patient took the MDK to court, she lost, with a judgement against her this March.

Regardless, on appeal to the Social Court, the plaintiff was found to be within her rights to claim coverage for the drug. Further, the court found that the MDK had grossly misrepresented the plight of the patient and had written four “expert” opinions on the case without accurately describing not only the case, but also ignoring the patient’s and doctor’s rights to prescribe such a drug by focusing on perceived “negative health effects” such as an impact on appetite to dissuade coverage.

In an even more intriguing piece of fallout, the court ruled that the woman’s insurer must not only pay for the cost of the drug for a year but further, must continue to do so if she can prove a positive impact – even before the overall case has finally been decided. Not to do so would violate her basic rights (of being German).

It Still Sounds Like All Greek (if Not German) 

Here is the underlying importance of the case and why this is also likely to further force not only health insurers but all regional MDKs to get a bit more hip on medical cannabis.

1. The first is that a woman who is severely disabled – enough for it to impact her income – has a health condition that clearly fits her eligibility for medical cannabis currently.
2. The second is that her insurer turned her down because of (repeated) badly written coverage reports from the regional approver.
3. The third is that the court has decided that this decision is actually in the hands of the doctor (first) not the MDK – and since the original prescriber had justifiably prescribed the drug, it was not the right of the MDK to try to sidestep the professional opinion of the primary doctor. Nor within the purview of the insurer to rely on the MDK rather than the doctor to try to deny coverage.
4. The precedent set here is also important – namely that the insurer must pay for the drug for a year to determine if it will make a difference – and further on an interim basis while the entire discussion of medical cannabis is being examined by authorities (more generally).

Overall Longer-Term Impact – Good News For Patients

The decision is basically an escalation to the Landessozialgericht (regional social court) from the first interaction with a local one (which has now been overruled) – and further before a final regional ruling has been made. It is significant because this should (as the judges no doubt intended) stop local MDK’s from slowing down the approval of cannabis-related drugs specifically – if all other factors justify the prescription.

Logically, this should also now break a bit of a dam free in prescribing and obtaining approvals for cannabis under German healthcare. Starting with the fact that the regional approvers may not slow down the process of mandating covered payment for a drug originally prescribed (rightly) by the patient’s doctor and further for a rare condition for which no other drug could treat.

For the best update on all industry developments, be sure to book your tickets to the International Cannabis Business Conference when it returns to Europe in 2020

Even with the impact of Covid, the German cannabis market has continued to power forward. Several new distribution deals have been finalized in the last six months, and a German distributor for the domestically, bid-grown cannabis has been chosen.

Furthermore, the reference price for wholesale medical cannabis flower has also been established. 

And despite the fact that they were far from copacetic about the same, German insurers are now directly on the hook to reimburse a drug they are also now setting a commercial “end-user” price for.

This means that the country, of roughly 83 million people has a working, if still evolving market for a drug, even in its raw form, a set of standards, and at least the outline of a supply chain that is totally integrated into the mainstream medical system here.

There is no other country in the world, besides Israel, that has accomplished the same.

Medical Cannabis Is Not The Only Discussion In The Room

Furthermore, despite all the advances on other parts of this discussion (namely both “hemp” and the “CBD” markets), not to mention the now ongoing drumbeat for further reform and of the recreational kind all over the continent, there is no regulated market that even comes close to what has now been firmly established auf Deutschland.

Namely, although it can still be a fight if not a major administrative, paper-strewn pain to become a medical cannabis patient, that possibility is becoming more and more mainstream.

And further, certainly, in Germany it is absolutely possible to buy hemp-based products if you want to. You just pay out the nose for high-quality product.

What Does This Mean For Other European Countries?

There is little chance that the European Union will be able to deflect if not punt on the topic of medical cannabis this December after the WHO makes what is expected to be at least a clarifying decision about what cannabis actually is. That this may still leave CBD in the “narcotic basket” is one issue. Hopefully, hemp will drop out of the discussion – leaving still the thorny issues surrounding “novel food” which will also not just fade away.

However, by redefining the plant as a drug, even if only looking at it through the THC lens, the WHO is lining up to at least support the infrastructure created nationally by a few countries (Germany and Israel being two of the leading cannabis medical infrastructures in the world). And everyone else, will in the end, find themselves playing catch-up.

For the best analysis and understanding of the changing market in Germany if not across Europe, be sure to attend the next International Cannabis Business Conference in Europe in 2021

As the leaves begin to turn this year and the days grow shorter, a period also known as Q’3 2020, what and where is the status of the German medical cannabis market?

That is a very good question, in part because of the evolving shape of both the medical and non-medical market here.

In summary, here are the major takeaways:

Nobody Knows How Many Patients There Actually Are: By industry estimates and reports drawn from the public reporting of Germany’s association of public health insurers (GKV), there have been about 100,000 applications so far since 2017 to the major statutory health insurers (who cover 90% of the population). Of these, it is estimated that there are about 60,000 regular patients. The amount of actual patients however is currently unknown.

When one counts the actual number of activist patients, those who are buying and or cultivating in collectives, or who go to the black market out of sheer frustration in getting a doctor to write a prescription (or affording flower in a pharmacy), the pool of real patients in Germany is much, much larger.

Further medical reform here is clearly in the offing no matter how slow. And no matter how delayed German grown cannabis has been here, it is coming – distributed via one specialty distributor in Frankfurt. 

A former health minister and vice-chancellor of Germany also just made waves, if not a strong political statement when he recently joined the board of a Swiss cannabis company.

Imports Will Continue To Play A Large Role: There is no doubt in anyone’s mind that exports from the rest of the world (and increasingly, NOT Canada) are entering the German medical market.

This is true of both the medical and not medical market (including industrial hemp and what hemp extract can find its way to market in a variety of tortured routes).

The Hemp Market Is Still Intriguingly Bizarre: The British are setting sail in a new direction on all things hemp and CBD. Brussels, in the meantime, is very scientifically confused, or perhaps just bureaucratically diplomatic. They lose nothing by having their hands pushed by a new UN decree on the status of cannabis now on the schedule for December. The losers, generally, are hemp producers in Europe who are not ready to play the game of hop, skip and specialty import supply chain tactics. There is light in other words, but also clearly a bit of tunnel left to go.

Be sure to book your tickets for the International Cannabis Business Conference next year when it returns to Europe.

Germany is undisputedly the market leader in Europe when it comes to sales and overall numbers of cannabis consumers. However, prices have remained high here for a number of reasons. That is now coming to an end.

Pharmacies Have Been Forced To Lower Their Markups
Until the beginning of March 2020, German pharmacies were allowed to mark-up cannabis from distributors by 100%. This has now been renegotiated between the German Pharmacy Association and the German Association of Public Health Insurers. Until now, pharmacies have been unconcerned with price. Now, with markups lower, they will have to change their procedures.

More Competition Among Distributors
There are currently 50 distributors who are authorized to distribute medical cannabis in Germany. That is up from 17 last year. At the same time, the amount of cannabis entering the country has remained relatively stable over the last year. In addition to flower, there is now another competitor for the dronabinol (synthetic) market. Price competition between distributors is about to heat up. They have sold floss product to pharmacies for upwards of $10 a gram for about the last year. Before that, prices were even higher. 

Price Wars Between Producers
Producers have sold into the German market at prices that have steadily dropped. Until the beginning of 2019, there were reports of Canadian LPs selling floss at CA $13 dollars a gram. As of now, with price impacts felt just about everywhere in the chain, the standard price per gram is still about 5 euro a gram. Expect that too, to drop as German domestic production comes online (set by the government at 3.20 euros a gram). On the dronabinol side of the market, this too is expected to drop with a new competitor now aiming for the German market, to compete with Canopy Cannabis, who bought the domestic German producer at about the time that the German cultivation bid was decided in the first half of 2019.

Direct Impact On Patients
While the “average” German patient who obtains cannabis by prescription and has been approved by their public health insurer, the vast majority of cannabis patients are still stuck in a very difficult place. Obtaining pre-approval for coverage is a long and drawn-out process. With that approval, publically insured patients pay only $12 for their prescriptions. Without it, they are forced to pay more than $20 per gram. Private patients, who may represent as much as a quarter of the market (but nobody is sure) also have to pay out of pocket. And nobody is quite sure how many cannabis patients there actually are.

Domestic Production Is Coming
The biggest existential threat to all importers right now is German domestic cultivation. That is expected to become available starting at the end of 2020. 

Bottom line? There are big shakeups coming, and in every direction.

For an up-to-date analysis of the German market, be sure to book your tickets for the International Cannabis Business Conference when it returns to Berlin.