A guest article by attorney Kai-Friedrich Niermann, KFN+ Law Office (im Original bei Krautinvest erschienen)
The last two weeks have been a rollercoaster of emotions for the country, but especially for the cannabis industry. Chancellor Scholz had to sack the finance minister, whereupon the traffic light coalition finally collapsed. The „traffic light“ coalition, which had been responsible for one of the most comprehensive reform projects in drug policy in recent decades, broke down largely due to differences in economic and fiscal policy. But this reform was a societal modernization that can be built upon in the coming years.
hemp liberalization and intoxication clause
Under the leadership of the Federal Ministry of Agriculture, the federal government agreed on a plan to liberalize industrial hemp in September, which was then on the agenda of the Bundesrat on Friday, 22.11.2024. In particular, the intoxication clause was to be abolished and the cultivation of industrial hemp further liberalized. The vote on the committee recommendations was surprisingly positive and the motion by the lead agricultural committee to reintroduce the so-called „intoxication clause“ into the law was rejected.
It is also interesting that the Federal Council pointed out in the opinion of its Agriculture Committee that the commercial trade in clones and seeds is permitted and should therefore be more strictly regulated, analogous to the cultivation associations (!).
Next, the law would now formally go to the Bundestag for its first reading. The original plan was that the first reading would take place in the Bundestag in week 48. This will be followed by a request for comments and a hearing. The final debate in the Bundestag was then to take place in week 51. The second round in the Bundesrat could then have taken place on 02/14/2025, with subsequent promulgation and entry into force at the beginning of March 2025.
Whether this will happen now and if the law will be put on the agenda of the Bundestag’s plenary session is unfortunately very questionable and will be clarified by Christmas at the latest. Most recently, even the CDU/CSU parliamentary group asked the federal government in November why the THC content was not increased to 1.0% THC in the industrial hemp liberalization project, which the relevant trade associations, such as the farmers‘ association, had recently demanded in order to increase the competitiveness and sustainability of the German hemp industry (BT-Drucksache 20/13684, page 76). Therefore, the CDU/CSU also seems to be interested in this legislative proposal.
If the law is no longer put to the vote before the new elections in the remaining legislative period, the project would be subject to the principle of discontinuity and the process would have to be completely restarted by a new federal government in the newly elected Bundestag. This would be possible in April 2025 at the earliest if the coalition negotiations last two months and the project is reintroduced immediately. The subsequent procedure up to the promulgation of the law in the Federal Law Gazette would take a further 4-6 months. A new legal situation could therefore be expected at the end of 2025 at the earliest.
Hemp Farm + Hempro Int. v. Federal Republic of Germany
This means that two lawsuits against the Federal Republic of Germany, which we filed with the Administrative Court in Braunschweig in August 2021, are once again relevant. We had filed applications for two clients for a general ruling on CBD flowers and hemp leaf tea with the Federal Office of Consumer Protection and Food Safety (BVL), on the basis of the Tobacco Products Act and the LFGB. As CBD flowers and hemp leaf tea are legally tradable in Austria, Luxembourg and Belgium, the general ruling was intended to establish that these products can also be legally marketed in Germany due to the free movement of goods in the EU. The BVL refused to issue the general rulings, as misuse for intoxication purposes could not be ruled out in accordance with the case law of the Federal Supreme Court.
If the Bundestag is unable to conclude the project for the liberalization of industrial hemp in this legislative period, this procedure will probably be the last attack on the intoxication clause.
According to information from the Braunschweig Administrative Court, a date is to be set this year.
In addition, more and more decisions are also becoming known in which the seizure of CBD flowers is either not confirmed by the court of appeal, or proceedings are discontinued due to lack of suspicion pursuant to Section 170 (2) of the German Code of Criminal Procedure (StPO) and the seized flowers are subsequently released. This was also the case with cannabis activist and entrepreneur Wenzel Cerveny, who initially recovered CBD flowers seized by the Regensburg public prosecutor’s office, which is sort of sensational in the history of legalization.
Case law, in particular the Federal Court of Justice in its decision on the not insignificant quantity in April of this year (“nicht geringe Menge”), seems to be overwhelmed in matters of cannabis and propagation material. Official reasonings of the law (erroneous or not) are sometimes ignored and other times completely overrated, depending on one’s own traditional convictions. In this way, trust in the rule of law is undermined in the short term and permanently damaged in the long term!
Medical cannabis
The market for medicinal cannabis has developed rapidly since its removal from the Narcotic Act (BtMG) on April 1, 2024. The latest figures published by the BfArM indicate that around 60 tons of medicinal cannabis will be imported this year, possibly twice as much as last year. The number of patients is now likely to have increased to up to 300,000.
This development has been accompanied by the opening of numerous other so-called tele-clinics, which aggressively advertise their services and also provide prescriptions to patients without any contact with a doctor. Producers and importers of medical cannabis are also constantly promoting their products and building up their brands and products.
As a result, there are countless violations of the Therapeutic Products Advertising Act, the Model Professional Code of Conduct for Physicians, including the ban on remote treatment, and sometimes also of pharmaceutical quality requirements for the medicinal flowers dispensed.
With the „Cannabis as Medicine“ Act of 2017, the legislator made a conscious decision to use cannabis with its medicinal potential and to allow it in the form of flowers and extracts as a prescription drug, without clinical studies being able to prove the efficacy and safety of cannabis. This was preceded by a legal dispute before the Federal Administrative Court, in which the seriously ill plaintiff sought an exemption for the cultivation of cannabis. The Federal Administrative Court granted the plaintiff this exemption, whereupon the then Federal Government decided to further criminalize home cultivation, but to secure the supply of „patients“ from then on by law with a regular and regulated market for medicinal cannabis. Another deliberate decision was to no longer classify cannabis as a narcotic and to further simplify the prescription and access to medicinal cannabis with the MedCanG.
Of course, the possibility of prescribing medicinal cannabis is a breach of the system, as the President of the BfArM (Federal Drug Authority), Prof. Broich, classified it at the time, and we have to learn to live with this breach of the system. This includes accepting that we do not have all the data on toxicological safety and that safety cannot necessarily be derived from traditional use. It also means that „low-threshold“ access is based on data that is not conclusive in any of the indications for which it is prescribed. In some indications, prescribing may only be based on anecdotal data, and even in well-studied pain-related indications, there is a lack of conclusive studies.
This therefore does not include discussions about „fake“ and „real“ patients, as there is no exclusion of indications. Even those who obtain cannabis at a low threshold via a tele-clinic expect health benefits from this. It is also doubtful whether a clear distinction between recreational users and patients is even ever possible.
This should as well not include the quality of the flowers suffering as a result of increased and faulty GMP washing, with the corresponding risks for the patient.
Calls for stricter rules are therefore growing louder among some pharmacists and professional associations.
In fact the legal situation should reflect the reality of life to some extent. If there is a permanent discrepancy in this respect, the law will be undermined on the one hand and undesirable reactions will be provoked on the other. The industry should therefore be advised to abandon its aggressive marketing approach and limit itself, especially as most brands and products should now be sufficiently established. Competitors and authorities must pursue competition violations and quality deficiencies more consistently, and professional associations should intervene more consistently.
Otherwise, the dried medicinal cannabis flower, which is ultimately responsible for the legal violations, will indeed come under political scrutiny. A ban on dispensing as a prescription medicine would put an immediate end to the violations, but would also massively restrict patient care and, in the meantime, even destroy hundreds of jobs and business models.
Outlook after the election
The CDU/CSU has decided to continue its culture war against cannabis at all levels. Interior Minister Reul from North Rhine-Westphalia, for example, links cannabis legalization to the Dutch mocro-mafia without even having any evidence to back this up. Neither his Ministry of the Interior, nor the Federal Criminal Police Office, nor the Federal Government can identify or confirm an increase in crime as a result of legalization. Most recently, we were able to see the negative, but also fact-free position of the CDU/CSU on cannabis in a parliamentary debate in the Bundestag.
This raises the question of whether the CDU/CSU will actually include corresponding demands for a reversal of legalization in its election manifesto for the upcoming federal election campaign. And if it does, what will happen in any coalition negotiations with one of the partners who initiated and adopted the CanG, be it the Greens or the SPD or both?
Will there have to be a compromise, and if so, what will it look like?
Will there then be stricter regulations for personal possession, home grow or cultivation associations?
The cultivation associations got off to a slow start, and the applications and permits are still very limited. But, as we can see, it can also work, as with the CSC Ganderkesee, which was the first cultivation association to be able to supply cannabis to its members. The first recreational cannabis ever to be legally distributed in Germany.
Cultivation associations therefore have little mobilization potential and would be a suitable victim of conservative symbolic politics. Or will it be the (anti-systemic) medical cannabis flower, with its potential for constant violations of the law by those involved in the supply chain?
However, it seems certain that Pillar 2 will not be introduced in this legislative period. There is not enough time left for this and the relevant staff in the Ministry of Health has already been dissolved. The possibility of implementing the so-called research clause in the KCanG should also be viewed rather critically. Even if the two positions in the Federal Institute of Food and Agriculture (BEL) that are to be set up and the corresponding ordinance were to come into force, it cannot be assumed that applications for pilot projects would be approved. I do not believe the lawmaker desires a patchwork of model projects, each with their own regulations, to be spread across the country without these projects being flanked by common guidelines.
The next major opportunities to reform cannabis policy will probably only arise once the framework decision (2004/757/jha) has been amended at EU level. In May of this year, Rene Repasi and Carmen Wegge announced a corresponding initiative by the EU Parliament on Instagram. The amendment of the Framework Decision is expected to take the entire legislative period of the new EU Parliament. Only then will further steps towards a secure legalization of cannabis be possible for all EU member states.