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US-Regulation today

Currently, cannabis remains illegal under federal law as a Schedule I drug, but state-level policies vary. Twenty-four states and D.C.—covering 53% of the population—have legalized cannabis for recreational use, while 38 states permit medical use. This disparity creates a complex legal landscape, often leading to excessive tax burdens and limited access to banking services for cannabis retailers. However, the upcoming election may change policies beyond US borders.

What’s on the Line for Cannabis Regulation?

For the first time, both major presidential candidates have shown support for a significant change in federal cannabis policy. This bipartisan shift suggests that regardless of who wins, the US may be inching toward a more unified approach to cannabis regulation. Voters in Florida, North Dakota, South Dakota, and Nebraska will also have a direct say in cannabis legalization through ballot measures, signaling the growing momentum for reform across the country.

Kamala Harris’s Position

Kamala Harris has been a prominent advocate for cannabis reform. In 2019, as a senator, she was the lead sponsor of the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, a bill aimed at descheduling cannabis that would remove cannabis entirely from the Controlled Substances Act (CSA). Although it did not pass the Senate, this showcases how Harris’s stance on cannabis has evolved significantly over time. In 2010, as California’s Attorney General, she opposed a state measure to legalize recreational cannabis. And ten years later, she was advocating for complete federal legalization. Currently, as Vice President, Harris leads discussions on criminal justice and cannabis reform within the Biden administration, focusing on rescheduling cannabis under a less strict section of the CSA.

Donald Trump’s Position

Donald Trump’s position on cannabis has been more inconsistent. He supports the idea that the legalization of recreational cannabis should be left up to individual states and recently stated he would vote for Florida’s ballot measure to legalize it. Trump has also endorsed the rescheduling of cannabis under the CSA, aligning this aspect of his stance with the Biden administration’s current efforts. However, Trump’s approach to medicinal cannabis has been somewhat ambiguous. While he stated in 2016 that he “likes” cannabis when used for medicinal purposes and believes its health benefits should be explored further, he has also expressed doubts about its effectiveness, claiming it might do “significant damage.” Moreover, during his presidency, his administration took several anti-cannabis actions, including rescinding an Obama-era policy that directed federal officials not to pursue cannabis-related prosecutions in states where the drug is legal.

Rescheduling Uncertainty: Potential Ripple Effects on European Cannabis Policies

Rescheduling cannabis would be a significant reform but not equivalent to full descheduling. President Biden has acknowledged that rescheduling at the federal level is “not a done deal.” While the Justice Department proposed moving cannabis to Schedule III, the final decision lies with the DEA, with a public hearing scheduled for December 2. This uncertainty has weakened investor confidence. If rescheduling stalls, barriers to medical research and commercial activities will persist. Federal reclassification could also influence European policies, prompting countries to reconsider regulations and impacting trade, research, and legal frameworks, given the US’s role in the global cannabis market.

This election could mark a turning point for cannabis regulation, not just in the US but across the globe, as countries closely watch how the evolving American stance might shape the future of cannabis policy worldwide.

Anything else?

Do you have specific questions or suggestions for the Cannabis Briefing? Then send us an email to briefing@www.cansativa.de. If you are interested in revolutionising the cannabis industry with us, then stay tuned and follow our briefings!

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With legalising greetings,

1. What is Grashaus Projects, and who is behind it?

Grashaus Projects is a pilot initiative in the Swiss canton of Baselland, designed to study the legal distribution of cannabis and its impact on participants’ health and well-being. The project aims to determine whether legal cannabis distribution, combined with professional advice through our retail model, can promote safer use. We operate two dispensaries in Allschwil and Liestal, with space for up to 4,000 participants—about 1,000 have registered so far. The study, running for up to five years, has specific criteria for participation: participants must live in Baselland, be of legal age, meet certain health requirements, and already be regular cannabis users. The project is supported by the Sanity Group in collaboration with the Swiss Institute for Addiction and Health Research (ISGF) in Zurich, , which is responsible for the scientific part of the project. Importantly, the project is non-profit, with all proceeds reinvested in cannabis research or addiction prevention or donated.

2. What are the goals of the project?

The Grashaus Project, like the other Swiss pilot projects, seeks to explore whether and how legalization in Switzerland can create value. The goal is to test different models of legal cannabis distribution, scientifically monitor participants’ consumption data, and prioritize consumer protection and harm reduction. Additionally, we aim to promote safer use and destigmatize cannabis, moving it out of the “taboo” category and integrating it as a normal part of society. We hope to support a responsible and value-driven approach to legalization.

3. What challenges did you encounter during implementation?

The biggest challenge was working with the authorities, particularly the Federal Office of Public Health (BAG), as our key stakeholders. The approval process was lengthy and required a lot of patience due to numerous questions and adjustments. This can be a significant hurdle, especially for smaller organizations with limited resources. Gaining acceptance within the local community was also crucial, and we had to work hard to garner support. Additionally, reaching potential participants has been challenging, given the strict rules on how the study can be communicated.

Another aspect we’ve observed is that the pricing of the products can be a challenge and is not always seen as an attractive alternative to the illegal market. Some consumers find the prices too high, especially compared to cheaper offers from dealers who often provide bulk discounts. Such pricing promotions are not possible in our studies, as they could encourage consumption. The higher prices are partly due to higher production costs and the fact that only a few domestic growers are licensed, limiting the selection. It’s also challenging to introduce new products into the study, which restricts product variety. Many cannabis enthusiasts enjoy trying new strains, and due to the pricing and limited selection, some participants may turn back to the illegal market.

4. What initial insights or trends have you observed?

After the first six months, we conducted an interim evaluation. We found that participants previously consumed cannabis from illegal sources on 20 days per month, but now it’s down to 10 days—a halving of illegal use, which we see as a positive trend. Interestingly, flower consumption is slightly declining, while the use of extracts has increased by 50%, which is positive as these products are not smoked and fall under safer use products. High-THC products remain the most popular, likely due to habits from the illegal market, where high THC levels are often advertised but rarely achieved.

5. What learnings could be valuable for Germany’s legalization efforts once model projects are allowed there?

What has been done well and what Germany should definitely adopt is the testing of various distribution models. In Germany, this could be done through social clubs, pharmacies, specialty stores, and possibly even consumption lounges, similar to coffee shops—something that is not possible in our pilot project. This approach would best identify which models most effectively promote education, safer use, and consumer protection.

I also hope that Germany, like Switzerland, allows not only the sale of flowers and hashish but also edibles, oral extracts, vape pens, and possibly products like rosin, which are currently not permitted in Switzerland. The demand is there: many people want to try alternative consumption methods, move away from tobacco, and use products that are gentler on their lungs.

Another point is the sourcing of products. In Switzerland, all products come from licensed domestic growers, which limits the selection since imports are not allowed. To create a viable alternative to the illegal market, Germany should allow more flexibility, whether through the import of cannabis from international producers or by making it easier for smaller growers to obtain licenses. This would increase product variety and enhance the attractiveness of legal offerings.

Another positive aspect is the enrollment process for the study. I believe it’s very important to establish and verify participation criteria because, at the end of the day, it’s about protecting and prioritizing the health of the participants.

Anything else?

Do you have specific questions or suggestions for the Cannabis Briefing? Then send us an email to briefing@www.cansativa.de. If you are interested in revolutionising the cannabis industry with us, then stay tuned and follow our briefings!

We wish you a good read!

With legalising greetings,

Czech Republic’s Progressive Cannabis Reforms

The Czech Republic is advancing cannabis reforms under the “Cannabis Management Act,” with plans for personal cultivation, licensed dispensaries, and a seed-to-sale tracking system. A leaked draft of the bill revealed that it goes further than Germany’s model by proposing a fully regulated cannabis market. However, the recent resignation of Jindřich Vobořil, the reform architect, has raised concerns about its implementation. Despite this, the bill is still seen as a major development in EU cannabis regulation.

The Netherlands’ Experiment with Legal Cultivation

The Netherlands, known for its tolerance of cannabis, still has limited legal production and distribution systems. In late 2023, the Controlled Cannabis Supply Chain Experiment began to assess whether the production, distribution, and sale of quality-controlled cannabis could be regulated. The experiment aims to study the impact on crime, safety, and public health. Despite challenges like supply shortages, the experiment expanded to eight additional cities this summer. The “Wietexperiment” is expected to continue until 2028.

Malta’s Cannabis Associations

Malta’s cannabis reform came into effect in 2021, and the first nonprofit cannabis clubs began providing products to members earlier this year. While cannabis possession (up to 7 grams and 4 plants) is decriminalized, full legalization has not been enacted. Cannabis can only be accessed through regulated, nonprofit associations, with strict limits on purchase amounts. Each club can serve up to 250 members and must adhere to guidelines overseen by the Authority for the Responsible Use of Cannabis (ARUC). New amendments were introduced emphasizing product safety, including requirements for indoor or greenhouse cultivation, quality control for water sources, and enhancing community involvement through nonprofit associations. There are currently eight clubs operating.

Switzerland’s Pilot Programs

Switzerland’s cannabis laws remain strict, but recent pilot programs are exploring regulated access. These pilot trials, launched in 2022, allow a limited number of participants to legally buy and consume cannabis under strict regulations, aimed at studying the effects of legal cannabis on public health and crime. The findings are meant to inform future cannabis policies, focusing on harm reduction and controlled safer consumption methods. By now six pilot projects are operating in different cities with diverse approaches and can already present initial findings.

Challenges and Opportunities

Across Europe, cannabis reform is a topic of increasing public and political debate. While Germany and Malta have made concrete legislative changes, others, such as Switzerland and the Netherlands, are in the experimental stages. Regulatory challenges persist, especially regarding supply chain management, product quality control, and ensuring that legal markets can outcompete the black market. The ongoing shifts in European cannabis policy signal that the continent is moving towards a more progressive and regulated future, though each country’s approach is unique.

Anything else?

Do you have specific questions or suggestions for the Cannabis Briefing? Then send us an email to briefing@www.cansativa.de. If you are interested in revolutionising the cannabis industry with us, then stay tuned and follow our briefings!

We wish you a good read!

With legalising greetings,

Background of the decision

For those who might not recall: In July 2023, the German Bundestag passed the Engpassgesetz (ALBVVG1), which, among other things, defined that certain specialist doctors should be excempted from the so-called Genehmigungsvorbehalt. This prior approval requirement meant that health insurance companies had to approve the prescription for reimbursement beforehand. The G-BA was tasked with defining specialist groups and the necessary medical qualifications , that would no longer require prior approval (Genehmigungsvorbehalt) from health insurance for prescribing medical cannabis.

In November, the G-BA published a draft and consulted various stakeholders for feedback. Several associations called for completely abolishing the Genehmigungsvorbehalt or at least including general practitioners, who are the second largest group of prescribers. They play a crucial role in the current patient care landscape with cannabis medicines, especially in rural areas, and considering the growing shortage of specialists.

Implementation and Impact

While the Committee took their time, the decision was more positive than originally anticipated. Doctors from 16 specialties, including general medicine, anesthesiology, internal medicine, neurology, and psychiatry, can now prescribe medical cannabis without prior health insurance approval at GKV expenses. Five additional qualifications, such as geriatrics, palliative medicine, and specialized pain therapy, are also included. The G-BA ensured that the feedback from the consultation period was considered and selected those specialists who can best assess the requirements for a cannabis prescription.

This change empowers a large number of German medical practitioners to prescribe medical cannabis more freely and less bureaucratic. The decision eliminates the cumbersome approval process from health insurance companies, significantly reducing the administrative workload for doctors. As a result, patients can expect faster access to necessary treatments.

Documentation and Compliance Remain the Same.

It is important to note that while the process for doctors to prescribe medical cannabis at the expenses of the GKV has been simplified, the requirements for a cannabis prescription to be reimbursed by health insurance have not changed. Patients in Germany have a statutory right to medical cannabis if they have a life-threatening illness or a serious condition that significantly impairs their quality of life. Additionally, a series of conditions must be met. Therefore, doctors must still carefully document the prescription of medical cannabis, including the indication, treatment course, and achieved therapy results.

Patient Advocacy Pays Off

This decision is thanks to the long-standing efforts of stakeholders who have highlighted the issues faced by severely ill patients waiting for health insurance approval. Their persistent advocacy has been instrumental in driving this change. The decision marks a significant shift towards the normalization of medical cannabis in the healthcare system, potentially increasing its acceptance and integration into standard medical practice.

Anything else?

Do you have specific questions or suggestions for the Cannabis Briefing? Then send us an email to briefing@www.cansativa.de. If you are interested in revolutionising the cannabis industry with us, then stay tuned and follow our briefings!

We wish you a good read!

With legalising greetings,

Self-Medication Through Self-Cultivation? A Historical Perspective

The idea of self-medicating with home-grown cannabis is far from new. There was a time when this was the only option for many patients facing a lack of alternative therapies. Take, for instance, the landmark case of an MS patient who was acquitted of illegal possession and cultivation of cannabis because he had no other therapeutic options. This case played a pivotal role in paving the way for the legalization of “cannabis as medicine” in Germany, eventually in 2017.

Since then, Patients can obtain cannabis via prescription, ensuring product safety and quality, and significantly enhancing medical care. Furthermore, as of April 1, with the new Cannabis Law (CanG), medicinal cannabis saw additional regulatory relaxations, making it no longer classified as a narcotic and available through standard prescriptions.

Administrative Relief and Destigmatization

Pharmacies have experienced significant relief with the removal of cannabis from the Narcotics Act. Cannabis no longer needs to be stored in safes, and the cumbersome documentation requirements for narcotics have been lifted. These changes save time and reduce administrative burden. However, medical cannabis remains a prescription drug, that requires identity and plausibility checks in the pharmacy. Such controls are essential to ensure patients receive high-quality and safe medication. Cannabis flowers are also analytically tested by manufacturers to detect and prevent unwanted contamination.

The partial legalization has also helped to destigmatize the topic of cannabis in the public eye. Cannabis is increasingly seen as medicine and not just a recreational substance. This is an important step in reducing stigma and recognizing cannabis as a legitimate therapeutic option. The increased public attention has helped to improve understanding and acceptance of medicinal cannabis.

Challenges Ahead: Separating Medicinal and Recreational Cannabis

But with the partial legalization of recreational cannabis, some new challenges have emerged. Many healthcare practitioners worry that the medical significance of cannabis might be overshadowed by its recreational use. There is concern that patients might opt for self-medication through home or club cultivation, potentially compromising their treatment.

Self-therapy with cannabis without medical supervision can lead to inadequate treatment of symptoms or underlying conditions. Wrong dosages and usage frequencies can cause interactions and side effects, risking patient health. Additionally, medicinal cannabis is subject to the specifications in the EU monograph, which ensure the active ingredient content, purity, and absence of contaminants. These standards protect patients and guarantee therapeutic efficacy.

While homegrown or club-grown cannabis is likely safer than from the illicit market, it is not intended for medical treatment and can pose health risks such as microbial contamination, especially for immunocompromised individuals. Not only the product quality itself is essential but usage also differs significantly. Patients typically take cannabis daily for medicinal purposes, use various administration routes, and apply controlled, low doses to alleviate their symptoms. They often suffer from poor physical health, psychological well-being, and overall life quality. Their primary goal is symptom relief rather than getting high, which is the main difference from recreational users who use cannabis mainly for pleasure, relaxation, and social effects.

The Path Forward

As we navigate this new landscape, it is crucial to maintain a clear distinction between medicinal and recreational cannabis. Ensuring stringent quality controls and medical supervision for medicinal cannabis will protect patient health and uphold the therapeutic benefits of this versatile plant.

Anything else?

Do you have specific questions or suggestions for the Cannabis Briefing? Then send us an email to briefing@www.cansativa.de. If you are interested in revolutionising the cannabis industry with us, then stay tuned and follow our briefings!

We wish you a good read!

With legalising greetings,

From the 1st of July, a new framework, the Cannabis Flower Monograph of the European Pharmacopoeia (Ph. Eur.) is set to be implemented in 39 countries, establishing a gold standard for the quality, safety, and efficacy of medical cannabis products. Join us as we unpack these developments, understand their broader impact, and consider what this means for the future of medical cannabis therapy across the EU.

Enhanced Quality and Safety

EU monographs are crucial documents that establish quality standards for medicinal products. Essentially, a monograph is a detailed written study that provides specifications for the identity, purity, and quality of a medicinal substance. It includes tests, procedures, and acceptance criteria, which are legally enforceable in regulatory settings.

Germany, along with other European countries such as the Netherlands, has played a pioneering role in establishing strict standards for medical cannabis, significantly influencing the framework for the EU. The development of the Cannabis Flower Monograph for the German Pharmacopoeia (Deutsches Arzneibuch, DAB) began in 2015, shortly after the announcement of new legal regulations for the medical use of cannabis flowers and extracts. The first version of such a monograph was published in May 2016 in the German Drug Codex (Deutscher Arzneimittel-Codex, DAC) and was later revised multiple times.1 These strict standards, together with those of other leading European monographs such as the Dutch, inspired the development of the new EU Monograph by the European Pharmacopoeia (Ph. Eur.), which harmonizes quality requirements within the EU.

In October 2022, the European Pharmacopoeia (Ph. Eur.) published the initial draft of its new cannabis flower monograph, seeking feedback from the public.2 After a period of public consultation, the draft reflects a collaborative effort to incorporate stakeholder feedback into the regulations. This inclusive approach ensures that the monograph addresses the concerns of manufacturers, healthcare providers, and patients alike, promoting broader acceptance and adherence.

What does the new cannabis flower monograph say?

Key aspects of the monograph include stringent controls on the chemical composition of the cannabis flower. For instance, the contents of total tetrahydrocannabinol (THC) and total cannabidiol (CBD) in the product must not deviate from the label by more than ±10 percent. This ensures that patients receive medications consistent with what is prescribed, enhancing both safety and efficacy.

Additionally, the monograph specifies that foreign matter must constitute no more than 2% of the preparation, and defines that prescribed cannabis flower must not contain any seeds or leaves longer than 1.0 cm. These measures prevent contamination and ensure product purity but may present challenges for some manufacturers.

Noteworthy revisions within the EU monograph include the increase in allowable drying loss from 10% to 12%. Additionally, arsenic has been newly classified as a heavy metal, leading to significantly stricter permissible limits for heavy metal contamination—a positive development enhancing patient safety.

Legal and Regulatory Impact

The Ph. Eur. Cannabis flower monograph, which will replace existing national monographs in countries like Germany, Denmark, the Netherlands, and Switzerland, is legally binding. This means that from July 1, 2024, all medical cannabis products in the EU must comply with these standards. This harmonization eliminates discrepancies in quality standards across borders, facilitating analyses in laboratories and pharmacies as well as smoothening regulatory processes and market operations.

This updated EU monograph represents a crucial step toward uniform quality standards across the EU, ensuring that all medical cannabis products adhere to stringent guidelines prioritizing patient safety and treatment effectiveness. Despite the many challenges cannabis patients face, such as access difficulties, and the stigma surrounding the therapy, we are heartened by these small but significant improvements. These changes promise to enhance the therapeutic experience for patients across Europe, ensuring they receive the safest and most effective treatments possible.

Anything else?

Do you have specific questions or suggestions for the Cannabis Briefing? Then send us an email to briefing@www.cansativa.de. If you are interested in revolutionising the cannabis industry with us, then stay tuned and follow our briefings!

We wish you a good read!

With legalising greetings,

You are both a pharmacist and an entrepreneur. What motivates you?

For one thing, I’m often under pressure, yet I try to remain as relaxed as possible. I am somewhat traditional in my view that a pharmacist should act more like a family doctor than a merchant. In the same way as a family doctor, we serve as the local pharmacy for many. We advise and consult; people know and trust us, especially in areas where we have specialized like #kinkgesund and medizinal.com. Meanwhile, I am fully in the startup mindset. We are working to reinvent the pharmacy. As an entrepreneur, I am passionate about personalized medicine, which I hope will emerge soon. Personalized pharmacy fascinates me! In this area, I consider myself an activist, highly critical of Big Pharma and the industrial approach to people’s health. Things need to change.

One of your main focuses is providing medicinal cannabis. What have been the greatest challenges for you as both a pharmacist and entrepreneur in recent years?

Medicinal cannabis still has not fully established itself, which presents daily challenges for me. The greatest difficulties stem from our role as a pharmacy, including resistance from insurance companies, misinformation from associations, and biased Pharma PR. There’s a prevailing belief that only therapies involving finished pharmaceutical products are viable, leading to a subtle distrust towards patients who are supposedly only meant to receive standardized industrial products. This undermines our pharmacological expertise, despite our deep understanding of how these treatments work and their benefits to patients. It appears that the Joint Federal Committee (German: Gemeinsamer Bundesausschuss, G-BA) and the Federal Ministry of Health are undermining our efforts to integrate cannabis flower therapy. Moreover, the lack of research on medicinal cannabis further complicates the situation.

What, in your opinion, is the biggest misconception about medicinal cannabis?

We still face the same old prejudices. A major misconception is that cannabis that can be smoked cannot be medicinal. Many think that prescriptions for cannabis flowers are merely for pleasure. But that’s incorrect. The “failed legalization”, as I see it, is worrying because I fear that insurance companies will eventually succeed, and the funding for the flowers will be cut off. (We managed to prevent this once in 2023). This would be detrimental for patients with severe illnesses who genuinely benefit from it.

What has changed for you since the enactment of the cannabis law?

The chaos in pharmacies has increased. We struggle to distinguish between genuine patients and recreational consumers. The influx of inferior goods and the rise of dubious online platforms (and I don’t want to generalize) complicate our work further. Unfortunately, we missed establishing a clear separation here. It is not the pharmacy’s role to decide whether someone is truly a patient or whether the prescribing doctor is legitimate.

Doctors may find it easier now to address the issue and make prescriptions. However, despite legalization, public perception hasn’t shifted much. The topic has gained societal acceptance, yes, but whether more commitment is seen from already-known doctors or whether new doctors are getting involved is hard to tell.

Why do you consider the legalization to have failed?

The announcement that Germany would legalize cannabis prompted manufacturers to ramp up capacities for a market that doesn’t exist. The second pillar of legalization1, which would address commercialization, is missing. What was supposed to reach cannabis shops is now being pushed into pharmacies. This has resulted in a dubious online infrastructure that declares consumers as patients. The second pillar is clearly lacking. I advocate for medicinal cannabis as a serious medicine, not for serving recreational consumers indirectly. I aim to establish a robust second pillar to then discuss where recreational consumers can purchase their cannabis in the future.

What would you like from the federal government to sustainably strengthen and further develop the provision of medicinal cannabis?

The legalization has pressured medicinal cannabis because the government failed to clearly differentiate it from recreational cannabis. This urgently needs to be addressed! In my opinion, we need more government quality controls and significantly more research. We must work towards establishing binding indications. Additionally, better recognition and funding of patient-specific pharmacy work are essential. We have developed our expertise through self-motivation, given that medicinal cannabis is not covered in our formal education. This subject should undoubtedly be included in the curricula for doctors and pharmacists.

Anything else?

Do you have specific questions or suggestions for the Cannabis Briefing? Then send us an email to briefing@www.cansativa.de. If you are interested in revolutionising the cannabis industry with us, then stay tuned and follow our briefings!

We wish you a good read!

With legalising greetings,