Last September, the 2nd European Cannabis Law Conference took place in Dortmund, organized by the INCBA Europe conference team with Kai-Friedrich Niermann, Daniel Haymann, Marie Sanchez and Robert Jappie. The conference took place alongside the Cannabis Business Expo and Intertabac, the largest global tobacco trade fair. With 7 tracks and 28 speakers, current topics in global cannabis law were discussed over two days, from the reclassification of cannabis in the USA and its global consequences, semi-synthetic cannabinoids in the USA and Europe, GMP requirements, to the emerging market for medical cannabis in Ukraine and much more. The conference was accompanied by an extensive social program for networking, which the international cannabis legal scene thoroughly enjoyed.
Here are some session highlights:
Ukraine recently legalized medical cannabis and significantly de-regulated industrial hemp. The government and Ministry of health of Ukraine have approved subordinate legislation ensuring market functioning and control, including licensing, quota allocation, import permits, and a digital tracing system. Notably, the MOH has defined the medical conditions eligible for medical cannabis prescriptions and limited permitted forms to capsules, oral liquid forms, and dental paste. Inhalable forms are expected to be permitted at a later stage. Pharmacies are required to compound cannabis-based medicines based on a respective pharmacopeia monograph and only using APIs registered with the MOH.
Israel, the world's largest medical cannabis market per capita, has recently simplified access by transitioning from a licensing system to a prescription-based approach. Israel’s local cultivation market is thriving, and imports (mainly from Canada) are expanding, though concerns about alleged dumping practices by some foreign suppliers have emerged. The country also leads in R&D for cannabis clinical applications and innovations in safe, precisely dosed administration forms and devices. Ukraine can learn valuable lessons from Israel, particularly in addressing PTSD and chronic pain for war veterans, as well as the quasi-reimbursement system, where the Ministry of Defense subsidizes veterans’ access to medical cannabis.
Cannabis regulations in each country are abundant, complicated, many times confusing and as a norm, constantly changing. Trying to navigate international cannabis transactions while complying with different countries’ regulations, customs, languages and currencies only adds to the challenges of correctly advising cannabis industry participants, irrelevant of which continent they call home.
In November 2023, the German government decided to lift all restrictions on the cultivation of medicinal cannabis in Germany. Since April 1 the three already licensed growers of medical cannabis in Germany will be able to produce cannabis without quantity and product restrictions, as well as any other company that can grow cannabis to pharmaceutical standards. The Single Convention Panel discussed the consequences for international exports and imports of medical cannabis regarding the restrictions of the Single Convention, the chances for a medical cannabis export industry in the US after reclassification, and the global impact reclassification of cannabis in the US will have on financing and investments.
The panel on navigating the challenging path to Good Manufacturing Practices (GMP) compliance in the cannabis industry underscored significant differences between regulatory frameworks in Europe and the United States. In Europe, the sector must adhere to stringent pharmaceutical GMP standards, particularly for medical cannabis, ensuring consistent product safety and quality. In contrast, the US faces fragmented regulations, with state-level standards varying widely and no federal oversight, complicating operations across state lines. Our panelists explored how these regulatory landscapes shape business models and operations, and the best strategies for overcoming the considerable challenges. One key takeaway was the proverb, “a jack of all trades is a master of none.” Many cannabis operators try to be cultivators, processors, distributors, and product developers across pharmaceutical, cosmetic, and food sectors simultaneously. The best path to GMP compliance is to choose one element of the supply chain, focus on one vertical, and master it.
Marketing and Advertising of Cannabis products has become a hot topic in Europe, as medical markets continue to scale. The panel addressing these issues brought together leading legal experts and commercial operators from the UK and Germany. Jon Robson – CEO of Mamedica (one of the UK's leading medical cannabis clinics) gave fascinating insights in respect of the innovative and aggressive marketing strategies employed by his company to navigate the UK's restrictive advertising regime. There was an in-depth discussion on the approach of the regulators in policing promotional activities in the medical sector, and there was also detailed consideration of marketing opportunities in Germany following the implementation of the CanG legalization regime. This combination of legal analysis and commercial experience contributed to an engaging overview of how a new industry establishes and promotes itself to patients and consumers. What was clear is that the rest of Europe will be watching developments in Germany very closely, as successful growth and commercialization there will likely make legalisation efforts in other European nations easier.
Another important issue which developed over the last two years was the topic of semi-synthetic cannabinoids. Most countries have seen those new substances invade the market, mostly taking advantage of loopholes in local legislation. From the complex and uneven legal landscape in the USA to the application of restrictive policies by most Member States in Europe, the panelist discussed the obvious inappropriate answers provided by competent authorities to the semi-synthetic cannabinoids issue so far. They also explored how the Act on Psychomodulatory substances, which is expected to be voted in Czech Republic early 2025, could offer a different path and change the status of semi-synthetical cannabinoids on the market. The question of what other legal paths the legislators could consider in order to regulate semi-synthetic cannabinoids and ensure legal security and user safety was also discussed.
Finally, the North American panel compared, contrasted and provided updates on the different regulatory approaches to cannabis in both Canada and the United States. Regarding Canada, the discussion focused on the completion of the legislative review of the Cannabis Act and highlighted several recommendations regarding high potency cannabis products, cannabis research, medical distribution and excise taxation that will likely be the subject of new amendments in the years to come. Regarding the US, the discussion focused on the Federal announcement of the rescheduling of cannabis, as well as its impact on research, adult use, and financing/tax credits implications. At the state level, Alaska and Oregon were used as examples of different approaches to THC and hemp frameworks through the lens of standardization, interstate commerce and where things will likely go from there, from an enforcement and commercial perspective.
