MCN speaks to the International Institute for Cannabinoids about cannabis education, policy and prohibition in Slovenia.
MCN speaks to ICANNA’s Expert Associate Dušan Nolimal, MD, MSPH and Assistant Professor Tanja Bagar, PhD about the Slovenian cannabis landscape and the need for further policy action on legalisation.
What is the current medical and legal status of cannabis in Slovenia?
In Slovenia, cannabis for medical purposes (comprising cannabis extracts, resin and whole plant) was legalised in March 2017. The policymakers removed cannabis from Schedule 1 of controlled substances – the most tightly restricted category reserved for drugs which have ‘no currently accepted medical use’ – and placed cannabis on the list of drugs regarded as possessing a high potential for abuse with medical value, Schedule 2.
Although this was a crucial step in improving patient access to cannabis products, few patients have actually benefitted from the change. The Government and Ministry of Health have been consistently criticised as a result of poor frameworks for patient access to cannabis. Up until now, no prescriptions for medical cannabis have been issued and no pharmacy has imported medical cannabis, making it effectively inaccessible in Slovenia. Some patients have benefitted very much from food products containing CBD – however, with the introduction of EU Novel Foods regulation in 2019, CBD sold as a food supplement has become illegal in Slovenia.
There is a difference between cannabis medicinal products and preparations. The distinction is between products which have a marketing authorisation for medical use and those that do not. In practice, however, the term ‘medical cannabis’ refers to a wide variety of preparations and products that may contain different active ingredients and use different methods of administration. ‘Medicinal products’ refers to the plant-derived and synthetic cannabinoid-containing products with a marketing authorisation in place. The general term ‘cannabis preparations’ is used to refer to items derived from the cannabis plant which do not have a marketing authorisation for medical use. Cannabis preparations can vary greatly in composition; this means that they can be difficult to test for efficacy in clinical trials. In general, such regulatory framework is insufficient and often contradictory, with many grey areas and there is a lack of clarity regarding the specifics of the approaches and how they are applied in practice.
Thus, Slovenia now allows the medical use of cannabis or cannabinoids in some form – however, their legal availability is mostly only on paper. Physicians are only slowly adapting to the new regulations and often feel uncomfortable in prescribing cannabis-based medications due to the ongoing controversy surrounding its medical and legal status.
Despite the legalisation of cannabis for medical purposes, patients in need still lack access to this medicine. Only a very small number of patients with a limited range of conditions have been provided treatment in the form of cannabis products or preparations, meaning that medical cannabis remains inaccessible for the vast majority of patients in need. Meanwhile, cannabis plant flower, resin, and medicinal products such as Sativex and Epidyolex cannot be obtained at Slovenian pharmacies.
The use may further be restricted by the lack of health insurance coverage, as the national regulatory framework is not clear about how the legalisation should work in practice. There is a clear preference among patients for cannabis plant and its derivatives, rather than pharmaceutical products: plant-derived cannabis preparations are often preferred because of the purported entourage effect, meaning that the combination of cannabinoids and other substances in whole plant products has a greater medical effect than single molecule cannabinoids.
Medical cannabis is regularly or occasionally used by more than 30,000 patients and users in remission, comprising around 1.5% of the Slovenian population. Cannabis users and their advocates say that the legalisation of cannabis in the country was coupled with obstacles to access, forcing many patients to turn to the illegal market. It is harder for patients to access medical cannabis, which is legal, than it is to get illicit recreational cannabis. All of this undermines the ability of patients to have secure access to a quality product that is consistent in form and dosage, which would allow them to really gain the benefits of using cannabis in a medical context.
The insufficient regulatory approach highlights the need to clarify the cannabis regulatory framework and its applications in practice. There is considerable need to provide education, training and support for physicians and other healthcare professionals; also, there is a need for primary research data to support clinical use. Policymakers and regulators need to address areas of uncertainty and focus on further developing the science, as well as regulations. Professional and patient groups need to be actively involved in decision-making and be taken seriously.
What is the role of ICANNA in the European cannabinoid industry? What are your main objectives as an organisation?
There was a great need to establish an independent formal international organisation, as we are facing increasing interest in the topic all over the world. Although there is a significant amount of information available regarding the various uses of cannabis and the effects of cannabinoids, there is also plenty of misinformation present in both the civil and state spheres. At the same time, we are witnessing an intense increase in users of medical cannabis. These patients are more or less left to themselves, or with synthetic preparations as their sole option.
A large number of research findings and practical experience are known about the effects of cannabinoids on health and wellbeing from scientifically advanced countries around the world and taking into consideration that the endocannabinoid system is a vital part of each and every human being, it would be irrational and irresponsible to neglect this field. The field of cannabinoid research is highly promising from several angles and deserves a multi-faceted discussion for the wellbeing of individuals and prosperity of governments.
The objective of the Institute is to bring together experts from diverse fields, enable an integrated approach in this field, and provide a neutral and independent space for open discussion about cannabinoids. It is also of vital importance to provide access to verified, justified and scientific information about the plant, its ingredients and potentials.
What educational courses does ICANNA offer? How can doctors, therapists and other professionals benefit from wider education on medical cannabis?
Most of the educational work we do is in co-operation with other organisations, however we also independently organise education provision for medical staff and the general public; we are actively engaged in educational courses for medical doctors in Austria and many other regions. We have also published a book titled **Hanf medizin** in German, which is currently being translated into Slovenian and English.
The hemp/cannabis plant has long been a part of our human experience on this planet. It has been used in medicine for thousands of years; and for a long time doctors prescribed and provided diverse preparations of cannabis. Nowadays, the situation is not much different. Surveys indicate that over 50% of patients with a chronic condition use cannabinoids; the number goes up to 80% in oncological patients. Hemp medicine is here to stay and rightfully so.
Understanding what cannabinoid molecules do in our body and the importance of the endocannabinoid system for our health and wellbeing are crucial in giving hemp its rightful place in medicine: not as panacea, a plant remedy for all diseases, but as a well-studied bouquet of bioactive molecules with immense potential. Hemp is one of the best studied plants, with tens of thousands of published papers, so the argument we hear many times – that we do not have enough research data – is farfetched to say the least. The complex chemical composition of hemp, and its even more complex interaction with our body naturally calls for even more research, but we already know enough to say beyond doubt that these molecules are safe – much safer that majority of medicine described in the EU pharmacopoeias – and effective in treating many medical conditions; and there is a dire need for all medical professionals to be aware of it.
What would be the benefits to patient safety and wellbeing of ending the prohibition of cannabis in Slovenia?
While most cannabis use in Slovenia is occasional and few significant issues are associated with it, nonetheless it is precisely because of its potential risks that it needs to be properly regulated, to protect patients, minors and other vulnerable groups. It is precisely because cannabis is not harmless — because cannabis use disorder and use by minors and other vulnerable groups are real problems — that we need to end its prohibition: the ending of the prohibition of cannabis in our country would also bring the possibility to regulate production and supply of cannabis for medical uses. Prohibition has failed to have any sustained impact in reducing the illicit market for cannabis and other drugs, while imposing a heavy burden upon society and creating negative public health impacts. Rather than basing legislation on ideology, new regulation would be based on evidence of what works, focusing on real measures of success like reducing health and social harms, not just measures like cannabis seizures and arrests. Many of the harms of prohibition would disappear and a range of new opportunities would open up. The criminal cannabis markets would be replaced by state regulation.
First, there would be improved health outcomes for communities and patients. Professionals, patients and communities would gain access to evidence-based cannabis education. Potency of cannabis would be regulated, with information on strength, benefits and risks clearly displayed on packaging. Health professionals would be able to provide patients with the necessary support to access and effectively use their cannabis medication, to achieve optimal therapeutic benefits and improve their quality of life. There would be reductions in potential health harms as people switch to controlled and less harmful cannabis products and preparations, or to less harmful methods of consumption if these become accessible.
Furthermore, there would be less stigma and discrimination against cannabis users in general, as well as fewer drug law enforcement-related human rights abuses of patients. In general, there would be less drug-related crime with fewer people involved; and thus fewer criminal profits available to fuel corruption. There would be less pressure on the criminal justice system and a generally reduced prison population, which will improve social cohesion at the community level. This will bring considerable financial savings, especially from reduced criminal justice and prison spending. The resources spent on cannabis prohibition would be redirected into other areas, either within law enforcement or for other health, social, educational and economic programmes. The legally regulated cannabis market would trigger and increase in tax revenue. Cannabis policy would become genuinely public health-based, delivering more effective health-led prevention, education, harm reduction and treatment responses.
How can interdisciplinary co-operation benefit research into cannabis and cannabinoids?
Cannabis as a plant (Cannabis sativa L.) has so many potential uses that it reaches a wide range of fields in both science and industry. The plant in itself is interdisciplinary, from biology, to agronomy, to technology, to ecology, health and much more. To best research its medical benefits, we need an interdisciplinary approach, as it is clear that the ‘one molecule-one target’ approach is not working in this case. Our bodies are much more than the sum of their mechanical parts; and so are the constituent parts of hemp.
Keeping in mind that these molecules aim to evoke or strengthen the basic biochemical balance in our cells, tissues, body and life, it is natural that a harmonious bouquet of ingredients will do a better job than a single synthetic molecule. This is not to say that activators or blockers of cannabinoid receptors or enzymes do not have their place, because they do – but let’s also give the plant its freedom, give people their freedom to choose, and free the way for cannabinoids to do what they do best: support or create balance.
Tanja Bagar, PhD
Dušan Nolimal, MD, MSPH
International Institute for Cannabinoids