Committee on Legal Affairs
Complete euphoria: With doctors prescribing marijuana as a medicine for seriously ill patients in some Member States, concerns rise about the supply of the drug through legal means as many patients are still turning to the black market. Taking into account the advantages of marijuana use for medical purposes, what steps should the EU take in drafting a loophole-free regulation on the matter that could further be implemented throughout all Member States?
By Paula Vermaas (NL)
The Case Study
After enduring years of chronic pain following medical complications, the Irish Alicia Maher and her husband Gerry moved to Spain in 2019 to access cannabis for her condition.
Before discovering medical cannabis, Alicia had been prescribed numerous medications in Ireland which had her feeling “wiped out” and unable to leave the couch for the best part of two years. By self-medicating with cannabis vapes, which she was ordering from the USA, Alicia managed to slowly get off her medication. However, as ordering from the USA became more difficult, she turned to getting cannabis from dealers. After having concerns regarding the safety of the product, the couple decided to move to Spain where cannabis was more easily accessible. When in 2020 Alicia finally managed to have cannabis prescribed for her through the ministerial licence route, she found it was not covered by her medical card. As she did not qualify for the Medical Cannabis Access Programme, this meant that it would cost her over €1,000 a month: four times the price she was paying in Spain. So, the couple decided to stay. Together with the group Patients for Safe Axes, which Alicia keeps advocating for, among others, the range of conditions under the Medical Cannabis Access Programme to be expanded. In hopes of one day moving back to be reunited with her family in Ireland.
Abstract
Over the years, medical cannabis has become more and more accessible to patients in need in Member States. Currently, each Member State is allowed to implement their own policies regarding the usage, cultivation and distribution of medical marijuana. This has resulted in a lot of differences between Member States and inequalities for the users. High prices and strict bureaucracy, result in many patients not having access to the medicine, which for some is often a last resort. This is if the patient even knows about its existence. Due to a lack of education, doctors and patients alike are often unaware of the benefits that medical marijuana may provide. The issue of a lack of access to medical marijuana is pressing, as many patient’s suffering can be relieved with the usage of these medicinal products.
Image 1:Key Concepts
- Cannabis sativa: the scientific name for the plant from which cannabis products are made. Two genetically distinct forms of the plant are industrial cannabis (hemp) and medical cannabis, or, cannabis as a drug (marijuana). The main difference between the two is the percentage of psychoactive chemicals present. Hemp contains a maximum of 0.2% THC of its total weight. Medical cannabis contains more.
- Cannabinoids: the chemicals in the cannabis plant that produce its therapeutic effects.
- Tetrahydrocannabinol (THC): the most present cannabinoid in ‘psychoactive’ cannabis plant types and responsible for many of the medicinal effects of cannabis. It posses mind-altering effects, which are often experienced as pleasant and relaxing by users.
- Cannabidiol (CBD): the second major cannabinoid in cannabis. Similarly to THC, it has medicinal effects. However, it does not induce a psychotropic state, meaning. its use does not result in feelings of intoxication.
- Cannabis-based medicines: the term adopted by the European Parliament to specify the cannabis-based medicinal products that have undergone clinical trials, like all medicinal products, and have achieved approval from expert regulatory authorities.
Key Actors and Stakeholders
The United Nations (UN)
An underlying structure for all EU policy-making regarding narcotic drugs and psychotropic substances, including cannabis, is formed by three UN conventions, held in 1961, 1971, and 1988. These conventions, signed by all EU member states, form the fundamental structure for regulating the production, trade, and possession of over 240 psychoactive substances. Narcotic drugs and psychotropic substances, such as cannabis, are categorised based on their health risks, potential for abuse, and therapeutic value. The UN office specialised in drugs is the Office on Drugs and Crime (UNODC). The UNODC supports Member States in addressing drug-related issues by providing legislative support, law enforcement, implementing drug use prevention interventions and providing drug dependence treatment and care services.
European Commission
The European Commission ‘is the EU’s politically independent executive arm’. Responsible for proposing and implementing new European policies and legislation. Since public health falls under the EU’s supporting competences, the EU has limited power to intervene in Member States’ legislation and law-making in this area. It can only support, coordinate or complement the Member State’s action, but has no power to pass laws.
European Medicines Agency (EMA)
The EMA has the authority to grant EU-wide cross-national authorisation for medicine while sharing expertise with Member States in the assessment of new medicines and new safety information. The Committee on Herbal Medicinal Products (HMPC) works on the Agency’s stance on herbal substances and preparations and further information and recommendations. For example, in 2021 the committee published the Compilation of terms and definitions for Cannabis-derived medicinal products.
European Monitoring Centre for Drug Addiction (EMCDDA)
Note: starting 2 July 2024, the EMCDDA will become the European Union Drugs Agency (EUDA), as it will be ‘granted stronger powers to tackle current and future drug problems’.
The EMCDDA is an EU agency responsible for providing evidence-based information on drugs, drug addiction and their consequences. This information is used to support EU and national policymaking. Every year they release the European Drug Report. In these reports, the most recent one being the European Drug Report 2023, a big focus is put on cannabis, as it is the most commonly consumed illicit drug in Europe. The EMCDDA reports and analyses the drug’s situation in Europe, including frequency of use, treatment demand, seizures, price. The centre also provides publications discussing and analysing current policies in response to cannabis within the EU, and questions what an appropriate policy response to cannabis would entail.
The European Medical Cannabis Association (EUMCA)
The EUMCA is the main representative for the medical cannabis industry. They represent ‘ethical European manufacturers and suppliers of pharmaceutical-grade medicinal cannabis products’, patient advocacy groups and healthcare stakeholders. Through active collaboration with European authorities, national governments as well as the EU, and creating policy frameworks, the EUMCA states that its ‘primary goal is to create a standardised and harmonised regulatory prescribing framework to which all EU Countries can confidently ascribe’.
EU citizens
2024 is being labelled as the biggest year for elections yet: never before have this many elections been planned in single year. With the population of over 60 countries (including EU Member States such as Romania, Belgium, Portugal, Slovakia, Finland and Croatia) going to the polls in 2024 and the EU election being held in June, the EU citizens, who are the users and distributors of medical marijuana, can have a considerable influence on medical marijuana legislation.
Patient advocacy groups
The people who suffer under the issues surrounding medical cannabis are in the end the patients and their loved ones. To advocate for improved access to medical marijuana, multiple patient advocacy groups have been set up around Europe. One of those, for example, is ‘MAMAKA- Mothers for Cannabis’, founded by Jacqueline Poitras. Through this association, Poitras has played a leading role in changing Greece’s cannabis policy. MAMAKA is also part of the IACM Patient Council (part of the International Alliance for Cannabinoid Medicines), an ‘international coalition of patient organisations that have gathered to give a voice to patients the world over and to work together in order to protect their rights and interests in the ever-developing world of medicinal cannabis’. The IACM Patient Council also holds representatives from patient advocacy groups from all over the world, including numerous Member States.
Bedrocan
Bedrocan is one of the oldest producers of legal medicinal cannabis in the world which is based in the Netherlands. It is an EU Good Manufacturing Practice (GMP)-certified producer of pharmaceutical-grade medicinal cannabis. Since 2003, it has been the producer of medicinal cannabis in order of the Dutch Office of Medicinal Cannabis (OMC), part of the Ministry of Health. Through this office, all orders and issues related to medicinal cannabis in and from The Netherlands are handled, including distribution to pharmacies, and export to EU as well as non-EU countries. Last year, the company announced that it will be opening a new facility in Denmark to be able to ‘conduct business directly with other commercial entities’ and ‘better meet the growing international demand for its high-quality medicinal cannabis products’.
What Has Happened so Far?
Cultivation
International law does not prohibit cannabis cultivation for medicinal purposes, however, it is essential to note that the regulatory landscape for cannabis, including its cultivation and use for medicinal purposes, varies across countries. The 1961 UN Convention establishes a general regulatory framework in case a country opts for cannabis cultivation not designated for industrial or horticultural use. To achieve good quality, the EMA provides Guidelines on Good Agricultural and Collection Practices (GACP), in addition to the UN Conventions and the World Health Organisation‘s (WHO) guidelines on good agricultural and collection practices for medicinal plants. This ensures a quality control system for medicinal plants and herbal substances throughout the cultivation-to-distribution process.
In the EU, cultivation of medicinal cannabis is permitted in some Member States, with an established authority for cannabis cultivation and defined responsibilities. For instance, in Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the regulatory body responsible for overseeing the cultivation of medicinal cannabis. The BfArM ensures compliance with stringent quality standards, including adherence to GACP. Patients in Germany can access medicinal cannabis products through a tightly regulated system that requires them to register with the Federal Opium Agency. Moreover, the Netherlands, with its Office of Medicinal Cannabis (OMC), meticulously regulates the cultivation, production, and distribution of medicinal cannabis, emphasising the importance of quality control and standardised strains. In Portugal, the Infarmed – National Authority of Medicines and Health Products plays a pivotal role in overseeing the cultivation of medicinal cannabis, ensuring that environmental considerations and sustainable practices are integrated into cultivation processes.
Education
There is a lack of education on medicinal marijuana and its benefits. Not only in doctors, but in society, in general, there is stigma surrounding the use of medical marijuana, with its users often being described as ‘drug addicts’, and doctors refusing to prescribe cannabis-based medicines, or simply not being informed on the medical benefits of the products and their access. The latter is also an issue facing many patients, as they are not provided with medicinal cannabis as an option by their physician, many only learn about it through self-research or when their attention is put to it by an acquaintance. All in all, this results in the fact that many patients who might benefit from medical marijuana do not know of its existence and are faced with stigma and prejudices when accessing the medicines.
In 2022, Neuraxpharm initiated the Change for Health campaign to enhance the acceptance of medical cannabis. The campaign seeks to prompt a shift in perspectives among healthcare professionals, regulators, patients, and the public, advocating for a reconsideration of preconceived notions about cannabis and for its recognition as a viable and personalised treatment option. Neuraxpharm is actively driving this transformative change for health throughout society, urging healthcare professionals, patients, and the general public to reassess their views on cannabis and embrace it as an effective and tailored treatment choice. The campaign aims to deliver more accurate information to patients, physicians, and pharmacies and is currently active in Germany, the Czech Republic, and Switzerland. As legislative frameworks evolve, the initiative is expected to be expanded to include other countries as well.
Lack of centralised EU legislation
The decentralised legislation currently implemented in the EU results in inequalities and inadequate access for patients to cannabis-based medicines. While there are some countries which have allowed the use of medical cannabis as you can see in Picture 2, each country has allowed different medicines, different ways of accessing them and different regulations on coverage or reimbursement by health care insurance. Especially concerning the latter point, many countries are seriously lacking, resulting in unaffordable prices for many patients.
For example, in 2017, Greece legalised medical cannabis. However, as a result of limited national investment in medical cannabis and the banning of the import of medical cannabis products in 2021, patients have no access to medical cannabis products and are turning to the black market. On the other side, Germany allows the costs of cannabis medication to be covered or reimbursed by health insurance companies in certain instances. However, patients relying on statutory insurance must undergo an application process for coverage, and statistics show that approximately 30-40% of these applications face rejection. Furthermore, in the Netherlands, any doctor is authorised to prescribe cannabis flowers from four specific varieties, each characterised by distinct cannabinoid profiles. This prescription is allowed for spasticity caused by multiple sclerosis, spinal cord trauma, any type of chronic pain, palliative care, and complications of cancer, acquired immunodeficiency syndrome (AIDS), and hepatitis.
Picture 2: Countries that have provisions for medical use of cannabis, 2021
Food for thought
Medicinal marijuana has proven benefits for relieving pain and decreasing symptoms from numerous conditions. However, medical marijuana products are not easily available to patients. There is a need for centralised EU regulation and policies surrounding this issue and educate healthcare providers on the benefits of cannabis-based medicines.
Hopefully, this Topic Overview has provided you with enough knowledge to start working on solutions for this problem. When doing so, try to think of, for example, ethical considerations: how does providing access to medical marijuana align with key arguments in Western medical ethics? Also ask why: Why is there a need for different policy and how and who would it benefit? What is, in the end, the goal?
Hopefully, all of this is not making you feel too overwhelmed. I will be here every step of the way to help you in this process and do not forget that EYP is about much more than the academic part. Enjoy the EYP experience of fun games, getting to know new people and improving your public speaking!
Valuable Links to Browse
How come patients are not prescribed medical marijuana more often? In this video, David Casarett explains how as a doctor he only learned about medical marijuana through an experience with a patient. In this video, Hugh Hempel talks about how he, as a father of patients, was also left to do research himself into the world of medical marijuana. More patient stories are readable through the websites of patient advocacy groups represented by IACM. To learn more about policies already in place, check out the EMCDDA page on cannabis and this document published by the UNODC last year.