The German Bundestag opened the market for medical cannabis in Germany with the "Cannabis as Medicine" Act in spring 2017. Whereas previously patients had to apply to the Federal Institute for Drugs and Medical Devices (BfArM) for an exemption according to Section 3 (2) of the Narcotics Act (BtMG) and pharmacies in turn could only purchase cannabis flowers and preparations with a permit, patients can now obtain medicinal cannabis with a doctor's prescription. Another consequence of the law was that the BfArM founded the Cannabis Agency, which is responsible, among other things, for controlled cultivation and harvesting in Germany as well as dispensing to pharmacies. However, the demand for medicinal cannabis is still largely met by imports.
Legal situation in the EU
The different legal handling of medical cannabis in the EU increasingly poses challenges to the growing cannabis market. Divergent regulations in the member states in particular make it difficult to import and export smoothly and are increasingly hampering companies with plans to expand into various European markets. The "European market", in which many companies, especially from North America, but recently also from South America, Africa, the Middle East and the Pacific region, want to gain a foothold, does not exist for medical cannabis. This state of affairs was caused, among other things, by the reputation of cannabis as an illegal and exclusively harmful drug, which has persisted to this day at the legislative level, making research into the medicinal potential of the plant difficult. Thus, each EU member state decides for itself whether a substance falls under the respective national narcotics law or not. Even marketability is left to the decision of each member state. Uniform basic conditions are only created by the UN Single Convention on Narcotic Drugs of 1961, according to which, in accordance with Article 23 and Article 28, paragraph 1, certain conditions are imposed on the cultivation of cannabis, without the fulfilment of which no cultivation, import or processing of cannabis flowers and extracts should take place. To this end, uniform quality requirements for medicinal products apply throughout Europe in the form of the Good Practice for the Collection and Cultivation of Medicinal Plants (GACP) for cultivation and the Good Manufacturing Practice (GMP) for post-harvest processes. So far, however, there is no cross-national legislation.
Standardization efforts
Calls for the implementation of a regulatory framework for medicinal cannabis have already been made in 2019. In January 2019, the Director-General of the World Health Organization (WHO) made a series of recommendations to the United Nations to adjust the scope of control of cannabis and cannabis-related substances. This led to the European Parliament adopting a resolution in the same year calling on the European Commission to regulate the use of medicinal cannabis and to remove regulatory and financial obstacles that hindered the further development and dissemination of medicinal cannabis. Among other things, Parliament called on the Commission to set up a network bringing together, among others, the EMA, national competent authorities and patient organizations, as well as other relevant stakeholders, to ensure effective implementation of the cannabis-based medicines strategy. MEPs called, among other things, for the establishment of a clear legal definition of medicinal cannabis, the promotion of research and innovation in this field and the coverage of costs for effective medicinal products by health insurers. Since this year, these demands have been given additional weight by the founding of the Medicinal Cannabis Alliance by three Members of the European Parliament. Currently, after a pandemic-related interruption, the Commission is working on the development of a directive for the harmonization of the European market for medicinal cannabis in the Member States.
Proposals for uniform legislation at EU level
In principle, a European regulatory construct is also desirable, but it remains controversial how such harmonization should best take place.
Among other things, the resolution of the European Parliament calls for the authorization of medicinal cannabis as a finished medicinal product.
However, such a solution could cause considerable difficulties for providers of medicinal cannabis. This is because medicinal products are subject to the requirement of clinical trials. The aim is to prove safety for patients and the desired efficacy. However, clinical trials for medicinal cannabis are not expedient, as they would not lead to a uniform result due to the different active ingredient content of the cannabis flowers. The reason for this is that cannabis, as a non-synthetic product, varies in its THC and CBD content from plant to plant. Even the monograph on "cannabis flowers" of the German Pharmacopoeia provides for a deviation of the actual from the stated THC/CBD active substance content of up to +/- 10 percent. In addition, the performance of clinical studies is very cost-intensive.
Another proposal comes from Tjalling Erkelens of Bedrocan. He sees the reason for the regulatory patchwork in the fact that medicinal cannabis is not treated as an active ingredient, which would, however, result in an automatic classification in the European regulatory apparatus on medicines, which is already standardized in this respect. His proposal is therefore to forego harmonization efforts and instead treat cannabis as a regular active pharmaceutical ingredient.
The goal must therefore be to create a European regulatory framework that results in the same handling of medicinal cannabis for all countries and thus allows the advantages of the Schengen area to take effect, especially for cross-border trade. It would already be helpful if one of the demands of the European Parliament to the European Commission were implemented by establishing a clear legal definition of medicinal cannabis. It would also be helpful to make a clear distinction between cannabis-based medicinal products authorized by the European Medicines Agency (EMA) or other medicines authorities, medicinal cannabis that is not supported by clinical studies and other uses of cannabis (such as recreational or industrial use). This is the only way to ensure that the increasing demand for medicinal cannabis can be adequately met in the long term.