Under the current German Narcotic Drugs Act (Betäubungsmittelgesetz, BtMG) cannabis is one of the narcotic drugs that cannot be marketed (Section 1 BtMG, Annex 1). Anyone who wishes to cultivate, produce, trade in, import or export cannabis or otherwise place it on the market requires a licence from the Federal Institute for Drugs and Medical Devices (BfArM). In recent years, Luther has provided legal support to a number of clients in obtaining such a licence. Special attention must be paid to the legal requirements regarding the equipment at and security of the production facilities as well as the reliability and expertise of those responsible.
The exemptions set out in Annexes I and III to the BtMG must also be observed:
Since 2017 the most important exception has been the significantly increased possibility of dispensing cannabis for medical purposes. Since then, the dispensing of medical cannabis to patients with serious illnesses has been possible on the basis of a doctor’s prescription and is also reimbursed by the statutory health insurance scheme. The number of patients benefiting from therapy with medical cannabis has been steadily increasing ever since. This is a highly regulated market with demanding safety and quality standards, in which the German Medicines Act (Arzneimittelgesetz, AMG) must be complied with in addition to narcotic drugs law. The cultivation of medical cannabis in Germany is controlled by the Cannabis Agency established at the BfArM. However, as the growth in demand cannot be met so far by local cultivation, the import of medical cannabis is of great importance. Luther assists international providers in accessing the market and navigating the complex procedures.
Furthermore, cannabis seeds that are not intended for illegal cultivation can be marketed. Foods made from cannabis seeds - from salad oil to pastries to beer - are not subject to the German Narcotic Drugs Act and are legal if they meet the regulations laid down in food law.
It is also permissible to trade in cannabis that originates from cultivation in EU countries using certified seeds listed in the EU Plant variety database or whose THC (tetrahydrocannabinol) content does not exceed 0.2%, provided that the trade is solely for commercial or scientific purposes that exclude abuse for intoxicating purposes. However, cultivation still requires a licence. This exemption limit of 0.2% THC is crucial with regard to products containing cannabinol (CBD), which have developed significant market potential, especially recently. However, practice has also shown that a large number of definition issues arise, especially in the case of foodstuffs/nutritional supplements.
Also exempt from narcotics regulations is commercial hemp grown by agricultural enterprises from certified sowing seeds of varieties listed in the EU plant variety database. It must be a commercial hemp variety with a low THC content eligible for EU aid for the production of hemp. Authorised persons do not need a licence for cultivation, which is however subject to an obligation to notify and is controlled by the Federal Office for Agriculture and Food. A great variety of commercial hemp products is legally available on the market. However, the requirements laid down in food law as well as those set out in Regulation (EC) No 1223/2009 on cosmetic products, among other things, must be complied with in respect of these products as well. What is new is that the European Council has increased the THC content for promoted hemp varieties to 0.3% within the framework of the Common European Agricultural Policy (CAP). The change is to come into force on 1 January 2023. This could significantly expand the catalogue of approved varieties in the EU.
The legalisation of the distribution of cannabis to adults for recreational use, which is now provided for in the coalition agreement, will not only require a fundamental change in narcotic drugs law but will also necessitate the introduction of new regulations. This would affect both the requirements for licensed dispensaries and the setting of safety and quality standards, but also local cultivation that is expected to be under state control. Other countries, such as Canada, which have opened up legal access to cannabis for recreational purposes in recent years, continue to make a strict distinction between medical cannabis and cannabis for recreational use. This could also prove to be a feasible approach for Germany, but it raises numerous new legal questions.
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Cornelia YzerOf Counsel
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