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19 February 2020
In Germany, marijuana and cannabis – or rather, the (active) substances contained therein – remain (in principle) prohibited substances (ie, they are considered drugs). An opening of the market for 'consumption' is still unforeseeable. Nevertheless, the possible positive medical effects of cannabis have been recognised.
Cannabis-containing finished medicinal products have been available on prescription in Germany for some time. In 2017 the amendment of various acts permitted the state-controlled cultivation of cannabis and allowed the production of cannabis-containing medicinal products in pharmacies. This article provides an overview of the legal framework applicable to cannabis products – especially cannabis-containing medicinal products – and the current discussions and developments relating thereto.
Cannabis-containing products are classified based on whether the product:
Annex I of the German Narcotics Act states that cannabis is a not marketable product. The possession, cultivation or trade of cannabis is therefore illegal. The term 'cannabis' encompasses a broad range of products. According to Annex I, marijuana, plants and parts of plants belonging to the genus cannabis are not marketable. In addition, Annex I lists certain processing forms and ingredients of cannabis such as cannabis resin and cannabinols such as Δ9-Tetrahydrocannabinol and other tetrahydrocannabinols (THCs) (ie, the substance to which particularly psychoactive effects are attributed).
However, Annex I sets out a number of exceptions regarding the marketability of cannabis. For example, cannabis seeds and products thereof, plants and plant parts of cannabis are marketable if they originate from cultivation in EU member states with seed certification or if their THC content does not exceed 0.2% and the trading thereof serves exclusively commercial or scientific purposes, which excludes their misuse for intoxication purposes.
The classification of a cannabis-containing product as novel food is unlikely, as many conditions would have to coincide: if cannabis-containing products are not subject to the German Narcotics Act according to the requirements set out above, they can in principle be marketed as foodstuffs and – under the requirement that they are novel – as novel food. The classification as foodstuffs must be proven by the entity that places the product on the market. In particular, the product must not have a pharmacological effect (in such cases, it would be classified as a medicinal product).
In individual cases – depending on the ingredients of the final product – it may be difficult to deny a pharmacological effect. For example, according to the German authorities (eg, the Federal Institute for Drugs and Medical Devices and the Federal Office of Consumer Protection and Food Safety), the cannabidiol (CBD) in cannabis clearly has pharmacological properties due to its interactions with biological receptors (eg, the antipsychotic or sedative effects of CBD). Further, in 2016 CBD was added to the Narcotic Drugs Prescription Ordinance's list of prescription medicinal products.
If the absence of a pharmacological effect can be demonstrated, products that include CBD as an ingredient could be classed as novel foods under the EU Novel Foods Regulation (2015/2283) and would then be subject to authorisation. However, certain products prepared from the cannabis sativa plant or parts thereof (eg, seeds, seed oil, hemp seed flour and defatted hemp seed) are not subject to the Novel Foods Regulation, as these products have a history of consumption in the European Union and are therefore not 'novel'. As they are not novel, the fact that they may have CBD as an ingredient does not make them a novel food.
Theoretically, the use of medical marijuana has been permitted in Germany for quite some time. Practically, marijuana was used only in the rarest cases and played only a minor role in the pharmaceutical market. Recognising the medical benefits, the German parliaments passed the act amending narcotics and other regulations. This act, which came into force in 2017, serves to establish the marketability and prescribability of further cannabis medicinal products such as dried cannabis flowers and cannabis extracts each in standardised quality. The aim is to enable patients with serious illnesses to obtain these medicinal products for therapeutic purposes by dispensing them in pharmacies, if they are indicated in an appropriate way and alternative therapies for the illness do not exist. Notably, medicinal products containing cannabis may no longer be sold only as finished medicinal products, but also after preparation in pharmacies.
On the one hand, the law aims to improve the care of the patients just addressed. At the same time, the safety of narcotics traffic is to be maintained. In order to achieve this purpose, the aforementioned act amended various provisions of the German Narcotics Act. According to Annex III of the act, the distribution of cannabis-containing products is now permitted if these products come from a cultivation that is used for medical purposes and is under state control. According to Section 19(2a) of the act, state control is performed by the Federal Institute for Drugs and Medical Devices.
In accordance with these provisions, the Federal Institute for Drugs and Medical Devices approved the applications of three companies to produce cannabis in May 2019. These companies must deliver the first harvest until late November 2020. The harvest must be produced according to and meet the quality standards of good agricultural and collection practices and good manufacturing practice. A production volume of 10.4 tons was granted, which can be adjusted upwards by 10% if necessary. The harvest will be bought by the Federal Institute for Drugs and Medical Devices and will then be resold to medical marijuana manufacturers, wholesalers and pharmacies.
Under Section 21(1) of the Medical Products Act, only finished medicinal products that have been authorised by the Federal Institute for Drugs and Medical Devices may be placed on the market. Whether the cannabis-containing medicinal products to be produced in pharmacies are subject to this principle remains debatable. Currently, nine different formulas for cannabis-containing substances that are (finally) produced in pharmacies and then distributed to patients exist. Depending on the manufacturing process, either based on a doctor's prescription only or as a bulk-produced medicinal product (ie, it is produced in small quantities in advance), various exceptions to the approval principle just outlined can be considered. Notably, these bulk-produced medicinal products cannot be confused with so-called 'bulkware' (ie, medicinal products in large packages that are already ready for use).
According to Section 4(1) of the Medical Products Act, medicinal products that are manufactured only because of a prescription are not considered finished medicinal products. Therefore, they do not require a marketing authorisation under Section 21(1) of the act.
According to Section 21(2) of the Medical Products Act, bulk-produced medicinal products are – up to a certain extent – exempt from the marketing authorisation requirement. Decisive for the applicability of the exemption on bulk-produced medicinal products is whether essential manufacturing stages take place in a pharmacy. This requirement is not part of the wording applicable to prescription medicinal products but is nevertheless also applied to these medicinal products. Therefore, in this context, the fact that cannabis is not planted, harvested and made transportable by pharmacies, but by the companies presented above, seems problematic. Are pharmacies performing essential manufacturing stages when producing cannabis-containing medicinal products with the effect that a marketing authorisation is not needed?
The answer to this question remains uncertain. However, it seems more reasonable to decline the need for a marketing authorisation: a marketing authorisation for a medicinal product can be granted only if enough data regarding, among other things, the effectiveness and associated risks of the product are available. This has not been the case with medical marijuana until now. As the abovementioned act of 2017 aimed to strengthen the supply of cannabis-containing medicinal products to patients, an obligation to obtain a market authorisation would be contrary to the purpose of existing laws.
This assessment is also consistent with a Dusseldorf Higher Regional Court judgment of 2018, in which the court accepted the amendment to the law described above to improve the supply medicinal products containing cannabis to patients. At the same time, however, the court insisted that, according to the Medical Products Act, a distinction must be made between finished medicinal products and those that are prepared on prescription. Without excluding the possibility of manufacturing cannabis-containing medicinal products without a marketing authorisation in pharmacies, the court ruled that a marketing authorisation is required for industrially manufactured cannabis-containing medicinal products.
For further information on this topic please contact Caroline von Nussbaum, Fabian Huber or Ulrich Spiegel at Simmons & Simmons LLP by telephone (+49 2 11 4 70 53 0) or email (firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). The Simmons & Simmons LLP website can be accessed at www.simmons-simmons.com.
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