The key points paper on legalised cannabis products

The above-mentioned Paper is not yet a legislative proposal that could be put to a vote in parliament. Nevertheless, it can be assumed that the key points presented could also be found in a future legislative proposal. But the fact that the plans are still subject to constant changes can also be seen from the circumstance that another version of the Paper circulated shortly before, which provided for stricter guidelines in some areas (e.g. THC concentration and possession quantities). 

Only certain forms of cannabis to be allowed

First of all, we take a look at which cannabis products, following the Paper, are actually subject to the legalisation plans. It is intended to allow only certain forms of cannabis for consumption purposes. In particular, synthetically produced cannabinoids will not be allowed. 

Products for smoking, inhalation, nasal and oral administration in the form of capsules, sprays and drops shall be allowed as dosage forms. An extension to so-called edibles, which are products other than food offered for oral consumption, is to be considered through an evaluation. 

The Paper mentions that further specifications for cannabis for human consumption will be defined in order to ensure quality and purity. However, the Paper does not specify these requirements in detail. In particular, the published version of the Paper does not contain a clear definition of the maximum THC content. However, THC contents will have to be declared and there will be specifications on plant protection products, mycotoxins and microorganisms (e.g. setting of maximum limits). Mixtures with tobacco and nicotine as well as the addition of flavours will not be allowed.

Sales restrictions and distribution in authorities-licensed and monitored shops

The minimum age limit for the sale and purchase of cannabis will be set at 18 years of age. Due to the increased risk of cannabis-related brain damage in adolescence, it is being considered whether an upper limit for the THC content should be set for the supply of cannabis to adults up to the age of 21.  Further, a controlling effect with regard to the THC content is to be achieved through a linear taxation based on the THC content.

Only a maximum purchase quantity per person corresponding to the maximum allowed own possession quantity (between 20 and 30 grams) may be sold per purchase and no sales may be made for third parties.

The controlled distribution of cannabis for consumption purposes will be allowed in authorities-licensed and monitored shops, whilst distribution through pharmacies is also being considered.

The shops shall be focused solely on the sale and advice with regard to consumption cannabis. There will be no combination with the sale of other stimulants such as tobacco and alcohol.

The operators and sales personnel of the shops will be obliged to provide proof of their expertise and specific counselling and prevention skills. In addition, a contact person for the protection of minors will have to be appointed for each shop. A counselling interview will have to be offered with every purchase.

The shops will have to ensure a necessary minimum distances from schools, children's and youth facilities. In addition, a limit on the density of shops, taking into account the population density must be observed.

Only adults will be allowed access to the shops. To ensure this, a consistent age check will have to be carried out when entering the shops (or in pharmacies before the sale).

Whether or not shops with the possibility of consumption on site should also be allowed is still being examined. Likewise, the questions of whether and to what extent online or mail-order sales to private individuals should be allowed require further examination.

General advertising ban

Furthermore, the legalisation plans in the Paper foresee a general ban on the advertising of cannabis for human consumption, which will also apply to the design of the packaging. Cannabis for human consumption will, therefore, only be sold in neutral outer packaging without any promotional design. 
Advertising suggestions for purchase by the shops in the external presentation or on the internet will be prohibited. Only factual information, for example about the place of sale, will be allowed.

Strict requirements for packaging and package leaflets

In terms of packaging, cannabis will only be allowed to be sold in child-resistant containers in neutral packaging.

The following mandatory information will have to be indicated on the packaging:

• producer/cultivator and cultivation country
• weight
• harvest date
• type
• minimum shelf life
• THC and CBD concentration
• warnings with regard to age limit, no consumption during pregnancy and no consumption in connection with the (imminent) driving of a vehicle or the operation of machinery
• QR code via which information on cannabis use can be accessed

Cannabis products will have to be accompanied by educational information about cannabis, low-risk use and the risks of use, as well as information about advisory and therapeutic services.

Production and distribution under strict state monitoring by licensing and control

The system of licensing and monitoring

Production and distribution of cannabis products shall be subject to strict state monitoring by licensing and control at all levels. According to the Paper, the entire supply and trade chain (cultivation, processing, transport, wholesale, retail) shall be subjected to a control system (track and trace) that includes documentation of the individual steps in the chain.

The cultivation, processing, storage, transport and sale of cannabis for human consumption shall only be permitted if a licensee has been granted a licence by the federal or regional authorities to carry out the activity. It will be possible for each element of the supply chain to be granted a separate licence. For granting of licences a fee will be charged and a quantity limit will be set. The duration of the licence will be limited in time and may be extended several times upon application.

The authorities or mandated institutions shall have the right to inspect all parts of the supply chain to ensure that they are complying with their requirements. Violations will be an administrative offence and punishable by a fine. Repeatedly violating the regulations may result in criminal prosecution and the licence may be revoked.

Requirements for licenses

Licensees could be natural persons or legal entities. They shall be obliged to provide the authorities with insight into all aspects of their activities related to cannabis for human consumption. In particular, they shall have to meet the following requirements to get a licence:

• proof of required reliability,
• proof of the required reliability of the persons who have access to cannabis plants or products derived therefrom,
• proof of the required expertise of the licensee or the person responsible for managing the business,
• proof of entry of the beneficial owner in an EU business register,
• proof of sufficient financial solvency in relation to the scope of the licence applied for,
• development of a protection concept for theft and fraud.

Specific requirements for cultivation are being developed

Finally, the Paper states that appropriate criteria for production are still being developed. It will be essential that the cultivation method ensures adequate quality control.

Hurdles in the legal framework to overcome

According to the Paper, the current assessment is that international trade with cannabis for consumption purposes is most likely not in line with existing international frameworks. According to the international framework conditions, only international trade for medical or scientific purposes is possible, and only under strict conditions.

 In Addition, there are further legal hurdles that make it questionable whether the German government will be able to realize its legalization plans as set out in the Paper. A number of experts see the plans as incompatible with international law and European law.

International framework

With regard to international law, the following conventions for the international control system concerning the use of drugs must be considered in particular:

• Single Convention on Narcotic Drugs of 1961
• Convention on Psychotropic Substances of 1971
• UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988

The agreements do not provide for national regulation for non-medical reasons. Even if production, trade and distribution were to be completely controlled by the state, Germany could still be considered in breach of the agreements. On the other hand, there are also experts that argue for a restrictive interpretation of the conventions with regard to cannabis, as the conventions would not sufficiently differentiate between "soft" and "hard" drugs. Expert reports by the Scientific Service of the German Bundestag also mention these hurdles in relation to international law, and also mention further ones that exist from the perspective of European law. The reports were not commissioned by the government, but by the opposition. In all of the expert reports, however, the Bundestag lawyers refrain from any assessment of whether the government coalition can succeed in achieving compatibility with international law in the legislative process. They merely document which legal hurdles the government might have to overcome.

EU framework

With regard to European law, there are concerns mainly for the reason that Germany is bound by (two) existing EU treaties that could stand in the way of legalization:

• First, the EU Framework Decision of 2004: According to this decision, each EU Member State must criminalize the production, offering and sale of drugs. It applies to all drugs listed in the 1971 Convention on Psychotropic Substances, including cannabis. The framework decision also requires each Member State to punish violations with "effective, proportionate and dissuasive criminal penalties."
• Second, the Schengen Protocol: Under this protocol, the signatory countries, including Germany, have committed to "prevent the illicit export of narcotic drugs of all kinds, including cannabis products, as well as their sale, procurement and distribution, by administrative and criminal means."

Moreover, experts agree that the approach chosen in the Netherlands is not a model for the legalization plans in Germany. There, the "Opium Act" still applies, which makes the cultivation, sale and possession of cannabis a punishable offense. However, possession and sale of smaller quantities is "de facto decriminalized." The police would confiscate the drugs in all cases, even if they were within the tolerance range. The sale of cannabis is "formally illegal" but is not prosecuted within the tolerance limit. Cultivation and acquisition of larger quantities of cannabis continue to be fully punishable. In contrast, under German plans, these aspects would be exempt from criminal liability and be formally legalized.

Bottom line and next steps

As could be seen, the current cannabis legalisation plans in parts already contain detailed criteria, e.g. on the requirements for indications on the packaging and the packaging leaflets.  

However, it is also clear that a consensus for the characteristics of the cannabis products themselves has not yet been found and, thus, no detailed specifications are possible, e.g. for cultivation.

Even though the Paper is to be seen as an important step towards the elaboration of cannabis legalisation, it is not yet expected that legislation proposal will be introduced in parliament in the direct aftermath. German Federal Health Minister Karl Lauterbach appears wanting to seek a formal notification procedure of a legislative proposal by the EU Commission. In December 2022 he informed on how to proceed: "We want legal certainty. That is why we are seeking notification of the legislative proposal by the EU Commission as soon as it is available. Key points cannot be notified, only a legislative proposal." In addition, Lauterbach's Ministry of Health commissioned an expert opinion that examines the consequences of a controlled distribution of cannabis to adults. The aim is obviously to convince the EU Commission that the planned law will limit cannabis consumption, reduce the black market and improve the protection of children and young people.

According to Lauterbach, there should be no delays as a result of obtaining the expert opinion. The legislative proposal is still expected to be finalized in the first quarter of 2023 and subsequently submitted to the Commission for notification. In the case of a positive reaction from Brussels, the plan is to put the legislative proposal to the vote in parliament as early as the second half of 2023.

Authored by Dr. Christiane Alpers and Lasse Heber.