Medical Cannabis

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Medical cannabis products continue to grow in the German healthcare market. From the patient's point of view, this is welcome, as many therapies have been proven to benefit from medical cannabis. And as demand increases, so does the number of providers. The use of medical cannabis is tied to many legal and regulatory issues, however, which manufacturers, contracting authorities, distributors and users should address.

Our advisory range focuses in particular on:

Intellectual property

The protection of intellectual property plays an enormously important role, in particular in young research-intensive sectors such as the area of cannabis products. Companies dedicated to the production and marketing of medical cannabis should apply for trademark protection and patent protection, wherever possible. On the other hand, they should pay close attention to the correct labeling and advertising of their products, since both tend to be more strictly regulated in the health sector than in other industries.

SKW Schwarz will support you in licensing your cannabis products and advise you on all related contracts. We are registering trademarks and designs for you, while we are working together with specialized patent attorneys as regards research and development. Protection of trade secrets, data protection, and competition law are part of our daily business.

Commercial and distribution law

Distribution and supply chains need to be established or used when placing medical cannabis on the market in Germany. Our lawyers will support you in drafting and reviewing the relevant contracts on the basis of their many years of experience in all issues relating to commercial and distribution law. We support suppliers and distributors of medical cannabis during negotiations and, in cases of dispute, represent them in court or in arbitration proceedings.

We are covering regulatory specifics in the healthcare sector through close collaboration with our peers from the fields of Regulatory & Compliance.

Regulatory

Commercial trading in medical cannabis in general has been permitted in Germany since 2017. It continues to be regulated, however, and is subject to numerous provisions of narcotics law and medicinal products law.

Our lawyers will support you in obtaining licenses to distribute narcotics in accordance with the Narcotics Act, to manufacture cannabis under the Medicinal Products Act, or to distribute medical cannabis to other re-sellers . Where required, we can also procure a special license as a finished medicinal product on your behalf. We will assist you in submitting the necessary proof of special expertise and compliance with product quality and safety with your applications.

At present, cannabis products without a medical purpose are considered narcotics that may only be brought to market under strict requirements in Germany. This applies, for instance, to suppliers of cannabis-containing foodstuffs or CBD products. We will navigate you through the legal particularities of food, drug, or narcotics law, such as the provisions on “novel food” and cosmetics, in order to protect you from trading restraints or even criminal sanctions.

Cannabis cultivation associations - what you need to know

The current Cannabis Act (CanG) opens up the possibility of establishing cannabis cultivation associations, the so-called Cannabis Social Clubs (CSC). The aim of this draft law is to create a legal framework for the regulation of cannabis use in Germany. Find out how this draft implements the 1st pillar of private and communal home cultivation for adults.

Find out more about the requirements, restrictions and protective measures for growers' associations and cooperatives, as well as steps for setting these up in our detailed article.

To the article "Cannabis cultivation associations"

Transactions in the medical cannabis sector

To date, medical cannabis transactions have mainly taken place in the U.S. and Canada. In Germany, activity in the venture capital/private equity sector has seen an expansion, however, due to certain capital market products (derivatives) around cannabis products. In 2019, eight transactions with a total volume of some EUR 37 million were concluded. While many transactions continue to be led by U.S. investors, it is expected that other regions will also participate in financing in the near future.

The SKW Schwarz Corporate / M&A team specializes in life sciences transactions. In the field of medical cannabis, we are offering comprehensive advice on venture capital, private equity, and M&A transactions. We are also advising on transactions and financing in the pharmaceutical and biotech sectors, and relating to MedTech and digital health products. In the life sciences sector, our lawyers are also advising on capital market products, including the placement and marketing of securities (in particular, participation certificates) and other financial products (such as investment schemes and subordinated loans).

Public procurement law: Invitations to bid

Producers and marketers of medical cannabis are also confronted with public procurement law: Health insurance companies have been considered “public contracting authorities” for some time now and are therefore subject to the rules of public procurement law. Services in the field of medical cannabis must therefore also be publicly advertised. Cannabis producers and distribution companies will have to familiarize themselves with the rules for public bidding to succeed against competitors.

Our experts for public procurement law advise suppliers of medical cannabis on analyzing the key parameters when preparing to participate in invitations to bids. We are drafting the bidding documents on your behalf, including required supporting documents. If the contract is won by another bidder and there are doubts as to whether it was duly awarded, our lawyers will also be at your side when legal action needs to be taken.