Peter homberg is a partner in the Dentons Berlin office. Picture: Dentos

Access instead of bureaucracy

A newly forming industry association warns the European Commission not to block patients’ access to the emerging EU market for medicinal cannabis. At the BIO-Europe in Hamburg, European Biotechnology spoke with one of the initiators, Peter Homberg.

EuroBiotech_A new association on the topic of medical cannabis is currently being formed in Europe. Mr Homberg, what can you tell us about the motivation to do so as one of the initiators?
Homberg_In March 2017, the German government liberalised the cultivation of medicinal cannabis, so that it can be prescribed for medical purposes. At the same time, licensed growers were allowed to produce certain quantities [10.4 tonnes over four years] in Germany, but these amounts will not be sufficient to cover the total annual requirement of almost 43 tonnes. Further regulatory changes are imminent: we expect changes from Brussels, because at the beginning of this year, the European Parliament called on the European Commission to harmonise the legal framework in Europe for the use of medicinal cannabis. The current situation in the Member States is extremely heterogeneous: Germany is open to medical applications; other countries are not. But, Denmark and the UK have followed suit; France has even set up a very small but remarkable experimental programme, in which medical cannabis is voluntarily tested by a limited number of patients. Other countries are also demonstrating appreciation for the desire of certain patient groups to test the use of medicinal cannabis, as they are currently dependent on preparations with significant side effects, such as patients with chronic pain.

EuroBiotech_What does this mean for the manufacturers of medicinal cannabis as well as of synthetic cannabinoids?
Homberg_ Let me come to the European Parliament resolution of earlier this year: on the one hand, it includes harmonisation, which is a positive development for importers from the current, leading Amo- Canadian market for medicinal cannabis. On the other hand, however, there are also less positive demands, such as those for mandatory market authorisation for such products. It is still unclear how extensive the corresponding clinical studies should be. However, it is clear that under these circumstances, patients would no longer have the same access to medical cannabis as of today. Because cannabis is not a finished drug or a widely-tested drug, this industry-hostile regulation should be proven in the interest of the benefitting patients.

EuroBiotech_What objectives will your association pursue accordingly?
Homberg_We will represent the interests of the European cannabis industry. This also means significant educational work regarding how cannabis works medically. Above all, however, it is important to provide quick and easy access to medical cannabis in Europe, where patients urgently need the treatment and demonstrably benefit from it.

EuroBiotech_What is the market potential in Europe compared to world market leader Canada?
Homberg_The USA and Canada are the clear world market leaders to date, which are now being closely followed by Germany, where the responsible German regulatory authority, BfArM, has granted 13 licenses to three suppliers to grow 10.4 tons of medical cannabis in Germany within the next four years. It is one of the largest markets. We can see how Canada has made access, prescription, and medical use of cannabis and its ingredients possible without the massive regulation recently called for by the EP.

Peter Homberg focuses on life sciences, IP, corporate law, and M&A transactions in the life sciences and high-tech sector, as well as in R&D and cooperation agreements, cross-border IP licensing, and IP strategies. He has extensive experience providing legal advice on compliance issues. Additionally, he is the head of the European Cannabis sector group

First published in European Biotechnology Winter Edition 2019