EU market for medical cannabis still far from full bloom

Over 60,000 people are registered in Germany as health insurance patients prescribed with medical marijuana, according to the latest data released in June 2019. [SHUTTERSTOCK]

A temporary shortage of Dutch hemp flowers intended for export to Germany has put the spotlight on a lack of diversified supply sources and uniform quality standards in the growing European market for medical cannabis.

In the first half of June, the Dutch government office responsible for exporting medical marijuana informed German wholesalers that a delay of up to six weeks may occur in the shipment of their products.

In 2019, the Dutch Office of Medical Cannabis (OMC) increased its yearly exports of cannabis flowers for medical use in Germany to 2.5 tonnes, after a request coming straight from Berlin.

With this last surge, medical cannabis flowers imported from the Netherlands now account for more than a third of the German market, whose overall capacity doubled compared to the previous year to reach 6.7 tonnes annually.

However, the entire Dutch exports to Germany rests on the shoulders of a single business firm, Bedrocan, which manages production capacity at national level.

The delay in the delivery originates from some additional testing the Dutch supplier needed to perform before releasing the batches for export.

Such a temporary interruption in the supply chain exposed potential bottlenecks caused by a lack of diversification in the production of medical cannabis for the German market.

And the situation might deteriorate in the future, as demand for medical marijuana has rapidly expanded in the country since a 2017 decision allowing German physicians to prescribe medical pharmaceutical-grade cannabis flowers or cannabis extract to seriously ill patients.

Over 60,000 people are registered in Germany as health insurance patients prescribed with medical marijuana, according to the latest data released in June 2019.

Germany votes to ease access to medical marijuana

The German Bundestag today (19 January) unanimously passed legislation granting seriously ill patients easier access to medical marijuana. EURACTIV Germany reports.

Towards an integrated European supply chain

The boom in the German market for medical cannabis comes with challenges in meeting growing demand and developing a robust sales network.

This is why the German government created in 2017 a new body within the German Medicines Agency (BfArM) tasked with regulating the nascent domestic industry and  issuing licenses for the import of medical cannabis.

In its first three years, the German Cannabis Agency has faced structural pitfalls which are intrinsic to a market under development but that is not in full blossom yet.

Until recently, only Canada, the Netherlands and Austria were authorised to export cannabis-based products to Germany under the 1961 UN Single Convention.

This has led to a form of over-reliance on a few cultivator countries. In order to cope with the demand, BfArM has recently issued additional authorisations to a number of other countries such as Portugal, Spain, Switzerland, Israel, Colombia and Uruguay.

Since then, cannabis flowers from Portugal became available in Germany for the first time at the end of 2019.

Canadian-based cannabis company Tilray aims at making its Portuguese facility in Cantanhede a European base for its project to set up a fully integrated supply chain in the EU.

Shipping flowers produced in Europe represents a potential game-changer for the uptake of the regional market.

EU should adopt German standards on medical cannabis, campaigners say

Germany’s regulatory approach to medical cannabis is good practice and should be replicated across Europe, according to newly-born European Medicinal Cannabis Association (EUMCA).

A matter of quality

Although they increase the supply sources of cannabis-based medical products, the new German import authorisations also reveal underlying issues with quality standards at EU level.

As things stand, licensed medical products receive the EU good manufacturing practice (GMP) certification, a set of standards that all drug manufacturers must comply with.

Cultivators in the EU have the advantage that this certification is automatically recognised in other EU member states, although there are mutual recognition agreements (MRAs) for third countries too.

Before hitting the market, all medical cannabis sold in Europe needs to be produced and tested under European GMP, together with good distribution practices (GDP) certification for warehousing and distribution.

And while there are strict European controls on how cannabis-based drugs are manufactured, there is a complete lack of harmonised quality standards.

This generates discrepancies in the way national bodies assess the quality of a cannabis-based drugs intended for export and the standards in force in the country importing that product.

For instance, the Dutch authority applies national lead levels to measure the absence of heavy metals in the drug, instead of the EU Ph monograph levels.

As a result, quality standards may vary in each country in the absence of an overarching benchmark for quality at EU level.

Building a homogeneous set of quality standards for medical cannabis is crucial for industry representatives lobbying for an EU regulatory framework.

However, the process leading to harmonised EU rules for medical cannabis has stalled, although it is broadly welcomed by many stakeholders and lawmakers.

MEP: EU framework on medical cannabis to give ‘peace of mind’ to patients

A strong EU regulatory framework on medical cannabis is needed to provide investors with stability but also to give peace of mind to patients struggling with fragmented legislation among member states, socialist MEP Miriam Dalli said.

(Edited by Frédéric Simon)

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