Germany awards domestic cultivation licences to Aphria, Aurora and Demecan

05.04.2019

Germany has awarded three companies licences to cultivate medicinal cannabis, bringing the long-delayed tendering process that has stymied Europe’s largest market to an end.

Germany’s health regulator, the Federal Institute for Drugs and Medical Products (BfArM), informed the 79 applicants of the outcome on Wednesday.

Canadian companies, Aurora and Aphria, which includes Nuuvera, and the German company Demecan, a joint venture with Wayland Group, will be allowed to grow a combined total of 10,400kg of medical cannabis over the next four years.

Of the 13 lots available in the process, Aphria received five, according to Hendrik Knopp, Managing Director of Aphria Deutschland. Aurora also received five and Demecan received the remaining three lots. Each lot allows the holder to grow 200kg per year.

German company, Lexamed, which successfully sued BfArM last year, was not successful.

Research by Prohibition Partners estimates the German medicinal market is currently worth about €133m and is set to be worth more than €1bn by 2020 when the first large-scale harvest is expected to take place.

Supply Concerns

Georg Wurth, German Hemp Association

Georg Wurth, German Hemp Association

‘Finally, it's moving forward,’ said German Hemp Association CEO, Georg Wurth. ‘But the planned quantity in Germany will not be enough to avoid further supply bottlenecks. We expect three things: a fast start to cultivation, further licensing and, above all, falling prices for cannabis flowers in pharmacies.’

Advocacy groups in Germany have long said the tender process grossly underestimated the amounts required to meet demand and have called for the government to lift the 10,400kg cap on the total cannabis produced over the four years. The companies may apply to increase their capacity by 10% each year.

Experts said there was little surprise in the three winning names, as they had the experience and facilities to match the high expectations of Germany’s regulators.

Kai-Friedrich Niermann, founder of law firm KFN+

Kai-Friedrich Niermann, founder of law firm KFN+

‘I think this was the only possible decision and a good decision,’ said Kai-Friedrich Niermann, founder of law firm KFN+. ‘When Europe says medical it means medical – these firms would have to ensure that patients are supplied with only the absolute highest quality medicinal grade cannabis flowers and products.’

While the market will be watching for appeals against the decision, the current government is happy with the modest size of the tender and there is little chance of revision.

‘BfArM, under the direct control of Jens Spahn the head of the Ministry of Health, is not in favour of large-scale cultivation of medical cannabis in Germany,’ he told Prohibition Partners. ‘A cannabis industry, even if it is medicinal, is undesired for now.’

He said all eyes would be on the next federal election in 2021. After which the ruling parties may agree on a new framework for domestic production. If they don’t, the field would be wide open for Canadian firms who could drive out domestic growers.

‘Until that point the companies have to prove they are able to produce first-class medical cannabis products, and that a competitive domestic market makes sense,’ he said.

Recapping Germany’s tendering process

Germany legalised medical cannabis in March 2017, but rising patient numbers, which have grown from an initial 1,000 to over 40,000 today, have helped create the third largest medical cannabis market in the world.

To supply the rising patient demand, a tender process for domestic growers was drawn up by BfArM. However, to qualify for approval, German firms had to meet a number of qualifications, one of which was the experience of growing cannabis. As no one was allowed to grow cannabis in Germany prior to the law change, no firms could legally progress to the next stage of the tender process.

Domestic growers sued BfArM forcing them to redraft the rules in order to allow local firms to acquire a reference from outside growers, who would then transfer their experience to a German applicant.

A limited number of applicants made it through the second tender, the majority of which ran out of time due to the complexities of the process. Their only option was to sue BfArM again, and one applicant was backed by a Dusseldorf court in March 2018, who agreed the regulator had made a mistake in not extending the timeline. As a result, BfArM halted the tender process entirely and started over.

Following the court ruling in March 2018, the second round of the tendering process to ascertain who could cultivate cannabis in Germany was initiated and became a single step instead of two.

Imports likely to continue

Imports into Germany will continue even after domestically produced cannabis becomes available. However, this has never been a cheap or straightforward process.

The bulk of the imported medical cannabis comes from Canada and the Netherlands, which are currently the only countries legally approved in Germany to import.

What happens now?

There is a ten-day standstill period before any contracts are signed, during which time unsuccessful applicants can challenge the decision.

The regulator has not made any announcement, which is unusual for a public tendering process in Germany, said Peter Homberg, partner and head of Dentons European Cannabis Practice in Berlin. Will this indicate further twists in what has been a convoluted process? No one is sure.

Peter Homberg, partner and head of Dentons European Cannabis Practice

Peter Homberg, partner and head of Dentons European Cannabis Practice

‘It is my belief that other participants in the tender process who have not been awarded a licence will probably challenge the decision,’ Homberg told Prohibition Partners.

Whatever the outcome, the largest cannabis market in Europe has made progress towards regional leadership in the European market, but the long and arduous tendering process provides valuable lessons to those following in their wake.

For more on Germany and the regulatory landscape inside the burgeoning European cannabis market, download The European Cannabis Report™ for free now.

Germany awards domestic cultivation licences to Aphria, Aurora and Demecan

View All