Germany’s Ministry of Health has officially published its draft law for ‘Pillar 1’ of its plans to liberalise access to adult-use cannabis.
Alongside the 163-page draft, the government has published a Q&A document revealing that as the law does not require the approval of the Bundesrat, ‘it is scheduled to come into force at the end of 2023’.
While the draft is largely focused on laying out provisions of how the proposed cannabis clubs can operate (which Business of Cannabis will be exploring over the coming days), crucially it confirms the government’s plans to remove ‘all cannabis-related active substances’ from the list of narcotics.
Bloomwell’s Co-Founder and CEO Niklas Kouparanis, who has been highlighting the potential of this change since the new framework was announced in April, said: “Now it’s official: The Ministry of Health no longer wants to classify cannabis as a narcotic. With this reclassification, a new era of progressive and solution-oriented drug policy is beginning in Germany after decades of stigmatisation.
‘Huge growth’ on the horizon
While Pillar 1, which focuses on the rollout of cultivation clubs across the country, has been criticised for leaving little room for businesses to flourish as they had once anticipated, this key change is expected to not only drive significant growth in the medical cannabis market, but also remove the ongoing prosecution of CBD traders throughout Germany.
Speaking at last week’s ICBC Berlin, German cultivator Demecan’s Managing Director Dr Philipp Goebel said he believed the market was ‘set to see huge growth’.
“I think there will be a major change with that first pillar, and taking that (cannabis) out of the narcotics law will definitely grow the market in terms of medical cannabis.”
Pressed on whether he had solid figures on his expectation of growth rates, Dr Goebel added: “I don’t have more exact estimations, but estimates are between a factor of three and ten.
“I think it will take some more education of doctors as well, but it will definitely lead to growth.”
Hurdles will fall
Narcotic drugs (“Betäubungsmittel”, BtM) as defined by the German Narcotic Drugs Act (“Betäubungsmittelgesetz”, BtMG) are the substances and preparations listed in Schedules I to III of the Narcotics Act.
As Dr Goebel explained to the audience, prescribing and handling narcotic substances in all areas of the supply chain is currently ‘a nightmare’.
“A narcotic prescription is a serialised prescription, so the doctors need to apply it to obtain it.
“So, they’re very restricted on how to prescribe medical cannabis right now. And in the pharmacy the workload to handle narcotics is also tremendous. And for ourselves as well, we need to do a full inventory twice a year. It’s a nightmare.
“I think by taking it out of narcotics law, many hurdles which are out there right now in the market will fall, and we will be able to serve more patients adequately.”
This was echoed by Dentons’ Peter Homberg in an earlier session, who said he believed there were ‘certain barriers, at least psychologically’ for doctors prescribing narcotics due to the extra levels of admin required.
“We know that in the medical market there is a certain reluctance of physicians to prescribe cannabis for medical purposes.”
In a statement following yesterday’s news, Mr Kouparanis said: “If medical cannabis is no longer considered a narcotic, we can reduce logistical hurdles and costs for production, storage, distribution and delivery. The administrative roadblocks for prescribing doctors will also be eased. Germany can act as a role model for other EU member states, setting an example for progressive medical cannabis policies.”
Furthermore, Dr Goebel suggested that the Drug Supply Shortage Control and Supply Improvement Act, which was passed by the Bundestag last month, would further help reduce barriers for medical cannabis prescriptions.
This legislation, cited numerous times as a positive step forward during the conference, will reduce the approval period for a first medical cannabis prescription to two weeks, or four weeks if an expert opinion is required.
Another panellist, EUMCA General Secretary Sita Schubert, questioned where this change in status would leave cannabis in terms of reimbursement.
She said: “There are over-the-counter products which are not reimbursed. There are medicinal preparations which are not reimbursed, and then we have products which are reimbursed by legislation, and these are, for example, narcotics. As cannabis does not yet have a marketing authorisation process which went through the GBA to be listed in prescription, I don’t understand under which kind of status it will be reimbursed?”
CBD
It’s not just medical cannabis that stands to benefit from this change, however.
The host of the panel, renowned cannabis lawyer Kai-Friedrich Niermann, began by reminding the audience that CBD traders were still routinely being prosecuted for the ‘trading of CBD oil’.
He went on to emphasise previous assertions from the day’s discussions that perhaps the most significant part of the new framework was the removal of cannabis from the Narcotics Act.
“This is a milestone for all the CBD flower traders and CBD oil traders which have been prosecuted. This is a milestone for the consumers and probably a milestone for the medical cannabis industry.”
