A cannabinoid drug company has opted to undertake its trials in America due to the complexities of the UK’s licensing regime.
The same understaffed Government department that issues farmers shotgun permits to kill crows is also responsible for analysing 10,000-page medical cannabis trial submissions.
And, a new report is calling on the UK’s recently-elected Labour Government to amend the regulations and end this administrative ‘nightmare’.
Speaking at an on-line conference examining the mis-firing UK medical cannabis research landscape, Dr Andy Yates, Chief Scientific Officer at Artelo Biosciences, elaborated on the industry’s frustrations.
He explained how it is currently working on trials for three synthetic cannabis drugs: “Our second drug, which is a modifier of the human endocannabinoid system is the one where we are actually taking our clinical trials to the US.
“This is simply because we have had so many problems here in the UK. I do believe that is a loss for UK plc…and the US will get the subsequent studies…this is a great shame for endocannabinoid science in the UK.”
Dr Yates was speaking at an event organised by the recently-launched Cannabinoid Research & Development Group (CRDG), following the launch of a CRDG report that calls for wholesale reform of the UK medical cannabinoid research sector.
One of the primary changes the industry craves is the re-scheduling of cannabis under the UK Drugs Licensing regime.
While cannabis-based medicinal products were reclassified to Schedule 2 in 2018 most cannabinoids are still Schedule 1 drugs – which classes them as having no medicinal value.
Consequently, this classification necessitates a licence for research purposes from the Home Offices’ Drugs and Firearms Licensing Unit (DFLU).
This entails adhering to strict rules around research locations, drug transport, additional licensing of the hospitals which conduct the trials and the medical professionals involved in the research.
As well as this administrative burden the industry has deep concerns about the under-resourced DFLU department and its sparse knowledge of medical cannabis licensing.
Dr Yates, who described the current situation as a ‘nightmare’, elaborated: “My main concern with the Home Office as a licensing unit of controlled substances is that they are simply not resourced or skilled to do the job in the medicinal space.
“The majority of people on their staff are involved with whether to issue shotgun licenses to a farmer, or an amateur, or professional shooter.
“We’re talking about drug developments packages…that can be tens of thousands of pages long of scientific data or evidence….and quite frankly the Home Office cannot have a conversation of that complexity.”
Also speaking at the event was Clarissa Sowemimo-Coker, Chief Executive Officer, of UK pharma company Oxford Cannabinoid Technologies.
“We have had the same frustrations; new applications are really difficult to get though the system. It takes a very long time… when we renewed our licence following a change of premises it took 18 months before anyone (from the DFLU) could come out.
“Because we had a licence in place we could continue. But had that been the barrier for us starting and ending research then suddenly our business isn’t viable. Investors aren’t waiting 18 months…they’re not paying 18 months of overheads without any progress. It’s incredibly frustrating,” she said.
In addressing these issues the CRDG report calls for the transfer of cannabinoid licensing for medical, research and development purposes from the Home Office to the Department of Health & Social Care (DHSC), in particular the Medicines and Healthcare Regulatory Products Agency (MHRA).
In 2023, aware of the cannabis industry’s frustrations, the Advisory Council on the Misuse of Drugs had sought solutions.
This included rescheduling cannabinoids from Schedule 2 to 5, based on scientific evidence, or exempting clinical studies approved by the MHRA from requiring Schedule 1 licences.
Dr Yates added: “The current situation has had a dramatic impact on my company’s R&D. We will no longer place trials in UK, they will go elsewhere and all that budget and expertise moves elsewhere.
“I hope one day that can bring that research back to the UK, but currently I would not be pushing for that fight with my board of directors, given the unacceptable delays we have faced with previous projects.”
Business of Cannabis has approached the Home Office for comment and is awaiting a response.
As well as the two companies mentioned above, the CRDG’s members include Ananda Developments, Brains Bioceutical and Curaleaf International.
The CRDG has evolved from The Centre for Medicinal Cannabis, which itself formed in November 2019. The CRDG bills itself as a ‘research strategy group led by academics, researchers, clinicians, patients and industry’.
The post UK Red Tape Is Forcing Cannabis Investment Overseas appeared first on Business of Cannabis.
Continue reading...
The same understaffed Government department that issues farmers shotgun permits to kill crows is also responsible for analysing 10,000-page medical cannabis trial submissions.
And, a new report is calling on the UK’s recently-elected Labour Government to amend the regulations and end this administrative ‘nightmare’.
Speaking at an on-line conference examining the mis-firing UK medical cannabis research landscape, Dr Andy Yates, Chief Scientific Officer at Artelo Biosciences, elaborated on the industry’s frustrations.
Problems In The UK
He explained how it is currently working on trials for three synthetic cannabis drugs: “Our second drug, which is a modifier of the human endocannabinoid system is the one where we are actually taking our clinical trials to the US.
“This is simply because we have had so many problems here in the UK. I do believe that is a loss for UK plc…and the US will get the subsequent studies…this is a great shame for endocannabinoid science in the UK.”
Dr Yates was speaking at an event organised by the recently-launched Cannabinoid Research & Development Group (CRDG), following the launch of a CRDG report that calls for wholesale reform of the UK medical cannabinoid research sector.
One of the primary changes the industry craves is the re-scheduling of cannabis under the UK Drugs Licensing regime.
While cannabis-based medicinal products were reclassified to Schedule 2 in 2018 most cannabinoids are still Schedule 1 drugs – which classes them as having no medicinal value.
Consequently, this classification necessitates a licence for research purposes from the Home Offices’ Drugs and Firearms Licensing Unit (DFLU).
This entails adhering to strict rules around research locations, drug transport, additional licensing of the hospitals which conduct the trials and the medical professionals involved in the research.
As well as this administrative burden the industry has deep concerns about the under-resourced DFLU department and its sparse knowledge of medical cannabis licensing.
Home Office Unsuitable
Dr Yates, who described the current situation as a ‘nightmare’, elaborated: “My main concern with the Home Office as a licensing unit of controlled substances is that they are simply not resourced or skilled to do the job in the medicinal space.
“The majority of people on their staff are involved with whether to issue shotgun licenses to a farmer, or an amateur, or professional shooter.
“We’re talking about drug developments packages…that can be tens of thousands of pages long of scientific data or evidence….and quite frankly the Home Office cannot have a conversation of that complexity.”
Also speaking at the event was Clarissa Sowemimo-Coker, Chief Executive Officer, of UK pharma company Oxford Cannabinoid Technologies.
“We have had the same frustrations; new applications are really difficult to get though the system. It takes a very long time… when we renewed our licence following a change of premises it took 18 months before anyone (from the DFLU) could come out.
“Because we had a licence in place we could continue. But had that been the barrier for us starting and ending research then suddenly our business isn’t viable. Investors aren’t waiting 18 months…they’re not paying 18 months of overheads without any progress. It’s incredibly frustrating,” she said.
In addressing these issues the CRDG report calls for the transfer of cannabinoid licensing for medical, research and development purposes from the Home Office to the Department of Health & Social Care (DHSC), in particular the Medicines and Healthcare Regulatory Products Agency (MHRA).
In 2023, aware of the cannabis industry’s frustrations, the Advisory Council on the Misuse of Drugs had sought solutions.
This included rescheduling cannabinoids from Schedule 2 to 5, based on scientific evidence, or exempting clinical studies approved by the MHRA from requiring Schedule 1 licences.
Forced Overseas
Dr Yates added: “The current situation has had a dramatic impact on my company’s R&D. We will no longer place trials in UK, they will go elsewhere and all that budget and expertise moves elsewhere.
“I hope one day that can bring that research back to the UK, but currently I would not be pushing for that fight with my board of directors, given the unacceptable delays we have faced with previous projects.”
Business of Cannabis has approached the Home Office for comment and is awaiting a response.
As well as the two companies mentioned above, the CRDG’s members include Ananda Developments, Brains Bioceutical and Curaleaf International.
The CRDG has evolved from The Centre for Medicinal Cannabis, which itself formed in November 2019. The CRDG bills itself as a ‘research strategy group led by academics, researchers, clinicians, patients and industry’.
The post UK Red Tape Is Forcing Cannabis Investment Overseas appeared first on Business of Cannabis.
Continue reading...
