THE Department of Health & Social Care (DHSC) has announced that emergency measures to ensure supplies of childrens’ epilepsy cannabis medication remain accessible in the UK will be extended for another three months.
Supplies of Bedrocan oils, which are prescribed to around 40 children who suffer from drug-resistant epilepsy in the UK, were placed under threat in January last year as the post-Brexit transition period came to an end.
A temporary agreement between the DHSC and the Dutch Government to keep supplies flowing from the Netherlands, where the three Bedrocan oils are produced, has now been extended until July 1 2022, a year after the initial deadline.
The further extension is designed to ‘allow domestic production to be established and approved’ in the UK, but the process is understood to be taking far longer than initially anticipated.
Another Extension
On March 15 2022, the DHSC’s Parliamentary Under-Secretary Maria Caulfield provided an official written response to Conservative MP Alberto Costa.
When asked what progress the Department had made on transferring the manufacture of these cannabis-based oils to the UK, she said: “The current producer of Bedrocan oils in the Netherlands and the chosen United Kingdom commercial partner are progressing the technology transfer agreement to manufacture three Bedrocan oils – Bedica, Bedrolite and Bedrocan – in the UK.”
Bedrocan oils are currently produced by Dutch pharmaceuticals company Transvaal Apotheek, which is based in The Hague.
It produces three oils including a Bedrolite, which contains high-levels of CBD but less than 1% THC, alongside Bedica and Bedrocan which contain much higher levels of THC.
As Grow Pharma’s CEO Pierre van Weperen explained to BusinessCann last year, following Brexit both Dutch and UK law prohibits the importation of these oils.
Following an outcry from the patients and their families who have experienced life-changing benefitsfrom these drugs, the Dutch Government agreed to a waiver to extend the legal exportation of the Bedrocan oils.
As a more permanent solution, Transvaal agreed to move production of these products to the UK through Glasgow based firm Target Healthcare, a process initially expected to take a few months.
The initial waiver allowed for the drugs to be imported from January 2021 until July 1 the same year. This was extended a second time to April 2022, and has now been extended a third time until July 2022.
“The Dutch Government has agreed to allow continued supply of all three Bedrocan oils against UK prescriptions for existing patients for a further three months until 1 July 2022. This should allow for domestic production to be established and approved for all three oils”
Why The Delays?
According to Transvaal’s Arwin Ramcharan QA, the ongoing delays have been due to a combination of Covid and licensing issues.
Target is reportedly already producing batches of the oils, which are then sent to the Netherlands for quality control to ensure they match the product produced in The Hague exactly.
Although Target is ready to begin full production of these oils, it is waiting on the licences from the MHRA before it can do so.
According to Ms. Caulfield, Target has now ‘been inspected by the the Medicines and Healthcare products Regulatory Agency and Home Office (MHRA) to obtain the necessary regulatory approvals and has agreement in principle to produce herbal medicines of this type following the successful production of Bedrolite oils.’
It is also understood to be in the process of receiving a schedule one licence from the Home Office to produce the higher-THC oils Bedrocan and Bedica.
Mr Ramcharan explained that when the deal was first announced, he was not aware just how stringent UK regulation would be compared to that of the Netherlands, where the process is much faster.
“I can understand why the UK Government is a little bit cautious because it is a new product. In the Netherlands we have been working with this product since 2007. So I understand why they are saying we have to do it properly, and make sure that everything is correct.”
He added that he was not in a position to speculate on when production may be completed, as this was now in the hands of the UK regulators.
BusinessCann has also approached Target for comment on the delays.
Quality Control
As Professor Mike Barnes explained in BusinessCann last year these particular flowers and production processes are bespoke and difficult to replicate.
Any slight variation in the oils could have potentially significant effects on the patients, so it is essential that they are replicated exactly in Target’s facility.
According to Mr Ramcharan, he has visited the facility ‘five or six times’ over the last year to train the staff and ‘do everything that is necessary to make sure that the products are the same’.
He added that he was in regular contact with the patients’ families, who were understandably worried about the transition.
“I am making sure that the product is the same because I promised them, I would help you guys and make sure that it is the same. And if it’s not the same I’m going to tell you, and then you can decide what to do, but that’s not the case.”
Production at Target is reportedly ‘right on schedule’ and Mr Ramcharan said he is ‘very pleased’ with the results, which showed no variations to the products produced in The Hague.
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