AS Brains Bioceuticals unveiled a significant expansion of its UK production facilities, it has warned that any future investment is under threat unless the UK Government changes its medical cannabis export rules.
In a letter sent recently to the UK Home Office, it says it has invested close to £40m in the UK to date and has further plans to expand its research and manufacturing facilities in Sandwich, Kent.
However, it has warned that any further investment could be under threat unless the UK Government allows for the export of the unlicensed cannabis medicines it manufactures.
The position taken by Brains echoes the view of much of the UK medical cannabis manufacturing industry, which faces competition from imports as UK patient numbers reach almost 10,000 and the industry’s value exceeds £15m.
Brains’ New Lab
Its submission to the Home Office came as Brains opened the doors to the recently completed major expansion of its research facility in Kent.
The newly expanded location, understood to be the UK’s largest EU GMP-grade cannabinoid research facility, will provide the company with an eightfold increase in capacity for manufacturing CBD and other cannabinoid products.
Its investment into the expansion is designed not only to facilitate growth in production of API and products, but also to expand its capabilities in ‘clinical research around the efficacy and safety’ of cannabinoids in the treatment of major diseases.
Addressing an audience at the facilities grand opening on September 29, Brains Chairperson and CEO Ricky Brar said: “This facility represents the highest standard in the world. We have assembled a world class team, and we’ve assembled tremendous partnerships.
“This is where we’ll create the purest API for the pharmaceutical and nutraceutical industry at a commercial capacity that hasn’t been seen before in the UK or in Europe.”
A Pilot Programme Exemption
In its letter to the Home Office, Brains requests that the Home Secretary permits Brains a licence to export, saying: “Our request is to allow a pilot programme exemption for BSPG Laboratories to support the life sciences sector and export THC from the UK.”
And continues: “This would enable us to develop a third facility and keep investment in the UK and not other EU jurisdictions where the export of cannabinoids is permitted, thus allowing us to support clinical trial programmes.”
Barinder Bhullar, Senior Vice President, Corporate Affairs at Brains Bioceutical, said in a statement to BusinessCann: “Brains Bio has made a submission to the Home Affairs Committee in the UK Parliament. Brains Bio looks forward to an opportunity to present to the committee in the near future.”
However, in a response to questions from BusinessCann on what action the Brains submission may elicit, it appears as though its request may fall on deaf ears.
‘No Plans To Change’ – Home Office
The Home Office told BusinessCann that existing UK policy ‘does not allow for cannabis- based prescription medicine (CBPM) ‘specials’ to be exported’.
Adding that when ‘medicinal cannabis legislation was introduced in 2018, the policy’s intention was to enable supply for UK patients’.
And, it provided the following statement: “Companies wishing to produce cannabis-based medicinal products require Home Office Controlled Drug Licences to lawfully undertake these activities.
“These robust and proportionate measures permit cannabis cultivation for lawful purposes, while protecting the public against their unlawful or unsafe use.
“While we keep legislative controls under review, we currently have no plans to change the licensing process or framework relating to cannabis, nor do we comment on individual licences.”
In the UK, the Drugs and Firearms Licensing Unit determines applications for controlled drugs licences on behalf of the Home Secretary.
Boost UK Life Sciences
And, the Home Secretary, the recently- appointed Suella Braverman, has powers to make activities, which would otherwise be unlawful, lawful through licensing.
Brains hopes its submission will see it become the first to secure an export licence, highlighting, in its letter, the potential benefits to the UK economy.
The letter says: “We look forward to continuing to contribute to building the UK Life Science Sector. Our knowledge, experience and expertise are at the forefront of cannabinoid manufacturing and research and driving innovation in the cannabinoid space.”
Brains’ bid to change the UK exporting rules is being supported by other UK-domiciled businesses.
EU Specials Market Worth €3bn
In a paper published last year, Pierre van Weperen, Managing Director of the Grow Group, and Jonathan Hodgson, CEO of Rokshaw Laboratories, petitioned for an ending of the UK cannabis export ban, saying: “New medicines developed in the UK should not just benefit British patients.
“By allowing the export of finished products, the UK’s medical cannabis industry could easily expand into the European market and become a major player in that larger market, thereby generating significant additional revenue for the UK and creating tens of thousands of extra jobs in the process.”
They also say such legislation would help drive down the costs for UK patients, as producing medicines for a bigger market would lead to renewed investment and deliver economies of scale.
The European unlicensed, cannabis specials market has the potential to grow to over €3bn by 2025, says Prohibition Partners in ‘The European Cannabis Report: 6th Edition’.
The industry has also highlighted how unlicensed products in other areas of medicine can be exported from the UK.