How to get a medical cannabis cultivation licence in the UK

How to get a medical cannabis cultivation licence in the UK

Author

Sam North is an experienced cannabis consultant and writer who provides education and guidance for businesses, commercial projects, and private clients. With over 5 years of industry experience, Sam is passionate about the potential of cannabis to help restore balance and well-being into people's lives.

Medical cannabis finally became a legal reality here in the UK on the 1st of November 2018, after more than two decades of lobbying and campaigning by patients, carers, charities, non-profit organisations, and doctors themselves. No longer are patients that require medical cannabis treatment left to suffer in silence or forced to seek alternative means of treatment. With the legalisation of medical cannabis, patients and doctors alike now have access to a range of new treatment options.

And while the regulations relating to the prescription of medical cannabis through the NHS is extremely restricted, with only three conditions being approved (and even then, only under exceptional circumstances), thankfully, there are other avenues of access.

Private clinics have sprung up nationwide, and these clinics are able to prescribe medical cannabis for a wide variety of conditions that are not approved by the NHS. For many patients, these clinics offer an invaluable lifeline, providing them with the access they need to obtain the cannabis based medical products that could improve their condition, and the related symptoms.

But what about those who want to take a more hands-on approach and cultivate their own medical cannabis? Is it possible to get either a commercial or private medical cannabis cultivation licence in the UK?

Let's have a quick look at what medical cannabis is exactly here in the UK and dig into the legislation to see what the requirements and steps are for obtaining a medical cannabis cultivation licence in the UK.

What is medical cannabis?

Firstly, let's clarify the difference between medical and recreational cannabis. Medical cannabis is cannabis that is administered specifically for medicinal purposes under the supervision of a doctor, while recreational cannabis typically refers to the use of cannabis for nonmedical purposes.

Medical cannabis is different from its recreational counterpart in terms of the specific strains and chemical composition used. Unlike street bought cannabis, medical cannabis is grown under strict conditions, monitored for quality and consistency, and its application is overseen by medical professionals. This ensures that patients receive a regulated and specific dosage of the appropriate cannabinoid for their condition. Here in the UK, the medical cannabis industry is subject to extremely stringent regulations, enforced by the governing body to ensure the safety and efficacy of medical cannabis products. 

How was medical cannabis legalised?

In the summer of 2018, an urgent review of cannabis-based medicinal products took place, leading the Advisory Council on the Misuse of Drugs (ACMD) and the UK’s Chief Medical Officer to make changes to the law that would allow expert doctors to legally issue prescriptions to patients who they decided could benefit from medical cannabis treatments.

It was recommended that the new law would not limit the types of conditions that can be considered for treatment. This allowed specialists to make decisions on prescribing cannabis-based products for medicinal use on a case-by-case basis, where patients are deemed to have special clinical needs that have not been met by traditional licensed medical products.

This meant that doctors who are on the General Medical Council (GMC) Specialist Register no longer needed to seek approval from expert panels in order to offer their patients access to cannabis-based medicines.

What did the UK Government review find?

A full government review of the legal status of medical cannabis took place in 2018 and was conducted in two parts.

Part one was overseen by the then Chief Medical Officer, Professor Dame Sally Davies, who reviewed the existing evidence for the application of cannabis-based medicinal products. She concluded that there was

"sufficient evidence of the therapeutic benefits of medical cannabis products for a range of medical conditions to be able to recommend that the class of medical cannabis be moved out of Schedule 1"

Part two of the review was conducted by the Advisory Council on the Misuse of Drugs (ACMD) who went on to agree that cannabis-derived medicinal products that reached a required medical standard should no longer be subject to ‘Schedule 1’ requirements and could be re-classified and moved into Schedule 2.

This opened the door for easier and wider access to medical cannabis prescriptions, officially changing the legal status of cannabis in the UK and opening up the potential for a new market in the production of licensable cannabis products.

Does this mean that anyone can legally grow medical cannabis in the UK?

Absolutely not. Private cultivation of cannabis, medical or not, remains illegal under UK law. 

Medical cannabis can only be prescribed to patients by doctors who are on the General Medical Council (GMC) Specialist Register, which is then sourced through a pharmacy that is licensed to dispense controlled medicines. The penalties relating to illegal private cannabis cultivation include up to 14 years imprisonment, an unlimited fine, or both.

Is it possible to obtain a commercial medical cannabis cultivation licence in the UK?

Yes, it is possible to obtain a commercial medical cannabis cultivation licence in the UK, but it is not a straightforward process.

Companies looking to manufacture cannabis-based medicinal products need to seek authorisation from two regulatory bodies – the MHRA and the Home Office. The burgeoning medical cannabis cultivation market has forced some changes to the overall process of applying for these licences.

Why?

The Home Office issues what are referred to as Controlled Drugs (CD) licences. This is the main licence required for commercial cannabis cultivation and supply, but to receive this licence, historically companies needed to have already received a manufacturing licence from the MHRA.

And this is where the issue arises.

To be eligible for the MHRA manufacturing licence, companies are required to fully demonstrate their ability to manufacture their product consistently and correctly. Prior to issuing a controlled drugs licence, the Home Office requires assurance that a company is capable of meeting the requirements set forth by the MHRA. So, this points to the fact that the MHRA licence must be issued first, right?

Yes, but new medical cannabis cultivation companies are unable to fulfil all the necessary processes required for the MHRA without first handling the 'controlled substances', and they can’t handle them until they hold a Home Office licence. All of this created a bit of a "catch 22" situation…

So, what was the solution?

As the medical cannabis industry grew, and this matter came to attention, the MHRA and the Home Office began to explore ways in which they could jointly approve companies that meet the industry's requirements while satisfying the regulatory needs of both government departments simultaneously. Thankfully, they have come to a resolution, with several companies now being granted these licences and paving the way for a safer and more transparent medical cannabis industry in the UK.

For a full explanation of this process, please head over to this UK government blog link. There is also this 22-page report that explains the MHRA licencing process in full detail.

How much does this process cost?

The application fee for the Home Office controlled drugs licence for cannabis cultivation currently stands at £4,700. On top of this, all sites that are looking to produce medical cannabis with a THC percentage of more than 0.2% must have a compliance visit, which comes at a cost of £1,371. The licence last for three calendar years, meaning all licences end on the 31st of December. This should be taken into consideration when planning your business operations, as a renewal will be required at this time, and the application process should be started as early to ensure the longest licence period possible.

The MHRA’s manufacturing licence fees for new businesses stands at £6,019, which covers both the application fee (£3,457) and the assessment fee (£2,562). Then there is the annual compliance report, which costs £283 unless there is a variation required, in which case it will set you back £565.

So, as we can see, the licencing fees alone can be quite hefty, making it a substantial investment for companies looking to enter the medical cannabis cultivation industry in the UK. However, with the potential for a lucrative and exponentially expanding market and increased accessibility for patients, it could prove to be a wise investment overall. Plus, with the recent changes to the licencing process mentioned above, it is becoming more feasible for new companies looking to enter the market.

How much does medical cannabis farm insurance cost?

How long is a piece of string? Insurance costs vary significantly from business to business, and with the industry still in its infancy, there are not yet many companies offering specialised medical cannabis cultivation insurance. However, some brokers do offer policies, and we expect to see more options on the market as the industry grows. As with any insurance policy, it is essential to shop around and compare prices and coverage thoroughly before making any decisions.

The larger the scale of the operation, the higher the risk, and ultimately, the higher your insurance will cost. To obtain an accurate quote for your specific business operations, it is best to speak with a specialist insurance broker who has experience with medical cannabis farm coverage and can assess your unique situation and provide you with tailored recommendations. As a rough estimate, however, expect to pay several thousand pounds for full coverage.

You may have to employ the services of multiple insurance companies to cover all aspects of your business, such as product liability, equipment, crops, facilities, personnel, and professional indemnity. It is essential to ensure you have adequate coverage to protect your business and its operations, as this will be a crucial factor in obtaining the necessary licences.

Conclusion

Obtaining a medical cannabis cultivation licence in the UK is a complex and expensive process and is only available to commercial producers. It remains illegal for individuals to grow their own medical cannabis, and there are no plans for this to change, at least in the foreseeable future.

However, with the recent changes to regulations and licensing processes, it is becoming more achievable for new businesses looking to enter the market. The fees for both Home Office controlled drugs licences and MHRA manufacturing licences can add up to several thousand pounds, but with the potential for securing a lucrative market share in an emerging and booming industry, many see it as a worthwhile investment. It is crucial to keep in mind that the licensing process can be lengthy, so planning every aspect of the application process is essential for success.

Releaf understands the importance of medical cannabis in treating various medical conditions. With our tailored monthly packages, specialist consultations for medical cannabis, and a unique medical cannabis card for protection, you can access the treatment you require without worrying about the stigma.

It is important to seek medical advice before starting any new treatments. The patient advisors at Releaf are available to provide expert advice and support. Alternatively, click here to book a consultation with one of our specialist doctors.


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