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Home Categories Biotech Medical Cannabis In The UK: Regulatory Mumble Jumble?

Medical Cannabis In The UK: Regulatory Mumble Jumble?

Although medical cannabis was legalized under the Medicines and Healthcare products Regulatory Agency Specials Licence in November 2018, a very small number of people have been offered the treatment including cannabis products within the NHS. Thus, in practice, a good portion of patients still have no access to it. There has been a big number of controversies among the people in need who have been campaigning to be able to access cannabis medical products that help for anxiety, arthritis, migraines, irritable bowel syndrome, fibromyalgia, and many more. 

UK Legislation Lagging Behind Other Countries

UK legislation appears a few steps behind many other countries in the world. Cannabis is universally considered a low-risk drug. The NHS research shows that 10% of users develop an addiction, as compared to 15% and 32% for alcohol and cigarettes respectively. Having said that, in 1928, it was added to the Dangerous Drug Act of 1920, and cannabis for medical use has only been approved in November 2018. However, the number of regulations is confusing to many. Thus, let us break them down.

Existing Regulations

The Cannabis-based products to be used for medical purposes are currently regulated through the Medicines Act of 1968, Human Medicines Regulations 2012, and MDR 2001. Thus, it can appear that the existing regulatory body in the United Kingdom regarding medical cannabis is quite extensive.

Breakthrough Of 2018

Having said that, the actual laws that were groundbreaking in any way in terms of cannabis-based medicinal products for human use came to effect only in November of 2018. In the upcoming months, we can expect further assessment as the UK government has ordered a two-year study of the effects of medical cannabis becoming legal. 

Regulations Regarding CBD In Its Pure Form

When it comes to the CBD in its pure form, as an isolated substance, it is regulated under General Product Safety Regulations 2005 and Regulation (EC) 1223/2009 (Cosmetics Regulation). CBD in its pure form has never been a substance that was controlled under the legislation dealing with the “misuse of drugs”.

Awkward Issue Of Food Products Including CBD

Having said that, the food products including CBD have over the years gathered legal issues that are not solved as of yet. Nonetheless, food products containing CBD are regulated through different acts and statutes that are governed by the Food Standards Agency (FSA). FSA is responsible for food safety and food law. Other CBD products are governed by local authorities in relation to POCA.

Authorities Governing The Medical Cannabis

The use of medical cannabis, on the other hand, is governed by The Medicines and Healthcare Products Regulatory Agency (the “MHRA”), an executive agency of the Department of Health and Social Care. It regulates the supply, manufacture, importation, and distribution of medicinal products for human use. The general rule is that a medicinal product needs to be the subject of marketing authorization, in other words, a license.  There is also a regulatory framework which applies in relation to unlicensed medicines, commonly referred to as “the specials”

Only Marketing Authorization

Currently, the marketing authorization in the UK was granted to only Epidyolex and Sativex. The former is a cannabidiol-based medicinal product used as adjuvant therapy for seizures. The latter is delta-9 tetrahydrocannabinol combined with cannabidiol and is used as a treatment for multiple sclerosis.

“Special” Category That Creates Legal Issues

So, does it mean that the UK doctors are only allowed to prescribe these two medicinal products in accordance with the November 2018 legislative change? No. Unlicensed medicines fall under the “special” category. In that case, it is up to the clinical decision to choose the accurate medication for the patient. The issue that a lot of patients are reporting is that doctors are hesitant of prescribing and it is likely due to the regulations being fairly new and medical cannabis being in its infancy in the United Kingdom. 

With the additional legal issues connected to classifying the CBD food products and the lack of clinical data regarding THC products, although technically there are regulations, there are clearly not specific enough. 

The UK has been lagging behind other European countries such as the Netherlands or the Czech Republic in terms of using medical cannabis. Thus, the news about NHS planning to start a clinical trial of cannabis oil in 2021 is met with enthusiasm by many.

Existing Research And Promising Results

Given the existing research, the effects appear promising. The non-psychoactive cannabinoids, such as CBD and THC are shown to be helping to tackle several physical and mental health conditions.

Proven Positive Effects Of Medical Cannabis

The positive effects of cannabis include lowering blood pressure, stabilizing blood sugar, stabilizing mood, relieving chronic pain, or reducing inflammation. However, the preliminary research has shown that it can also be effective in easing up the symptoms of serious physical conditions such as Alzheimer’s or Parkinson’s disease, as well as mental conditions such as PTSD or schizophrenia.

The concerns on the regulatory part that are most mentioned are possible negative effects of certain types of cannabis, as well as it being a slippery slope towards far more addictive and dangerous illegal substances. 

Global Medical Cannabis Market Forecast

The global medical cannabis market is forecasted to grow at a compound annual rate of more than 20% and reach USD82 billion by 2027. The companies that are so far projected to have the biggest market share are mostly Canadian companies such as Canopy Growth Corporation, CanniMed Ltd, Aphria Medical Cannabis, and Aurora Cannabis. Having said that, British GW Pharmaceuticals is also a key player.  After all, they introduced the first natural cannabis plant derivative that gained market approval globally, the multiple sclerosis treatment, Nabiximols.  

It is safe to assume that more UK-based companies will fight for their share of the pie once the market is more regulated. There is certainly an abundance of companies and the number of players on the European medical cannabis scene will not decrease anytime soon. 

However, at the present time, there is no pending legislation that could alter the applicable statutes or regulations in the United Kingdom. Large hopes are connected with the nearing end of trials that were started in November 2018. Moreover, Andrea Met, Director at Halo Labs claimed that the use of medical cannabis is increasing in the UK in 2020. This may be connected with doctors overcoming deeply-rooted negative associations and stigma of medical cannabis. Would that upward trend continue, it could offer relief to many NHS patients.

If you find any mistakes or inaccuracies in this article, please don’t hesitate to contact us via email at info@regtechglobal.com

Nel Tomczyk
Nel is a writer for RegTech Global. From her past experience, she gained a deep understanding of fintech, AI, regulations, and new technologies. She has vast experience in journalism and entrepreneurship.

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