Is MHRA really reclassifying CBD as a medicine?

A recent statement by the UK Medicines Healthcare products and Regulatory Agency will have the effect of reclassifying CBD, probably as a medicine. Some people welcome this decision as an overdue beginning of an overall medical market cannabis regulation in UK, while many others argue this sudden enforcement can drive many patients to purchase CBD products on the black market.

FOOD, SUPPLEMENT, OR MEDICINE?

Until this sharp MHRA statement, CBD-based products used to be sold in UK and the rest of the world as food supplements or cosmetics, not without some margins of uncertainty on materials, processes and CBD actual content. Today, apparently “Having taken into account all the scientific advice and evidence, The MHRA has come to an opinion that products containing cannabidiol will satisfy the second limb of the definition of a 'medicinal product' because it may be used by or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”. We are glad to know they are aware of these facts. Yet we don’t know whether this decision is a milestone in the campaign to normalise medical cannabis or it is just a little gift to a very few pharma companies.

If CBD products really are becoming subject to UK medicines’ regulation, then they will need a marketing authorisation, or a traditional herbal registration. A full marketing authorization for medicines production requires expensive procedures: just the applying fee is £103,000 and after that, the producer must provide clinical trials data on the new product.

CANNABINOIDS SELF-REGULATING MARKETS, AND THEIR LIMITS

Neurologist Professor Mike Barnes stated it is encouraging that the MHRA is recognising CBD’s medicinal value but it is concerning that many patients using CBD now will suffer a medicine shortage, as manufacturers likely have to stop production or distribution. Sharing the same concerns as Professor Mike Barnes, medical cannabis patients’ advocacy groups in UK agree there is a need for more control in the CBD market, in order to protect people from unreliable suppliers and make sure patients understand what they are taking in their body as supplements or therapy.

The overall CBD market in Europe is kind of going in the right direction with a self-regulation on products’ quality. Most of the European producers are responsibly selling perfectly safe and “compliant” products, with no sensational claims about cannabidiol healing properties. A few others used to sell products with uncertain origin and content, or they were trying to manipulate people with distorted information about CBD.

In this scenario, and with a huge market on the horizon, the crackdown from the MHRA was predictable. The British authorities took a responsibility about CBD market, while other governments in Europe don’t seem to feel like doing the same. Now it’s still unclear if this decision is completely on behalf of patients’ safety, or some other interests are on the table.

NEW POLICY ON MEDICAL CANNABIS, OR IS IT A FAVOR TO PHARMA COMPANIES?

As opposed to other countries, United Kingdom seems to finally start basing its medical cannabis policy on both laboratory evidence and patients’ anecdotal experience, instead of waiting for years of private research and clinical trials. Stating CBD as a medicine might be a step towards recognising the whole natural cannabinoid phytocomplex as a viable therapeutic agent.

At the same time, it’s hard not to notice that the British company GW Pharmaceutical wouldn’t mind an official recognition of CBD as a medicine. GW Pharmaceuticals is going to achieve approval in Europe for its novel drug Epidiolex, a liquid CBD formulation for the treatment of conditions such as paediatric epilepsy. A solid legal framework around CBD as a pharmaceutical substance would surely prevent a bunch of potential small competitors from having weird ideas.

It doesn’t look clear how many actual CBD manufacturers might be pulled apart from the market because of the high cost of certifying pharmaceutical processes and products. If most of them are forced to stop operations, first in UK then probably in Europe, the cannabinoids’ future billionaire marketplace will be on tap for just a very few monopolists.

THE BEST IS YET TO COME

Today, strong anecdotal evidence is available about CBD efficacy in treating chronic and neuropathic pain, multiple sclerosis, epilepsy, anxiety, depression, addictions, and many other ailments. CBD is getting more and more popular as many people find it really helps their condition without adverse effects. This happens in a reverse-research scenario, where official medicine and scientific lab trials are towed by patients’ autonomous experience. Now we’re going to sit and watch what happens as MHRA is now suggesting people to talk to a healthcare professional about their CBD therapeutic self-prescribed use. Most of family doctors in Europe have no idea of what CBD is, thus we can’t wait to hear from them.

This MHRA’s move has been disputed by a number of people in the CBD industry. The short amount of time given for businesses to cease trade is particularly questionable, as it looks like a push out of the market for many entrepreneurs who already invested in standardized high-quality supplies and processes. Many associations and media contacted MHRA about all these concerns and a reply is still pending. For the sake of patients and for everyone’s right to freely choose therapies, all citizens should put pressure on MHRA in order to keep CBD-based natural remedies and food supplements under the same quality control process as food.