A recent statement from the UK Medicines and Health Products Regulatory Agency will have the effect of reclassifying CBD as a medicine. Many people have greeted this decision as the late start of a global regulation of the medical marijuana market, while others argue that this sudden imposition could push many patients to purchase CBD products on the black market.
AFOOD, SUPPLEMENT OR MEDICATION
Until this MHRA statement, CBD products used to be sold, both in the UK and around the world, as dietary supplements or cosmetics, not without some uncertainty as to material, process and actual CBD content. At present, apparently, “taking into account evidence and scientific advice, the MHRA has concluded that products containing cannabidiol meet the second requirement of the definition of ‘medicinal’, because they can be used for , or administered to, human beings with a view to restoring, correcting or modifying physiological functions through a pharmacological, immunological or metabolic action, or in establishing a medical diagnosis”. We are glad to know that you are aware of these facts. But we don’t yet know if this decision is a milestone in the campaign for medical cannabis normalization or simply a gift to a few pharmaceutical companies.
If it is true that CBD products are going to be subject to British medicinal regulation, they are going to need authorization for their commercialization, or registration as traditional herbs. A full marketing authorization for a medicine has very expensive procedures: the application already costs £103,000, and after that the manufacturer must provide clinical data on the product.
mSELF-REGULATED CANNABIS MARKETS AND THEIR LIMITS
Neurologist and Professor Mike Barnes has said he is encouraged that the MHRA is recognizing the medicinal value of CBD, but is concerned that many of the patients now using it will experience a shortage of the drug, as it is most likely that manufacturers have to stop production and distribution. Medical cannabis patient support groups in the UK share this concern with Professor Mike Barnes, agreeing that more control is needed in the CBD market in order to protect consumers from unreliable suppliers. and to ensure that patients know what they are putting into their bodies in the form of a supplement or therapy.
The CBD market in Europe is generally going in the right direction, with self-regulation on the quality of its products. Most European producers sell products that are completely safe and comply with certain standards, without sensational claims about the healing properties of cannabidiol. Others used to sell products of uncertain origin and content, or tried to manipulate people with distorted information about CBD.
In this case, and with a huge market on the horizon, the MHRA’s action was predictable. The British authorities have assumed responsibility for the CBD market, while other European governments do not seem to want to do the same. It is not yet clear if this decision has been made for the safety of patients or there are other hidden interests.
noNEW MEDICAL MARIJUANA POLICY OR A FAVOR TO PHARMACEUTICALS?
Unlike other countries, it appears the UK is finally starting to base its medical marijuana policy on both laboratory evidence and anecdotal patient experience, rather than waiting years for private research and clinical trials. The classification of CBD as a medicine could be a step towards the recognition of the entire natural cannabinoid phytocomplex as a viable therapeutic agent.
At the same time, it is easy to see that the British company GW Pharmaceutical would not mind if CBD was officially recognized as a medicine. GW Pharmaceuticals is on the brink of getting European approval for its new drug Epidiolex, a liquid CBD formulation for the treatment of disorders such as pediatric epilepsy. A good legal framework around CBD as a pharmaceutical would help prevent a bunch of small competitors from coming up with weird ideas.
It is not known how many CBD manufacturers will have to withdraw from the market due to the high cost of certifying pharmaceutical processes and products. If most of them are forced to stop their operations, first in the UK and then in Europe, the future multi-billion dollar market for cannabinoids will only be in the hands of a few monopolies.
LOR BETTER IS YET TO COME
Today, there is strong anecdotal evidence for the efficacy of CBD for the treatment of chronic and neuropathic pain, multiple sclerosis, epilepsy, anxiety, depression, addiction, and many other ailments. CBD is becoming more and more popular as it helps many people to combat their disorders without adverse side effects. This occurs in a retro-investigation scenario, where official medicine and laboratory tests are towed by the individual experiences of patients. Now let’s sit back and see what happens, as the MHRA is suggesting that people talk to a health professional about the therapeutic use of self-prescribed CBD. Most European GPs have no idea what CBD is, and we’d like to know what they’re going to say.
This action by the MHRA has been challenged by many people in the CBD industry. The short period that companies have been given to stop selling is especially questionable, as it seems to force many entrepreneurs who have already invested in quality supplies and processes to leave the market. The MHRA has been contacted by numerous associations and media regarding all of this, and is awaiting their response. For the sake of patients and the right to choose therapies, all citizens should lobby the MHRA to keep CBD natural remedies and dietary supplements under the same quality control process as food.