Specialist doctors in the UK will be able to legally prescribe cannabis-derived medicinal products by the fall it has been anounced!
Doctors will be able to prescribe cannabis products to patients from 1 November, the UK Home Secretary Sajid Javid said.
Before this Cannabis was a controlled drug as classified by the Misuse of Drugs Act 1971 with a follow-up to this law, the Misuse of Drugs Regulations Act 2001, placing it under Schedule 1, which is the category for substances with no medicinal value.
Cannabis plants are made up of more than 100 different cannabinoids, which have different impacts on the body and are concentrated to different extents in different parts of the plant. The most well-known of these are THC, the psychoactive cannabinoid – the one that recreational users use to get “high”, and CBD, which does not have this effect.
While almost all cannabinoids were controlled substances in the UK under the Misuse of Drugs Act, CBD or Cannabidiol, as it is also known, was not.
So industrial hemp, which can be used for things such as building materials and clothing, could be grown under licence in the UK as it is a strain of the cannabis plant that contains little or no THC, but does contain CBD. CBD oil can also be extracted from industrial hemp and, as it is a legal cannabinoid, can be sold in the UK.
In 2016, the Medicines and Healthcare products Regulatory Agency (MHRA) said that CBD products, if advertised for these medical purposes, needed to be licensed.
As licences for CBD oil as a medicine have not been granted yet the products can only be sold as long as claims are not made about their medical benefits. So many Vitamin / Health Food companies are selling CBD oils as food supplements.
Sativex, which is a 50-50 mix of THC and CBD produced in a lab, has been approved for use in the UK by the MHRA as a treatment for multiple sclerosis since 2013. However, in 2014, the National Institute for Health and Care Excellence, which issues guidance to the UK National Health Service doctors, gave the medicine a “do not recommend” status, saying it was not cost-effective as each 10ml bottle containing 90 doses costs about $180.
The new regulations will apply to England, Wales, Scotland and Northern Ireland after Mr Javid decided to relax the rules on when cannabis products could be given to patients following a review into medicinal cannabis earlier this year.
This review followed a public outcry over two young epilepsy sufferers, Alfie Dingley and Billy Caldwell, being denied access to cannabis oil even though their parents said the product helped to control their seizures.
Hannah Deacon, Alfie’s mother, welcomed the move, saying: “We urge the medical world to get behind these reforms so they can help the tens of thousands of people who are in urgent need of help. I have personally seen how my son’s life has changed due to the medical cannabis he is now prescribed.”
Professor Mike Barnes, the medical cannabis expert who secured the first long-term licence for its use for Alfie, encouraged doctors to embrace the changes to the laws on prescribing medicinal cannabis.
An initial review by the UKs chief medical officer Dame Sally Davies concluded there was evidence medicinal cannabis has therapeutic benefits. The Advisory Council on the Misuse of Drugs (ACMD), which carried out the second part of the review, then said doctors should be able to prescribe medicinal cannabis provided products met safety standards and recommended cannabis-derived medicinal products should be placed in schedule two of the Misuse of Drugs Regulations 2001.
The Home Office says that Cannabis Oil can contain a maximum THC content of 0.2% and that the THC must not be easy to separate from it.
UPDATE – June 2019
Although Medicinal cannabis was legalised in the UK November 2018 so far, virtually no-one has been able to get it. So what has taken so long?
The new law in 2018 moved cannabis from schedule 1 under the Misuse of Drugs Regulations 2001, meaning it had no therapeutic value, to schedule 2, which is for drugs which are controlled but have a recognised medical use and can be prescribed in certain circumstances.
Cannabis-based medicines can come in the form of whole cannabis flowers, oils or capsules, or a single compound which can be isolated and extracted.
Medicinal cannabis is currently unlicensed in the UK, so doctors can prescribe it only if a patient has a need that can’t be met by licensed medicines and under the new rule, regular Doctors are not allowed to prescribe cannabis-derived medicines, it has to be a specialist consultant, for example in neurology or paediatrics.
“Prescribing cannabis is new to UK doctors and so it may take a while before they begin doing so”, says Dr David McDowell, a pain specialist who described the current process as “tortuous”.
The prescriptions are valid for 28 days and, at the moment, doctors are advised to prescribe a month’s worth at a time.
One of Dr McDowell’s patients, who is set to receive his first supply of medical cannabis, suffers from Crohn’s Disease – a painful inflammatory bowel disease. He said he had been prescribed opiates in the past, which had made his condition worse.
“It’s a hard thing to do to yourself to put up with becoming addicted to opioids or putting up with the vomiting and nausea that come with immune-suppressing drugs,” he said.
The National Health Service England said that cannabis-based products would be prescribed only where there was “clear published evidence of benefit” that couldn’t be achieved by a licensed medicine.
In October 2019, the National Institute for Health and Care Excellence (NICE) plans to publish guidelines concerning the medicinal cannbis, and the UK National Health Service will then use this to decide whether it will eventually fund the drug routinely for some patients.
Other conditions cannabis might be prescribed for include multiple sclerosis and cancer.
At every stage of the process, getting cannabis-based medicines to patients is very tightly regulated, adding to the delay.
The first batch of legal cannabis has been shipped into the UK from the Netherlands has been grown at a specially regulated site for cannabis for medical purposes and the export has to be approved by the Dutch government in the form of whole flowers. These contain more than one active pharmaceutical ingredient which makes it more complicated to get approval than importing a single compound like, say, morphine.
While morphine is also a controlled substance, it has a well-established medical use, meaning processes are in place to import and regulate it.
Importers in the UK need to apply to the Home Office for a licence to bring in the cannabis from overseas and the process can take up to 28 days, so by the time it’s completed, the prescription may have expired.
These delays are why companies involved in the process of importing medical cannabis say its important to bring in a bulk amount which can reduce these delays, meaning when patients’ supplies run out there’s stock available and they don’t have to have a gap in their treatment.
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