UK: CBD Update – MHRA Delays Deadline For Manufacturer Compliance Until End Of Year
Manufacturers of CBD products were rocked last month by the announcement that the Medicines and Healthcare products Regulatory Agency had taken the the decision to classify products containing CBD as Medicines. While generally regarded as a positive move long-term, the decision to give manufacturers and retailers only 28 days to voluntarily comply had been met with dismay by the industry, who were expecting to have to cease trading on Friday 4th November.
With three days remaining until the original deadline, the MHRA have issued an update to the their statement, extending the compliance deadline until the end of the year:
“While MHRA has given its opinion that products containing cannabidiol (CBD) used for medical purposes are medicines, we have also carefully considered the needs of individuals using CBD products to treat or manage the symptoms of medical conditions.
“Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012.
“We have today written to the manufacturers of CBD to make them aware of the timeline for engagement.
“It is vital that medicines meet safety, quality and efficacy standards to protect public health.”
The MHRA have cited concerns for patients who may not have had time to seek alternative treatments, but the extension also gives a brief respite to those in the industry to continue trading.
Commenting on the decision to extend the deadline, Baroness Meacher, co-chair of the APPG on Drug Policy Reform, which released a comprehensive review on medical cannabis in September, sees the move as positive: “We are delighted that the MHRA listened to our concerns about a rapid withdrawal of CBD from patients who need it. In particular we warned the MHRA that the original deadline of 4th November for the withdrawal of CBD from the market could have put epileptic children’s lives at risk. It is now urgent that the government reschedule cannabis so that medicinal products can be developed, as in many other countries. To ensure safety, such products should be regulated.”
Professor Mike Barnes, author of the APPG report, while acknowledging the extension was a step in the right direction, notes it did not go far enough. “Whilst this is an improvement from a ban starting today I cannot see any value in delaying only a few months. Some patients indeed may find an alternative medicine from their doctor in that timescale but many people will have already been through the alternative medications and determined that CBD is the only treatment for their condition.
“This is the case, for example, for children with epilepsy who will have almost certainly have been under the care of a neurologist and tried available anticonvulsants and found that CBD is the only treatment that works for them.”
Stating that much more time would be needed for the industry to prepare itself for regulation, Prof Barnes lad the responsibility with the MHRA to help support them through the regulatory procedure: “The MHRA does not seem to realise the impact of this arbitrary and rushed decision which will clearly be detrimental and potentially have very serious (and in some cases life threatening) implications for some people. The MHRA need to work with the manufacturers and the medical profession to determine the best way forward that both recognises that cannabis based products have medicinal value, and as such need proper trials of efficacy and safety, yet on the other hand does not place existing users at risk of harm.”
Jon Liebling, political director of United Patients’ Alliance, while grateful for the short-term reprieve, said more information was still needed to help clarify what many patients and manufacturers have found to be a hugely confusing situation since the MHRA announcement. “Whilst we and our patients are pleased that additional time has been given, there are many important questions to be answered, such as how some CBD containing products could and should be regulated as a simple food/health supplement and for how full plant extract products will be regulated as the MHRA’s own rules negate their definition as a medicine.
“We remain deeply concerned that people who benefit will be unable to source their therapeutic and effective products after December 31st and may have to suffer unnecessarily as a result. We urge the authorities to clarify and answer these questions as soon as possible.”