01 Nov MHRA Backtracking Super Fast On CBD Ban.
This statement was published on the MHRA website at lunchtime today.
“Update 1 November 2016
An MHRA spokesperson said:
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.”
Originally the MHRA wrote to CBD suppliers in threatening terms:
“You must cease to sell, supply, promote, advertise or process orders for the above products until appropriate authorisation has been granted for them. You must confirm this in writing within 28 days from the date of this letter that you have taken the above steps.”
So quite a change in tone. The MHRA seems to have recognised that contrary to its declared mission ‘to improve health’, its original statement actually endangered the health of tens of thousands of people.
Additionally, solicitors representing the UKCTA have now written to the MHRA seeking clarification of its intentions and making three crucial points:
- The letters to CBD suppliers and the MHRA’s original press statement have caused serious financial damage to the CBD industry.
- The MHRA has conducted no effective consultation with stakeholders.
- The MHRA’s own guidelines require it to consider each product on a case by case basis and a blanket ban on products containing CBD would be unlawful.
Professor Mike Barnes, scientific and medical advisor to CLEAR, commented:
“The MHRA’s new stance is an improvement from their previous position. However, I cannot see any value in delaying only a few months. Some patients might be able to find an alternative medicine from their doctor but many people will have already tried alternative medications and found that CBD is the only satisfactory 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 specialist and tried available anticonvulsants and found that CBD is the only treatment that works for them. 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”.