15 Oct The British Medical Journal (BMJ) Features The CLEAR Medicinal Cannabis Campaign.

By Nigel Hawkes

By Nigel Hawkes

“Muddled thinking” over cannabis leaves patients in limbo, warn campaigners

BMJ 2016; 355 doi: http://dx.doi.org/10.1136/bmj.i5556 (Published 14 October 2016) Cite this as: BMJ 2016;355:i5556

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Companies selling cannabis based products have been told to remove them from the market within 28 days, after a review by the Medicines and Healthcare Products Regulatory Agency (MHRA) determined that they were medicinal products.

Campaigners for cannabis law reform welcomed the recognition that cannabidiol (CBD) had medicinal properties but warned that the MHRA’s action would deprive thousands of users of a product they relied on. They said that it was impossible to obtain marketing authorisation in the timescale given and may never be possible given the high costs of clinical trials and lack of patent protection for a product that contained many components.

“In the long term, it’s a good thing,” said Peter Reynolds of the pressure group CLEAR Cannabis Law Reform. “But my immediate concern is for the tens of thousands of people who use CBD and have become reliant on it. We urgently need interim measures so that supplies can continue.”

The MHRA sent letters on 3 October to 18 companies that sold CBD, saying that it had concluded that CBD met the definition of a medicinal product as defined in the Human Medicines Regulations as “any substance or combination of substances which may be used 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.”

This meant, the letter said, that CBD products required a marketing authorisation before they could be sold. Marketing authorisation for drugs requires lengthy clinical trials, only justifiable if the product has patent protection. An alternative route is under the traditional herbal medicines regulations, but that requires evidence that the product has 30 years of use and applies only to minor conditions, where medical supervision is not required. Reynolds said that he thought it unlikely that CBD could qualify by this route.

Mike Barnes, a neurologist and former NHS consultant and chief executive, is clinical adviser to CLEAR. He said, “The decision by the MRHA to treat CBD products as medicines has also been done without thought to the consequences for many thousands of people in the UK who currently benefit from the products. It will have very significant, and in many cases terminal, impact on the many legitimate businesses that provide high quality products.

“The government must now act to sort out their muddled thinking and try to help those people with long term and often painful conditions who benefit from the ready and hitherto legal availability of natural cannabis products. It is ironic that in acknowledging the therapeutic benefits of CBD, the MRHA is effectively suspending access to a product that has enhanced the lives of thousands for many years.”

Crispin Blunt, an MP and CLEAR supporter, has written to the MHRA saying that the decision to designate CBD as a medicine is directly contradicted by the Home Office’s position that cannabis has no medicinal value.

“It is vital that we do not let this anomaly in government policy cause harm to people’s health,” his letter said. He asked for details of how the decision was reached, the consultations undertaken, which specific regulatory regime MHRA proposed for these products, and whether the continued supply of these products, regulated as food supplements, could be ensured until such time that medicinal marketing authorisations could be obtained.

The MHRA has not yet posted details on its website about the decision. In a statement it said that people who used CBD should speak to their GP or other healthcare professional. “We can provide regulatory guidance to any company who may wish to apply for a licence,” the statement added.

  • discerner

    Current and past evidence about the effectiveness of cannabis in all it’s various forms as a medicine is indubitable, and should be taken into account by the MHRA to resolve this temporary impasse – but?

  • Manda

    Yes I think CBD etc. should be regulated but not just cut the supply chain dead for the millions of us who use it. It will be devastating because it helps our conditions when normal pharmaceuticals don’t.
    This year I have been averaging 2 hours broken sleep over 24 hours, from pain & muscle spasms. I started vaping CBD 10 days ago & after a couple of days of taking when needed, I’m able to sleep up to 3 hours of unbroken sleep.

    Hemp/cannabis/CBD has been used for millennia for certain ailments. It is mentioned as a treatment in writings from the early Roman era & before. To me it would be like doing the same to lavender oil for it’s proven medicinal properties.

    At the end of the day it all down to a big pharma company trying to drain the NHS of more money so they can get richer. If this goes the way it looks like, people will no longer buy CBD from their suppliers so will be blocking up gp surgeries trying to get prescriptions for CBD or something else. As CBD will be prescription only, the NHS will be doubly shafted. Firstly they’ll have to buy the product from 1 supplier at 4 times the cost. Secondly because they will be subsiding the prescription. Plus the CBD will be available in 1 form only, which may not suit everyone.

  • davidraynes

    http://www.bbc.co.uk/programmes/p04bkhlj#play

    http://www.bbc.co.uk/programmes/p04bkhlj

    Debate
    between Peter Reynolds of CLEAR & David Raynes NDPA.

    Available for 29
    days.

    Starts 31mins 05 Seconds into recording
    Ends 41mins 41 into
    recording.

    (If one has the patience there may be other callers on the
    subject later).