United Kingdom Medical Cannabis Regulations Enter into Force

The past six months have seen an unprecedented rate of change for both the global and European cannabis industries. Today, for the first time, patients across the United Kingdom will be able to be prescribed a range of cannabis-based medicinal products.

Since the announcement that medical cannabis products would be rescheduled, a series of announcements from the Home Office and Medicines and Healthcare products Regulatory Agency (MHRA) have shed some light on how the new system will work, but many questions remain.

In September, it was announced how the UK would define cannabis-based medicinal products (CBMPs). The new regulations themselves, the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018, were laid before the House on October 11, 2018, in a written statement by the Home Secretary, Sajid Javid.

Yesterday, NHS England published a letter which set out their expectations of what the regulatory change means in practice for clinicians. It cautiously provided some further detail on what patients can expect in the next year.

“NHS England expects that cannabis-based products for medicinal use should only be prescribed for indications where there is clear published evidence of benefit or UK Guidelines and in patients where there is a clinical need which cannot be met by a licensed medicine and where established treatment options have been exhausted.”

Although the regulations do not limit the types of conditions that can be considered for treatment with cannabis-based medicines, the initial prescribing guidance offered is much more restrictive.

The National Institute of Health and Care Excellence (NICE) has been commissioned to produce formal guidelines for clinicians on the prescribing of CBMPs by October 2019 at the latest. In the interim, The British Paediatric Neurology Association (BPNA) and the Royal College of Physicians (RCP) were asked to provide guidance on the use of CBMPs for paediatric patients with certain forms of severe epilepsy, chemotherapy-induced nausea, and chronic pain.

In their guidance, the BPNA recommended Epidiolex for children’s epilepsy only, while the RCP advised that CBMPs that can be used for chemotherapy-induced nausea and vomiting, but not chronic pain:

  • The interim clinical advice offered by the BNPA on the use of CBMPs in paediatric patients with certain forms of severe epilepsy advises that pure CBD (Epidiolex®) should be the default choice when considering prescription of a CBMP in intractable epilepsy in children. It also recommends that it be used as an add-on therapy not as a substitute for regular treatment.

  • The BPNA does not recommend prescribing any other non‐licensed cannabis‐based products for medicinal use at this time. They stressed that they wanted to see these products undergo randomised clinical trials for efficacy and safety before they would recommend their prescription in the UK.

  • The RCP guidance around recommended that CBMPs be should be an option for use in patients with intractable chemotherapy induced nausea and vomiting who have failed standard therapies, but not used as a first-line treatment. With regards to chronic pain the RCP did not recommend CBMPs are a treatment, saying there was no robust evidence of their efficacy.

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Epidiolex, a CBD drug made by UK company GW Pharmaceuticals, was recently the first cannabis medicine to be made federally legal in the United States. Activism by parents of children with severe forms of epilepsy was crucial in prompting the UK government to make a swift decision on cannabis this summer. The recommendation that CBMPs not yet be prescribed for patients or chronic pain is also significant, as research published by the British Medical Journal in 2016 found that around 28 million people in the UK could be suffering from chronic pain.

Drug policy think tank Volteface director, Steve Moore, who has been campaigning alongside patient groups, was hopeful but cautious:

“Initially, the programme will be very slow. There are not enough physicians trained, legal products available to import or clinical data available to inform prescription decisions. We are focusing now on how best to integrate cannabis-based medicinal products into a healthcare systems.”

So far, medical cannabis patient groups have reacted to the NHS guidance with disappointment at the body’s very limited recommendations for medicines.

However, when the full clinical guidelines on prescribing CBMPs are issued by NICE next year is likely when we’ll see the true extent of patient access in the UK. In the meantime, Hanway Associates continues to monitor all developments relating to the regulation of and access to cannabis medicines in the UK closely.

For more insights and advice on cannabis regulations in the United Kingdom and Europe, please get in touch info@hanwayassociates.com.