Article.

The UK’s medical cannabis legislation is broken. Here’s one view on how to fix it

11/07/2019

At a glance

Since legalisation last November, just a handful of UK patients have been prescribed medical cannabis. The law is not working. On June 28 2019, the Centre for Medical Cannabis proposed a solution: a new authority that can compile research while helping thousands of patients…

Last November, the government legalised medical cannabis in the UK. Many different groups cheered the news. Investors, entrepreneurs, but most of all patients.

For many thousands of people, cannabis is an effective and safe treatment for conditions such as MS, anxiety, sleep disorder and epilepsy. After a long battle, these people looked forward to a future in which cannabis-based products formulated for medical use in humans (CBMPs) would be safe and legal.

It hasn’t quite worked out.

The framing of the legislation saw to that. CBMPs might be legal in theory, but in practice it is almost impossible for patients to obtain a prescription. Indeed, on 20 May 2019, Seema Kennedy, the Public Health Minister said just six NHS prescriptions had been issued since November 2018, with ten private prescriptions issued from January 2019 to February 2019.

What is to be done?

On June 28 2019, The Centre for Medicinal Cannabis* (CMC) made a suggestion in a new report Breaking The Embargo: A Proposal To Break The UK Public Health Medicinal Cannabis Impasse.

Its main proposal was the creation of a new government body: The Cannabinoid Clinical Trials Authority. It believes this organisation can:

  • Offer clinical data and insight
  • Provide routes of access to safe, regulated CBMPs through trials
  • Generate clinical comprehensive data
  • Establish centres of excellence

Before we dig into the detail of the proposal, let’s just re-cap what’s lacking from the current legislation.

The fundamental problem lies with the absence of supporting evidence for the efficacy of cannabis. This is a consequence of decades of illegality.

Because of this research vacuum, CBMPs are designated as ‘special products’. In other words, as ‘exceptional’ medicines that lack the usual supporting evidence of safety.

But doctors who prescribe ‘specials’ can be held personally liable for any attributable medical misadventure. Who can blame them for steering clear?

As the report says: “Without the results of definitive trials showing efficacy, there’s nothing to base commissioning decisions on…so virtually no specialist doctor is minded to waste valuable time dealing with the bureaucracy of issuing one.”

It concludes that many patients are turning to street cannabis to treat conditions such as multiple sclerosis, chronic pain, palliative states and epilepsy. This puts them at risk of multiple contaminants.

While it would be understandable to despair at this impasse, the CMC prefers to see it as an opportunity.

It believes the Cannabinoid Clinical Trials Authority can not only tackle the problem but also be an example to the many other countries that are either on, or considering, the route to legalisation.

The new authority will have two main goals:

  1. Generate clinical data and knowledge

The CMC advises an initial focus on: chronic severe pain; refractory epilepsy; spasticity in multiple sclerosis; anxiety; PTSD; sleep disturbance. The authority will commission trials that are carried out by academic centres of excellence, with support from industry to minimise costs.

  1. Facilitate early patient access

The report suggests that CCTA trials will be a safe route to treatment for patients. It says that once recruited, participants will receive a 30-day prescription in a fully controlled environment.

The CMC wants to start this process quickly. It argues that, should the CCTA be established in summer 2019, trials could begin in summer 2020. According to this timeline, 10,000 patients could be enrolled in clinical trials by autumn 2024.

That’s a huge number of people getting the help they need.

And the CMC also concludes that launching the CCTA will have a beneficial effect for the country as a whole.

It says: “Should the authority be implemented, within five years the UK will become the world leader in CBMP prescribing excellence, in place of an ever-growing black market.”

* The Centre for Medicinal Cannabis (CMC) is the UK’s industry membership body for businesses and investors operating in cannabis based medicinal products (CBMPs) and cannabidiol (CBD) wellness markets. Memery Crystal’s CEO Nick Davis is the CMC’s legal advisor.

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