The drug that brought about policy regulation was GW Pharmaceuticals’ Epidiolex (cannabidiol), which is approved for epilepsy. Credit: GW Pharmaceuticals.

The UK home secretary announced that as of November 1, specialist doctors will be given the option to legally prescribe patients cannabis-based products if their patients would benefit from the treatment. This will stop regulations from limiting the disease indications that cannabis-based medicines can be prescribed for, and physicians will no longer need to seek approval from an expert panel for patients to access these medicines.

While this important policy change will undoubtedly impact the medicinal use of cannabis-based products, it still remains unclear how quickly, and to what extent, it will influence actual clinical practice.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

With the National Institute for Health and Care Excellence set to release guidelines for clinicians in October 2019, some uncertainty exists surrounding how cannabis-based products will be prescribed in the near future. Furthermore, both the British Pediatric Neurology Association and the Royal College of Physicians will be responsible for providing clinical advice to physicians. Due to the fact that cannabis is a controlled substance, these products can only be prescribed by specialists, not by general practitioners.

GlobalData believes that it is highly likely that cannabis-based products will be moved to Schedule 4 of the Misuse of Drug Regulations 2001, similar to Bayer’s cannabidiol molecule Sativex (nabiximols), which is approved for muscle spasticity. Schedule 4 drugs can be obtained in the UK with no restriction on supply, but can only be lawfully possessed under prescription.

The drug that brought about the policy change was GW Pharmaceuticals’ Epidiolex (cannabidiol), which is approved for epilepsy. It is also currently in Phase III development for infantile spasm and tuberous sclerosis. If Epidolex proves to have strong efficacy and boast a good safety profile in the indications mentioned above, GW Pharmaceuticals will have more of an incentive to apply for approval in the UK. The new policy change will help to increase sales if physicians can prescribe the drug without expert panel opinions. This will help the company compete with Bayer’s Sativex and possibly become a major player in the UK cannabinoid market.

Furthermore, there are two other companies with cannabis-based products at Phase II stage in Europe: Kalytera Therapeutics and Axim Biotechnologies, which are indicated for graft versus host disease and irritable bowel syndrome (IBS), respectively. In April 2017, Axim Biotechnologies’ CanChew (cannabidiol) completed its Phase II trial and there were no significant adverse effects.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

All patients who participated in the study saw a decrease in levels of pain caused by IBS with a trend curve showing that patients had 50% higher pain reduction when administered CanChew compared with placebo. If Axim can boast promising Phase III results, it has the potential to be the third company in the UK with an approved cannabis-based product.

The new policy change could see more companies conducting clinical research for cannabis-based products in the UK. Although there are still some uncertainties in how clinicians will administer the product, the new policy change suggests that the UK is warming to the idea of medicinal cannabis.