Cannabis contains many compounds called cannabinoids. The two most well-known of these - tetrahydrocannabinol (THC) and cannabidiol (CBD) are increasingly mentioned by the media. These cannabinoids are thought to help treat conditions such as chronic pain, seizures and certain mental health conditions. CBD does not have the psychoactive effects of THC.
Medical cannabis is described by the NHS as “cannabis-based medicine used to relieve symptoms”. It is currently only available in the UK on specialist prescription for severe epilepsy, muscle problems caused by multiple sclerosis, and chemotherapy-induced nausea or vomiting, when other treatments have not proved effective.
While products containing THC levels in excess of 0.2% are generally prohibited in Europe and classified as “controlled substances”, CBD is not classified as such. As a result, there are a number of unregulated CBD products on the market which may have little or no effect.
Medicinal products containing cannabinoids can only be placed on the market if a marketing authorisation has been obtained from the appropriate regulator. Depending on the levels of THC in the product, the appropriate licences would also need to be obtained for import and distribution of such products.
Due to the complexity of the regulatory regime for medicinal products, which further increases if a controlled drug is incorporated into a product, there are many hurdles for companies to overcome to be able to manufacture and sell cannabis-based medicinal products.
This article looks at the developments and challenges to date and what the future looks like for medicinal cannabis in the UK.
Since November 2018, specialist medical practitioners in the UK have been able to prescribe certain cannabis-based products for medicinal use without needing a further licence. In November last year, the National Institute for Health and Care Excellence (NICE) issued guidance around prescribing cannabis-based medicinal products, including Sativex (to treat spasticity in adults with MS) and Epidyolex (to treat seizures). The guidance also set out a number of recommendations for further research.
These recommendations were welcomed by MS and epilepsy charities but patient groups are calling for more research to be done and for greater access to medicinal cannabis. NHS prescriptions for unlicensed and licensed cannabis-based medicines are scarce and many patients who cannot afford private healthcare to access medicinal cannabis have to resort to illegal sources if they wish to access cannabis for medical purposes.
Accessing medicinal cannabis could be a lifeline for many people suffering with chronic pain but, despite relaxation of the legislation, it is still proving difficult for those in need to access it. This is partly due to the fact that there is still insufficient evidence to prove the effectiveness and safety of medicinal cannabis, making practitioners reluctant to prescribe something that has been thought of as a dangerous drug for so long.
Some patients therefore choose to self-medicate with CBD products. As above, these are unregulated and may vary in quality and effectiveness. However, the Food Standards Agency has now reclassified some CBD products as ‘novel foods’ which have to go through a safety assessment and authorisation to be legally marketed in the EU. That being said, many CBD products remain available on shop shelves.
In June 2018, the US Food and Drug Administration also approved its first cannabinoid drug in the US for the treatment of seizures. Further synthetic cannabis-related drugs have since been approved and in autumn 2019 the US National Institutes of Health announced research awards of $3 million to investigate the pain-relieving properties of cannabis components.
The Cannabis Act also came into force in Canada in October 2018 introducing various changes to improve patient access to medicinal cannabis in Canada.
These developments suggest that there is both growing potential and patient demand to increase the medicinal cannabis market globally.
Aside from the regulatory hurdles to increasing the availability of cannabis-based medicines, companies must also navigate various other legal and commercial issues. For example, the EU General Court has recently ruled that a trade mark including the term ‘cannabis’ was not registerable as a European Union trade mark for public policy reasons.
There may also be difficulties in patenting cannabis-related products. In the UK, a patent will only be granted for an invention that is not excluded, is novel, involves an inventive step, and is capable of industrial application. Companies in the cannabinoid market may potentially be able to patent the following:
In addition, an invention will only be said to be novel if it does not form part of the state of the art - ie information that has been made available to the public anywhere in the world. Until recently, cannabinoid medicinal products were prohibited from development meaning that the prior art may be limited, possibly improving patentability. However, as the market for cannabis-related products continues to grow, novelty could become harder to prove.
In a recent report by the Commons Select Committee in the UK, titled “Drugs policy: medicinal cannabis” (the Report), it was recognised that chemical compounds in cannabis-based products for medicinal use can be difficult to patent. Inventors may instead seek to protect the processes involved in their production by patent, as these may offer greater chances of success.
Greater investment in commercial research and development is required to expand the UK market and successful patent applications may pave the way for growth. Notably, in October 2019, several UK patent applications were made concerning the use of CBD preparations for treatment purposes. It will be interesting to see how these applications progress.
The Report also made several recommendations to improve patient access to medicinal cannabis products. The National Institute of Health Research in the UK was called on to engage with patients and clinicians and to encourage greater research into treatment of specified conditions.
The Report recognised that medicinal products are usually developed by industry, given the income streams available, and called for greater industry involvement in developing medicinal cannabis products and supplying products for research. It also recommended that the Government and pharmaceutical industry ensure that the necessary clinical trials into medicinal cannabis are taken forward.
The Medicines and Medical Devices Bill announced in the Queen’s Speech in December 2019 year may also help encourage R&D in the UK as it aims to relax certain rules for low-risk clinical trials and to speed up medicine approvals to create a more competitive, streamlined system in the UK.
These will be welcome developments for patients for whom medicinal cannabis products make a huge difference to their quality of life. The questions are how long will it take for medicinal cannabis to become commonplace and how relaxed could regulators become without risking harming patients? There is still some way to go before medicinal cannabis becomes more widely accessible but patient needs should be at the forefront of industry and government decision-making to ensure that more research and clinical trials are funded and implemented.