Medicinal cannabis – the state of play two years on
The accessibility of medicinal cannabis took another step forward on 22 March when Scotland’s first medicinal cannabis clinic was given authority to open by the regulator. Against this background, we consider the state of play of medicinal cannabis in the UK since its legalisation in 2018 and explore some potential product liability implications that may arise.
Updated regulations and guidelines
In our previous article we considered what constitutes cannabis-based products for medicinal use (CBMPs) and the legalisation of CMBPs in the UK as a result of The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland Regulations) 2018 (the 2018 Regulations). Since the 2018 Regulations were implemented, further guidelines and recommendations have been published.
In November 2019, NICE published guidelines for the prescription of CBMPs for people suffering from intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy. The guidelines state that initial prescription should only be given by a specialist with expertise in the condition being treated. However, beyond this initial prescription, GPs and independent prescribers can legally prescribe CBMPs.
Other recommendations include:
- June 2019: the Health and Social Care Committee urged the UK Government to swiftly support more CBPM trials, including large scale randomised controlled trials.
- March 2020: the MHRA updated its guidance to specifically address CBD products, setting out the MHRA’s position on the classification of CBD products and the supply of CBPMs.
- November 2020: the Advisory Council on the Misuse of Drugs (ACMD) recommended that the ACMD should be commissioned to assess the impact of the rescheduling CBMPs over two years as there is not yet sufficient evidence available to fully assess any and all consequences of the 2018 legislative change. They also recommended the UK Government review international legislation facilitating usage of CBMPs.
The present position
According to the ACMD there are three licensed CBMPs approved by NICE, which were prescribed to approximately 800 patients a year between 2017-2019.
To make CBMPs more accessible, in March 2020 import restrictions were lifted by the Home Office and MHRA. Licensed wholesalers can now import larger quantities and hold supplies for future use. However, as a result of Brexit, since 1 January 2021 UK prescriptions can no longer be lawfully dispensed in an EU Member State.
A 2019 NHS Report highlighted three main barriers to UK patients obtaining prescriptions:
- Clinical evidence
- Guidance to support clinicians
- Cost and supply
There is currently no dedicated UK medicinal cannabis regulatory system, meaning there is a relative lack of evidence available to healthcare professionals regarding the benefits and risks of CBMPs. The 2018 Regulations and NICE Guidelines have also been criticised by patients, campaigners and doctors as being too limiting.
Patients’ difficulties accessing CBMPs have been reported, with anecdotal evidence suggesting this is caused by a lack of quality RCT data available to clinicians. The Department for Health and Social Care has advised that more research is required before CBMPs can be routinely prescribed.
Potential product liability implications
As previously advised, there are various potential grounds for CBD-related product liability claims. These include:
- Harmful pesticides contaminating the product
- Products expiring prior to delivery
- Incorrect labelling
- Failure to warn the patient of the product’s potential side effects and/or contraindications when taking it with other medicines.
Whilst there has yet to be a UK cannabis product liability case, there have been two high-profile cases abroad:
- In 2015, a lawsuit was filed in Colorado against LivWell by two medical cannabis patients, alleging contamination of LivWell marijuana by an agricultural pesticide that produces hydrogen cyanide gas when burned. The defendant succeeded after the court determined that there was no evidence of actual injury to any consumer caused by the allegedly contaminated product.
- In 2020, the Canadian case of Organigram Holdings Inc. v Downton concerned a 2016 recall of some Organigram medical cannabis products containing traces of pesticides not approved for use in cannabis. The defendant succeeded after the plaintiff failed to provide evidence that their alleged symptoms were linked to exposure to the product.
As CBMP use becomes more widespread, product liability claims against UK CBD manufacturers may materialise. CBD manufacturers and their insurers should therefore ensure:
- Rigorous pre and post marketing and monitoring of product safety
- Regular reviews of instructions/warnings and labelling of products
- Robust product recall plans are in place.
The increased demand for CBD both medicinally and on UK high streets is likely to lead to greater funding, research and availability for UK consumers.
Project Twenty21 is currently trialling CBMPs on up to 20,000 patients in the UK and Channel Islands over a two year period. The study aims to be the largest body of evidence in Europe for the effectiveness of CBMPs and it is hoped findings will show that the benefits of CBMP treatment far outweigh any potential risks. Results are expected at the end of 2021.
Wider use and understanding of CBD products in healthcare may also pave the way for other restricted drugs to be considered medicinally, e.g. the use of so called ‘magic mushrooms’ to treat mental health issues.
Whilst there is still work to be done to ensure CBMPs are easily accessible to all, the news from Scotland is further evidence that progress is being made, and that with increased accessibility comes increased potential for claims.
- Medical cannabis and potential product liability implications
- Product liability class action hurdles – lessons from recent Canadian and UK decisions
- Europe’s cannabis products regulatory regime: evergreen or erratic? Part 1: Food products
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- Guidance on regulation of CBD food products – implications for insurers and manufacturers
- Insuring the emerging cannabis industry