Research Trials Lending More Legitimacy to Europe’s Medical Cannabis Markets

cannabis Trials

By Oliver Bennett, Special Contributor to New Frontier Data

As the European medical cannabis industry inexorably progresses, there remains one fundamental element still required – more sound and multiply sourced evidence that cannabis indeed helps treat the medical conditions for which it is being marketed.

Hence the rising number of research trials, particularly regarding serious diseases where the stakes are highest. Without a backdrop of peer reviews and longitudinal studies, the sector must rely on evidence that is not as substantiated as it could be, or is at best anecdotal. Subsequently, the European cannabis industry with some urgency is calling for better guidance and more clinical trials for medical cannabis.

Among the most notable trials being run out of the U.K. is Project Twenty21. Associated with Drug Science, and pioneering legalisation advocate David Nutt, the plan is to help patients access affordable medical cannabis treatment while also creating the U.K.’s largest evidence base to then inform the country’s National Health Service (NHS). Funded by several medical cannabis companies, and launched in November 2019, Project Twenty21 aims to collect data from up to 20,000 medical cannabis patients over a two-year period in what is described as Europe’s largest medical cannabis experiment. By the end of this year, the goal is to have a comprehensive record about several tested conditions — from chronic pain to epilepsy, MS and PTSD to anxiety – using EU GMP-certified medical cannabis.

In the EU, with member states taking increasingly liberal stances regarding the use of cannabis, the Medicinal Cannabis Europe organisation was launched in 2018, with a similar premise that its findings would feed into a social benefit, providing better access to medical cannabis, and lend advocacy “in favour of a regulatory framework on medicinal cannabis… [and] enable patients’ fair access in a clear and well-regulated European market.”

Based in Brussels, Medicinal Cannabis Europe’s Secretary General Stuart Lambie and Deputy Secretary Quentin Galland have expressed that the agency’s “objectives are to make safe, regulated cannabis-based medicinal cannabis products available to European citizens in all member states [and] to attract European funding for research and innovation” to help remove the stigma attached to medicinal cannabis.”

The group was energised by the EU Court of Justice’s late-2020 ruling that CBD is not a narcotic, and the United Nations’ reclassification of cannabis from Schedule 4 – two landmark events bolstering public acceptance of cannabis.

The Medical Cannabis Group’s work hopes to stimulate a process of regulation and standardisation, as the lack of credible research is hampering regulatory solutions to cannabis. Earlier, cannabis has had to deal with factors such as the EU’s Herbal Medicines Directive, which requires decades of evidence.

With clinical trials described as providing good results for many conditions, they will speed up acceptance of new products, adding to a very limited range including the European Medicines Agency (EMA)’s grant of Orphan Drug Designation to U.K.-based GW Pharmaceuticals for its CBD-based Epidiolex to treat severe epilepsy among children. This has led to some cautious and sometimes piecemeal approaches whether in Croatia (where Epidyolex is available) or in Finland (where only Sativex is used to treat multiple sclerosis [MS] patients. There remains room in the medical marketplace to offer more products.

There are other trials, some conducted nationally, which may help to change this. France is proceeding with its medical cannabis programme after identifying companies including Australian Althea, Canada-based Aurora, and Tilray, Israel’s Panaxia and the U.K.- based Emmac Life Sciences to supply some 3,000 patients for two years – part of a programme to assess cannabis’ effectiveness on a range of conditions from epilepsy to multiple sclerosis, along with any effects arising from chemotherapy. Using oil, pills, and vaporisers, the French trial is expected to simulate the potential real-life usage of cannabis. In 2019, Ireland began a pilot program and five-year trial in 2019 with the Medical Cannabis Access Programme, again to offer access to medical cannabis products with proper clinical guidance. In Denmark, a 2018 trial scheme was introduced to run until the end of this year, aiming to assess both the benefits of medical cannabis and build a domestic supply framework with cultivation – the directive being to achieve a high standard of care alongside a strong and trustworthy supply chain.

All such trials and touch points will move Europe towards a better-informed medical cannabis space – and they should prove useful in gauging efficacy, particularly as some studies are readjusting earlier suppositions about the benefits of medical cannabis.

Tests from the International Association for the Study of Pain task force suggest that claims for the benefits for medical cannabis have been unreliable, while a U.S. study has shown that cannabis has not been as effective with PTSD as earlier supposed. Trials will also support cannabis’ benefits, as in the findings of an Italian study (about medical cannabis for refractory fibromyalgia) showing significant improvements in pain relief.

Along with new findings will come further issues to be resolved – including how to handle prescriptions, whether patients receiving treatment will be state-aided or funded by private insurance schemes, if medical cannabis will be used for some ailments and not others – and how counterfeit drugs can be avoided. In the aggregate, all such questions will help toward building cases for a trusted medical cannabis industry – and should effectively inform an ever more coordinated regulatory approach across Europe.