On June 23rd, 2020, GW Pharmaceuticals, one of the world leaders in pioneering, developing and delivering FDA-approved cannabis medicines, announced that the UK Home Office has reclassified CBD (cannabidiol) as a Schedule 5 drug, moving it from Schedule 2. This change will take effect immediately in of the United Kingdom, although Northern Ireland will be enacting separate legislation. Being Schedule 5 the most relaxed category conceived by the Misuse of Drugs Regulations, the immediate consequence of this will directly impact the availability of regulatory-approved cannabis-based medicine. And, of course, being GW the only producer of regulatory-approved CBD medicine, with their product Epidiolex, it is no surprise the broader public is receiving this news from a press release issued by the company’s PR department, via Globe Newswire.
According to the press release, the ACMD and its Technical Committee endorsed the schedule change before Conservative MP Kit Malthouse, Minister of State for Crime and Policing, on 29 January 2020. This endorsement came after the submission of a written dossier and oral presentation on behalf of the MHRA, which relied on the substantial data provided by GW Pharmaceuticals, which the company collected in the context of the Epidiolex’s review and subsequent approval by the regulatory authorities in September 2019. The CBD-based medication is approved in the European Union as adjunctive therapy for the seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients from 2 years of age and older.
“The decision to move EPIDYOLEX to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole – reducing costs and ensuring the medicine can be dispensed more easily,” declared Chris Tovey, GW’s Chief Operating Officer. The amount pre-clinical and clinical data that GW collected in support of the medicine’s approval by regulatory authorities resulted to be “pivotal to this important schedule change”. In the press release, Mr. Tovey then proceeded “to thank the MHRA, ACMD and Home Office” for the prompt tackling of the data made available to them, and for consequently “making this change in such a short timeframe”. GW renewed its corporate commitment “to expanding the high-quality evidence base for cannabis-based medicines and securing further regulatory approvals” in the best interest of the patients and the healthcare system.
The recommendation was accepted by the Minister on April, 22nd 2020 and secondary legislation was scheduled to enforce the change on June, 3rd 2020. GW’s medicine is now exempt from all controlled drug requirements. As a result, patients can now have more flexibility on the amount of medicine they can receive and are now finally able to benefit from repeat prescriptions. At the same time, healthcare professionals can now benefit from reduced controls in regard to the storage and reporting requirements that affected Epidiolex as long as it remained under Schedule 2.
However, it has to be noted that this move will only serve a small fraction of the industry, as far as producers and distributors go, and, from a certain perspective, it looks like yet another power move on behalf of a company that has pretty much monopolized medical cannabis in Europe since the early 2000’s. In its recommendation to Mr. Malthouse, the ACMD mentioned the “low risk of abuse potential, low risk of dependency and low risk of diversion” as grounds for reclassifying cannabidiol from Schedule 2 to Schedule 5 of controlled substances. It has to be noted that the ACMD recommendation is specifically related to GW’s Epidiolex, a choice the institution justifies by pointing out that no other entity has sought regulatory approval of their CBD-based products.