John Binns and David Hardstaff of BCL Solicitors LLP ask if a new report should put a spring in the step of UK businesses with an interest in medicinal cannabis and cannabidiol (CBD)
What does the UK government-appointed Taskforce on Innovation, Growth and Reform (TIGRR) think about medicinal cannabis? A close look at the report it issued in summer 2021 suggests some surprisingly positive answers.
A post-EU bounce
The impetus for appointing TIGRR came from the UK’s exit from the EU, with the Prime Minister, Boris Johnson, convening it on 2nd February 2021 ‘to scope out and propose options for how the UK can take advantage of our newfound regulatory freedoms’. It is unashamedly political, with three Conservative MPs as its members (Sir Iain Duncan Smith, Theresa Villiers and George Freeman), but also independent from the government.
Two proposals in the report published by TIGRR on 16th June 2021 are of particular interest to the cannabis industry. The first (numbered 11.15, on page 81) is in part of a section on clinical trials, under the subheading ‘Cannabinoid Medicines’. The second (number 16, on page 109) is less obvious, and concerns a hybrid category of products referred to as ‘nutraceuticals’.
Let medicines be medicines?
Few in the medicinal cannabis sector would argue with the sentiment of proposal 11.15, which says that regulation of medicinal cannabinoids and medicinal cannabidiol (CBD) should move from the Home Office to the Medicines and Healthcare products Regulatory Agency (MHRA).
In practice, of course, the MHRA already does lead on medicinal products, although licences from the Home Office are also needed where the medicine contains a controlled drug, and it is to them that anyone wanting to do research involving cannabis currently has to turn.
A question of mindset
The mindset of the Home Office is understandably focused on aspects such as security of samples, rather than commerciality or science. But in truth, a licence to conduct research on a controlled drug (which CBD will only be if it contains tetrahydrocannabinol (THC)), whether dealt with by them or the MHRA, will always need to have security firmly in mind.
There would certainly be advantages of having a joined-up approach to the regulation of research into potential medicines and the medicines themselves. It might also be said that the unique issues raised by cannabis call for a bespoke agency, covering all aspects of cannabis regulation. Either way, the need for efficiency and expertise in this sector is clear.
Breaking down silos
The proposal on ‘nutraceuticals’ is perhaps more controversial, suggesting a new regulatory regime for products that are not strictly medicines, but are (or are marketed as) ‘health-enhancing’ foods and supplements. Though CBD is not mentioned, of course, a huge chunk of that sector is clearly in this category.
There are precedents for the regulation of ‘medicine-like’ products, such as homoeopathic and traditional herbal remedies, and of ‘novel foods’, with which CBD companies have been wrestling of late. Broadly speaking, the former is dealt with by the MHRA and the latter by the Food Standards Agency (FSA). TIGRR’s proposal encourages a more joined-up approach.
A new path?
With respect to cannabis and CBD products in general, the logic of proposals 11.15 and 16 together surely suggests a new path for their regulation, at least where the THC content is at a low enough level to protect consumers’ safety. For medicinal activities, including research, the MHRA should take the lead from the Home Office; for low-THC nutraceutical products, a new regime would make their regulation as controlled drugs unnecessary.
It remains to be seen whether the government will take up the proposals of TIGRR in general, but with respect to cannabis and CBD, the innovative and problem-solving approach they suggest is surely to be embraced. In a sector that sometimes feels beleaguered on all sides by regulatory barriers, a dose of political energy may be just what is required.
John Binns and David Hardstaff are lawyers at BCL Solicitors LLP, specialising in cannabis and CBD regulatory issues.