The developing legal approach in the UK to medical cannabis highlights the problems law makers have in responding adequately to clinical and technological advances: especially those that challenge conventional views.
This has arguably stifled innovation in medical cannabis research in the UK, and prevented patients from receiving worthwhile treatments.
This note considers the deficiencies in the existing legal regime, and how the UK’s legal and policy approach to medical cannabis is now evolving at unprecedented speed.
This should lead to legal rules that reflect evidence based research and patient experiences; provide opportunities for entrepreneurship; and, most importantly, relieve life limiting symptoms in patients.
The curiosity is why policy makers and government have been so slow to act in the face of evidence of the benefits of cannabis based medicines, and the growth of legal markets internationally - two thirds of adults in the United States now have access to medical or recreational cannabis.
It is doubtful that the wider policy against normalising recreational cannabis fully explains the reluctance of law makers to act. Indeed, there is evidence that effective decriminalisation is occurring locally in some areas of the UK.
Figures obtained by the BBC show that arrests for possession have fallen by 46% since 2010, while usage has remained the same. Durham Police for example, no longer targets cannabis users or growers.
The case of Billy Caldwell, a 12-year-old with severe epilepsy forced the issue of medical cannabis onto the front pages in June 2018.
He suffers around 100 fits a day, which dramatically reduce when using cannabis oil.
He had been prescribed the oil in Canada but it was confiscated at the UK border. He was then admitted to hospital in the UK after his seizures intensified.
Following a public outcry, the oil was eventually made available under licence by the Home Office.
Other children have since applied to the Home Office for licences to use the oil to treat epilepsy and seizures.
The UK as world leader in production/export of medical cannabis
The irony of this is that in 2016 the UK was, according to the United Nations, the world’s main producer and exporter of medical cannabis.
So, why was Billy Caldwell denied access to cannabis oil, while the UK was producing at least 95 tons of (medical) cannabis, and exporting 2.1 tons?
The existing law on medical cannabis
At the moment cannabis is a ‘Schedule 1’ drug. This refers to Schedule 1 of the Misuse Of Drugs Regulations 2011.
This means that it is considered to have little or no therapeutic value, and cannot be prescribed or held legally with a prescription.
Contrast, for example, opium, a Schedule 2 drug, which can be prescribed. The law allows licensing of Schedule 1 drugs in two circumstances: either for research or “other special purpose”.
There is very little public information on licences.
Only one cannabis based medicine – Sativex – has been granted a Home Office licence.
Sativex accounts for all the production and export statistics referenced by the United Nations.
Sativex – the existing UK cannabis based medicine
Sativex is a cannabis-based medicine developed for the treatment of multiple sclerosis (MS).
In 1998 GW Pharmaceuticals obtained a research licence from the Home Office.
During development in 2006, the Home Office issued a licence to doctors to enable them “at their own risk” to privately prescribe Sativex for MS.
Finally, in April 2013 Sativex was ‘scheduled’ under the Misuse of Drugs Regulations 2001, as a Schedule 4 part 1 controlled drug for MS.
As such, Sativex is recognised by government as having medicinal benefits, and can be produced, prescribed and exported in the UK.
There is an obvious tension between the ‘scheduling’ of Sativex and government’s view that cannabis has no legitimate medicinal uses.
Clearly some cannabis based medicines have therapeutic benefit.
The government review
Following public pressure, on 19 June the new Home Secretary, Sajid Javid announced a government review.
Stage 1 has been conducted at breakneck speed, with the first part now published. The Chief Medical Officer for England and Wales Reports that there is “conclusive evidence of the therapeutic benefits of cannabis based medicinal products for certain medical conditions and reasonable evidence of therapeutic benefit in several other medical conditions” (para. 1.4).
She recommends reclassifying all medical based cannabis products to allow these to be prescribed by registered practitioners. Part 2 of the review was commissioned on 3 July.
The Advisory Council on the Misuse of Drugs has to report on whether cannabis related medicines should be rescheduled (as Sativex was).
The outcome must be published by the end of July.
Change within weeks?
It is almost certain that the Chief Medical Officer’s recommendations will be followed and that the UK will reschedule cannabis to allow practitioners to prescribe cannabis based medicine for specific conditions. This will bring the UK regime into line with scientific research and public opinion. However, the change will only have been achieved through a combination of negative publicity, shifting public opinion and the appointment of a new Home Secretary.
Innovation and the law
Legal and regulatory requirements are important, but it is critical that they do not stifle innovation.
Ideally, the Home Office could have developed clear guidelines on how treatments could have been developed within the existing law.
This hasn’t been the Home Office approach.
Freedom of Information requests seeking disclosure of the terms on which the Sativex licences were granted have been refused on grounds of commercial confidentiality, and no guidance has been available to support research and development.
As a result, there has been little clarity on how Home Office adjudicates applications for licences for research or ‘other special purpose’.
This approach has most probably stifled innovation in the UK.
Legal markets undoubtedly foster and support research and development: in the US, medicinal cannabis is now a mainstream drug for chronic pain, posttraumatic stress disorder and opioid use disorder, and clinical trials are ongoing assessing cannabis based treatments for complications after bone marrow transplants, obesity and osteoporosis.
The story of medical cannabis law in the UK, is a good illustration of why regulators and law makers should favour open guidance and principles in developing legal frameworks.
These tend to be flexible enough to encourage innovation and risk taking, while protecting consumers and patients.
Arguably much more could have been done, even within the existing law in the UK, to foster research and development.
Assuming the law in the UK develops to allow legal prescription, we will see new cannabis based treatments for patients with epilepsy, MS, chronic pain, and for the symptoms of chemotherapy.