UK law on medical cannabis changed six months ago - what have we learned?
On November 1, 2018, the UK changed the law on medicinal cannabis. Medicinal cannabis products were moved from schedule 1, meaning they have no medicinal value, to schedule 2, which allowed doctors to prescribe them under certain circumstances. This change to the Misuse of Drugs Regulations 2001 was partly a response to a rapid evidence review commissioned by the Home Secretary for the Chief Medical Officer, which concluded that some medicinal cannabis products were effective for some medical conditions, and formal advice from the UK government’s Advisory Council on the Misuse of Drugs to change the schedule.
Perhaps a more powerful driver of the rescheduling was a well-organised publicity campaign that received public support due to a compelling and difficult-to-challenge emotional narrative of sick children, the use of confrontational tactics, large financial backing, and privileged access to national media and senior politicians. But did this wave of media publicity and public support lead to unrealistic expectations about accessing medicinal cannabis?
Difficult to access
Since rescheduling, many NHS patients have been frustrated by what they see as a slow and bureaucratic system that has denied them access to cannabis treatments. Formal figures are not available but the number of NHS prescriptions since rescheduling is low – perhaps less than 100.
Difficulty accessing medicines on the NHS is not unique to cannabis, as seen with other medicines in the news, such as expensive chemotherapies and Orkambi for cystic fibrosis. Drugs available on the NHS are often a source of great controversy and provoke discussion about the affordability of medicines, their effectiveness and the ethics of providing or denying access to particular patient groups. Rescheduling to allow prescriptions on the NHS means that cannabis products are now also subject to the same types of debate.
Some cannabis medicines are available to patients regardless of the rescheduling decision. These are products developed by pharmaceutical companies and have been formally licensed for use in the same way as other medicines. Sativex is licensed to treat multiple sclerosis, and Epidiolex is undergoing a licensing review and is expected to be approved for treating severe forms of epilepsy.
However, rescheduling means that herbal cannabis and cannabis oil preparations that have not gone through this formal licensing process can now also potentially be prescribed as medicines. Although some of these products are manufactured to a high standard, they have not been formally licensed as medicines. Hence, while these are the types of products that people in the media spotlight, such as Billy Caldwell, have been using, many doctors resist prescribing them.
In other countries where medicinal cannabis has been available for longer and is more widely prescribed, special regulatory systems have been developed to oversee access. In the Netherlands, for example, the national Office for Medicinal Cannabis, part of the Ministry of Health, regulates a system where people under the care of their family doctor can access a prescribed unlicensed herbal cannabis or cannabis oil product from an authorised provider through their pharmacist.
In the UK, a dedicated medicinal cannabis regulatory system doesn’t yet exist and patients can only access cannabis under a system designed for traditional medicines. This was partly because the decision to reschedule cannabis was taken so quickly, but also to allay fears that cannabis products would be diverted to the recreational market.
While NHS England and professional associations have published guidelines for doctors on prescribing medicinal cannabis, these are cautious and reflect the uncertain evidence.
Cannabis products which have yet to be formally approved as medicines are only available on the NHS under what are known as “specials”, and only after other types of treatment have been tried. Only consultants can prescribe these specials and many of them don’t think cannabis is as effective as existing treatments.
Several NHS Trusts have also refused to pay for cannabis treatments, even if prescribed by a consultant, as they are not convinced they provide good value for money for the NHS. Patients can still get private medicinal cannabis prescriptions from a consultant, as they can with any other medicine, but this creates unequal access based on the ability to pay.
Cannabis medicine is a new area of therapeutic practice, so regulatory systems need to be carefully developed and fine-tuned, new cannabis medicines have to be licensed, healthcare providers need to be trained and prescribing guidelines need to be formalised. Definitive clinical guidance on these medicines is expected from NICE in October 2019. This will help to clarify and standardise clinical decisions on prescribing. But for many patients, this might be too long to wait, and it is possible that the guidance may even conclude that there is limited use for medicinal cannabis products in the NHS.
Conflicts of interest
Perhaps the biggest winners from medicinal cannabis rescheduling will be early financial investors (including the tobacco industry) who seek to capture a growing market and who have supported campaigning groups and private medicinal cannabis clinics. As the UK medicinal cannabis market matures, awareness of conflicts of interest need to be made more apparent.
In light of perceived barriers to access, provocative and well-publicised patient actions designed to evoke public sympathy and a response from ministers have continued. In impassioned parliamentary debates, MPs have called for patient access to medicinal cannabis to be prioritised over formal evidence that they are effective and affordable medicines. They have also direct criticised professional clinical bodies that are perceived to be blocking access to these products. However, reactive decisions based on a fear of bad headlines do not lead to good policy.
It is important that the proper regulatory development process is allowed to proceed. The UK needs a medical cannabis system that is responsive to patient needs but also one that is palatable to regulators and conforms with medical practice and standards. Otherwise, progress in this important field will stall.