The law in the UK was changed in November 2018 to make prescribing of medical cannabis legal, but parents have been struggling to secure prescriptions. For parents whose children have a condition for which they feel medicinal cannabis is helping, not having the medicine readily available is incredibly frustrating and leads to considerable distress.
The current situation with regard to prescribing medicinal cannabis is far from straightforward.
Which types of cannabis-based medicines are available in the UK?
There are broadly speaking three types of cannabis-based medicines available in the UK:
1. “Pure” cannabidiol (CBD)
Epidiolex is the best known form of pure CBD and has been developed to a pharmaceutical grade and has undergone clinical trials. It is legal to prescribe in the UK and is most commonly used in adults and children with Lennox-Gastaut syndrome and Dravet syndrome (which are rare forms of epilepsy). It currently has a restricted availability through the compassionate use program for these conditions.
There is good evidence suggesting that Epidiolex is moderately effective for these conditions.
Epidiolex is not currently licensed in the UK, but it is currently going through the European Medicines Agency. It is already licensed in the USA and has been the subject of clinical trials.
NHS England is currently undertaking a review, on the instruction of the Secretary of State for Health. This is due to be published shortly and will contain recommendations on how barriers to accessing medical cannabis in the UK may be overcome .
Alongside this, Epidiolex is undergoing a Health Technology Appraisal by the National Institute for Health and Care Excellence (NICE).
Once the Technology Appraisal is published NHS Specialised Commissioning will decide on the funding model.
If approved by NICE and they found it to be cost effective we would anticipate Epidiolex then being available outside the compassionate use programme.
"Pure" products that only contain CBD, such as Epidiolex, do not carry the risks linked with THC.
2. Cannabidiol (CBD) plus Tetrahydrocannabinol (THC) containing products
THC is the principal psychoactive constituent of cannabis.
The main theoretical risks of THC cannabis products are:
- Psychosis – there is evidence that regular cannabis use increases your risk of developing a psychotic illness such as schizophrenia1
- Dependency on the medicine – although scientists believe this risk is probably small when its use is controlled and monitored by a specialist doctor1
Generally, the more THC the product contains, the greater these risks are.
There is also evidence to suggest that it can have:
- Effects on cognition – there is evidence from animal and human data that THC containing products affect cognition and memory2
- Pro-convulsant effects – whilst some animal studies have shown THC to have an anticonvulsant effect, some have also shown it to be pro-convulsant3
CBD plus THC products are not currently licensed in the UK and we are not aware of any clinical trials planned by the pharmaceutical companies who manufacture them.
There is no good quality research behind these products and no evidence that they are safe to prescribe or that they are clinically effective. Therefore neurologists are extremely reluctant to prescribe because there is not enough known about side effects. This would be the same for any drug that does not have proven benefits – unless it is subject to minimum safety and efficacy assessments before marketing.
3. Non-pharmaceutical grade Cannabis oils
These are readily available to buy in health stores and online. These products are not classed as medicines and are not licensed. They have varying levels of ingredients, contain impurities as they are not pharmaceutical grade, and as they tend to have very small amounts of CBD, it is unclear how effective they are and what the side effects may be.
However, there are products available online that contain very high levels of THC and these pose significant theoretical risks to children.
Which medicine do UK doctors prescribe?
Given the lack of research for the effectiveness and safety of CBD plus THC, where there is a medical case, paediatricians will prescribe Epidiolex if clinically indicated.
However, Epidiolex is currently only able to be prescribed as part of the ‘compassionate use’ programme. That means that the manufacturer only provides a limited number of doses per hospital neurological unit. Therefore, NHS clinicians only have enough product to prescribe to a limited number of patients.
Clinicians can prescribe Epidiolex outside the compassionate use programme, but this remains difficult as although they may prescribe it, the cost of the drug still needs to be met before it can be supplied.
This situation is clearly frustrating for children, parents and clinicians.
Why is cannabis-based medicine readily prescribed in some other countries?
In some countries, CBD plus THC products are more readily prescribed on private prescription. However, there is not enough research for these products to be deemed safe or effective and therefore they are only prescribed in the UK under very specific conditions.
The National Institute for Health Research (NIHR), on behalf of the Department for Health and Social Care (DHSC), made a call out for evidence on the effectiveness of other cannabis-based medicines. This call is currently open and closes on 31 July 2019.
Paediatricians always act in the best interest of their patients. Clinicians, patients and their families must be confident that any prescribed medication is both safe and effective.
What is the RCPCH calling for?
Despite an expectation that cannabinoid based drugs for treatment of epilepsy would become freely available following the Home Secretary’s announcement in November 2018 this has not been the case; the RCPCH requests action from the NHS, licensing authorities, manufacturers and suppliers to make an evidence-based product available for those who need it.
The RCPCH requests:
- The current technology appraisal by NICE to be expedited, subject to early licensing, and the subsequent decision by NHS Specialised Commissioning on funding for Epidiolex to follow quickly.
- In the meantime, the pharmaceutical company that manufactures Epidiolex to redistribute existing supplies of the drug on the compassionate use programme so that it is prescribed to those who need it most.
- The avoidance of unnecessary delays in the current licensing process.
- Appropriate industry-based research and development to be completed on all available cannabis-based medicines that are marketed either directly or indirectly as anti-epileptic agents.
Other points to note
The RCPCH is unable to comment on individual cases as we do not have the information to hand that the treating clinician will have.
- 1. a. b. NHS. Medical Cannabis (and cannabis oils): www.nhs.uk/conditions/medical-cannabis/
- 2. Borgan F, Beck K, Butler E, et al. The effects of cannabinoid 1 receptor compounds on memory: a meta-analysis and systematic review across species. Psychopharmacology 2019 doi: 10.1007/s00213-019-05283-3[published Online First: Epub Date]|
- 3. Rosenberg EC, Patra PH, Whalley BJ. Therapeutic effects of cannabinoids in animal models of seizures, epilepsy, epileptogenesis, and epilepsy-related neuroprotection. Epilepsy & behavior : E&B 2017;70(Pt B):319-27 doi: 10.1016/j.yebeh.2016.11.006[published Online First: Epub Date]|