The Home Secretary Sajid Javid today formally announced the rescheduling of cannabis-based medicinal products. The changes will come into effect on 1 November.
This means that from the start of November, UK specialist clinicians will be able to prescribe cannabis-based medicinal products. They will be able to do this for patients “with exceptional clinical need” without having to apply for a licence. At the moment, clinicians must apply to an expert panel for a licence for cannabis-based medicines.
Rescheduling means that cannabis-based medicines will no longer be listed as Schedule 1 under the Misuse of Drugs regulation 2001. Schedule 1 products are thought to have no therapeutic effect.
Specialist clinicians will not be limited by condition when prescribing cannabis-based medicines. However, initial guidance for clinicians will focus on use in children with severe forms of epilepsy, people with chronic pain and to help with nausea from cancer treatment.
It is expected that NHS England and the Department of Health and Social Care (DoHSC) will provide guidance for specialist clinicians before the start of November. The British Paediatric Neurology Association (BPNA) is also expected to put together clinical advice for use of cannabis-based medicines in children with severe epilepsies.
Epilepsy Action has said this “represents an important step towards ensuring people with epilepsy who might benefit from these treatments are able to access them.”
Recognised the potential
The organisation’s statement added: “While cannabis-based medicines won’t be limited by condition, the interim guidance will focus on three conditions, one of which is severe epilepsy in children.
“We are pleased that the government have recognised the potential of cannabis-based medical products to improve the lives of some children with the most severe and treatment-resistant epilepsies. We also welcome how quickly the government have acted on this important issue.
“We know that some families have had problems accessing cannabis-based medicinal products through the expert panel set up to review applications. Epilepsy Action shares these concerns.
“When the changes come in to force, the expert panel will end and decisions will be made directly by specialist clinicians. We hope that this will make access to cannabis-based medical products easier for children who could benefit from them.
“Safety has always been front and centre of our work on cannabis-based medicinal products. However, it is vital that these products are available and accessible to those children who could benefit from them.”
Access and definitions
Up until the changes come into effect specialist clinicians will still be able to apply for a licence to the expert panel set up in June. This panel was set up as a temporary measure until the change to the legislation is put into effect.
Currently, there are three ways for people to access a cannabis-based medicine. This can be through a normal prescription process for MHRA approved medicines that have a licence, such as Sativex. This is a medicine to treat the condition multiple sclerosis (MS).
For medicines that do not have a licence, from 1 November a specialist medical practitioner will be able to prescribe these as a ‘special medicinal product’. Specialists will only be able to do this if there is clear evidence of a benefit and all other options have been unsuccessful. It will also need to be in line with the available clinical guidance.
People may also be able to access cannabis-based medicines by taking part in clinical trials studying these medicines.
Ahead of the rescheduling, the Medicines and Healthcare products Regulatory Agency (MHRA) was also tasked with providing a definition of cannabis-based medicines. The MHRA has set out three criteria which a product has to meet to be considered a cannabis-based medicine. These are:
- Is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative
- Is produced for medicinal use in humans
- Is a medical product, is an ingredient for a medical product or is used to produce an ingredient for a medical product
Not a move to legalise recreational use
Today’s changes come after the government launched a review into cannabis-based medicines in June this year. This followed Home Secretary Sajid Javid issuing a special licence for cannabis oil to a 12-year-old boy with severe epilepsy.
The review was carried out by Dame Prof Sally Davies, Chief Medical Officer for England, and the Advisory Council on the Misuse of Drugs (ACMD). It concluded that cannabis-based medicines should not be listed as Schedule 1. It found that there is evidence of medical benefit to cannabis-based medicines for some conditions.
The government has continuously stressed that this is not a move to legalise the recreational use of cannabis.
The ACMD’s full report is expected in July 2019, followed by clinical guidelines from the National Institute for health and Care Excellence (NICE).