At the end of July, the UK Government recognised that cannabis has medicinal value and should be available on prescription. This new step brings the UK in line with 40 other countries and 31 US states, where the use of cannabis medicinally is already legal.
Home Secretary, Sajid Javid, recently announced that new regulations in England, Wales, Scotland and Northern Ireland will allow doctors to prescribe cannabis products to their patients.
This new law – which comes into effect from 1 November – will not limit the types of conditions that can be considered for treatment and doctors will no longer need to get approval from a panel of experts to give their patients access to such medicine.
Mr Javid said: “Having been moved by heart-breaking cases involving sick children, it was important to me that we took swift action to help those who can benefit from medicinal cannabis.
“The decision to prescribe is only restricted to a doctor on the Specialist Register of the General Medical Council where the cannabis-based product is an unlicensed ‘special’ medicinal product for use by a specific patient. Once a product is licensed by the MHRA, it will be available for prescription in the same way as any other Schedule 2 drug.”
So what does this mean? How will this affect doctors and how exactly will the process work?
In order to be deemed a “cannabis-based product for medicinal use in humans”, the substance needs to be:
- a preparation or product containing cannabis, cannabis resin, cannabinol or a cannabinol derivative
- produced for medicinal use in humans
- a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product.
If all three criteria are met, the substance will be considered a Schedule 2 drug under the 2001 regulations.
Obtaining the products
A cannabis-based product can only be ordered for medicinal use in humans if the product is:
- a special medicinal product that is for use in accordance with a prescription or direction of a specialist medical practitioner
- an investigational medicinal product without a marketing authorisation that is for use in a clinical trial
- a medicinal product with a marketing authorisation
What guidance will doctors receive?
NHS England and the DHSC will shortly provide guidance ahead of the regulations coming into force. There will also be interim clinical guidance provided by the professional bodies. Similarly, the MHRA will provide ‘specials’ guidance on the manufacture, importation, distribution and supply of unlicensed cannabis-based products for medicinal use.
NICE clinical guidelines are expected to be provided in October 2019.
Doctors will be expected to only prescribe cannabis-based medicinal products within their own areas of practice and the decision should be agreed by the multidisciplinary team. Initially, prescribing will be restricted to specialists, not GPs.
Before prescribing cannabis-based products, doctors will be expected to be certain of the contents and quality. The GMC guidelines will need to be followed in terms of having adequate knowledge of the patient’s health, medical history and treatment requirements.
When it comes to prescribing unlicensed medicines or ‘specials’, doctors must be confident, that based upon an assessment of an individual patient’s need, the prescription is medically necessary. The GMC has a list of examples where there is no other suitable licensed medicine that would meet the patient’s needs.
When prescribing these unlicensed medicines, it’s crucial that doctors give patients sufficient information on the medicines proposed, allowing them to make an informed decision, and recording the reasons for prescribing them.
It may take more than a year for the NHS to devise procedures for the prescribing and distribution of cannabis-based medicines.
Until the changes come into force at the start of November, the Independent Expert Panel will continue to consider any applications made.
When announcing the new regulations, Mr Javid made it clear that this is not a move towards legalising cannabis for recreational use and the penalties for unauthorised supply and possession will not change.