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This publication is available at https://www.gov.uk/government/publications/cannabis-based-medicines-expert-review-panel/cannabis-and-cannabis-based-medicinal-products
The government has announced a review of the scheduling of cannabis. The review will be in 2 parts:
- part 1 will cover the medicinal and therapeutic benefits of cannabis and cannabis-based medicinal products
- part 2 will provide an assessment based on the balance of harms and public health needs of whether cannabis and cannabis-based medicinal products should be rescheduled under the Misuse of Drugs Regulations 2001
The review will not cover the classification of cannabis as a class B drug, or any of the penalties for the illicit offences involving cannabis. The penalties for the relevant offences relating to cannabis under the Misuse of Drugs Act 1971 remain the same.
In the interim period, we will consider licence applications for the use of cannabis and cannabis-based medicinal products in exceptional cases where there is an unmet clinical need. We have established an expert panel of clinicians to advise ministers on any licence applications to prescribe cannabis and cannabis-based medicinal products.
This will ensure that advice to ministers on licensing in these cases is clinically led and based firmly upon medical evidence, and that patients and their families have access to the most appropriate course of medical treatment as swiftly as possible.
Patients and parents
The expert panel will only be able to review applications from senior clinicians with the right expertise in your, or your child’s, condition. This is to make sure that any proposed course of treatment is agreed by your existing medical team and is a safe and effective approach. If you would like an application to be taken forward on your behalf, speak to your medical team.
The expert panel will consider the merits of each case to establish whether the criteria below has been met. They will make a clinical assessment of an exceptional and unmet clinical need which the product would address, taking into account the urgency of the case and any prior treatment with the product, through clinical trial or otherwise.
The expert panel will also consider the products in question and the appropriateness of alternative courses of action.
A list of panel members’ biographies and registers of interest is available.
Criteria for submissions to the panel
To make sure that the course of treatment is safe and effective, the panel will be looking for the specialist clinician to show that there are exceptional clinical circumstances. They would be expected to show that there is no other lawful medicinal product (whether licensed or not) that would meet the specific need of the patient. The specialist clinician would be expected to accept full responsibility for risks and liability.
The panel may also consider whether the patient has previously benefited from the product under the lawful direction of a doctor (potentially in another jurisdiction) and whether an existing clinical trial indicates the product will be effective for the patient’s condition.
The criteria for applications is set out in full in the expert panel’s terms of reference above.
Applying to the expert panel
Process for considering a licence
Once an application has been submitted to the expert panel through the formal procedure set out above, the expert panel’s secretariat will triage the application to ensure that the basic criteria have been met (as set out above).
Based on the information supplied, the secretariat may either ask for further information or refer the application to the expert panel for consideration.
The expert panel will be responsible for assessing the merits of each application and may also contact the applicant for further information if required. The expert panel will then make a finding which will be shared with the Home Office or the Department for Health in Northern Ireland, as appropriate.
Once this stage is reached, the applying clinician will be invited to register their licence application with the Home Office or the Department of Health in Northern Ireland. Once registered, further information will need to be submitted by the applicant to show that they are able to comply with the UK government’s regulatory framework concerning misuse and diversion of drugs.
The Home Office or the Department of Health in Northern Ireland will then assess whether the licence can be issued. The Home Office and the Department of Health in Northern Ireland lead on regulatory governance and are independent of the expert panel. They will however consider the clinical assessment before concluding whether a licence can be issued.
The government has committed to consider such applications as swiftly as possible. For drug licence applications made following consideration by the expert panel, the government will only require site visits or checks through the Disclosure and Barring Service by exception. Waiving these requirements will ensure that any application for a licence submitted following consideration by the expert panel can expect to receive a drug licensing decision within 4 weeks. Should the panel be presented with an emergency case, expedited decisions will be able to be made.
The Home Office will continue to retain responsibility for ensuring compliance with the UK government’s regulatory framework on controlled drugs.
It is the Secretariat’s responsibility to triage applications to ensure that they contain the correct content (for example all fields completed and the content of an appropriate quality) and evidence to enable a decision to be made by the expert panel (EP). The Secretariat will pass ‘complete and correct’ applications to the EP. The EP will have 10 working days from receipt of a ‘complete and correct’ application in which to consider the application, meet and provide their recommendation. Applications that miss the deadline will be referred to the next scheduled EP meeting for consideration.
The following dates have, so far, been confirmed for when the expert panel will meet to review the applications received:
- 9th August 2018
- 23rd August 2018
- 6th September 2018
- 20th September 2018
Fees for licences
We are currently reviewing the fees payable for a licence. These fees will not be paid by the patient or parent but by the institution the applying clinician belongs to.
The government has committed to reviewing the fees paid for licences that are awarded as a result of the advice of the expert panel. That review will take place urgently and will conclude by July, with any legislation being laid before Parliament at the first available date following its conclusion.
Importation of products
If a domestic licence has been issued, the usual process should be followed to import a controlled drug into the UK.
Your personal information
The expert panel privacy notice explains how we will use your personal information.