Factsheet: Expert panel and licensing process

The Government has announced the establishment of an expert panel of clinicians to advise Ministers on any licence applications to prescribe cannabis-related medicinal products in exceptional cases where there is an unmet clinical need.
This will ensure that advice to Ministers on licensing in these cases is clinically led, 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.
The panel will be chaired by the Chief Medical Officer for Northern Ireland, Dr Michael McBride.

The expert panel is an interim measure whilst a review into the scheduling of cannabis is ongoing.
The two-part review will cover the medicinal and therapeutic benefits of cannabis and cannabis-related medicinal products and then will provide an assessment based on the balance of harms and public health needs of whether cannabis and cannabis-related medicines should be rescheduled.
The review will not cover the classification of cannabis as a Class B drug.

The expert panel will only consider applications made by General Medical Council (GMC) registered clinicians listed on the relevant specialist register and with an active licence to practice, countersigned by a medical director or equivalent to ensure the proposed course of treatment is a safe and effective approach.
The senior clinician will have to show that there is an exceptional clinical need and that there is no other non-Schedule 1 medicinal product (whether licensed or not) that would meet the specific need of the patient. They would also 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 direction of a doctor and whether an existing clinical trial indicates the product will be effective for the patient’s condition.
The full criteria for applications is set out in the panel's terms of reference.

An application from a senior clinician listed on the General Medical Council's (GMC) specialist register should be made using this application form and then sent to: secretariat@Expertpanel.gov.uk.

Once an application has been submitted to the panel’s email address, the expert panel’s secretariat will triage the application to ensure that the criteria (as set out above) have been met. The Secretariat may either ask for further information or refer the application to the 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 panel will then make a recommendation to the Home Office or the Department for Health in Northern Ireland.
The panel will not provide clinical advice such as recommending a particular drug or dosage; this will remain the responsibility of the patient’s clinical team.
Once a recommendation has been made, the applying clinician will submit a final licence application to the Home Office or the Department of Health Northern Ireland who will decide whether to issue a licence. Applications will be considered as swiftly as possible.

The Home Office is currently reviewing the fees payable for licences that are awarded as a result of the advice of the expert panel.
Current fees are not paid by the patient or parent but by the institution that the applying clinician belongs to.

Further information can be found here.

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