On 18 June, I announced the creation of an expert panel to advise Ministers on individual applications to prescribe cannabis-based medicinal products. As of today (27 June), the panel is now accepting applications, and will meet for the first time later this week. The clinical panel will be chaired by the Chief Medical Officer for Northern Ireland, Dr Michael McBride. Further members of the panel will be announced this week.
Clinicians must be at the heart of the process. The panel will consider applications from GMC registered practitioners who are listed on the relevant specialist register and with an active licence to practice. These applications must be countersigned by a medical director or an equivalent. This will provide the reassurance that prescribing these currently unlicensed and potentially untested products is in the best interests of the patient. Applications will not be accepted from members of the public.
The panel will assess applications against several criteria. These include: -
- Evidence of exceptional clinical circumstances, in line with existing principles applied to individual funding requests within the NHS; or,
- Whether there is evidence from existing clinical trials or other clinical data which indicate that a patient will benefit from a cannabis-based medicinal product; or,
- Whether the clinician considers there is an otherwise unmet special clinical need that could be addressed through use of a cannabis-based medicinal product by the patient.
In considering these criteria, the panel will be assessing whether the attending clinician, who has the responsibility for the case, is making an evidence based and reasonable request for a specific case. The panel cannot make clinical decisions for a patient not under their care. The full terms of reference and criteria, along with details for clinicians on how to apply are available on gov.uk.
The panel will not be responsible for issuing licences: only the Home Secretary or the Department of Health in Northern Ireland can give the formal approval of a Schedule 1 licence – both, however, will have due regard to the Panel’s recommendations.
As I, and the Home Secretary made clear last week, we will be led by clinical decision making. To streamline the application process as much as possible, for applications made through the expert panel to prescribe cannabis-based medicinal products, the Government will not require a site visit unless absolutely necessary. The Government will also not require a fresh DBS check from clinicians, or other individuals involved in the treatment of a patient involving a cannabis-based medicinal product, where they are practising under an existing DBS check. Waiving these requirements will ensure that any application for a licence submitted following consideration by the expert panel, where a visit and fresh DBS check are not required, can expect to receive a drug licensing decision within 2-4weeks. Should the panel be presented with an emergency case, the panel will consider cases as quickly as is necessary dependent on the medical circumstances.
The Government is also committed to reviewing the fees paid for licenses that are awarded as a result of the advice of the expert panel. That review will be take place urgently and will conclude before summer recess, with any legislation laid before the House at the first available date following its conclusion. In the meantime, for applications for a licence made by the NHS, neither individual patients nor their families will be asked to make any financial contribution towards the cost of any licence that may be issued.
On 19 June, the Home Secretary announced a two phase review looking at the scheduling of cannabis. Part one of the review will consider the available evidence of the medicinal and therapeutic benefits of cannabis and cannabis based products. Professor Dame Sally Davies will take this part forward. If Part one concludes that there is evidence of medicinal and therapeutic benefit, then part two will consider the appropriate schedule for cannabis-related products, based on the balance of harms and public health requirements. Part two will be led by the Advisory Council on the Misuse of Drugs (ACMD), with clinical input as required. The ACMD will not reassess the evidence issued by Professor Dame Sally Davies which I have received today.
This statement has also been made in the House of Lords: