Asked by: Jeff Smith (Labour - Manchester, Withington)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will clarify guidance on the ability for a prescription for medical cannabis given by a specialist to subsequently be taken over by a GP under a shared care arrangement.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The law requires that unlicensed cannabis-based products for medicinal use (CBPMs) be supplied under either the prescription or direction of a clinician on the General Medical Council’s (GMC) Specialist Register. As with all areas of clinical practice, the GMC’s guidance states that all doctors must recognise and work within the limits of their competence. This is supported by the National Institute for Health and Care Excellence’s guideline ‘Cannabis-based medicinal products’, which states that after the initial prescription, subsequent prescriptions of CBPMs may be issued by another prescriber as part of a shared care agreement under the direction of an initiating specialist prescriber, if:
- shared care is appropriate and in the person’s best interest;
- the person's clinical condition is stable; and
- the other prescriber is confident to make a fully informed prescribing decision about cannabis-based medicinal products.
If a general practitioner (GP) accepts ongoing shared care responsibilities and continues prescribing once a patient has been initiated and stabilised on CBPMs, they must be confident to accept the associated legal and professional responsibilities associated with doing so, which are increased in the case of an unlicensed product. This includes accountability for the quality of the product prescribed. Treatments initiated privately would not usually be prescribed by a GP under shared care unless the requested treatment is approved under existing National Health Service policies or there are exceptional circumstances. This remains the case even if that privately funded treatment has been shown to have clinical benefit for the individual patient. This applies to all treatments.
Asked by: John Baron (Conservative - Basildon and Billericay)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when he plans to respond to the correspondence from the hon. Member for Basildon and Billericay of 1 April , 30 April, 9 June and 23 June 2021 on the Medical Cannabis Under Prescription campaign with reference JB32121.
Answered by Edward Argar - Minister of State (Ministry of Justice)
We replied to the hon. Member on 6 August 2021.
Asked by: Ronnie Cowan (Scottish National Party - Inverclyde)
Question to the Home Office:
To ask the Secretary of State for the Home Department, what assessment her Department has made of the processing time of Letters of Declaration for the import of cannabis-based products for medicinal use by the Drugs and Firearms Licensing Unit; what steps she is taking to tackle delays in that processing; and if she will make a statement.
Answered by Kit Malthouse
All applications are considered individually on their merits and with regards to our obligation under International Conventions and Domestic law. Applications for importation of Cannabis Based Products for Medicinal Use in Humans (CBPMs) are already expedited, where documentation and regulatory approval is provided, in recognition of the need to ensure continuity of the supply of unlicensed medicines.
The Medicines and Healthcare Products Regulatory Agency guidance- “The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans specials” - was updated in March 2020 to enable pharmaceutical wholesalers to move from a system where they can only apply to import the quantity specified on a prescription, to a system that allows the import of CBPMs in anticipation of prescriptions.
Licensed wholesalers could hold supplies of products to be drawn on when in receipt of a prescription from a specialist doctor on the General Medical Council (GMC) Specialist Register. The Drug & Firearms Licensing Unit (DFLU) continues to expedite applications made in response to this updated guidance, where all relevant documentation and regulatory returns have been made by the wholesalers.
No officials have been seconded from the Drug and Firearms Licensing Unit. Since 25 March 2020, it has delivered its regulatory functions remotely, issuing a total of 1,699 controlled drug import-export licences.
It is presently operating a next day turnaround for applications where all required information has been submitted with the application.
Asked by: Ronnie Cowan (Scottish National Party - Inverclyde)
Question to the Home Office:
To ask the Secretary of State for the Home Department, with reference to the guidance document entitled, The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans specials, published by the Medicines and Healthcare Products Regulatory Agency in March 2020, what steps the Drugs and Firearms Licensing Unit in her Department is taking to speed up the process of granting import licences for cannabis-based products for medicinal use since that guidance was published; and if she will make a statement.
Answered by Kit Malthouse
All applications are considered individually on their merits and with regards to our obligation under International Conventions and Domestic law. Applications for importation of Cannabis Based Products for Medicinal Use in Humans (CBPMs) are already expedited, where documentation and regulatory approval is provided, in recognition of the need to ensure continuity of the supply of unlicensed medicines.
The Medicines and Healthcare Products Regulatory Agency guidance- “The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans specials” - was updated in March 2020 to enable pharmaceutical wholesalers to move from a system where they can only apply to import the quantity specified on a prescription, to a system that allows the import of CBPMs in anticipation of prescriptions.
Licensed wholesalers could hold supplies of products to be drawn on when in receipt of a prescription from a specialist doctor on the General Medical Council (GMC) Specialist Register. The Drug & Firearms Licensing Unit (DFLU) continues to expedite applications made in response to this updated guidance, where all relevant documentation and regulatory returns have been made by the wholesalers.
No officials have been seconded from the Drug and Firearms Licensing Unit. Since 25 March 2020, it has delivered its regulatory functions remotely, issuing a total of 1,699 controlled drug import-export licences.
It is presently operating a next day turnaround for applications where all required information has been submitted with the application.
Asked by: Ronnie Cowan (Scottish National Party - Inverclyde)
Question to the Home Office:
To ask the Secretary of State for the Home Department, how many officials in the Drugs and Firearms Licensing Unit in her Department have been seconded to work on the response to covid-19; and if she will make a statement.
Answered by Kit Malthouse
All applications are considered individually on their merits and with regards to our obligation under International Conventions and Domestic law. Applications for importation of Cannabis Based Products for Medicinal Use in Humans (CBPMs) are already expedited, where documentation and regulatory approval is provided, in recognition of the need to ensure continuity of the supply of unlicensed medicines.
The Medicines and Healthcare Products Regulatory Agency guidance- “The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans specials” - was updated in March 2020 to enable pharmaceutical wholesalers to move from a system where they can only apply to import the quantity specified on a prescription, to a system that allows the import of CBPMs in anticipation of prescriptions.
Licensed wholesalers could hold supplies of products to be drawn on when in receipt of a prescription from a specialist doctor on the General Medical Council (GMC) Specialist Register. The Drug & Firearms Licensing Unit (DFLU) continues to expedite applications made in response to this updated guidance, where all relevant documentation and regulatory returns have been made by the wholesalers.
No officials have been seconded from the Drug and Firearms Licensing Unit. Since 25 March 2020, it has delivered its regulatory functions remotely, issuing a total of 1,699 controlled drug import-export licences.
It is presently operating a next day turnaround for applications where all required information has been submitted with the application.
Asked by: Mike Penning (Conservative - Hemel Hempstead)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the timeframe is for the process evaluation being undertaken by the NHS on prescribing cannabis-based products for medical use; and if he will he make a statement.
Answered by Seema Kennedy
NHS England has been asked to provide an interim report to the Secretary of State for Health and Social Care by the end of May 2019. The review will be clinically led by the NHS England and NHS Improvement Medical Director and Chief Pharmaceutical Officer, drawing on further specialist support as required.
NHS England will work with patient groups and the All Party Parliamentary Group on Medical Cannabis under Prescription to identify a sample of patients that have been seeking to access cannabis-based products for medicinal use through the National Health Service. Case reviews will involve interviews with relevant individuals who are involved in the decision to prescribe cannabis-based products for medicinal use, including patients, carers and relevant trust staff.
Asked by: Mike Penning (Conservative - Hemel Hempstead)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, who he will be engaging with in the process evaluation on prescribing cannabis-based products for medical use.
Answered by Seema Kennedy
NHS England has been asked to provide an interim report to the Secretary of State for Health and Social Care by the end of May 2019. The review will be clinically led by the NHS England and NHS Improvement Medical Director and Chief Pharmaceutical Officer, drawing on further specialist support as required.
NHS England will work with patient groups and the All Party Parliamentary Group on Medical Cannabis under Prescription to identify a sample of patients that have been seeking to access cannabis-based products for medicinal use through the National Health Service. Case reviews will involve interviews with relevant individuals who are involved in the decision to prescribe cannabis-based products for medicinal use, including patients, carers and relevant trust staff.
Asked by: Alex Sobel (Labour (Co-op) - Leeds North West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the British Medical Journal's article, Assessment and management of cannabis use disorders in primary care, published on 1 April 2010, if his Department will make an assessment of the implications for his policies of the findings on cannabis use disorder referenced in that article.
Answered by Steve Brine
The change to the law to allow access to cannabis-based products for medicinal use does not change existing rules and policies on recreational use and misuse of cannabis. The Government has no plans to legalise cannabis and the penalties for unauthorised supply and possession remain unchanged.
Access to medicinal cannabis is strictly controlled. It must be prescribed by, or under the direction of, a specialist doctor on the Specialist Register of the General Medical Council. The specialist must consider all licensed medicines before prescribing any unlicensed cannabis-based medicine and such a prescription must be in the patient’s best interest, taking into consideration the evidence of benefit and potential for harm to that particular patient.
Asked by: Norman Lamb (Liberal Democrat - North Norfolk)
Question to the Home Office:
To ask the Secretary of State for the Home Department, if he will publish the advice used to inform his Department on the requirements that (a) the decision to prescribe medicinal cannabis products must be made by a specialist doctor and (b) medicinal cannabis products may only be prescribed when the patient has an unmet special clinical need that cannot be met by other treatments.
Answered by Nick Hurd
The prescription of these products by doctors on the Specialist Register of the General Medical Council (GMC) and only where there is an unmet clinical need follows the principles used by the Interim Expert Panel on cannabis-based products for medicinal use. This approach was agreed by senior clinicians on the Expert Panel, Chaired by Dr Michael McBride, Chief Medical Officer for Northern Ireland. This approach was subsequently supported by the Advisory Council on the Misuse of Drugs (ACMD) in their advice to the Home Secretary on rescheduling cannabis. The ACMD advice has been published and is available at the following link:
Any unlicensed medicines, including cannabis-based products for medicinal use, will be supplied under long-standing arrangements for the supply of what are known, in healthcare settings, as ‘specials’. This process is underpinned by the Human Medicines Act and, outside of clinical trials, only allows these unlicensed medicines to be prescribed where there is an unmet clinical need. This restriction is in place because unlicensed medicines have not been through the same quality, safety and efficacy tests as licenced medicines.
Asked by: Vicky Foxcroft (Labour - Lewisham, Deptford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether all patients with health conditions previously determined by the Medicines and Healthcare products Regulatory Agency to benefit from the use of cannabis will automatically qualify for prescriptions for medicinal cannabis.
Answered by Steve Brine
Subject to Parliamentary approval, from 1 November doctors on the General Medical Council’s specialist register can make the decision to prescribe cannabis-based products for medicinal use where deemed clinically appropriate and in the best interests of patients. Prescribers will need to follow local governance procedures for prescribing unlicensed medicines.
The regulations do not limit the types of conditions that can be considered for treatment and will only be able to be supplied under the prescription or direction of a specialist doctor.