Licences for Cannabis based products for medicinal use (CBPMs)
Introduction
Following a change in the scheduling of cannabis based medicinal products under the Misuse of Drugs Legislation, medicinal cannabis was allowed to be used in very limited circumstances. Public consultation findings asked for a cautious approach, with strict controls and medical oversight.
In Summer 2022, the Department of Health and Social Care granted licence to Karson’s Pharmacy for the importation and dispensing of cannabis based products for medicinal use (CBPM) for patients issued with prescriptions from CQC registered private prescribing clinics.
The service formally commenced on 1 December 2022 as a ‘pilot’ to ensure the safe, secure and controlled importation and supply of products. This approach recognised the benefit of having some licencing controls in place due to the fact CBPM had not previously been available under private prescription on the Island.
In its role as regulator, the Department has recently concluded a 12 month review of the terms and conditions in which the licence was originally issued. Taking into consideration matters relating to patient accessibility, affordability and safety the Department has now made a number of policy decisions which will affect service provision on the Isle of Man.
Proposed changes to the service
Licenses for importation and dispensing
- From 11 July 2024, the Department will accept applications from registered pharmacies (based on the Isle of Man) who wish to obtain a licence to import and dispense CBPM. Once a licence has been approved, the registered pharmacy will be able to establish a supply chain with UK wholesalers and dispense CBPM to individuals with private prescriptions
- This policy decision allows an unrestricted number of registered pharmacies to apply for a licence which is likely to see an expansion of service provision on the Island
Private prescribing clinics
- During the pilot, individuals have only been able to obtain prescriptions from CQC registered private prescribing clinics in England. The private prescriptions are issued by prescribers who are listed on the General Medical Council (GMC) specialist register
- Going forward, the Department has made a policy decision to allow the establishment of private prescribing clinics for CBPM on the Island. To operate a private prescribing clinic, providers will be required to register with the Department’s Registration and Inspection team as an independent medical agency
- It is anticipated that individuals based on the Isle of Man will be able to access an ‘end to end’ services that are closer to home and offer a more patient centric service
- This policy decision intends to support individuals have greater choice and be able to access local prescribing clinics or continue to seek support from off-Island prescribing clinics
Will the changes increase or reduce costs associated with obtaining CBPM
- CBPM is not available on the NHS which means prescriptions cannot be obtained from Manx Care prescribers. Individuals will therefore continue to be responsible for paying all costs and fees associated with obtaining private prescriptions
- Whilst the changes to the licensing regime may create opportunities through the introduction of commercial competition, the Department is not responsible for setting any cost(s) or fee(s) associated with CBPM
Guidance for prospective licence holders and private prescribing clinics
How to obtain a licence to import and dispense cannabis based products for medicinal use
You will need to contact the Department of Health and Social care via email: Enquiries.DHSC@gov.im
Who is able to obtain a licence
Licences will only be issued to the pharmacy superintendent of registered pharmacies in accordance with the Misuse of Drugs Act 1976.
Conditions to the licence
Licence holders will provide the Department with monthly reports detailing the amount of CBPM being imported to the Isle of Man (to satisfy reporting obligations under the UN Convention on Narcotic Substances 1988.
What the Regulatory oversight looks like
The Departments’ appointed person(s) will undertake six monthly inspections to ensure all licence holders are importing, storing and dispensing in accordance with the terms and condition of their licence and statutory requirements under the Misuse of Drugs Act 1976.
In accordance with the requirements of the Medicines Act 2003, licence holders will be required to report any untoward incidents concerning CBPM to the Department by contacting Enquiries.DHSC@gov.im
Will the licence enable bulk import and export of CBPM
No. The licence will simply allow the licence holder to import and dispense CBPM in accordance with an individual prescription. Licence holders will be responsible for providing monthly reports reconciling import quantities with individual prescriptions. Bulk import and or export of CBPM requires a wholesale dealer’s licence which can be obtained from the Gambling Supervision Commission.
Licence fee
The Department is currently developing legislation that will see the introduction of licence fees. However the Regulations will not become effective until December 2024 (at the earliest). The Department will issue an interim licence without charge which will expire at the end of November 2024.
Re-applying for a licence when the regulations become effective
You will need to re-apply for your licence and you will be required to make a payment for this licence. There will not be any retrospective charge, however failure to make payment for the new licence will bring to an end the ability to import CBPM.
More about licence fees
The fee proposal will be consistent with the costs of licencing across the British Isles and would be subject to annual inflationary uplifts. For business planning purposes the annual fee for importation of CBPM by a registered pharmacy for supply on an individual prescription should be considered to be £7,500 this will be subject to approval by Tynwald.
Prescribing clinics
Registering to become an Independent Medical Agency
You will need to contact the Department of Health and Social Care Registration and Inspection team (R&I) on +44 1624 642422 or RandI@gov.im
Who will be able to prescribe
The initial prescribing of CBPM will remain limited to those persons who are permitted on the GMC Specialist register and who prescribe on behalf of the provider registered with the DHSC as an independent medical agency or registered with the CQC.
Will IOM patients be required to use on Island prescribing clinics
No, the individual will have the choice to access services from off-Island prescribing clinics or on-Island prescribing clinics registered with the DHSC R&I team.
What the regulatory oversight looks like
Organisations seeking to establish private prescribing clinics on the Island will be subject to the Islands regulatory requirements as stipulated in the Regulation of Care Act 2013. Organisations will be required to register as an Independent Medical Agency and be subject to inspection (annual) in accordance with the applicable minimum standards and regulations.
More information
For pharmacies wishing to purchase a licence for importing and dispensing CBPM’s you can contact:
Email: dhsc@gov.im
Telephone: +44 1624 685816
For clinics wishing to offer patients CBPM prescriptions you can:
Email: RandI@gov.im
Telephone: +44 1624 642422
