It is open to a registered medical practitioner to apply for a Ministerial Licence under the Misuse of Drugs Acts 1977 to 2016. Such a licence, if granted, enables the licensee (the medical practitioner) to legally prescribe the Schedule 1 controlled drug - cannabis, containing tetrahydrocannabinol (THC) - for a named patient. Licences have been granted in respect of twenty individual patients.
Cannabidiol (CBD) is derived from cannabis. However, since it does not have psychoactive properties it is not controlled under the Misuse of Drugs Acts, and a Ministerial Licence is not required. CBD oil is sometimes marketed as a nutritional or dietary supplement, however it should be noted that it is not authorised as a medicinal product in Ireland.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
I wish to advise the Deputy that no reimbursement programme currently exists for the reimbursement of medicinal cannabis oil products. However, patients who have a valid medical prescription for medical cannabis and a Ministerial licence and who have sourced a cannabis-based product may submit an application to the HSE for reimbursement approval.
If approval is given, the PCRS, when authorised to proceed, will make the necessary arrangements to cover the costs involved for the patient.
Three patients have a Ministerial licence and have been approved by the HSE for their product and travel costs to the Netherlands.
I have asked the HSE to advise their policy for reimbursement of CBD products and will advise the Deputy as soon as this information is received. The number of families using CBD oil is not known.
Until suitable medical cannabis products are made available in Ireland, prescribers and their patients are sourcing the prescribed product from a pharmacy in The Netherlands, on foot of their medical prescription. Due to current Netherlands government policy, Bedrocan products, sold as cannabis oil formulations, are not currently permitted to be commercially exported from the Netherlands, but are only supplied in the Netherlands on foot of a valid medical prescription when presented to the appropriate pharmacy.
A second pathway for access to medical cannabis is being established, through the Medical Cannabis Access Programme (MCAP). Good progress is being made in establishing the Access Programme but it is not yet in operation. The Programme aims to facilitate access to certain ‘acceptable’ cannabis products which have not been authorised as medicines by a statutory Medicines Competent Authority. Availability of cannabis products that are of an appropriate quality standard and are affordable to patients is critical in establishing the access programme.
Department officials are working intensively on finding solutions to the supply of appropriate products for Irish patients.
Medical practitioners, patients and interested parties are encouraged to consult the Department of Health website which contains information on medical cannabis, including clinical guidance on the use of medical cannabis and details on how a medical practitioner may apply for a Ministerial licence for medical cannabis.