The Minister for Health has signed legislation to allow for the operation of the Medical Cannabis Access Programme on a pilot basis for five years.
The Programme will facilitate access to cannabis-based products for medical use in line with legislation.
The signing of the legislation underpinning the Access Programme allows for commencement of the operation of the Access Programme, the first stage of which is for potential suppliers to apply to have their medical cannabis products assessed for suitability for medical use. Currently no medical cannabis products are available in Ireland, however, this legislation now means that commercial operators whose cannabis products meet the specified requirements set out in the legislation will be able to supply these products to the Irish market. Cannabis products will only be listed in Schedule 1 of the Misuse of Drugs Prescription and Control of Supply of Cannabis for Medical Use once they have been assessed as suitable for medical use under the Medical Cannabis Access Programme.
Once suitable medical cannabis products are made available, the Access Programme will make it possible for a medical consultant to prescribe a cannabis-based treatment for a patient under his or her care for the following medical conditions, where the patient has failed to respond to standard treatments:
Work on the establishment of Programme began in March 2017, on foot of the conclusions from the Health Products Regulatory Authority’s (HPRA) expert report Cannabis for Medical Use – A Scientific Review , which was prepared at the request of the Minister for Health. Following publication of the report, Minister Harris established an Expert Reference Group to advise on the development of a Medical Cannabis Access Programme.
The Group developed clinical guidelines for the Programme, which are available below.
The HSE will establish and maintain a Register for the Medical Cannabis Access Programme to facilitate the enrolment and recording of certain data including patient identifiers (in anonymised format), prescribers enrolled in the Programme, as well as prescribed / supplied medical cannabis products.
The underpinning secondary legislation for the Programme includes:
Accepted Specified Controlled Drugs (cannabis-based products) for use under MCAP
The following specified controlled drug products have been accepted as being suitable for use under the Medical Cannabis Access Programme:
Based on the information provided by the applicants, the products listed in the table above are considered by the Health Products Regulatory Authority (HPRA) to meet the criteria in parts (a) – (f) of the definition of a ‘specified controlled drug’ set out in the Misuse of Drugs (Prescription and control of supply of cannabis for medical use) Regulations 2019 and, accordingly, can be considered for inclusion in Schedule 1 to those Regulations.
The Minister for Health has accepted the HPRA’s advice and as these products are in line with the clinical guidance for the scheme, they have now been added to Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019, which can be found at the following link, http://www.irishstatutebook.ie/eli/2019/si/583/made/en/pdf
As these products will be subject to international export licensing requirements, which are outside the control of the Department of Health, they are not expected to be available in Ireland for a further period.
The HSE will meet the cost of cannabis products listed in Schedule 1 of the Misuse of Drugs Prescription and Control of Supply of Cannabis for Medical Use, under the Medical Cannabis Access Programme and supplied through community pharmacies for patients with a qualifying medical condition, in line with the existing support schemes for medicines dispensed through community pharmacy, namely the Long-Term Illness Scheme, GMS (Medical Card) Scheme and the Drug Payment Scheme. Products will only be listed in Schedule 1 of the Misuse of Drugs Prescription and Control of Supply of Cannabis for Medical Use once they have been assessed as suitable for medical use under the Medical Cannabis Access Programme.
Authorisation will be on a named-patient arrangement and subject to the following conditions:
Guidance for Suppliers / Importers of cannabis-based products
For further information operators should contact the HPRA at firstname.lastname@example.org