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Publication

Medical Cannabis Access Programme

Published: 15 November 2018
From: Department of Health

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:

  • Spasticity associated with multiple sclerosis
  • Intractable nausea and vomiting associated with chemotherapy
  • Severe, refractory (treatment-resistant) epilepsy.

Background

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.

Clinical Guidance on Cannabis for Medical Use

Download

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.

Legislation

The underpinning secondary legislation for the Programme includes:

  • The Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 set out the legal provisions for the operation of the Medical Cannabis Access Programme and the legal obligations for healthcare professionals and commercial operators
  • The Misuse of Drugs (Designation) (Amendment) Order 2019 amends S.I. No. 533 of 2017, Misuse of Drugs (Designation) Order 2017 by removing from the scope of the Order certain cannabis-based products that will be permitted for use under the Medical Cannabis Access Programme
  • The Misuse of Drugs (Amendment) Regulations 2019 amends S.I. No. 173 of 2017 – Misuse of Drugs Regulations 2017 to reschedule certain acceptable cannabis-based products for medical use under the Medical Cannabis Access Programme from Schedule 1 to Schedule 2.

Accepted Specified Controlled Drugs (cannabis-based products)

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.

Reimbursement

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:

  • Treatment is consultant-initiated
  • Online reimbursement approval is required for each patient
  • All standard approved treatments have been exhausted for that patient
  • New patients are initiated on Irish pharmacy-supplied products
  • Enrolment on the Medical Cannabis Access Programme does not automatically mean approval for reimbursement of cannabis-based products.

Guidance for Suppliers / Importers

Guidance for Suppliers / Importers of cannabis-based products

  • Cannabis products that can be used in the Medical Cannabis Access Programme are defined as ‘specified controlled drugs’ in legislation and the definition outlines the specific requirements for those products.
  • Only products included in the schedule of specified controlled drugs can be prescribed by medical consultants under the Medical Cannabis Access Programme.
  • The criteria cannabis products must meet in order to be considered by the Minister for inclusion on the schedule are set out in the legislation and can be found in the operator guidance issued by the HPRA
  • Each cannabis-based product for medical use must be accompanied by a specific patient information leaflet, as referenced in the HPRA's Operator Guidance (see above). It is essential that all suppliers of cannabis-based products ensure that every patient receives this leaflet with their prescribed product. Please click here to view and download the Patient Information Leaflet.

Print Version available here.

  • Details on how to apply for a licence to possess, supply or import medical cannabis products for use under the Medical Cannabis Access Programme in accordance with the requirements for schedule 2 products in the Misuse of Drugs Regulations 2017 can be found in the operator guidance issued by the HPRA

For further information operators should contact the HPRA at controlleddrugs@hpra.ie

Additional Information

Cannabis for Medicial Use FAQ

Download

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