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Publication

Medical Cannabis Access Programme

Published: 15 November 2018
From: Department of Health

On 26th June 2019, the Minister for Health 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 and with the clinical guidance for the scheme.

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 considered for suitability for medical use under the scheme.

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 (subject to import / export licensing requirements). Cannabis products will only be listed in Schedule 1 of the Regulations once they have been considered as suitable for use under the Medical Cannabis Access Programme.

The Medical Cannabis 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

The Medical Cannabis Access Programme is not required or intended for authorised medicinal products but rather is to facilitate access to cannabis-based products that are not authorised as medicines but are of a standardised quality and meet an acceptable level of quality assurance during their manufacturing process.

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Once the Medical Cannabis Access Programme commences the HSE will establish and maintain a Register 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.

Please note: The MCAP register is not currently operational. Patients and Healthcare Professionals are advised to consult this page for updates which will be published when available.

Legislation

The underpinning secondary legislation for the Programme includes:

  • The Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2019, update to Schedule 1.
  • 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)

The following specified controlled drug products (cannabis-based products) have been accepted as being suitable for use under the Medical Cannabis Access Programme:

Based on the information provided by 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: SI 649 - 3 Medicinal Cannabis Access Programme Products.

For further educational information on accepted specified controlled drugs, healthcare professionals should contact the relevant manufacturer at the following contact email:

    Name of Manufacturer Contact Email
    Aurora Cannabis Enterprises Inc., 4439 Township Road 304, Cremona, Alberta, Canada, T0M 0R0 clientcare@auroramj.com
    MGC Pharmaceuticals d.o.o., Kamniška ulica 29, 1000, Ljubljana, Slovenia ashok@ipslabs.co.uk
    Tilray Canada Ltd., 1100 Maughan Road, Nanaimo, BC, V9X 1J2, Canada EUdocumentrequest@tilray.com

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 Medical Use FAQ

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