Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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346. To ask the Minister for Health the details of the medical cannabis access programme that he has recently signed into operation on a pilot basis for a period of five years; if the programme will be rolled out nationwide; the access procedure once availability is in place; when supply arrangements will be operable; and if he will make a statement on the matter. [49819/19]

Simon Harris (Wicklow, Fine Gael)
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As the Deputy is aware, legislation was signed in June which will allow for the operation of the Medical Cannabis Access Programme (MCAP) on a pilot basis for five years.

Commercial medical cannabis suppliers whose cannabis products meet the specified requirements set out in the legislation, and which have been listed in Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations, will be able to supply these products into Ireland.

Cannabis products will only be listed in the Schedule once they have been accepted as being suitable for medical use by patients under the Medical Cannabis Access Programme.

The Health Products Regulatory Authority has considered the information provided by applicants to supply cannabis-based products under the MCAP and products from two companies, Aurora Cannabis Enterprises Inc., and MGC Pharmaceuticals, have been recommended as being suitable for use under the MCAP on the basis that they meet the criteria in parts (a) – (f) of the definition of a ‘specified controlled drug’ as set out in the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 and which are in line with the clinical guidance for the scheme.

The two products are Aurora High CBD Oil Drops and CannEpil.

On 22 November, amending legislation was signed by the Minister for Health to reflect the addition of these products to Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019.

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These products are subject to international controlled drug export licensing requirements. Such requirements are outside the Department's control and therefore products may not become available in Ireland for a further period.