David Cullinane (Waterford, Sinn Fein)
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2264. To ask the Minister for Health the status of the medication PCBD-110; if it will be approved for addition to the medical cannabis access programme or otherwise approved for prescription and reimbursement; and if he will make a statement on the matter. [20341/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Prospective suppliers of products to the Medical Cannabis Access Programme (MCAP) can apply to the Health Products Regulatory Authority (HPRA), acting on behalf of the Minister for Health, to have a cannabis product considered for inclusion in the schedule to the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019.

Applicants must provide evidence to demonstrate that the proposed cannabis product meets the requirements of a ‘specified controlled drug’ as defined in the MCAP legislation. The onus is on prospective suppliers to submit applications to the HPRA.

Reimbursement is a matter for the Primary Care Reimbursement Centre (PCRS) in the HSE.

David Cullinane (Waterford, Sinn Fein)
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2265. To ask the Minister for Health if, in view of Brexit, any products currently listed as to be available via the medical cannabis access programme will be available in June 2021; if he will bring forward amendments to the legislation which underpins the programme or has consulted the Minister for Justice to permit the addition of products which have not been produced and prescribed in another EU state to the programme; and if he will make a statement on the matter. [20342/21]

David Cullinane (Waterford, Sinn Fein)
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2266. To ask the Minister for Health if he is considering amendments to legislation relating to the medical cannabis access programme or has consulted the Minister for Justice on such matters; and if he will make a statement on the matter. [20343/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 2265 and 2266 together.

Products are submitted to the Health Products Regulatory Authority (HPRA) for assessment under the Misuse of Drugs (Prescription and control of supply of cannabis for medical use) Regulations 2019 for inclusion in the MCAP. The operationalisation of the programme is the responsibility of the HSE and it is expected to commence in June.

Amendments to the legislation underpinning the MCAP are a matter for the Minister for Health only. Departmental officials have been made aware by HPRA of applications by producers of cannabis-based products which currently do not meet the requirements as set out in the legislation and is the subject of ongoing discussions.

David Cullinane (Waterford, Sinn Fein)
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2267. To ask the Minister for Health if he is considering adding any pure cannabidiol product with trace tetrahydrocannabinol content to the medical cannabis access programme considering that no products on the programme currently are suitable for treating epilepsy; and if he will make a statement on the matter. [20344/21]

David Cullinane (Waterford, Sinn Fein)
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2268. To ask the Minister for Health if there are barriers to adding pure cannabidiol products to the medical cannabis access programme; and if he will make a statement on the matter. [20345/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 2267 and 2268 together.

The objective of the Medical Cannabis Access Programme (MCAP) is to allow access to products containing a substance controlled under the Misuse of Drugs framework.

Pure CBD (containing no THC, a controlled substance) does not fall within the framework, and is therefore not eligible for inclusion in the MCAP.