David Cullinane (Waterford, Sinn Fein)
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925. To ask the Minister for Health his plans regarding expanding the medicinal cannabis access programme; his plans for operationalising the programme and regarding delivery of medicinal products; the way in which he envisages the programme functioning; and if he will make a statement on the matter. [8798/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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In the Health Products Regulatory Authority (HPRA) report “Cannabis for Medical Use – A Scientific Review”, the HPRA advised that if access to cannabis is to be permitted for medical purposes that it should only be made available for the treatment of patients with specified medical conditions which have failed to respond to all other previous treatments, and where there is at least modest evidence that cannabis may be effective.

The specified medical conditions (medical indications) are:

1. Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision;

2. Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision;

3. Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision.

The HPRA did not consider that the available evidence supported the use of cannabis in other medical conditions.

The MCAP has been included in the HSE Service Plan 2021 and is a five year pilot programme for the treatment of the three specified conditions.

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.

Pharmacists will be able to dispense cannabis-based products for medical use to patients as set out in the legislation, on foot of a valid prescription, once suppliers make the specified controlled drugs available on the Irish market.

David Cullinane (Waterford, Sinn Fein)
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926. To ask the Minister for Health the number of exemptions for cannabis products given under the ministerial licence; the products which have been made available by licence; his plans to harmonise this with the medicinal cannabis access programme; and if he will make a statement on the matter. [8799/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Ministerial licence pursuant to Section 14 of the Misuse of Drugs Acts permits the licenced clinician to, inter alia, prescribe cannabis-based products for their patients. To date 141 licences have been issued for the treatment of 55 different patients

The medical decision to prescribe or not prescribe any treatment, including cannabis treatment, for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process. The decision on which products to prescribe and the sourcing of those products rests solely with the licenced clinician.

The two separate pathways for accessing cannabis for medical use in Ireland are:

- The Medical Cannabis Access Programme (MCAP)

- Ministerial Licence under Section 14 of the Misuse of Drugs Acts 1977-2016

Both the MCAP and Ministerial Licence are separate routes to access Medical Cannabis, and should not be confused with each other.

Further details on both routes are available on the Department's website.

David Cullinane (Waterford, Sinn Fein)
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927. To ask the Minister for Health the status of the work underway to review and revise difficulties with the medicinal cannabis access programme; and if he will make a statement on the matter. [8800/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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In the Health Products Regulatory Authority (HPRA) report “Cannabis for Medical Use – A Scientific Review”, the HPRA advised that if access to cannabis is to be permitted for medical purposes that it should only be made available for the treatment of patients with specified medical conditions which have failed to respond to all other previous treatments, and where there is at least modest evidence that cannabis may be effective.

The specified medical conditions (medical indications) are:

1. Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision;

2. Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision;

3. Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision.

The HPRA did not consider that the available evidence supported the use of cannabis in other medical conditions.

The MCAP has been included in the HSE National Service Plan 2021.

The HSE will be responsible for the operation of the programme. 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.