Violet-Anne Wynne (Clare, Sinn Fein)
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1630. To ask the Minister for Health the status of the medical cannabis access programme; and if he will make a statement on the matter. [34522/21]

Thomas Gould (Cork North Central, Sinn Fein)
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1897. To ask the Minister for Health the status of the medical cannabis access programme. [35776/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1630 and 1897 together.

The provision of the Medical Cannabis Access Programme is as a result of recommendations by the Health Products Regulatory Authority in their “Cannabis for Medical User – A Scientific Review”.

The review stated that if the policy decision is to make cannabis available for medical purposes, the HPRA advised that it should recognise patient need, but be evidence based. It was advised, that treatment with cannabis be only permitted under a controlled access programme for the treatment of patients with the following medical conditions which have failed to respond to standard treatments;

- spasticity associated with multiple sclerosis;

- intractable nausea and vomiting associated with chemotherapy;

- severe, refractory (treatment-resistant) epilepsy.

Subsequently the Minister for Health established an Expert Reference Group to advise on the development of a Medical Cannabis Access Programme. This Group developed detailed Clinical Guidelines for the MCAP to be followed by clinicians, which contained inter alia guidance on ingredient combinations that are recommended for each of the three indications included in the MCAP.

The Medicinal Cannabis Access programme (MCAP) is a 5-year pilot programme. The purpose of the programme is to facilitate access to acceptable cannabis-based products for medical use that are of a standardised quality and which meet the requirements outlined in the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (as amended).

This is an important and positive step forward for those individuals who are suffering serious ill health but for whom conventional treatments are not working.

There are currently 4 products assessed by the HPRA for inclusion in Schedule 1 of the Regulations, more products are currently being assessed by the HPRA.

Reimbursement of the products, prescribed by approved medical consultants and supplied through community pharmacies for a specified therapeutic indication in line with Schedule 2 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (as amended) will be on an individual named patient basis aligned to the patient’s eligibility under the community drug schemes (Medical Card, Long Term Illness Scheme and Drugs Payment Scheme). It cannot be assumed that reimbursement approval will be forthcoming on submission of applications. A reimbursement decision will be communicated with the prescribing consultant in writing.

On 15^thJuly, I announced that the Medical Cannabis Access Programme (MCAP) was now open for medical consultants to make an application for themselves and their patients to be registered for the programme.

Registration by consultants and their patients on the Cannabis for Medical Use Register, to be operated by the HSE, is required for the prescribing of cannabis-based products under the MCAP.

It is hoped that over time as more acceptable products are made available on the MCAP.