Neale Richmond (Dublin Rathdown, Fine Gael)
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2392. To ask the Minister for Health the steps that have been taken towards permitting the use of medicinal marijuana; and if he will make a statement on the matter. [37696/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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There are two separate pathways for accessing cannabis for medical use in Ireland.

Medical Cannabis Access Programme (MCAP)

The provision of the Medical Cannabis Access Programme (MCAP) 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).

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 the 19th July, the Minister for Health announced that the 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.

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

Pending full operation of the MCAP and for medical indications not included in the MCAP, doctors may continue to utilise the Ministerial licensing route to prescribe medical cannabis for their patients, should they wish to do so.

In line with the Chief Medical Officer's advice, the granting of a licence for cannabis for medical purposes must be premised on an appropriate application being submitted to the Department of Health, which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.

Since the first licence issued in December 2016, 178 licences have been approved for the treatment of 64 individual patients.

It is important to note that 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.