Hildegarde Naughton (Galway West, Fine Gael) | Oireachtas source

I thank the Deputy for raising this matter, which I am taking on behalf of the Minister, Deputy Stephen Donnelly. MCAP is operated by the primary care reimbursement service of the HSE and is a statutory programme to enable clinicians and patients to access prescribed cannabis-based products for the treatment of three specific conditions, as specified in the HPRA's 2017 report, Cannabis for Medical Use - A Scientific Review, which was commissioned by the Minister for Health. The three conditions are spasticity associated with multiple sclerosis resistant to all standard therapies and interventions while under expert medical supervision, intractable nausea and vomiting associated with chemotherapy despite the use of standard antiemetic regimes while under expert medical supervision, and severe refractory treatment-resistant epilepsy that has failed to respond to standard anticonvulsant medications while under expert medical supervision.

The prescribed cannabis-based products are not authorised medicines that have gone through the normal processes for medicines to get a marketing authorisation, hence the requirement for the programme to access the products. There are authorised cannabis-based medicines for the treatment of conditions such as epilepsy, multiple sclerosis and nausea. As such, these are not available for inclusion in the programme and can be prescribed like any other authorised medicine in the normal manner. The Misuse Of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019, SI 262/2019, set out the legal provisions for the operation of the medical cannabis access programme and the legal obligations for healthcare professionals and commercial operators. Schedule 1 of the regulations comprises the specified controlled drugs, specifications for which are defined in the regulations, which may be included in the programme for patient treatment. Manufacturers can apply to the HPRA to have their cannabis-based product assessed for inclusion in Schedule 1 as a product that meets the requirements for a specified controlled drug, as set out in the regulations. Any addition to the Schedule 1 products is done by way of ministerial approval, by statutory instrument. Ten cannabis-based products have been added to the regulations for prescribing by consultants for their patients.

The MCAP commenced in late 2021. To date, 49 patients have been treated under the programme. Some 34 patients have been treated for reason 1, which is spasticity associated with multiple sclerosis resistant to all standard therapies and interventions. Three patients are for reason 2, which is intractable nausea and vomiting associated with chemotherapy despite the use of standard antiemetic regimes. Twelve patients are for reason 3, which is severe refractory epilepsy that has failed to respond to standard anticonvulsant medications.

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