544. Deputy Violet-Anne Wynne asked the Minister for Health further to Parliamentary Question No. 579 of 31 January 2023, if he is satisfied that only 49 patients to date proves the success of the MCAP scheme; and if he will make a statement on the matter. [50914/23]

Stephen Donnelly, Minister for Health: The HPRA, in its report “Cannabis for medical use- a scientific review” stated that if cannabis products that are not capable of being authorised as medicines, are made available through an access programme, patients and healthcare professionals must recognise the limitations of the programme in assuring the safety, quality and effectiveness, as compared with what would be expected for an authorised medicine.

The HPRA also advised that cannabis 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. This means that any patient availing of MCAP treatment are those who have failed to respond to all other previous treatments.

The recommendation was the MCAP should be for the treatment of three stated conditions:

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.

Since the initial report a cannabis-based medicine, Epidyolex has been granted a market authorisation for the treatment of certain epilepsies, antiemetics including cannabis based medicines containing dronabinol nabilone have become more prevalent. Unlike the products offered on the MCAP these are all authorised medicines, which have become available after the recommendation of the MCAP.

I am satisfied that Irish patients have authorised medicines that can be accessed for the treatment of their conditions and there is an option for these patients should those conventional treatments fail to access unauthorised products should their clinician deem it appropriate.

An evidence based synthesis and clinical review of the MCAP has been being carried out by the Health Research Board for the Department of Health. A clinical review group will complete an assessment to see if there is evidence to support the recommendation of the addition of any other clinical indications to the MCAP programme.