603. Deputy Neasa Hourigan asked the Minister for Health if he will provide a timeline for when the clinical review group will complete its work to determine if evidence exists to expand the scope of the medical cannabis access programme; and if he will make a statement on the matter. [6555/24]

Stephen Donnelly, Minister for Health: The HPRA, in their 2017 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. There appears to be a significant gap between the public perception of effectiveness and safety, and the regulatory requirement for scientific data which is mandatory to determine the role of cannabis as a medicine. Any proposal to circumvent the medicines regulatory system, established by law, would require careful consideration, so as to avoid unintended consequences, and lower standards of patient protection.

At that time it was recommended that an Access Programme be for the treatment of three stated conditions:

1. Refractory Epilepsy;
2. Spasticity as a result of Multiple Sclerosis; and
3. Nausea as a result of chemotherapy.

The MCAP was intended to be run on a 5 year pilot basis, subject to review. Given the passage of time since the initial recommendation the review was brought forward to ascertain if currently there is sufficient evidence to expand the scope of the programme.

It is anticipated that the work of the clinical review group will be completed in the second quarter of 2024.