Dáil Éireann Debate, Thursday - 18 January 2024
24. Deputy Gino Kenny asked the Minister for Health if he will consider expanding the Medicinal Cannabis Access Programme to include other conditions outside of the current terms of reference of the programme; and if he will make a statement on the matter. [1651/24]
View answerIn it’s 2017 publication “Cannabis for Medical Use – A Scientific Review” the Health Products Regulatory Authority found that at that time
• There was an absence of scientific data demonstrating the effectiveness (efficacy) of cannabis products. The safety of cannabis as a medical treatment is not well characterised.
• There was insufficient information on its safety during long term use for the treatment of chronic medical conditions, such as those for which there is a public interest.
• Most cannabis products available under international access schemes did not meet pharmaceutical quality requirements and were not capable of being authorised as medicinal products (medicines).
• There was 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.
• The HPRA advised that if the policy decision was to make cannabis available for medical purposes, 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;
• Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision;
• Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision;
• Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision.
It was also recommended that the MCAP be a 5 year pilot project subject to review.
After the necessary legislation was put in place and products sources for the programme the MCAP commenced in 2021. Given the time elapsed since the initial publication the decision was taken to commence an evidence review before the 5 years pilot period had been completed.
The current review consists of an evidence gathering, evidence synthesis and finally a clinical review to determine if evidence exists to expand the scope of the programme. In the circumstances it is appropriate to wait for the findings of the clinical review group before any decisions are taken whether or not to expand the conditions covered by the programme.
