Mr. Muiris O'Connor:

I can come in on the Deputy's question about the risk of illegal access. Those risks are very carefully managed and controlled within the programme. Mr. Flanagan and Dr. Nolan spoke about the specificity about who receives the cannabis-based products and the clear clinical need identified by a medial professional that is required. The doctor-patient relationship is at the heart of the management of the treatment.

Benefit-risk analyses feed into the Health Products Regulatory Authority, HPRA, assessment of drugs. Such an analysis did inform the restriction of availability and a number of conditions at an earlier point. I will ask Dr. Nolan to speak a little more to be benefit-risk analysis and how that works.