Dr. Lorraine Nolan:

I will start, if I may, and then perhaps Dr. Elaine Breslin will come in at the end in response to the question about clinical trials. A couple of points have been made and I wish to pick up on the point raised by Deputy O'Brien on the legalisation of cannabis. I believe we need to ensure this a health-led debate about the medicinal use of cannabis from a medical viewpoint and a treatment viewpoint. The recreational use of cannabis is not part of this.

As I understand it, recreational use might be examined by the national drugs strategy next year as well.

I refer to the point Deputy Gino Kenny made on the cannabis Bill. Some provisions in the Bill would remove cannabis and the THC cannabinoids from the misuse of drugs framework, which would have the effect of legalising them from that point of view. The proposals in the Bill are not fitting for something that is really a legislative proposal for medicinal use. I should make that point.

I am heartened by the point Deputy Durkan raised about patient safety, which was echoed by Deputy O'Connell. Our role is to protect patient safety. That is the reason for our existence. That is the reason we are taking an approach that is robust and involves sufficient expert consultation to ensure that if we make a decision to introduce this, based on evidence of patient benefit, it is done safely. We must remember the way this would be used. It is a supportive treatment so if we make that decision, and we cannot pre-empt the outcome of the review, many patients would remain on their conventional therapy, so even the safety issue becomes complex. We must consider how this material, containing in excess of 100 active components, may interact with other medications as well. Those are the types of issues involved, so it is important we give this time and carry out a thorough review.

Deputy Jonathan O'Brien asked what format our advice to the Minister would take. We intend to do this in a robust way. Certainly, there will be a report on the outcome of the findings of the working group, which we will present to the Minister as well.