Dr. Lorraine Nolan:

One of the reasons we suggested primary legislation is that the misuse of drugs legislation, on which I am focusing, currently treats cannabis as a Schedule 1 drug. It is usually the case that if a substance or drug is to be used medically, it is rescheduled into Schedule 2. This has been the case, for example, for Salivex, which is an authorised cannabis based medicine. In the case of Salivex, the confidence in terms of rescheduling it was largely generated by the fact that it was authorised as a medicine. On the basis of this authorisation, which means it met the full data requirements in terms of quality, safety and efficacy, it was moved into Schedule 2. There was full confidence in allowing all prescribers to prescribe the drug in line with the conditions that it set out for treating it.

The issue here is that we are not proposing a rescheduling of cannabis from Schedule 1 to Schedule 2 because we have not reached the point, except in the case of the three products Dr. Breslin mentioned, where they meet the requirements for authorisation of a medicine. That type of rescheduling is not appropriate in this case. The reason we suggested primary legislation would be necessary is that one needs to enable some form of prescribing provision for this because the access system currently operates under a licence granted by the Minister. This places the Minister very much at the heart of the clinical decision making process, which is not appropriate in the context of an access programme that we decide. Clinicians need to be allowed to use their clinical judgment. This limited provision allowing a Schedule 1 drug to be prescribed fundamentally changes the construct of the misuse of drugs legislation. For this reason, we consider that primary legislation would be required. Having said that, our role is not to develop legislation as the Department of Health has the expertise in this area.