Dr. Lorraine Nolan:

I may be answering this in the wrong context, so Senator Conway should stop me if I am going off the point to answer his question. What we were saying in the opening statement is that it was the lack of evidence to support a demonstration of whether these products had an efficacy, meaning they would work, or they were safe. For us, that evidence is generated through a very long development programme for any medicine, and it can take a number of years for that to happen. That has been very well illustrated by the pandemic and much of the information that was in the public domain as to what contributes to the authorisation of vaccines. We all heard about the coverage of the pivotal clinical trials. One can see through that process that there is a comprehensive building of evidence which demonstrates the safety and efficacy. That is done through clinical trials but also in terms of characterisation of the manufacturing processes, so they can stand over the quality of these products. In the context of what is in the MCAP, the evidential base for those is not there. The contrast to that would be the other two authorised cannabis medicines which are Epidiolex and Sativex. They come onto the marketplace with that evidence wealth behind them and a confidence in the fact that the benefit-risk evaluation has been carried out, but by the company that has been independently reviewed by regulatory experts, and they have received a marketing authorisation. That, in total, is the type of scientific basis or scientific evidence we were addressing.

I hope that answers the Senator's question.