Dr. Kevin Kelleher:

We spent a significant amount of time discussing what information would be provided. It was based on what we had been doing historically in all our vaccine programmes but also, more particularly, because of the nature of this programme, on the extensive consultation that we carried out in 2010.

We have engaged in further extensive consultation since. We have repeatedly spoken to people in this and other countries about what would be an appropriate way to go about it. That is why we are where we are. We have repeatedly thought about whether the patient information leaflet, PIL, should be given out. The reason we do not give it out is the complexity of the document compared to what people require. We have made every effort in our documentation to cover what is included in the document but in much simpler language. We heard somebody try to describe what was in the PIL and how complex it was. We have put great effort into trying to ensure the document covers exactly what is in the PIL but in a much simpler way to ensure people understand the problems and it gets out. We will continue to do so. While we will reconsider what happens as a consequence of today’s discussion, we must take account of all aspects of it to ensure it is understandable. A very important issue is that the language used in most PILs on most drugs is not easily understandable. Every one of them is very difficult to read, even for medical practitioners, let alone the public.