Ms Emily O'Reilly:

Yes. We continue to monitor the EMA. The investigation we concluded in 2019 concerned the way in which it held pre-planning meetings, with which we in Ireland are all familiar, that can be held between developers and local authorities on possible developments they want to do. Equally, the EMA had pre-regulatory decision meetings with pharmaceutical companies, which would say they were thinking of looking for authorisation on certain things. They asked what the EMA thought and there would be a discussion. There were, therefore, concerns around that so we looked at it. Basically, we made recommendations to the EMA, which it accepted. This meant the people who were involved with the pre-authorisation meetings were not really the ones ultimately making decisions on that.

We knew at the beginning that the EMA was going to be the focus of much attention because of the power it has. The member states, of course, form the board of the EMA and are the ones that ultimately decide or agree on any recommendation it makes regarding the authorisation of vaccines. We were, therefore, looking very carefully at its transparency in that regard. There is still much anti-vaccination opinion. It is not even people who are anti-vaccination ideologically but those who are genuinely nervous about vaccines. We knew, therefore, that everything the EMA did had to be really open and transparent. So far, we have been happy with the response. It has spoken about fast-tracking certain procedures into the future. Sometimes when people hear the term "fast-track", they think about skimping on important bits of the process. I am sure that is not what the EMA is thinking of. It is an agency which, from my experience, takes its responsibilities incredibly seriously. Nonetheless, we will be keeping an eye on that to see its intent and how things are panning out.