Mr. Jim Breslin:

I will start with the Deputy's final question. We touched on the recognition of qualifications earlier, but there is a risk of divergence. We have different scenarios. We have a regulator-to-regulator arrangement that will be in place in the context of no deal, which is based on the fact that we know the standards are currently equivalent. The most ideal scenario is an agreement to avoid no deal. The next most ideal is that, in the future relationship between the UK and EU, something is concluded on recognising qualifications between the EU and UK. That would be great. We would then be fairly close to where we started. In the event that the UK and Ireland have a bilateral arrangement, it will not be a bilateral arrangement so much as the two regulators understanding the qualifications in both jurisdictions and recognising them because they are equivalent. If UK standards were no longer equivalent, it would be an issue for both regulators. That will not happen by accident. The UK would have to decide that it wants its professionals to be different from those of the EU. That would be a big decision to be made in the UK. Our regulator would have to make the implications of such a move very clear and plan for it were it to happen. That is the same for the whole EU rule book. It is not just about professional qualifications. If the UK diverges from the EU in any element of standards, it will have implications for trade, movement and so on. It is a big policy question for people in Westminster who have a lot on their minds at the moment. If they got that freedom, how would they use it?

Moving on to the other areas, Dr. Nolan will certainly be able to talk on dual-labelling and marketing authorisation holders, MAHs. She may also be able to talk on the TPN. On shortages, it would helpful if the HPRA representatives talked about the medicines shortage framework. From the contact the HPRA and the HSE are having with wholesalers, we know that they are looking at ordering to ensure that there are no artificial reasons for products being taken down. They will continue to do that up to and beyond Brexit.