Ms Vicky McGrath:

I will go back to the Senator's first question and then move on to the cross-Border directive. In terms of the BeNeLuxA initiative, it is five months in. We need to give them a little time to do some work but it comes down to transparency. Have they made any progress? What have they done? None of us seems to know. The initiative has been signed. That is great. We had all the fanfare but we do not know whether anything has happened in the intervening period. I would not throw it out as being a case of wanting to go with a larger country. We need to let it bed down.

That rolls very well into the cross-Border directive and what we refer to as the European reference networks. The Commission has decreed that Europe needs to work as one when it comes to rare diseases. There is no longer an Irish rare disease healthcare system; it is a European rare disease healthcare system. In so doing, I would expect the likes of BeNeLuxA to work with the German and the French authorities. They will start to work together and then to do reimbursement for drugs across Europe. The chances are that some of these therapies will be made available, as in administered, in only one or two countries because the diseases are so rare. There are so few patients they will end up having to travel, and that is how we will get access to it. We will get access to it because Ireland is signed up to these reference networks. We are still in the very early stages. There are 24 networks. Some countries have representations in all 24. Currently, we have representations in two, but we understand at least 21 applications are due to be submitted by the next deadline. The deadline has not been set, so it is not that we are behind the ball in that regard. By the middle of next year, we expect to have the applications in and, hopefully, they will be processed by the end of the year to ensure Ireland is well represented in the European realm in terms of these reference networks. They will provide many solutions. The will provide some of the infrastructure we want around the registries and ensuring we have the best care pathways. It is a major burden to put on the European reference networks, but the pharmaceutical sector is calling for it.

The challenge we face is that the pharmaceutical industry will stop coming to Ireland seeking to get drugs reimbursed because our population is too small. If the industry is dealing with Europe, there is some hope that it will end up coming across. It will be a challenge for our health system to equate to Germany's, but we have to address that in the years ahead. There are positives, but in the intervening period, we need to readdress the existing system and make sure that we do not fall behind. We must also consider the other drugs and diseases that are not termed "rare".