Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)

An additional 34 staff were recruited in the HSE and they are dispersed across a range of relevant teams, including the negotiation and pre-clearance teams. There has been a 100% increase in the number of people working on this. What is important now is that they are working as efficiently as possible.

It is a two-way stream, however, as the Deputy knows. It is also necessary for the drug companies to produce their documentation in an efficient and complete way. As with all things, whether drug companies or financial services companies and the Central Bank, there will be variation. The best possible and most efficient system is one in which both sides are working in the most efficient way possible. I will be ascertaining the benefit of the 34 staff and whether there are more efficient processes possible on the HSE side, but I recognise that there is also the drug side.

We had a good meeting last week on some of the drugs. As the Deputy is well aware, once the EMA gives approval for a drug, it is then necessary for the drug company to make an application. One of the challenging tasks for me or any public representative is trying to answer the completely reasonable questions of parents who want a drug for their child that has been approved by the EMA but regarding which a drug company has not, or has not yet, made an application to Ireland. We went through a list of several drugs – we can do that again privately – for which, unfortunately, an application was not made in Ireland, an application was made and withdrawn, or licences were lost elsewhere. There are several disruptions and we just have be honest about some of that.

On the Duchenne muscular dystrophy drug the Deputy alluded to, from the State’s perspective and mine, we tried to do everything we could proactively. We proactively reached out to the drug company to encourage it to send its documents to us. I met the Italian Minister of Health on Friday in Luxembourg and asked him whether he could encourage the drug company to make an application, but ultimately the drug company needs to make an application. When a company applies regarding any of the various drugs, we need to be able to respond in the most efficient way possible.

We want to develop an early access programme but we are going to have to be careful about the intersection of three different things. To step one tiny degree back from the patient need, we are aware that some of the newer drugs that have been financed by private equity companies, in particular – it is great that there is innovation and new drugs coming out – are exceptionally expensive. Where there are drugs that involve millions of euro per dose, we have to get the balance right regarding how we incorporate them into our system and achieve the most efficiency, and also regarding the price we are able to reach in a small country in what is a commercial negotiation with a drug company. There is a matrix here that has to be got right from the perspectives of the State and patient. It is a case of the State not spending too much or spending too soon, yet I am more than acutely aware of patient needs and the impact the drugs can have. I am endeavouring to have an early access scheme, conscious of all the various elements concerning the State. I will try to provide the best transparency I can on the progress of different drugs, recognising that the companies do in fact need to make applications.