Mr. Shaun Flanagan:

It is drug budget resources. The NCPE and the pharmaceutical unit did have a challenge around human resources but that is no longer an excuse as over the last 18 months the HSE has given us substantial resources. I will give a practical example, which might better explain the delay. Commercial negotiations can take a long time. It can be hard to get a company to the point of an offer that will be acceptable to the State. The system is broken internationally from a pricing point of view in that we have a system whereby companies come with lists prices of, say, €100, and they get involved with one country in non-transparent negotiations and reduce the price to, say, €90; they then move on to the next country for which they reduce the price to €80 and then for a third country they reduce it to €70. If Ireland is the first country it pays €100. It is unfortunate but true that the further down the line a country is, the better the offer it gets. It is not possible for me to put particular information into the public domain but I will try to illustrate what happens in the case of a non-orphan drug. The drug Pablociclib - Ibrance - is used to treat breast cancer. It was approved by the EMA in 2016. At the time of the pricing and reimbursement application the company in question applied for a price of €3,800 per pack. This would have resulted in a budget impact of €66 million. This was in commercial negotiation for over a year. Eventually, a pricing decision was made in a different country. The price offering given to us at that point was €2,190 per pack. Within three months the HSE had completed all processes and had reimbursed it. The net difference is €28 million over five years. If we go early, we pay more which means we can reimburse fewer drugs. The challenge is getting the balance right in terms of the right amount to be spend at a premium over other prices versus fighting as hard as we can for reduced prices.