Mr. Shaun Flanagan:

To respond to Deputy Billy Kelleher's question on the period before 2009 and the changes that have occurred, it is important to note that there has been a series of framework agreements with the industry dating back to the 1970s. Prior to 2013, the HSE or the State had no statutory powers on the Statute Book it could use; therefore, everything had to be done by agreement. If there was no agreement, there was no alternative. To the best of my knowledge, the 2013 agreement represented the first time the State actually legislated and provided powers for the health service to set prices. That changed the dynamic.

On the rationale for using the basket of nine countries, the original basket contained five countries. In 2006 there was a long negotiation. I was not involved, but I understand the negotiators reported directly to a Cabinet sub-committee. At that point it was agreed that the basket would be increased from five to nine countries. Austria, Belgium, Finland and Spain were added and regarded as lower price countries — that is what is coming out in the recent data we have received — than the countries that had been included in the previous basket.

On the subject of the dynamics of the basket, there is no doubt that companies operate a process of what one might call waves of launches. Wave 1 features high price countries and is followed by waves 2, 3 and 4. The first in line are most expensive, about which there is no doubt. That is how companies operate and it is a rational way to operate. Twenty-five of the 28 countries in the European Union operate some form of basket system. To the best of my knowledge, there are three countries that operate what is called a free-pricing market. They are Germany, Denmark and the United Kingdom which are usually in an early wave. The position in the United Kingdom can vary, but the three countries are in our basket. From 2006 onwards, it was recognised that just relying on a basket would result in the same answer all of the time. This led to the requirement to put in place a health technology assessment process. Therefore, it is not a simple matter of companies coming to us with an average for nine countries and stating this represents the price. That is the absolute maximum price they can achieve.

If that is the absolute maximum price they can achieve, they are required to justify the price in the health technology assessment. If the health technology satisfies at a threshold of €45,000 per QALY, it is an automatically important point. It is not a line in the sand above which we will not reimburse. It is an agreed position and, if they satisfy it in their economic dossiers, they are automatically reimbursed.

If they do not satisfy it, we are into pricing negotiations. Those pricing negotiations are commercially confidential and non-transparent. Due to spillover effects into other countries, if the price in Ireland drops, the price in other countries drops. We have pricing reductions that range from 5% to 40% in various medicines. I cannot reveal them because most of the time companies will say they will provide the discount as long as it is regarded as commercially confidential and not revealed in a public forum. That leaves us in a difficult position when presenting to the committee. However, members should be aware that the basket is not the set point. The basket is the starting point and they are required to justify the price and bring it through a full assessment process. Having satisfied the assessment process, the price stands. If they do not satisfy it, difficult negotiations go ahead. As members are aware from recent times, we sometimes reach a stand-off position where companies are holding a line on a price that we feel is completely inappropriate. Where the companies are unwilling to move, decisions must be made on that basis.

With regard to the question on eculizumab or soliris, I can categorically say the reimbursement is progressing. However, the DG said in his press release that there was a screening programme. It is incumbent on the clinicians in question to complete a form, go through the screening process and reimbursement will continue from there. Some patients are through that process and we have applications from four patients. That is the turnover of a relatively quick process. Most of them have been turned around in 24 or 48 hours. If there has not been reimbursement, I assume it is down to the fact that the application form has just been received, has not been received or has not been completed.