Mr. Oliver O'Connor:

We dealt with the question regarding the nine countries. Senator Crown asked about the general pricing policy of the industry internationally. Unlike the situation under the United States Government at federal level, for example, we have the health technology assessment, HTA, run by the National Centre for Pharmacoeconomics, which is designed by the Health Information and Quality Authority, with the latter having issued substantial guidelines in this regard. The HTA sets a threshold price level above which, in theory, a drug will be rejected. It is a €45,000 threshold per what is called a quality-adjusted life-year. However, the guidelines also state that there is no fixed cost effectiveness threshold above or below which technologies are guaranteed to be rejected or accepted for reimbursement. The process is there as a check on whether a new product is cost effective, how it should be paid for, whether it represents value for money and so on. Price is a factor in that, but it is not a rigid mechanical rule. Not many of us would want such a rule, because we have to take into account social conditions and Irish preferences.

As Senator Crown would know, this is a very complex area. HIQA has set out complex guidelines in this regard and there are many people in our companies, including statisticians and clinically qualified personnel, who spend a lot of time and effort doing the analysis to meet the tests that are set by the State for determining whether new drugs are cost effective.