Mr. John Hennessy:

I will comment briefly on Deputy O'Connell's points first, many of which I agree with. The biosimilar and substitution point is fair enough but we have also seen dramatic levels of biosimilar penetration across different jurisdictions and states. While in Ireland it is quite low at present, other countries appear to have moved ahead on substitution. That is where we aim to go as well.

Mr. Judge covered the governance point. The trigger for that governance review is probably the volume of applications coming through, particularly in the cancer and rare diseases space. It has dramatically increased on what it was five and ten years ago.

On the point about who shouts loudest, we cannot control that. At all points we try to ensure that our systems and processes are fair, transparent and equitable and, in particular, that they are evidence-based so decisions are taken on the basis of evidence rather than who is shouting loudest at any point in time.

On Senator Colm Burke's question about cost breakdown, we have a large volume of information on cost and the breakdown of what is happening in pharmaceuticals. By and large, it reveals stabilisation and even cost reduction in the generic and high volume spaces. For example, expenditure on the drugs payment and the long-term illness schemes is currently running at levels similar to those in 2000 on a cost per item basis. We are experiencing a significant increase in the high tech, cancer, orphan drugs and rare disease areas. There are two graph lines. One is stable while the other is increasing. We will be happy to share that data with the committee. I will need to check further about local variation and uptake as I am not sure if we can get that information easily, but we will certainly look for it.

On the Senator's final point on whether we can do more, I believe we can do more to drive value. It is related to the points about biosimilars and substitution. However, it is useful to remember as well that it is difficult to move patients off a drug or product they have been on for some time and sometimes the claims of products are not necessarily that they are curative but that they prevent or reduce deterioration. That is difficult to measure objectively in a manner that would result in the withdrawal of a drug from a patient.

I appreciate the difficulties prescribers have in that regard.