Mr. Shaun Flanagan:

In terms of biosimilars, yes I agree we need to make progress there. We are in discussions with a number of biosimilar companies around additional pricing opportunities with them. There are automatic price reductions that take place. There is a 30% price reduction that has taken place on the brands where a biosimilar has been introduced. It is timely to flag that a number of our hospital groups have started tender processes for some biosimilars and in particular for infliximab. I refer to formal tender processes with clinicians within the hospital groups. Clearly the difference between the biosimilars and the generics is that with generics there is a substitution available at the pharmacy level. That is not an opportunity currently with biosimilars. Evidence may develop over time to get that and make it easier. However, even with generics it was very difficult to get all clinicians on side around them and the committee will know that from its own experience.

What changed the market in Ireland almost overnight was the ability to enforce some level of substitution. I am not suggesting that the evidence is strong enough there yet for biosimilars but I think it is challenging to try to get clinicians to use them. It is about encouragement, trying to bring clinicians along and to get them to prescribe biosimilars. That is a bit of a challenge in some areas but particularly when the clinicians do not necessarily see the advantages of the biosimilar. Sometimes the clinicians may not realise that the inability of the HSE to maximise the use of biosimilars could be impacting on the new drugs that they want. We need people to buy in and understand that there is a life cycle when a biosimilar is introduced. If it is not used there is an opportunity cost. That is something the committee has clearly identified. We do not have the size of fund that we would wish to have available for all new medicines. That involves people taking a public good approach rather than a "what is in it for me" approach. Occasionally in our engagements there tends to be a "what is in it for me" and "what is in it for my service locally" approach. We need to get beyond that and we need people to realise that if there are biosimilars then the failure to proscribe them does have costs. People might not necessarily be aware of them and maybe there is no new drug on the horizon in their space but there are new drugs on the horizon in other spaces. I would echo that. We are working with a number of the biosimilar companies trying to learn from their experience in other countries around how they manage to leverage and get better utilisation.

In terms of phenylketonuria, PKU and the timelines, there was an assessment in 2009 and a decision was made that Sapropterin, or Kuvan, would not be reimbursed at that time. The fact that we are looking again at it shows that the HSE is always open to taking that approach. That addresses some of the questions that the Senator was asking around Translarna, as in is the door closed. The door is never closed. We will always look again at a medicine. The door is never closed. We say no to the application that we have at the current time but if new information becomes available a new assessment process is started and that is what has happened in the case of Sapropterin, or Kuvan. We are due to meet the company. I do not want to get into the issue of the newspaper media and the outcome of the negotiations, but the meeting with the company is due in the next weeks as opposed to months.

I cannot answer the question on an extortionate approach being taken for the simple reason that I have to engage with the industry and if I was to go and say it was extortionate it might-----