Mr. John Hennessy:

We might try to reconcile our positions on the matter.

In terms of cost effectiveness, I agree with the Deputy that there is more than cost effectiveness involved in the process. My experience is that where the clinical benefits are strong the products tend to be approved and cost is not the overriding factor. I am talking about products that clearly transform the lives of patients or save their lives. Where the clinical benefits are quite marginal and the prices are extremely high, that leads to a more protracted assessment and negotiation process. That is the space in which we are having much of our conversation today.

I wish to say to Mr. Flanagan that the process for Kuvan is ongoing and we need to see the process through to conclusion and, obviously, give people due process, rights of reply, etc. Further discussions are on the cards.

I am not sure I accept the analysis of the compassionate access to Respreeza. The State and the HSE was not involved at the start of those programmes and was not involved at any stage in the process up to now. It seems a bit disingenuous to now hand it over to the HSE and the State. I imagine it is not an issue of price, even though we still have to meet the company to clarify the issue. It would appear not to be a cost issue. If it is not a cost issue then it would appear to be an attempt to get a product approved by a different mechanism. If the product went through an application process that was concluded and the result was issued then getting involved in the compassionate access programme could be considered to be an approach to get Respreeza approved in spite of that decision. We have yet to hear the explanations and I do not want to pre-empt the discussions. I am sure that the committee members have also pondered the reasons the company is not prepared to continue the status quoand to provide for the administration of the drug. There must be some explanation for it doing so but I do not know what it is at the moment. We await the meeting with the company to clarify.

Deputy Brassil and other Deputies have asked what should happen.

What is being suggested is a change of policy that would somehow make access to orphan drugs easier. What would be needed to do that is to relax the criteria that need to be considered. The obvious thing that accompanies that is providing the funding to meet the cost. If it is made easier for orphan drugs to be approved in this jurisdiction then there will be an inevitable cost that will come with that. I might ask Mr. Flanagan to comment on the biosimilars point.