Mr. Finian Judge:

I will try to take the end questions on policy and the Department's role in the order that they were asked. Deputy O'Reilly asked about the committee's role, which is a very good question. We have the committee's report and we are also aware that a Private Members' Bill has been published on the area. With regard to how we can take on board what the committee has to say and how to reflect it with regard to the Commission's thinking, we will examine the committee's report in detail. As we sit in council over the next 12 months, debating this proposal line for line, we will certainly take on board what the committee has to say in its report. That has very much been an involvement of the committee in our thinking for the next 12 months. We will relay to the Commission, at the council groups, precisely what the committee has said in its report.

Deputy O'Connell raised this issue of Orkambi. The answer to her question is that yes, there is a facility for the HSE, if resources are substantial, to make a submission to the Department and to the Minister in that regard. The Minister and his colleague, the Minister for Finance, are involved in the process. The Deputy also raised the issue of countries favouring their own products. In that respect, as we have discussed this proposal at council, we will ensure that there is no undue influence by any one company or manufacturer in that entire process. Deputy O'Connell spoke about the drugs spend and breaking it down between high-tech and orphan. In recent days, we gave a letter to the Chair of the committee where we broke down the spend between the different community drug schemes. We can certainly work more on that if the committee wishes to see a more detailed breakdown. We are restricted by the data collected by the primary care reimbursement service, PCRS, in the HSE. Deputy O'Connell's other point was on a separate process for orphan drugs. As we all know, there is not a separate rule set in the Act as laid down by the Oireachtas for orphan drugs. Having said that, the HSE is always mindful of the particular challenges posed by orphan drugs. It is under active consideration. A new committee has been established under the national rare disease plan. There is a likelihood that that new committee will look at the feasibility or the merit in establishing new entry and exit criteria for orphan drugs. It is up for consideration.

Deputy Durkan spoke about piloting a separate rule set for orphan drugs. I think I have answered that. Deputy Durkan made a point that we should look to our EU partners and grow collaboration with them. This is precisely the point that the Taoiseach and Minister have been making quite a lot. We are already involved in the Valletta collaboration. The Minister only very recently wrote to his colleagues in Belgium, the Netherlands, Luxembourg and Austria, seeking to join what is known as the BeNeLuxA collaboration. We are trying to do as much as we can to build on the experience and power of getting into the space of joint pricing.

Senator Colm Burke talked about the pharmaceutical company frustration in the process. There is no doubt that, post the HTA process, there can be delays in final decision-making. Much of that delay is down to the fact that a decision from the NCPE, even one to say that it does not stand up, is a decision that it does not stand up at the price submitted. That is a catalyst for the process to begin at the HSE level to go back to the companies involved and renegotiate price etc. Much of the delay is because commercial negotiations are reopened and the HSE is seeking to attain the best price possible for the drug. The Senator also raised the issue of collaboration, which I have mentioned. I think I have covered most of the issues that were put to the Department.