Mr. Shaun Flanagan:

The biggest challenge around the availability of new drugs relates to the funding of them, regardless of whether they are orphan or non-orphan drugs. I tried to give information earlier which made it clear that even though in many instances there is an assumption that the only matter and factor that the process considers is cost-effectiveness, that is not the case. I used to be the head of the negotiating teams in the HSE. I have moved from that role and I am now a member of the drugs group. I see, along with my colleagues on the drug group, that we look at everything. We look at unmet need, clinical evidence, cost-effectiveness and economic evidence such as the budget impact. We look at the representations we receive and at the lived experience of the patients as they are submitted in the National Centre for Pharmacoeconomics, NCPE, documents. People have an opportunity to provide information as part of the NCPE process around their experience of what they believe the drug will do for them. All of that information is looked at by the drugs group. There is ample evidence, some of which we can provide afterwards to the committee, that drugs are approved even when they are not cost-effective in a conventional sense.

It should be a matter of recognising unmet need, recognising that the drug works well and that it will make a substantial difference to an individual patient's life. Then it will get approved.

The reality is that for rare diseases, orphan drugs are often very expensive. There can be difficult negotiations. The same can be true in the case of non-orphan drugs. There can be difficult negotiations in trying to get the budget impact of a drug to a level that the State feels is reasonable. As I say, there are the industry engagements. I refer here to the 2022 IPHA agreement. A significant feature of the deliberations on the latter relates to sharing the information on what would work better on both sides. One of the issues on which we all agreed was that it would help if we could in some way get to the end of the negotiation quicker. That would involve the companies being in a position to get to their final offer. Sometimes that can be challenging.