Mr. Richard Lodge:

I am happy to kick off on a couple of those questions. Deputy Durkan asked if there is a better way. We heard this morning that there has to be a better way and there has to be a better process.

One of the issues is the recommendations in 2014 for the promised technical review committee for orphan drugs. That touches on the questions from the Vice Chairman also. I think it is three years since that was proposed and nothing has yet happened. That is not strictly true because a chair has been appointed. To address what we could do better, we could implement the recommendations. It is as simple as that. To answer the question from the Vice Chairman about how I would score the strategy, it would score quite highly. It is definitely the way to go. It is definitely what needs to happen. Scoring it on implementation is easy. It is zero, because three years later we are not aware of anything that happened. We were not aware until this morning that a chair had been appointed.

I have some experience with the process for oncology. There is a lot that can be learnt and borrowed from the oncology systems. My biggest concern about the current process relates to the delays. I will ask Ms Kelly to update the committee on some of the delays regarding Translarna in a moment but I must say that communication is a serious concern. There is a simple reason for that. At present, the drug companies put in applications to have their drugs licensed. Therefore, the communication is between those committees and back to the drug companies. We are not aware of the mechanisms by means of which patient input or expert clinical opinion is fed into that process. Unfortunately, we are in a situation whereby patients are aware of the trials. They are aware of the drugs that the companies are seeking to be licensed, so they approach the drug companies directly. The information the patients receive comes via the drug companies, from the HSE, which is not ideal because they will have a completely different agenda and the information we receive as patient representatives comes then from the patients who met with the drug companies. There has got to be a way of short-circuiting that route and going direct.