Dr. Derick Mitchell:

To come back to Deputy O'Reilly's question on other jurisdictions, under the health Act a number of criteria are defined against which the reimbursement and assessment processes are measured. The nine criteria offer a degree of flexibility. In particular, in terms of what we are speaking about today, there are other countries that have managed to put in another level of criteria for orphan drugs that greatly recognises the specific unmet need with regard to more rare conditions. I am thinking in particular of Sweden. It comes back to the other question that was asked. Sweden was able to put in place these principles because it had a degree of public trust in the system's ability to assess, evaluate and make decisions. It also has a very well-recognised national registry system. It has a health information system that is able to monitor effectiveness in a much better way than we have in Ireland. It comes back to Deputy Donnelly's point that an IT system and a national electronic health record for individual patients with individual identifiers definitely need to be part of a national strategy on what we are speaking about, in terms of personalised medicine and precision medicine. The patient registries have a very important role to play. They have been doing phenomenal work for a number of years with very little resources. They are approaching a tipping point in terms of their ability to sustain this. At the same time, they are being very innovative in bringing in new solutions for how patients can be effectively monitored, whereby they take their medication and, ultimately, we are able to show the improvement in outcomes.