Dr. Máirín Ryan:

Deputy O'Reilly asked when we have a lot of work already ongoing and everything appears to be operating successfully, why do we need the regulation? The work we have done already has been about piloting joint assessments. The EC Health Technology Assessment Network and the European network of HTA, EUnetHTA, has conducted 18 non-drug assessments to date, I think, to which HIQA has contributed to eight, and ten drug assessments. This is about having a system where all drugs that come to the market or have a new indication, as well as all high risk medical devices would be subject to joint clinical assessment once it is ramped up. That means approximately 100 assessments annually. The regulation is about bringing the efficiency to ramp up production.

Deputy O'Connell asked about particular sub-groups. When the assessments are undertaken, each country will have the opportunity to contribute to deciding how the assessment will be undertaken including highlighting factors such as particular subgroups or particular comparators that are in the national context so that they might be taken into account. On mitigating the bias towards products produced in our own jurisdiction, each assessment team will probably consist of an average of ten countries which will contribute. There will be a joint assessor and the rest will be reviewers. There is oversight in terms of mitigating any bias that might creep into the process. On the assessments being conducted through English, to date all the EUnetHTA work has been conducted through English. Many of the European agencies publish their assessments in English and we hope that English will be the common language but that is yet to be determined.

Regarding Deputy Durkan's comments, quality assurance is paramount when it comes to health technology assessment. We were very strong in influencing the work content of joint action 3, which is going on now, in that it would incorporate the development of a quality assurance framework in the context that if the regulation comes through that, the quality assurance framework will then be fit for purpose. On subsidiarity, we see efficiencies in the clinical assessments being available to use across the countries. There is obviously an efficiency there, but the regulation requires each country to adopt a common methodology which will offer further opportunities for co-operation in future. There is also a mechanism to support voluntary co-operation so the regulation is around mandatory co-operation for clinical assessment but there is also a framework to support voluntary co-operation in other assessments. For example, if Valetta and BeNeLuxA are trying to co-operate on the economic domains, the regulation provides a framework that will also support that work, but it is voluntary rather than mandatory.