Dr. Ambrose McLoughlin:

I thank the Chairman and committee members. I am happy to be here to discuss the two reports submitted to the Oireachtas by the Department of Health on EU developments in 2013. I am joined by Mr. Eugene Lennon, who was the chief attaché prior to and during Ireland's Presidency, and Ms Audrey Hagerty, who is head of the Department's European Unit.

In 2013 the Department’s work at EU level was dominated by the Irish Presidency of the Council of the European Union. In this regard I acknowledge the Department’s significant contribution to the success of the Irish Presidency with many notable achievements in health, which I will mention later. I acknowledge the hard work and commitment of the staff in the Department of Health and its agencies in making the Presidency the success it was. This was evident at home and in Brussels, Strasbourg, Luxembourg and Geneva. The commitment of the Minister, Deputy Reilly, and that of the Ministers of State, Deputies White and Lynch, was essential to progressing the health agenda.

In 2013, our work was focussed on our Presidency of the Council of the EU. We decided to focus on progressing the legislative agenda and within this we prioritised legislation to promote public health, innovation and research. We reached a first reading agreement with the European Parliament on the regulation to protect citizens against serious cross-border health threats. This will help member states prepare and protect citizens against possible future pandemics and environmental disaster, strengthen risk preparedness and response planning, improve access to vaccines for member states and have clearer risk and crisis communication to the public and health care professionals.

We reached a general approach to the directive on tobacco products at Council in June 2013. This would not have been possible without the Minister’s strong belief in and commitment to the importance of the dossier and his personal support in working to progress it. The support of Commissioner Borg and his team was also critical to the success of the work on the directive which has been formally adopted and comes into force in two weeks time. This directive is a key tool in preventing our young people from starting to smoke. It aims to make tobacco products and smoking less attractive and thus discourage initiation among young people.

We achieved a first read-through on a proposal for a regulation on clinical trials on medicinal products. Clinical trials on medicines promote pharmaceutical innovation in the EU and innovation in clinical practice. Clinical trials are essential for the development of new medicines and to improve and refine treatments with existing medicines. Clinical trials are also a key contributor to growth and jobs. A regulatory environment which supports and nurtures clinical research will benefit patients and is also essential for the growth of the pharmaceutical industry in Ireland and the EU. An objective of the regulation is to address the decline in the numbers of clinical trials carried out in the EU. Agreement was reached on the new regulation last January.

The proposal for a regulation on general and in-vitro medical devices – in effect two complex proposals - was significantly progressed with a progress report produced at the end of the Irish Presidency. We want patients to have access to new, innovative and lifesaving medical devices but they need to be assured of their safety. We also want the EU to be a global leader in medical devices innovation.

In addition to the legislative programme, the Irish Presidency also hosted a number of health policy events, including an informal meeting of Health Ministers in March 2013 which was attended by 22 Ministers who discussed childhood obesity, the impact of the economic crisis on health systems, children with complex developmental needs, including autism, and smoke free environments. A touchstone issue is the impact of the economic crisis on health systems and two messages are clear. These are the challenge of cutting the cost of services and not the services themselves, and of articulating the dual benefit of investing in health, which are beneficial to the health and well-being of our citizens, but also the economic benefits that accrue from a healthy society. The Minister for Children and Youth Affairs, Deputy Fitzgerald, co-chaired the session on childhood obesity and at the informal meeting the European Commission agreed to mandate the EU high-level group on nutrition and physical activity to develop an action plan on childhood obesity. Ireland presented the EU action plan at a Greek Presidency conference earlier this year and its implementation will be included in the Council conclusions under preparation. The plan will play a central role in the development of national plans to tackle childhood obesity.

In May 2013, we hosted eHealth Week, which attracted more than 2,500 international delegates and 100 exhibitors. We achieved agreement on a declaration to prioritise the use of ICT in health among member states to contribute to a better, safer, sustainable and innovative health care system for all European citizens. In May 2013, we also marked the EU month of the brain with the "Healthy Brain: Healthy Europe - a new Horizon for brain research and healthcare" conference. This was a high-level expert conference, co-hosted with DG Research and Innovation, on the future of brain research. Commissioner Geoghegan-Quinn’s support and that of her officers was critical to the conference’s success.

I acknowledge the significant engagement by the Minister of Health, Social Services, and Public Safety, Edwin Poots MLA, and his officials, at key events during the course of the Presidency, including the informal meeting of Health Ministers, the joint meeting of chief medical and chief nursing officers, and the ehealth conference.

In the second half of 2013, we had significant liaison with the health ministry of Lithuania, which assumed the EU Presidency for the first time. Its priority was modern, responsive and sustainable health systems and it developed Council conclusions on this topic which were adopted on 10 December in Brussels. These conclusions stressed the necessity to enhance the abilities of EU member states to practically apply the principle of health in all policies, encouraged confidence in best practice, and gave guidance for further development of health policy in European Union member states as well as at European Level. Agreement between Council, the Commission and the European Parliament on the tobacco products directive was finalised and agreement on the regulation on clinical trials of medicinal products was also reached. These agreements built on the significant progress made by the Minister, Deputy Reilly, on these issues during our Presidency. The Lithuanian Presidency progressed further the legislative proposals in the field of medical devices and agreement was reached on a proposal for a regulation on fees payable to the European Medicines Agency for the conduct of pharmocovigilance activities.

Four Commission proposals in the area of health were notified to the committee in the course of the six month period from July to December 2013. The transposition of three proposals was notified in the same period. I am happy to deal with any questions.