Dáil Éireann Debate, Tuesday - 29 January 2013
644. Deputy Ray Butler asked the Minister for Health if he will ensure that there is an adequate focus by the Irish EU Presidency on the clinical trials and medical devices directives which have direct implications for the 250 medical technology companies here, which export €7.2billion worth of product annually and employ 25,000 people; and if he will make a statement on the matter. [4350/13]
View answer645. Deputy Ray Butler asked the Minister for Health if he will confirm that the EU Medical Device Directive which is crucial to the 25,000 or so persons employed in this industry here is a key priority to advance during the course of the Irish running of the EU Presidency and remains the centrepiece of Presidency health agenda; and if he will make a statement on the matter. [4529/13]
View answerI propose to take Questions Nos. 644 and 645 together.
The Clinical Trials Proposal and the two Medical Devices Proposals (one on medical devices and one on in vitro diagnostic medical devices), are high priority proposals for the Irish Presidency and have been identified as two of the four priority areas for the Health Presidency programme. The objective of the Clinical Trials proposal is to address the decline in the numbers of clinical trials carried out in the EU. 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 also is essential for the growth of the pharmaceutical industry both in Ireland and in the EU in general.
The medical devices proposals are also designed to strengthen the EU regulatory system in the area of medical devices. The proposals are designed to ensure that all medical devices placed on the European market are safe for patients and to improve patient access to new innovative treatments. Following significant patient safety issues across Europe relating to hip and breast implants, patient safety is a key concern. There is, as the Deputy points out, a substantial and well established medical devices industry in Ireland and a strong and effective regulatory system is crucial for the continued success and development of this industry.
My Department hopes to make significant progress in the negotiations of both of these proposals during the Irish Presidency of the EU Council. My colleague, the Minister for Health, Dr James Reilly met with the rapporteurs for the proposals in the European Parliament earlier this month to personally assure them of Ireland's commitment to making progress during the Irish Presidency.
