Dáil Éireann Debate, Tuesday - 14 May 2013
593. Deputy Damien English asked the Minister for Health if he will provide a detailed update on the progress of the EU’s clinical trials proposal and two medical devices proposals which could have an impact on the 25,000 people employed in the pharma and medical technologies sectors here; if these proposals will be on the agenda for the EPSCO Council meeting in June 2013; and if he will make a statement on the matter. [22220/13]
View answerThe 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 by ensuring that all medical devices placed on the European market are safe for patients, and to improve patient access to new innovative treatments.
To date there have been 6.5 meetings of the Council Working Party on Pharmaceuticals and Medical Devices during the Irish Presidency dedicated to examination of the Clinical Trials Proposal. The dossier is complex but work is progressing well.
The Presidency team aims to complete a first examination of this entire Proposal by the end of the Irish Presidency. The Irish Presidency team has also been working outside of Council Working Party meetings to review the technical annexes of the Proposal. A number of informal meetings have taken place with Ms. Glenis Willmott MEP, rapporteur on this dossier.
There have also been 5 meetings of the Council Working Party on Pharmaceuticals & Medical Devices dedicated to examination of the two large Proposals on Medical Devices and In Vitro Diagnostic Medical Devices. These are challenging and technical dossiers consisting of approximately 200 articles and nearly 30 annexes. Good progress has been made to date and the Presidency’s intention is to examine a substantial number of chapters of both proposals in parallel during the Presidency. The Presidency team has also convened a number of meetings of medical devices experts in Brussels to review and improve a number of technical annexes of the Proposals, and has held informal meetings with the EP rapporteurs on these dossiers, Ms. Dagmar Roth Behrendt MEP and Dr. Peter Liese MEP.
Both proposals will be on the agenda for the EPSCO meeting in June where it is proposed to present Presidency Progress Reports on the Clinical Trials and Medical Devices Proposals.
