Tuesday, 5 March 2013

Questions (460, 508)

Damien English

Question:

460. Deputy Damien English asked the Minister for Health the progress made on the EU medical devices and clinical trials directives; if his attention has been drawn to the fact that a number of med-tech and pharma industry bodies have raised concerns that progress has been slow and that more should be done to progress these directives; and if he will make a statement on the matter. [11197/13]

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Damien English

Question:

508. Deputy Damien English asked the Minister for Health the progress that the Irish EU Presidency has made to date in progressing the EU medical devices and clinical trials directives; if these dossiers remain a priority for the Irish EU Presidency; if his attention has been drawn to the concerns raised by a number of med-tech and pharma industry bodies that progress to date on these directives has been slow; if additional resources will be allocated during the Irish Presidency to ensure that this issue is a top priority during our tenure; and if he will make a statement on the matter. [11196/13]

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Written answers (Question to Health)

I propose to take Questions Nos. 460 and 508 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. I am not aware of any concerns raised by med-tech and pharma industry bodies that progress to date has been slow under the Irish Presidency and indeed I am surprised that anyone would have that perception.

To date Departmental officials have chaired seven meetings of the relevant Council Working Party in Brussels and significant progress has been made. With regard to the Clinical Trials Proposal my plan is to complete a first examination of this entire Proposal by the end of the Irish Presidency. A number of informal meetings have taken place with Ms Glennis Wilmott, MEP, Rapporteur in the European Parliament for this Proposal.

With regard to the two Medical Devices Proposals, a discussion has already taken place on some of the key chapters and informal meetings have taken place with the European Parliament rapporteurs on these dossiers, Ms Dagmar Roth Behrendt, MEP and Mr Peter Liese, MEP. In addition, my colleague, the Minister for Health, Dr James Reilly met with the rapporteurs for the Proposals in the European Parliament in January last to personally assure them of Ireland's commitment to making progress during the Irish Presidency. Both Minister Reilly and I are very happy with the progress made to date.