Billy Kelleher (Cork North Central, Fianna Fail)
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414. To ask the Minister for Health if he supports amendments Nos. 30, 191, 193, 250 and 253 to the European legislation on clinical trials on medical products for human consumption; and if he will make a statement on the matter. [51532/13]

Alex White (Dublin South, Labour)
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The objective of the Clinical Trials Proposal is to encourage clinical trials on medicines to be carried out in the EU. The Proposal was one of 4 priority areas identified for the Irish Health Presidency Programme. The Proposal is also a priority for the Lithuanian Presidency and negotiations are currently taking with the European Parliament to try to reach agreement before the end of the Lithuanian Presidency.

The amendments referred to by the Deputy relate specifically to transparency on clinical trials. The Commission Proposal provides for a publically accessible EU database which will contain details of all trials submitted for authorisation in the EU and summaries of their results within one year after they have ended. The European Parliament’s amendments provide for even greater transparency in term of improving access to information. Transparency in clinical trials is fully supported by the Irish Government.