Written answers

Tuesday, 1 February 2011

Department of Health and Children

EU Directives

2:30 pm

Photo of Beverley FlynnBeverley Flynn (Mayo, Fianna Fail)
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Question 148: To ask the Tánaiste and Minister for Health and Children the position regarding the implementation of the EU Blood Directive; her views on the latest Commission report on the matter; the position proposed to a renewed definitive for principal of voluntary donations; and if she will make a statement on the matter. [4673/11]

Photo of Mary CoughlanMary Coughlan (Tánaiste; Minister, Department of Education and Science; Minister, Department of Health and Children; Donegal South West, Fianna Fail)
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Four European Directives have been introduced since 2004 to ensure that Member States have in place standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. This legislation ensures that the blood supply throughout Europe meets the standards specified.

Blood requirements set out in EU Directives 2002/98/EC and 2004/33/EC relating to quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and certain technical requirements are regulated under SI No. 360 of 2005 (Quality and Safety of Human Blood and Blood Components). These Regulations, which were transposed into Irish law in July 2005, designate the Irish Medicines Board (IMB) as the Competent Authority and require all blood establishments be authorised by the IMB and hospital blood banks to be accredited to ISO 15189 standard.

EU Directive 2005/61/EC relating to human blood and blood component traceability requirements and notification of serious adverse reactions and events was transposed by SI No. 547 of 2006 and EU Directive 2005/62/EC regarding community standards and specifications relating to a quality system for blood establishments was transposed by SI No. 562 of 2006.

The IMB has implemented the legislation and all blood establishments and blood banks comply with the requirements.

The latest Commission report on the matter dated the 19 January 2010, reported a satisfactory implementation of Directive 2002/98/EC. Member States, including Ireland, had successfully designated and set up their competent authorities, as well as inspection systems, control measures and haemovigilance systems.

The report further stated that Member States had to finalise the accreditation/designation/authorisation/licensing process for all blood establishments. I can confirm that all four Irish blood establishments are authorised by the Irish Medicines Board.

The principles governing voluntary and unpaid donation of blood and blood components are set out in article 20 of Directive 2002/98/EC. It states that Member States shall take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are, in so far as possible, provided from such donations.

Currently the Irish Blood Transfusion Service (IBTS) operates to an internal policy of voluntary and unpaid donation from all donors.

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