James Bannon (Longford-Westmeath, Fine Gael)
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Question 578: To ask the Minister for Health the position regarding blood stem cell collection in respect of a person (details supplied) in County Wicklow; and if he will make a statement on the matter. [18495/11]

James Reilly (Dublin North, Fine Gael)
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EU Directive 2004/23/EC on the Quality and Safety of Tissues and Cells and the Regulations made under the Directive (S.I. No.158 of 2006) set standards of quality and safety for human tissues and cells which are intended for human applications. These Regulations apply to the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells when intended for human applications. They also apply to manufactured products derived from human tissues and cells intended for human applications.

The Irish Medicines Board is the competent authority under the Regulations. All tissue establishments, including companies which procure stem cells for human applications, must be authorised to carry out their activities and are subject to regular inspections. The organisation to which the Deputy refers is authorised by the Irish Medicines Board as a tissue establishment and may therefore collect cord blood once it complies with any governance arrangements which may be in place in any particular hospital.