Billy Kelleher (Cork North Central, Fianna Fail)
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To ask the Minister for Health if he has brought forward his proposal to the Government for the draft of the Human Tissue Bill; if not, when will he do so; the length of time after that the formal drafting of the Bill will commence; and if he will make a statement on the matter. [39510/12]

Billy Kelleher (Cork North Central, Fianna Fail)
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To ask the Minister for Health if he will confirm that the Human Tissue Bill will introduce the opt-out organ donation system; and if he will make a statement on the matter. [39511/12]

Billy Kelleher (Cork North Central, Fianna Fail)
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To ask the Minister for Health his plans to carry out a public consultation process on the opt-out organ donation system; if so, the timeframe for same;; and if he will make a statement on the matter. [39513/12]

James Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 206, 207 and 209 together.

The Heads of a Human Tissue Bill that willmeet the key recommendation of the Madden Report on Post Mortem Practice and Procedures that no hospital post-mortem may be carried out and no tissue retained without consent/authorisation are at an advanced stage of preparation and I expect to bring these to Government by the end of the year. The Deputy will also be aware that the Programme for Government envisages the introduction of an opt-out system of organ donation, with a view to improving the availability of organs for patients in need of transplantation. This will of course require detailed consideration and further consultation and my Department is examining how best to undertake this and the timeframe involved.

Billy Kelleher (Cork North Central, Fianna Fail)
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To ask the Minister for Health if he will confirm that all of the processes and procedures have been put in place by him and the Health Service Executive to comply with the EU Directive 2010/53/EU which came into effect on 27 August; and if he will make a statement on the matter. [39512/12]

James Reilly (Dublin North, Fine Gael)
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EU Directive 2012/53/EU was transposed by the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations, S.I. No. 325 of 2012, which I signed into Irish law on 27 August. The Irish Medicines Board is the competent authority under the Regulations and it must authorise donation and transplantation in accordance with the requirements of the Regulations. The Regulations apply to donation, procurement, testing, characterisation, transport and transplantation of organs. They set out a clear legal framework for the application of quality and safety standards for human organs intended for transplantation.

My Department is working with the HSE and the IMB to ensure that hospitals meet the requirements in the Regulations. The HSE's National Organ Donation and Transplantation Office is overseeing the development of guidance documents, which will set out the appropriate processes and procedures to comply with quality and safety standards for all aspects of donation and transplantation. It is also assisting hospitals through its National Transplant Advisory Group, to comply with the Regulations. I am confident that hospitals will meet the requirements of the Regulations, when they are inspected by the IMB. Compliance with the Regulations will assure both donors and organ recipients that the organ donation and transplantation system is operating in accordance with the best possible standards of quality and safety.