Written answers

Tuesday, 19 June 2012

8:00 pm

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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Question 697: To ask the Minister for Health if he expect at his meeting next week with his fellow EU Ministers of Health that the subject of transposing the EU directive 2010/53 on the Quality and Safety of Organ Donation and Transplantation into national primary legislation will be discussed; and if he will make a statement on the matter. [29872/12]

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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Question 698: To ask the Minister for Health if a draft statuary instrument at this late stage is ready and being the first time ever in the history of the State that Ireland will legislate on organ donation or organ transplantation; if he will share the draft instrument with the Oireachtas Health Committee in view of the importance of cross party agreement on such an important topic of public interest especially for the 500 to 600 people awaiting a life saving organ transplant; and if he will make a statement on the matter. [29873/12]

Photo of James ReillyJames Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 697 and 698 together.

EU Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation must be transposed into national law by 27 August this year. The Directive will be transposed by means of a Statutory Instrument under the European Communities Act, 1972 and not primary legislation. The Directive sets out a common framework on quality and safety standards for organs intended for transplantation and applies to donation, procurement, testing, characterisation, transport and transplantation of organs. The text of the EU Directive in its draft form was examined by the Joint Oireachtas Committee on European Scrutiny on 27 January 2009.

The Department of Health has established a steering group comprising officials from the Irish Medicines Board, which will be the competent authority under the Regulations transposing the Directive, and the HSE's National Organ Donation and Transplantation Office. A national workshop aimed at hospitals and voluntary agencies was held on 24 April to discuss the Directive and its implications for the organ procurement and transplantation system. Information from this workshop and other relevant documents are on my Department's website.

A draft Statutory Instrument has recently been sent to drafting counsel for consideration. My officials would be happy to provide the Joint Committee on Health and Children with a copy of the draft Statutory Instrument following its consideration by drafting counsel. The Regulations to transpose the Directive cannot regulate for issues over and above those prescribed in the Directive. This is a matter for primary legislation.

My Department is currently advancing legislative proposals for the Human Tissue Bill. A public consultation was carried out previously on a draft general scheme of the Bill and the proposals are being revised following on from this public consultation and in line with legal advice. I expect to bring the legislative proposals to Government later this year, seeking the formal drafting of the Bill. This Bill will put in place a legal framework in relation to the donation of organs and tissue by living and deceased persons. The transposition of EU Directive 2010/53/EU is not on the health agenda for the meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) which I am attending later this week.

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