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The workings of Biobanks in the absence of any Legislative Framework
As research into human health and medicine continues to progress, the emergence of “Biobanks” throughout Europe is increasing. Often referred to as a “Bank of Life”, a Biobank houses small human tissue or blood samples and associated data. Given the highly regulated area of Bioethics, it is surprising that no legislative framework exists for the establishment and running of Biobanks in Ireland.
However, in circumstances where the scope of a Biobank deals with blood materials and/or human tissues and cells, legislation introduced in 2005 and 2006 will apply.
The 2005 Regulations(1) govern (i) the collection and testing of blood or blood components, whatever their intended purpose and/or (ii) the processing, storage and distribution of blood and blood components, when they are intended to be used for transfusion.
The 2006 Regulations(2) govern the donation, procurement, testing, processing, preservation, storage or distribution of tissues and cells for either human application or manufactured products.
Both Regulations require a permit to carry out any of the above activities. An application for the permit must be made to the Irish Medicines Board. In addition, Biobanks under the 2005 and 2006 Regulations are also subject to the general data protection provisions as set out in the Data Protection Acts 1988 and 2005.
However, it is clear that a legislative framework specific to the establishment and operation of Biobanks in Ireland is long overdue. While independent small Biobanks are operating currently in Ireland, a report published in November 2008 by the Government’s expert group on a National Cancer Biobank, concluded that a publicly funded Biobank was essential to the future of cancer research and patient care in Ireland. The National Cancer Strategy 2006 to 2009 also calls for the creation of a National Biobank infrastructure.
1. European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005 introduced into Irish law in order to give effect to provisions of Directive 2002/98 of the European Parliament and Council. 2. European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 introduced to give effect to Directive 2004/23 of the European Parliament and Council.