Vol. 522 No. 2
244 Mr. Allen asked the Minister for Health and Children if his attention has been drawn to the US Federal Drugs Administration's expressed concern regarding the safety of tissue, some of which may be exported here and to other EU countries. [18222/00]
245 Mr. Allen asked the Minister for Health and Children if he will introduce a new regulatory body to police the importation and use of products made from human tissues, following reports that untested tissue is being brought into Ireland. [18223/00]
I propose to take Questions Nos. 244 and 245 together.
A framework already exists for the regulation of many products which are derived from human tissue which originates in Ireland or elsewhere. For example, the most widely transfused human tissue in use here is human blood or its components such as plasma, red cells or platelets and these must comply with the following before they are used in the Irish health sector: council recommendation on the suitability of blood and plasma donors and the screening of donated blood in the European Community, 29 June 1998; European Community Guide to good manufacturing practice for medicinal products (vol. IV of the rules governing medicinal products in the European Community); and guide to the preparation, use and quality assurance of blood components (fifth edition, 1999) – Council of Europe. There is also a substantial regulatory framework for the use of medicines and medical devices in Ireland. The Irish Medicines Board (IMB) was established under the Irish Medicines Board Act, 1995, to licence the manufacture, preparation, importation, distribution and sale of medicinal products in Ireland. This volume of work provides for the regulation of human and veterinary medicinal products used in Ireland, whether they are manufactured in Ireland or abroad.
The use of medical devices in Ireland is governed by the European Communities (Medical Devices) Regulations, 1994, S.I. 252 of 1994, and the European Communities (Active Implantable Medical Devices) Regulations, 1994, S.I. 253 of 1994. These regulations transposed the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC into Irish law respectively. Directive 98/79/EC on in vitro diagnostic medical devices is due to be transposed shortly and it is hoped that a further directive on medical devices incorporating derivatives of human blood or plasma will be adopted in the very near future.
In addition to the statutory framework in place, individual hospitals have their own protocols and auditing systems in place whereby human tissues and products which incorporate them are subject to inspection procedures before they are used. I recognise that despite the regulatory framework in place that there are wider issues which need attention concerning the harvesting and use of human tissues which originate in Ireland or elsewhere. I am currently planning the establishment of a specialist group to consider these issues and to advise me as to the updating of legislation and legalities in this area.
