Dáil Éireann debate -
Tuesday, 30 Jan 2001

Vol. 529 No. 1

Written Answers. - EU Directives.

Bernard Allen

Question:

744 Mr. Allen asked the Minister for Health and Children if all EU Commission standards and directives are being complied with by his Department and its subordinate boards in relation to standards to safeguard blood and blood products. [2458/01]

Minister for Health and Children (Mr. Martin)

EU legislative requirements in relation to medicinal products are covered by Council Directive 65/65/EEC, as amended, which lays down special provisions for medicinal products derived from human blood or plasma i.e. blood products. The Irish Medicines Board (IMB) is the competent authority for the purposes of this directive. The IMB was established under the Irish Medicines Board Act, 1995, to licence the manufacture, preparation, importation, distribution and sale of medicinal products in Ireland. The remit also includes the regulation of medicinal products, including blood products, used in Ireland. The board also has responsibility for the supervision and control of medicinal products placed on the market in this country. All medicinal products, including blood products, used in Ireland are licensed and monitored by the IMB which is a guarantee of their compliance with Council Directive 65/65/EEC. However, Council Directive 65/65/EEC, as amended, specifically excludes blood components such as whole blood, plasma and blood cells of human origin.

The IMB is also the regulatory authority for the collection, screening, processing and quality control facilities in respect of human blood, blood components and blood products. The lMB inspects the IBTS by conducting two full inspections and investigations each year, and reports annually to the Minister on these inspections. The IMB apply the following EU directives and guidelines in their inspections of the IBTS:

–EC Directive No. 91/356/EEC dated 13 July 1991 which lays down the principles and guidelines of good manufacturing practice for medicinal products for human use;

–European Community Guide to Good Manufacturing Practice for Medicinal Products (vol. IV of the Rules Governing Medicinal Products in the European Community);

–Guide to the Preparation, Use and Quality Assurance of Blood Components (5th edition, 1999) Council of Europe.

Three annual reports have been presented and published to date which outline the significant progress made by the IBTS in ensuring compliance, nevertheless, specific instances of non-compliance have been reported which are being addressed.

There are currently no EU directives which deal specifically with blood safety and quality, although there are a number of relevant Community initiatives in this area. The most recent and most significant is Council Recommendation No 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the Community. I have been advised that the IBTS complies with all provisions of this recommendation.

The European Commission, under the current Swedish Presidency, is considering a draft proposal for a directive of the European Parliament and of the Council entitled "Proposal for a directive setting high standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components in order to ensure a high level of human health protection in the Community". My Department, in consultation with the IBTS and the IMB, are contributing to the development of this directive and I am assured that the level of compliance with the current provisions of the draft directive is very high. For my part, I will ensure that the IBTS has adequate resources to introduce any new measures which may be necessary to ensure full compliance with the directive once it is adopted.