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Dáil Éireann debate -
Tuesday, 30 Jan 2001

Vol. 529 No. 1

Written Answers. - Bovine Disease Controls.

Bernard Allen

Question:

539 Mr. Allen asked the Minister for Health and Children if his attention has been drawn to a letter sent by the Food and Drug Administration to manufacturers of FDA regulated products requesting that bovine derived materials from cattle which have resided in or originated from countries where BSE has been diagnosed not be used in the manufacture of FDA regulated products intended for administration to humans; and the action his Department has taken on foot of the 1993 letter. [1103/01]

The Irish Medicines Board has informed me that it is aware of some documentation issued by the Food and Drug Administration (FDA) in the United States regarding controls in relation to the use of bovine derived materials and BSE. It has indicated that it is not clear exactly to which letter the Deputy is referring. However, the Irish Medicines Board supports the European view and current EU policy which only completely excludes bovine materials from high risk BSE areas, specifically the United Kingdom and Portugal. Bovine materials from areas with lower levels of BSE are permitted – these include Ireland and Denmark – provided that the materials comply with the relevant EU guidelines and Directives regarding minimising the risk of transmitting such agents.

Bernard Allen

Question:

540 Mr. Allen asked the Minister for Health and Children if his Department is monitoring the use of bovine derived drugs on an ongoing basis; if he has carried out an assessment of the use of bovine derived drugs in hospitals here; and if alternatives to bovine derived drugs are used when available. [1104/01]

The Irish Medicines Board is the competent authority in this country for the authorisation, control and supervision of medicinal products placed on the market. Under the Medicinal Products (Licensing and Sale) Regulations, 1998, which give effect in this country to EU Council Directive 65/65/EEC, medicinal products, including vaccines, on the market in this country must be the subject of product authorisations granted by the Irish Medicines Board. Before the board will grant an authorisation, it must be satisfied as to the safety, quality and efficacy of the product concerned.

The Irish Medicines Board monitors the use of all authorised medicinal products on an on-going basis via a range of post authorisation mechanisms. With a view to minimising the risk of transmitting animal Spongiform Encephalopathy agents via medicinal products, the board required all authorisation holders to demonstrate that their medicinal products were manufactured in a manner which minimised that risk. This action was taken in harmony with the competent authorities in the other member states of the European Union on the basis of Commission Directive 1999/82/EC, which related to clinical standards and protocols in respect of the testing of medicinal products.

In view of the range of medicinal and other products that contain various substances derived from bovine origin the matter is by no means simple. The thrust of any action in this area is to minimise the risk of transmission of the infective agents rather than replacement of the materials used. This approach includes the sourcing of materials from countries with lower levels of BSE.

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