NETHERLANDS: ACT ON THE PROVISION OF BLOOD The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.388. 1. Member to Agreement notifying: NETHERLANDS. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Ministry of Health, Welfare and Sports. Agency or authority designated to handle comments regarding the notification can be indicated if different from above. National Enquiry Point. 3. Notified under Article 2.9.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): The proposal relates to the restructuring of the Dutch organization which provides human-blood products. This new private organization will be responsible for taking, preparing and distributing these products. The blood products concerned are both medicines based on human blood or plasma in the sense of Directive 89/381/EEC, and other products based on human blood. 5. Title, number of pages and language(s) of the notified document: Act on the Provision of Blood (14 pages, available in English). 6. Description of content: The Bill aims to improve the provision of human-blood products. For this purpose, a private organization has been appointed to ensure that these products are provided effectively. This organization will be taking over the tasks of the current blood banks in terms of blood donation and the preparation of blood products other than those specified in Directive 89/381/EEC. In addition, the organization will be taking on the task of the Central Laboratory for Blood Transfusion of the Dutch Red Cross, especially the preparation of blood products, as mentioned in the Directive. The proposal outlines the framework within which the organization should provide the service, as well as the policy instruments avaialble to the Minister to ensure that this organization carries out its tasks in accordance with the points of departure and limiting conditions -- which may pertain to, INTER ALIA, the preparation of blood products -- formulated by the Minister. Finally, with a view to being self-sufficient in terms of blood products, the proposal contains an import and export clause which applies to blood products as specified in the Directive, insofar as these originate in countries other than EU Member States. 7. Objective and rationale: Of old, the provision of blood in the Netherlands has been in the hands of private organizations. Since the joint cooperation between these organizations is rather lacking, the general wish has been expressed to work more closely together. From 1998 onwards, this wish will be honoured when an organization will be set up which, pursuant to the present Bill, will be responsible for the effective provision of products prepared from human blood. 8. Relevant documents: Blood Transfusion Act; Act of 10 April 1997 amending the Blood Transfusion Act. 9. Proposed date of adoption: 1 January 1998; Proposed date of entry into force: 1 January 1998. 10. Final date for comments: 1 October 1997. 11. Text available from: National enquiry point. (0239)

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