Biotechnology, pharmaceutical and medical issues (Extract from Preparations for the Health and Consumer Affairs Council on 2-3 December)

December 2, 2002

Brussels, 29 November 2002

The Presidency will present a progress report on the human cells directive. The Commission presented its proposal for a directive on quality and safety standards for human tissue and cells used in medical therapy in June 2002 (see IP/02/894 ). The proposal has not yet finished its First Reading in the European Parliament so ministers can not reach any definitive conclusions. The proposed directive aims to establish EU-wide quality requirements for the donation, procurement and testing of tissues and cells. It sets standards for tissue establishments and requires traceability systems for cells and tissue so that they can be followed from donor to patient and back. Common donation, procurement, processing, preservation, storage and distribution requirements are introduced for cells and tissue used for human transplantation. These requirements do not apply to tissues and cells used for other purposes, such as industrial applications and medicinal products, other EU legislation may however apply (for example the pharmaceutical and medical devices directives). The proposal calls on Member States to collaborate in implementing the proposed measures and to establish accreditation and monitoring structures.

Technical standards will be updated by a Regulatory Committee, following the structure of the Blood Safety Directive, as agreed in co-decision. Further information:

http://europa.eu.int/comm/health/ph/others/human_tissues/index_en.htm

Patient Mobility and Health Care Developments in the EU (TM)

There is a wide range of issues linked to patient mobility and health care in the Internal Market. At their meeting in June 2002, Health Ministers agreed on Council Conclusions on patient mobility and health care developments in the EU. These Conclusions call for a "high-level process of reflection" and Commissioner David Byrne will inform ministers orally on the progress which has been achieved so far.

Bioterrorism and Health Security (TM)

Commissioner Byrne will provide an update on activities at EU and international levels as a follow-up to the Health Council Conclusions of November 2001: Work with the Health Security Committee and progress with the implementation of the action programme of co-operation on preparedness and response to biological and chemical agent threats. In developing this work, the EU is also co-operating with the G7 countries, Mexico and the World Health Organisation (WHO) in the framework of the Global Health Security Action Plan (see also MEMO/02/122 ).

Progress report on the review of the EU pharmaceutical legislation (PH)

The Commission will address the ongoing review of the pharmaceutical legislation following a progress report of the Danish Presidency. The discussion will focus on one of the three legislative acts which form the Commission package proposal to amend the current pharmaceutical legislation, which is the Regulation on the European Medicines Evaluation Agency, EMEA and the centralised procedure. The package includes also two directives, one directive amending the EU code on human medicines and one directive amending the Community code on veterinary medicines.

The European Parliament adopted its opinion at the first reading on 23 October. In its vote on the three legislative acts, the Parliament backed many key parts of the Commission's proposal such as the Commission proposal to extend the scope of the centralised procedure. In particular with regard to the regulation, the Parliament's position is very close to that of the Commission. The proposals need to be endorsed by the Council before the European Parliament may complete its second reading.

DN: MEMO/02/6 Date: 29/11/2002

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