Tissue and Cell Standards, Pharmaceutical legislation, bio-terrorism, patient mobility (Extract from Health and Consumer Affairs: Successful Council meeting on 2 December)

December 4, 2002

Brussels, 3 December 2002

Quality and Safety Standards for Human Tissues and Cells (TM)

The Presidency presented 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 could 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. Commissioner David Byrne reminded ministers that "it is in all our interest for this directive to be adopted as quickly as possible". The Greek Minister for Health and Social Welfare, Kostas Stefanis, announced that the proposal will be one of the public health priorities of the incoming Council Presidency of Greece.

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

Bioterrorism and Health Security (TM)

Commissioner David Byrne provided 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 ).

David Byrne will participate in a G7+ meeting in Mexico from 6 December on to take stock and to decide on a number of key issues such as the development of an international scale for reporting bioterror incidents for public communications, the holding of an evaluation exercise especially regarding plans for the case of a smallpox outbreak, the launch of a new international network of high-level laboratories and the identification of a workplan on chemical incidents preparedness.

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

The Council took note of the progress report. A brief exchange of views took place, in particular on the three legislative acts:

- the scope of the centralised procedure for granting marketing authorisations

    - the composition of the Management Board of the European Medicines Evaluation Agency (EMEA)

    - the provisions on renewal of marketing authorisations

The Commission will proceed in revising its proposed Regulation on EMEA (in the light of the amendments of the European Parliament tabled during its first reading on 23 October 2002). In principle, the Commission's modified proposal should be ready for a Common position by the Council shortly.

The Member States were invited by the Danish Presidency to continue discussions on outstanding issues.

Patient Mobility and Health Care Developments in the EU

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 informed ministers orally on the progress which has been achieved so far and the great interest to participate in this informal process. Preparatory meetings have been held to structure the high-level reflection process around three main themes: 1) European-wide cooperation to enable better use of resources, 2) information requirements for patients, professionals and policy-makers and 3) access to and quality of care. A first meeting of the high-level reflection process itself is envisaged for February 2003. "Member States are responsible for their own healthcare systems and will remain so. It is not the aim of this reflection process to change that, but it is an opportunity to reflect and to collectively consider the full range of issues affecting health and health systems at European level and to see how best to respond. European Health systems share many common aims, whilst remaining distinctively national. This reflection process is intended to work towards a common vision of how Europe should help to support and foster those aims", David Byrne said.

DN: MEMO/02/8 Date: 03/12/2002

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