Brussels, 02 Dec 2002
The Council took note of a progress report from the Presidency on the proposal for a Directive aimed at setting quality and safety standards for the donation, procurement, testing, processing, storage and distribution of human tissues and cells. It agreed that examination of the proposal should continue with a view to enabling a rapid adoption.
The proposal is aimed at strengthening requirements on the suitability of donors and the screening of donated substances, whilst establishing national accreditation and monitoring structures, and establishing provisions for a register of accredited establishments and for a quality system for tissues and cellsŒrelated establishments. It also aims to establish rules for ensuring the traceability of tissues and cells of human origin from donor to patient and vice versa, as well as a system for the regulation of imports of human tissues and cells from third countries, ensuring equivalent standards of quality and safety.
The Council heard a report from the Commission on the ongoing reflection process on patient mobility and health care developments in the European Union, and in particular on progress made in developing an organisational framework in this regard. The President noted the importance that the Council attaches to this matter, and its intention to follow developments at its future meetings.
It is recalled that, at its meeting on 26 June, the Council agreed on conclusions emphasising the value of the Commission pursuing a highŒlevel reflection process, in close coŒoperation with the Council and the Member States, with the aim of identifying options for possible further action.
The Council heard a report from the Commission on work underway with the aim of preventing and limiting the consequences of possible chemical or biological terrorist threats.
The Commission's report, which will shortly be followed up by a formal communication, focuses on the establishment of a Health Security Committee, comprising high-level representatives of the Member States, responsible for alert raising, exchanging information and co-ordinating health responses in the event of a bioŒterrorist attack.