Brussels, 25 June 2002
Commissioner Byrne will present the Commission's proposal for a Directive on safety and quality standards for human cells and tissues used in therapy throughout the European Union (see IP/02/894 ). The measure aims to ensure comprehensive binding requirements for these human substances from donor to patient. EU action in this area is needed because each year in Europe, hundreds of thousands of patients undergo some form of therapeutic treatment based on the use of human tissues and cells. The establishment of quality and safety standards throughout the EU will help to reassure the public that human tissues and cells derived from donations in another Member State nonetheless carry the same guarantees as those in their own country. It falls under the responsibility of Member States to decide which cells are permitted. These safety and quality standards will only be applied to the cells and tissues which Member States decide to permit. The proposal fully respects the existing ethical orientations of the Charter of Fundamental Rights, the advice of the European Group on Ethics and the Council of Europe. However, binding ethical rules are strictly the responsibility of the Member States.
(TM) (Thorsten Münch, Per Haugaard)
DN: MEMO/02/150 Date: 25/06/2002