Fleshing out regulations on human tissues and bone

The consultation, which runs until 1 October 2004, seeks to flesh out the new legislation. The rules – which entered into force on 7 April 2004 – set out minimum health and safety standards for the donation, storage and use of human tissues and cells across the Union.

They prohibit the commercial sale of human tissues and cells. The new regimen also requires that data on the donation, transfer and use of human tissues and cells should be kept for at least 30 years after clinical use to enable full traceability.

The European Parliament and the Council of Ministers adopted, in March 2004, Directive 2004/23/EC. Under the terms of the Directive, the Commission is charged with the task of setting the technical requirements for its implementation.

The current consultation covers the early phases of the process: donation, procurement, testing, as well as criteria for donor eligibility and acceptance of tissues and cells. A separate consultation will address the technical requirements for processing, preservation, storage and distribution of human tissues and cells.

Read more here.