Nieuwe richtlijn aangenomen over kwaliteits- en veiligheidsstandaarden menselijk weefsel (en)

The Council of Ministers today adopted a directive setting high quality and safety standards for dealing with human tissues and cells throughout the EU (see IP/02/894). Health and Consumer Protection Commissioner David Byrne welcoming today's adoption by the Council said "We now have rules in place with comprehensive and binding requirements for the safety and quality of cells and tissues from donor to patient. This is positive news for hundreds of thousands of patients in Europe who every year, undergo some form of therapeutic treatment based on the use of human tissues and cells. Patients can now be sure that human tissues and cells derived from donations in another Member State nonetheless carry the same guarantees as those in their own country." There will be a register of the entities operating in this field across the EU, quality and safety systems which must apply, what professional requirements and training are needed, provisions for Member State inspections and penalties and mandatory standards and procedures for the tissues and cells chain: donation, testing, procurement, processing, preservation, storage and distribution. It falls under the responsibility of Member States to decide which cells are permitted. These safety and quality standards only apply to the cells and tissues which Member States decide to permit.

The directive sets out quality requirements related to the donation, procurement and testing of tissues and cells as well as standards for tissue establishments in order to ensure a comparable level of safety throughout the EU. Traceability standards, which will ensure that tissues and cells can be followed from donor to patient and back, are also introduced. When the tissues and cells are to be used for other purposes, such as industrial applications and medicinal products and treatments, these latter processes will be covered by other EU legislation.

The directive sets high standards for the suitability of tissue and cell donors and makes provision for the training of staff who are directly involved in any part of the process.

Technical standards will be updated by a Regulatory Committee, following the structure of the 2002 Blood Safety Directive, as agreed in co-decision. All relevant scientific committees will be consulted as appropriate.

The Directive has to be implemented by Member States within two years.