An EU Directive setting standards of quality and safety with regard to human organs intended for transplantation was endorsed by the European Parliament yesterday.

The vote was hailed by the European Commissioner for Health and Consumer Policy, John Dalli, as a major step forward for the over 50,000 European patients waiting for an organ transplantation.

"Organ transplantation is a life-saving operation and often the only available treatment for end-stage organ failure. Common standards across Europe will guarantee the highest level of quality and safety of organs while ensuring that all donations are voluntary and unpaid. This is key to ensure that European citizens that need an organ transplantation can benefit from the best possible quality and safety conditions," Mr Dalli said. The move, he added, was a concrete example of how EU legislation could work to save lives and foster solidarity in Europe.

The directive will lead to quality and safety structures being put in place across the EU for the donation and transplantation of organs. This will also facilitate the exchange of organs and expand the pool of organs available, ensuring a better match between donor and recipient.

A competent authority will be appointed in each member state to ensure that the standards set are complied with. In addition, there will be a system for the authorisation of organ procurement and transplantation based on common quality and safety criteria.

National quality programmes will be introduced to ensure continuous monitoring of performance, leading to learning and improvement. Member states will launch organ traceability systems and systems for the reporting of serious adverse events and reactions and transplant teams across the EU will have their mind at rest that they will get the right and complete information required regardless of the country of origin of the organ.

Apart from setting standards, the measures introduced by the directive should help to fight "organ trafficking".

After adoption by the Council and publication in the Official Journal in June, EU members will have 24 months to transpose the directive into national law. Member states will have to report to the commission every three years on the implementation of the directive.

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