The Official Journal of the European Union publishes on 6 August 2010, Directive 2010/45/EU of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. In addition to its main concern, the security and quality of human organs, the Directive also contributes indirectly to combating organ trafficking by introducing a series of mechanisms aiming to it.

The Directive considers that in order to reduce the risks and maximise the benefits of transplantation, Member States need to operate an effective framework for quality and safety, which  should be implemented and maintained throughout the entire chain from donation to transplantation or disposal, and should cover the healthcare personnel and organisation, premises, equipment, materials, documentation and record-keeping involved.

For that reason, the Directive on standards of quality and safety of human organs intended for transplantation lays down rules to ensure standards of quality and safety for human organs intended for transplantation to the human body, in order to ensure a high level of human health protection. The transplantations Directive was put forward by the Commission in 2008 and has been one of the priorities identified by Spanish presidency of the Council of the European Union in the filed of health as part of the joint efforts made by the Union in order to guarantee the quality and safety of organs coming from any Member state, also preventing organ trafficking through the establishment of competent authorities, the authorisation of transplantation centres, the establishment of conditions of procurement and systems of traceability.

These provision will apply to the donation, testing, characterisation, procurement, preservation, transport and transplantation of organs intended for transplantation. In those cases where such organs are used for research purposes, they will only apply where they are intended for transplantation into the human body.

The Directive lays down that Member States will have to ensure that a framework for quality and safety is created, including the adoption and implementation of operating procedures for

• the verification of donor identity
• the verification of the details of the donor's or the donor's family's consent, authorisation or absence of any objection
• the verification of the completion of the organ and donor characterisation
• the procurement, preservation, packaging and labelling of organs
• the transportation of organs
• ensuring traceability and guaranteeing compliance with the Union and national provisions on the protection of personal data and confidentiality
• the accurate, rapid and verifiable reporting of serious adverse events and reactions
• the management of serious adverse events and reactions

Member States will bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 27 August 2012, and will have to inform the Commission as soon as these measures are taken.