Commission Implementing Directive 2012/25/EUShow full title

Commission Implementing Directive 2012/25/EU

of 9 October 2012

laying down information procedures for the exchange, between Member States, of human organs intended for transplantation

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2010/53/EU of the European Parliament and of the Council, of 7 July 2010, on standards of quality and safety of human organs intended for transplantation(1), and in particular to Article 29 thereof,

Whereas:

(1) In order to ensure a high level of public health the exchange of human organs between Member States requires a detailed set of uniform procedural rules for the transmission of information on organs and donor characterisation, for the traceability of organs and for the reporting of serious adverse events and reactions.

(2) A variety of stakeholders in the Member States may be involved, as senders or as addressees, in the transmission of information for the exchange of human organs, such as competent authorities, delegated bodies including European organ exchange organisations, procurement organisations and transplantation centres. Where such bodies send or receive information for the exchange of human organs, they should act in accordance with the common procedures laid down in this Directive. These procedures should not preclude additional verbal contacts, in particular in case of urgencies.

(3) In the implementation of this Directive, Member States are to ensure that the processing of donors’ and recipients’ personal data complies with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(2). In order to enhance awareness of the persons processing information transmitted pursuant to this Directive, it is appropriate to include a reminder in the written communications pursuant to this Directive.

(4) In order to allow for rapid responses in case of alerts, and in order to facilitate the implementation of the obligation, provided for in Article 10(3)(b) of Directive 2010/53/EU, to keep data needed to ensure full traceability for a minimum of 30 years after donation, and without prejudice to the obligations of other bodies in that respect, it is appropriate that competent authorities or delegated bodies handle and record that information. Procurement organisations and transplantation centres should therefore ensure that their respective competent authorities or delegated bodies receive a copy of the information on organ and donor characterisation exchanged pursuant to this Directive, where applicable.

(5) Given the current variety of practices between Member States, it is not appropriate at this stage to provide for a standard form for the transmission of information on organ and donor characterisation in this Directive. However, in order to facilitate mutual understanding of the information transmitted, such a standard form should be developed in the future, in cooperation with the Member States.

(6) A serious adverse event or reaction may be detected in a Member State of origin or destination and may be of concern for the quality and safety of the donated organs and as a consequence for the health of recipients, and in case of living donation also for the health of the donor. When organs are exchanged between Member States, such concerns may occur in different Member States. Moreover, organs from one donor might be transplanted into recipients in different Member States so that, if a serious adverse event or reaction is first detected in one Member State of destination, the competent authorities or delegated bodies in the Member State of origin and in the other Member States of destination have to be informed. It is essential to ensure that all competent authorities or delegated bodies of all the Member States concerned are informed without undue delay. In order to reach this objective, Member States should ensure that all relevant information is disseminated among all Member States concerned through a set of written reports. Initial reports should be updated if additional relevant information becomes available.

(7) The transmission of information is very often a matter of urgency. It is essential that the senders of information are able to identify and inform rapidly the relevant addressees. The competent authorities or delegated bodies of a Member State should, where appropriate in accordance with the repartition of competence in the Member State concerned, transfer the information received pursuant to this Directive to the appropriate recipient. A list of national contact points, including their contact details, should be made available at Union level and be constantly kept up to date.

(8) The measures provided for in this Directive are in accordance with the opinion of the Committee on organ transplantation, established under Article 30 of Directive 2010/53/EU,

HAS ADOPTED THIS DIRECTIVE:

(1)

OJ L 207, 6.8.2010, p. 14, corrected by OJ L 243, 16.9.2010, p. 68.

(2)

OJ L 281, 23.11.1995, p. 31.