Commission Implementing Directive 2012/25/EUShow full title

Article 1 Scope

This Directive shall apply to the cross-border exchange of human organs intended for transplantation within the European Union.

Article 2 Subject matter

In line with Article 29 of Directive 2010/53/EU, this Directive sets out:

(a)

procedures for the transmission of information on organ and donor characterisation;

(b)

procedures for the transmission of the necessary information to ensure the traceability of organs;

(c)

procedures for ensuring the reporting of serious adverse events and reactions.

Article 3 Definitions

For the purpose of this Directive, the following definitions shall apply:

(a)

‘Member State of origin’ means the Member State where the organ is procured with the purpose of transplantation;

(b)

‘Member State of destination’ means the Member State to which the organ is sent for the purpose of transplantation;

(c)

‘National donor/recipient identification number’ means the identification code attributed to a donor or a recipient in accordance with the identification system established at national level pursuant to Article 10(2) of Directive 2010/53/EU;

(d)

‘Specification of the organ’ means (1) the anatomical description of an organ including: its type (e.g. heart, liver); (2) where applicable, its position (left or right) in the body; and (3) whether it is a whole organ or a part of an organ, mentioning the lobe or segment of the organ;

(e)

‘a delegated body’ means a body to which tasks have been delegated in accordance with Article 17(1) of Directive 2010/53/EU or a European organ exchange organisation to which tasks have been delegated in accordance with Article 21 of Directive 2010/53/EU.

Article 4 Common procedural rules

1. Member States shall ensure that the information transmitted pursuant to this Directive between competent authorities or delegated bodies, procurement organisations and/or transplantation centres:

(a) is transmitted in writing either electronically or by fax;

(b) is written in a language mutually understood by the sender and the addressee or, in absence thereof, in a mutually agreed language, or, in absence thereof, in English;

(c) is transmitted without undue delay;

(d) is recorded and can be made available upon request;

(e) indicates the date and time of the transmission;

(f) includes the contact details of the person responsible for the transmission;

(g) contains the following reminder:

‘Contains personal data. To be protected against unauthorised disclosure or access.’.

2. In case of urgencies, the information can be exchanged in a verbal form, in particular for exchanges pursuant to Articles 5 and 7. These verbal contacts must be followed by a transmission in writing in accordance with those Articles.

3. The Member States of destination or origin shall ensure that the receipt of the information transmitted in accordance with this Directive is confirmed to the sender, in accordance with the requirements set out in paragraph 1.

4. Member States shall ensure that designated personnel in competent authorities or delegated bodies:

(a) are available 24 hours a day and 7 days a week, for urgent situations;

(b) are able to receive and transmit information pursuant to this Directive without undue delay.

Article 5 Information on organ and donor characterisation

1. Member States shall ensure that, where organs are envisaged for exchange between Member States, prior to exchanging the organ, the competent authority or delegated body of the Member State of origin transmits the information collected to characterise the procured organs and the donor, as specified in Article 7 and in the Annex to Directive 2010/53/EU, to the competent authorities or delegated bodies of the potential Member States of destination.

2. Member States shall ensure that, where some of the information to be transmitted in accordance with paragraph 1 is not available at the time of the initial transmission and becomes available later, it is transmitted in due time to allow for medical decisions:

(a) by the competent authority or delegated body of the Member State of origin to the competent authority or delegated body of the Member State of destination; or

(b) directly by the procurement organisation to the transplantation centre.

3. Member States shall take appropriate measures to ensure that procurement organisations and transplantation centres transmit to their respective competent authorities or delegated bodies a copy of the information pursuant to this Article.

Article 6 Information to ensure the traceability of organs

1. Member States shall ensure that the competent authority or delegated body of the Member State of origin inform the competent authority or delegated body of the Member State of destination of:

(a) the specification of the organ;

(b) the national donor identification number;

(c) the date of procurement;

(d) name and contact details of the procurement centre.

2. Member States shall ensure that the competent authority or delegated body of the Member State of destination inform the competent authority or delegated body of the Member State of origin of:

(a) the national recipient identification number or, if the organ was not transplanted, of its final use;

(b) the date of transplantation, if applicable;

(c) name and contact details of the transplantation centre.

Article 7 Reporting of serious adverse events and reactions

Member States shall ensure that the following procedure is implemented by their competent authorities or delegated bodies:

(a)

Whenever the competent authority or delegated body of the Member State of destination is notified of a serious adverse event or reaction that it suspects to relate to an organ that was received from another Member State, it shall immediately inform the competent authority or delegated body of the Member State of origin and transmit without undue delay to that competent authority or delegated body an initial report containing the information set out in Annex I, in so far as this information is available.

(b)

The competent authority or delegated body of the Member State of origin shall immediately inform the competent authorities or delegated bodies of each concerned Member State of destination and transmit them each an initial report containing the information set out in Annex I, whenever it is notified of a serious adverse event or reaction that it suspects to be related to a donor whose organs were also sent to other Member States.

(c)

When additional information becomes available following the initial report, it shall be transmitted without undue delay.

(d)

The competent authority or delegated body of the Member State of origin shall, as a rule within three months of the initial report transmitted pursuant to point (a) or (b), transmit to the competent authorities or delegated bodies of all Member States of destination, a common final report containing the information set out in Annex II. The competent authorities or delegated bodies of the Member States of destination shall provide relevant information in a timely manner to the competent authority or delegated body of the Member State of origin. The final report shall be drawn up after collecting relevant information from all Member States involved.

Article 8 Interconnection between Member States

1. Member States shall communicate to the Commission the contact details of the competent authority or delegated bodies to which the relevant information shall be transmitted for the purpose of, on the one hand, Article 5, and, on the other hand, Articles 6 and 7. These contact details include at least the following data: the organisation’s name, telephone number, e-mail address, fax number and postal address.

2. Where a Member State has several competent authorities or delegated bodies, it shall ensure that the information received by one of them pursuant to Article 5, 6 or 7 is forwarded to the appropriate competent authority or delegated body at national level, in accordance with the repartition of competences in that Member State.

3. The Commission shall make available to the Member States a list of all competent authorities and delegated bodies designated by Member States in accordance with paragraph 1. The Member States shall keep the information in that list up to date. The Commission may entrust the establishment and maintenance of this list to a third party.

Article 9 Transposition

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 10 April 2014 at the latest.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 10 Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 9 October 2012.

For the Commission

The President

José Manuel Barroso