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10.10.2012 Official
Journal
of
the
European
Union L
275/27
DIRECTIVES
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,
transmitted pursuant to this Directive, it is appropriate to
include a reminder in the written communications
pursuant to this Directive.
Having regard to the Treaty on the Functioning of the European
Union,
(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
Having regard to Directive 2010/53/EU of the European
2010/53/EU, to keep data needed to ensure full tracea
Parliament and of the Council, of 7 July 2010, on standards
bility for a minimum of 30 years after donation, and
of quality and safety of human organs intended for transplan
without prejudice to the obligations of other bodies in
tation (
that respect, it is appropriate that competent authorities

1 ), and in particular to Article 29 thereof,
or delegated bodies handle and record that information.
Procurement organisations and transplantation centres
should therefore ensure that their respective competent
Whereas:
authorities or delegated bodies receive a copy of the
information on organ and donor characterisation
exchanged pursuant to this Directive, where applicable.
(1)
In order to ensure a high level of public health the
exchange of human organs between Member States
(5) Given
the
current
variety
of
practices
between
Member
requires a detailed set of uniform procedural rules for
States, it is not appropriate at this stage to provide for a
the transmission of information on organs and donor
standard form for the transmission of information on
characterisation, for the traceability of organs and for
organ and donor characterisation in this Directive.
the reporting of serious adverse events and reactions.
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.
(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
(6)
A serious adverse event or reaction may be detected in a
European organ exchange organisations, procurement
Member State of origin or destination and may be of
organisations and transplantation centres. Where such
concern for the quality and safety of the donated
bodies send or receive information for the exchange of
organs and as a consequence for the health of recipients,
human organs, they should act in accordance with the
and in case of living donation also for the health of the
common procedures laid down in this Directive. These
donor. When organs are exchanged between Member
procedures should not preclude additional verbal
States, such concerns may occur in different Member
contacts, in particular in case of urgencies.
States. Moreover, organs from one donor might be trans
planted 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 auth
(3) In
the
implementation
of
this
Directive,
Member
States
orities or delegated bodies in the Member State of
are to ensure that the processing of donors’ and
origin and in the other Member States of destination
recipients’ personal data complies with Directive
have to be informed. It is essential to ensure that all
95/46/EC of the European Parliament and of the
competent authorities or delegated bodies of all the
Council of 24 October 1995 on the protection of indi
Member States concerned are informed without undue
viduals with regard to the processing of personal data
delay. In order to reach this objective, Member States
and on the free movement of such data ( 2 ). In order to
should ensure that all relevant information is
enhance awareness of the persons processing information
disseminated among all Member States concerned
through a set of written reports. Initial reports should
( 1 ) OJ L 207, 6.8.2010, p. 14, corrected by OJ L 243, 16.9.2010, p. 68.
be updated if additional relevant information becomes
( 2 ) OJ L 281, 23.11.1995, p. 31.
available.

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L 275/28
EN
Official Journal of the European Union
10.10.2012
(7) The
transmission
of
information
is
very
often
a
matter
of (e) ‘a delegated body’ means a body to which tasks have been
urgency. It is essential that the senders of information are
delegated in accordance with Article 17(1) of Directive
able to identify and inform rapidly the relevant
2010/53/EU or a European organ exchange organisation
addressees. The competent authorities or delegated
to which tasks have been delegated in accordance with
bodies of a Member State should, where appropriate in
Article 21 of Directive 2010/53/EU.
accordance with the repartition of competence in the
Member State concerned, transfer the information
Article 4
received pursuant to this Directive to the appropriate
recipient. A list of national contact points, including
Common procedural rules
their contact details, should be made available at Union
1. Member
States
shall
ensure
that
the
information
trans
level and be constantly kept up to date.
mitted pursuant to this Directive between competent authorities
or delegated bodies, procurement organisations and/or trans
(8) The
measures
provided
for
in
this
Directive
are
in plantation centres:
accordance with the opinion of the Committee on
organ transplantation, established under Article 30 of
(a) is transmitted in writing either electronically or by fax;
Directive 2010/53/EU,
(b) is written in a language mutually understood by the sender
HAS ADOPTED THIS DIRECTIVE:
and the addressee or, in absence thereof, in a mutually
agreed language, or, in absence thereof, in English;
Article 1
Scope
(c) is transmitted without undue delay;
This Directive shall apply to the cross-border exchange of
(d) is recorded and can be made available upon request;
human organs intended for transplantation within the
European Union.
(e) indicates the date and time of the transmission;
Article 2
(f) includes the contact details of the person responsible for the
Subject matter
transmission;
In line with Article 29 of Directive 2010/53/EU, this Directive
(g) contains the following reminder:
sets out:
‘Contains personal data. To be protected against unautho
(a) procedures for the transmission of information on organ
rised disclosure or access.’.
and donor characterisation;
2. In
case
of
urgencies,
the
information
can
be
exchanged
in
(b) procedures for the transmission of the necessary
a verbal form, in particular for exchanges pursuant to Articles 5
information to ensure the traceability of organs;
and 7. These verbal contacts must be followed by a trans
mission in writing in accordance with those Articles.
(c) procedures for ensuring the reporting of serious adverse
events and reactions.
3. The
Member
States
of
destination
or
origin
shall
ensure
that the receipt of the information transmitted in accordance
Article 3
with this Directive is confirmed to the sender, in accordance
Definitions
with the requirements set out in paragraph 1.
For the purpose of this Directive, the following definitions shall
4. Member
States
shall
ensure
that
designated
personnel
in
apply:
competent authorities or delegated bodies:
(a) ‘Member State of origin’ means the Member State where the
(a) are available 24 hours a day and 7 days a week, for urgent
organ is procured with the purpose of transplantation;
situations;
(b) ‘Member State of destination’ means the Member State to
(b) are able to receive and transmit information pursuant to
which the organ is sent for the purpose of transplantation;
this Directive without undue delay.
(c) ‘National donor/recipient identification number’ means the
Article 5
identification code attributed to a donor or a recipient in
accordance with the identification system established at
Information on organ and donor characterisation
national level pursuant to Article 10(2) of Directive
1. Member
States
shall
ensure
that,
where
organs
are
2010/53/EU;
envisaged for exchange between Member States, prior to
exchanging the organ, the competent authority or delegated
(d) ‘Specification of the organ’ means (1) the anatomical
body of the Member State of origin transmits the information
description of an organ including: its type (e.g. heart,
collected to characterise the procured organs and the donor, as
liver); (2) where applicable, its position (left or right) in
specified in Article 7 and in the Annex to Directive
the body; and (3) whether it is a whole organ or a part
2010/53/EU, to the competent authorities or delegated bodies
of an organ, mentioning the lobe or segment of the organ;
of the potential Member States of destination.

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EN
10.10.2012 Official
Journal
of
the
European
Union L
275/29
2. Member
States
shall
ensure
that,
where
some
of
the
containing the information set out in Annex I, whenever it
information to be transmitted in accordance with paragraph 1
is notified of a serious adverse event or reaction that it
is not available at the time of the initial transmission and
suspects to be related to a donor whose organs were also
becomes available later, it is transmitted in due time to allow
sent to other Member States.
for medical decisions:
(a) by the competent authority or delegated body of the
(c) When additional information becomes available following
Member State of origin to the competent authority or
the initial report, it shall be transmitted without undue
delegated body of the Member State of destination; or
delay.
(b) directly by the procurement organisation to the transplan
(d) The competent authority or delegated body of the Member
tation centre.
State of origin shall, as a rule within three months of the
initial report transmitted pursuant to point (a) or (b),
3. Member
States
shall
take
appropriate
measures
to
ensure
transmit to the competent authorities or delegated bodies
that procurement organisations and transplantation centres
of all Member States of destination, a common final report
transmit to their respective competent authorities or delegated
containing the information set out in Annex II. The
bodies a copy of the information pursuant to this Article.
competent authorities or delegated bodies of the Member
States of destination shall provide relevant information in a
Article 6
timely manner to the competent authority or delegated
body of the Member State of origin. The final report shall
Information to ensure the traceability of organs
be drawn up after collecting relevant information from all
1. Member States shall ensure that the competent authority
Member States involved.
or delegated body of the Member State of origin inform the
competent authority or delegated body of the Member State of
Article 8
destination of:
Interconnection between Member States
(a) the specification of the organ;
1. Member
States
shall
communicate
to
the
Commission
the
(b) the national donor identification number;
contact details of the competent authority or delegated bodies
to which the relevant information shall be transmitted for the
(c) the date of procurement;
purpose of, on the one hand, Article 5, and, on the other hand,
Articles 6 and 7. These contact details include at least the
(d) name and contact details of the procurement centre.
following data: the organisation’s name, telephone number, e-
mail address, fax number and postal address.
2. Member States shall ensure that the competent authority
or delegated body of the Member State of destination inform
2. Where
a
Member
State
has
several
competent
authorities
the competent authority or delegated body of the Member State
or delegated bodies, it shall ensure that the information received
of origin of:
by one of them pursuant to Article 5, 6 or 7 is forwarded to
the appropriate competent authority or delegated body at
(a) the national recipient identification number or, if the organ
national level, in accordance with the repartition of
was not transplanted, of its final use;
competences in that Member State.
(b) the date of transplantation, if applicable;
3. The
Commission
shall
make
available
to
the
Member
(c) name and contact details of the transplantation centre.
States a list of all competent authorities and delegated bodies
designated by Member States in accordance with paragraph 1.
Article 7
The Member States shall keep the information in that list up to
date. The Commission may entrust the establishment and main
Reporting of serious adverse events and reactions
tenance of this list to a third party.
Member States shall ensure that the following procedure is
implemented by their competent authorities or delegated bodies:
Article 9
Transposition
(a) Whenever the competent authority or delegated body of the
Member State of destination is notified of a serious adverse
1. Member
States
shall
bring
into
force
the
laws,
regulations
event or reaction that it suspects to relate to an organ that
and administrative provisions necessary to comply with this
was received from another Member State, it shall
Directive by 10 April 2014 at the latest.
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
When Member States adopt those provisions, they shall contain
an initial report containing the information set out in
a reference to this Directive or be accompanied by such a
Annex I, in so far as this information is available.
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(b) The competent authority or delegated body of the Member
State of origin shall immediately inform the competent
2. Member
States
shall
communicate
to
the
Commission
the
authorities or delegated bodies of each concerned Member
text of the main provisions of national law which they adopt in
State of destination and transmit them each an initial report
the field covered by this Directive.

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L 275/30
EN
Official Journal of the European Union
10.10.2012
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

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EN
10.10.2012 Official
Journal
of
the
European
Union L
275/31
ANNEX I
Initial Report for suspected serious adverse events or reactions
1. Reporting Member State
2. Report identification number: country (ISO)/national number
3. Contact details of the reporter (competent authority or delegated body in the reporting Member State): telephone,
e-mail and, when available, fax
4. Reporting centre/organisation
5. Contact details of coordinator/contact person (transplant/procurement centre in the reporting Member State):
telephone, e-mail and, when available, fax
6. Reporting date and time (yyyy/mm/dd/hh/mm)
7. Member State of origin
8. National donor identification number, as communicated under Article 6
9. All Member States of destination (if known)
10. National recipient identification number(s), as communicated under Article 6
11. Onset date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm)
12. Detection date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm)
13. Description of serious adverse event or reaction
14. Immediate measures taken/proposed

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L 275/32
EN
Official Journal of the European Union
10.10.2012
ANNEX II
Final Report of serious adverse events or reactions
1. Reporting Member State
2. Report identification number: country (ISO)/national number
3. Contact details of the reporter: telephone, e-mail and, when available, fax
4. Reporting date and time (yyyy/mm/dd/hh/mm)
5. Identification number(s) of initial report(s) (Annex I)
6. Description of case
7. Involved Member States
8. Outcome of the investigation and final conclusion
9. Preventive and corrective actions taken
10. Conclusion/Follow-up, if required

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Document Outline

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