Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Date: 2004-03-31
Institutions: Council of the European Union, European Parliament
Subjects: cytology, health control, medicine, quality standard, safety standard, surgery

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DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 31 March 2004

on setting standards of quality and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissues and cells

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(4)

Having regard to the Treaty establishing the European
Community, and in particular Article 152(4)(a) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and
Social Committee (2),

Following consultation of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

(5)

Whereas:

(1)

(2)

(3)

The transplantation of human tissues and cells is a
strongly expanding field of medicine offering great
incurable
opportunities for
diseases. The quality and safety of
these substances
should be ensured, particularly in order to prevent the
transmission of diseases.

the treatment of as yet

The availability of human tissues and cells used for
therapeutic purposes is dependent on Community citi-
zens who are prepared to donate them. In order to safe-
guard public health and to prevent the transmission of
infectious diseases by these tissues and cells, all safety
measures need to be taken during their donation,
procurement, testing, processing, preservation, storage,
distribution and use.

It is necessary to promote information and awareness
campaigns at national and European level on the dona-
tion of tissues, cells and organs based on the theme ‘we
are all potential donors’. The aim of these campaigns
should be to help European citizens decide to become
donors during their lifetime and let their families or legal
representatives know their wishes. As there is a need to
ensure the availability of tissues and cells for medical
treatments, Member States should promote the donation
of tissues and cells,
including haematopoietic progeni-
tors, of high quality and safety, thereby also increasing
self-sufficiency in the Community.

(1) OJ C 227 E, 24.9.2002, p. 505.
(2) OJ C 85, 8.4.2003, p. 44.
(3) Opinion of the European Parliament of 10 April 2003 (not yet
published in the Official Journal), Council common position of 22
July 2003 (OJ C 240 E, 7.10.2003, p. 3), position of the European
Parliament of 16 December 2003 (not yet published in the Official
Journal) and decision of the Council of 2 March 2004.

(6)

(7)

(8)

There is an urgent need for a unified framework in order
to ensure high standards of quality and safety with
respect to the procurement, testing, processing, storage
and distribution of tissues and cells across the Com-
munity and to facilitate exchanges thereof for patients
receiving this type of therapy each year. It is essential,
that
therefore,
human tissues and cells, whatever their intended use, are
of comparable quality and safety. The establishment of
such standards, therefore, will help to reassure the public
that human tissues and cells that are procured in
another Member State, nonetheless carry the same guar-
antees as those in their own country.

that Community provisions

ensure

As tissue and cell therapy is a field in which an intensive
worldwide exchange is taking place,
it is desirable to
have worldwide standards. The Community should
therefore endeavour to promote the highest possible
level of protection to safeguard public health regarding
quality and safety of tissues and cells. The Commission
should include in its report to the European Parliament
and to the Council information on the progress made in
this respect.

Tissues and cells intended to be used for industrially
manufactured products,
including medical devices,
should be covered by this Directive only as far as dona-
tion, procurement and testing are concerned, where the
processing, preservation, storage and distribution are
regulated by other Community legislation. The further
manufacturing steps are covered by Directive 2001/83/
EC of the European Parliament and of the Council of 6
November 2001 on the Community code relating to
medicinal products for human use (4).

This Directive should apply to tissues and cells including
haematopoietic peripheral blood, umbilical-cord (blood)
and bone-marrow stem cells, reproductive cells (eggs,
sperm), foetal tissues and cells and adult and embryonic
stem cells.

This Directive excludes blood and blood products (other
and human
than haematopoietic progenitor
organs, as well as organs, tissues, or cells of animal
origin. Blood and blood products are currently regulated
by

cells)

(4) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Commis-

sion Directive 2003/63/EC (OJ L 159, 27.6.2003, p. 46).

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Directives 2001/83/EC and 2000/70/EC (1), Recommen-
dation 98/463/EC (2)
and Directive 2002/98/EC (3).
Tissues and cells used as an autologous graft (tissues
removed and transplanted back to the same individual),
within the same surgical procedure and without being
subjected to any banking process, are also excluded from
this Directive. The quality and safety considerations asso-
ciated with this process are completely different.

(9)

The use of organs to some extent raises the same issues
as the use of tissues and cells, though there are serious
differences, and the two subjects should therefore not be
covered by one directive.

(10)

(11)

(12)

This Directive covers tissues and cells intended for
human applications, including human tissues and cells
used for the preparation of cosmetic products. However,
in view of the risk of transmission of communicable
diseases, the use of human cells, tissues and products in
cosmetic products is prohibited by Commission Direc-
tive 95/34/EC of 10 July 1995 adapting to technical
progress Annexes II, III, VI and VII to Council Directive
76/768/EEC on the approximation of the laws of the
Member States relating to cosmetic products (4).

This Directive does not cover research using human
tissues and cells, such as when used for purposes other
than application to the human body, e.g. in vitro research
or in animal models. Only those cells and tissues that in
clinical trials are applied to the human body should
comply with the quality and safety standards laid down
in this Directive.

This Directive should not interfere with decisions made
by Member States concerning the use or non-use of any
specific type of human cells, including germ cells and
embryonic stem cells. If, however, any particular use of
such cells is authorised in a Member State, this Directive
will require the application of all provisions necessary to
protect public health, given the specific risks of these
cells based on the scientific knowledge and their particu-
lar nature, and guarantee respect for fundamental rights.
Moreover, this Directive should not interfere with provi-
sions of Member States defining the legal term ‘person’
or ‘individual’.

(1) Directive 2000/70/EC of

the European Parliament and of

the
Council of 16 November 2000 amending Council Directive 93/42/
EEC as regards medical devices incorporating stable derivates of
human blood or human plasma (OJ L 313, 13.12.2000, p. 22).
(2) Council Recommendation of 29 June 1998 on the suitability of
blood and plasma donors and the screening of donated blood in the
European Community (OJ L 203, 21.7.1998, p. 14).

(3) Directive 2002/98/EC of

the
Council of 27 January 2003 setting standards of quality and safety
for the collection, testing, processing, storage and distribution of
human blood and blood components (OJ L 33, 8.2.2003, p. 30).

the European Parliament and of

(4) OJ L 167, 18.7.1995, p. 19.

(13)

(14)

(15)

(16)

The donation, procurement, testing, processing, preser-
vation, storage and distribution of human tissues and
cells intended for human applications should comply
with high standards of quality and safety in order to
ensure a high level of health protection in the Com-
munity. This Directive should establish standards for
each one of the steps in the human tissues and cells
application process.

The clinical use of tissues and cells of human origin for
human application may be constrained by limited avail-
ability. Therefore it would be desirable that the criteria
for access to such tissues and cells are defined in a trans-
parent manner, on the basis of an objective evaluation
of medical needs.

It is necessary to increase confidence among the Member
States in the quality and safety of donated tissues and
cells,
living donors and
respect for deceased donors and in the safety of the
application process.

in the health protection of

allogeneic

and cells used for

Tissues
therapeutic
purposes can be procured from both living and deceased
donors. In order to ensure that the health status of a
living donor is not affected by the donation, a prior
medical examination should be required. The dignity of
the deceased donor
respected, notably
through the reconstruction of the donor's body, so that
it is as similar as possible to its original anatomical
shape.

should be

(17)

The use of tissues and cells for application in the human
body can cause diseases and unwanted effects. Most of
these can be prevented by careful donor evaluation and
the testing of each donation in accordance with rules
established and updated according to the best available
scientific advice.

(18) As a matter of principle,

tissue and cell application
programmes should be founded on the philosophy of
voluntary and unpaid donation, anonymity of both
donor and recipient, altruism of the donor and solidarity
between donor and recipient. Member States are urged
to take steps to encourage a strong public and non-
profit sector involvement in the provision of tissue and
cell application services and the related research and
development.

(19)

Voluntary and unpaid tissue and cell donations are a
factor which may contribute to high safety standards for
tissues and cells and therefore to the protection of
human health.

(20) Any establishment may also be accredited as a tissue and
cell establishment, provided it complies with the stan-
dards.

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licensed under

the provisions of

(21) With due regard to the principle of transparency, all
tissue establishments accredited, designated, authorised
or
this Directive,
including those manufacturing products from human
tissues and cells, whether subject or not to other Com-
munity legislation, should have access to relevant tissues
and cells procured in accordance with the provisions of
this Directive, without prejudice to the provisions in
force in Member States on the use of tissues and cells.

(22)

the fundamental

This Directive respects
rights and
observes the principles reflected in the Charter of Funda-
mental Rights of the European Union (1) and takes into
account as appropriate the Convention for the protec-
tion of human rights and dignity of the human being
with regard to the application of biology and medicine:
Convention on human rights and biomedicine. Neither
the Charter nor the Convention makes express provision
for harmonisation or prevents Member States from
introducing more stringent requirements in their legisla-
tion.

(23) All necessary measures need to be taken in order to
provide prospective donors of
tissues and cells with
assurances regarding the confidentiality of any health-
related
authorised
provided
personnel, the results of tests on their donations, as well
as any future traceability of their donation.

information

the

to

(24) 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 the free movement of such data (2) applies to
personal data processed in application of this Directive.
Article 8 of
that directive prohibits in principle the
processing of data concerning health. Limited exemp-
tions to this prohibition principle are laid down. Direc-
tive 95/46/EC also provides for the controller to imple-
ment appropriate technical and organisational measures
to protect personal data against accidental or unlawful
destruction or accidental
loss, alteration, unauthorised
disclosure or access and against all other unlawful forms
of processing.

(25) An accreditation system for tissue establishments and a
system for notification of adverse events and reactions
linked to the procurement, testing, processing, preserva-
tion, storage and distribution of human tissues and cells
should be established in the Member States.

comply with the provisions of this Directive. Member
States should ensure that the officials involved in inspec-
tions and control measures are appropriately qualified
and receive adequate training.

(27)

testing, processing, preservation,

Personnel directly involved in the donation, procure-
ment,
storage and
distribution of human tissues and cells should be appro-
priately qualified and provided with timely and relevant
training. The provisions laid down in this Directive as
regards training should be applicable without prejudice
to existing Community legislation on the recognition of
professional qualifications.

(28) An adequate system to ensure the traceability of human
tissues and cells should be established. This would also
make it possible to verify compliance with quality and
safety standards. Traceability should be enforced through
accurate substance, donor, recipient, tissue establishment
and laboratory identification procedures as well as
record maintenance and an appropriate labelling system.

(29) As a general principle, the identity of the recipient(s)
should not be disclosed to the donor or his/her family
and vice versa, without prejudice to legislation in force
in Member States on the conditions of disclosure, which
could authorise in exceptional cases, notably in the case
of gametes donation, the lifting of donor anonymity.

(30)

In order to increase the effective implementation of the
provisions adopted in accordance with this Directive, it
is appropriate to provide for penalties to be applied by
Member States.

(31)

Since the objective of this Directive, namely to set high
standards of quality and safety for human tissues and
cells throughout the Community, cannot be sufficiently
achieved by the Member States and can therefore, by
reason of scale and effects, be better achieved at Com-
munity level, the Community may adopt measures in
accordance with the principle of subsidiarity as set out
in Article 5 of the Treaty. In accordance with the prin-
ciple of proportionality, as set out in that Article, this
Directive does not go beyond what is necessary in order
to achieve that objective.

(26) Member States should organise inspections and control
measures, to be carried out by officials representing the
competent authority, to ensure that tissue establishments

(32)

(1) OJ C 364, 18.12.2000, p. 1.
(2) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

It is necessary that the best possible scientific advice is
available to the Community in relation to the safety of
tissues and cells;
in particular in order to assist the
Commission in adapting the provisions of this Directive
to scientific and technical progress in the light of the
rapid advance in biotechnology knowledge and practice
in the field of human tissues and cells.

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(33)

(34)

The opinions of the Scientific Committee for Medicinal
Products and Medical Devices and that of the European
Group on Ethics in Science and New Technologies have
been taken into account, as well as international experi-
ence in this field, and will be sought in the future when-
ever necessary.

The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (1),

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Objective

This Directive lays down standards of quality and safety for
human tissues and cells intended for human applications,
in
order to ensure a high level of protection of human health.

Article 2

Scope

1.
This Directive shall apply to the donation, procurement,
testing, processing, preservation, storage and distribution of
human tissues and cells intended for human applications and
of manufactured products derived from human tissues and cells
intended for human applications.

Where such manufactured products are covered by other direc-
tives, this Directive shall apply only to donation, procurement
and testing.

2.

This Directive shall not apply to:

(a) tissues and cells used as an autologous graft within the

same surgical procedure;

(b) blood and blood components as defined by Directive 2002/

98/EC;

(c) organs or parts of organs if it is their function to be used
for the same purpose as the entire organ in the human
body.

(1) OJ L 184, 17.7.1999, p. 23.

Article 3

Definitions

For the purposes of this Directive:

(a) ‘cells’ means individual human cells or a collection of
human cells when not bound by any form of connective
tissue;

(b) ‘tissue’ means all constituent parts of the human body

formed by cells;

(c) ‘donor’ means every human source, whether living or

deceased, of human cells or tissues;

(d) ‘donation’ means donating human tissues or cells intended

for human applications;

(e) ‘organ’ means a differentiated and vital part of the human
body, formed by different tissues, that maintains its struc-
ture, vascularisation and capacity to develop physiological
functions with an important level of autonomy;

(f) ‘procurement’ means a process by which tissue or cells are

made available;

(g) ‘processing’ means all operations involved in the prepara-
tion, manipulation, preservation and packaging of tissues
or cells intended for human applications;

(h) ‘preservation’ means the use of chemical agents, alterations
in environmental conditions or other means during
processing to prevent or retard biological or physical dete-
rioration of cells or tissues;

(i) ‘quarantine’ means the status of retrieved tissue or cells, or
tissue isolated physically or by other effective means,
whilst awaiting a decision on their acceptance or rejection;

(j) ‘storage’ means maintaining the product under appropriate

controlled conditions until distribution;

(k) ‘distribution’ means transportation and delivery of tissues

or cells intended for human applications;

(l) ‘human application’ means the use of tissues or cells on or

in a human recipient and extracorporal applications;

(m) ‘serious adverse event’ means any untoward occurrence
associated with the procurement,
testing, processing,
storage and distribution of tissues and cells that might lead
to the transmission of a communicable disease, to death or
life-threatening, disabling or incapacitating conditions for
patients or which might result in, or prolong, hospitalisa-
tion or morbidity;

(n) ‘serious adverse reaction’ means an unintended response,
including a communicable disease, in the donor or in the
recipient associated with the procurement or human appli-
cation of tissues and cells that is fatal,
life-threatening,
disabling, incapacitating or which results in, or prolongs,
hospitalisation or morbidity;

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(o) ‘tissue establishment’ means a tissue bank or a unit of a
hospital or another body where activities of processing,
preservation, storage or distribution of human tissues and
cells are undertaken.
It may also be responsible for
procurement or testing of tissues and cells;

(p) ‘allogeneic use’ means cells or tissues removed from one

person and applied to another;

(q) ‘autologous use’ means cells or tissues removed from and

applied in the same person.

Article 4

Implementation

1. Member States shall designate the competent authority or
authorities responsible for implementing the requirements of
this Directive.

This Directive shall not prevent a Member State from
2.
maintaining or introducing more stringent protective measures,
provided that they comply with the provisions of the Treaty.

In particular, a Member State may introduce requirements for
voluntary unpaid donation, which include the prohibition or
restriction of imports of human tissues and cells, to ensure a
high level of health protection, provided that the conditions of
the Treaty are met.

the decisions of

This Directive does not affect

3.
the
Member States prohibiting the donation, procurement, testing,
processing, preservation, storage, distribution or use of any
specific type of human tissues or cells or cells from any speci-
fied source,
including where those decisions also concern
imports of the same type of human tissues or cells.

In carrying out the activities covered by this Directive, the
4.
Commission may have recourse to technical and/or administra-
tive assistance to the mutual benefit of the Commission and of
the beneficiaries, relating to identification, preparation, manage-
ment, monitoring, audit and control, as well as to support
expenditure.

CHAPTER II

OBLIGATIONS ON MEMBER STATES' AUTHORITIES

The competent authority or authorities shall

take all
2.
necessary measures to ensure that tissue and cell procurement
complies with the requirements referred to in Article 28(b), (e)
and (f). The tests required for donors shall be carried out by a
qualified laboratory accredited, designated,
authorised or
licensed by the competent authority or authorities.

Article 6

Accreditation, designation, authorisation or licensing of
tissue establishments and tissue and cell preparation
processes

1. Member States shall ensure that all tissue establishments
where activities of testing, processing, preservation, storage or
distribution of human tissues and cells intended for human
applications are undertaken have been accredited, designated,
authorised or
the
purpose of those activities.

licensed by a competent authority for

2.
The competent authority or authorities, having verified
that the tissue establishment complies with the requirements
referred to in Article 28(a), shall accredit, designate, authorise
or license the tissue establishment and indicate which activities
it may undertake and which conditions apply. It or they shall
authorise the tissue and cell preparation processes which the
tissue establishment may carry out in accordance with the
requirements referred to in Article 28(g). Agreements between
tissue establishments and third parties, as referred to in Article
24, shall be examined within the framework of this procedure.

3.
The tissue establishment shall not undertake any substan-
tial changes to its activities without the prior written approval
of the competent authority or authorities.

4.
The competent authority or authorities may suspend or
revoke the accreditation, designation, authorisation or licensing
of a tissue establishment or of a tissue or cell preparation
process if inspections or control measures demonstrate that
such an establishment or process does not comply with the
requirements of this Directive.

5.
Some specified tissues and cells, which will be determined
in accordance with the requirements referred to in Article 28(i),
may, with the agreement of the competent authority or autho-
rities, be distributed directly for immediate transplantation to
the recipient as long as the supplier is provided with an accred-
itation, designation, authorisation or licence for this activity.

Article 5

Supervision of human tissue and cell procurement

Article 7

Inspections and control measures

1. Member States shall ensure that tissue and cell procure-
ment and testing are carried out by persons with appropriate
training and experience and that they take place in conditions
accredited, designated, authorised or licensed for that purpose
by the competent authority or authorities.

1. Member States shall ensure that the competent authority
or authorities organise inspections and that tissue establish-
ments carry out appropriate control measures in order to
ensure compliance with the requirements of this Directive.

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2. Member States shall also ensure that appropriate control
measures are in place for the procurement of human tissues
and cells.

3.
Inspections shall be organised and control measures shall
be carried out by the competent authority or authorities on a
regular basis. The interval between two inspections shall not
exceed two years.

Such inspections and control measures shall be carried
4.
out by officials representing the competent authority, who shall
be empowered to:

(a) inspect tissue establishments and the facilities of any third

parties as specified in Article 24;

(b) evaluate and verify the procedures and the activities carried
out
third
in tissue establishments and the facilities of
parties that are relevant to the requirements of this Direc-
tive;

(c) examine any documents or other records relating to the

requirements of this Directive.

Guidelines concerning the conditions of the inspections
5.
and control measures, and on the training and qualification of
the officials involved in order to reach a consistent level of
competence and performance, shall be established in accord-
ance with the procedure referred to in Article 29(2).

6.
The competent authority or authorities shall organise
inspections and carry out control measures as appropriate
whenever there is any serious adverse reaction or serious
adverse event. In addition, such an inspection shall be orga-
nised and control measures shall be carried out at the duly
justified request of the competent authority or authorities in
another Member State in any such case.

shall, upon the request of another
7. Member States
Member State or the Commission, provide information on the
results of inspections and control measures carried out in rela-
tion to the requirements of this Directive.

Article 8

Traceability

1. Member States shall ensure that all
tissues and cells
procured, processed, stored or distributed on their territory can
be traced from the donor to the recipient and vice versa. This
traceability shall also apply to all relevant data relating to
products and materials coming into contact with these tissues
and cells.

2. Member States shall ensure the implementation of a
donor identification system which assigns a unique code to
each donation and to each of the products associated with it.

3.
All tissues and cells must be identified with a label that
contains the information or references allowing a link to the
information referred to in Article 28(f) and (h).

4.
Tissue establishments shall keep the data necessary to
ensure traceability at all stages. Data required for full trace-
ability shall be kept for a minimum of 30 years after clinical
use. Data storage may also be in electronic form.

The traceability requirements for tissues and cells, as well
5.
as for products and materials coming into contact with these
tissues and cells and having an effect on their quality and
safety, shall be established by the Commission in accordance
with the procedure referred to in Article 29(2).

6.
The procedures for ensuring traceability at Community
level shall be established by the Commission in accordance
with the procedure referred to in Article 29(2).

Article 9

Import/export of human tissues and cells

1. Member States shall take all necessary measures to ensure
that all imports of tissues and cells from third countries are
undertaken by tissue establishments accredited, designated,
authorised or licensed for the purpose of those activities, and
that imported tissues and cells can be traced from the donor to
the recipient and vice versa in accordance with the procedures
referred to in Article 8. Member States and tissue establish-
ments that receive such imports from third countries shall
ensure that they meet standards of quality and safety equivalent
to the ones laid down in this Directive.

by

tissue

2. Member States shall take all necessary measures to ensure
that all exports of tissues and cells to third countries are under-
designated,
taken
authorised or licensed for the purpose of those activities. Those
Member States that send such exports to third countries shall
ensure that the exports comply with the requirements of this
Directive.

establishments

accredited,

3.

(a) The import or export of tissues and cells referred to in
Article 6(5) may be authorised directly by the competent
authority or authorities.

(b) In case of emergency, the import or export of certain
tissues and cells may be authorised directly by the
competent authority or authorities.

(c) The competent authority or authorities shall take all
necessary measures to ensure that imports and exports
of tissues and cells referred to in subparagraphs (a) and
(b) meet quality and safety standards equivalent to those
laid down in this Directive.

4.
The procedures for verifying the equivalent standards of
quality and safety in accordance with paragraph 1 shall be
established by the Commission, in accordance with the proce-
dure referred to in Article 29(2).

Article 10

Register of tissue establishments and reporting obligations

1.
Tissue establishments shall keep a record of their activ-
ities, including the types and quantities of tissues and/or cells
procured, tested, preserved, processed, stored and distributed,
or otherwise disposed of, and on the origin and destination of
the tissues and cells intended for human applications,
in
accordance with the requirements referred to in Article 28(f).
They shall submit to the competent authority or authorities an
annual report on these activities. This report shall be publicly
accessible.

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The competent authority or authorities shall establish and
2.
maintain a publicly accessible register of tissue establishments
specifying the activities for which they have been accredited,
designated, authorised or licensed.

report

to the Commission on these
Member States shall
measures before 7 April 2006 and thereafter every three years.
On the basis of these reports the Commission shall inform the
European Parliament and the Council of any necessary further
measures it intends to take at Community level.

3. Member States and the Commission shall establish a
network linking the national tissue establishment registers.

Article 11

Notification of serious adverse events and reactions

1. Member States shall ensure that there is a system in place
to report, investigate, register and transmit information about
serious adverse events and reactions which may influence the
quality and safety of tissues and cells and which may be attrib-
uted to the procurement, testing, processing, storage and distri-
bution of tissues and cells, as well as any serious adverse reac-
tion observed during or after clinical application which may be
linked to the quality and safety of tissues and cells.

2.
All persons or establishments using human tissues and
cells regulated by this Directive shall report any relevant infor-
mation to establishments engaged in the donation, procure-
ment, testing, processing, storage and distribution of human
tissues and cells in order to facilitate traceability and ensure
quality and safety control.

3.
The responsible person referred to in Article 17 shall
ensure that the competent authority or authorities is or are
notified of any serious adverse events and reactions referred to
in paragraph 1 and is or are provided with a report analysing
the cause and the ensuing outcome.

4.
The procedure for notifying serious adverse events and
reactions shall be established by the Commission, in accordance
with the procedure referred to in Article 29(2).

Each tissue establishment shall ensure that an accurate,
5.
rapid and verifiable procedure is in place which will enable it
to recall from distribution any product which may be related to
an adverse event or reaction.

CHAPTER III

DONOR SELECTION AND EVALUATION

Article 12

Principles governing tissue and cell donation

1. Member States shall endeavour to ensure voluntary and
unpaid donations of tissues and cells.

2. Member States shall take all necessary measures to ensure
that any promotion and publicity activities in support of the
donation of human tissues and cells comply with guidelines or
legislative provisions laid down by the Member States. Such
guidelines or legislative provisions shall
include appropriate
restrictions or prohibitions on advertising the need for, or avail-
ability of, human tissues and cells with a view to offering or
seeking financial gain or comparable advantage.

Member States shall endeavour to ensure that the procurement
of tissues and cells as such is carried out on a non-profit basis.

Article 13

Consent

1.
The procurement of human tissues or cells shall be
authorised only after all mandatory consent or authorisation
requirements in force in the Member State concerned have
been met.

2. Member States shall, in keeping with their national legis-
lation, take all necessary measures to ensure that donors, their
relatives or any persons granting authorisation on behalf of the
donors are provided with all appropriate information as
referred to in the Annex.

Article 14

Data protection and confidentiality

1. Member States shall take all necessary measures to ensure
that all data, including genetic information, collated within the
scope of this Directive and to which third parties have access,
have been rendered anonymous so that neither donors nor reci-
pients remain identifiable.

2.

For that purpose, they shall ensure that:

(a) data security measures are in place, as well as safeguards
against any unauthorised data additions, deletions or modi-
fications to donor files or deferral records, and transfer of
information;

(b) procedures are in place to resolve data discrepancies; and

(c) no unauthorised disclosure of information occurs, whilst

guaranteeing the traceability of donations.

Donors may receive compensation, which is strictly limited to
making good the expenses and inconveniences related to the
donation. In that case, Member States define the conditions
under which compensation may be granted.

3. Member States shall take all necessary measures to ensure
that the identity of the recipient(s) is not disclosed to the donor
or his family and vice versa, without prejudice to legislation in
force in Member States on the conditions for disclosure,
notably in the case of gametes donation.

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Article 15

Selection, evaluation and procurement

Article 17

Responsible person

The activities related to tissue procurement shall be
1.
carried out in such a way as to ensure that donor evaluation
and selection is carried out in accordance with the require-
ments referred to in Article 28(d) and (e) and that the tissues
and cells are procured, packaged and transported in accordance
with the requirements referred to in Article 28(f).

2.
In the case of an autologous donation, the suitability
criteria shall be established in accordance with the requirements
referred to in Article 28(d).

3.
The results of the donor evaluation and testing proce-
dures shall be documented and any major anomalies shall be
reported in accordance with the requirements referred to in the
Annex.

4.
The competent authority or authorities shall ensure that
all activities related to tissue procurement are carried out in
accordance with the requirements referred to in Article 28(f).

CHAPTER IV

Every tissue establishment shall designate a responsible
1.
person who shall at least fulfil the following conditions and
have the following qualifications:

(a) possession of a diploma, certificate or other evidence of
formal qualifications in the field of medical or biological
sciences awarded on completion of a university course of
study or a course recognised as equivalent by the Member
State concerned;

(b) at least two years' practical experience in the relevant fields.

The person designated in paragraph 1 shall be responsible

2.
for:

(a) ensuring that human tissues and cells intended for human
applications in the establishment for which that person is
responsible are procured,
tested, processed, stored and
distributed in accordance with this Directive and with the
laws in force in the Member State;

(b) providing information to the competent authority or autho-

rities as required in Article 6;

PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES
AND CELLS

(c) implementing the requirements of Articles 7, 10, 11, 15,

16 and 18 to 24 within the tissue establishment.

Article 16

Quality management

1. Member States shall take all necessary measures to ensure
that each tissue establishment puts in place and updates a
quality system based on the principles of good practice.

The Commission shall establish the Community standards
for activities

2.
and specifications referred to in Article 28(c)
relating to a quality system.

3.
Tissue establishments shall take all necessary measures to
ensure that the quality system includes at least the following
documentation:

— standard operating procedures,

— guidelines,

— training and reference manuals,

— reporting forms,

— donor records,

shall

Tissue

inform the

establishments

3.
competent
authority or authorities of the name of the responsible person
referred to in paragraph 1. Where the responsible person is
permanently or temporarily replaced, the tissue establishment
shall immediately inform the competent authority of the name
of the new responsible person and the date on which the duties
of that person commence.

Article 18

Personnel

Personnel directly involved in activities relating to the procure-
ment, processing, preservation, storage and distribution of
tissues and cells in a tissue establishment shall be qualified to
perform such tasks and shall be provided with the training
referred to in Article 28(c).

Article 19

Tissue and cell reception

— information on the final destination of tissues or cells.

Tissue establishments shall take all necessary measures to
4.
ensure that this documentation is available for inspection by
the competent authority or authorities.

1.
Tissue establishments shall ensure that all donations of
human tissues and cells are subjected to tests in accordance
with the requirements referred to Article 28(e) and that the
selection and acceptance of tissues and cells comply with the
requirements referred to in Article 28(f).

Tissue establishments shall keep the data necessary to

5.
ensure traceability in accordance with Article 8.

2.
Tissue establishments shall ensure that human tissue and
cells and associated documentation comply with the require-
ments referred to in Article 28(f).

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Tissue establishments shall verify and record the fact that
3.
the packaging of human tissue and cells received complies with
the requirements referred to in Article 28(f). All tissues and
cells that do not comply with those provisions shall be
discarded.

The acceptance or rejection of received tissues/cells shall

4.
be documented.

Tissue establishments shall ensure that human tissues and
5.
cells are correctly identified at all times. Each delivery or batch
of tissues or cells shall be assigned an identifying code,
in
accordance with Article 8.

tissue establishments
5. Member States shall ensure that
have agreements and procedures in place to ensure that, in the
event of termination of activities for whatever reason, stored
tissues and cells shall be transferred to other tissue establish-
ment or establishments accredited, designated, authorised or
licensed in accordance with Article 6, without prejudice to
Member States' legislation concerning the disposal of donated
tissues or cells, according to the consent pertaining to them.

Article 22

Labelling, documentation and packaging

6.
Tissue and cells shall be held in quarantine until such
time as the requirements relating to donor testing and informa-
tion have been met in accordance with Article 15.

Tissue establishments shall ensure that labelling, documentation
and packaging conform to the requirements referred to in
Article 28(f).

Article 20

Tissue and cell processing

1.
Tissue establishments shall include in their standard oper-
ating procedures all processes that affect quality and safety and
shall ensure that they are carried out under controlled condi-
tions. Tissue establishments shall ensure that the equipment
used, the working environment and process design, validation
and control conditions are in compliance with the requirements
referred to in Article 28(h).

2.
Any modifications to the processes used in the prepara-
tion of tissues and cells shall also meet the criteria laid down in
paragraph 1.

3.
Tissue establishments shall include in their standard oper-
ating procedures special provisions for the handling of tissues
and cells to be discarded, in order to prevent the contamination
of other
the processing environment or
personnel.

tissues or cells,

Article 21

Tissue and cell storage conditions

1.
Tissue establishments shall ensure that all procedures
associated with the storage of tissues and cells are documented
in the standard operating procedures and that
the storage
conditions comply with the requirements referred to in Article
28(h).

Article 23

Distribution

Tissue establishments shall ensure the quality of tissues and
cells during distribution. Distribution conditions shall comply
with the requirements referred to in Article 28(h).

Article 24

Relations between tissue establishments and third parties

1.
Tissue establishments shall establish written agreements
with a third party each time an external activity takes place
which influences the quality and safety of tissues and cells
processed in cooperation with a third party, and in particular
in the following circumstances:

(a) where a tissue establishment entrusts one of the stages of

tissue or cell processing to a third party;

(b) where a third party provides goods and services that affect
tissue or cell quality and safety assurance, including their
distribution;

(c) where a tissue establishment provides services to a tissue

establishment which is not accredited;

(d) where a tissue establishment distributes tissue or cells

processed by third parties.

Tissue establishments

third
2.
parties on the basis of their ability to meet the standards laid
down in this Directive.

shall evaluate and select

Tissue

2.
all
processes are carried out under controlled conditions.

establishments

ensure

shall

that

storage

Tissue establishments shall keep a complete list of the
3.
agreements referred to in paragraph 1 that they have estab-
lished with third parties.

3.
Tissue establishments shall establish and apply procedures
in order to
for the control of packaging and storage areas,
prevent any situation arising that might adversely affect the
functioning or integrity of tissues and cells.

Processed tissues or cells shall not be distributed until all

4.
the requirements laid down in this Directive have been met.

4.
Agreements between tissue establishments and third
parties shall specify the responsibilities of the third parties and
detailed procedures.

5.
Tissue establishments shall provide copies of agreements
with third parties at the request of the competent authority or
authorities.

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CHAPTER V

(b) requirements for the procurement of human tissues and

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

cells;

(c) quality system, including training;

Article 25

(d) selection criteria for the donor of tissues and/or cells;

Coding of information

(e) laboratory tests required for donors;

1. Member States shall establish a system for the identifica-
tion of human tissues and cells, in order to ensure the trace-
ability of all human tissues and cells pursuant to Article 8.

2.
The Commission, in cooperation with the Member States,
shall design a single European coding system to provide infor-
mation on the main characteristics and properties of tissues
and cells.

(f) cell and/or tissue procurement procedures and reception at

the tissue establishment;

(g) requirements for the tissue and cell preparation process;

(h) tissue and cell processing, storage and distribution;

(i) requirements for the direct distribution to the recipient of

specific tissues and cells.

Article 26

Reports

1. Member States shall send the Commission, before 7 April
2009 and every three years thereafter, a report on the activities
undertaken in relation to the provisions of
this Directive,
including an account of the measures taken in relation to
inspection and control.

the Council,

2.
The Commission shall transmit to the European Parlia-
ment,
and Social
the Regions the reports
Committee and the Committee of
submitted by the Member States on experience gained in imple-
menting this Directive.

the European Economic

Before 7 April 2008 and every three years thereafter, the
3.
Commission shall transmit to the European Parliament, the
Council, the European Economic and Social Committee and the
Committee of the Regions a report on the implementation of
the requirements of
in particular as regards
inspection and monitoring.

this Directive,

Article 27

Penalties

Member States shall lay down the rules on penalties applicable
to infringements of the national provisions adopted pursuant
to this Directive and shall take all measures necessary to ensure
that they are implemented. The penalties provided for must be
effective, proportionate and dissuasive. Member States shall
notify those provisions to the Commission by 7 April 2006
and shall notify it without delay of any subsequent amend-
ments affecting them.

CHAPTER VI

CONSULTATION OF COMMITTEES

Article 28

Technical requirements and their adaptation to scientific
and technical progress

The following technical requirements and their adaptation to
scientific and technical progress shall be decided in accordance
with the procedure referred to in Article 29(2):

(a) requirements for the accreditation, designation, authorisa-

tion or licensing of tissue establishments;

Article 29

Committee

1.

The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3.

The Committee shall adopt its Rules of Procedure.

Article 30

Consultation of one or more scientific committees

The Commission may consult the relevant scientific commit-
tee(s) when defining or adapting the technical requirements
referred to in Article 28 to scientific and technical progress.

CHAPTER VII

FINAL PROVISIONS

Article 31

Transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive not later than 7 April 2006. They shall forthwith
inform the Commission thereof.

When Member States adopt these measures they shall contain a
reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by the
Member States.

2. Member States may decide for one year after the date laid
down in the first subparagraph of paragraph 1 not to apply the
requirements of this Directive to tissue establishments bound
by national provisions before the entry into force of this Direc-
tive.

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3. Member States shall communicate to the Commission the
texts of the provisions of national law that they have already
adopted or which they adopt in the field governed by this
Directive.

Article 33

Addressees

This Directive is addressed to the Member States.

Article 32

Entry into force

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Union.

Done at Strasbourg, 31 March 2004.

For the European Parliament

For the Council

The President

P. COX

The President

D. ROCHE

INFORMATION TO BE PROVIDED ON THE DONATION OF CELLS AND/OR TISSUES

ANNEX

A. Living donors

1. The person in charge of the donation process shall ensure that the donor has been properly informed of at least
those aspects relating to the donation and procurement process outlined in paragraph 3. Information must be
given prior to the procurement.

2. The information must be given by a trained person able to transmit it in an appropriate and clear manner, using

terms that are easily understood by the donor.

3. The information must cover: the purpose and nature of the procurement, its consequences and risks; analytical
tests, if they are performed; recording and protection of donor data, medical confidentiality; therapeutic purpose
and potential benefits and information on the applicable safeguards intended to protect the donor.

4. The donor must be informed that he/she has the right to receive the confirmed results of the analytical tests,

clearly explained.

5. Information must be given on the necessity for requiring the applicable mandatory consent, certification and

authorisation in order that the tissue and/or cell procurement can be carried out.

B. Deceased donors

1. All information must be given and all necessary consents and authorisations must be obtained in accordance with

the legislation in force in Member States.

2. The confirmed results of the donor's evaluation must be communicated and clearly explained to the relevant

persons in accordance with the legislation in Member States.