Common Position (EC) No 50/2003 of 22 July 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Date: 2003-07-22
Institutions: Council of the European Union
Subjects: health policy, organ transplantation, quality standard, safety standard

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COMMON POSITION (EC) No 50/2003

adopted by the Council on 22 July 2003

with a view to the adoption of a Directive 2003/. . ./EC of the European Parliament and of the
Council of . . . on setting standards of quality and safety for the donation, procurement, testing,
processing, preservation, storage and distribution of human tissues and cells

(2003/C 240 E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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),

Whereas:

(1) The transplantation of human tissues and cells

is a
strongly expanding field of medicine offering great oppor-
tunities for the treatment of as yet incurable diseases. The
quality and safety of these substances should be ensured,
particularly in order
the transmission of
to prevent
diseases.

(2) The availability of human tissues and cells used for thera-
peutic purposes is dependent on Community citizens who
are prepared to donate them. In order to safeguard 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.

(3)

at national

is necessary to promote information and awareness
It
campaigns
and European level on the
donation 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
families or
lifetime and let
legal representatives know their wishes.

their

(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 and Decision of the European Parliament . . . (not
yet published in the Official Journal).

testing,

storage

processing,

procurement,

therapy each year.

(4) There is an urgent need for a unified framework in order to
ensure high standards of quality and safety with respect to
the
and
distribution of tissues and cells across the Community and
to facilitate exchanges thereof for patients receiving this type
of
that
Community provisions ensure that human tissues and
cells, whatever
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 guarantees as those in
their own country.

is essential,

therefore,

their

It

(5) As tissue and cell therapy is a field in which an intensive
worldwide exchange is taking place, it is desirable to have
worldwide standards.

and testing are

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

the European Parliament and of

(7) This Directive excludes blood and blood products (other
than haematopoietic progenitor cells), human organs, as
well as organs, tissues, or cells of animal origin. Blood and
currently regulated by Directive
blood products are
2001/83/EC, Directive 2000/70/EC (5), Recommendation
98/463/EC (6) and Directive 2002/98/EC (7). Tissues and
cells used as an autologous graft (tissues removed and trans-
planted 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 associated with this process
are completely different.

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

2002/98/EC (OJ L 33, 8.2.2003, p. 30).

(5) Directive 2000/70/EC of

the European Parliament and of

the
Council of 16 November 2000 amending Council Directive
stable
93/42/EEC as
derivates of human blood or human plasma (OJ L 313, 13.12.2000,
p. 22).

regards medical devices

incorporating

(6) 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).

(7) Directive 2002/98/EC of

the European Parliament and of

the
Council of 27 January 2003 setting standards of quality and
and
safety
storage,
distribution of human blood and blood components
and
amending Directive 2001/83/EC.

testing, processing,

collection,

the

for

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

tissues and cells,

should be required. The dignity of the deceased donor
should be respected.

(9) This Directive covers tissues and cells intended for human
including human tissues and cells used for
applications,
in view
the preparation of cosmetic products. However,
of the risk of transmission of communicable diseases, the
tissues and products in cosmetic
use of human cells,
products
Commission Directive
by
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 (1).

prohibited

is

(10) 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
trials are applied to the human body should
clinical
comply with the quality and safety standards laid down
in this Directive.

(11) 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
for funda-
protect public health and guarantee respect
mental
should not
interfere with provisions of Member States defining the
legal term ‘person’ or ‘individual’.

rights. Moreover,

this Directive

(12) 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 Community.
This Directive should establish standards for each one of
the steps in the human tissues and cells application
process.

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

(14) Tissues and cells used for allogeneic 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

(15) 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.

(16) 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
tissue and cell
sector involvement
application services and the related research and devel-
opment.

in the provision of

(17) The procurement of human tissues and cells must take
the Charter of
the general principles of
into account
the European Union (2) and of
Fundamental Rights of
the Convention for the protection of human rights and
dignity of the human being with regard to the application
of biology and medicine: Convention on human rights and
biomedicine, in particular in relation to donor consent.

(18) 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 information provided to the authorised personnel,
the results of tests on their donations, as well as any future
traceability of their donation.

(19) Directive 95/46/EC of the European Parliament and of the
Council of 24 October 1995 on the protection of indi-
viduals with regard to the processing of personal data and
the free movement of such data (3), 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 exemptions
to this
prohibition principle are laid down. Directive 95/46/EC
provides also for the controller to implement appropriate
technical and organisational measures to protect personal
data against accidental or unlawful destruction or acci-
dental
loss, alteration, unauthorised disclosure or access
and against all other unlawful forms of processing.

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

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

(2) OJ C 364, 18.12.2000, p. 1.
(3) OJ L 281, 23.11.1995, p. 31.

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(21) Member States should organise inspections and control
measures, to be carried out by officials representing the
competent authority, to ensure that tissue establishments
this Directive. Member
comply with the provisions of
involved in
should ensure
States
inspections
appropriately
qualified and receive adequate training.

the officials
are

and control measures

that

(22) Personnel directly involved in the donation, procurement,
testing, processing, preservation, storage and distribution
of human tissues and cells
should be appropriately
qualified and provided with timely and relevant training.
The provisions laid down in this Directive as regards
to
training should be
existing Community legislation on the recognition of
professional qualifications.

applicable without prejudice

(23) 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.

(24) As a general principle,

the identity of

the recipient(s)
should not be disclosed to the donor or his family and
vice versa, without prejudice to legislation in force in
Member States on the conditions of disclosure, which
could authorise in particular cases the lifting of donor
anonymity.

(25) In order to increase the effective implementation of the
provisions adopted under this Directive, it is appropriate
to provide for penalties to be applied by Member States.

cannot be

the Community,

(26) Since the objective of this Directive, namely to set high
standards of quality and safety for human tissues and cells
throughout
sufficiently
achieved by the Member States and can therefore, by
achieved at
reason of
Community 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
principle of proportionality, as set out in that Article,
this Directive does not go beyond what is necessary in
order to achieve that objective.

and effects, be better

scale

(27) It is necessary that the best possible scientific advice is
available to the Community in relation to the safety of
tissues and cells;
the
Commission in adapting the provisions of this Directive
to scientific and technical progress.

in particular

in order

to assist

(28) 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,
international
experience in this field, and will be sought in the future
whenever necessary.

as well

as

(29) 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

the exercise of
procedures
conferred on the Commission (1),

for

implementing powers

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
directives,
apply only to donation,
shall
this Directive
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.

Article 3

Definitions

For the purposes of this Directive:

(a)

(b)

(c)

(d)

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

‘tissue’ means all constituent parts of the human body
formed by cells;

‘donor’ means every human source, whether living or
deceased, of human cells or tissues;

‘donation’ means donating human tissues or cells intended
for human applications;

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

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(e)

(f)

(g)

(h)

(i)

(j)

(k)

(l)

formed by different

‘organ’ means a differentiated and vital part of the human
body,
its
structure, vascularisation and capacity to develop physio-
logical functions with an important level of autonomy;

that maintains

tissues,

‘procurement’ means a process by which tissue or cells are
made available;

‘processing’ means all operations involved in the prep-
aration, manipulation, preservation and packaging of
tissues or cells intended for human applications;

‘preservation’ means the use of chemical agents, alterations
in environmental conditions or other means during
processing to prevent or retard biological or physical
deterioration of cells or tissues;

‘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;

‘storage’ means maintaining the product under appropriate
controlled conditions until distribution;

‘distribution’ means transportation and delivery of tissues
or cells intended for human applications;

‘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
testing, processing,
associated with the procurement,
storage and distribution of tissues and cells that might
lead to the transmission of a communicable disease, to
incapacitating
death or
life-threatening, disabling, or
conditions for patients or which might
in, or
result
prolong, hospitalisation or morbidity;

(n)

(o)

(p)

(q)

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

‘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;

‘allogeneic use’ means cells or tissues removed from one
person and applied to another;

‘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
protective
measures, provided that they comply with the provisions of
the Treaty.

introducing more

stringent

or

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.

States prohibiting

This Directive does not affect

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

the

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

the beneficiaries,

CHAPTER II

OBLIGATIONS ON MEMBER STATES' AUTHORITIES

Article 5

Supervision of human tissue and cell procurement

shall

States

ensure

1. Member
and cell
procurement 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.

tissue

that

The competent authority or authorities shall

2.
take all
necessary measures to ensure that tissue and cell procurement
complies with the requirements referred to in Article 28(b), (f)
and (g). 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

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The competent authority or authorities, having verified
2.
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
to in Article 28(h). Agreements
between tissue establishments and third parties, as referred to
in Article 24, shall be examined within the framework of this
procedure.

referred

whenever there is any serious adverse reaction or serious
adverse event.
such an inspection shall be
organised 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.

In addition,

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

The

tissue

3.
any
substantial changes to its activities without the prior written
approval of the competent authority or authorities.

shall not undertake

establishment

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 establishment or process does not comply with the
requirements of this Directive.

Some specified tissues and cells, which will be determined
5.
in accordance with the requirements referred to in Article
28(k), may, with the agreement of the competent authority
or authorities, be distributed directly for immediate transplan-
tation to the recipient as long as the supplier is provided with
an accreditation, designation, authorisation or license for this
activity.

Article 7

Inspections and control measures

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

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.

4.
Such inspections and control measures shall be carried
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
third
in tissue establishments and the facilities of
this
to the requirements of

that are relevant

out
parties
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.

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 referred to in Article 28(g) and (i).

The procedures for ensuring traceability at Community
4.
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.
Those Member States 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.

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

that
shall ensure that

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) examine any documents or other records relating to the

requirements of this Directive.

5.
The competent authority or authorities shall organise
inspections and carry out control measures as appropriate

(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.

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

to recall from distribution any product which may be related to
an adverse event or reaction.

Article 10

DONOR SELECTION AND EVALUATION

CHAPTER III

Register of tissue establishments and reporting obligations

Tissue

establishments

shall keep a record of

tested, preserved, processed,

1.
their
activities, including the types and quantities of tissues and/or
cells procured,
stored and
distributed, or otherwise disposed of, and of the origin and
intended for human
destination of
applications, in accordance with the requirements referred to
in Article 28(g). They shall submit to the competent authority
or authorities an annual report on these activities. This report
shall be publicly accessible.

the tissues and cells

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

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
tissues and cells and which may be
quality and safety of
attributed to the procurement,
testing, processing, storage
and distribution of tissues and cells, as well as any serious
adverse reaction 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
information to establishments
engaged in the donation,
procurement, 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).

Article 12

Principles governing tissue and cell donation

1. Member States shall
take the necessary measures to
encourage voluntary and unpaid donations of human tissues
and cells with a view to ensuring that, insofar as is possible,
they are obtained from such donations.

report

to the Commission on these
Member States shall
measures before . . . (*) 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.

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
availability of, human tissues and cells with a view to
offering or seeking financial gain or comparable advantage.

3. Member States shall encourage the procurement of tissues
and cells to be carried out on a non-profit basis.

Article 13

Consent

1.
The procurement of human tissues or cells shall be auth-
orised 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 Article 28(d).

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
recipients remain identifiable.

5.
Each tissue establishment shall ensure that an accurate,
rapid and verifiable procedure is in place which will enable it

(*) Two years after the entry into force of this Directive.

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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
records, and
modifications
transfer of information;

files or deferral

to donor

The Commission shall establish the Community standards
for activities

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

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

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

— standard operating procedures,

(c) no unauthorised disclosure of information occurs, whilst

guaranteeing the traceability of donations.

— guidelines,

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.

— training and reference manuals,

— reporting forms,

— donor records,

Article 15

— information on the final destination of tissues or cells.

Selection, evaluation and procurement

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

carried out

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

5.
Tissue establishments shall keep the data required for full
traceability for a minimum of 30 years. Data storage may also
be in electronic form.

In the case of an autologous donation, the suitability
the

2.
criteria
requirements referred to in Article 28(e).

accordance with

established

shall

be

in

The

results of

the donor

evaluation and testing
3.
procedures shall be documented and any major anomalies
shall be
requirements
referred to in Article 28(d).

reported in accordance with the

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(g).

5.
In the case of cells used for reproduction purposes, the
conditions for donor selection, evaluation and procurement
shall be laid down in accordance with the requirements
referred to in Article 28(j).

CHAPTER IV

PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES
AND CELLS

Article 16

Quality management

Article 17

Responsible person

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 under paragraph 1 shall be

2.
responsible for:

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

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

orities as required in Article 6;

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.

(c)

implementing the requirements of Articles 7, 10, 11, 15,
16 and 18 to 24 within the tissue establishment.

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Tissue

inform the

shall
the name of

competent
establishments
3.
authority or authorities of
the responsible
person referred to in paragraph 1. Where the responsible
person is permanently or temporarily replaced, the tissue estab-
lishment 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
procurement, 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

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(f) and that the
selection and acceptance of tissues and cells comply with the
requirements referred to in Article 28(g).

Tissue establishments shall ensure that human tissue and
the
and

2.
cells
documentation
requirements referred to in Article 28(g).

comply with

associated

3.
Tissue establishments shall verify and record the fact that
the packaging of human tissue and cells received complies with
the requirements referred to in Article 28(g). 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.

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

Tissue and cells shall be held in quarantine until such
testing and

6.
time as
information have been met in accordance with Article 15.

relating to donor

the requirements

Article 20

Tissue and cell processing

include in their

Tissue establishments shall

1.
standard
operating procedures all processes that affect quality and safety
and shall ensure that they are carried out under controlled
conditions. Tissue
the
equipment used, the working environment and process design,
validation and control conditions are in compliance with the
requirements referred to in Article 28(i).

establishments

ensure

shall

that

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

Tissue establishments shall

standard
3.
operating procedures special provisions for the handling of
tissues and cells to be discarded,
the
contamination of other
the processing
environment or personnel.

in order to prevent

include in their

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
referred to in
conditions comply with the requirements
Article 28(i).

Tissue

2.
all
processes are carried out under controlled conditions.

establishments

ensure

shall

that

storage

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

4.
Processed tissues or cells shall not be distributed until all
the requirements laid down in this Directive have been met.

Article 22

Labelling, documentation and packaging

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

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(i).

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;

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(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

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

shall evaluate and select

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

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 . . . (***) and
shall notify it without delay of any subsequent amendments
affecting them.

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

CHAPTER VI

CONSULTATION OF COMMITTEES

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

CHAPTER V

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

Article 25

Coding of information

1. Member States shall establish a system for the identification
of human tissues and cells, in order to ensure the traceability 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
information on the main characteristics and properties of
tissues and cells.

Article 26

Reports

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

The Commission shall

European
2.
Parliament, the Council, the European Economic and Social
Committee and the Committee of
the Regions the reports
submitted by the Member States on experience gained in
implementing this Directive.

transmit

to the

Before . . . (**) and every three years

3.
the
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 this Directive, in particular as regards
inspection and monitoring.

thereafter,

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, author-

isation or licensing of tissue establishments;

(b) requirements for the procurement of human tissues and

cells;

(c) quality system, including training;

(d)

information to be provided on the donation of cells and/or
tissues;

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

(f)

laboratory tests required for donors;

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

the tissue establishment;

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

(i)

tissue and cell processing, storage and distribution;

(j) determination of conditions for the selection, evaluation
and procurement of cells used for reproduction purposes;

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

specific tissues and cells.

Article 29

Committee

(*) Five years after the entry into force of this Directive.
(**) Four years after the entry into force of this Directive.

(***) Two years after the entry into force of this Directive.

1.

The Commission shall be assisted by a Committee.

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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.

reference on the occasion of their official publication. The
methods of making such reference shall be laid down by the
Member States.

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

consult
The Commission may
Committee(s) when defining or
requirements
technical progress.

Scientific
technical
referred to in Article 28 to scientific and

the
adapting

relevant
the

CHAPTER VII

FINAL PROVISIONS

Article 31

Transposition

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
Directive.

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 32

Entry into force

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

Article 33

Addressees

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive not later than . . . (*). 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

This Directive is addressed to the Member States.

. . .

For the European Parliament

The President

For the Council

The President

(*) 24 months after the date of entry into force of this Directive.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 20 June 2002 the Commission forwarded to the Council a proposal for a directive of the
European Parliament and of the Council on setting standards of quality and safety for the donation,
procurement,
testing, processing, preservation, storage and distribution of human tissues and
cells (1).

The European Economic and Social Committee delivered its opinion (2) on the proposal on 11
December 2002.

The European Parliament delivered its opinion (3) on 10 April 2003.

2. Following delivery of the European Parliament's opinion, the Commission forwarded to the Council

an amended proposal (see document 10122/03 SAN 130 CODEC 779).

3. On 22 July 2003 the Council adopted its common position in accordance with Article 251(2) of the

Treaty.

II. OBJECTIVES

The Commission's proposed Directive is intended to set detailed quality and safety standards for human
tissues and cells for human applications, with respect to the activities ranging from their procurement
up to their distribution.

In particular the proposed Directive:

— sets requirements for the accreditation of the establishments involved in these activities, inspections,

control measures, etc.;

— provides for the traceability of donated tissues and cells, as well as the regulation of imports and

exports of these substances;

— provides for principles, minimum standards and obligatory procedures for the whole chain

(donation, procurement, testing, processing, storage and distribution);

— sets minimum applicable quality and safety standards,

including professional qualifications and

required training.

III. ANALYSIS OF THE COMMON POSITION (4)

A. AMENDED COMMISSION PROPOSAL

The Council's common position is to a great extent in line with the Commission's amended
proposal.

In particular, the Council shares the Commission's argument that amendments of an ethical nature
are not acceptable, since they fall outside the scope of Article 152 of the Treaty. The Council has
however agreed to insert a general reference in the preamble to the need for altruism and non-profit
procurement (recital 16). The Council further notes that the Commission in its amended proposal
introduced the clarification of provisions, as a result of their examination of the proposed Directive
by the Council.

The Council adopted — wholly, partly, or retaining only the substance — 15 of the 35 amendments
adopted by the European Parliament, which were taken up, either wholly or in part,
in the
Commission's proposal.

(1) OJ C 227 E, 24.9.2002, p. 505.
(2) OJ C 85, 8.4.2003, p. 44.
(3) Not yet published in the Official Journal.
(4) The numbering of the recitals and Articles follows that adopted in the common position.

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B. AMENDMENTS ACCEPTED BY THE COMMISSION BUT NOT TAKEN UP IN THE COMMON POSITION

These were amendments 78, 12, 13, 20, 80, 32, 38, 55, 56, 57, 58, 63, 64, 66, 69, 85, 72, 74, 75
and 76.

Amendment 78

The Council considers that, given the Directive's legal basis, this amendment falls outside the scope
of the Directive. Moreover, the Council considers that the initial Commission's text is more appro-
priate, whereas the essence of the Parliament's amendment is covered by the current text of Article
4(3).

Amendment 12

The Council considers that this amendment falls outside the scope of the Directive.

Amendment 13

The Council considers that the text adopted in the common position reflects in the best way the
current situation, with respect to the international texts concerned.

Amendment 20

The proposed insertion of an explicit reference to those specific categories of cells and tissues is not
needed, since they are covered by the current text of the proposal.

Amendment 80

The aim pursued with this amendment is adequately covered, according to the Council, both by
recital 11 and Article 4(3) of the Directive.

Amendment 32

The essence of the amendment is reflected in Article 10(1) of the common position.

Amendment 38

The proposed additional text is rather vague and may result in legal uncertainty. This amendment
would be unworkable in practice, since it would mean applying traceability requirements to
everything (including gloves, test tubes, etc.) that could come into contact with tissues and cells.

Amendment 55

The Council considers that two years of experience in the relevant fields are sufficient.

Amendment 56

The Council considers that the aim pursued with this amendment is reflected in recital 14, which
provides for the respect of the dignity of the deceased donor. Moreover, such an issue could be
examined in the context of the requirements for procurement, through the comitology procedure.

Amendment 57

The Council considers that the aim of the amendment is sufficiently covered by the text in the first
sentence of Article 24(1) of the common position.

Amendment 58

Refers to text which has been deleted.

Amendments 63, 64, 66, 69, 85, 72, 74, 75 and 76

Refer to the Annexes of the initial Commission's proposal, which, according to the common
position, are referred in their entirety to the comitology procedure (cf. part D).

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C. AMENDMENTS REJECTED BY THE COMMISSION BUT TAKEN UP IN THE COMMON POSITION

Amendments 4, 5 and 6 were accepted wholly or in part.

D. PRINCIPAL CHANGES INTRODUCED BY THE COUNCIL

The Council introduced a series of amendments to the amended Commission's proposal, particularly
in order to clarify the provisions and ensure a more efficient implementation of the Directive, while
safeguarding the Member States' competence.

The Council introduced the following main changes:

The Member States' competence in implementing the Directive

The necessary margin of manoeuvre left to the Member States with respect to various aspects of the
Directive, given the scope of Article 152 of the Treaty, has been further reaffirmed in certain cases,
such as the matter of publicity or promotion activities in this field (Article 12(2)) or as regards access
to the donated tissues and cells (deletion of Article 25 of the Commission's proposal).

Enhancement of the accreditation requirements (Article 6)

An accreditation requirement not only for the establishments dealing with tissues and cells in their
activities, but also for the procedures that they perform has been introduced, in order to guarantee
the efficient application of the Directive.

Reference of the Annexes to the comitology procedure (Article 28)

The Council considers appropriate to refer the matters treated by the Annexes in the Commission's
proposal to the regulatory committee procedure, given the advantages of the latter for regulating
very detailed and technical requirements in connection with the application of the Directive.

The list of the technical requirements (Article 28) is made more complete, with the introduction in
the list of provisions concerning the elaboration of requirements for the accreditation, designation,
authorisation or licensing of tissue establishments, for the tissue and cell preparation process, for the
determination of conditions for the selection, evaluation and procurement of cells used for repro-
duction purposes, as well as of requirements for the direct distribution to the recipient of specific
tissues and cells (Article 28(a), (h), (j) and (k)).

Other changes

— The requirement for the notification of serious adverse events and reactions (Article 11(2)) is

extended to all personnel involved in the process.

— A new recital was adopted (recital 9) clarifying the legal status of cosmetic products. Some
definitions were deleted whenever deemed to be unnecessary (tissue bank and tissue procurement
team) or replaced by a comprehensive definition. New definitions have been inserted to the text
(donation and storage).

— Certain terms and provisions throughout the text have been differentiated in comparison to the
Commission's amended text, without nevertheless any substantial change to their actual content.