Common Position (EC) No 28/2002 of 14 February 2002 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 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
Date: 2002-02-14
Institutions: Council of the European Union
Subjects: blood transfusion, public health, quality standard, safety standard, trade in organs

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COMMON POSITION (EC) No 28/2002

adopted by the Council on 14 February 2002

with a view to adopting Directive 2002/. . ./EC of the European Parliament and of the Council of
. . . setting standards of quality and safety for the collection, testing, processing, storage and
distribution of human blood and blood components and amending Directive 2001/83/EC

(2002/C 113 E/05)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

the detection and inactivation and elimination of trans-
fusion transmissible pathogenic agents.

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 Economic and Social
Committee (2),

Having regard to the opinion of
Regions (3),

the Committee of

the

Acting in accordance with the procedure laid down in Article
251 of the Treaty (4),

Whereas:

(1) The extent to which human blood is used therapeutically
demands that the quality and safety of whole blood and
blood components be ensured in order to prevent
in
particular the transmission of diseases.

(2) The availability of blood and blood components used for
therapeutic purposes is dependent largely on Community
citizens who are prepared to donate. In order to safeguard
public health and to prevent the transmission of infectious
diseases,
their
precautionary measures
collection, processing, distribution and use need to be
taken making appropriate use of scientific progress in

during

all

(1) OJ C 154 E, 29.5.2001, p. 141.
(2) OJ C 221, 7.8.2001, p. 106.
(3) Opinion delivered on 20 September 2001 (OJ C 19, 22.1.2002,

p. 6).

(4) Opinion of the European Parliament of 6 September 2001, Council
Common Position of 14 February 2002 and Decision of
the
European Parliament of
(not yet published in the Official
Journal).

. . .

(3) The

and

safety,

quality,

efficacy

requirements

of
proprietary
products
industrially-prepared medicinal
derived from human blood or plasma were ensured
through Directive 2001/83/EC of the European Parliament
the Council of 6 November 2001 on the
and of
Community code relating to medicinal products
for
human use (5). The specific exclusion of whole blood,
plasma and blood cells of human origin from that
Directive, however, has led to a situation whereby their
quality and safety,
in so far as they are intended for
transfusion and not processed as such, are not subject
is essential,
to any binding Community legislation.
therefore,
purpose,
that whatever
Community provisions should ensure that blood and its
components
and safety
throughout the blood transfusion chain in all Member
States, bearing in mind the freedom of movement of
citizens within Community territory. The establishment
of high standards of quality and safety, therefore, will
help to reassure the public that human blood and blood
components which are derived from donations in another
Member State none the less meet the same requirements
as those in their own country.

comparable quality

intended

are of

the

It

(4) In respect of blood or blood components as a starting
for the manufacture of proprietary medicinal
material
products, Directive 2001/83/EC refers to measures to be
taken by Member States to prevent the transmission of
infectious diseases, comprising the application of
the
monographs of
the European Pharmacopoeia and the
the Council of Europe and the
recommendations of
World Health Organisation (WHO) as regards in particular
the selection and testing of blood and plasma donors.
Furthermore, Member States should take measures to
promote Community self-sufficiency in human blood or
blood components and to encourage voluntary unpaid
donations of blood and blood components.

purpose,

(5) In order to ensure that there is an equivalent level of
safety and quality of blood components, whatever their
intended
the
collection and testing of all blood and blood components
including starting materials for medicinal products should
be established by this Directive. Directive 2001/83/EC
should be amended accordingly.

requirements

technical

for

(5) OJ L 311, 28.11.2001, p. 67.

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(6) The Commission's communication of 21 December 1994
on blood safety and self-sufficiency in the European
Community identified the need for a blood strategy in
order to reinforce confidence in the safety of the blood
transfusion chain and promote Community self-suffi-
ciency.

(7) In its resolution of 2 June 1995, on blood safety and
self-sufficiency in the Community (1), the Council invited
the Commission to submit appropriate proposals in the
framework of the development of a blood strategy.

and

safety

(8) In its resolution of 12 November 1996 on a strategy
the
towards
blood
European Community (2),
the
Commission to submit proposals as a matter of urgency
with a view to encouraging the development of a coor-
dinated approach to the safety of blood and blood
products.

self-sufficiency

in
invited

the Council

(9) In its resolutions of 14 September 1993 (3), 18 November
1993 (4), 14 July 1995 (5), and 17 April 1996 (6) on blood
safety and self-sufficiency through voluntary unpaid
donations in the European Community,
the European
importance of ensuring the
Parliament
highest
reiterated its
continued support for the objective of Community self-
sufficiency.

level of blood safety and has

stressed the

(10) In elaborating the provisions of this Directive account has
been taken of the opinion of the Scientific Committee for
Medicinal Products and Medical Devices as well as inter-
national experience in this field.

(11) The nature of autologous

transfusion necessitates a
specific consideration in respect of how and when to
apply the different provisions of this Directive.

(12) Hospital blood banks are hospital units which perform a
limited number of activities, storage, distribution, and
compatibility tests. In order to ensure that the quality
and safety of blood and blood components
are
preserved during the whole transfusion chain, while
taking account of the specific nature and functions of
hospital blood banks, only provisions relevant to these
activities should apply to hospital blood banks.

(13) Member States

an appropriate
mechanism for designating, authorising, accrediting or

should ensure

that

(1) OJ C 164, 30.6.1995, p. 1.
(2) OJ C 374, 11.12.1996, p. 1.
(3) OJ C 268, 4.10.1993, p. 29.
(4) OJ C 329, 6.12.1993, p. 268.
(5) OJ C 249, 25.9.1995, p. 231.
(6) OJ C 141, 13.5.1996, p. 131.

licensing exists to ensure that the activities of blood estab-
lishments
in accordance with the
requirements of this Directive.

are performed

(14) Member States should organise inspection and control
measures, to be carried out by officials representing the
competent authority,
the
blood establishment with the provisions of this Directive.

to ensure the compliance of

(15) Personnel directly involved in the collection,

testing,
processing, storage and distribution of blood and blood
components need to be appropriately qualified and
provided with timely and relevant
training, without
prejudice to existing Community legislation on the recog-
nition of professional qualifications and on the protection
of workers.

(16) Blood establishments

policy

objectives

should establish and maintain
quality systems involving all activities that determine the
quality
and
them by such means as quality planning,
implement
quality
quality
assurance,
improvement within the quality system,
taking into
account the principles of good manufacturing practice
as well as the EC conformity assessment system.

responsibilities

control,

quality

and

and

It

(17) An adequate system to ensure traceability of whole blood
and blood components should be established. Traceability
should be enforced through accurate donor, patient, and
laboratory identification procedures, through record main-
tenance, and through an appropriate identification and
labelling system.
system is
is desirable
developed in order to enable the unique and unmistakable
identification of blood donations and blood components
in the Community.
In the case of blood and blood
components imported from non-member countries, it is
important
traceability be
level of
that an equivalent
stages
in the
ensured by the blood establishments
preceding importation into the Community. The same
requirements of traceability which apply to blood and
blood components collected in the Community should
be ensured in the stages following importation.

that

a

(18) It is important to introduce a set of organised surveillance
procedures to collect and evaluate information on the
adverse or unexpected events or reactions resulting from
the collection of blood or blood components in order to
prevent similar or equivalent events or reactions from
occurring, thereby improving the security of transfusion
by adequate measures. To this end a common system of
notification of serious adverse events and reactions linked
to the
and
distribution of blood and blood components should be
established in Member States.

collection, processing,

storage,

testing,

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(19) It is important that when abnormal findings are reported
to the donor, relevant counselling is also provided.

(20) Modern blood-transfusion practice has been founded on
the principles of voluntary donor services, anonymity of
both donor and recipient, benevolence of the donor, and
absence of profit on the part of
the establishments
involved in blood transfusion services.

related to the health of an individual be subject to rein-
forced protection. However, it covers only personal data
and not that rendered anonymous. This Directive should
therefore introduce additional safeguards to prevent any
unauthorised changes to donation registries, or processing
records, or the unauthorised disclosure of information.

(26) The Commission should be empowered to establish
technical requirements and adopt any necessary changes
thereto and to the Annexes in order to take into account
scientific and technical progress.

prospective

(21) All necessary measures need to be taken in order to
blood
donors
provide
components with assurances regarding the confidentiality
of any health-related information provided to the auth-
the tests on their
orised personnel,
the results of
their
donations as well as any future traceability of
donation.

blood

or

of

(22) According to Article 152(5) of the Treaty, the provisions
of this Directive cannot affect national provisions on the
donations of blood. Article 152(4)(a) of the Treaty states
that Member States cannot be prevented from maintaining
or introducing more stringent protective measures as
regards standards of quality and safety of blood and
blood components.

area

(23) Voluntary and unpaid blood donations are a factor which
can contribute to high safety standards for blood and
blood components and therefore to the protection of
human health. The efforts of the Council of Europe in
supported and all necessary
this
measures should be taken to encourage voluntary and
unpaid donations
through appropriate measures and
initiatives and through ensuring that donors gain greater
public recognition, thereby also increasing self-sufficiency.
The definition of voluntary and unpaid donation of the
Council of Europe should be taken into account.

should be

therapeutic
(24) Blood and blood components used for
purposes or
should be
for use in medical devices
obtained from individuals whose health status is such
that no detrimental effects will ensue as a result of the
donation and that any risk of transmission of infectious
diseases is minimised; each and every blood donation
should be tested in accordance with rules which provide
assurances that all necessary measures have been taken to
safeguard the health of individuals who are the recipients
of blood and blood components.

(25) Directive 95/46/EC of the European Parliament and 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 (1) requires that data

(27) Setting of

technical

requirements and adaptation to
progress should take into account the Council recommen-
dation of 29 June 1998 on the suitability of blood and
plasma donors and the screening of donated blood in the
EC (2),
the Council of
recommendations of
Europe and the WHO as well as indications of relevant
European institutions and organisations
the
monographs of the European Pharmacopoeia.

such as

relevant

(28) It is necessary that the best possible scientific advice is
available to the Community in relation to the safety of
blood and blood components,
in particular as regards
adapting the provisions of
this Directive to scientific
and technical progress.

(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
procedures
implementing powers
the exercise of
conferred on the Commission (3).

for

(30) 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.

(31) Since the objectives of this Directive, namely to contribute
to general confidence both in the quality of donated blood
and blood components and in the health protection of
donors, to attain self-sufficiency at a Community level
and to enhance confidence in the safety of the transfusion
chain among the Member States, cannot be sufficiently
achieved by the Member States and can therefore by
its scale and effects be better 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
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 those objectives.

the Treaty.

(1) OJ L 281, 23.11.1995, p. 31.

(2) OJ L 203, 21.7.1998, p. 14.
(3) OJ L 184, 17.7.1999, p. 23.

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(32) Responsibility for the organisation of health services and
the provision of medical care should remain the respon-
sibility of each Member State,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Objectives

This Directive lays down standards of quality and safety of
human blood and of blood components, in order to ensure a
high level of human health protection.

Article 2

Scope

1.
This Directive shall apply to the collection and testing of
human blood and blood components, whatever their intended
purpose, and to their processing, storage, and distribution
when intended for transfusion.

2. Where blood and blood components are collected and
tested for the sole purpose and exclusive use in autologous
transfusion and are clearly identified as such, the requirements
to be complied with in respect thereof shall be in accordance
with those referred to in Article 28(g).

(e)

(f)

(g)

‘Blood establishment’ shall mean any structure or body that
is responsible for any aspect of the collection and testing of
their
human blood or blood components, whatever
intended purpose, and their processing,
storage, and
distribution when intended for transfusion. This does not
include hospital blood banks;

‘Hospital blood bank’ shall mean a hospital unit which
stores and distributes and may perform compatibility
tests on blood and blood components exclusively for use
within hospital
including hospital-based trans-
fusion activities;

facilities,

‘Serious adverse event’ shall mean any untoward occurrence
associated with the collection, testing, processing, storage
and distribution, of blood and blood components that
might lead to death or life-threatening, disabling or inca-
pacitating conditions for patients or which results in, or
prolongs, hospitalisation or morbidity;

(h) ‘Serious

adverse

reaction’

shall mean an unintended
response in donor or
in patient associated with the
collection or transfusion of blood or blood components
incapacitating, or
that is fatal,
which results in, or prolongs, hospitalisation or morbidity;

life-threatening, disabling,

This Directive shall apply without prejudice to Directives

3.
93/42/EEC (1), 95/46/EC or 98/79/EC (2).

(i)

4.

This Directive does not apply to blood stem cells.

‘Blood component release’ shall mean a process which
enables a blood component to be released from a quar-
antine status by the use of systems and procedures to
ensure that the finished product meets its release specifi-
cation;

Article 3

Definitions

For the purposes of this Directive:

(a)

‘Blood’ shall mean whole blood collected from a donor and
processed either for transfusion or for further manufac-
turing;

(b) ‘Blood component’ shall mean a therapeutic constituent of
blood (red cells, white cells, platelets, plasma) that can be
prepared by various methods;

(c)

‘Blood product’ shall mean any therapeutic product derived
from human blood or plasma;

(d)

‘Autologous transfusion’ shall mean transfusion in which
the donor and the recipient are the same person and in
which pre-deposited blood and blood components are
used;

(1) Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices (OJ L 169, 12.7.1993, p. 1). Directive as last amended by
Directive 2000/70/EC (OJ L 313, 13.12.2000, p. 22).

(2) Directive 98/79/EC of the European Parliament and of the Council
of 27 October 1998 on in vitro diagnostic medical devices (OJ L
331, 7.12.1998, p. 1). Directive
amended by Directive
as
1999/166/EC (OJ L 61, 1.3.2001, p. 17).

(j)

‘Deferral’ shall mean suspension of the eligibility of an
individual
to donate blood or blood components such
suspension being either permanent or temporary;

(k)

‘Distribution’ shall mean the act of delivery of blood and
blood components to other blood establishments, hospital
blood banks and manufacturers of blood and plasma
derived products. It does not include the issuing of blood
or blood components for transfusion.

Article 4

Implementation

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

2.
This Directive shall not prevent a Member State from
maintaining or introducing in its territory more stringent
protective measures which comply with the provisions of the
Treaty.

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In particular, a Member State may introduce requirements for
voluntary unpaid donations,
including the prohibition or
restriction of imports of blood and blood components which
do not satisfy such requirements provided that the conditions
of Article 30 of the Treaty are met.

3.
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

Designation, authorisation, accreditation or licensing of
blood establishments

1. Member States shall ensure that activities relating to the
collection and testing of human blood and blood components,
whatever their intended purpose, and to their preparation,
storage, and distribution when intended for transfusion, are
undertaken only by the blood establishments which have
been designated, authorised, accredited or licensed by the
competent authority for that purpose.

2.
For the purpose of paragraph 1, the blood establishment
shall submit the information listed in Annex I to the competent
authority.

enable blood establishments operating under their legislation to
comply with the requirements of this Directive.

Article 8

Inspection and control measures

1. Member States shall ensure that the competent authority
organises inspections and appropriate control measures in
blood establishments to ensure that the requirements of this
Directive are complied with.

Inspection and control measures shall be organised by the
2.
competent authority on a regular basis. The interval between
two inspections and control measures shall not exceed two
years.

3.
Such inspection and control measures shall be carried out
by officials representing the competent authority who must be
empowered:

(a) to inspect blood establishments as well as facilities of any
third parties on its own territory entrusted by the holder of
licence
the designation, authorisation, accreditation or
referred to in Article 5 with the task of carrying out
evaluation and testing procedures pursuant to Article 18;

(b) to take samples for examination and analysis;

3.
The competent authority, having verified whether the
blood establishment complies with the requirements set out
in this Directive, shall
indicate to the blood establishment
which activities it may undertake and which conditions apply.

(c)

subject

to examine any documents relating to the object of the
in force in the
to the provisions
inspection,
Member States at the time of the entry into force of this
Directive and which place restrictions on these powers with
regard to the descriptions of the method of preparation.

No substantial change in activities shall be undertaken by
4.
the blood establishment without prior written approval by the
competent authority.

The competent authority may suspend or revoke the
5.
designation, authorisation, accreditation or licence of a blood
establishment if inspection or control measures demonstrate
that
the blood establishment does not comply with the
requirements of this Directive.

Article 6

Hospital blood banks

Articles 7, 10, 11(1), 12(1), 14, 15, 21 and 23 shall apply to
hospital blood banks.

4.
The competent authority shall organise inspection and
other control measures as appropriate in the event of any
serious adverse event or
in
accordance with Article 15.

reaction or suspicion thereof

CHAPTER III

PROVISIONS FOR BLOOD ESTABLISHMENTS

Article 9

Responsible person

Blood

1.
shall
(‘responsible person’), responsible for:

establishments

designate

a

person

Article 7

Provisions for existing establishments

Member States may decide to maintain national provisions for
nine months after the date laid down in Article 31 so as to

— ensuring that every unit of blood or blood components has
been collected and tested, whatever its intended purpose,
and processed, stored, and distributed, when intended for
transfusion,
in compliance with the laws in force in the
Member State,

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— providing information to the competent authority in the
licensing

authorisation,

accreditation

designation,
procedures as required in Article 5,

or

— implementation of the requirements of Articles 10, 11, 12,

13, 14 and 15 in the blood establishment.

The

2.
minimum conditions of qualification:

responsible person shall

fulfil

the

following

(a) he/she shall possess 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) he/she shall have practical postgraduate experience in
relevant areas for at least two years, in one or more estab-
lishments which are authorised to undertake activities
related to collection and/or testing of human blood and
blood components, or to their preparation, storage, and
distribution.

The Commission shall establish the Community standards
2.
and specifications referred to in Article 28(h) for the activities
relating to a quality system to be carried out by a blood estab-
lishment.

Article 12

Documentation

1. Member States shall take all necessary measures in order
to ensure that blood establishments maintain documentation
on operational procedures, guidelines, training and reference
manuals, and reporting forms.

2. Member States shall take all necessary measures in order
to ensure that access is provided to these documents for
entrusted with inspection and control measures
officials
referred to in Article 8.

Article 13

Record keeping

3.
The tasks specified in paragraph 1 may be delegated to
other persons who shall be qualified by training and experience
to perform such tasks.

1. Member States shall take all necessary measures to ensure
that blood establishments maintain records of the information
required in Annexes II and IV and under Article 28(b), (c) and
(d). The records shall be kept for a minimum of 15 years.

Blood establishments shall notify the competent authority
4.
of the name of the responsible person referred to in paragraph
1 and other persons referred to in paragraph 3 together with
information on the
for which they are
responsible.

specific

tasks

5. Where the responsible person or such other persons
referred to in paragraph 3 is permanently or temporarily
replaced, the blood establishment shall provide immediately
the name of the new responsible person and his or her date
of commencement to the competent authority.

Article 10

Personnel

Personnel directly involved in collection, testing, processing,
storage,
and distribution of human blood and blood
components shall be qualified to perform those tasks and be
provided with timely, relevant and regularly updated training.

CHAPTER IV

QUALITY MANAGEMENT

Article 11

Quality system for blood establishments

The competent authority shall keep records of the data
2.
received from the blood establishments according to Articles 5,
7, 8, 9 and 15.

CHAPTER V

HAEMOVIGILANCE

Article 14

Traceability

1. Member States shall take all necessary measures in order
to ensure that blood and blood components collected, tested,
processed, stored, released and/or distributed on their territory
can be traced from donor to recipient and vice versa.

implement a system for

To this end, Member States shall ensure that blood estab-
lishments
identification of each
single blood donation and each single blood unit and
components thereof enabling full traceability to the donor as
well as to the transfusion and the recipient thereof. The system
must unmistakably identify each unique donation and type of
blood component. This
established in
accordance with the requirements referred to in Article 28(a).

system shall be

1. Member States shall take all necessary measures to ensure
that each blood establishment establishes and maintains a
quality system for blood establishments based on the principles
of good practice.

With regard to blood and blood components imported from
non-member countries, Member States shall ensure that the
donor identification system to be implemented by blood estab-
lishments permits an equivalent level of traceability.

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2. Member States shall take all necessary measures in order
to ensure that the system used for the labelling of blood and
blood components collected, tested, processed, stored, released
and/or distributed on their territory complies with the identi-
fication system referred to in paragraph 1 and the labelling
requirements listed in Annex III.

Article 15

Article 19

Voluntary and unpaid blood donation

1. Member States shall encourage voluntary and unpaid
blood donations with a view to ensuring that blood and
blood components are in so far as possible provided from
such donations.

Notification of serious adverse events and reactions

1. Member States shall ensure that:

2. Member States shall inform the other Member States and
the Commission of the actions taken by them to achieve the
objective set out in paragraph 1.

— any serious adverse events (accidents and errors) related to
the collection, testing, processing, storage and distribution
of blood and blood components which may have an
influence on their quality and safety, as well as any
serious adverse reactions observed during or after trans-
fusion which may be attributed to the quality and the
safety of blood and blood components are notified to the
competent authority,

— blood establishments have in place a procedure accurately,
efficiently and verifiably to withdraw from distribution
blood or blood components associated with the notification
referred to above.

These serious adverse events and reactions

shall be
2.
notified in accordance with the procedure and notification
format referred to in Article 28(i).

CHAPTER VI

PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD
AND BLOOD COMPONENTS

Article 16

Provision of information to prospective donors

Member States shall ensure that all prospective donors of blood
or blood components in the Community are provided with
information referred to in Article 28(b).

Article 17

Information required from donors

Member States shall take all necessary measures to ensure that,
on agreement of a willingness to commence the donation of
blood or blood components, all donors in the Community
provide the information referred to in Article 28(c) to the
blood establishment.

Article 18

Eligibility of donors

Blood establishments

1.
are
shall
evaluation procedures in place for all donors of blood and
blood components and that the criteria for donation referred
to in Article 28(d) are met.

ensure

there

that

The

results of

2.
evaluation and testing
procedures shall be documented and any relevant abnormal
findings shall be reported to the donor.

the donor

Article 20

Testing of donations

Blood establishments shall ensure that each donation of blood
in conformity with
and blood components
requirements listed in Annex IV.

tested

is

Member States shall ensure that blood and blood components
imported into the Community are tested in conformity with
requirements listed in Annex IV.

Article 21

Storage, transport and distribution conditions

Blood establishments shall ensure that the storage, transport
and distribution conditions of blood and blood components
comply with the requirements referred to in Article 28(e).

Article 22

Quality and safety requirements for blood and blood
components

Blood establishments
shall ensure that quality and safety
requirements for blood and blood components meet the high
standards in compliance with the requirements referred to in
Article 28(f).

CHAPTER VII

DATA PROTECTION

Article 23

Data protection and confidentiality

Member States shall take all necessary measures to ensure that
including genetic information, collated within the
all data,
this Directive to which third parties have access
scope of
the donor is no
have been rendered anonymous so that
longer identifiable.

For that purpose, they shall ensure:

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

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

(c) that no unauthorised disclosure of such information occurs,

whilst guaranteeing the traceability of donations.

CHAPTER VIII

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.

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

3.

The Committee shall adopt its rules of procedure.

Article 24

Information exchange

The Commission shall meet regularly with the competent auth-
orities designated by
to exchange
the Member
information on the experience acquired with regard to the
implementation of the provisions of this Directive.

States

Article 25

Reports

send

shall

States

the Commission,
1. Member
commencing on 31 December 2003 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.

to

The Commission shall

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

transmit

to the

transmit

The Commission shall

European
3.
Parliament, the Council, the Economic and Social Committee
and the Committee of the Regions, commencing on 1 July
2004 and every three years
thereafter, a report on the
implementation of the requirements in this Directive, and in
particular those relating to inspection and control.

to the

Article 26

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
to the Commission by the date
notify those provisions
specified in Article 31 at
the latest and shall notify it
without delay of any subsequent amendments affecting them.

CHAPTER IX

COMMITTEES

Article 27

Regulatory procedure

Article 28

Technical requirements and their adaptation to technical
and scientific progress

the technical

The adaptation of
in
Annexes I to IV to technical and scientific progress shall be
decided in accordance with the procedure referred to in Article
27(2).

requirements

set out

The following technical requirements and their adaptation to
technical and scientific progress shall be decided in accordance
with the procedure referred to in Article 27(2):

(a)

traceability requirements;

(b) information to be provided to donors;

(c)

information to be obtained from donors including the
identification, health history, and the signature of
the
donor;

(d) requirements concerning the suitability of blood and
screening of donated blood

plasma donors and the
including:

— permanent deferral criteria and possible exemption

thereto,

— temporary deferral criteria;

(e) storage, transport and distribution requirements;

(f) quality and safety requirements

for blood and blood

components;

(g) requirements applicable to autologous transfusions;

(h) Community standards and specifications
quality system for blood establishments;

relating to a

(i) Community procedure

for notifying

serious

adverse

1.

The Commission shall be assisted by a committee.

reactions and events and notification format.

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Article 29

Consultation of scientific committee(s)

Article 31

Transposition

the

consult

relevant

The Commission may
scientific
requirements
committee(s) when establishing the technical
referred to in Article 28 and when adapting the technical
requirements set out
to IV to scientific and
technical progress,
in particular with a view to ensuring an
level of quality and safety of blood and blood
equivalent
components used for
transfusion and blood and blood
components used as a starting material for the manufacture
of medicinal products.

in Annexes I

CHAPTER X

FINAL PROVISIONS

Article 30

Amendment of Directive 2001/83/EC

Article 109 of Directive 2001/83/EC shall be replaced by the
following:

‘Article 109

For the collection and testing of human blood and human
plasma, Directive . . ./. . ./EC of the European Parliament
and of the Council of . . . setting standards of quality and
safety for the collection, testing, processing, storage and
distribution of human blood and blood components and
amending Directive 2001/83/EC (*) shall apply.

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

2. Member States shall communicate to the Commission the
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 Communities.

Article 33

Addressees

This Directive is addressed to the Member States.

Done at . . .

___________
(*) OJ L . . .’

For the European Parliament

The President

For the Council

The President

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

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INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR
PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN
THE

ACCORDANCE WITH ARTICLE 5(2)

ANNEX I

Part A: General information

— identification of the blood establishment,

— name, qualification and contact details of responsible persons,

— a list of hospital blood banks which it supplies.

Part B: A description of the quality system, to include:

— documentation, such as an organisation chart,

including responsibilities of responsible persons and reporting

relationships,

— documentation such as site master file or quality manual describing the quality system in accordance with Article

11(1),

— number and qualifications of personnel,

— hygiene provisions,

— premises and equipment,

— list of standard operating procedures for recruitment, retention and assessment of donors, for processing and testing,
distribution and recall of blood and blood components and for the reporting and recording of serious adverse
reactions and events.

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REPORT OF THE BLOOD ESTABLISHMENT'S PRECEEDING YEAR'S ACTIVITY

ANNEX II

This annual report will include:

— total number of donors who give blood and blood components,

— total number of donations,

— an updated list of the hospital blood banks which it supplies,

— total number of whole donations not used,

— number of each component produced and distributed,

— incidence and prevalence of transfusion transmissible infectious markers in donors of blood and blood components,

— number of product recalls,

— number of serious adverse events and reactions reported.

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ANNEX III

LABELLING REQUIREMENTS

The label on the component must contain the following information:

— the official name of the component,

— the volume or weight or number of cells in the component (as appropriate),

— the unique numeric or alphanumeric donation identification,

— name of producing blood establishment,

— the ABO group (not required for plasma intended only for fractionation),

— the Rh D group, either Rh D positive or Rh D negative (not required for plasma intended only for fractionation),

— the date or time of expiry (as appropriate),

— the temperature of storage,

— the name, composition and volume of anticoagulant and/or additive solution (if any).

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BASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONS

ANNEX IV

The following tests must be performed for whole blood and apheresis donations,
donations:

including autologous predeposit

— ABO group (not required for plasma intended only for fractionation),

— Rh D group (not required for plasma intended only for fractionation),

— testing for the following infections in the donors:

Hepatitis B

(HBs-Ag)

Hepatitis C

(Anti-HCV)

HIV 1/2

(Anti-HIV 1/2)

Additional tests may be required for specific components or donors or epidemiological situations.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 26 January 2001 the Commission forwarded to the Council a proposal for a Directive of the
European Parliament and of the Council setting standards of quality and safety for the collection,
testing, processing, storage, and distribution of human blood and blood components and amending
Council Directive 89/381/EEC (1).

The European Parliament delivered its opinion on 6 September 2001 (see Doc. 10974/01 Codec
750 SAN 93).

2. The Economic and Social Committee delivered its opinion (2) on the proposal on 30 May 2001 and

the Committee of the Regions did likewise on 20 September 2001 (3).

3. Following delivery of

the Commission announced its intention to submit an
amended proposal further to Parliament's opinion. This amended proposal was forwarded to the
Council on 26 November 2001 (see Doc. 14312/01 SAN 151 Codec 1226).

these opinions,

4. On 14 February 2002 the Council agreed its Common Position in accordance with Article 251(2) of

the Treaty.

II. OBJECTIVES

The proposal for a Directive, which is based on Article 152 (4)(a) of the Treaty, aims to set standards of
quality and safety for human blood and blood components to be applied for the greater part of the
blood transfusion chain and to introduce safeguards for all blood, regardless of its final use, including
related medical applications. It is intended to complement other initiatives dealing with blood-based
industrial and medical applications and treatments.

III. ANALYSIS OF THE COMMON POSITION (4)

A. AMENDED COMMISSION PROPOSAL

The Council's Common Position is broadly in line with the Commission's amended proposal. The
Council shares, in principle, the Commission's response to some key concerns of Parliament.

Thus, as described in the amended proposal, the scope of the Directive has been extended to the
collection and testing of blood and blood components for all purposes, including the manufacturing
of medicinal products; the more technical annexes have been replaced by a regulatory committee
procedure which would be used to develop and update the relevant provisions; a provision has been
added that requires Member States to encourage voluntary, unpaid donation of blood and blood
components.

The Council adopted, wholly, partly, or retaining only the substance, 34 of the 50 amendments
adopted by the European Parliament, which were taken up in the Commission proposal.

NB: The changes in structure (particularly as regards the addition of new recitals, deletion of some,
and inclusion or deletion of Articles and the reformulated Annexes (see Section C) make it difficult
in several cases to establish a precise correspondence between Parliament's amendments,
the
Commission's amended proposal and the Council's Common Position. Thus a great majority of
amendments could not be taken up literally but are in fact covered in substance or in principle by
the Common Position.

(1) OJ C 154 E, 29.5.2001, p. 141.
(2) OJ C 221, 7.8.2001, p. 106.
(3) Not yet published in the Official Journal.
(4) The numbering of the recitals, Articles and Annex 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 4, 9, 18, 24, 25, 29, 36, 37, 49, 50, 52, 53, 57, 58, 59 and 68.

Amendments 4, 9, 37, 52, 53 and 68

The Council considers that, given the Directive's legal basis, these amendments fall outside the scope
of the Directive.

Amendments 18, 24, 25, 29, 36, 57, 58, 59

Refer to texts which have been deleted.

Amendment 49

This amendment does not have a place in the context of an article on notification of adverse events
or reactions.

Amendment 50

The Council considers it appropriate that the competent authorities determine the period for which
records should be kept.

C. PRINCIPAL CHANGES INTRODUCED BY THE COUNCIL

The Council carried out a relatively extensive revision of the text of the proposal in order to better
structure and clarify its provisions and to address more fully and systematically certain key issues of
particular concern to the Member States.

The Council introduced the following main changes.

Hospital blood banks (Articles 3(f) and 6)

Hospital blood banks, being units within a hospital performing limited tasks, were in principle
included in the definition of blood establishment. However, given their limited functions and close
links to the organisation and delivery of health services and medical care, it was not appropriate to
submit such blood banks to all the obligations of the Directive.

The Council therefore, introduced a definition of hospital blood banks and an Article specifying
which provisions of the Directive would apply to them.

Designation, authorisation, accreditation or licensing of blood establishments (Article 5)

The Council extended the concept of accreditation to cover all different modalities of recognition of
a blood establishment existing in the Member States, according to the principle of subsidiarity.

Responsible person and personnel (Articles 9 and 10)

The Council considered that the question of appropriate qualifications and timely, relevant and
regularly updated training is to be dealt with according to the principle of subsidiarity.

Voluntary unpaid donation (Articles 19 and recital 23)

No provision on this issue was included in the Commission's proposal, as the Commission
considered that such a provision is not compatible with the Treaty.

The Council included instead a provision for the encouragement of voluntary and unpaid blood
donations by Member States.

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The Council has added a provision on information thereon to the other Member States and the
Commission as well as a recital referring, inter alia, to the Council of Europe's efforts in this area as
well as to the Council of Europe's definition of voluntary and unpaid donation. Furthermore, the
Council has added in Article 4(2) an explicit reference to the possibility for a Member State to
to introduce
implement more stringent protective measures, and in particular,
maintain or
requirements for voluntary unpaid donations, including the prohibition or restriction of imports
of blood and blood components which do not satisfy such requirements, provided that
the
conditions of Article 30 of the Treaty are met.

Structure and content of the Annexes

The Council considered it useful to maintain a number of the Annexes originally proposed by the
Commission, albeit in a simplified form, in order to set key reference points defining the framework
for the implementation of some important provisions of the Directive which constitutes the basis of
the quality and safety system at Community level. These annexes regard the information to be
provided by blood establishments to the competent authority for the purposes of designation,
authorisation, accreditation or licensing namely, its identification and general
information on its
personnel, and a list of hospital blood banks it supplies, as well as a basic description of a quality
system; the report of the blood establishment's preceding year's activity; labelling requirements; basic
testing requirements for whole blood and plasma donations.

These Annexes would also be updated and reviewed through the committee procedure. The more
technical Annexes, as noted earlier, were replaced by a regulatory committee procedure as requested
by Parliament and accepted by the Commission in its revised proposal.

Other changes

— The Council deleted the Article on clinical tests to be carried out before blood donation (Article

15 of the amended proposal), which it considered outside the scope of the Directive,

— new recitals were added, clarifying certain provisions relative to autologous transfusion, hospital
blood banks, quality system and the traceability of imported blood and blood components.
Other recitals were deleted, due to the alterations introduced to the Articles. Certain definitions
were altered according to the Articles and deleted whenever deemed to be unnecessary.