Amended 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
Date: 2001-11-15
Institutions: European Commission
Subjects: blood transfusion, health control, marketing, product safety, public health, quality standard, safety standard, storage

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Amended 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)

(2002/C 75 E/08)

COM(2001) 692 final (cid:151) 2000/0323(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 16 November 2001)

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,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

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

Whereas:

(1) The extensive therapeutic use of human blood demands
that the quality, safety and efficacy of whole blood and
blood components be ensured, whatever the intended
purpose, in order to prevent the transmission of diseases.

(2) The availability of blood and blood components used for
therapeutic purposes is dependent on Community citizens
who are prepared to donate; in order to safeguard public
health and to prevent
infectious
diseases
precautionary
by
measures during their collection, processing, distribution
and use need to be taken,
taking full advantage of
scientific advances in pathogen detection and inactivation.

the transmission of

components,

blood

all

(3) The

and

safety,

quality,

efficacy

requirements

industrially-prepared medicinal

of
products
proprietary
derived from human blood or human plasma were
through Council Directive 89/381/EEC of
ensured
14 June 1989 extending
scope of Directives
65/65/EEC and 75/319/EEC on the approximation of
provisions laid down by Law, Regulation or Adminis-
trative Action relating to proprietary medicinal products
and laying down special provisions for medicinal products

the

derived from human blood or human plasma (2); whole
blood, plasma, and blood cells of human origin are
specifically excluded from that Directive, and this 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 to any binding Community legis-
lation. It is essential, therefore, that whatever the intended
purpose, Community provisions should ensure that blood
and its components are of comparable quality 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 that are derived from donations in another
Member State nonetheless carry the same guarantees as
those in their own country.

the

(4) In respect of blood or plasma as a starting material for the
manufacture of proprietary medicinal products, Article 3
of Directive 89/381/EEC mentions measures to be taken
transmission of
by Member States
to prevent
infectious diseases, referring to the application of
the
the European Pharmacopoeia and the
monographs of
recommendations of
the Council of Europe and the
World Health Organisation as regards in particular the
selection and testing of blood and plasma donors.
Furthermore, by the same Directive, Member States
should also take measures to promote Community self-
sufficiency in human blood or human plasma; and to
encourage voluntary unpaid donations of blood and
plasma.

(5) In order to ensure that there is an equivalent level of
safety and quality of blood components, whatever their
intended purpose, technical in requirements for collection
and testing of all blood and blood components including
starting materials for medicinal products should be estab-
lished by this Directive. Directive 89/381/EEC should be
amended accordingly.

(6) It is necessary for the Commission and the Member States
to step up biotechnological research into the production
of blood components and products for therapeutic use
and research into new technologies enabling blood and
blood precursors and derivatives
to be stored more
effectively and for longer periods.

(1) OJ C 154 E, 29.5.2001, p. 141.

(2) OJ L 181, 28.6.1989, p. 44.

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(7) The Commission’s Communication of 21 December 1994
on Blood Safety and Self-sufficiency in the European
Community (1)
identified the need for a blood strategy
in order to reinforce confidence in the safety of
the
blood transfusion chain and promote Community self-
sufficiency.

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

(9) The Council in its Resolution of 12 November 1996 on a
strategy towards blood safety and self-sufficiency in the
European Community (3)
invited the Commission to
submit proposals as a matter of urgency with a view to
encouraging the development of a coordinated approach
to the safety of blood and blood products.

(10) The

in

its

European

Parliament

resolutions

of
14 September 1993 (4), 18 November 1993 (5), 14 July
1995 (6), and 17 April 1996 (7) on blood safety and self-
sufficiency through voluntary unpaid donations in the
European Community has stressed the importance of
level of blood safety and has
ensuring the highest
the objective of
reiterated its continued support
Community self-sufficiency.

for

(11) In accordance with the principles of subsidiarity and
proportionality set out in Article 5 of the Treaty, the
objectives of the proposed action, 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
reason of its scale and effects be better achieved by the
Community. This Directive confines itself to the minimum
required in order to achieve those objectives and does not
go beyond what is necessary for that purpose.

(12) 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.

therapeutic
(13) 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 to their state of health will

(1) COM(94) 652 final.
(2) OJ C 164, 30.6.1995, p. 1.
(3) OJ C 374, 11.12.1996, p. 1.
(4) OJ C 268, 4.10.1993, p. 29.
(5) OJ C 329, 6.12.1993, p. 268.
(6) OJ C 249, 25.9.1995, p. 231.
(7) OJ C 141, 13.5.1996, p. 131.

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
Community citizens who are the recipients of blood and
blood components.

(14) Modern blood-transfusion practice has been founded on
the principles of voluntary and unpaid donor services,
anonymity between both donor and recipient, benev-
olence of the donor, and absence of profit on the part
of
involved in blood transfusion
services.

the establishments

prospective

(15) 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
donations as well as any future traceability of
their
donation.

blood

or

of

(16) The Community entirely supports
unpaid

the principle of
blood
and
voluntary,
the
components,
Community
blood
components, and to ensure respect for ethical principles
in their donation.

of
to attain self-sufficiency throughout
of
in the

donation

supply

blood

blood

and

(17) 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 (8) requires that data
related to the health of an individual be subject to rein-
forced protection. However, it covers only personal data
and not that rendered anonymous so that the person is no
longer
therefore
introduce additional safeguards to prevent any unauth-
orised changes
to donation registries, or processing
records, or the unauthorised disclosure of information.

identifiable. This Directive

should

adverse

and notification of

(18) A common system of accreditation for blood estab-
and
lishments
reactions linked to the collection, processing,
testing,
storage, and distribution of blood and blood components
should be established in Member States. Three competent
authorities should be able to withdraw or suspend accredi-
tation if a blood establishment does not comply with the
requirements of this Directive.

events

(19) Blood establishments

policy,

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

responsibilities

objectives

control,

quality

and

and

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

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(20) 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

(21) 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. The provisions
laid down in this Directive as regards training should be
applicable without prejudice to existing Community legis-
lation on the recognition of professional qualifications and
on the protection of workers.

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Objectives

The objective of this Directive is to ensure a high level of
protection of human health by establishing quality and safety
standards for human blood and its components.

Article 2

Scope

(22) 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 labelling system. The
labelling system should also allow the identification of the
establishments where the blood or blood components was
collected.

This Directive shall apply to the collection and testing of
1.
human blood and blood components, whatever their intended
purpose, and to their processing, storage, and distribution
when intended for transfusion, with the aim of ensuring high
standards of safety and quality.

2.

This Directive shall not apply to autologous transfusion.

(23) It is necessary that the best possible scientific advice in
relation to the safety of blood and blood components is
available to the Community. The Comission should
consult the relevant scientific committee(s) for setting up
the technical requirements and for adapting the provisions
of this Directive to scientific and technical progress.

(24) The Commission should be empowered to establish
technical requirements and adopt any necessary changes
thereto in order
scientific and
technical progress.

to take into account

(25) Since the measures necessary for the implementation of
this Directive are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (1),
they should be adopted by use of
the regulatory
procedure provided for in Article 5 of that Decision.

(26) 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.

3.

This Directive shall not apply to blood stem cells.

4.
This Directive shall apply without prejudice to the
requirements of Directive 98/79/EC of the European Parliament
and of the Council of 27 October 1998 on in vitro diagnostic
medical devices (2), Council Directive 93/42/EEC of 14 June
1993 concerning medical devices (3), Directive 2000/70/EC of
the European Parliament and of the Council of 16 November
regards
2000 amending Council Directive 93/42/EEC as
incorporating stable derivates of human
medical devices
blood or human plasma (4), and Directive 95/46/EC of
the
European Parliament and the Council of 24 October 1995 on
the protection of individuals with regard to the processing of
personal data and the free movement of such data (5).

Article 3

Definitions

For the purposes of this Directive:

(a) (cid:145)Autologous transfusion(cid:146) shall mean the transfusion of auto-
logous
pre-deposit,
pre-operative normovolaemic haemodilution or peri-
operative salvage.

by means

obtained

blood

of

(b) (cid:145)Blood(cid:146) shall mean whole blood collected from a donor and
processed either for transfusion or for further manufac-
turing.

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

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

(2) OJ L 331, 7.12.1998, p. 1.
(3) OJ L 169, 12.7.1993, p. 1.
(4) OJ L 313, 13.12.2000, p. 22.
(5) OJ L 281, 23.11.1995, p. 31.

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(c) (cid:145)Blood component(cid:146) shall mean a therapeutic constituent of
blood (red cells, white cells, platelets, plasma) that can be
prepared by various methods.

Article 4

Implementation

(d) (cid:145)Blood product(cid:146) shall mean any therapeutic product derived

from human blood or plasma.

1. Member States shall designate the competent authority
this
responsible
Directive.

requirements of

implementing

the

for

(e) (cid:145)Blood establishment(cid:146) shall mean any structure or body that
is involved in any aspect of the collection and testing of
human blood or blood components, whatever
their
intended purpose, and their processing,
storage, and
distribution when intended for transfusion.

2. Member States shall ensure that the competent authority
implements the structural,
technological and organisational
requirements for accreditation and organises inspections and
other control measures
intended to guarantee compliance
with the provisions of this Directive.

(f)

shall mean formal

(cid:145)Inspection(cid:146)
control
according to adopted standards to evaluate and assess
compliance with this Directive and other relevant legis-
lation to identify problems and approaches
to their
resolution.

and objective

(g) (cid:145)Adverse event(cid:146)

shall mean any untoward occurrence
associated with the collection, testing, processing, storage,
distribution,
blood
components that might lead to death or life-threatening,
disabling or
for patients or
which results in or prolongs hospitalisation or morbidity.

incapacitating conditions

transfusion

blood

and

and

of

(h) (cid:145)Adverse reaction(cid:146) shall mean a harmful and unintended
response in donor or
in patient associated with the
collection or transfusion of blood or blood components
that is fatal,
incapacitating, or
which results in or prolongs hospitalisation or morbidity.

life-threatening, disabling,

(i)

(cid:145)haemovigilance(cid:146) shall mean a set of organised surveillance
procedures relating to adverse events or adverse reactions
in donors or recipients, related to the quality and safety of
the blood or blood component involved.

(j)

(cid:145)Deferral(cid:146) shall mean suspension of
individual
suspension being either permanent or temporary.

the eligibility of an
to donate blood or blood components such

(k) (cid:145)Accreditation(cid:146)

shall mean formal acknowledgement of
compliance with accepted
for procedures,
activities, or services following an inspection by an auth-
orised institute or organisation.

standards

(l)

(cid:145)Voluntary, unpaid donation(cid:146) shall mean that the person
gives blood or blood components of his/her own free will
and receives no payment for it, either in the form of cash,
or in kind which could be considered a substitute for
money. This would include time off work other than that
reasonably required for donation and travel. Small tokens,
refreshments,
are
compatible with voluntary and unpaid donation.

and reimbursement of direct

costs

3.
This Directive shall not prevent a Member State from
maintaining or implementing on its territory more stringent
protective measures which comply with the provisions of the
Treaty. Those more stringent measures shall be safety measures
totally based on current scientific knowledge and not present
an obstacle to the implementation of this Directive.

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
relating to identification, preparation,
of
management, monitoring, audit and control, as well as to
support expenditure.

the beneficiaries,

CHAPTER II

OBLIGATIONS ON MEMBER STATES’ AUTHORITIES

Article 5

Accreditation of blood establishments

1.
The competent authority shall grant accreditation to
their activities as
blood establishments for the purposes of
described in Article 2. Any substantial change in the particulars
of the accreditation or any new activity must be approved.

To this end, the blood establishment shall deliver a notification
to the competent authority, providing its name, address,
telephone and fax numbers, as well as the name of
the
responsible person according to Article 8 and the information
referred to in Article 28(1.a).

The competent authority empowered to grant the accredi-
2.
submitted in the
the particulars
tation shall verify that
application comply with the requirements set out
in this
Directive and indicate whether the activities for which the
blood establishment sought accreditation may proceed.

The blood establishment may commence the activities for
3.
which it
the
sought accreditation only upon receipt of
competent authority’s written approval and compliance with
any conditions referred to therein.

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If

the competent authority finds that

the prescribed
4.
standards have not been complied with,
it may immediately
withdraw or temporarily suspend accreditation, depending on
the seriousness of the infringement.

In the event of temporary suspension, the competent authority
shall carry out an inspection within a period of three months,
which may lead to withdrawal of
the
infringement has not been remedied or if other infringements
are found.

accreditation if

Article 6

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
enable blood establishments operating under their legislation to
comply with its requirements.

Article 7

Inspection and control measures

1.
The competent authority shall organise inspections and
appropriate control measures in blood establishments to ensure
that the requirements of this Directive, in particular those laid
down in Article 5, 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 one
year.

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

(a)

inspect blood establishments as well as facilities of any
third parties on the
its Member State
entrusted by the holder of the accreditation referred to in
Article 5 with the task of carrying out evaluation and
testing procedures pursuant to Article 18;

territory of

(b) take samples;

subject
at

(c) examine any documents relating to the object of

the
in force in the
inspection,
Member States
this
Directive and which place restrictions on these powers
with regard to the descriptions of the method of prep-
aration.

to the provisions
the

time of notification of

The competent authority may organise inspection and
4.
intervals depending on the
control measures at
results of
in any case
organise an immediate and appropriate inspection in the
event of an adverse event or adverse reaction.

the previous

inspection.

shorter

shall

It

CHAPTER III

PROVISIONS FOR BLOOD ESTABLISHMENTS

Article 8

Responsible person

Blood

1.
shall
((cid:145)responsible person(cid:146)), responsible for:

establishments

designate

a

person

(cid:151) 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,

(cid:151) Providing information to the competent authority in the

accreditation procedure as required in Article 5,

(cid:151) Implementation of the requirements of Articles 9, 10, 11,
12, 13, 14, 15, 18, 19, 20, 21, and 22 in the blood estab-
lishment,

The responsible person shall fulfil the following minimum

2.
conditions of qualification:

(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 of at least 4 years, or a course of at least 3 years
recognised as equivalent by the Member State concerned;

(b) he/she shall have practical post-graduate 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 testing of human blood and
blood components, or to their preparation, storage, and
distribution.

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.

4.
Blood establishments shall notify the competent authority
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 are 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.

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Article 9

Personnel

Article 12

Record keeping

directly

Personnel

1.
testing,
involved
processing, storage, and distribution of human blood and
blood components shall be qualified to perform such tasks
and shall be provided with timely and relevant
training
which shall be regularly updated.

collection,

in

1. Member States shall take all necessary measures to ensure
that blood establishments maintain records of the information
required under Article 28(1.f),
(g), and (h), as well as the
prevalence of
transfusion transmissible infectious agents in
blood and plasma donors, and confirmed positive serocon-
versions. These records shall be kept for a minimum of 30
years.

The training of

the personnel shall be provided on
2.
recruitment, and then at regular intervals of at
least once
every year. It shall be repeated in the event of a transfer or a
change of job, as well as following the introduction of any new
technology.

The competent authority shall keep records of the data
2.
received from blood establishments according to the provisions
of Article 5 for a minimum of 30 years.

It shall be assessed periodically and at least every two years
(proficiency testing).

3.
Training guidelines addressing the issues determined
according to Article 28(1.c) shall be provided for personnel.

3.
The competent authority shall keep records of haemo-
vigilance data, which they possess according to the provisions
of Article 13 or are notified to them according to the
provisions of Article 14. These records shall be kept for a
minimum of 30 years.

CHAPTER IV

QUALITY MANAGEMENT

Article 10

CHAPTER V

HAEMOVIGILANCE

Article 13

Traceability

Quality system for blood establishments

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.

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

The Commission shall establish the Community standards
2.
and specifications referred to in Article 28(1.k)
for to the
activities relating to a quality system to be carried out by a
blood establishment.

Article 11

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
officials
entrusted with inspection and control measures
referred to in Article 7.

To this end, Member States shall ensure that blood estab-
lishments implement a donor identification system and label
each single blood unit and components thereof in such a way
as
in accordance with the
requirements referred to in Article 28(1.b).

to permit

traceability

full

2. Member States shall take all necessary measures in order
to ensure that blood and blood components collected, tested,
processed, stored or distributed on their territory are labelled as
including an identification of
required under Article 28(1.d),
blood
blood
the
component was collected.

establishment where

blood

the

or

In respect of blood and blood components imported from
3.
third countries, Member States
technical
measures having equivalent effect to ensure that blood and
blood components meet
the same standards as blood and
blood components collected in the Community.

implement

shall

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Article 14

Notification of adverse reactions and events

1. Member States shall ensure that:

blood or blood components, all donors on their own territory
provide the information required under Article 28(1.f) to the
blood establishment.

(cid:151) Any adverse events (accidents and errors) related to the
collection, testing, processing, storage and distribution of
an
blood and blood components which may have
influence on their quality and safety, as well as any
adverse reactions observed during or after
transfusion
which may be attributed to the quality and the safety of
blood and blood components are notified to the competent
authority.

(cid:151) Each blood establishment has in place a procedure to notify
to the competent
such adverse reactions and events
authority and to remove defective blood and blood
components
rigorously, effectively, and verifiably from
distribution channels.

2.
The Community procedure for notifying these adverse
reactions and events, and the notification format, shall be
established as referred to in Article 28(1.l). A retrospective
research procedure shall also be established.

CHAPTER VI

PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD
AND BLOOD COMPONENTS

Article 15

General clinical tests

A medical examination, comprising at least an interview and
blood pressure check by a doctor, shall be carried out before
any donation of blood or blood components; the doctor shall
be responsible to ensure, in particular, that donors are given
the necessary information and that the required information is
gathered from donors. The doctor
is also responsible for
assessing the eligibility of donors.

Article 18

Eligibility of donors

Blood establishments shall ensure that in order to protect
1.
the health of both the donor and the recipient,
there are
evaluation procedures in place for all donors of blood and
blood components and that the criteria for donation required
under Article 28(1.g) are met.

Blood and blood components shall be collected from
the criteria for donation referred to in

2.
donors who meet
Article 28(1.g).

The

results of

evaluation and testing
3.
procedures shall be documented and any relevant abnormal
findings shall be reported to the donor.

the donor

Article 19

Voluntary and unpaid blood donation

Member States shall encourage voluntary, unpaid donation of
blood and blood components, and shall take the necessary
measures to promote the use of blood and blood components
derived from voluntary, unpaid donations.

Article 20

Testing of donations

Blood establishments shall ensure that each donation of blood
in conformity with
and
blood
requirements
taking full
advantage of scientific advances in pathogen detection.

components
referred to in Article 28(1.h),

tested

is

Article 16

Article 21

Provision of information to donors and recipients

Member States shall ensure that all donors of blood or blood
components on their own territory are provided with
information as required under Article 28(1.e), and similarly
to ensure that all recipients are provided with information
about possible adverse transfusion reactions and events.

Freezing, storage and transport conditions

Blood establishments shall ensure that the freezing, storage and
transport conditions of blood and blood components comply
with the provisions referred to in Article 28(1.i).

Article 17

Information required from donors

Member States shall take all necessary measures to ensure that,
upon agreement of a willingness to commence the donation of

Article 22

Quality requirements for blood components

Blood establishments shall ensure that quality requirements for
blood components meet high standards in compliance with the
provisions referred to in Article 28(1.j).

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CHAPTER VII

DATA PROTECTION

Article 23

Data protection and confidentiality

Member States shall take all necessary measures in accordance
with Directive 95/46/EC to ensure that all data,
including
personal data and genetic information, collated within the
this Directive to which third parties have access
scope of
have been rendered anonymous so that
is no
longer identifiable.

the donor

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;

(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

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

Article 24

Information exchange

1.
The Commission shall meet regularly with the competent
authorities designated by the Member States to exchange
information on the experience acquired with regard to the
implementation of measures for
the protection of human
health, pursuant to this Directive.

Information on the collection and distribution of blood
2.
and blood components and data on clinical use must be
available for the purposes of implementing this Directive and
charting the degree of national and regional self-sufficiency.

3. Where new epidemiological or scientific data suggest
there are risks to human health related to the collection,
testing, processing, storage and distribution of blood and
the Commission may
blood components and derivatives,
arrange for emergency meetings.

Article 25

Reports

States

1. Member
the Commission,
commencing on 31 December 2003 and every two years
thereafter, a report on the activities undertaken in relation to

shall

send

to

the provisions of this Directive, including an account of the
national measures taken in relation to inspection and control.

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

The Commission shall

3.
European
Parliament, the Council, the Economic and Social Committee
and the Committee of the Regions, every three years, a report
on the functioning of requirements in the Directive, and in
particular those relating to inspection and control.

transmit

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 32 at
the latest and shall notify it
without delay of any subsequent amendments affecting them.

CHAPTER IX

COMMITTEES

Article 27

Committee procedure

The Commission shall be assisted by a committee
the Member States and

1.
composed of
representatives of
chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be three months.

Article 28

Technical requirements and their adaptation to technical
and scientific progress

1.
The following technical requirements shall be determined
in accordance with the procedure referred to in Article 27(2):

(a)

information to be provided by the blood establishment to
the competent authority before accreditation;

(b) traceability requirements

including the possible estab-

lishment of a common coding system;

C 75 E/112

EN

Official Journal of the European Communities

26.3.2002

(c)

training guidelines;

(d)

labelling requirements for blood and blood components;

(e)

information to be provided to donors;

(f)

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

including the
the

(g) requirements concerning the suitability of blood and
plasma donors and the screening of donated blood such as:

(cid:151) physical acceptance criteria

(cid:151) donation volumes and frequency

(cid:151) permanent deferral criteria and possible exemption

thereto

(cid:151) temporary deferral criteria;

(h) requirements relating to the testing of donations of whole

blood and blood components;

(i)

freezing, storage, and transport requirements;

(j) quality and safety requirements for blood components;

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

relating to a

(l) Community procedure for notifying adverse reactions and

events and notification format.

The provisions

2.
referred to in paragraph 1 shall be
reviewed and if necessary adapted to scientific and technical
progress at least once a year under the procedure referred to in
Article 27(2). Establishment of technical specifications and the
adaptation to progress shall be performed taking into account
relevant recommendations of the Council of Europe and the
WHO as well as indications of relevant European institutions
and organisations.

Article 29

Consultation of scientific committee(s)

the

The Commission may
scientific
consult
committee(s) when setting up and adapting the technical
referred to in Article 28 to scientific and
requirements
technical progress,
in particular with a view to ensuring an
level of quality and safety of blood and blood
equivalent
transfusion and blood and blood
components used for

relevant

components used as a starting material for the manufacture
of medicinal products.

CHAPTER X

FINAL PROVISIONS

Article 30

Amendment of Directive 89/381/EEC

Paragraphs 1, 2 and 3 of Article 3 of Directive 89/381/EEC are
replaced by:

. . ./. . ./EC of

For the collection and testing of human blood and
(cid:145)1.
the European
human plasma Directive
Parliament and of
[setting standards of
the Council
quality and safety for the collection, testing, processing,
storage, and distribution of human blood and blood
components and amending Council Directive 89/381/EEC]
applies.(cid:146)

Article 31

Transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
than 31 December 2002. They shall
Directive not
forthwith inform the Commission thereof.

later

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 twentieth day
following that of its publication in the Official Journal of the
European Communities.

Article 33

Addressees

This Directive is addressed to the Member States.