Opinion of the Economic and Social Committee on the "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: 2001-05-30
Institutions: European Economic and Social Committee
Subjects: European standard, blood transfusion, public health, safety standard

C 221/106

EN

Official Journal of the European Communities

7.8.2001

Opinion of the Economic and Social Committee on the ‘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’

(2001/C 221/18)

On 12 February 2001 the Council decided to consult the Economic and Social Committee, under
Article 152 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Employment, Social Affairs and Citizenship, which was responsible for preparing the
Committee’s work on the subject, adopted its opinion on 2 May 2001. The rapporteur was Mr Ribeiro.

At its 382nd plenary session of 30 and 31 May 2001 (meeting of 30 May), the Economic and Social
Committee adopted the following opinion by 114 votes for with three abstentions.

1.

Introduction

Progress in medical science has meant that blood has

1.1.
become more of a key issue in public health.

1.2.
The use of blood in medical practice means that it is
necessary to draw up rules to guarantee quality, safety and
efficacy in the delivery of these services, particularly as regards
the protection of donors and recipients.

2.

Background

of

The

Treaty

Amsterdam,

2.1.
particular
Article 152(4)(a) and (5), provided the Community with an
opportunity to implement measures ensuring the quality
and safety of blood and blood components when they are
administered in medical therapy.

in

2.2.
However, any Community legislation must take into
account every step in the system for collecting and processing
blood, and must respect the Member States’ responsibilities for
the organisation and delivery of health and medical care.

2.3.
Previous Community initiatives in this area must be
borne in mind, particularly the Council Recommendation on
the suitability of blood and plasma donors and the screening
of donated blood in the European Community (98/463/EC)
and the Council Directive which lays down special provisions
for medicinal products derived from human blood or human
plasma (89/381/EEC).

2.5.
Directive 98/79/EC, which covers diagnostic medical
devices made for in vitro use, should now be supplemented
because it does not contain requirements relating to the quality
and safety of blood which may be used in the preparation of
the above-mentioned medical devices.

3.

Limitation of the application of this directive

The Community thinks, and rightly so, that the quality and
safety requirements relating to haematopoietic cells must be
dealt with in the framework of legislation to be published
subsequently and incorporated in the standards relating to
tissues and cells of human origin.

4.

The aim of this proposed directive

This proposed directive is designed to supplement the Com-
munity’s current system, guaranteeing an equivalent level of
safety and quality for blood in all EU Member States, whatever
its intended purpose.

This will go a long way to reassuring the public.

5.

Strategy

The present proposal for a directive aims to guarantee the
same conditions in all Member States for the system of blood
collection and processing.

To this end it proposes to:

5.1.
establish regulatory and administrative foundations
which can be transposed into Member States’ national legis-
lation;

2.4.
In view of the Council of Europe’s representativity and
importance, its recommendations in this sphere ought to be
taken into consideration. These include the following:
R(96) 11, R(95) 15, R(95) 14 and R(86) 6.

5.2.
lay down an equivalent system for attributing responsi-
bility in the Member States for the notification and approval
of blood establishments, for the certification of good clinical
and laboratory practice, for the accreditation of the staff
the procedures and
involved and for the certification of

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methodologies employed in all the establishments involved in
the collection, testing, processing, storage and distribution of
whole blood and blood components;

7.4.1.
In any case, doctors specialised in this area ought
always to be properly represented on this committee. There
must be maximum transparency in the appointment of these
experts.

5.3.
set up a committee of Member States’ representatives,
responsible for periodically updating the technical standards,
and create a system to monitor adverse reactions and accidents
associated with the collection, processing and use of blood
and blood components (haemovigilance).

6. Content of the proposed directive

This proposal for a directive comprises nine chapters which
can be divided into four distinct parts:

— 1st part — deals with general provisions (chapters I to IV)

— 2nd part — focuses on technical aspects (chapter V and

annexes)

— 3rd part — establishes the requirements relating to data
protection, exchange of information between the Member
States, reports and penalties (chapters VI and VII)

— 4th part — regulates the consultation of committees, the
adaptation of the annexes to technical progress and the
implementation of the text (chapters VIII and IX).

7. General comments

The Economic and Social Committee notes that the

7.1.
proposed Directive aims to protect public health.

7.2.
The Committee deems it necessary to highlight clearly
the social, humanitarian and benevolent contribution made by
blood donors and the civil society bodies which encourage
blood donation. It underlines the altruism of blood donations
which, because they are voluntary, anonymous and unpaid,
warrant public acknowledgement.

7.3.
The Committee approves the text of this proposal in
general, subject to the general and specific comments below
regarding some of the provisions it contains.

7.4.
The Economic and Social Committee is generally
critical of the fact that there are numerous detailed rules in the
proposal, particularly in the annexes. It feels that the proposed
directive should, in contrast, aim to lay down general principles
and objectives. These rules should comprise only one annex
with scientific and technical data which can be adjusted to
reflect recognised scientific progress, proposed by scientists
specialised in this area, meeting in an ‘ad hoc’ committee. The
updating procedure must not lead to formal changes being
made to the directive.

7.4.2.
For this reason, the Committee has decided not to
make detailed comments about the technical and scientific
components of the annexes.

The Committee welcomes this proposed directive
7.5.
which consolidates equality of rights for people throughout
the Community.

7.6.
The Committee considers the wording of Article 4(3)
to be ambiguous, since the internal movement of goods in
Member States must comply with quality and safety aspects
imposed within each Member State. Steps must be taken to
ensure that it is not possible for blood or blood components
to be used in a Member State unless they comply with any
stricter national requirements which might apply in that
country. The Commission will have to assess the potential
legal impact of this conflict of objectives.

7.7.
The Economic and Social Committee notes that this
proposed directive respects the individual features of each
Member State’s health system, by advocating a uniform basis
for quality and safety in the system for collecting and
processing blood without blocking any ad hoc improvements
which individual Member States might wish to introduce.

7.8.
The Committee approves of the fact that in each
Member State a system has been set up for the notification,
approval, accreditation,
inspection, monitoring and certifi-
cation of blood establishments and the accreditation of the
staff involved in the process.

The Committee also welcomes the provisions relating
7.9.
to training and qualifications for professionals in the sector,
especially since these will not prejudice legal requirements
concerning mutual recognition of diplomas.

7.10.
The Committee considers that one of the EU’s priority
objectives is to lay down the foundations for achieving high
safety and quality standards for blood and blood components
used within its territory. As a consequence it deems the
provisions contained in this proposed directive to be positive,
since, taking into account ethical and deontological principles
as well as current international standards, they ensure that this
objective will be met, necessarily covering the eligibility of
donors and the collection, testing, processing, storage and
distribution of whole blood and its components.

7.11.
management and control system for blood establishments.

The Committee approves of the creation of a quality

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7.12.
The Economic and Social Committee agrees with the
establishment of a system for exchanging information on
issues cropping up in the course of the system for collecting
and processing blood, using a suitable labelling and filing
system, so as to secure its traceability.

The Committee is pleased to see that the proposed
7.13.
directive creates mechanisms for continuous, rapid updates of
the annexes, laying down the scientific criteria which determine
the approach adopted by those involved in the system for
collecting and processing blood.

7.14.
The Economic and Social Committee does however
feel that this proposed directive should state explicitly that it
applies to both public, charitable and private establishments,
irrespective of their size or the way they are organised.

The Committee recommends that it should in some
7.15.
way be made explicit in the proposal that tasks which might
involve direct contact with donors or recipients of blood or
its components should come under the exclusive technical
responsibility of properly qualified health service staff with the
appropriate back-up.

7.16.
In view of the shortage of blood and given that blood
donors make a humanitarian and benevolent gesture which is
anonymous and unpaid, the Economic and Social Committee
suggests that the Commission urge Member States to carry out
more campaigns aimed at enhancing the public image of blood
donors and thus providing the best incentive possible to give
blood.

or with skills in transfusion medicine’ (1).

Article 3(h) should read as follows:

‘Adverse event
8.3.
shall mean any untoward occurrence inconsistent with the
procedural standards in force, associated with the collection,
testing, processing, storage, distribution and transfusion of
blood and blood components’.

Article 4(1) should read as follows:

8.4.
‘Member States
shall establish, or designate, the competent authority, not
involved in the process, which will be responsible for
implementing the requirements of this directive’.

8.5.
Article 5(2) should read as follows: ‘Where the respon-
sible person is permanently replaced, the blood establishment
shall provide immediately to the competent authority the
name of the new responsible person and his/her date of
commencement. The competent authority must be informed
of the name of the stand-in for the responsible person when
the latter is temporarily absent’.

Article 9(1) should read as follows:

8.6.
‘the responsible
person must be a doctor specialised or with skills in transfusion
medicine1’. (See point 8.2).

8.7.
Article 10(1) should read as follows: ‘Personnel directly
involved in collection, testing, processing, storage and distri-
bution of human blood and blood components must be
suitably qualified for their tasks and shall be provided with
timely and relevant training’.

Article 10(2) should read as follows: ‘additional training

8.8.
of the personnel shall be provided on recruitment ...’.

7.16.1.
Self-sufficiency in the blood sector is one EU
objective, which has to be secured. In line with the draft
Directive, the Committee stresses how vital it is not to allow a
mercenary, profit-oriented approach to blood donations to
develop on the part of the establishments which collect and
process blood.

Article 11(1) should read as follows: ‘The competent
8.9.
authority shall take all necessary measures to ensure that each
blood establishment establishes and maintains a quality system
for blood establishments (“QSBE”) in keeping with current
quality standards’.

7.17.
The Committee notes that this proposed directive
does not draw a clear distinction between homologous and
autologous blood donations.

8.10.
Article 12(2) should read as follows: ‘Member States
shall take all necessary measures in order to ensure that access
is provided to these documents for officials entrusted with

8.

Specific comments

8.1.
The Economic and Social Committee proposes that the
following be added to Article 1: ‘the present directive does not
cover the effective therapeutic use of blood and blood
components’.

(1)

Transfusion Medicine

Minimum length: 5 years

Austria

Germany
Denmark
France
Italy
Ireland
Portugal
Sweden

Blutgruppenserologie und
Transfusionsmedizin
Transfusionsmedizin
Klinisk immunologi
Transfusion sanguine (*)
Immunoematologia
Transfusion Medicine
Imuno-hemoterapia
Transfusionsmedecin

8.2.
The Committee suggests that Article 3(e) should read
as follows: ‘responsible person shall mean a doctor specialised

(*) ‘After 4 or minimum 5 years of another specialty, e.g.

‘Haematology’.

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inspection and control measures referred to in Article 8,
without prejudice to the privacy of blood donors and recipi-
ents’.

8.11.
In Article 13(1), second paragraph, second line:
‘preferably computerised’, should be inserted after the word
‘system’.

8.12.
At the end of Article 14(1) the following sentence
should be inserted: ‘There will also have to be a procedure
relating to “look-back”’.

Article 14(2) should read as follows:

8.13.
‘The person
responsible for the blood establishment shall notify the
competent authority ...’. The following should also be inserted:

a)

The competent authority shall analyse and classify
serious adverse reactions and events in order to
introduce preventative measures.

8.14.
In Annex II, Part A, first indent, the e-mail address
should also be requested. The fourth indent should read as
‘hygiene and safety requirements (e.g. protective
follows:

Brussels, 30 May 2001.

garments, and compulsory compliance with accepted protec-
tion and hygiene standards in work area)’.

Part B of Annex II of

8.15.
the original Commission
document will have to include an additional indent, to read as
follows:
‘Number of new donors per year’. The following
phrase should be added at the end of the current third indent:
‘and the reasons for this’.

8.16.
The following should be added to the first column in
the table in Annex III: ‘Informatics experience applicable to
this area’.

The text in the fourth column should read as follows: ‘Training
in human blood biology and chemistry’.

The text in the fifth column should read as follows: ‘Specialis-
ation or with skills in transfusion medicine (see Point 8.2)’.

8.17.
Part 4 be inserted, worded as follows:

It is proposed that in Annex VI an introduction to a

‘4. Requirements relating to auto-transfusion

Auto-transfusion is not covered by these restrictive criteria
and will be subject to specific requirements.’

The President

of the Economic and Social Committee

Göke FRERICHS