Opinion of the Committee of the Regions 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: 2001-09-20
Institutions: European Committee of the Regions
Subjects: blood transfusion, pharmaceutical legislation, pharmaceutical product, product safety, public health

C 19/6

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Official Journal of the European Communities

22.1.2002

Opinion of the Committee of the Regions 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’

(2002/C 19/03)

THE COMMITTEE OF THE REGIONS,

having regard to the Proposal from the Commission 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
[COM(2000) 816 fin — 2000/0323 (COD)];

having regard to the decision by the Council on 12 February 2001, under the Articles 265(1) and 152 of
the Treaty establishing the European Community, to consult the Committee of the Regions on the matter;

having regard to its Bureau’s decision of 13 June 2000 to instruct Commission 5 for Social Policy, Public
Health, Consumer Protection, Research and Tourism to prepare the Committee’s work on this subject;

having regard to its opinion on the Communication from the Commission to the Council, the European
Parliament, the Economic and Social Committee and the Committee of the Regions on the health strategy
of the European Community — Proposal for a Decision of the European Parliament and of the Council
adopting a programme of Community action in the field of public health (2001-2006) [COM(2000) 285
fin — 2000/0119 (COD)] (CdR 236/2000 fin) (1);

having regard to the Council Resolution of 12 November, 1996 on a Strategy Towards Blood Safety and
Self Sufficiency in the European Community;

having regard to the Draft Opinion (CdR 66/2001 rev. 2) adopted by Commission 5 on 16 July 2001
[rapporteur: Ms Sexton (IRL/ELDR)];

whereas there have been serious issues affecting public health as a result of problems in the safety of the
blood supply in several Member States in recent years and it is essential that all necessary measures are
taken to prevent such events arising in the future,

unanimously adopted the following opinion at its 40th plenary session of 19-20 September 2001
(meeting of 20 September).

1.

Introduction

1.3.
The Committee believes that it is important to secure
public confidence in the safety of blood and blood products
and the proposal should contribute to this.

The Committee of the Regions broadly welcomes the
1.1.
Proposal for a Directive of the European Parliament and of the
Council setting standards of quality and safety for the collec-
tion, testing, processing, storage and distribution of human
blood and blood components and amending Council Directive
89/381/EEC.

The safety of blood transfusion throughout the EU is
1.2.
of very great importance and the Committee considers that
the proposed directive should go some way to establishing a
coherent legislative framework to ensure a high level of quality
of blood and its components and safety for donors and
recipients.

(1) OJ C 144, 16.5.2001, p. 43.

2. Views and recommendations

The Committee is aware that new technologies are
2.1.
becoming available that will improve safety in blood trans-
fusion, such as increased specificity and sensitivity in tests
of blood donations for infectious diseases, and additional
processing techniques that may be applied to eradicate residual
viruses or bacteria in the blood components. The Committee
considers that
the standards in use
throughout the Union reflect these developments, and that
they ensure that they are applied in a consistent and effective
manner. There is clearly a need to regulate and inspect the
application of appropriate standards throughout the Union,
and the Proposal is to be warmly welcomed for this reason.

is important

that

it

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2.2.
The Committee has however a number of concerns
about the inadequacy of the content of some of the appendices
accompanying the proposed directive. While it is not the CoR’s
role to discuss the technical and scientific components of the
annexes in the proposed directive in detail, it does feel that
they warrant new, up-dated and substantiated proposals by
experts in the field.

EU sets up its own technical standard drafting and review
process,
it would be more likely to achieve and maintain
excellence in all aspects of the transfusion process throughout
the Union and applicant states, if it were to use as a basis such
a model. The Committee also recommends that the Union
should consider the adoption of an effective mechanism to
oversee the adherence to and proper implementation of these
standards across the Member States.

The CoR believes that there is a clear need to ensure
2.3.
that the standards envisaged in the proposed directive always
reflect best-established practice, and do not fall behind the
state of the art in other countries or regions. It also considers
that it is essential to ensure that the process of developing and
maintaining the standards of quality and safety, which will
always be subject to continuous change, is not inferior to the
process that the Member States or the regions could, and in
many cases currently do, implement and maintain themselves.

2.3.1.
The CoR is aware that blood-transfusion services and
regulatory bodies, whether organized and administered within
national or regional structures, use existing technical, oper-
ational and quality standards. These standards are used for
operational and quality assurance purposes and for regulatory
and accreditation purposes, and are based on published
guidelines continually up-dated by large panels of experts. The
Committee considers that the proposed directive does not
contain operational standards that compare favourably with
such existing publications.

The Committee therefore feels that

2.3.2.
it could be
difficult to resource in terms of available experts a parallel
process of equal skill and expertise given that many of the best
national and international experts in blood transfusion and in
the regulatory processes in the EU are already engaged in the
up-dating and drafting of the recognized guidelines or their
own national standards.

2.3.3.
Furthermore, the CoR feels that the process in the
proposed directive for maintaining the EU standards for blood-
transfusion establishments is manifestly not as good as the
best already in existence. The proposed Directive should
include a process for regular review (preferably an annual
review) which allows for a wide consultation of experts before
standards are adopted.

The CoR also considers that Member States should
2.3.5.
have the option of setting other safety standards so that only
blood and blood components meeting these standards would
be imported into these States when necessary.

2.4.
The CoR would like to highlight that regional differ-
ences exist within the EU in other aspects of the blood-
transfusion process. There are different regional traditions in
approaches to blood donation, as well as regional differences
in prevalence of diseases that impact on blood-transfusion
demands, (e.g. thalassaemia). In addition, seasonal movements
of persons within the EU create regional demands and
pressures that may impact on the ability of some regions to
supply adequate, and therefore safe blood-transfusion services
in a Community capacity.

2.4.1.
The CoR therefore recognizes that the implemen-
tation of this proposed directive will place financial burdens
on some blood-transfusion services and may also result in
shortages of blood and blood product in some regions. The
CoR would therefore like to remind the Commission that the
Council in its Resolution of 12 November 1996, requires the
issue of self sufficiency in blood to be addressed at the EU level
and would welcome further proposals to overcome this
problem.

is not envisaged in the proposal,

2.4.2. While it
the
Committee feels that a Community initiative would be wel-
come to ensure that the influx of large numbers of persons on
vacation to some regions does not stress the adequacy and
therefore the safety of the blood supply in those regions. In
general holiday visitors tend not to donate blood in the regions
they are visiting, though the transfusion requirements of a
large holiday population may be considerable in those regions.
The Committee of the Regions therefore calls for Community
initiatives to ensure self-sufficiency in blood during holiday
periods in regions with particularly large numbers of tourists.

2.3.4.
The CoR strongly recommends that the Union should
give serious consideration to availing of the excellent and
established processes currently available and in use in Member
States, in particular through the Council of Europe. When the

The Committee believes that the availability through-
2.5.
out
the EU of high quality comparable data on blood
transfusion matters in different regions is of considerable
in
importance. Such information will be of benefit to all
establishing and maintaining the highest quality of blood-
transfusion service provision throughout the Union.

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2.6.
The CoR believes that the availability of such infor-
mation throughout the Union will be facilitated by coherent
information-technology practices in the Member States, and
calls on the Commission to take account of the requirements
for such information-technology practices in Member States.

2.7.
The Committee believes that specific funds should be
made available to applicant countries to ensure that any
in rapidly achieving
particular difficulties that may exist
compliance with the provisions of the proposed directive are
identified and resolved.

Brussels, 20 September 2001.

The President

of the Committee of the Regions

Jos CHABERT

Opinion of the Committee of the Regions on the ‘Communication from the European
Commission: Services of General Interest in Europe’

(2002/C 19/04)

THE COMMITTEE OF THE REGIONS,

having regard to the communication from the European Commission: Services of General Interest in
Europe (COM(2000) 580 final);

having regard to the decision of its Bureau on 12 December 2000, in accordance with Article 265(5) of
the Treaty establishing the European Community, to draw up an opinion on this matter and to instruct
Commission 6 for Employment, Economic Policy, Single Market, Industry and SMEs to undertake the
preparatory work;

having regard to the communication from the European Commission: Services of General Interest in
Europe (COM(1996) 443 fin);

having regard to the resolution of the European Parliament of 17 December 1997 (R4-0357/1997) on
the said communication;

having regard to the opinion of the Economic and Social Committee of 22 September 1997 (CES
0605/1997);

having regard to the opinion of the Committee of the Regions of 16 January 1997 (CdR 148/96 final) (1);

having regard to the Lisbon European Council;

having regard to the Charter of Fundamental Rights;

having regard to the Nice European Council;

having regard to the conclusions of the Stockholm summit;

having regard to the draft opinion (CdR 470/2000 rev. 2) adopted by a majority by Commission 6 on
2 July 2001 (rapporteur: Mr Joseph (F/PSE); mayor of Bastidonne, vice-president of the Provence-Alpes-
Côte d’Azur region);

(1) OJ C 116, 14.4.1997, p. 52.