Opinion of the European 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 donation, procurement, testing, processing, storage, and distribution of human tissues and cells" (COM(2002) 319 final — 2002/0128 (COD))
Date: 2002-12-11
Institutions: European Economic and Social Committee
Subjects: cytology, health care, health control, health legislation, organ transplantation, product safety, public health, quality standard, therapeutics

C 85/44

EN

Official Journal of the European Union

8.4.2003

3.2.
The Committee especially welcomes the objective of
greater transparency and certainty and would stress the fact
that the Member States themselves view the a posteriori control
system to be a highly important tool for the harmonisation of
marketing procedures.

4. Conclusion

The Committee welcomes the Commission’s proposal
4.1.
to amend the ten directives concerned with a view to
establishing a clear legal basis for the Community’s financial
contribution to comparative tests and trials on seed and
propagating material.

Brussels, 11 December 2002.

The President

of the European Economic and Social Committee

Roger BRIESCH

Opinion of the European 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 donation,
procurement, testing, processing, storage, and distribution of human tissues and cells’

(COM(2002) 319 final — 2002/0128 (COD))

(2003/C 85/14)

On 2 July 2002, the Council decided to consult the European 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 25 November 2002. The rapporteur was
Mr Bedossa.

At its 395th plenary session (meeting of 11 December 2002), the European Economic and Social
Committee adopted the following opinion by 97 votes to one with seven abstentions.

1. Background

Each year in Europe,

1.1.
500 000) receive human tissue and cell grafts.

thousands of patients (over

These include both ‘traditional’ grafts, whose therapeutic
benefits have been recognised for decades (corneas, bone,
skin, arteries, heart valves, haematopoietic cells), and rapidly
developing biotechnological methods.

academic groups, the regulatory situation in Europe is far from
uniform, and it is high time it was clarified. Where health
authorities have not arranged for controls, it is basically up to
the users of materials of human origin to choose, depending
on the product concerned, the organisations responsible for
retrieving, processing and supplying it. The user has no control
over them and has to rely on the results of the grafts and
feedback from peers. There is no organised monitoring system.
Safety levels are improving in countries where regulations are
in place, but consequently rules differ from one country to
another.

Despite the various recommendations of the World
1.2.
Health Organisation and the Council of Europe, and the
publication of rules for good practice by various European

On the eve of enlargement, and in the context of

1.3.
globalisation, it is time to put this state of affairs in order.

8.4.2003

EN

Official Journal of the European Union

C 85/45

1.4.

The need for a European approach

1.4.1. T h e e v e r - i n c r e a s i n g v o l u m e o f p r o d -

u c t s i n c i r c u l a t i o n

Trade in the EU and with third countries, in both traditional
graft materials and the products of biotechnology, is flourish-
ing. The share of imported graft materials can, for instance, be
as high as 25 %, as is the case for corneas in France.

1.4.1.1.
The diversity of national standards makes it more
difficult to carry out proper checks on imported products that
may enter the EU through a Member State where rules are
lacking and then begin to circulate within the EU without all
of the appropriate safety guarantees. Harmonised standards
would, however, would make for safer and more controllable
trade.

1.4.2. — The diversity of national regulations makes it
more difficult for producers and tissue banks to export outside
the Member States of the European Union. The industry will
inevitably demand harmonisation on a par with that which
applies to medicines and medical devices, such as in vitro
diagnostic devices.

— As the new biotechnologies take off, trade grows but so
do the serial risks. Barriers are increasing as a result of
Member State regulations.

— Following the blood contamination case and Creutzfeldt-
Jakob disease, the public has become more aware and
much more demanding, in particular owing to heightened
media interest in health issues.

2. Regulatory structure

2.1.
The European Economic and Social Committee (EESC)
welcomes the Commission’s move, outlined in the introduc-
tion to the Explanatory Memorandum, to introduce specific
Community legislation — stringent yet flexible — to cover all
the areas concerned. The main aim is to secure a high level of
health protection, in terms of quality and safety, as provided
for in Treaty Article 152, not least given the very wide-ranging
ethical issues involved.

2.2.
The EESC notes with concern the following aspects
defined by the European Group on Ethics in Science and New
Technologies (EGE), which stressed the urgent need to regulate
the conditions under which human tissues circulate within the
European market:

If the EU does not rationalise in this area, it will suffer from
the growing contrast with other developed countries.

— the ethical imperative to protect health;

— respect for the integrity of the human body;

1.4.3.

r e q u i r i n g

P r o d u c t s
a h i g h l e v e l o f
s a f e t y a n d g i v i n g r i s e t o m a j o r e t h i c a l
c o n s i d e r a t i o n s

— the prior, informed and free consent of the living donor;

— protection of identity through guaranteed anonymity.

As with any activity involving products of human origin, these
techniques carry a risk of specific complications, linked in
particular to the transmission of infectious diseases. They also
raise certain ethical questions relating to the origin of grafts
and, in particular, donor consent, anonymity, and the free
nature of the donation.

1.4.4.
should be made:

On the subject of safety the following comments

— The incidence of reported cases cannot be ignored.
it is
Although the risk is residual for other diseases,
comparable to the level that has led to the recall or
withdrawal of blood derivatives.

In addition, more should be done to promote the donation of
organs, tissues and cells.

2.3.
Donation must be free as it is an act of solidarity,
promoting shared aims and increasing the availability of
substances of human origin.

2.4.
The EESC notes that currently there is a major diver-
gence between Member States, and even more so among
the applicant countries, on the issues surrounding donor
protection, procedures for obtaining tissues, the activities of
tissue banks, the suitability of donors, and the importation of
human substances, etc.

C 85/46

EN

Official Journal of the European Union

8.4.2003

2.5.
Since the Porto conference in 2000 and, above all, the
conference of experts held in Malaga in March 2002, it would
seem that these experts are at last in agreement on the need
for this directive:
i.e. a Community directive to set ‘high
standards of safety and quality for the procurement, testing,
processing, storage, and distribution of human tissues and
cells’.

— An inspection system for all establishments is essential.

— European databases will monitor the introduction of

products in the Member States.

— Member States will be responsible for monitoring, with

centralisation at Community level.

The scope may broaden as the demarcation lines for these
measures have still to be defined in detail.

3.2.1.

P e n a l t i e s

3. Rules applicable to the field as a whole

There should be a system of penalties to impose on organis-
ations that do not comply with the standards; these could
extend to closing down an establishment on grounds of public
health.

3.1. General, common, compulsory and organic rules

3.1.1.
Safety rules are defined on the basis of existing rules
for good practice. These include compulsory criteria for the
ethical and biological selection of donors.

3.1.2.
maintained for
reflecting recommendations for blood donation safety.

Traceability is a must, while donor anonymity is
labelling and accompanying documents,

3.1.3. Where national rules on ethical matters apply, they
may refer to:

— the Bioethics Convention of

the Council of Europe

(surgical residues and living donors);

— Council of Europe Resolution (78)29 on the harmonis-
ation of legislation of member States relating to removal,
grafting and transplantation of human substances;

4. General comments

The EESC welcomes the precise and detailed way in which the
Commission has defined the scope of the directive.

Such demarcation lines are necessary as the definitions are
precise and it is important not to step outside the sphere of
public health. This directive concerns applications to the
human body only.

Donation, procurement and testing are specified as it
is
essential to secure a high level of quality and safety in these
areas.

The EESC therefore welcomes the fact that:

— blood, blood products and human organs are excluded

from this directive;

— Opinion No 16 of 7 May 2002 of the European Group
on Ethics in Science and New Technologies on the
patenting of human cells.

— a different strategy will apply for the transplantation of

human organs;

3.2.

Establishment of a system for the authorisation and inspection
of organisations that store and process (their legal status being
public)

— The system will be the Member States’ responsibility.

— Authorisation for these bodies must be granted on the
basis of a common frame of reference established at
Community level and in line with Community rules. It is
up to each Member State to ensure this happens.

— organs, tissue and cells for xenotransplantation are not

covered by this text as much more research is required;

— specific measures will apply for tissue and grafts for
autologous purposes, as the rules on quality and safety
are different;

— in the case of stem cells and embryonic or foetal cells and
tissue, the ethical questions are vast and as yet there is no
consensus or harmonisation of decisions; if, however, a
these cells is accepted in a
particular application of
Member State, the relevant provisions of this directive
will apply.

8.4.2003

EN

Official Journal of the European Union

C 85/47

4.1.

Scope

The EESC is more than aware that this directive is important
and necessary.

As the scope is extremely vast and difficult to grasp, clearer
definitions are needed, to lessen confusion between homolo-
gous (allogeneic) and autologous origins, and mention should
be made of certain special measures or exceptions.

Certain types of product should be included, others should be
the subject of special measures.

Reproductive cells should not fall within the scope of this
directive owing to the highly specific qualification procedures
that apply to them in the context of medically assisted
reproduction. Provision should possibly be made for a specific
directive to cover this area.

4.2.

Processing, preservation, storage and distribution of tissue and
cells for use in human transplantation

4.2.1.

The EESC welcomes at least two provisions:

When tissue and cells for human transplantation have to
undergo preparation or differentiation, additional quality
measures must apply.

When tissue or cells have to undergo highly technical modifi-
cations, such as ‘tissue engineering processes’, this will be
covered by further specific legislation.

4.3. Obligation of Member State authorities

4.3.1.
description of the obligations of Member State authorities.

The EESC warmly welcomes the highly detailed

4.3.2.
The proposal does not interfere with decisions made
by the Member States concerning the use or non-use of any
particular type of cell or tissue; if, however, any particular use
of such cells is authorised in a Member State, this proposal will
require the application of all provisions necessary to protect
public health and guarantee respect for fundamental rights.

— Every Member State maintains responsibility for the
organisation and supply of health services and medical
care.

— The establishment of high quality and safety standards
will reassure the public in the Member States, smoothing
the path for donations from other Member States.

— The inspection and accreditation of national structures is
a means of securing high safety and quality standards.
The same is true for the training levels of the staff
concerned.

— Traceability of all tissue and cells from the donor to the
recipient is essential, as is the monitoring of reactions
and events.

— Lastly, the ever-growing volume of imports of tissue and
cells from third countries should only be carried out by
accredited tissue banks, supervised by the competent
authority, to ensure that standards are at least equivalent
to those in force in the European Union.

4.4. Quality, safety and ethical issues in donor evaluation

— Quality and safety standards in donor selection and
evaluation must be high in order to protect the health of
recipients.

— There must be a high level of protection for the rights
and health of donors and recipients. Exchange and
allocation activities should not give rise to financial gain;
they should be voluntary and unpaid in accordance with
the texts of the Council of Europe and of the EGE.

— The procurement of human cells and tissue must be
conducted with respect for the Charter of Fundamental
Rights and the principles of the Convention on Human
Rights and Biomedicine.

— The EESC welcomes the importance attributed to tissue
banks, which must ensure quality and safety throughout
the process.

5. Special considerations

5.1.
The objectives of the directive are clear, in particular
the need for a strong, clear and transparent regulatory
framework at European level to cover all the parties concerned,
and, on the eve of enlargement, for general rules to be valid
throughout the European Union.

— The directive respects all existing national organisations,

procurement centres and/or tissue banks.

The legal basis is clear-cut

5.2.
particular (4)(a)).

(Articles 152 and in

C 85/48

EN

Official Journal of the European Union

8.4.2003

5.3. While the principles of subsidiarity and proportionality
are certainly upheld, the directive implements a common
approach that requires effective cooperation and coordination,
in view of its transnational dimension.

It should also be noted in relation to this article that medicines
are already excluded from the directive from the processing
until the distribution stage; there is no need to mention that
autologous cells destined for manufacturing are excluded from
the scope of the directive as far as processing, storage or
distribution is concerned.

5.4.
This proposal provides the regulatory and administrat-
ive framework for the current, spectacular growth in move-
ments of tissue and cells of human origin.

5.5.
The proposal puts the European Union at the cutting
edge of the debate on this subject within the World Health
Organisation.

6. Specific EESC recommendations

6.1.
The word ‘donation’ is too narrow for the scope of the
directive, which targets both autologous and allogeneic uses.
The Committee proposes that it be replaced by the term
‘retrieval’, to refer to operations conducted with a view to
grafting the elements retrieved, and ‘collection’ to refer to
the collection of surgical residues for reuse for therapeutic
purposes.

These terms would replace ‘procurement’ which should then
be eliminated from the rest of the directive. The terminology
in the current blood directive must also be brought into line.

In addition, the second paragraph of Article 2(1) should be
reworded to make it clear that ‘testing’ relates to the retrieval
and collection rather than the product.

In the French version, the term ‘conservation’ is prefer-

6.2.
able to the more restrictive term ‘stockage’.

6.5.
The current wording of the list of definitions in
Article 3 could raise a number of issues, as experts and
consultants may wish to make amendments in order to bring
it into line with their understanding of the field. The EESC
would make the following comments in this respect:

6.5.1.
‘Tissue’: it would be better to use the definition given
by Council of Europe Recommendation No R (94) 1 on human
tissue banks, namely: ‘all constituent parts of the human body,
including surgical residues but excluding organs, blood and
blood products as well as reproductive tissue (...). Hair, nails
(...) and body waste products are also excluded’.

6.5.2.
The EESC proposes restricting the concept of the
donor to living or deceased individuals for the time being, as
the use of foetal or embryonic elements of human origin is
liable to generate ethical debates or controversies in individual
EU Member States, which would be difficult to manage in the
Union context.

6.5.3.
The EESC is in favour of excluding organs from this
directive, as these cannot be stored. Organs are subject to
different specific procedures, made necessary by transplan-
tation.

6.5.4.
The EESC believes that ‘transportation’ should be
removed from the definition of ‘distribution’, as it is distinct
from distribution as an activity and is mentioned specifically
in Article 23.

6.3.
Article 1 should be reworded as follows: ‘This Directive
lays down standards of quality and safety of human tissues
and cells for use on humans, (instead of “used for application
to the human body”)
in order to ensure a high level of
protection of human health’ as this covers all uses on humans
(external and internal).

6.5.5.
The EESC proposes replacing the term ‘transplan-
tation’ with the usual terms ‘graft’ (used in particular for tissue
grafts) and ‘administration’ (used for certain cell therapies).
‘Patient’ should replace ‘recipient’, as the notion of recipient
seems to limit the definition to allografts.

6.4.
Article 2 contains a serious inaccuracy when referring
to ‘industrially manufactured products’: it would be preferable
if the provisions of this directive were to apply to all products
other than medicines, such as tissues and cells incorporated
within medical devices.

6.5.6. More precision is needed in the definition of ‘delayed
autologous use’, by analogy with the definition used in the
blood directive, which is more meaningful (‘transfusion in
which the donor and the recipient are the same person and in
which pre-deposited blood and blood components are used’).

8.4.2003

EN

Official Journal of the European Union

C 85/49

6.5.6.1.

Special measures must be taken for:

— autologous cells;

— autologous tissues for differentiated use;

— surgical residues and placentas;

— tissues and cells for cosmetic surgery.

6.5.7.
notions of
Articles 10 and 11 make specific reference to them.

The EESC believes it is important to define the two
in detail, as

‘traceability’ and ‘biomonitoring’

— ‘Traceability’: refers to all the information and measures
that enables the rapid tracking and pinpointing of each
of the stages from donor selection to the therapeutic use
of tissues and cells including retrieval or collection,
testing, processing, storage and distribution. Traceability
enables a link to be made between the donor and the
is based on the anonymous
patient(s)/recipient(s).
coding of individuals.

It

— ‘Biomonitoring’: uses traceability data and includes all
formal procedures for the supervision of undesirable
events and reactions experienced by donors, recipients/
patients, and for the epidemiological monitoring of
donors.

7.1.2. — In the French version,
‘stockage’..., should be
replaced by ‘conservation’ (in English ‘storage’) which defines the
technical stage in
whole process of preservation (active,
preparation) and storage (static stage, maintaining tissues or
cells in a given state).

7.1.3. — Of human origin, should be added at the end of
the title, to cover the subject more completely.

7.1.4.

The title would then be:

‘Directive of the European Parliament and of the Council
setting standards of quality and safety for the donation,
retrieval, collection, procurement, testing, processing, stor-
age and distribution of tissues and cells of human origin.’

7.2.
The directive’s seven chapters describe more or less
comprehensively the authorisation system to which specialised
establishments, i.e. tissue banks, will be subject. Consent will
therefore be given to authorised teams.

It would however be wise to include an appendix containing
an approved list of authorised products per speciality, with
simple formalities and reviewed frequently to take account of
the rapid progress of knowledge in the sector.

7. General proposals

7.1.

The title: the definition is incomplete.

Incorporation within the directive of compulsory ‘pro-
7.3.
cedural authorisation for the preparation of a given type of
product (tissue/cell)’, describing procedures and practices, by
product type, for all stages, from retrieval to distribution.

7.1.1. — ‘procurement’ should be replaced by:

— retrieval: surgery carried out by a specialised team (from
the hospital or tissue bank) on site or at another site;

— collection: a surgical act in the case of surgical residues
(femur heads, explanted hearts) or placentas, and a
medical act in the case of stem cells;

— procurement: administrative and health procedure to
obtain tissue or cells from another licensed body (tissue
the
bank, sterilisation/inactivation laboratory without
status of a tissue bank, hospital cell therapy units);

another possibility would be to keep ‘procurement’ throughout
the directive, but alter its definition in Article 3e, using the
three concepts above.

7.3.1.
with ‘standard operating procedures’.

This could be included under Article 20 which deals

This authorisation, which could be granted by the
7.3.2.
supervisory
under
Article 4.1), would guarantee the safety and quality of trans-
plants.

responsible

(designated

authorities

7.4.
The EESC takes the view that a specific directive should
be drafted to cover cases of tissues and cells that fall outside
the scope of
the present directive, where more in-depth
research and high-tech development is required, for instance
for use in treatments the aim of which is not to re-establish a
function — as is the case with the grafting of tissues and cells
— but which require growth and ‘exceptional’ differentiations.

C 85/50

EN

Official Journal of the European Union

8.4.2003

7.5. Agreements between tissue banks and healthcare establish-
ments that supply and/or use tissues (the same for cell therapy
units and healthcare establishments)

7.5.1.
This type of document does not appear under
Article 24 (Relationship of tissue banks with third parties) or
Article 25 (Access to human tissues and cells).

These agreements, common practice in most of the
7.5.2.
countries, govern relations between the supplier of transplants
(tissue banks) and the user surgeon/care establishment, on the
one hand, and the retrieving surgeon/retrieving healthcare
establishment and tissue bank, on the other, in the form of a
contract listing commitments relating to quality, quantity,
responsibility, contact and transport techniques, invoicing and
disputes.

7.5.3.
This practice should probably be introduced under
Article 25 (Access to human tissues and cells), at European
level.

7.8. Confusion between tissue banks and units dealing with cells

Clarification is needed throughout the directive for the follow-
ing terms, to differentiate them from the definition of tissue
banks:

— Tissue and cell bank,

— Cell bank,

— Cell therapy unit,

— Tissue centre,

— Third party units — provision of technically advanced

services.

7.9.
The EESC thinks that the impact assessment carried
out is inadequate and hopes not only for more thoroughness
in this area, but also for the inclusion of a regular report on
such matters, which could also be useful in view of the areas
of application that are currently excluded and on which the
Commission will issue further proposals for directives in the
future.

7.6. Clinical trials

8. Conclusion

While retaining clinical trials involving the use of tissues or
cells for therapeutic use within the scope of the directive,
special provisions must be made to take account of their
specific characteristics (authorisation for retrieval and pro-
cessing, and applications in the context of the clinical trial)
and existing regulations on biomedical research. By definition,
a clinical trial will not necessarily use procedures that have
prior product authorisation.

7.7.

European health certificate

There should be a ‘European health certificate’ for all
7.7.1.
tissue and cell products covered by the directive, prepared by
the Member State banks.

7.7.2.
This certificate would set out the results of and
techniques used in the compulsory tests for the biological
evaluation of these products, thus facilitating trade between
countries.

7.7.3.
The EESC thinks it would be useful to form a
central data bank containing all the available information on
authorised centres, on the products present and/or made in
the tissue banks or in the other authorised centres, on health
certificates and on biomonitoring.

8.1.
This specific directive is urgent, and the measures
chosen are necessary and coherent, as reflected by the regulat-
ory approach taken. Moreover, this trade in tissues and cells is
based on fundamental principles: the anonymity of the donor,
the voluntary nature of the donation, the solidarity implied,
the fact that no price tag can be attached to these human body
parts.

The EESC would make the same comment as the
8.2.
Commission:
in view of extremely rapid scientific develop-
ments in these areas, provision must be made for the text to
be updated regularly, to take account of proven scientific
progress, while upholding the principle of coherence.

8.3.
It would make sense to incorporate within the Directive
a compulsory ‘procedural authorisation’ for the preparation of
a given type of product (tissue/cell), describing procedures
and/or practices, by product type, for all stages, from retrieval
to distribution. This authorisation would provide a guarantee
of the safety and quality of transplants.

8.4. Give a clear definition of the responsibility of each of the

players

Responsibility for the transfer of a product (tissue/cells) usually
lies with the tissue bank. Responsibility for the health and
safety of a product can, however, fall into three areas:

— health establishment, site of retrieval or collection: selec-
tion of potential donor, technical and health conditions,
traceability and biomonitoring;

8.4.2003

EN

Official Journal of the European Union

C 85/51

— tissue bank or cell therapy unit: preparation process,
microbiological
tests (transmissible diseases, bacteria,
etc.), biological and functional validation, traceability and
biomonitoring;

— transplant surgeon: risk/benefit analysis in the light of the
health profile of the product and the vital urgency for the
patient, traceability.

8.5.
Provision should be made for a Europe-wide agreement
between healthcare establishments that supply and/or use

tissues (likewise for cell therapy units and healthcare establish-
ments).

8.6.
The appendices are an integral part of the Directive,
but there is a risk that their regular updating could be hindered
for administrative reasons. For this reason, the EESC believes
that Article 29 should mention the regular modification of
these appendices to take account of scientific progress, and
make it obligatory to update.

Brussels, 11 December 2002.

The President

of the European Economic and Social Committee

Roger BRIESCH

Opinion of the European Economic and Social Committee on the ‘Communication from the
Commission to the Council and the European Parliament on a Community return policy on
illegal residents’

(COM(2002) 564 final)

(2003/C 85/15)

On 14 October 2002 the Commission decided to consult the European Economic and Social Committee,
under Article 262 of the Treaty establishing the European Community, on the above-mentioned
communication.

The Section for Employment, Social Affairs and Citizenship, which was responsible for preparing the
Committee’s work on the subject, adopted its opinion on 25 November 2002. The rapporteur, working
without study group, was Mr Pariza Castaños.

At its 395th plenary session (meeting of 11 December 2002) the European Economic and Social
Committee adopted the following opinion by 103 votes to one with ten abstentions.

1. Summary of the Commission proposal

Return policy is presented by the Commission as
1.1.
immigration and asylum policy. The
an integral part of
Commission notes that, on the one hand, legal immigration
channels must be consolidated and protection given to those
needing it and, on the other, illegal residents must be returned
(preferably voluntarily, but by force if necessary), since ‘A
credible threat of forced return and its subsequent enforcement
send a clear message to illegal residents in the Member States
and to potential illegal migrants outside the EU that illegal

entry and residence do not lead to the stable form of residence
they hope to achieve’ (1) Hence a return policy is a necessary
adjunct to a comprehensive immigration and asylum policy.

1.2.
The Commission’s communication also responds to
the call of the Seville European Council of 21 and 22 June
2002 for the approval by the end of the year of the basic
components of an expulsion and repatriation policy.

1.3.
Before establishing the bases of a return policy, the
Commission had already opened a broad debate on the issue.

(1) Point 1.22 (2nd para.) of the communication.