Opinion of the European Economic and Social Committee on the "Proposal for a Council Decision amending Decision 2002/834/EC on the specific programme for research, technological development and demonstration: Integrating and strengthening the European research area (2002-2006)" (COM(2003) 390 final — 2003/0151 (CNS))
Date: 2003-10-29
Institutions: European Economic and Social Committee
Subjects: ESC opinion, EU programme, bio-ethics, cytology, embryo and foetus, medical research, research policy

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Official Journal of the European Union

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Opinion of the European Economic and Social Committee on the ‘Proposal for a Council
Decision amending Decision 2002/834/EC on the specific programme for research, technological
development and demonstration: “Integrating and strengthening the European research area”
(2002-2006)’

(COM(2003) 390 final — 2003/0151 (CNS))

(2004/C 32/17)

On 25 July 2003 the Council decided to consult the European Economic and Social Committee, under
Article 166 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Bureau of the European Economic and Social Committee instructed the Section for the Single Market,
Production and Consumption to prepare the Committee’s work on the subject.

In view of the urgent nature of the work, the Committee decided at its 403rd plenary session of 29 and
30 October 2003 (meeting of 29 October) to appoint Mr Wolf as rapporteur-general and adopted the
following opinion by 71 votes to 26 with eight abstentions.

1.

Introduction and point of departure

The Commission proposal deals with the limits that are to
apply, under the sixth EU R&D framework programme, to
research into the medical and biological potential of human
stem cells procured from ‘supernumerary’
(frozen) human
embryos.

Life sciences and medicine are key aspects of the sixth
1.1.
framework programme of
the European Community for
research, technological development and demonstration activi-
ties. The first point of the specific programme covering this
thematic area is the application of ‘life sciences, genomics and
biotechnology for health’, including ‘somatic gene and cell
therapies (in particular stem cell therapies)’ and ‘immunother-
apies.’ The sixth framework programme adopted by the
Council and the Parliament provides the legal basis for the
Commission proposal.

1.3.
The specific programme adopted by Council on
30 September 2002 allows the funding of research activities
involving the use of human embryos and human embryonic
stem cells except in three areas:

— research activity aiming at human cloning for repro-

ductive purposes (reproductive cloning);

— research activity intended to modify the genetic heritage
of human beings which could make such changes heri-
table (germline gene therapy) (2);

— research activities intended to create human embryos
solely for the purpose of research or for the purpose of
stem cell procurement, including by means of somatic
cell nuclear transfer (commonly referred to as therapeutic
cloning).

1.2.
Community funding of stem cell research using human
somatic stem cells and embryonic stem cells from supernumer-
ary human embryos is provided for under research priority (i)
Advanced genomics and its applications for health in the
section Application of knowledge and technologies in the field
of genomics and biotechnology for health. For example, in
this section:
focus on:.... development and
testing of new preventive and therapeutic tools, such as
therapies (in particular stem cell
somatic gene and cell
therapies, for example those on neurological and neuromuscu-
lar disorders) and immunotherapies’ (1).

‘Research will

1.4.
At the Council meeting of 30 September 2002, the
Council and the Commission agreed, however, that ‘detailed
implementing provisions concerning research activities involv-
ing the use of human embryos and human embryonic stem
cells shall be established by 31 December 2003.’ Until that
time, the Commission will not propose to fund such research,
with the exception of proposals for projects that involve the
use of banked or isolated human embryonic stem cells in
culture.

(1) OJ L 294, 29.10.2002, p. 10.

financed.

(2) Research relating to cancer treatment of the gonads can be

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The Commission’s purpose in submitting the present
1.5.
Proposal for a Council Decision amending Decision 2002/
834/EC on the specific programme for research, technological
development and demonstration: ‘Integrating and strengthen-
is thus to
ing the European research area’
establish the implementing provisions mentioned in point 1.4.

(2002-2006)

The Commission’s proposal was drawn up in the light
1.6.
of an interinstitutional seminar on bioethics that took place
on 24 April 2003. This seminar provided an opportunity for
a discussion and sharing of views between experts (scientific,
legal, and in ethics) and representatives of the European
Parliament, the Council, the Commission, the Member States
and the accession and candidate countries. However, the
proposed guidelines also draw on the principles laid down by
the European Group on Ethics, and in particular this group’s
opinion no. 15 on Ethical aspects of human stem cell research
and use (1).

1.6.1.

This group was guided by the following principles:

— the principle of respect for human dignity;

— the principle of human autonomy which entails the
giving of informed consent, respect for privacy and the
protection of personal data;

— the principle of justice and of beneficence (especially with
regard the improvement and protection of health);

2. Gist the Commission proposal

The gist of the Commission proposal is set out in its annex
which is reproduced verbatim here:

‘In order to be funded by the Community, research projects
involving the procurement of stem cells from human embryos
must also meet the following conditions:

(a)

(b)

(c)

(d)

prior to the start of research activities, participants must
obtain ethical advice at local or national
in the
countries where the research will be carried out;

level

the human embryos used for the procurement of stem
cells must have been created before 27 June 2002 as a
result of medically-assisted in vitro fertilisation designed
to induce pregnancy, and were no longer to be used for
that purpose;

the project must serve particularly important research
aims to advance scientific knowledge in basic research or
to increase medical knowledge for the development of
diagnostic, preventive or therapeutic methods to be
applied to humans;

all other alternative methods (including existing or adult
stem cell lines) must have been examined and demon-
strated not to be sufficient for the purposes of the
research in question;

— the principle of freedom of research (which must be

balanced against other fundamental rights) and;

(e)

the free, express, written and informed consent of the
donor(s) should be provided in accordance with national
legislation prior to the start of the research activities;

— the principle of proportionality (the research activity
to the objective to be achieved and
must be vital
there must be no more appropriate alternative methods
available).

1.7.
The Commission proposal thus addresses a field of
research which combines both high expectations for medical
applications and profound ethical questions.
It concerns
especially the procurement of new embryonic stem cells from
human supernumerary embryos. In order to properly address
both these scientific expectations and the ethical concerns, the
Commission is proposing to fund such research only under
strict and restrictive conditions.

(1) http://europa.eu.int/comm/european–group–ethics/index–en.htm

(f)

no monetary compensation or other benefit in kind must
be granted or promised for the donation;

(g)

the protection of personal data, including the genetic
data, of the donor(s) must be ensured;

(h) where appropriate, the participants in research projects
must follow quality and safety standards on donation,
procurement and storage in accordance to the state of
the art, in order to ensure in particular the traceability of
these stem cells.

The scientific evaluation and the ethical review organised by
the Commission of
include
verification of these conditions. The conditions set out in
point
(c) and (d) shall be assessed during the scientific
evaluation.

the research proposals shall

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The opinions of the European Group on Ethics in Science and
New Technologies, and in particular those relating to research
involving the use of human embryonic stem cells will be taken
into account.

into liver cells, muscle cells and nerve cells. This development
potential is one reason why priority is given to the use of stem
cells in cell therapy procedures. Research in this field is being
conducted worldwide.

The participants in research projects should use their best
efforts to make the newly derived human embryonic stem cell
lines available to the scientific community on a non-profit
making basis for research purposes.

A list of research projects involving the use of all types of
human embryonic stem cells funded under the sixth frame-
work programme will be published yearly by the Commission’.

3.6.
The earliest stage of a stem cell in the development of
the organism is the fertilised ovum. The cells continue to
divide, becoming ‘blastocysts’ between the fourth and the
seventh day of development. A blastocyst contains two cell
groups, the outer specialised cell layer (trophoblast) and the
internal cell mass (embryoblast). This embryoblast consists of
pluripotent stem cells (embryonic stem cells [ES cells]), which
are progenitor cells for all later development stages of the
organism.

3. The Committee’s comments I: Medical and scientific

aspects and the EU research programme

3.1.
In a number of opinions, the Committee has expressed
its wholehearted support for the successful structuring of the
European research area as a key step towards attaining the
Lisbon objectives, incorporating and developing the potential
of European research, and preventing the migration of cutting-
edge European research and top-level European researchers.
To that end, it is vital to give European research the oppor-
tunities it needs to achieve excellence in global competition.

3.2.
In its opinion on the sixth framework programme,
the Committee strongly endorsed all the thematic actions
proposed therein,
including the research priorities under
discussion here. A key element of these priorities is research
into, and using, stem cells.

3.7.
For some time, embryonic stem cells of animals —
particularly mice — have been studied in development biology
In contrast to more specialised (tissue-
and cell biology.
specific) stem cells, they are able to reproduce identically
through many cell division cycles and can be maintained in
culture (cell lines) — something not normally possible (or
possible only with difficulty and for a short time) in the case
of tissue-specific stem cells.

3.8.
Embryonic stem cells can be generated only from
blastocysts, i.e. from early embryos from the fourth to the
seventh day of their development.

3.8.1.
Blastocyst production is a routine procedure in
reproduction medicine: in vitro fertilisation (IVF). It has long
been in use, for instance, in the breeding of farm animals.

Stem cells are progenitor cells of other, more special-
3.3.
ised cells; from them, various types of specialised cells can
develop (multipotency). Haematopoietic stem cells have been
known for a long time (and used in therapy for leukaemia and
other types of cancer).

3.8.2.
The first human conceived by IVF was born in 1978.
This procedure was initially highly controversial but it has
now been introduced in all developed countries.

3.4.
Knowledge is now available, however, about tissue-
specific stem cells for many tissues. These are referred to in the
Commission report as somatic stem cells, which are generally
also known as adult stem cells.

Stem cells are able to generate different cell types to
3.5.
match the surrounding tissue (‘plasticity’) although many of
the particulars surrounding the extent to which they have this
facility remain unknown. It has been proven, for instance, that,
in the right tissues, haematopoietic stem cells have developed

3.8.3.
In most countries, in vitro fertilisation is subject to
regulation and restriction under the law and/or professional
rules of conduct. In certain cases,
it can enable otherwise
infertile couples to have children of their own and is thus a
beneficial procedure for the parties involved.

3.8.4.
This procedure involves, initially, developing several
embryos (e.g. six), of which three, for instance, are implanted

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into the womb at the first attempt, while the other ‘super-
numerary’ (1) embryos are frozen and put into storage for a
number of years for possible future use. Many of them can be
kept implantable during that time.

3.8.5.
Depending on the ‘parental project’ — and what is
possible medically — supernumerary embryos of this kind are
bound to be produced that have no prospect of ever being
lodged, implanted or nidated (a pre-condition for the develop-
ment of human life).

Human embryonic stem cells (HES) were successfully
3.9.
procured and established as cell lines in culture in 1998. Since
then, many research teams have generated HES lines.

3.10.
then, for three main reasons:

Research into and using HES has grown apace since

In human medicine, therapeutic stem cell appli-
3.10.1.
cations, which are currently performed only in haematology
and oncology (and to date using only tissue-specific stem
cells), may be used to treat many serious, common illnesses.
If successful, the expected therapeutic, human and indeed
economic benefits involved would be enormous.

3.10.2.
be resolved in the field of stem cell biology.

For that to happen, fundamental issues still need to

3.10.3. Many of these fundamental issues relating to stem
cell biology can be resolved using animal ES cells.

But a number of

3.10.4.
to therapeutic
applications in the treatment of human illnesses can only be
resolved using human stem cells.

issues crucial

4. The Committee’s comments II: Ethical and legal

aspects

Blastocysts are four- to seven-day-old embryos made
4.1.
up of some 200 cells that have reached a differentiation stage
(trophoblast and embryoblast). They normally do not survive
withdrawal of ES cells. The procurement of HES cells thus
involves the destruction of human embryos that are a few days
old.

These embryos are not yet foetuses (2), but small balls
4.2.
of approximately 200 cells. As described in scientific literature,
HES lines have been generated from embryos that were
developed for IVF but were not ultimately used to induce a
pregnancy (known as ‘supernumerary’ embryos).

4.3.
Supernumerary embryos such as these are placed in
cold storage in dedicated facilities across Europe and, if they
no longer the subject of a ‘parental project’, are later destroyed
in line with national rules.

4.4.
The question is, however, whether it should be permiss-
ible to kill such supernumerary embryos procured through
IVF (3) (which, after all, have no potential for life) in order to
procure stem cell lines.

4.5.
The ethical aspects of this procedure are thus tied to
the key issue of whether and under what conditions it may be
justifiable to use potential human life for an extrinsic purpose
— even in cases where, as with supernumerary embryos, the
subject involved is in any case doomed to certain death (4).

3.10.5. Many issues crucial to therapeutic applications in
the treatment of human illnesses can also be resolved using
tissue-specific stem cells (adult stem cells).

3.10.6.
issues can only be resolved using HES cells.

At current levels of knowledge, however, some key

4.6.
These issues have been widely discussed in all countries
in which HES lines have been procured — and in many in
which they have not — with widely varying results. The legal
provisions that have been adopted show broad agreement on
the substantive principles involved (a ‘core consensus’) but
differ widely on key points of detail. This is true both at
global level and between the Member States of the European
Community.

(1) In Germany,

there are only a limited number of

‘genuine’
supernumerary embryos, as, generally speaking, those ‘super-
numerary’ ova procured as a result of hormone treatment for
the woman/prospective mother but not used for the initial
implantation are, following sperm penetration, frozen at the so-
called ‘pre-nucleus stage’, i.e. before the emergence of a common
cell nucleus. In German linguistic usage, these are not yet termed
embryos. However, in individual cases, embryos designed for first
implantation are, for various reasons, not implanted, and are
subsequently frozen.

(2) The term foetus denotes an embryo from around the twelfth week

of gestation until birth.

(3) Thus, the Commission proposal under discussion here is con-
cerned only with the procurement of stem cell
lines from
supernumerary embryos generated from IVF, not therefore from
cloning (somatic cell nuclear transfer — SCNT) or from induced
cell division that has recently been under discussion (parthenogen-
esis).

(4) Society generally takes a positive view of this issue in the case of

organ donations from adults killed in accidents.

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4.7. Member States’ differing stances on this issue to some
extent also reflect the differing viewpoints of the general public
and various social groups within the individual countries. As a
result, individual Member States have adopted a variety of
legal provisions through democratic channels that reflect the
majority view in the countries concerned.

4.8.
These provisions also reflect differences of opinion as
to the moment in the development of a human embryo at
which individual human life begins.

4.8.1.

Views vary widely:

— Some believe that human life begins at the fusion of

ovum and sperm (or their cell nuclei).

— Others take the view that life does not begin until the

embryo is lodged/implanted/nidated (1) (2) in the womb.

— For others,

life does not begin until the gastrulation
phase (3) (formation of the ‘primitive streak’ that emerges
between the twelfth and fifteenth day of an embryo’s
development).

— Still others consider that a relatively long evolutionary
process is involved, making it impossible to fix an exact
time. An arbitrary decision is thus needed, for instance,
from the twelfth week (4) after the embryo lodges in the
womb (i.e. at the transition from embryo to foetus).

5. The Committee’s comments III: Europolitical aspects

and international practice

5.1.
Given the range of views within civil society outlined
above and Member States’ differing legal positions on the
matter, it is clearly necessary — and also makes political sense
— for the Commission to adopt a moderate and, if anything,
restrictive middle course in its proposals for EU rules on this
sensitive issue that is nonetheless also of vital importance in
the light of the opportunities it affords.

5.2.
This includes the Commission’s proposal not to adopt
Community laws binding on the Member States in this area,

(1) Hence some commentators (see,

Jahrbuch für
Wissenschaft und Ethik 7 (2002) ,Walter de Gruyter Berlin —
New York) also use the term ‘pre-embryos’ to denote embryos
existing before nidation (or in other cases before gastrulation).
(2) Hence there is no ban on contraception that prevents nidation

for instance,

(e.g. intrauterine coils).

(3) Ulrich Steinvorth, Jahrbuch für Wissenschaft und Ethik 7, 2002,
p. 165, Walter de Gruyter Verlag. The main argument for this
view is that a possible multiple-birth pregnancy cannot be ruled
out until after this stage.

(4) In some Member States, this time period also plays a key role in

abortion legislation.

but instead to establish the potential research framework, i.e.
to lay down the limits within which the Commission can
support research projects using human stem cells (within the
purview of the sixth framework programme).

5.3.
The ethical and legal aspects of stem cell research were
last discussed in depth at European level at the Commission’s
invitation in spring 2003; the present Commission proposal is
the result.

5.4.
The Committee respects the views of those, including
some of its own members, who reject, on ethical grounds, any
procurement of human stem cell lines from supernumerary
embryos generated in the course of in vitro fertilisation, and
thus also reject the Commission proposal.

Looking at the overall picture, however, the Committee
5.5.
nonetheless considers that the Commission proposal (repro-
duced in point 2 above) offers a balanced, well-thought-out
approach that weighs up ethical principles against the potential
prospect of treating diseases — although this inevitably, and
regrettably also, places considerable restrictions on research
possibilities and opportunities.

5.6.
The Committee trusts that the proposed rules are
compatible with the Charter of Fundamental Rights of the
European Union, not
least since the cases mentioned in
Article II — 3(2) (b), (c) and (d) of the charter are explicitly
excluded in the Commission’s proposal and the earlier Council
decision (see point 1.4).

5.7.
This also applies therefore to all the individual pro-
visions set out in the Commission proposal — from (a) to (h).
The proposal focuses on the procurement of new stem cell
lines from human embryos — a matter of some contention in
the Council deliberations — and lays down criteria (points (a)
to (h)) and procedures (the second to the fifth paragraph) to
that end. Turning to the individual points:

a)

b)

The Committee welcomes the mandatory consultation of
an ethics commission (5). This is in line with normal
international practice. The fact that this allows account
to be taken of the legislation or rules applying in the
individual Member States is also important.

The procurement of new stem cell lines is limited to
human embryos created for IVF treatment before the start
of the sixth R&D framework programme but which will
no longer be considered for use in inducing a pregnancy,
and are thus deemed supernumerary. This arrangement
reflects the legislative consensus in those countries in
which the procurement of HES lines and/or the use of
existing lines is regulated by law. Having a cut-off date
prevents the improbable, but nonetheless conceivable
scenario whereby human embryos are procured specifi-
cally for research purposes. (Under the rules adopted for

(5) The Committee has reservations however about whether this
measure is also necessary in Member States where it is not
required under national law.

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c)

d)

e)

f)

g)

h)

sixth R&D framework programme, reliable steps must be
taken to rule out such a scenario and the practice is
permitted under certain conditions only in Great Britain.)

There is agreement in international law that projects to
be supported must serve particularly important research
aims.

It is also standard international practice to demonstrate
in advance that alternative methods for achieving the
research objectives in question (for instance animal
experiments or tests using tissue-specific human [adult]
stem cells) have been fully explored. That can of course
be done only in the light of currently available knowledge
and should not delay pending decisions unduly.

The requirement to secure donors’ informed consent is
also in line with international norms and is, moreover,
common practice in the case of organ donations.

Paragraph 3 refers to opinions of the European
5.8.2.
Group on Ethics in Science and New Technologies This
provision may potentially help ensure that account is consist-
ently taken of state-of-the-art knowledge in the rapidly
developing field of stem cell research.

5.8.3.
Paragraph 4 lays down that newly derived HES lines
are to be made available freely (and on a non-profit making
basis) to the scientific community. The Committee feels it is
vital in this regard that the Commission wants to ‘contribute
to the establishment of public stem cell banks and their
networking at European level’. This point ties in with consider-
ations of the European Science Foundation.

5.8.4.
The standardisation this brings represents added
is also a key prerequisite and secure
European value.
foundation for ongoing research. It is in the interest of both
Europe and the world and cuts the number of embryos needed
to procure stem cells.

It

The Committee welcomes the proposal to rule out any
payment (1) as this broadly reflects international
legal
practice.

5.8.5.
New HES lines procured with support under the
sixth framework programme should therefore be deposited in
a public stem cell bank.

The requirement to protect personal data on all matters
such as these is also self-evident.

5.8.6.
as a result of the patenting of existing stem cell lines.

This can also counter the restrictions placed on use

The quality assurance and traceability requirements relate
to the current legal position and knowledge of work with
biological materials from patients and those involved in
experiments. These requirements are also important for
the establishment of stem cell banks mentioned in
point 5.8.3 below.

5.8.7.
Paragraph 5 is also welcomed; in it, the Commission
commits itself to publishing the projects it supports in which
HES cells are used (but not the names of the people working
on those projects).

5.8.
The paragraphs after point (h), hereinafter referred to
as paragraphs 2 to 5, deal with procedures for safeguarding
those criteria and look at some of the reasons behind the
measures.

6. The Committee’s comments IV: Member States with

differing national laws

5.8.1.
Paragraph 2 sensibly spreads the responsibility for
examining the criteria under points (a) to (h). The scientific
evaluation alone can determine the status of research objectives
and whether these can only be attained using newly established
HES lines. In contrast, points (a), (b) and (e) to (h) set out
formal criteria which are to be examined on an administrative
level using uniform yardsticks. Non-compliance with one of
the criteria rules out support for the project concerned.

(1) In this case too, there is an analogy to organ donations.

legal systems vary widely. Not all
6.1. Member States’
Member States explicitly address stem cell research. Some
countries’ laws are more liberal than the Commission’s pro-
posal, others more restrictive. The development is in a state of
flux.

fully exploit

6.2.
Thus, scientific institutions in Member States with
more restrictive laws may not take part in stem cell research
the scope afforded under the
projects that
Commission proposal (in other words where they are not
restricted to stem cell
lines whose use is permitted in all
Member States), and cannot, therefore, apply for financial
assistance in relation to such projects.

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Conversely, scientific institutions in Member States
6.3.
with more liberal laws are not entitled to EU research funding
either, unless they restrict themselves to research that meets
the conditions laid down in the Commission proposal.

6.4.
This situation is unsatisfactory, on the one hand,
because all Member States contribute to the Community
budget and thus also to the Community resources used to
promote research, and, on the other, because exclusions such
as these also limit the potential of the European research area
by ruling out certain Member States (or rather their scientific
institutions)
from involvement in the networked research
programme (and from a share in the support).

In the Committee’s view, however,

6.5.
this does not
preclude the Council, acting by a qualified majority and having
consulted the Parliament, from adopting this Commission
proposal to amend Decision 2002/834/EC.

6.6.
However, the Community’s funding remit does not
include the right to standardise or harmonise Member States’
laws.

In the light of the above, the Committee recommends

6.7.
the following:

6.7.1. When implementing this research programme, the
Commission should work to ensure that the individual projects
or programme elements are structured in such a way that
research institutes that would otherwise be excluded can still
be involved as far as possible in some aspects or subsections
of the ventures, where the activities concerned do not violate
European or national law.

6.7.2.
In future revisions of their national legislation, the
Member States concerned should seek, as far as possible, to
come into line with these proposals so that, gradually, uniform
rules are established that apply to all Member States. This is
good for European research and medicine, not least given the
high level of international networking and cooperation that
exists in this field. The Committee feels that the present
proposal offers a good compromise in this regard.

Brussels, 29 October 2003.

7.

Summary

7.1.
This proposal comes in response to the request made
by the Council to the Commission in September 2002. It
addresses those points in the implementing provisions of the
sixth R&D framework programme that
felt
required regulation.

the Council

7.2.
The proposal on this sensitive but, given the oppor-
tunities it affords, nonetheless vitally important issue adopts a
moderate and, if anything, restrictive approach, treading a
‘middle way’ between the different national laws that apply in
the Member States. It thus represents a compromise between
diverging individual viewpoints.

7.3.
The proposed rules meet the challenge. They allow
support to be given to key scientific research serving important
medical and biological ends. They give special priority to
projects fostering international coordination and cooperation.
They establish clear criteria and procedures to comply with
the appropriate ethical and legal factors.

7.4.
The Committee respects the views of those, including
some of its own members, who reject, on ethical grounds, any
procurement of human stem cell lines from supernumerary
embryos, and thus also reject the Commission proposal.

7.5.
In the light of all the factors involved, however, the
Committee recommends that, bearing in mind the detailed
points made above, the Commission proposal be accepted.

The Committee again asks the Commission to ensure
7.6.
in implementing the scientific programme, the pro-
that,
gramme elements are broadly structured in such a way so as
not to rule out the involvement of top-rate scientific insti-
tutions in some Member States.

It again calls on Member States to pursue the same
7.7.
objective in future revisions of national legislation and to seek
an overarching consensus on what is, admittedly, a very
difficult issue, thereby broadening the scope of the fundamen-
tal agreement that currently exists on core issues (see point 1.3
above) to encompass a future coherent set of rules accepted by
all Member States.

7.8.
New HES lines, which are procured with support under
the sixth framework programme, should be stored in a public
stem cell bank and be freely accessible to European researchers.

The President

of the European Economic and Social Committee

Roger BRIESCH