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)
Date: 2003-07-09
Institutions: European Commission
Subjects: EU programme, EU research policy, bio-ethics, cytology, embryo and foetus, medical research

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 9.7.2003
COM (2003) 390 final

2003/0151 (CNS)

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)

(presented by the Commission)

EXPLANATORY MEMORANDUM

Introduction

There is strong scientific interest world-wide in stem cell research. Although much basic and
preliminary  research  is  still  needed,  the  investigation  of  stem  cells  has  the  potential  to
contribute greatly to a better understanding of the development of human life. Scientists are
hopeful that stem cell research will provide essential progress in the development of therapies
in  several  fields  of  medicine.  This  is  particularly  the  case  for  the  treatment  of  various
degenerative diseases like Alzheimer’s  and  Parkinson’s  but  also  for  more  common  diseases
like diabetes.

Stem cell research raises ethical questions, particularly when it involves the use of embryonic
stem cells derived from human supernumerary embryos. At the same time, the suffering of so
many  patients  who  currently  have  no  hope  of  an  adequate  cure,  imposes  an  ethical  duty  to
advance research.

Obviously,  research  involving  the  use  of  a  human  embryo  can  only  take  place  within  a
framework of strict ethical conditions and safeguards.

Taking  full  account  of  the  opinions  of  the  European  Group  on  Ethics  in  Science  and  New
Technologies,  the  European  Commission  is  now  proposing  a  coherent  set  of  strict  ethical
guidelines for deciding on and  for monitoring the community  funding of research involving
the derivation of embryonic stem cells from human supernumerary embryos. Funding for this
research  is  included  in  the  scope  of  the  sixth  framework  programme  of  the  European
Community 
technological  development  and  demonstration  activities
(2002 – 2006), as adopted by the European Parliament and the Council1.

research, 

for 

With the present proposal, the Commission  responds to a question that was  left  open in the
decision-making  process  on  the  specific  programme  of  the  sixth  framework  programme  for
research,  namely  under  what  conditions  community  funding  can  be  made  available  for
projects involving such research.

The  specific  programme  for  research,  technological  development  and  demonstration:
“Integrating  and  strengthening  the  European  Research  Area”  (2002-2006)  (Decision
2002/834/EC)2 (hereinafter referred to as "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  reproductive  purposes  (reproductive

cloning),

–  research  activity  intended  to  modify  the  genetic  heritage  of  human  beings  which  could

make such changes heritable (germline gene therapy)3,

–  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 
3 

OJ C 232, 29.8.2002, p. 1.
OJ L 294, 29.10.2002, p. 1.
Research relating to cancer treatment of the gonads can be financed.

2

                                                
Community  funding  for  stem  cell  research,  involving  human  somatic  stem  cells  as  well  as
embryonic stem cells derived from human supernumerary embryos, is foreseen in the specific
programme, in particular under the priority thematic area 1.1.1 « Life sciences, genomics and
biotechnology for health », research priority (i) "Advanced genomics and its applications for
health",  section  “Applications  of  knowledge  and  technologies  in  the  field  of  genomics  and
biotechnology  for  health”.  As  an  example, 
focus
on…development and testing of  new  preventive  and therapeutic tools, such as somatic gene
and cell therapies (in particular stem cell  therapies, for example those on neurological and
neuromuscular disorders)”4.

this  section  “Research  will 

in 

At the Council meeting of 30 September 2002, the Council and the Commission agreed that
“detailed implementing provisions concerning research activities involving 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. Such proposals shall be reviewed in light of the provisions already incorporated in
the specific  programme  and  according  to  procedural  modalities  agreed  by  the  committee  of
Member States that assists the Commission in the implementation of the specific programme.

The Commission  stated  that  it  would  submit,  on  the  basis  of  article  166(4)  of  the  Treaty,  a
proposal establishing further guidelines on principles for deciding on the Community funding
of research projects involving the use of human embryos and human embryonic stem cells.

As also agreed at the Council meeting of 30 September 2002, the Commission published in
April  2003  a  staff  report  on  the  scientific  advances  and  needs  as  well  as  the  evolution  of
international  and  national  legislation,  regulations  and  ethical  rules  regarding  the  issue  of
research involving the use of human embryonic stem cells [SEC(2003)441]5. This report was
transmitted to the European Parliament and the Council as a basis for discussion at an inter-
institutional seminar, without prejudging the current proposal.

On  24  April  2003,  the  inter-institutional  seminar  on  bioethics  took  place,  related  to  human
embryonic  stem  cell  research  under  the  sixth  framework  programme  for  research.  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.  The
conference video can be visited in five languages on the internet6.

Commission proposal

The  Commission  now  submits,  based  on  Article  166(4)  of  the  Treaty,  a  proposal  to  the
Council for  the modification of  the  specific  programme,  on  which  the  European  Parliament
will express its opinion.

This proposal addresses an important emerging field of research, which combines both high
expectations  for  medical  applications  and  profound  ethical  questions.  It  concerns  especially
the procurement of embryonic stem cells from human supernumerary embryos. This research
will  allow  the  derivation  of  new  human  embryonic  stem  cell  lines,  needed  by  the  scientific

4 
5
6 

OJ L 294,29.10.2002, p. 10.
http://europa.eu.int/comm/research/conferences/2003/bioethics/index_en.html
http://europa.eu.int/comm/research/conferences/2003/bioethics/index_en.html

3

                                                
community  to  advance  knowledge  and  evaluate  the  real  potential  of  this  research  for
developing medical applications. In order to address both these scientific expectations and the
ethical  concerns,  the  Commission  is  proposing  to  fund  such  research  only  under  strict
conditions.

Within the specific programme, human somatic stem cell research (cells isolated from foetal
or  adult  tissue)  constitutes  the  main  area  of  human  stem  cell  research  in  terms  of  projects
funded.  Human  somatic  stem  cell  research  started  more  than  20  years  ago  and  has  already
demonstrated lifesaving therapeutic applications, while the culture of human embryonic stem
cells was first made possible 5 years ago.

Research  on  human  embryonic  stem  cells  and  research  on  human  somatic  stem  cells  are
complementary since they have both advantages and limitations. A  comparison  between the
two, appears today to be an essential element for advancing basic research and for assessing
their potential use for medical applications.

Concerning the derivation of new human embryonic stem cell lines, community funding can
only  be  made  available  for  the  derivation  of  these  cells  from  human  embryos  created  as  a
result  of  medically-assisted  in  vitro  fertilisation  designed  to  induce  pregnancy  and  were  no
longer  to  be  used  for  that  purpose.  Such  human  embryos,  commonly  referred  to  as
supernumerary embryos, are kept frozen in dedicated facilities across Europe and are destined
to  be  destroyed,  according  to  national  rules  in  place,  if  they  are  no  longer  the  subject  of  a
"parental project".

this  research  from  community  funding  would  have  a  negative 

Excluding 
impact.
Collaborative research at community level avoids duplication of research and thus contributes
to  a  reduction  in  the  use  of  human  supernumerary  embryos  for  the  derivation  of  human
embryonic  stem  cell  lines.  In  addition  community  funds  stimulate  exchanges  of  results  and
expertise among research teams from  different Member  States.  This  is  expected  to  result  in
more rapid scientific progress for the benefit of patients across Europe even for those patients
in countries where this research is not allowed.

By  funding  research  projects  involving  the  procurement  of  stem  cells  from  human
supernumerary embryos and setting strict ethical rules, the European community contributes
in  a  responsible  way  to  advancing  this  science  for  the  benefit  of  patients  across  the  world,
while at the same time ensuring that it takes place within a clear ethical framework.

In parallel, the Commission is publishing in July 2003 a call for proposals on the set-up of a
European  registry  of  stem  cells.  It  will  fund,  on  the  basis  of  a  suitable  proposal,  such  a
registry and contribute to the establishment of public stem cell banks and their networking at
European level. This should help scientists to access the different stem cell lines available in
Europe in an easier and more affordable way. In doing so, the Commission will contribute to
optimising the use of existing stem cell lines and help to ensure, in particular, that new human
embryonic stem cell lines will be created only if necessary. This topic is part of the priorities
set for the second call for proposals within the specific programme.

These  guidelines  will  apply  to  the  implementation  of  this  specific  programme.  Scientific
advances and national provisions will be regularly monitored by the Commission so as to take
account  of  any  relevant  developments.  In  2005,  the  Commission  will  produce  a  report
providing  an  assessment  of  the  stem  cell  research  funded  at  community  level  and  of  the
application  of  the  guidelines  established  by  this  decision.  The  report  will  be  taken  into
account in the preparation of successive research programmes.

4

The European context

There  is  a  great  diversity  among  Member  States  concerning  the  ethical  acceptability  of
various  research  fields  and  this  is  reflected  in  the  national  laws,  in  accordance  with  the
principle of subsidiarity.

No research involving the use of human embryos or human embryonic stem cells, of any type,
will be supported by Community funding to a legal entity established in a country where such
research  is  forbidden.  Participants  in  research  projects  must  conform  to  current  legislation,
regulations, and ethical rules in countries where the research will be carried out.

Regulatory procedure

According  to  the  article  6(3)  of  the  decision  2002/834/EC  on  the  specific  programme  for
research,  technological  development  and  demonstration:  "Integrating  and  strengthening  the
European  Research  Area"  (2002-2006),  any  research  project  involving  the  use  of  human
embryos and human embryonic stem cells will be submitted to a regulatory committee. This
committee is, in this instance, the programme committee for this specific programme and the
appropriate  configuration  is  the  one  on:  "Life  sciences,  genomics  and  biotechnology  for
health".

Implementation details

Scope

The proposed guidelines are intended to apply specifically to Community funding of research
activities involving the procurement of stem cells from human embryos created before before
27  June  2002  as  a  result  of  medically-assisted  in  vitro  fertilisation  designed  to  induce
pregnancy and no longer to be used for that purpose (supernumerary embryos).

Reference

The  proposed  guidelines  are  based  on  the  principles  established  by  the  European  Group  on
Ethics, especially the fundamental ethical principles underlined in the opinion No 15 "Ethical
aspects of human stem cell research and use"7.

Guidelines

This proposal amends the specific programme by introducing specific conditions for deciding
on the Community funding of research activities involving the procurement of stem cells from
human  supernumerary  embryos.  These  conditions  will  be  assessed  during  the  course  of  a
scientific evaluation and an ethical review, both of which will be systematically performed for
such research.

In  the  course  of  the  scientific  evaluation,  the  experts  will  assess  whether  the  proposed
research  project  serves  particularly  important  research  aims,  whether  there  is  an  adequate
alternative method to the use of these human embryonic stem cells and whether there are high
quality and safety standards on donation, procurement and storage.

7 

http://europa.eu.int/comm/european_group_ethics/index_en.htm

5

                                                
In the course of the ethical review, the experts will assess whether ethical  advice  at local or
national level  in the  countries  where  the research will be carried out is  provided,  whether  a
free, express and informed consent of the donors is obtained, whether the measures taken to
protect the personal data including genetic data are adequate, and the absence of any monetary
compensation for the donation.

Whenever the procurement of human embryonic stem cells from supernumerary embryos (as
defined above) is not foreseen at the start of the project but is envisaged at a later stage during
its implementation, a scientific evaluation and an ethical review will be implemented before
these research activities may be undertaken.

This community funded research may only use existing human supernumerary embryos that
were created before 27 June 2002, the date of adoption by Parliament and Council of the sixth
framework programme.

In  order  for  this  research  to  benefit  the  scientific  community  at  large,  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 for research purposes. In this respect, the
Opinion  N°  16  "Ethical  aspects  of  patenting  inventions  involving  human  stem  cells"  of  the
European Group on Ethics in Sciences and New Technologies is providing guidance.

In order to ensure transparency in Community funding of research activities involving human
embryonic stem cells, the Commission will publish yearly a list of research projects involving
the use of human embryonic stem cells funded under the sixth framework programme.

This  proposal  amends  the  Decision  2002/834/EC  on  the  specific  programme  for  research,
"Integrating  and  strengthening  the  European  Research  Area"  (2002-2006).  The  text  of  the
proposed guidelines (see Annex) is to be introduced after the 17th paragraph of Annex I, Part
1.1 "Priority Thematic Areas of Research”8.

8 

OJ L 294, 29.10.2002, p. 8.

6

                                                
2003/0151 (CNS)

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)

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
166(4) thereof,

Having regard to the proposal by the Commission9,

Having regard to the Opinion of the European Parliament10,

Having regard to the Opinion of the European Economic and Social Committee11,

Whereas:

(1)

(2)

(3)

At  the  Council  meeting  of  30  September  2002,  the  Commission  stated  that,  until
implementing provisions are established by 31 December 2003, it will not propose to
fund  any  research  involving  the  use  of  human  embryos  and  human  embryonic  stem
cells,  with  the  exception  of  the  study  of  banked  or  isolated  human  embryonic  stem
cells in culture.

An  inter-institutional  seminar  on  bio-ethics  took  place  on  24  April  2003  on  human
embryonic  stem  cells  research  under  the  sixth  framework  programme  for  research.
There an open debate was held among experts and representatives of the Council, the
European Parliament and the Commission, on the basis of a Commission staff working
paper12 on human embryonic stem cell research.

In accordance with the statements to the Council minutes of 30 September 2002 and
following the inter-institutional seminar of 24 April 2003, further guidelines should be
established on principles for deciding on the Community funding of research projects
involving the use of human embryos and human embryonic stem cells.

9 
10

11

12

OJ C […], […], p. […].
OJ C […], […], p. […].
OJ C […], […], p. […].
SEC (2003) 441 of 3.4.2003.

7

                                                
(4)

(5)

(6)

(7)

(8)

(9)

(10)

There is a great diversity among Member States concerning the ethical acceptability of
various research fields and this is reflected in the national laws in accordance with the
principle  of  subsidiarity.  In  particular,  regulation  and  legislation  of  research  using
human  embryos  and  human  embryonic  stem  cells  is  handled  very  differently  among
Member  States.  The  specific  programme  already  provides  that  national  provisions
apply  and  no  research  forbidden  in  any  given  Member  State  will  be  supported  by
Community funding to a legal entity established in that State.

In light of the current state of knowledge on human embryonic stem cells, new human
embryonic stem cell lines, derived from human supernumerary embryos, are required.

This  decision  is  intended  to  apply  specifically  to  Community  funding  of  research
activities  involving  the    procurement  of    stem  cells  from  human  embryos  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  (supernumerary
embryos).  This  decision  amends  the  specific  programme  by  introducing  several
conditions for deciding on the Community funding of such research.

The present conditions are based on the principles established by the European Group
on  Ethics,  especially  the  fundamental  ethical  principles  underlined  in  the  opinion
No.  15:  the  principle  of  respect  for  human  dignity  (which  requires  provisions  of
guarantees  against  risks  of  arbitrary  experimentation);  the  principle  of  human
autonomy which entails the giving of informed consent and the protection of personal
data; the principle of justice and of beneficence (namely with regard the improvement
and  protection  of  health);  the  principle  of  freedom  of  research  (which  should  be
balanced  against  other  principles)  and;  the  principle  of  proportionality  (non-
availability of  adequate alternative methods in view of the scientific objectives to be
reached).

These conditions should be assessed during the course of a scientific evaluation and an
ethical review.

In order for this research to benefit the scientific community at large, 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 for research purposes.

In order to ensure transparency a list of research projects involving the use of human
embryonic  stem  cells  funded  under  the  sixth  framework  programme  should  be
published annually by the Commission.

(11)

The Decision 2002/834/EC13 should be amended accordingly.

13

OJ L 294, 29.10.2002, p.1.

8

                                                
HAS ADOPTED THIS DECISION:

Article 1

Annex I to Decision 2002/834/EC is amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels,

For the Council
The President

9

Annex

In part 1.1 of annex I to Decision 2002/834/EC, the following text shall be inserted after the
17th paragraph.

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

(b) 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
(c)
knowledge  in  basic  research  or  to  increase  medical  knowledge  for  the  development  of
diagnostic, preventive or therapeutic methods to be applied to humans;

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

the  free,  express,  written  and  informed  consent  of  the  donor(s)  should  be  provided  in

(e)
accordance with national legislation prior to the start of the research activities;

(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 the research
proposals shall include verification of these conditions. The conditions set out in point (c) and
(d) shall be assessed during the scientific evaluation.

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.

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 framework programme will be published yearly by the Commission”.

10