Amended 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 pursuant to Article 250 (2) of the EC Treaty)
Date: 2003-11-26
Institutions: European Commission
Subjects: EU financing, EU programme, EU research policy, cytology, embryo and foetus, medical research, research project

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 26.11.2003
COM (2003) 749 final

2003/0151 (CNS)

Amended 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 pursuant to Article 250 (2) of the EC Treaty)

EXPLANATORY MEMORANDUM

1.

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2.

BACKGROUND

30  September  2002:  adoption  of  the  Decision  concerning  the  specific  programme
"Integrating  and  strengthening  the  European  Research  Area"  under  the  6th  RTD
Framework Programme.

23  April  2003:  Inter-institutional  Seminar  on  research  into  human  embryonic  stem
cells.

9  July  2003:  Commission  proposal  amending  the  Decision  concerning  the  specific
programme.

29 October 2003: Endorsed by the European Economic and Social Committee.

19  November  2003 :  Adoption  of  Parliament’s  opinion  with  18  amendments  to  the
Commission’s proposal.

AIM OF THE COMMISSION’S PROPOSAL

The  Commission’s  proposal  follows  on  from  the  Council  meeting  of  30  September  2002
which adopted the specific programme "Integrating and strengthening the European Research
Area”  under  the  6th  Framework  Programme.  The  Commission  proposal,  based  on  Article
166(4), sets  out  a  coherent  set  of  guidelines  concerning  the  principles  which  should  govern
decisions concerning Community financing of research projects involving the procurement of
stem cells from supernumerary human embryos.

In order to allay fears that Community funding might indirectly encourage the production of
embryos by in vitro fertilisation (IVF) over and above the number required, and to send out a
political signal, the Commission is proposing that only supernumerary embryos created before
27 June 2002 (date of adoption of the 6th Framework Programme) can be used.

3.

COMMISSION OPINION ON THE AMENDMENTS ADOPTED BY PARLIAMENT

3.1

General assessment.

In  general,  the  amendments  adopted  by  Parliament  tally  with  the  approach  proposed  by  the
Commission  by  allowing  the  Community  funding  of  research  projects  involving  the
procurement  of  human  embryonic  stem  cells  from  supernumerary  embryos  and  hence  the
creation  of  new  lines.  However,  certain  amendments,  and  in  particular  those  aimed  at
removing  the  cut-off  date  for  the  creation  of  supernumerary  embryos  call  into  question  the
approach adopted by the Commission on 9 July 2003.

3.2

Amendments  accepted  by  the  Commission  in  whole  or  in  part  or  subject  to
reformulations

Amendments 4, 7, 12 and 13 can be accepted as adopted by Parliament since they clarify the
text of the proposal and specify its content.

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Amendments  8,  14  et  17  can  be  accepted  as  a  whole  but  subject  to  reformulation  for
clarification.

Amendments  1,  6,  9,  15,  and  18  are  also  acceptable  but  only  in  part  and  subject  to
reformulations.

3.3

Amendments not accepted by the Commission

A  number  of  amendments  cannot  be  accepted  (amendments  2,  3,  5,  10,  16  and  19)  which
amend the substance of the proposal. This applies in particular to amendments 5 and 10 which
do not contain a cut-off date for embryos used for the procurement of stem cells, as proposed
by the Commission to take account of ethical sensitivities.

3.4

Conclusion

Pursuant  to  Article  250(2)  of  the  EC  Treaty,  the  Commission  hereby  amends  its  proposal
accordingly.

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2003/0151 (CNS)

Amended 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 Commission1,

Having regard to the Opinion of the European Parliament2,

Having regard to the Opinion of the European Economic and Social Committee3,

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
paper4 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.

1 
2

3

4

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

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(4)

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 regardingof research
using human embryos created for the purpose of in vitro fertilisation and not used
for  this  purpose  any  more  (i.e.  supernumerary  embryos)  and  human  embryonic
stem  cells  is  handled  very  differently  among  the  Member  States.  Therefore  this
decision  in  no  way  affects  national  laws  concerning  embryonic  stem  cells.  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.

(5)

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.

(6)        The  aims  of  stem  cell  research,  especially  the  alleviation  and  cure  of  diseases
which are currently not or not sufficiently treatable, are to be supported.

(67)

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.

(8)        Transplantation  of  human  embryonic  stem  cells  to  patients  during  the
commitment  phase  of  the  6th  framework  programme  (until  the  end  of  2006)  is
not foreseen because strong basic research is still necessary.

(9)        This decision concerns the use of human embryos for research only and not for
therapeutic  purposes.  Research  on  human  embryonic  stem  cells  is  desirable  for
the development of innovative treatments and, in particular, of treatments using
adult stem cells.

(710) 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).

(811) These conditions should be assessed during the course of a scientific evaluation and an

ethical review.

(12)      The  experience  from  scientific  communities  from  other  regions  of  the  world

should also be used.

(913)

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.

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(1014) 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.

(15)      The existence of supernumerary embryos after in vitro fertilisation constitutes an
ethical  dilemma  and  making  them  available  for  research  purposes  requires
strong ethical safeguards.

(1116) The Decision 2002/834/EC5 should be amended accordingly.

5

OJ L 294, 29.10.2002, p.1.

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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

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Annex

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

"Research on the use of human stem cells may be financed depending on the contents of
the proposal and the legal framework of the Member State(s) involved.

“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;

(c)
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;

(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;

(e)
the  free,  express,  written  and  informed  consent  of  the  donor(s)  should  have  been
provided  in  accordance  with  national  legislation  prior  to  the  start  of  the  research
activitiesprocurement of the cells;

(f) no monetary compensation, or other benefit in kind or other consideration may must be
granted or promised for the donation of embryos used for the procurement of stem cells;

(g) the  protection  of  personal  data,  including  the  genetic  data,  of  the  donor(s)  must  have
been ensured during the procurement and for any use thereafter;

(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.

Projects  with  adult  somatic  stem  cells  and  umbilical  cord  blood  cells  should  be
encouraged and particularly comparative studies between all types of human stem cells.

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.

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In  order  to  contribute  to  optimising  the  use  of  human  embryonic  stem  cell  lines,  the
Commission will support the initiative to set-up of a European registry.

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”.

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