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8-Humans: EC sets rules for embryo use in stem cell research



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                                  PART I
-------------------------------- GENET-news -------------------------------

TITLE:  EU Sets Rules for Embryo Use in Stem Cell Research
SOURCE: Reuters, by Aine Gallagher
DATE:   Jul 10, 2003

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EU Sets Rules for Embryo Use in Stem Cell Research

BRUSSELS - The European Commission backed guidelines Wednesday to
regulate the use of embryos in EU-funded research, hoping to heal
divisions between Catholic states and scientists.

 The Vatican, the predominantly Catholic countries Ireland, Spain,
Portugal, Austria and Italy and also Germany oppose embryo stem cell
research on ethical grounds. Scientists say it could yield cures for
Alzheimer's and Parkinson's disease.

Stem cells are the body's "master cells," capable of growing into other
types of cells. One way to obtain them is by therapeutic cloning:
creating embryos whose stem cells can then be detached.

The Roman Catholic Church insists that embryos are not mere clumps of
cells but represent human life. By removing stem cells, the embryo is
destroyed.

Under the draft rules, EU scientists would only receive funding from
Brussels if they use stored or frozen embryos left over from fertility
treatment and created before June 27, 2002 -- the date when the EU agreed
on its 2003-06 research program.

"By setting strict ethical rules ... for such funding, the EU 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," EU Research Commissioner
Philippe Busquin said in a statement.

A maximum of 2.2 billion euros is available in EU funds. To date, Britain
is the only EU state to embrace the technology.

The Commission's draft guidelines need the approval of the European
Parliament and a majority of EU member states, whose research ministers
will debate the proposal in November.

Busquin said he hoped for final agreement by the end of 2003, but
feelings run high on the issue.

"Europe must reject this Commission proposal which seeks to fund research
using unborn human beings, whether that is as frozen embryos or as
aborted babies," Irish Member of the European Parliament Rosemary Scallon
said in a statement.

The Commission of the Bishops Conferences of the European Community, a
religious lobby group, pointed out that promising research had taken
place using stem cells taken from living adults rather than embryos.

Biotech companies said they were pleased with the Commission plan. "It
will encourage development in this field across the EU," said the
BioIndustry Association in a statement.



                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  European Commission proposes strict ethical guidelines on EU
        funding of human embryonic stem cell research
SOURCE: European Commission, Press Release IP/03/969
        http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.
        gettxt=gt&doc=IP/03/969|0|RAPID&lg=EN&display=
DATE:   Jul 9, 2003

------------------- archive: http://www.genet-info.org/ -------------------


European Commission proposes strict ethical guidelines on EU funding of
human embryonic stem cell research

DN: IP/03/969
Date: 09/07/2003
TXT: FR EN EL
PDF: FR EN EL
DOC: FR EN EL

IP/03/969

Brussels, 9 July 2003

European Commission proposes strict ethical guidelines on EU funding of
human embryonic stem cell research

Today the Commission adopted a proposal for guidelines on EU-funded human
embryonic stem cell research. The EU 6th Research Framework Programme
(FP6 2003-2006), as adopted by the Council of Ministers and the European
Parliament in 2002, allows for the funding of human embryonic stem cell
research in relation to the fight against major diseases. Such research,
in particular when it involves the derivation of stem cells from human
supernumerary embryos, can only take place within a framework of clear
and strict ethical guidelines. The EU research programme includes ethical
provisions related to sensitive areas of research. In light of the
sensitive nature of human embryonic stem cell research, the Council and
the Commission agreed at the time of the decision-making process on FP6
that further ethical guidelines would be adopted before the end of 2003
for deciding on and for monitoring the EU funding of human embryonic stem
cell research. Today's proposal presents a coherent set of strict ethical
guidelines that will apply to the EU funding of research projects
involving the derivation of stem cells from human supernumerary embryos.
In parallel, the Commission is publishing a call for proposals for the
set-up of a European registry of stem cells and for contributing to the
establishment of public stem cell banks. In this way, the EU will
contribute to an optimal access to and use of stem cells, ensuring that
the results of research ultimately become more quickly available to all
patients across Europe.

Research Commissioner Philippe Busquin said : "The decision to fund human
embryonic stem cell research from the Sixth Framework Programme was
already taken by Council and Parliament last year. By funding this
research and by setting strict ethical rules for such funding, the EU
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."


Stem cell research

Stem cells are basic cells that multiply and differenciate into
specialised cells, tissue and even organs. Stem cell research is a
promising area of biotechnology for human health. It offers the prospect
of developing new methods to repair or replace tissues or cells damaged
by injuries or diseases and to treat serious chronic diseases such as
Parkinson's or Alzheimer's as well as more common diseases such as
diabetes. Stem cell research is expected to provide a better
understanding of human life and of disease development. It will lead to
the development of safer and more effective drugs. It does, however,
raise ethical questions when stem cells are derived from human
supernumerary embryos.


The scope of the Commission proposal

The Commission proposal does not aim to set universal ethical principles,
which is not a role for the EU. It does not aim to provide guidelines for
EU Member States either, since every Member State must decide for itself
on this issue. The Commission proposal only sets out the conditions for
EU (FP6) research involving the derivation of stem cells from human
supernumerary embryos. The proposal is fully in line with the various
opinions of the European Group on Ethics (EGE), in particular opinion
n15 of November 14, 2000, "Ethical aspects of human stem cell research
and use". The Framework Programme respects national rules and values as
no funding is made available for a specific research activity in a Member
State where that research is forbidden.


The stem cell debate

Funding for human embryonic stem cell research has always been possible
under previous Framework Programmes and any project related to this issue
was subject to an ethical review by a broad group of experts in the
field. In the decision-making process on the Specific Programmes
implementing FP6, the Council and the Commission agreed that additional
guidelines on human embryonic stem cell research would be put in place
before the end of 2003. During that period, no projects involving
derivation of new stem cell lines from human supernumerary embryos would
be funded. The Commission committed itself to submitting a legislative
proposal identifying these guidelines, on which the European Parliament
will be consulted. The three Institutions agreed to reach a decision on
this issue before the end of 2003.

The opinion of the European Group on Ethics

The EGE identified the following principal requirements regarding human
embryonic stem cell research and the procurement of embryonic stem cells
from supernumerary embryos:
- Free and informed consent from the donating couple or woman.
- Approval of the research by an authority.
- No financial gain for donors.
-Anonymity of the donors and protection of the confidentiality of
personal information of the donors.
- Transparency regarding research results.


Guidelines for human embryonic stem cell research at EU level

The Commission proposal deals with a very precise research topic, namely
the derivation of stem cells from supernumerary embryos with no parental
project. These embryos, maximum 5 to 7 days old and of a microscopic
dimension, are frozen as a result of in-vitro fertilisation (IVF)
treatment and are donated by parents for research. They will, at some
point, be disposed of without being used either for IVF or for research
purposes. The proposal does not aim to create human embryos for the
purpose of stem cell procurement, including by means of somatic cell
nuclear transfer, (commonly referred to as therapeutic cloning). The
creation of human embryos for research is explicitly excluded from the
scope of FP6 funding.

To meet a concern that EU funding would provide indirect incentives for
the production of more embryos than needed for IVF, the Commission
proposes that only supernumerary embryos can be used that were created
before 27 June 2002, the date of adoption of the EU 6th Research
Framework Programme.

FP6 funding for the derivation of new stem cells will only be made
available if proposals successfully pass a rigorous scientific peer-
review and an ethical review, for which this proposal suggests the
criteria. The derivation of stem cells from supernumerary embryos is only
one element in the broader EU approach to stem cell research, which also
includes funding for adult (somatic) stem cells, training of researchers
in this field, etc.


What exactly is the Commission proposing?

The Commission's proposal acknowledges that this issue is controversial,
with many open questions, but also recognises the potential it offers for
curing diseases and principle of freedom of research which is enshrined
in the European Charter of Fundamental Rights. It proposes the following
guidelines:
- The EU will not fund human embryonic stem cell research where it is
forbidden by a Member State;
- Human embryonic stem cells can only be derived from supernumerary
embryos that are donated for research by parents and that were created
before 27 June 2002, the date of the adoption of the Framework Programme.
These embryos are destined to be destroyed at some point in time;
- Potential research project partners applying for EU funding must seek
ethical advice at national or local level in Member States where the
research will take place, even in countries where obtaining such ethical
advice is not mandatory;
- Research will be funded only when it is demonstrated that it meets
particularly important research objectives;
- Research will be funded only when there is no adequate alternative
available. In particular, it must demonstrated that one cannot use
existing embryonic or adult stem cell lines;
- Supernumerary embryos will be used only if informed consent has been
given by the donor(s);
- Embryo donor(s) will not be permitted to make any financial gain;
- Data and privacy protection of donors must be guaranteed;
-Traceability of stem cells will be required;
- Research consortia will be required to engage in making available new
human embryonic stem cells to other researchers.

The Commission intends to fund the creation of a European registry, an
initiative advocated by nearly all Member States. Such a registry at
European level should reduce the need for derivation of stem cells from
human supernumerary embryos in the future.

Collaborative research at EU level should contribute to a reduction of
the use of human embryos. By sharing resources and results within a
European project, duplication of research activities will be reduced.
Furthermore, more rapid scientific progress can be achieved by bringing
together multidisciplinary teams.




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GENET
European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
Kleine Wiese 6
D - 38116 Braunschweig
Germany

phone:  +49-531-5168746
fax:    +49-531-5168747
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