Introduction
The relation between
ethics, law, and public policy
has a long tradition in Western thought and practice going back to
Plato’s
“Nomoi” (722d) where he stresses the importance of “introductions” (‘proimia’) that should used in order to
make laws more understandable and acceptable to the citizens (1). Aristotle makes a difference
between individual and political virtues.
Political and legal practice are supposed to rest on ethical
counselling on the
basis of morality (‘ethos’). Since
Modernity, and particularly since Thomas Hobbes, there is not just a
difference
but a split between morality, law and public policy. Since Hegel
through Pierce
and Rorty there is a (pragmatic) search for overcoming it. Today’s mass
media
and particularly the internet have created new forms of mediation
without eliminating
the differences.
Ethics councils within
the sphere of public policy
have the function of reflecting on the moral and legal foundations of
specific controversial
issues without being itself neither a legal nor
a moral authority. Their task is
reflection, not decision-making or dogmatic proclamation. They should
counterbalance ethical arguments and give an opinion on matters that
remain
controversial and subject to revision. Today’s public policy has a need
for
such counsels particularly with regard to new developments in science
and
technology. This is the case since twenty years or so in the field of
biology (bioethics) (2) but it becomes more and more obvious also
with regard to the new information and communication technologies (information ethics) (3).
Of course, such ethics bodies are not unproblematic not only concerning
their
legitimating body – in some cases it is the parliament, in other cases
the
executive –, but also with regard to possible controversial standpoints
that
may differ with present laws and/or directives. In other words, it is
important
that such bodies are politically independent, pluralist, and
multidisciplinary
and that they view themselves not just as guarantee of an established
morality
or of current law, but as a critical space where an open debate on
legally and
morally controversial issues can take place. Although they might look
for
consensual opinions, consensus should not be a conditio
sine qua non of their proposals. It is also not their
function to make public policy ‘more moral,’ but to encourage ethical
reflection within the public sphere.
The European Group on
Ethics in Science and New
Technologies (EGE) is such an independent, pluralist and
multidisciplinary body
which advises the European Commission on ethical aspects of science and
new
technologies in connection with the preparation and implementation of
Community
legislation or policies.
In December 16, 1997 the
European Commission set up
the EGE for a three years mandate to succeed the Group of Advisers on
the
Ethical Implications of Biotechnology (GAEIB 1991-1997). During its
first
mandate the EGE (1998-2000) provided Opinions on subjects as diverse as
human
tissue banking, human embryo research, personal health data in the
information society,
doping in sport and human stem cell research. At a specific request of
the
President of the Commission, Romano Prodi, the Group also wrote the
"Report on the Charter on Fundamental Rights" related to
technological innovation. By a decision of March 26, 2001 the
Commission
adopted a revised mandate for the EGE with a duration of four years and
amended
the EGE remit.
During its second mandate (2001-2004) the EGE has
published
the following Opinions:
nr 16: Ethical
aspects of patenting inventions involving human stem cells (07/05/2002)
nr 17: Ethical
aspects of clinical research in developing countries (04/02/2003)
nr 18: Ethical
aspects of genetic testing in the workplace (17/09/2003).
Opinion nr 19 on “Ethical
aspects of cord blood stem cells banks” is in preparation. In its
Opinion nr 20 EGE will deal with “Ethical
Aspects of ICT in the Human Body.” Opinion nr 16, 17, and 19 were
requested by
the President of the European Commission, Romano Prodi. Opinions nr 18
and 20 are
an initiative of the Group.
Opinion nr 16
addresses the ethical implications of human stem cell research and its
uses. It
makes recommendations to set up a strict public control by centralised
authorities, on human embryo research where it is allowed, to take
measures to
prevent commercialisation of human embryos or cadaveric foetal tissue,
and to
ensure the respect of ethical principles through the control of public
authorities, concerning import of human stem cells, where allowed. The
Group
addresses the ethical dilemma that arises from the fact that patents
can
encourage scientific progress but they can also impair access to health
care
due to the need of a licence to use them and to the fees that will have
to be
paid to the patent holder. The Group is well aware that all procedures
involving directly or indirectly the human embryo are controversial.
Considering the risk of instrumentalisation and commercialisation of
the
embryo, the Group calls for a cautious approach, excluding the
patentability of
the process of creation of a human embryo by cloning of stem cells.
According
to the Group only human stem cell lines which have been modified by an
inventive process to get new characteristics for specific industrial
application are patentable. The Group stresses the urgent need to
engage a
public debate on that issue. It also calls for the creation of an EU
Registry
of unmodified human stem cell lines. The Group insists on the necessity
to
avoid the granting of too broad patents on stem cell lines that would
impair
further research and development. It also finds that the recourse to
compulsory
licence should be encouraged when the access to diagnosis and treatment
is
blocked by misuse of patent rights. One of the members of the Group
hold a
dissident opinion with the argument that human embryonic stem cells and
embryonic stem cell lines should be excluded from patentability because
it is
not possible to get them without destroying an embryo.
Opinion nr 17
deals with ethical aspects of clinical research in developing
countries. The 6th
Framework Programme (2002-2006) opens the possibility for developing
countries
to get EU funding in all research areas. This should make possible to
join
efforts in order to combat poverty-linked diseases such as AIDS,
malaria and
tuberculosis. It is in this context that the European Commission
requested the
EGE to submit an opinion. Clinical trials in developing countries give
rise to
ethical questions specifically linked to socio-economic inequalities
and
poverty but also to cultural diversity. The EGE stresses that the huge
economic
inequalities are the cause for most of the problems raised in this
opinion. The
implementation of EU research programmes in developing countries should
be
based on solidarity, in line with the Charter of Fundamental Rights.
The
general approach is that the fundamental ethical rules applied to
clinical
trials in industrialised countries, including the ones concerning the
use of
placebos, are to be applicable everywhere. The Group insists that the
scientific and ethical evaluation of research protocol should involve
local
committees, or local independent experts.
Opinion nr 18
raises not only ethical issues related to genetic testing with
particular
reference to genetic screening but also to the principle of justice and
non-discrimination in access to work. This issue has a particular
European
dimension since workers can freely cross borderlines within the EU.
According
to the Group, only the present health status of the employees should be
considered in the employment context with regard to genetic screening.
Moreover, the use of genetic screening in the context of medical
examination,
as well as the disclosure of the results of previous genetic tests, are
seen
“in general” as non ethically acceptable. Medical examination can
fulfil the
legitimate duties and right of employers concerning the protection of
health
and the assessment of ability. The Group states the conditions under
which
genetic testing could be considered.
Remit
of the EGE
1. Purpose: The European
Group on Ethics in Science
and New Technologies, hereafter the “Group”, shall act within the scope
of the
following remit.
2. Remit and
request for opinions: The task of the Group shall be to advise the
Commission
on all ethical questions relating to sciences and new technologies,
either at
the request of the Commission or on its own initiative. The Parliament
and the
Council may draw the Commission's attention to questions which they
consider of
major ethical importance. The Commission shall, when seeking the
opinion of the
Group, set a time limit within which such opinion shall be given.
3. Composition:
The Group shall have twelve members appointed for their expertise and
personal
qualities. It shall be independent, pluralist and
multidisciplinary.
4. Appointment: The
members of the Group shall be appointed by the Commission.
5. Term of
office: Each member of the Group shall be appointed for a term of four
years.
This term shall be renewable once. A member who resigns before
completion of
the term of office shall be replaced for the remainder of the term in
accordance with the procedure laid down in Point 4.
6. Reimbursement
of expenses: Travel and subsistence expenses for the Group’s meetings
shall be
covered by the Commission in accordance with the relevant
administrative
rules.
7. Chair: The
Group shall elect a chairperson and a vice-chairperson from among its
members
for the duration of the term of office.
8. Secretariat:
The Secretariat-General of the Commission, acting in close cooperation
with the
Group’s chairperson, shall be responsible for organising the work of
the Group
and its secretariat.
9. Working
methods: The Group’s regular working meetings shall not be open to the
public.
For the purposes of preparing its Opinions and within the limits of the
available resources for this action, the Group:
- may invite
experts either from a Member State of the Union
or from outside to take part in its proceedings on a given topic on the
agenda.
- may initiate
studies in order to collect all necessary scientific and technical
information
- may set up
working groups to consider specific issues
- may organize
public Round Tables in order to promote dialogue and improve
transparency
- may establish
closer links with representatives of the various ethics bodies which
exist in
the European Union and in the applicant countries.
10. Opinions:
Every opinion shall be published immediately after its adoption. Where
an
opinion is not adopted unanimously, it shall include any dissenting
point of
view.
11. Rules of
Procedure: The Group shall adopt its Rules of Procedure.
12. Activity
report: A report on the Group’s activities shall be produced under the
responsibility of the chairperson before the end of its term of office.
The
report shall be published.
13. Replacement
of previous text: This text describing the remit of the European Group
on
Ethics in Science and New Technologies shall replace the remit annexed
to the
Communication to the Commission of 12 December 1997 on the
establishment of the
European Group on Ethics in Science and New Technologies (SEC(97)2404)
Members
and Secretariat
By a
decision of
April 2, 2001 the Commission proceeded to the nomination of the twelve
members.
They are appointed for their competence and personal qualities. They
come from
different countries and are experts in disciplines such as biology and
genetics, medicine, informatics, law, philosophy or theology.
Following
the
resignation of Mrs Noelle Lenoir (France)
and Mr Spiros Simitis (Germany),
the Commission has nominated two new members: Mrs Catherine
Labrusse-Riou (France)
and Mr Nikos C. Alivizatos (Greece) for
September 2002.
Prof.
Göran
HERMERÉN (Sweden),
President, Philosopher, Professor of Medical Ethics,
Faculty of Medicine, Lund University
Prof. Linda NIELSEN (Denmark), Vice-President,
Professor of Law, Rector of the
University of Copenhagen.
Prof. Nicos C. ALIVIZATOS (Greece),
Professor of Constitutional Law, University of Athens.
Prof. Rafael CAPURRO (Germany), Professor of Information Management and
Information Ethics at Fachhochschule Stuttgart, Hochschule der Medien,
University
of Applied Sciences
Prof. Inez DE BEAUFORT (The Netherlands),
Professor of Health Care Ethics at the Medical Faculty of the Erasmus University,
Rotterdam.
Prof. Yvon ENGLERT (Belgium),
Head of Fertility Clinic, Free University of Brussels (ULB), Professor of Medical
Ethics
and Deontology, ULB
Prof. Catherine LABRUSSE-RIOU (France),
Centre de recherche en droit privé, Université de Paris.
Dr. Anne McLAREN (United Kingdom),
Geneticist, Research Associate at Wellcome CRC Institute, Cambridg
Prof. Pere PUIGDOMÈNECH ROSELL (Spain),
Research Professor at the Department for Molecular Genetics, Director
of
Institut de Biologia Molecular de Barcelona,
CSIC
Prof. Stefano RODOTA (Italy),
Professor of Civil Law, University
of Rome, Chairman
of the
Italian Data Protection Authority, Chairman of the European Group of
the Data
Protection Authorities.
Prof. Günter VIRT (Austria),
Professor of Theology, Institute
of Moral Theology, Catholic University of Vienna.
Prof. Peter WHITTAKER (Ireland),
Biologist, Professor of Biology, Institute
of Environment, Philosophy
and Public
Policy, University of Lancaster, Furness College
Secretariat of
the EGE
The Secretariat
is an integral part of the Group of Policy Advisers. Secretary of the
EGE is Ms
Christiane Bardoux., European Commission, 200 rue de la Loi (Brey
10/128), B-1049 Brussels.
EGE-Newsletter
"Ethically Speaking": providing information on the activities of the
National Ethics Committees.
Activities
2001-2004
2001
The Group under the
revised mandate held its first
meeting on 29 May in Brussels.
In his welcome message President Prodi requested the Group to give two
opinions:
- an Opinion (nr 16) on
the ethical aspects of patents resulting from research
into stem cells,
- an Opinion (nr 17) on the ethical aspects of clinical research in
developing
countries.
On June 11-12,
2001 the Group participates at the conference: "Ethics and Biomedical
Research" (Umea, Sweden), organised by the
Swedish
Presidency.
In preparation of
the Opinion nr 16 the Group organised on November 20, in
Brussels, a round-table debate on the
ethical aspects of patenting inventions involving human stem cells in
order to
discuss the topic with scientific experts, lawyers, philosophers, as
well as
representatives from the European Parliament, international
organisations,
representatives of patients, industry, religions, and other interested
parties.
2002
Under the Spanish
Presidency, on April 18-19, the Group held in Barcelona a working meeting and met
Members
of the Spanish Parliament and of Spanish working groups on bioethics.
The Group
also took part in the Platform "European African partnership on
clinical
trials programme for poverty related diseases."
Within the
preparatory work on its next opinion nr 17, the Group organised on
October 1, 2002
in Brussels a round-table debate on “The ethical aspects of clinical
research
in developing countries” with representatives of the European
Parliament,
international organisations, representatives of patients, industry,
religions,
and other interested parties.
Under the Danish
Presidency, on October 24-25, the Group
held a working meeting in Copenhagen
and met twelve members of the Danish Consumer Agency and of the
National Ethics
Committee. The Group also had a debate with researchers within the area
of
developing countries and took part in the conference on “Future Food on
Bioethics,” organised by the Danish Consumer Agency and hosted by the
Danish
Government.
2003
The
Group edited on 4th February the opinion nr 17 on “the ethical
aspects of
clinical research in developing countries”.
The
Group presented on 20th February a statement on “Advertising genetic
tests via
the Internet”.
Under
the Greek Presidency, on May 26th and 27th, the Group held a working
meeting in Athens
and met
the Greek Minister of Health, Dr. C. Stefanis. The Group
also
organized a debate with the Members of the Greek Bioethics Committee
(GBC),
chaired by Prof. George Koumantos, in order to prepare its last Opinion
nr 18
on "the ethical aspects of Genetic testing in the workplace".
The
Group adopted on 28 July the opinion nr 18 on “the ethical aspects of
genetic
testing in the workplace”.
Under
the Italian Presidency, on October 20th-22nd,
the Group
held a working meeting in Rome
and met members of the National Bioethics Committee (NBC), chaired by
Prof.
Francesco D'Agostino. The main theme of the exchange with members of
the NBC
was on genetic testing on the net. The EGE was then received by the
President of the Italian Republic, Mr Carlo Azeglio Ciampi. The
Group also met the organisers of the website "Storia e memoria",
representatives of Parliament who presented projects of law concerning
cord
blood banks, and Prof. Salvatore Mancuso, Director of the
Department of
Gynecology at the Catholic University in Rome
where the biggest umbilical cord cell bank is located.
The
Group is currently preparing the opinion nr 19 on "the Ethical
aspects of umbilical cord blood private banking". Indeed, the
development of private banks as well as their publicity on the web
raises
concerns and it is at the request of the Commission that the EGE will
submit
this opinion. This opinion should be ready in the beginning of 2004.
In
parallel, the Group is also looking at the ethical aspects attached to
information and communication technologies and is as well envisaging to
give an
opinion on the ethical aspects linked to nanotechnologies.
Opinions,
Statements,
and Publications
OPINIONS
The Opinions are available
at the EGE website:
https://ec.europa.eu/archives/bepa/european-group-ethics/publications/opinions/index_en.htm
GAEIB
1993-1997
nr 1: The ethical
implications of the use of performance-enhancers in agriculture and
fisheries
(12/03/1993)
nr 2: Products derived
from human blood or human plasma (12/03/1993)
nr 3: Opinion on
ethical questions arising from the Commission proposal for a Council
directive
for legal protection of biotechnological inventions (30/09/1993)
nr 4: The ethical implications of gene therapy
(13/12/1994)
nr 5: Ethical aspects of the labelling of the food
derived from modern
biotechnology (05/05/1995)
nr 6: Ethical aspects of
prenatal diagnosis (20/02/1996)
nr 7: Ethical aspects of
genetic modification of animals (21/05/1996)
nr 8: Ethical
aspects of patenting inventions involving elements of human origin
(25/09/1996)
nr 9: Ethical aspects of
cloning techniques (28/05/1997)
nr 10: Ethical aspects of
the 5th Research Framework Programme (11/12/1997)
EGE 1998-2000
nr 11: Ethical aspects of human tissue banking (21/07/1998)
nr 12:
Ethical aspects of research involving the use of human embryo in the
context of the 5th framework programme (23/11/1998)
nr 13:
Ethical issues of healthcare in the information society (30/07/1999)
nr 14:
Ethical aspects arising from doping in sport (14/11/1999)
nr 15:
Ethical aspects of human stem cell research and use (14/11/2000)
Report:
23/05/2000 Citizens Rights and New Technologies: A European Challenge.
Report on the Charter on fundamental rights related to technological
innovation requested by the President of the Commission, Romano Prodi.
EGE 2001-2004
nr 16:
Ethical aspects of patenting inventions involving human stem cells
(07/05/2002)
nr 17:
Ethical aspects of clinical research in developing countries
(04/02/2003)
nr 18:
Ethical aspects of genetic texting in the workplance (17/09/2003)
nr 19:
Ethical aspects of cord blood stem cells banks (in prep.)
STATEMENTS
Statement nr
1: On Advertising Genetic Tests via the Internet (24/2/2003)
PUBLICATIONS
Paper
version,
free of charge, available upon request.
General
Report
on the activities of the EGE 1998-2000
Genetic
testing in the workplace. Round Table Debate, Brussels, 6 March 2000.
Opinion
nr 15:
"Ethical aspects of human stem cell research and uses," accompanying
document including the text of the Opinion in French, English and
German as well as relevant texts of the European Institutions, National
Ethics Committees and experts on scientific, ethical or legal issues.
Revised edition, September 2002.
Opinion
nr 16:
"Ethical aspects of patenting inventions involving human stem cells"
(The text of the opinion is also available in German)
"A
history of
patenting life in the United States with comparative attention to
Canada and Europe," by Prof. Kevles. This study has been carried out at
the request of the EGE for the preparation of the opinion nr 16.
"Study on the patenting of inventions related to human stem cells" by
Prof. Van Overwalle. This study has been carried out at
the request of the EGE for the preparation of the opinion nr 16.
"National
regulations in the European Union regarding research on human embryos"
by Brigitte Gratton-
"The
ethical
aspects of biomedical research in developing countries," Proceedings of
the Round Table Debate held in Brussels on October 1, 2002.
Opinion
nr 17: “Ethical aspects of clinical research in developing countries”
(The text
of the opinion is also available in German.
Opinion
nr 18: “Ethical aspects of genetic testing in the workplace” (The text
of the
opinion is also available in German)
References
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