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European
Commission
Research D.G. / Life Sciences Directorates
Stem cells
Therapies for
the future?
EUR 20356
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Contents
3 Preface
5-10 Introduction
José-Maria Villa Valverde
The Discussion Platform
Stem cells, the science
EC research funding
11-29 Views and Opinions, Positions and Questions
New technologies, new problems
Legislation and regulation
A common position vs. pluralism
Patents and economic issues
Undetectable properties (why do we respect a human embryo?)
When does the embryo become a human being?
Respecting human rights, but whose?
Mums are something special
Women’s issues
Science fact or fiction – timescales
Banking and personal choice
Ethics or hypocrisy?
The citizens' input – but which citizens?
A kaleidoscope of passionately expressed views
Several questions – some answers
33 Summary and Conclusions
34 Statement from the Life Sciences High Level Group
Published by the
European Commission
LEGAL NOTICE
Neither the European Commission nor any person acting
on behalf of the Commission is responsible for the use which
might be made of the following information.
Luxembourg: Office for Official Publications
of the European Communities, 2002
OFFICE FOR OFFICIAL PUBLICATIONS
ISBN 92-894-3745-6
OF THE EUROPEAN COMMUNITIES
© European Communities, 2002
L-2985 Luxembourg
Printed in Belgium
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In April 2000, Philippe
Busquin, the European
Preface
Research Commissioner,
set up the Life Sciences
High Level Group, recently renamed the European Group
on Life Sciences (EGLS) to provide high-level advice on life sciences and
associated technologies. In addition to its role in informing the Research
Commissioner on the current situation and foreseeable developments,
the EGLS is responsible for supporting science communication strategies, such as engaging in informed and pluralistic stakeholders, debates
on life sciences issues. In this perspective, the EGLS has launched the
initiative of organising a Life Sciences Discussion Platform, which provides opportunities for debate between scientists and the various ‘stakeholders’.
Recent developments have opened up new possibilities for the use of
stem cells in the treatment of human diseases. Stem cell therapies are a source of tremendous hope to the countless
individuals suffering from currently incurable, long-term diseases. However, as one of the principal sources of stem
cells is the human embryo, these techniques also arouse doubts, fears and opposition. In December 2001, the EGLS
organised a meeting in Brussels to provide an opportunity for all interested parties to discuss stem cells and their possible use in future therapies, as part of the Life Sciences Discussion Platform.
In his opening address at this forum, Philippe Busquin affirmed that he, like others, believes that the 21st century will
be the “Century of Life” as life sciences and biotechnology appear to be the most revolutionary areas of science at the
moment. He stressed the importance of a role for Europe in the development of life sciences and in determining the
way in which this should be carried out.
“A recent survey shows that European citizens are interested in science and eager to learn, but also that they want,
more than ever before, to participate in defining the research agenda,” said Mr Busquin. “Today’s conference aims to
give science back to society; it is intended as more than just a conference; it should be a real discussion platform.” He
went on to express his desire that all of the participants present would take part in the debate and his pleasure that so
many people, from so many different backgrounds, had attended the forum.
According to Mr Busquin, “Stem cell research is symbolic of the opportunities that come with the spectacular progress
of the life sciences and of the questions it raises for each one of us. The challenge is to be consistent in developing policies applicable to health, the environment, consumer protection, the internal market, international trade, research and
innovation.” Mr Busquin observed “Research is at the heart of the matter, as the motor driving all policy pertaining to
living things and biotechnology.” He also expressed his satisfaction that the Council of Ministers’ meeting had reached
political agreement concerning the implementation of the European Research Area in the new Framework Programme.
The Commissioner rounded off his speech by reasserting the importance of debate: “Research must be free. At the same
time, we must ensure responsibility and the equitable use of new knowledge and new technologies. This can only
become a reality through dialogue, notably on a European scale.”
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1. Introduction
José-Maria Villa Valverde
“
I’ve had multiple sclerosis ever since 1992. Multiple sclerosis – we don’t know exactly what
its causes are, but we do know what happens when a person has multiple sclerosis. It attacks the
central nervous system; motor movements and cognitive perceptions are also affected. It may also
extend to other types of chronic illness. Capricious, unpredictable and mean, it’s the product of a
combination of genetic and environmental factors. It weakens our immune system and it appears
cruelly, generally at a young age. I simply wished to make this contribution as someone who is
affected by one of these debilitating illnesses and therefore by the currently available therapy. Well, I got a transplant
of these cells, haematopoietic stem cells, which serve to make blood cells and originate from my bone marrow, a socalled autologous bone marrow transplant. This type of bone marrow transplant has been done for years, in Spain at
least, and at European level another hundred patients have been treated. This treatment was carried out in the clinic
in Barcelona but it is also carried out in other European and American centres. The immune system is destroyed in
this type of degenerative disease and my treatment has made it possible to reconstitute this system using my own cells.
It’s too early to evaluate the results of the treatment that I have had, nor am I in a position to be able to carry out this
evaluation, but it is designed not to cure, but to stop the progression of this disease. I am fully convinced by this
treatment with stem cells and if this had not been the case … I mean I did take certain risks in having this treatment
but I weighed up my quality of life without treatment, a sort of a risk-benefit analysis, and I really think this treatment has been worthwhile. Stem cells have been used and I think they should be used for people who need this treatment urgently, I repeat, urgently! Those who have my type of illness find that their life gets worse from day to day so
I think it is the time to consider the health of millions and millions of people and not so much about the origins of
these cells. I am not just asking, I am demanding that this type of treatment be made possible and be institutionalised
and particularly that it also be made possible financially. Thank you.
Señor Villa Valverde said that he had attended primarily to listen to the ideas concerning stem cells being put forward
at European level. His views on the ethical debate were uncompromising: “On the one hand it seems logical that there
should be an ethical debate but on the other hand I don’t understand it. My disease is very progressive and gets worse
daily. I have multiple sclerosis, but this also concerns Parkinson’s disease, leukaemia and cancers. The list is endless. I
don’t think that for these people the ethical debate has any real meaning. They just don’t see it. What they urgently
need is a solution and at the moment the solution lies in stem cells.
”
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_The Discussion Platform
T
he 21st century may well be the century of the life sciences, and major developments and
improvements in medicine and human health are expected from the extraordinary progress sci-
entists are making in our understanding of biology. One aspect is regenerative medicine, that is, the possibility of replacing degenerated or damaged tissue, and thereby curing numerous diseases that are currently intractable. Stem cells are the tools central to this unprecedented approach to therapy. They are
cells with the intrinsic ability to develop into a diversity of new tissues and thereby replace or repair the
diseased, damaged or dysfunctional organs in the patient.
The only source of human stem cells is the human body itself – adults, foetuses, embryos or umbilical
cord. The origin of the material required to develop new clinical applications raises a variety of complex issues.
Scientific research on stem cells and therapies involving their use raise questions concerning the ethics of obtaining
these cells, the liberty of research, the basis of patenting, and the morality of manipulating human tissues in this way.
As part of the Life Sciences Discussion Platform co-ordinated by the European Group on Life Sciences, the European
Commission organised a meeting, entitled “Stem Cells: therapies for the future?” in Brussels on 18 and 19 December
2001. The forum was attended by over 750 people from 36 countries throughout Europe and elsewhere, including expert
scientists, clinicians, politicians, industrialists, representatives of interest groups, patient support groups and religions,
and interested private individuals. The event was free and open to all, but the European Commission also awarded 49
grants to individuals, particularly young people and people from accession countries, to enable them to attend.
In his opening address, Commissioner Philippe Busquin said: “For Europe, it is essential to take part in this development
of the life sciences, but also to determine how it is to be carried out in Europe and worldwide. We must organise with
these aims in mind. This discussion platform, organised by the Commission under the auspices of the European Group
on Life Sciences, should reflect these objectives. It is intended as an exercise in the governance of science.”
Stem cells are not an issue for Europe alone. The economic stakes are high and scientists around the world are working in this field. Both patients and the materials used for the work can cross frontiers.
Indeed, François-Xavier de Donnea, the Belgian Minister of Research, launching the proceedings, said: “Yet as in other
important matters such as the environment or WTO negotiations, the European Union must present and defend its
specific approach and its own values. We must first do the job at European level, in order to define a framework of
basic principles. Such a European framework is likely to strengthen our position when the time comes to discuss with
our partners the content of a worldwide framework.”
Illustrating its will to innovate and to maximise the impact of the debate, the discussion platform was webcast, and
members of the public were invited to express their opinions and views via e-mail before, during, or after the forum.
After each talk, there was a question-and-answer session, and the programme included two roundtable discussions and
a public debate. The aim was to air and publicise the current state of scientific knowledge and medical progress as a
basis for further discussion.
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In the view of Professor Axel Kahn “The idea of the European Group on Life Sciences is that the scientific facts are not
enough for making decisions in this area, but that we cannot discuss the ethical issues they raise without clarifying the
scientific facts. This discussion platform will therefore address both aspects. First we will learn about the research in
progress and the scientific aspects of stem cell therapies, then we will discuss the ethical and societal issues.”
Accordingly, the forum was organised into sessions introducing the real debate. The first sessions concentrated on the
science of stem cells and included presentations by top-level European researchers and clinicians:
1) Focusing the problem: the challenges of stem cell research
2) The input from research: the available know-how and its potential
3) Therapeutic prospects: the possible therapeutic outcomes
These were followed by presentations by industrialists, and specialists in ethics
and law addressing issues associated with stem cells:
1) Societal and ethical key issues: the citizen’s rights
2) Challenges for pharmaceutical development: from bench to patient
3) Governance of discovery and development
The sessions aimed to structure the wide-ranging exchanges of views the public had called for. Each introduction helped to set the scene and was followed
by questions and opinions from the audience, bringing the issue into focus.
The critical exercise, particularly for the chairs, was to depart from the formal
programme and to allow the public to set their own agenda, with a minority of experts setting
the boundaries so as to ensure a reasonable and balanced discussion. The discussion platform
essentially became a learning experience, in which each of the participants had the opportunity to learn from the diversity of views and information presented. This brochure illustrates the diversity of
opinions and views expressed by those who claim to know a little and those who want to know more. It covers more than just the conference interventions, and includes statements made by participants before and
during the forum, in both formal and informal settings, and comments sent via e-mail by webcast viewers.
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_Stem cells, the science
E
very individual is made up of innumerable cells of remarkable
diversity. In the adult, most cells have particular attributes and
functions: red blood cells transport oxygen round the body,
muscle cells allow movement, and nerve cells
control the movement of the muscles; some cells
secrete hormones, others defend against infection,
some detect noise and others light, making
hearing and sight possible.
Despite this diversity, each human starts as one single cell, the fertilised egg or
zygote, which has virtually none of these functions. The zygote divides, and the resulting
daughter cells divide, and divide again and again, to form the embryo. When there are 16
cells, the embryo implants into the mother’s uterus,
eventually developing into the foetus.
Specialist roles
The cells continue to divide, but as they do so, differences
appear – not all the cells are identical. This is called
differentiation, the process by which cells assume
specialised forms and functions. The outcome
is the extraordinary diversity of cell types present in the adult. This is
possible because the cells of the human embryo have the inherent ability to
give rise to all human cell types.
Throughout the development of the foetus and the child, this process of
differentiation continues at different rates in different tissues and organs, and
partially differentiated and immature cells are present alongside fully differentiated
cells. Furthermore, as part of normal physiological processes, cells in the body are
dying continually. For example, both the cells at the surface of the skin and
circulating blood cells die and are constantly being replaced. New
differentiated cells are supplied by the division and differentiation of less
specialised cells, cells which are maintained in the child and also in the
adult in a partly differentiated form ready to produce fully differentiated cells as required.
Multiplication and division
These cells, the cells in the embryo, foetus, child or adult that are
able to give rise to differentiated cells, are called stem cells. Stem
cells can be seen as apprentice cells, cells that are at some
stage on the path to becoming fully specialised and thus
able to fulfil a particular function. Generally, the further
along the path they have progressed, the more limited
the range of functions they will be able to fulfil. Scientists therefore call stem
cells that have started to specialise differentiated stem cells (or adult stem cells as
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Fig 1: High-power image at edge of aggregate culture
showing migration away from the aggregates. Blue is cell
nucleus, geen is nestin (neural stem cell marker), red is
GFAP, a marker of astroglia but also expressed in some
neural stem cells. Combination images bottom panels.
Fig 2: Human heterogeneous primary fetal brainstem cell
preparation showing that a proportion of the cells
(cell nucleus stained blue) are stem cells, showing the
characteristic filamentous expression of the neural
stem cell marker, nestin (in green).
they are found in adults), and each type of differentiated
stem cell can only give rise to a family of cell types.
Embryonic stem cells, the cells of the embryo, in contrast, have
the capacity to generate any cell type found in the human body.
Another important characteristic of stem cells is that as they divide and multiply, they can also give rise to cells like
themselves: in addition to producing differentiated cells with specialised functions, they can produce another
generation of stem cells ensuring a continuous supply. Thus, stem cells are entirely natural cells and indeed are central
to the normal healthy growth and development of the foetus and child, and maintenance and repair in the adult.
Fig 3: Fluorescence immunocytochemistry.
Clonal conditionally immortalized human neural stem cell
line showing that every cell (cell nucleus stained blue) also
expresses the neural stem cell filamentous marker, nestin
(in green). Note the homogeneity of the cells.
Fig 4: Similar to Fig 2, nestin marker
now stained with red fluorescence dye.
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Existing prospects
Many diseases that are currently difficult or impossible to treat are due to particular types of cell not functioning correctly: Parkinson’s disease, diabetes and some types of leukaemia, for example. The reason for the excitement about
stem cells is that it may be possible to use them to cure patients with these diseases. This approach to medicine is
unprecedented as it involves the regeneration of normal cells, tissues and organs. It may be possible to treat a patient
with stem cells such that both the immediate problem is corrected and also the normal physiological processes are
restored without the need for subsequent drug or similar treatment. Indeed, the scope of regenerative therapy is large.
It has the potential to allow the development of cures for numerous metabolic and degenerative diseases. Furthermore,
it is already being used successfully to reconstruct cartilage in damaged joints, and to regrow skin for patients with
severe burns. In such cases, stem cells from the patient him or herself can be used, avoiding the problems of rejection
and of finding appropriate donors.
As Alastair Kent said at the forum: “The potential benefits of human embryonic stem cells were first outlined nearly
40 years ago… At that time, the tools and techniques necessary to explore this potential had not been developed, so
any benefits were to remain theoretical. With recent advances in biology and the development of new practices and
procedures, it is becoming increasingly possible to undertake research that will allow us to develop such benefits. Our
current knowledge provides for a realistic prospect of this research yielding effective treatments and possibly even cures
for a range of currently incurable long-term diseases such as Parkinson's or Alzheimer’s, for improving the circumstances of those who have had strokes, and for helping those with a wide range of genetic disorders.”
EC research funding
The European Commission supports research through the Fifth Framework
Programme. Part of this funding goes to stem cell research. Thus the thematic programme
‘Quality of Life and Management of Living Resources’ (1998-2002) currently funds 15 research projects in
the area of stem cell research and therapy with a total EC contribution of €27.4 million (catalogue
available at http://europa.eu.int/comm/research/quality-of-life/ stemcells/about.html). However, EC
funding only accounts for 5% of all public research funding in Europe, and the Commission does
not have control over the uses made of it nationally. The EC funds facilitate networking between
many of the best teams in Europe, ensuring dynamism and synergy, as well as avoiding duplication.
The EC funding programme supports consortia of groups in different European Member States, and in the
academic, hospital and private sectors. In addition to clinical and academic research in the field, the Commission
also supports transnational and multidisciplinary research into bioethics and, in particular, the ethical, legal and
social aspects of stem cell research and use.
The programmes concerning stem cells supported by the EC are classified into four areas:
1) Neural stem cells, from basic research to clinical application
2) Stem cells, from differentiation to tissue engineering
3) Haematopoietic stem cell therapy, from bench to bedside
4) Ethical, legal and social issues
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Anne McLaren
Robert Goebbels
Martin Raff
2. Views and Opinions,
Positions and Questions
_New technologies, new problems
R
ecent scientific advances, including the development of stem cell therapies, have taken
medicine into a new epoch, in which previously unforeseen possibilities are raising new
questions and confronting society with new problems of an ethical, legislative and technological nature. Many of the participants expressed concerns about how to deal with the
uncertainties ahead, and a selection of their comments follow.
“What we’re seeing is the development of a new sort of medicine. Up till now, we have been using cell products. Here we’re
looking at the use of cells. This is a brand new sort of medicine, which brings new opportunities, but also new problems: safety issues which will have to be very carefully controlled, and ethical issues, which need to be debated.”
Derek Burke
“The Temporary Committee on Human Genetics and Medical Technology was created in January 2001. The Committee’s aim
was to examine the various issues connected with recent developments in human genetics and medical technology, including stem cell research … Our rapporteur Mr Francesco Fiori produced a very ‘mainstream’ report avoiding extreme positions,
but the subject raised such passions that in a session that lasted seven hours, the Committee had to deal with some 600
amendments. This created many inconsistencies in the text. The plenary session still had to deal with 250 amendments, and
the final text was so disfigured that nobody could identify with it and the report was rejected by the European Parliament.
The divide was not left-right. It went through all political groups.”
Robert Goebbels
“In the US, publicly funded research on stem cells is restricted so much that the quality of the science is threatened, whereas
industry-funded research is not regulated at all with little or no ethical overview. I’d like to think we could do better than that
in Europe.”
Anne McLaren
“If the use of embryonic stem cells is permitted, many physicians and a great part of mankind will probably not be able to
give their consent and will reject this procedure as an unacceptable appropriation to the detriment of the life of others. The
trust in an intact health system on a highly ethical level is therefore shaken. Well-being and health will then be generally
impaired.”
Hartmut Dunkelberg
“Patients are crying out for cell therapies. If you’re a clinician and your patients are saying “Please help me doctor”, it would
be tempting to try cell therapy, even though much more work is required to determine whether it might work and whether
it is dangerous. If you have a success you may well become famous; if there is a catastrophe, it could greatly slow down the
entire field. Consequently, although the current ethical discussions are important, they may become less so if there are some
real successes, as we saw with in vitro fertilisation.”
Martin Raff
“Most parliamentarians agreed that Europe should invest in this research and avoid leaving it solely to the private sector. A
major point of divergence was: which stem cells and which technologies should be used for this research? In my opinion, no
technique should be banned a priori. Research should be allowed to progress freely, within the limits of human dignity.
Legislators should ban unacceptable practices such as human cloning, but they should not confine research, which is by
nature unpredictable, to a straitjacket. I am confident that research based on genetics and stem cells will progress with or without Europe, but I strongly believe Europe should take an active part.”
Robert Goebbels
“The embryonic stem cells are more versatile and offer more promise to scientists in research … adult stem cells have ‘limited potential’ hence the present focus on embryonic stem cells..”
Parkinson’s Disease Society, UK
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Eliane Glukman
_Legislation and regulation
Peter Gruss
O
ne particular area of concern was the regulation of stem cell research and therapies. There
is currently no coherent Europe-wide legislation in this field, and it is clear that regulation
must be laid down in the future if we are to ensure that stem cell research and therapy
are both safe and ethical, and that practices are consistent throughout the European
Union. What follows is a collection of views on this theme.
“When it comes to regulating cloning technologies, there exist two radical but unassailable views: (1) All cloning technologies should be permitted and funded; (2) No cloning technologies should be permitted or funded. All in-between positions
will be open to attack from both sides, but most countries have adopted in-between solutions.”
Soren Holm
“The work of the legislators must be based on a sound and coherent understanding of the science: in the case of Parkinson’s
disease, stem cells can give results, and this is not only imagination but reality.”
Philippe Busquin
“Creating new human life solely to destroy it for potential benefit to others is unethical. It is a grotesque and unacceptable
commodification of human life, which should be forbidden by law.”
Ignacio Arsuaga
“… the new questions that have been raised by modern biomedicine cannot be answered solely with reference to the law.”
Christof Tannert
“The problem here is that both action and inaction have serious consequences, either for the embryo or for patients who are
suffering and who might be helped by embryonic stem cell-based therapy.”
Peter Gruss
“Here I would like to introduce legislation as a friend, not an enemy. Often it is presented as an unacceptable restriction of
the freedom of research. Yet I think we should have it … In areas such as stem cell research it is better to know that you are
safe and sound if you follow certain rules than to be in an area where you don’t know what is OK and what isn’t.”
Linda Nielsen
“The dynamic entrepreneurial, mercurial nature of research innovation means that such regulation will either kill it or move
its best talents elsewhere.”
Robert Brown
“I believe in freedom for research and in the right of scientists to learn more. Of course, there are limits to this. Not everything that is scientifically possible or technically feasible is desirable or acceptable for society. Obviously, rules are necessary,
but I would prefer codes of good conduct produced by the scientific community itself, enabling it to intervene against charlatans. Legislators, in my opinion, should limit themselves to prohibiting what is unacceptable, such as reproductive cloning
and genetic modification of the germ line. They should not stifle science by creating legislation that is too restrictive.”
Robert Goebbels
“This is a dynamic field where new developments happen fast and unpredictably. We are touching upon the freedom of
research. The economic stakes are high. The area is very sensitive, not least because it deals with human embryos. It is also
trans-boundary – in relation to countries, consequences, and cultures,” .... “The question is: should we regulate the method
or the purpose? If we regulate the method, we run into problems such as that posed by therapeutic cloning: part of the method
is the same as for reproductive cloning, but the purpose is not. On the other hand, you can’t get into a researcher’s head to
see what his purpose is. This is a difficult problem.”
Linda Nielsen
Eliane Gluckman agreed “It’s urgent that we decide what a stem cell is … these are cells with no status at the moment. If we
take, for example, umbilical cord blood, it’s a waste product and it’s not covered by any legislation. Yet, cord blood is used for
transplantation so it’s covered by legislation on organ transplantation. And yet, it’s not an organ, it’s cells, so it’s covered by
tissue legislation and then it is given intravenously and becomes blood. This isn’t a trivial point because depending on the
place attributed by each Member State to this product, the legislation could end up being quite different in the different countries… We’ve all sorts of rules relating to products that can and can’t be exported.”
“For embryonic cells the situation is more difficult and we have not yet resolved whether these are goods, products or something
else… The majority principle can also only be upheld, important as it is in the democracy, if the majority acts with self-restraint…
If something is done with the dignity of humankind that refers to only one type of creed or concept, this would be wrong. We
think that the legislators must not be bound in by any kind of ideology.”
Margot von Renesse
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Linda Nielsen
Margot von Renesse
Linda Nielsen pointed out that even in the absence of legislation, positions are taken and decisions made. “If the legislator does
not do it then professionals, or clinics or research institutions or somebody else will… When you have an embryo outside the
woman, does it need a passport? We are dealing with something here that it is difficult to put into our normal ways of
thinking…”
“This is a complex issue and there are a lot of difficult decisions; these are better done away from the cut and thrust of everyday politics, by taking the time and trouble to canvass opinions and to reach a reasoned conclusion. My main fear is that we
will create barriers of regulation and bureaucracy that will prevent the potential that stem cells hold out for very serious diseases being realised.”
Alastair Kent
“I don’t think we can say ‘let research go on unhindered’ and worry only about its application to humans. To seek morality
in research is a legitimate pursuit, recognised as early as 1947 in Nuremberg.”
Axel Kahn
“Clearly its [science’s] techniques and source materials must fall within what is accepted by the society of the day but this is
absolutely not the same as predicting, presupposing or making value judgements on its possible outcomes.”
Robert Brown
“I agree, but it is important to realise that ethical notions evolve with the state of knowledge. In the Middle Ages it was judged
unethical to study human anatomy. We owe it to a few brave researchers to have helped to change this view, and today we
have surgery.”
Robert Goebbels
“Some things that are lawful might not be ethical in every sense. Institutions and individuals must refrain from doing what
is unlawful, but they are free to make additional ethical provisions of their own.”
Linda Nielsen
“It is unreasonable to expect profit-making organisations to regulate themselves, as the recent scandal over the price of AIDS
drugs makes clear.”
Naomi Young
“It is important to proceed carefully, and that we the scientists generally have support for what we are doing. Decision-makers should understand that we as scientists are very concerned that this research proceeds in the best possible way. It will not
go quickly, it will take many years, and we need support both from society and a regulatory framework.”
Anders Bjorklund
“Different EU Member States have adopted different legislation in this area. The spectrum ranges from prohibition of abortion to allowing therapeutic cloning. In Germany, both the production of embryonic stem cells and therapeutic cloning are
prohibited. This is a serious obstacle to research aiming to develop embryonic stem cell-based therapies. The import of embryonic stem cells is allowed, however, under limited conditions, so research should be able to go on.”
Peter Gruss
“In Britain there has been extensive debate in the media, ethical committees established for some time, and free votes in both
Houses of Parliament. I think that in Britain we are close to a consensus for using embryonic stem cells for therapy under
strictly regulated ethical and safety control,” affirmed Derek Burke.
The Parkinson’s Disease Society of the UK is pleased that the UK government has decided to allow this research [on embryonic
stem cells] to proceed … to permit research that could lead to treatment benefiting many hundreds of thousands of people to go
forward. The Parkinson’s Disease Society does understand and respect the sincerely held views of people who have objections on
moral and ethical grounds to this research. Indeed, as their Parliamentary Officer, Rachel Haynes said, “We strongly support the
ban on human reproductive cloning and support the Government’s intention to reinforce the existing legislation which prohibits human cloning.”
“In the UK there are currently no regulations to protect cloned embryos, only IVF embryos. A law has just been passed there
that seeks to prohibit reproductive cloning. Unfortunately, it contains numerous loopholes. It prevents a cloned embryo being
inserted into a ‘uterus of a woman’ but does not take into account the possibility of creating a human clone entirely in vitro
(e.g. in an artificial womb) or in the womb of an animal.”
Paul Woolley
“Science is too unpredictable to be forced into a mould. In France and Germany, the two EU countries that chose to legislate very
early on in embryo research, many people are now wondering how to get out of the legislative straitjacket.” Robert Goebbels
“You mention that it is hard to get rid of restrictive measures like those adopted in Germany. Some people, myself included,
would say that this is fortunate: we do not have thousands of surplus embryos as in the UK, or human cloning as in the US.
We had a large majority backing this legislation. I am optimistic about science, but since nobody can define a specific step at
which the embryo becomes a human being, I believe the embryo should not be put to research use.”
Peter Kern
“My criticism of German legislation applies essentially to an aspect that to me seems illogical: the embryo is protected up to
the time it is aborted.”
Robert Goebbels
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_A common position vs. pluralism
I
t became clear from the debate that different Member States have already taken very different
positions regarding the regulation of stem cell research and therapy, and that diverse views exist
throughout the Union concerning what is and is not ethical. This raises the question as to whether
we should try to find a common position and to establish Europe-wide legislation or whether it
would be better to allow individual Member States to develop their own legislation consistent with
the demands of their individual cultures. Many participants expressed strong views on this subject.
“Within the European Union, each Member State has its taboos, whether they concern what is authorised or what is allowed.
Each State thus answers the ethical questions in its own specific way.”
François-Xavier de Donnéa
“It’s high time that we turned from a purely ethical debate to a political discussion … To simply believe that we can treat these
issues at national level is nothing more than an illusion.”
Ulrich Körtner
“The EU is culturally diverse, and I doubt if there is any common ethical framework capable of embracing the various opinions and beliefs within its boundaries. There is a risk of creating regulation that is either so bland as to be useless or so draconian as to be unacceptable.”
Alastair Kent
“I don’t think that it is a realistic goal at the present time to have a common European position because there is no agreement
on the status of the early embryo. For those who feel that the moral status of the early embryo is just the same as the moral
status of the baby or the adult, and that any research that destroys an embryo is the same as murder, for them human stem
cell research will never be ethically acceptable. They have the right to hold that view. It is not a view that most people in my
country [UK] hold: they feel that the early embryo deserves respect, but research with an embryo that would otherwise die is
acceptable. As not every European country agrees, there will not be a common European position. However, there is likely to
be a common position on banning cloning technology to make human babies.”
Anne McLaren
“Many people say it will be impossible to regulate in this area because there are too many cultural differences. My answer to
that is: there are indeed many differences, but they are not all of a nature that precludes common regulation.” Linda Nielsen
“There are subjects upon which it is impossible to achieve a consensus…Thirty years since the first law on abortion and there
still is no consensus in society on the ethics of abortion; but we have a law that allows people, women, recourse to abortion
if they so wish.”
Roberto Colombo
“I think we will see different European countries finding different solutions and moving at different rates towards that solution, because societal, ethical and religious backgrounds are so different from each other – that’s part of the attraction of
Europe.”
Derek Burke
“National prohibitions will be circumvented by the simple expedient of transferring embryos from one country to another.”
Rut Cazorla
“I believe we need some
work legislation. On the
and the development of
naked! I suggest that the
clarity, protective measures, and norm-setting in the area of stem cells, so I am in favour of frameother hand, the legislation put in place should not create too many stumbling blocks for research
promising therapies, so it should be sufficiently flexible. No suit fits all, but we should not be left
following issues might be dealt with at the following levels:
EU level:
patenting stem cells; organising a public registry; quality/safety assessment; reference practice;
ethical review; good clinical practice;
National level:
embryo research (at least for some time); specific consent issues;
Professional guidelines:
the remainder.”
Linda Nielsen
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Alastair Kent
François-Xavier de Donnéa
“We should consider that our situation in the EU may be ideal
for this issue. We have a diversity of approaches from outright
banning in some states to regulated/enabling in others. This
has stimulated familiar efforts to harmonise our approach
across Europe… Could it be that we should make a virtue of
state-level diversity in this instance since ‘selection’ of a simple single approach (i.e. harmonised) would be the most dangerous option. Rather, consider that a diverse approach will
allow us to facilitate say, adult stem cell research by one group
of states and embryonic in others, depending on their national strengths, leanings and moral alignments. Surely, this will generate a healthy tension across the Union, fostering competition. When we know more we can draw on both expertise and (most likely) synthesise ideal solutions ahead of our competitors by virtue of our diversity of approach.”
Robert Brown
One participant added “We have to guarantee the safety and the quality of these products and one of the serious difficulties
faced at European level is the need to guarantee imports, particularly those that come from outside Europe…There are also
significant economic interests at stake here and I think that the scientists and the businesses that might fund this sort of work
need to know what the attitudes are: what is allowed and what is not allowed… We have to have a minimum common legal
framework for Europe.”
“The complexity, sophistication and cost of such therapies require a European dimension of investment for funding knowledge and skills that our individual nations cannot sustain alone.”
Monty Gatehouse
“Destructive research on embryos and human cloning for whatever intention is prosecuted under criminal law in at least four
Member States of the EU. Common EU funds should respect basic legal principles in its Member States.”
European Youth Alliance
The Commission, in line with the opinion of the European Group on Ethics, feels that at this stage, when our knowledge is still limited, we should not prohibit exploration of the possibilities associated with all the potential sources of stem cells other than human
embryos produced explicitly for this end. This covers not only adult stem cells, but also stem cells originating from the umbilical
cord blood or from aborted foetuses, as well as those originating from spare human embryos.
There are different trends in Europe, but we need to establish networking between the best scientists in different countries to
ensure that the same best research is going to underpin ethical and regulatory debates in the various countries.
Philippe Busquin
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_Patents and economic issues
T
he private sector is clearly very interested in this area, which may potentially yield
treatments for millions of patients with long-term debilitating diseases for which there are
currently no effective treatments. However, research in this field is very expensive and there are
no guarantees that it will ever result in widely used treatments. Patents are seen as a way of
providing a return on this investment, but this issue also raises ethical concerns as stem cells
are alive and are therefore fundamentally different from the processes and products normally
patented. This subject generated a lively debate among the participants.
“Big money and industry on one side versus protection of human life and rights on the other… We must denounce the ideological marketing campaign behind the pressure for research on stem cells, which in reality pursues money, dehumanises the
embryo (by making abortion definitively acceptable) and pursues power (the promised sensation of manipulating life). We
should oblige the scientists and biotech companies to be responsible, to provide information concerning their investigations
and not ‘to sell humans’ for financial gain and/or fame.”
Alberto Tarifa
“The cost of generating something that is going to be used on a widespread basis throughout the world is going to be enormous. The money has to come from somewhere. The European Commission, for example, is funding stem cell research, and
it’s a help, but it can only support the very early stages of development. The cost is hundreds of millions of euros for a single
product that may in the end fail at the last stage and not become a product. It is only private sector funding and commercial
enterprise that can do that.”
John Sinden
The issue of patenting raised several comments from the floor: “From industry’s point of view, they want to patent cells. Would
this not be contrary to the law because you can say that you can’t patent nature. You can only patent the use of these natural things using various methods. The idea of patenting a cell … causes other difficulties. How would you define this cell? Is
it a four-cell embryo or is it an embryo of eight cells,- one of those cells? Or is it a surface cell? I think that it is very dangerous
to claim that it is possible to patent a cell or a part of a cell.”
“If you are not able to describe what you want to have patented there is the possibility of depositing a sample of that cell
line… and simply referring to that deposit.”
“Be very wary of broad patents that would in a way close down a lot of the research from among what we might like to see.”
Donald Bruce
“It was pointed out that patents ensure the publication of the contents: if an invention cannot be patented and thereby
rewarded, there is a risk that it will be kept secret.”
“Patents must be allowed for inventions – the inventiveness, the originality and the effort of the scientist should be rewarded. Knowledge, that which is not invented, should not be subject to patents. For example, the sequence of a gene is knowledge, and many scientists believe that it should not be patented. However, it should be possible to patent a test, product or
technique based on this sequence. So the principle is reasonably clear. In this area, stem cells themselves are human material
and should not be patented. This is the legislation in many countries already. However, cell lines derived from, and different
from, the original stem cells may be patented.”
Axel Kahn
“In this case it is more obvious that the law can be a friend, since it grants certain rights to certain individuals or institutions.
Furthermore, it is best to know what can be patented or not.”
Linda Nielsen
“Many people are concerned that stem cells should not be patented, both because they are part of the human body and
because company ownership of stem cell lines might not be in the best interests of the public.”
Donald Bruce)
“The question of a ban on patenting stem cells and of the ordre public clause … is very important, but in the European Group
on Ethics we are in the process of writing an opinion on this subject.”
Linda Nielsen
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Donald Bruce
Gerard Boer
“At the European Patent Office … we are eagerly awaiting its
[the European Group on Ethics] opinion on patentability…
Article 53a of the European Patent directive prohibits
patenting an invention “the publication and exploitation of
which is contrary to ordre public” – not “the patenting of
which is contrary to ordre public”. So how could research be allowed
but patenting not under this clause?”
Aliki Nichogiannopoulou
“This is a very difficult area, and this duality is indeed somewhat strange … I
think it is possible to argue for allowing research but not the commercial use of
that research. ”
Linda Nielsen
“When cells are isolated from an embryo or a human being and just multiplied, then probably you
do not have the right to patent it, but as soon as you give the cell added value, a modification, maybe
also differentiation in a particular way in an in vitro situation, that changes the cell completely with
respect to the origin and then you might have a good way of saying that this could be patented. ”
Gerard Boer
“Even if an embryo in its early stages is not considered to be a human person, human life should still be treated with great
respect – an ethical barrier has to be upheld. Accordingly, human life should not be manufactured since this risks turning
human embryos into products or possessions.”
Rut Cazorla
“As I see it, there is no way of doing in vitro fertilisation without creating spare embryos. These embryos are destined for
destruction. It would be very bad if we scientists could not find ways to make good use of these embryos. There is currently
no need to create embryos for research.”
Anders Björklund
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Anders Olauson
Axel Kahn
_Undetectable properties
(why do we respect a human embryo?)
T
he use of embryonic stem cells is particularly problematic in ethical terms because it calls
into question the status of the human embryo. Most people would accord more respect to an
embryo than to a ball of skin cells, for example, because the embryo has the potential to develop
into a human being whereas skin cells, for the moment at least, do not. There was appreciable
discussion on the reasons why embryos should be accorded special respect and the extent to
which the use of embryos to produce stem cells for research or therapy – a destructive process
– should be allowed.
From the floor in the first roundtable debate: “I think we all agree that there is something about embryos that makes some people believe we should not use them in science and makes other people believe that if we use them in science we should still
be careful and protect them. There’s, probably, almost nobody in this room who believes that we can just do whatever we
want with a human embryo.”
“Many people think that the embryo is just a ball of cells, a blob of jelly. It does, in fact, contain all of the DNA required to
make a fully grown adult. I believe that it may well have an immortal soul, that God loves him or her and that he or she may
go on to do great things given the chance.”
David Ashby
“Let’s hypothesise that in a couple of years what is now done for therapeutic cloning, by placing the nucleus into an egg, could
be done by exposing this nucleus to a biochemical extract, which recapitulates what the egg now doe … would I become a
collection of cells, any one of which could become a person if placed in the right context, in a womb… would I become a collection of embryos, or a collection of potential lives? Should I then stop shaving every day because I am killing thousands of
potential lives?”
Giuseppe Testa
“The fertilised egg is a human being already… The use of human embryos for research purposes therefore implies the existence of human beings with an inferior level of dignity.”
Pierre Goube de Laforest
“There are some people in the world who believe in reincarnation. For them … it’s a person even before it’s an embryo… There
is no right answer. We have to discuss that. We have to come to a consensus about what we really believe in. What is a person?”
Anders Olauson
Other speakers from the floor addressed this problem: “The problem is, of course, that life is a process in the sense that both
the sperm and the egg are alive before fertilisation, then things happen along the road… but of course we need to make a decision for all sorts of reasons, and implantation is as good as anywhere … When we think of the possibility of achieving a consensus, think also of the possibility of introducing double standards here.” and, “You have to make rules on how to deal with
cells that are in a test tube and also rules that should apply to an embryo that is on the way to becoming a child because it is
in a natural environment.”
According to Alastair Kent, the “definition of a person involves more than biological functioning. It involves sensitivity to the
environment, the ability to respond to situations, other people, and other beings. It is also about learned behaviour and socially acquired knowledge.”
“We don’t say, for example, that because a child does not know anything that we will not send him to school. No, we look at
the potential the child has to learn and we do what we can to nurture his potential. We have special programmes for the disabled
so that they can reach their full potential in life, we have retraining programmes for people going back to work. When a baby is
born, we do not say, this is a completely helpless being, and therefore we will let it die. No, we nurture it. In the same way the
POTENTIALITY of the human embryo is something that rightly should be recognized by our society.”
Vanessa Palmer
“Manipulation of human embryos is against human dignity; dignity is more than biological, it transcends the physical; the
embryo cannot defend itself, but an adult patient can. Donors give of their own free will, but embryos are simply taken.”
Hélène de Pierpont
“Even if the embryo is a type of human being, this is not a sufficient argument not to carry out research on embryos, because
research is carried out at all ages of human life, the newborn, the child, the adult, the elderly and the cadaver. I don’t see any
moral argument not to carry out research on supernumerary embryos… they are going to be destroyed anyway.” Axel Kahn
“You have a situation of the lesser of two evils. If you throw them [supernumerary embryos] away then I think that the argument
of doing something good with them is something that you should possibly consider, but only if there is no other alternative.”
Donald Bruce
18 STEM CELLS THERAPIES FOR THE FUTURE?
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Lana Skirboll
_When does the embryo
become a human being?
O
ne of the critical issues which provoked a diversity of opinions concerned the point at
which the embryo actually becomes a human being. Many of the most strongly held
opinions on the acceptability of embryonic stem cell use are rooted in firm convictions
concerning the status of the embryo at various points in its development and in various
conditions. The following extracts provide an illustration of the range of views put
forward on this subject.
“In Ireland we have particular difficulties with this because the right to life is very clearly written into our constitution… Our
government has now decided to put it as a referendum in the coming year and the wording they have taken in this referendum essentially says that the right to life begins at implantation; it does not begin at conception. … The Catholic bishops who
traditionally have had a very important influence on public opinion have come out in support of this.”
E.P. Cunningham
“The [Roman Catholic] Church has always taught, and continues to teach, that the fruit of human reproduction, from the
first moment of its existence, should be guaranteed the unconditional respect that is morally due to a human being in its corporeal and spiritual entirety. The human being should be respected and treated as a person from the instance of its conception and for this, from this moment onwards, its human rights should be respected, principally the inviolable right of all innocent human beings to life.”
Pilar Calva
“The notion of the pre-embryo is ideological and instrumental and appears to be the final a posteriori justification of a manipulatory practice that its proponents do not wish to abandon.”
Luis Laredo
“The destruction of embryos goes against the right to life of every human being. As the zygote initiates its own continuous
development until it reaches maturity as a person, there is no qualitative change.”
María Dolores Vila-Coro
“The embryo is an undifferentiated cluster of cells, which has the potential to become one or more babies. As it develops the
potential becomes refined, and there is gradual acceptance of the humanity of the individual.”
Alastair Kent
“Personhood cannot be acquired gradually. The development of the human organism is continuous by taking place without
any qualitative transitions. Human life is there from the beginning.”
Rut Cazorla
“The living human embryo is, from the fusion of the gametes onwards, a human being with a well-defined identity that begins
from this moment on its own co-ordinated, gradual and continuous development, in such a way that at no single stage can
it be considered to be a simple aggregation of cells.”
Pilar Calva
“Many people feel that the development of the individual only begins after implantation is complete which happens at about
14 days – implantation begins at about 7 days and takes about one week to complete. Before that, it is impossible to know
whether the embryo will develop into one baby, or twins or no baby, or even a tumour.”
Anne McLaren
“I think that there’s no possibility whatsoever of Europeans agreeing on that [the right to life beginning at implantation]. That
merely illustrates the very fundamental fault-line that we have on this question, and clearly takes us back to abortion and so
forth.”
Robin Gill
“In any case, we were all human embryos nine months before our birth. The question is: Why should we deny the same right
to be born that we had to other human embryos already existent or to be `produced’?”
Francisco Baciero
“In medical practice, doctors strive harder to save a foetus that is close to term than to rescue a very early pregnancy that is
failing.”
Alastair Kent
“If we are not sure whether embryos are human persons or beings we must adopt the safer course. Thus, in case of doubt in
such delicate matters we cannot experiment on human embryos.”
Rut Cazorla
“In 1979, the Ethics Advisory Board (USA) issued its report, concluding that "the human embryo is entitled to profound
respect; but this respect does not necessarily encompass the full legal moral rights attributed to persons.”
Lana Skirboll
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_Respecting human rights, but whose?
tem cell therapies are designed to cure patients and to improve the quality of life of
individauals suffering from disease. The ethical issues concerning the right to life of the
embryo are often seen as a major obstacle to the use of stem cells, but what about the
rights of the patients who might benefit from these treatments? Is an existing human life
more important than a potential human life, or does respect for the embryo outweigh all
other considerations? This conflict of interests and the ethical questions it raises
generated a wide diversity of comments.
S
“Research must respect life. Life is wonderful.”
Lourdes Alvarez de Mon
“And what about the people who are enchained in sickness and degenerative diseases? When we are pondering the ethical
issues surrounding new life, surely the human dignity of these people must weigh heavily on the scales. It may well constitute a ‘superior reason’ for supporting embryo research. Perhaps the true defence of human dignity is to use all the scientific
means we have to develop effective cures.”
Robert Goebbels
“Benefits may accrue to one group of people and the costs fall on another.”
Alastair Kent
“When we speak, for instance, of an ‘equal right to protection’, does this mean we are protecting an individual or an entity
that has the full potential to become an individual? And how does this balance against the rights of patients to receive adequate treatment for serious disease?”
Christof Tannert
“I hear a lot about respect for the embryo, respect for this little blob of cells, but how about respect for the patients? The
patients who are suffering now, who are suffering today, and they are waiting for therapies. Can you deny them their right to
therapy because you have such a lot of respect for this clump of cells that you can’t use it?”
comment from the floor
Other speakers from the floor addressed this problem: “The problem is, of course, that life is a process in the sense that both
the sperm and the egg are alive before fertilisation, then things happen along the road… but of course we need to make a decision for all sorts of reasons, and implantation is as good as anywhere … When we think of the possibility of achieving a consensus, think also of the possibility of introducing double standards here.” and, “You have to make rules on how to deal with
cells that are in a test tube and also rules that should apply to an embryo that is on the way to becoming a child because it is
in a natural environment.”
“The intention of utilisation does not change the nature of the embryo.”
European Youth Alliance
“Their removal from their protective membranes and their death do not generate spectacular images that can be used to drum
up sales or audiences, or to awaken consciences silenced by selfishness. Embryos cannot hold massive demonstrations
demanding rights; they can hold no political views and cannot compromise. All these things indicate the same thing: we are
imbibed in a culture of hypocrisy in which all have human rights but in practice we only recognise the rights of those who
can in some way or another defend themselves.”
Fernando Pérez Garijo
“We’re using embryos that would otherwise be destroyed – we’re not generating new embryos here. Let’s take into account
those people who are suffering from multiple sclerosis or Parkinson’s, causing them an enormous amount of unhappiness, and
weigh that against the rights of the donors of embryos, for example, and see what’s most important.”
John Sinden
“Drug therapies for Parkinson’s disease can cause side effects and stem cell research is promising for Parkinson's Disease.
Although the views of the ‘no’ lobby must be respected, mutual respect of our members is also essential, and whatever route
shows promise must be given a chance to help patients; consequently, research must be allowed.”
Rachel Haynes
“If human life is regarded as disposable in its early stage it will be regarded as disposable at a later stage of development also.”
Rut Cazorla
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John Sinden
Olle Lindvall
“I hope that these anti stem cell research pro-lifers have little or no knowledge
of the gradual debilitating effects of these diseases that stem cell therapy aims to
cure. I hope they do not have any experience of the distress and very poor quality of life and slow death awaiting those with these diseases. Unfortunately, the
pro-life lobby also takes an anti-euthanasia stance, which results in human
beings suffering the indignity and quality of life that one would not allow to
happen to a dog.”
Monty Gatehouse
“I have been in a wheelchair for more than ten years. I was left paraplegic by a road traffic accident. Let’s imagine that I could be cured of my paraplegia by treatment with stem
cells derived from embryos. I would not accept. I prefer to remain paraplegic rather than to kill a human being to be able to
walk. It would be absurd to kill another person to cure myself. It would be a return to a situation worse than slavery.”
Guillermo Juez
“Skin stem cells have been transplanted into human beings for over 18 years now… Here we are at the very edge of what we
can do in medicine. We have people with 95% burns… these people can go out of the ward in two ways, either they are dead
or they are treated with what modern medicine has; and what modern medicine has is to grow from a small sample of skin,
tremendous amounts of stem cells that you can transplant and that can help the patient survive. But what we can see today
is that we are making these patients monsters …”
Yann Barrandon
“It’s about patients with chronic severe disorders, which I’ve seen almost every day for the past 25 years, where you cannot
offer the patient any treatment. I think that is important for the balance of this discussion … I think that this is something
for the future … We do not know which type of cells will be useful for treating patients.”
Olle Lindvall
“The use of cloning to create new human beings reduces people to mere commodities, to products manufactured according
to the specifications of others.”
Ignacio Arsuaga
“Another problem is the extremely high cost of such treatment. In my country [Slovakia] it is unaffordable. So are we willing
to share our wealth with all living people and give equal treatment to everybody who needs it, or are we merely going to discuss the moral issues connected with respecting embryos in the freezer?”
Richard Veseley
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_Mums are something special
ne of the key elements of the ethical debate was whether embryos should be regarded as
human beings with full human rights. An interesting discussion arose from this on the
role of the mother in the development of an embryo into a human being. Unless
implanted in a uterus, an embryo cannot develop into a human being. For some
participants, this absolute requirement differentiates between embryos in two different
states, and has important ethical implications.
O
“The human embryo is alive, but the life process does not continue unless the embryo becomes implanted in a uterus and
develops there. The poet Aragon was right when he said: "Woman is the future of Man.”
Robert Goebbels
Prof. Christiane Nuesslein-Volhard suggested that part of the reason that we protect the embryo is because it is the product of a
woman and indeed still part of a woman. She went on to explain that the human embryo, like all mammalian embryos, cannot itself
produce more than a blastocyst following fertilisation; after this, development stops. Development is absolutely dependent on the
interaction with the human womb, the uterus. This blastocyst cannot use nutrients on its own. It requires the mother to supply various functions and all the mechanisms providing the nutrients for growth. Prof. Nuesslein-Volhard believes that there is a tendency to underestimate the role of the mother in the production of babies “The contribution of the mother is enormous and extremely and absolutely necessary,” she said. “The human embryo is not sufficient and it does not have the full programme for
becoming a human being… and this is true in all animals. The female organism always contributes much more to the young
than the male does, and this is the definition of male and female. In egg-laying animals they produce all these nutrients and
put them in the egg; it’s an enormous contribution and they make it before fertilisation. In the case of the mammals they contribute after fertilisation, but the contribution is absolutely required. You can’t just disregard this! …The embryo doesn’t have
anything on it’s own, only when it’s born is it an independent being.”
“I think that argument has just one flaw. A five-year-old, by itself, is also not able to produce a grown-up. So, I think there is
a twist in this argument that makes it not completely right.”
said another speaker
“Nature has equipped us with a protective reflex towards babies, as a means of protecting the human species. This reflex relies
on cues such as eye contact. I think we probably have no such natural protective reflex towards embryos, which develop where
we cannot see them. When we are considering research on embryos, should we not ‘fill the gap in nature’ with legislation that
protects the human embryo as part of the human species?”
Wolfgang Kruger
“I am not certain that nature has left a gap to be filled. I believe women when pregnant do feel an emerging sense of the child
to be. The emotional response would appear to develop gradually as pregnancy progresses. Given the fact that very early miscarriages are frequent, a full emotional response would be quite disabling for women who lose their pregnancies.”
Alastair Kent
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_Women’s issues
T
herapeutic cloning – the production of embryos specifically for
the isolation of stem cells for therapeutic purposes – and surplus
embryos from assisted reproduction programmes are the two main
possible sources of embryonic stem cells. In both cases, it is only
possible to produce embryos if ovules are first removed from the
woman. This procedure is difficult and raises a number of issues concerning the
rights and respect of women, issues which were touched on at the forum.
“Women’s dignity will be violated by reducing them to egg donors, and subjecting them to strong hormone therapy and surgical harvesting. Attitudes towards women would be adversely affected as a result.”
Rut Cazorla
“The harvesting of ovules leads to the instrumentalisation of women.”
European Youth Alliance
“I’m not allowed to donate eggs but sperm donors can earn money – that’s the sort of protection of women I can do without.”
a female participant
“It takes a lot of work to actually get the eggs and remove them. It’s quite a burden on the woman concerned and a lot of feminists are actually very critical of this; those are the reasons why we do not allow the donation of egg cells in Europe because
we don’t want poor women to be encouraged to sell them.”
Peter Liese
“The reason we have so many supernumerary embryos… is to protect women. Why? Well, when a woman has these hormone
injections so as to encourage hyperovulation, some of them don’t really tolerate these injections. There is nausea and then
there is a stereoscopic intervention to take the ovules from the ovary. If the first fertilised embryos don’t develop then we want
to be able to begin not at zero, not to have to begin all over again for the hyperovulation, and that is why we keep these fertilised embryos… This is in the interests of the women.”
Axel Kahn
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Anders Björklund
Alicia El Haj
_Science fact or fiction – timescales
A
key difficulty in discussing the use of stem cells and its regulation is knowing exactly what
will be possible in this respect and when. For some diseases, treatment of patients is
already under way, while for others it may never be possible. Many participants voiced
their views on the likelihood of such treatments and, in some cases, mentioned ethical
issues relating to the raising of public hopes.
“We should be careful when talking about potential, not to confuse possibilities with progress … if, in five years, these treatments haven’t been developed, which is entirely probable, the public could lose its remaining confidence in science. The possibilities of regenerative medicine, stem cell therapies, are not fantasy but real, but we are still at an early stage. Research must
continue, and we must consider what science tells us now.”
Axel Kahn
C. Pinset, talking about his biotech start-up company said “We’re not pretending to be able to abolish old age and unhappiness
– we are simply trying to solve a defined medical problem.”
“In the eyes of the public, stem cells look like a sudden breakthrough, like a Hollywood star arriving from nowhere to cure
disease. Yet stem cell biology has developed over many years as a result of pure research conducted worldwide and supported
by public organisms such as the National Institutes of Health.”
Lana Skirboll
“It is shameful that research into stem cells (or cloning) is presented as a panacea for curing many diseases and many people
when this is scientifically no more than a desire, way beyond the realms of possibility, and when the sophistication of the
techniques makes their routine application unthinkable.”
Alberto Tarifa
“It is irresponsible and a violation of patients’ dignity to raise hopes, which may not be fulfilled in their lifetime.”
European Youth Alliance
“It is clear that research in this area could lead to some major medical advances, which could improve the quality of life for
many people. Clinical trials could potentially take place in as little as three to five years for Parkinson’s disease therapies. This
offers great hope for the future.”
Parkinson’s Disease Society, UK
“The use of stem cells for implantation in various neurodegenerative diseases may be complicated by the fact that the
implanted cells migrate into various, wanted as well as unwanted directions.”
Bert Joosten
“Therapeutic cloning is clearly science fact – we are at a very early stage but I have no doubt that if research is left to continue and encouraged we will see treatments emerging in the not too distant future for people with very serious diseases.”
Alastair Kent
“Nuclear transfer, also called therapeutic cloning, is not necessary, and the technique is not well controlled. It would be dangerous to continue. We need more research in animals, and it may turn out that we never need to use it.” Anders Bjorklund
“When can we start seeing all the positive effects of this technology? I know that there is a difficult question but I am worried about those who are trying to stop this advance; I am sure once we can show them the good results of the research they
will stop moaning.”
Alex Arino
“I still work as a doctor. I want my patients to be helped but I recognise that there are also risks and those risks also have to
be discussed. In some cases, I have the impression that the risks in embryonic stem cell research are being played down and
at the same time people are being pessimistic about the prospects of adult stem cell research.”
Peter Liese
“Stem cells are already being used for example in cartilage transplants. This type of treatment involves autologous transplantation of adult stem cells, and the result is patients who can walk again. Furthermore, there are no problems of rejection and
no ethical problems.”
Alicia El Haj
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_Banking and personal choice
F
uture developments in the use of stem cells might involve the setting up of stem cell
banks. These could resemble blood banks, storing stem cells donated anonymously for
altruistic purposes. However, the storage of stem cells from a given individual for the
personal use of that individual alone is also possible. Such possibilities and their ethical
considerations were also discussed.
“As concerns stem cell banks, it is not impossible that there will be European agreements, as there are for organ donors. It’s
the same sort of issue. Currently we are only at the discussion stage.”
Philippe Busquin
The idea of stem cell banks generated several comments from the floor: “In Germany, if you want to bank cord blood for allogeneic use it is considered a ready-made drug, just like aspirin, and it requires a licence before you can put it into a patient…
There is presently no defined medical indication for the use of autologous cord blood cells. Companies keep cord blood for
autologous use for 99 years and you pay for it … it’s not illegal.”
“I think there should be no problem with them [private stem cell banks]. Of course, they’d have to be subject to public surveillance so as to meet safety and security requirements.”
“Is it possible that once the techniques are fully developed, everyone will have ‘their own’ bank of stem cells from birth
onwards? Or is the technique rapid and effective enough to “wait” until a disease occurs?” Vanina Belis and Catherine Bosly
Dr Gonzalo Herranz, Professor of Medical Ethics,,believes that “a procedure this complicated will almost certainly only be applicable on a case-by-case basis.”
“If it requires an individual to create a bank of their own tissues to prepare for all of the eventualities of life, it will only be
available to the richest.”
Luis Laredo
“I manage such a placental blood bank in Milan and the problem is that when we ask mothers to donate their placental blood,
they are very generous and very willing. Over the last few weeks and months in Italy we have seen companies suggesting that
this blood can be banked and conserved for autologous use in ten or fifteen years for the child of the woman donating it or
banking. But there is an ethical problem here because we are asking mothers to donate placental blood for altruistic purposes but at the same time there is the possibility of preserving blood for personal use, which is not at the moment justified.”
Paolo Rebulla
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Nissim Benvenisty
John Harris
_Ethics or hypocrisy?
uch of the public discussion that took place, both at the forum itself and by e-mail
exchange, concentrated on ethical issues, particularly those relating to the use of
embryos. As one of the participants pointed out, there are only two ethical positions
that can be considered unassailable in terms of rationale: 1) embryos are human
beings, with a right to life, and should not be used for research and treatment, and 2)
embryos are balls of cells which cannot be considered to be human beings so their use
for research and treatment is therefore acceptable. However, many participants expressed an intermediate
view that the embryo deserves special respect as it has the potential to become a human being, but that
embryonic stem cell research and therapy should be allowed, with careful regulation. The difficulty lies in
setting the boundaries of acceptable practice, and justifying the choices made without appearing to be
hypocritical. This sensitive issue generated numerous comments, some of which are included below,
across the whole spectrum of viewpoints.
M
“An act violating human dignity is not rendered ethical by its purpose.”
Rut Cazorla
“Three underlying ethical controversies can be identified:
1) Is destructive research on embryos, or any other destruction of embryos, wrong in itself because embryos have significantmoral status?
2) Is there a problem in producing embryos solely for the purpose of destructive research (or in the future derivation of stem
cells leading to the destruction of the embryo)?
3) Is reproductive cloning acceptable and, if not, is there a danger of a ‘slippery slope’? ”
Soren Holm
“Therapeutic cloning leads, in practice, to reproductive cloning. Once society becomes accustomed to therapeutic cloning it
is only a matter of time before reproductive cloning becomes acceptable.”
Rut Cazorla
“I am opposed to reproductive cloning, but on the basis that the primary intent in reproductive cloning is to create a human
life (like IVF treatment), is it not easier to justify reproductive cloning than therapeutic cloning on the basis that the latter
necessarily leads to the destruction of embryos?”
Paul Woolley
“If we are not careful, there could be a gradual erosion of essential ethical principles related to respect for human rights and
fundamental freedoms. These must be taken into account, clearly confirmed, and firmly reasserted.”
François-Xavier de Donnéa
“I think it is important that we don’t get the possibility of reproductive cloning out of proportion. If Professor Antinori succeeds in his aim somewhere the result will be a baby, not a weapon of mass destruction or a major threat to our society as we
know it.”
Alastair Kent
“…The attempt is very unlikely to actually produce a healthy baby. It is far more likely to produce either no baby, because it
died, or a deformed one…. It is unlikely, on the basis of animal research, that we will ever be in a position to try it on humans,
given that it has gone wrong so many times in so many species, you’d have to know that you were going to get it right almost
every single time from the beginning…”
Donald Bruce
“The only difference between therapeutic cloning (experimental cloning) and reproductive cloning is the outcome. The science for both is identical.”
Paul Woolley
“There is no doubt that if we create embryos for therapeutic cloning purposes, we will come closer to being able to do reproductive cloning. This raises anxieties about the ‘slippery slope’. To me this fear seems unjustified. We have a long tradition of
identifying slippery slopes in all areas and placing barriers to avoid slipping down them. We can do this with guns, we can do
it with drugs, and we should be able to do it with cloning.”
Alastair Kent
“Therapeutic cloning has dominated much of the ethical debate, which is unfortunate, as it may turn out to be irrelevant if
therapeutic cloning doesn’t work.”
Martin Raff
“Something that favours some at the expense of others can never be an advance. If we accept that research on embryonic stem
cells is valid, we accept for good the domination of certain humans over others, allowing them to end the life of the weakest
and most defenceless to benefit the most powerful.”
Rosa María Lakidain
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“This debate will determine the hierarchy of the values we hold: if
we destroy one life to save another, the right to life
forms no part of our values.”
Javier López
“But“ says John Harris, ”few people would condemn
killing in self defence if there is no alternative, and
many accept the necessity of war and even capital punishment under certain circumstances. Consequently,
destroying one life to save another does not necessarily conflict with
the ‘right to life’.”
“Most EU countries authorise abortion in the early weeks of pregnancy. The ‘superior reason’ that is taken into account is the physical and
psychological well-being of the potential mother. The desire of infertile couples to procreate is a ‘superior reason’ that justifies the decision to authorise in vitro fertilisation, even though this practice leads to the accumulation of ‘spare’
embryos. If we accept these two practices, I see no reason to prohibit research on stem cells derived from spare embryos that
would otherwise be destroyed. These embryos could be treated exactly like cells or tissues taken from cadavers, foetuses, or
live adults.”
Robert Goebbels
“Destructive embryo research is not morally equivalent to abortion. In abortion the rights of the mother conflict with the
rights of the embryo. However, no such conflict exists with embryos in vitro: the interests of scientists do not equate to those
of the mother and therefore in no case can they justify the destruction of the embryo.”
Rut Cazorla
“If you believe that scientists do not think about what they do, it is simply not true. Those who enter ethically complicated
fields are just as concerned as other people about getting it right. Other people may be afraid of new research because they
don’t know enough. Someone discovered fire – we now take its use for granted. That doesn’t mean that it isn’t dangerous.”
Anders Bjorklund
“When we talk about removing stem cells from foetuses, we are thinking in terms of removing tissues from dead organisms
and I don’t think anyone is actually against the removal of stem cells from an organism that is already dead. But, research on
embryonic stem cells involves live organisms, – preserved embryos. In other words, it is a process that destroys a living organism. In Europe, all countries have accepted rules on good clinical practice … you cannot perform any clinical practice on
human beings if it is likely to lead to their death or create irreparable damage. This is destructive research, research that
destroys embryos because without the stem cells that are removed the embryo cannot survive… In the US, the death penalty
is allowed…but the US has never authorised experiments to be carried out on those who are condemned to death. Even those
who are in favour of capital punishment thought that it was wrong to use someone, even someone who had only a few hours
to live, for experimental purposes. Why, in that case, should we experiment on embryos if they are not condemned to
death…or even if they are condemned to death but are still alive. ”
Roberto Colombo
According to John Harris: “this point is only valid if we believe that an embryo has the same moral status as an adult. But this
cannot be the case if we accept abortion.”
“There are at least two other human activities where embryos are created and destroyed: normal sexual reproduction and in
vitro fertilisation. In normal sexual reproduction, three to five embryos and early foetuses die and are expelled for each pregnancy brought to term ... anyone engaging in sexual reproduction with knowledge of this figure must believe that the potential good created (i.e. a child) outweighs the potential losses. In IVF, embryos are likewise created that are never implanted ...
and again we must assume that for a society that allows IVF, the good created outweighs the loss. So what about therapeutic
cloning? Are not the ends of therapeutic cloning at least comparable to the ends of sexual intercourse in terms of the decrease
of suffering and illness we can produce with these techniques? Can we stand back and let people continue to suffer, while
continuing to produce and destroy embryos in other activities? Parity of reasoning forces us to allow therapeutic cloning or
give up unprotected sexual intercourse.”
Soren Holm
“Your parallel between the loss of life resulting from normal attempts to reproduce and the loss of life resulting from therapeutic cloning seems to me unjustified: we are responsible for our actions, but not for natural circumstances. If a man stands
on top of a building and drops a brick and it kills somebody, he cannot justify his action on the basis of a previous incident
where a brick came loose accidentally. If a woman gives birth to a child during an earthquake, she cannot be considered
responsible for the death of that child in an earthquake!”
comment from the floor
Soren Holm: “I think you misunderstood my point. What I mean is that if you attempt human sexual reproduction knowing
its side effects, then you are responsible for those side effects.”
“As spare embryos from IVF will be destroyed anyway, it is a matter of debate whether it is better to use them for good purposes than to destroy them unused... Maybe in the end it will be clear that it just won't work, and then we will have been at
loggerheads for nothing.”
Peter Hoogendoorn
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Roberto Colombo
Erbert Schroten
Soren Holm
“The use of cord blood cells in stem cell therapies would avoid the ethical issues surrounding the status of the embryo. For
this reason, it will be interesting to compare cord blood and embryonic stem cells in terms of their therapeutic potential.”
Eliane Gluckman
“Is it not our responsibility to invest all our energies into adult stem cell research, thereby avoiding all the ethical problems
that therapeutic or experimental cloning entails?”
Paul Woolley
“We still don’t know whether adult stem cells hold the same potential as embryonic stem cells. The patients’ groups argued
that we should not continue down only one road when we don’t know which one will be fruitful.”
Lana Skirboll
“The only answer given to the question "Why do scientists prefer embryonic stem cells?" in the UK government briefing produced by the Wellcome Trust in December 2000 is that it is cheaper and more convenient. This is not an acceptable argument.”
Naomi Young
“To assess the performance of adult stem cells and compare it with embryonic stem cells, we obviously have to use embryonic stems cells.”
Eliane Gluckman
“By solving some of the scientific problems, we might ultimately be able to avoid some of the ethical issues.”
Peter Gruss
“It seems to me that to use cells and cell lines that have already been established, poses no ethical problems. I also see no ethical problems with the use of embryos, embryos that would be destroyed in any case because we do not keep spare embryos
indefinitely for research, as long as it is very clear that it is for well-founded programmes. As for therapeutic cloning, I’m afraid
that I really don’t see the usefulness.”
Eliane Gluckman
“Usually only two possibilities are mentioned for spare embryos: throwing them away or using them for research. I can see a
third possibility: adoption by couples with severe genetic defects, who cannot have their own IVF child.”
Comment from the floor
“My wife and I have no children and we ourselves have tried IVF so we were faced with these questions in a very real way ourselves and it took us probably two years to think through ethically what we should do before we actually took the step… All
things being equal, we would feel that the couple who has created the embryo has the responsibility to make sure that they
themselves make use of it in the way they intended. I feel that a couple has a moral responsability to produce only as many
embryos as they are prepared to have implanted, and to see they are used for that purpose.”
Donald Bruce
“I understand the need to be practical, but from an ethical standpoint, how can a government allow the use of embryonic
stem cells but not their derivation? ”
Nissim Benvenisty
“I don’t know; there appears to be a dual moral standard.”
Christof Tannert
“If embryonic stem cell research does result in the development of effective treatments or even cures for some diseases, those
countries which have prohibited the research will then face a dilemma as to how to respond to the health care needs of the
citizens who would benefit from such treatment.”
Alastair Kent
“The Research Council is certainly not the right place for an ethical debate, especially since this ethical debate has proved to
be difficult, even in groups of highly specialised experts. Yet I remain convinced that the ethical debate should be raised and
in no way avoided at European level.”
François-Xavier de Donnéa
“No one section of society has a monopoly of knowledge about what is ethical – everybody has a responsibility and duty to
discuss what we should accept. Some people will never agree with this research but this is not a view that most people would
go along with. But nobody should be allowed to make money in a way that is not ethical.”
Alastair Kent
“I will tell you what I see as the real ethical problem associated with stem cells. I am a paediatric rheumatologist. My ethical
problem is that stem cell treatment of rheumatic diseases in children has a mortality of 10%, and that by trying to help a child
who is suffering but not dying, I may kill him. I am here to support further research in this area to give my patients a better
chance.”
Richard Vesely
“I think we may have talked too much about embryonic stem cells, for which there may never be therapeutic applications. And
this has led to public concern that seems to have no raison d’être. We should let research continue, and make decisions later. ”
Eliane Gluckman
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_The citizens’ input – but which citizens?
Christof Tannert
T
he EC has called for debate on the issues concerning stem
cells and their use in therapy, and this discussion forum
was organised to facilitate such a debate. However, if
it is not possible to consult all European citizens
individually, whose views should be taken into account
in the decision-making process, and how?
“The unborn do not vote.”
Fernando Pérez Garijo
“A recent survey shows that European citizens are interested in science and eager to learn, but also that
they want, more than ever before, to participate in defining the research agenda.”
Philippe Busquin
“Not only scientists and doctors and medical industries (which are economically or scientifically interested) should have a
word about the question, but all members of society.”
Francisco Baciero
“A referendum is only as good as the debate in society that precedes it.”
Donald Bruce
“The debate is not open; we have not reached all layers of society. The opinions exchanged are mainly those of experts, and
the exchange does not take place in the public domain, but in ad-hoc groups. The public is not informed, but rather confronted with opinions of experts.”
Christof Tannert
“It’s very important that all members of society are involved. Scientists know most about the technology and the potential
risks, and can help the public make the decisions, but the scientists cannot make these decisions on their own: these are societal decisions. They must involve discussions with patient groups and ethical groups and ultimately it is a political decision
whether the consensus is sufficient to go ahead.”
Derek Burke
“When we seek to involve people in the debate, there is a problem: does anybody have a voice unless they belong to an organisation? How do we encourage people to engage in such a process amongst themselves? We have lost the art of doing this in
society and need to regain it.”
Donald Bruce
“Why is it so difficult to break down the emotional barrier put up by the public concerning the use of embryonic stem cells...
how do you reach the broad public without being scientifically incorrect or superficial?”
Christian Schaaf
“I wonder whether we really have the appropriate instruments allowing us to take a decision on this very sensitive issue… Is
it fair to take the opinions of majorities in such cases? And what does it mean to legislate on such sensitive issues? Does it
mean imposing one opinion on a minority or does it mean allowing for freedom of choice under shared framework rules?”
Francesco Lescai
“Who’s going to decide what is sufficiently abnormal to justify treatment – are we going to suppress human diversity? ”
Chantal Lebatard
“It would be interesting to hear more from people with ‘disorders’ who don’t want to be ‘cured’ and who feel that these technologies can threaten the right of individuals to their own identity.”
Alf Game
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_A kaleidoscope of passionately
expressed views
I
Inevitably, in a public debate on so sensitive an issue, a wide variety of opinions were expressed,
in some cases with great feeling. Below is a sample of some of the more passionately expressed
views illustrating the full diversity of the debate and the potential difficulties likely to be
encountered when trying to reach a consensus.
“Scientists believe in science, but science must serve mankind.”
“The freedom of research is not the freedom to do anything but, like other liberties, is constrained.”
“Motives such as financial gain or mere scientific interest cannot justify violating human dignity.”
Hélène de Pierpont
Axel Kahn
Rut Cazorla
“Embryonic stem cell research involves the killing of embryos to take the stem cells, it is as evil as abortion. The ends may be
good but they do not justify the means. I believe that it is immoral to create human beings simply to destroy them for research
purposes. Animal experimentation, I can live with but please, not humans.”
David Ashby
“It is a violation of the human dignity of the embryo for it to be used only as a means to an end.”
Rut Cazorla
“There were numerous comments expressing strongly held personal views about the ‘cannibalisation of human embryos’. ”
Naomi Young
“Human cloning for whatever purpose is unethical and unnecessary, and should be banned.”
Ignacio Arsuaga
“I hope that at the hour of decision concerning this law people in the world will think about what we are and the world we
want to create, and about Life, with a capital L, in the full sense of the word. There is too much to be done in many fields,
education, health, hunger and so on to waste the money unproductively of all in research that we know is harmful to Man...
also with a capital M. I am among those who believe that LIFE begins in the sacred moment of gestation in the uterus of the
mother, it cannot be any other way.”
Javier Martín
“Anyone who believes that embryos are human beings deserving sincere and profound respect, and that embryos have the
same value as ourselves, cannot resign them to being used as a raw material in industrial processes.”
Luis Laredo
There was equally aggressively expressed disagreement with these views:
“I ask that the pro-life lobby not become the no-(quality of) life lobby. Politically and philosophically our society should
decide to ‘Kill or Cure!’”
Monty Gatehouse
“It would be offensive to me if a religious belief that I don’t share prevents me from receiving a form of therapy that I need
to survive. I don’t mind if some people believe in a soul, for example, as long as it does not prevent others from getting treatments that could save their lives.”
Martin Raff
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Bernat Soria Escoms
Lars Wahlberg
“If we were to decide] that a brainless cluster of cells (a
human blastocyst) is a human being I would feel greatly
offended. The dignity of real human beings, their essence,
is in their capacity to perform willing and responsible
humane actions (saving lives of ill people, for example) and
only self-aware matter may (but unfortunately not necessarily does) have such a capacity.”
Andrei Rybouchkin
“Diabetes can be cured by transplantation of pancreatic
islets. The so-called Edmonton protocol is 100% successful, yet it requires
two to three donors per patient. In Spain, this means that realistically
only about 200 patients could be treated per year. This figure is very small
compared to the number of potential candidates for transplantation: all
of the 100,000 people suffering from type I diabetes and most of the 2 million patients with type II diabetes. This
is why we are turning to stem cells.”
Bernat Soria Escoms
“The only fear I have about stem cells is that we will not be able to use them for research and the treatment of serious diseases
because we put unreasonable and unfair obstacles in the way of realising the potential that they hold. It must be recognised
that there is a huge potential for good as well as the possibility of harm.”
Alastair Kent
People working in the field responded to the attacks on their motivations:
“I would like to comment a little bit … about the lack of humanity of the researchers. I resent that comment. The researchers
are working very hard to ease the lives of people who are in pain today. They are not taking embryos to hurt the embryos.
They are using the material they have been given to make life easier for others. This is not an issue of destroying embryos. It
is a matter of making life easier for those who are already here.”
Charlotte Wittrup
Dr. Yann Barrandon agreed: “As a doctor and as a scientist, I have been working for 18 years now on skin stem cells used for
cellular therapy to help people with severe burns. To pick up on the young lady who said that researchers are cold monsters
– we’re not. We have hearts and we think and feel and cry like others. I’ve looked at small children who were badly burned,
who were treated with adult stem cells and their own cells were stimulated that way. At the time, the ethical debate was should
we keep them alive or not. We did. We treated them with adult stem cells and I think it’s now our obligation as citizens, doctors and scientists, to give these children the possibility to live normally by giving them a skin that will allow them to do that
– and the only way to do this is to pursue research. I think it is incumbent upon us as citizens to allow work in this area.”
“Some people think that scientists are just technocrats who do everything that is possible, do not care about the consequences
and are impatient with people who disagree with them. There may be one or two like that. My experience is that they think
very hard about what they are doing, and a major motivation of medical research is to help people. Scientists are very concerned about that. What they don’t understand is where the rest of society is coming from – why they raise the concerns they
do. I think scientists have now realised that they have to involve themselves in debate and dialogue. They must explain and
listen to what is said to them and adapt what they are doing, and move patiently. They only get impatient because they care
very much about bringing benefit to patients. They may not understand why people are slow in responding, but people do
take time to reach their decisions. We scientists have to learn to be patient.”
Derek Burke
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_Several questions – some answers
inally, here is a selection of general questions, answers and comments on various themes dealt with
as part of the discussion platform.
“…you are giving a human being the potential of controlling or predetermining someone else’s genetics … each of us has the
right to have random genetics that no one else has fixed in advance.”
Donald Bruce
“Random genetics often kills and maims – the right to randomness doesn’t look so attractive to its victims. If we can take out
random harm surely no decent person could object?”
John Harris
“The pharmaceutical industry is not interested in rare disorders… we had to fight our way to bring in orphan drug regulation
in Europe… Who will set the agenda? Who will set the priorities? Who will keep tabs on the private risk capitalist guys who
now run the show…? How can we protect those affected by rare disorders?”
Anders Olauson
“Why do Americans care about what President Bush thinks about the matter… Why do researchers care about having federal
dollars to support them?”
Ole Hartling
“The short answer is: 20 billion dollars!”
Lana Skirboll
“I am speaking on behalf of the Pontifical Academy for Life. All of your arguments rest on a distinction between therapeutic
and reproductive cloning. Yet as a biologist, I can assert that they are exactly the same. Any embryo created by nuclear transfer is a new organism at the beginning of a new life cycle.”
Roberto Colombo
“As a medical doctor, I see two major differences: the intention and the outcome. I agree that both techniques create a human
being with a significant moral status, but with therapeutic cloning you neither intend to create nor do create a human child
who must live the life of a clone.”
Soren Holm
“If scientists were not allowed to do research on embryonic stem cells, what would they lack for developing new therapies?”
Donald Bruce
“I cannot answer your question. We simply don’t know enough yet. There could be cases where embryonic stem
cells would work and where adult stem cells would not. If so, blocking stem cell research would be closing the
door to applications of great importance to certain patients.”
Martin Raff
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3. Summary and Conclusions
his event was intended to be a meeting point for an exchange of information, a forum for
discussion, and a platform for debate. It was attended by over 750 people from 36 countries
throughout Europe and elsewhere, including expert scientists, clinicians, politicians, industrialists,
representatives of interest groups, patient support groups, and religions, and interested private
individuals. The event was free and open to all, but the European Commission also awarded 49
grants to individuals, particularly young people and people from accession countries, to enable
them to attend. It was webcast live, opening up the discussion platform to countless others who,
although unable to attend in person, were able to follow the debate and to participate via e-mail.
T
The forum began with a series of introductory presentations, describing current knowledge and the future
potential of stem cells for therapy and dealing with ethical, legal and societal issues. These presentations set the
scene for wide-ranging debates in which all participants were encouraged to express their views. The debates
were extremely lively, with an enormous number of opinions expressed by participants from very different
cultural and professional backgrounds. Inevitably, it was not possible to achieve total consensus, but widespread
explicit or implicit agreement was obtained on several points:
1.
It was generally accepted that the potential value of regenerative medicine involving stem cells is enormous,
but neither the full range of possibilities nor the limitations have been clearly identified as yet.
2.
There was also broad agreement that living human tissues, and human embryos in particular, should be
respected.
3.
Most participants felt that the use of differentiated (or adult) and umbilical cord blood stem cells was
acceptable, and of proven therapeutic value in particular situations.
4.
Many of those present seemed to feel that reproductive cloning was unethical and should be prohibited.
5.
It was felt to be important that science should not proceed in an ethical vacuum.
6.
The participants agreed that the ethical debate requires input from many diverse elements of society,
including the public at large and interest groups, not just scientists and technocrats.
7.
It was also clear that there is substantial diversity in Europe, both within and between Member States, as
concerns ethics in this field, and this may make it difficult to lay down common legislation.
8.
The participants also agreed that continued public debate is required, and that this discussion platform made
a valuable and stimulating contribution to this debate.
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Patrick Cunningham
Ernst-Lüdwig Winnacker
4. Statement from the Life Sciences
High Level Group
Victor de Lorenzo
Axel Kahn
he promises and concerns engendered by stem cell research have triggered a world-wide debate.
European citizens realise the significance of these issues and expect guidance to help them deal
with them. For this reason, the Life Sciences High Level Group thanks the European Commission and
the European Commissioner for Research, Philippe Busquin, for arranging such a stimulating meeting
on "Stem cells: therapies for the future?" which dealt with many of the current issues. The meeting was
organised in a new style, with panel debates as well as lectures, and with ample time for discussion,
both structured and free-ranging. The participants took full advantage of these opportunities for
discussion and debate. We hope that they will continue to do so through the webpage:
(http://europa.eu.int/comm/research/quality-of-life/stemcells.html).
T
As a contribution to this debate, in November 2001 the European Commission for Research published the results of a
survey across Member States as well as other European countries, on human embryonic stem cell research and use. The
report includes not only the current positions of national legislations, but also the results of public debate and the
views of the National Ethics Committee or similar bodies. This provides an opportunity for all European citizens to
inform themselves about the situation across the EU, enabling them to participate fully in the ongoing European
dialogue on this subject (http://europa.eu.int/comm/research/quality-of-life/stemcells/about.html).
The current research on human stem cells, obtained either from differentiated tissue or from embryos, is scientifically
sound and medically promising, and research using cells from both sources should be actively developed and
supported. Although the use of human stem cells in regenerative medicine is still at an early stage of development, it
is clear from the meeting that it has the potential to deliver real progress in the treatment of a number of severe
diseases. Some of the speakers described promising results using adult stem cells or stem cells derived from foetal tissue;
others spoke of the likely potential of embryonic stem cells, but all agreed that it was not possible at the present time
to foresee which type of stem cell would prove to be the most effective for treating particular diseases. None of the
scientists were in favour of prohibiting stem cell research in general, or any particular type of stem cell research. This
was a judgement based not only on the scientist’s freedom to choose the most-fruitful approach to research, itself an
ethical issue, but because research on a broad front is required if the urgent clinical problems are to be tackled and
human suffering alleviated.
Driven by the urgency of the clinical needs and the scientific promise of this relatively new field, research on all fronts
is advancing rapidly and is highly competitive. It is becoming increasingly clear that the present US government policy
of funding only research on pre-existing embryonic stem cell lines is inadequate: new lines need to be derived if this
approach is to realise its clinical potential. Although it was claimed that 64 embryonic stem cell lines were in existence
prior to August last year, it is now generally believed that no more than ten to 15 of these would be accepted by experts
as fulfilling the criteria for an established pluripotent embryonic stem cell line. Most of these are hedged around with
restrictive Material Transfer Agreements and other obstacles to free research.
Further, different lines have different properties, and the properties of a stem cell line will change with time.
A recently derived embryonic stem cell line will be truly pluripotent; that is, it should be possible to direct its
differentiation to form any of the cell types in the adult body. But as it continues to replicate in culture, its
potentialities for differentiation appear to become narrowed down, i.e. it is no longer truly pluripotent. Finally, all
existing human embryonic stem cell lines have been derived and maintained on a substrate of mouse cells, in a culture
medium that contains a variety of not fully characterised substances such as foetal calf serum. The use of such cells in
human patients, for example in clinical trials, would not be considered good clinical practice.
34 STEM CELLS THERAPIES FOR THE FUTURE?
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Anne McLaren
Hans Wigzell
Marc van Montagu
Christiane
Nüsslein-Volhard
Leonardo Santi
The Group agrees that:
•
The EU should continue to support research with all sources of human stem cells, including human
embryonic stem cells, to provide new clinical opportunities for therapy.
•
Reproductive cloning – which implies placing in a woman’s uterus an embryo derived by somatic cell nuclear
transplantation to initiate a pregnancy and thus produce a cloned baby – should be prohibited as it has been
already in many European countries. We applaud the Franco-German initiative to ask the UN to produce a
worldwide convention prohibiting reproductive cloning.
•
Derivation of human embryonic stem cells from nuclear transplantation (so-called therapeutic cloning) has
not been achieved and appears to raise considerable difficulties, scientific as well as ethical. Attempts to use
somatic cell nuclear transplantation to produce an embryo from which stem cells could be derived have been
unsuccessful in monkeys as well as in humans. It may be that the complex nuclear reprogramming required
to transform a specialised somatic (body) cell nucleus into a nucleus competent to support normal embryonic
development is not always possible, even if it were ethically acceptable. Research into additional strategies to
overcome immune rejection is therefore to be strongly encouraged.
•
Although the Group respects the special moral status of the human embryo even prior to implantation, it
agrees on the use of spare human embryos for the derivation of embryonic stem cell lines. The extent of
cultural pluralism in Europe means that consensus will not always be achieved, but the Group insists that in
those countries where research on human embryonic stem cells is allowed, it should be carefully regulated,
peer reviewed, scientifically sound, directed towards substantial goals and ethically controlled.
•
Publicly and privately funded research should be subject to the same regulations. The status of patents on stem
cells and their use should be clarified as soon as possible.
•
A registry of human embryonic stem cell lines should be established and maintained by the European
Commission.
To summarise, the Group considers that research on human stem cells offers valuable avenues into developmental
biology and medicine, which could revolutionise therapy, perhaps on a scale comparable to the introduction of
antibiotics.
The Life Sciences High Level Group was set up in April 2000 by the Research Commissioner Philippe Busquin to meet
his need for high-level advice on life sciences and biotechnologies. One of the Group's tasks is to inform the Research
Commissioner on the current situation in these fields and on imminent or foreseeable developments. Another duty is
to contribute to the organisation of Life Sciences discussion platforms, enabling scientists to engage in debate with the
various ‘stakeholders’ interested in both the risks and benefits of the new research findings and also in the
dissemination of new knowledge. This should facilitate information exchange and the development of mutual
understanding of the life sciences and biotechnology at all levels of the European community, especially including the
broad public. We fully accept that scientists must explain what research is being carried out and why, and its potential
risks and benefits, and in turn they must be made fully aware, through open debate, of the ethical and societal
implications of their research.
Signed by the members of the Life Sciences High Level Group, in December 2001: Derek Burke, Patrick Cunningham,
Victor de Lorenzo, Anne McLaren, Christiane Nüsslein-Volhard, Leonardo Santi, Marc van Montagu, Hans Wigzell,
Ernst-Lüdwig Winnacker and Axel Kahn (the President).
For more information on the European Group on Life Sciences:
http://europa.eu.int/comm/research/life-sciences/egls/index_en.html
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KI-NA-20-356-EN-C
For further information visit the Stem cells website on the Europa server:
http://europa.eu.int/comm/research/quality-of-life/stemcells.html
The Stem cells discussion platform was the starting point for a dialogue in which anyone concerned
by the importance of the changes being brought about by progress in the life sciences is welcome to
take part. Ideas, proposals for action and other initiatives should be sent to:
[email protected]
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