Human Genetics Commission
Information Gathering Session on Stem Cell Research:
Joint Meeting between Eurostem and the Human Genetics Commission
13 May 2002
Introduction
HGC Member Prof John Harris co-ordinates the Eurostem project, which aims to develop an
ethical framework for stem cell research and to monitor public reaction towards it in Europe.
Prof Harris arranged a meeting between HGC and Eurostem during the former’s visit to
Manchester in May 2002.
Five Eurostem members gave presentations, and each presentation was followed by a
short discussion.
Key points raised in presentations
Tissue Storage and Retention
Professor Margot Brazier, Chair of Retained Organs Commission
University of Manchester
Regulation of the use of human tissue
 There are numerous uses to which human tissue can be put; for example transplantation,
therapy, reproductive cloning. This makes it difficult to effectively regulate the retention
and use of tissue; however, transparency of the process, and the public trust so
engendered, are important in allowing research to progress.

The Retained Organs Commission (ROC) was established after revelations at the Royal
Liverpool Children’s Hospital at Alder Hey and at the Bristol Royal Infirmary that organs
and small tissue blocks were taken without consent from children in autopsy; particular
concern was excited by the removal of reproductive organ tissue. Tissue samples should
only be retained within a distinct framework of regulation underpinned by clear principles.

ROC have recommended that post-mortem tissue be regulated, but what about surgical
waste? Should ‘tissue’ encompass cell-regenerating material and body fluids? What
does respectful disposition of post-mortem material entail? Who has authority over the
reproductive material of someone who had given consent for her sample to be used in
post-menopausal HRT research but died before her menopause occurred?

How can use of human tissue be feasibly regulated?
Transparency and trust
 One common perception is that public opinion is misinformed and emotional, and the
media does not always facilitate understanding. There can be a basic failure of
communication between doctors/nurses and patients/relatives, eg parents of deceased
children may not be informed that their consent is required for removal of tissue. Doctors
may be reluctant to explain as they do not want to worry already distressed parents.
However, there may be ethical or cultural objections to the removal of even a few cells.

Dame Nora O’Neill in her 2002 Reith lecture series on trust and accountability
commented that while regulation was designed to indicate to the public that the
Government was in control, increasingly was being interpreted as indicating that a
situation was not right or was being covered up. Thus extending regulation, even if
justified, could paradoxically generate further mistrust. But if a system which engendered
strong public confidence could be created, then people would be willing to donate tissue,
for example, to a stem cell bank.

The value attached to dead body tissue is demonstrated by the elaborate rituals
surrounding death such as funerals and cremations, and the mutilation of a body in death
is often seen as the mutilation of the person. Language related to body parts also equally
relates to the person.
Discussion
 An element of flexibility is required in any regulatory framework governing the use of
human tissue. A ‘tickbox’ approach would do nothing to engender trust; instead broad
principles must be developed, adherence to which would induce public confidence.

Public perception of scientists and doctors are different; at ROC meetings there is a
different reaction to medical as opposed to non-medical scientists. The general view of
doctors is that they are either very good or very bad, but there is a general fear of
biological scientists who are felt to be working on hidden research agendas.
HFEA Licensing and Patient Recruitment: Realities and Fairness
Professor Peter Braude
King’s College London
Types and sources of stem cells
 There are three types of stem cells:
 Multipotent, able to produce many specialised cell types; most adult stem cells are
multipotent;
 Pluripotent, able to give rise of all cell types except extra-embryonic tissue; obtained
from embryonic stem cells;
 Totipotent, able to produce entire organisms; obtained from blastomeres.

Human embryonic germ cells, or EG cells, have been obtained from 5-8 week old fetuses
aborted for therapeutic reasons. Another source of stem cells could be from
parthogenetically-derived oocytes, ie there is no paternal contribution.

Human embryonic stem cells (ES cells) can be derived from cleavage stage human
embryos donated as surplus to human fertility treatment. Theoretically immunologically
tolerated stem cells should also be derived using the technique of cell nuclear
replacement (CNR) in human oocytes.
Relevant legislation
 Under terms of the Human Fertilisation and Embryology Act 1990, research using human
embryos can only be carried out under license from the Human Fertilisation and
Embryology Authority (HFEA). Research may only be allowed of deemed necessary and
desirable, and for strictly defined purposes. Whole embryos may not be grown in vitro
beyond 14 days although stem cells derived from embryos disaggregated before this time
may. Parthenogenetically created blastocysts are not embryos under the terms of the
Act, as they are not derived from fertilisation.

Information important to the HFEA in its decision making about granting a licence
includes: the source and disposal of the embryos; how audit and consent procedures are
3
managed; distribution of embryos between research and treatment; whether the centre is
adhering to the scope of the project originally granted. By August 2001, three stem cell
licences that involved the use of embryonic stem cells had been granted, all under the
terms of the original legislation.

The report from the House of Lords Select Committee, published in March 2000,
amongst many recommendations, approved the ethical derivation of stem cell lines from
human embryos, and recommended that further research should be carried out. It
recommended that embryos should not be created specifically for research unless there
was exceptional need that could not be met by the use of surplus embryos. CNR was
permitted (but not for reproductive cloning) and should be regulated by HFEA, and
consideration should be given to the setting up an UK stem cell bank.
Practical considerations
 The following requirements should be met: Those obtaining stem cells for research should be separate from those using them;
 Fully informed consent should be obtained for the use of embryos and eventual use
of stem cells;
 It should be possible for consent to be withdrawn;
 Considerations of possible therapeutic use should be realistic;
 Stem cells created for therapy will need to conform to Tissue Banking Regulations,
unlike those created for research
 The source of the cells should be known as traceability is a key issue in good
manufacturing practice.
Discussion
 Research carried out in an animal model, even a primate one, is only an approximation to
the human situation; even if a therapy works in chimpanzees, it does not automatically
imply that it could be used for the treatment of humans.

One view of donors not benefitting financially from treatment developed using their tissue
is that this is state-assisted robbery – it was an interesting question. The subject of
commercial applications, which had been raised in the House of Lords report, was very
pertinent to future development, and means of regulation would need to be considered.
The Status of Stem Cell Research in Germany
Professor Dr. Ludger Honnefelder
Institut für Wissenschaft und Ethik, Bonn
Ethical considerations
 The broader debate in Germany started in November in 1998 with the cultivation of
human embryonic stem (ES) cell lines in the USA (Note 1). The main considerations are to
what extent medical research is dependent on ES cells, and what level of protection
should be afforded to the human embryo. There are two basic positions on the latter
question: the restrictive position which acknowledges the human dignity of the embryo at
a very early stage of development, and the gradualist position which acknowledges that
full human dignity is achieved only when the embryo has reached a certain stage of
development.
 The Basic Law, the fundamental ethical regulations underlying the German constitution,
guarantees the freedom of research and science from political and social restrictions.
Research can only be restricted if it conflicts with other constitutional guarantees, such as
the right to life and inviolability of the person (Note 2). The aim to find treatments for, or
ways to prevent, disease has high moral ranking, but what ranking should be afforded to
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an early embryo, which can be destroyed in the process of obtaining stem cells?
 Consideration of whether or not human ES cells should be used needs to take into
account the mode of generating the embryos from which the ES cells will be isolated. The
technique of cell nuclear replacement is considered by some to raise large ethical issues
as it involves generating an embryo for research/treatment purposes only and also
predetermines an embryo’s genetic identity. Some feel that such considerations do not
apply to surplus embryos as these do not have the prospect of becoming humans, and
therefore their use would not violate the notion of human dignity.
 The ethical debate centres on whether there is a moral difference between the isolation of
human ES cells and their subsequent utilisation. The public debate is intense; a recent
survey of 1,000 people revealed that the vast majority of were critical of embryo research
of any kind or of importing and using of human ES cells.
Developments in Germany
 In March 1999 the German Science Foundation (DFG), the major German research
foundation, released a statement that human embryonic stem (ES) cells should not be
used regardless of how they were derived since they came from cells which were capable
of becoming a fully developed human being. Embryonic germ (EG) cells were better
candidates for research as they raised less ethical issues. There was no need to change
the law, particularly with the Embryo Protection Act already in place (Note 3).
 The receipt by the DFG of a grant application for research involving imported human ES
cells led the Foundation to publish revised regulations in May 2001. These commended a
step-by-step process for human stem cell research, starting with pluripotent stem cells
that could be imported from abroad. If these cells were found to be insufficient for
achieving the intended research goals, then the possibility of isolating ES cells from
human blastocysts should be considered. (Note 4)
 The German Parliament asked DFG to delay its decision on the grant application until a
public consultation had been carried out. The Parliament established an Ad Hoc
Commission, comprising both parliamentarians and experts, and in November 2001, the
Commission judged that the lowering of embryo protection standards could not be
justified. While a majority of Commission members favoured a total ban on importing ES
cells from abroad, some felt that a ban in principle on imported ES cells could be subject
to exceptions under certain restrictive conditions. (Note 5)
 The latter view was accepted by a second advisory body, consisting of scientists,
established by the German Federal Government. It was also adopted in the Stem Cell
Act, which was passed in April 2002 by parliamentarians representing different political
parties. The Act is based on the moral standards underlying the Protection of Embryo
Act, which was left unchanged. Concerns that the import of pluripotent ES cell lines by
German scientists might promote the creation of such cell lines abroad resulted in a ban in
Germany on the import of stem cells from lines created after December 2001. ( Note 6)
Discussion
 There is no legislation governing the use of imported products derived from ES cells.
Moreover, 10,000 children are born each year using IVF techniques and no stigma is
attached to children so born, even though these were developed through research on
embryos.
 It is possible in the current climate for German scientists to carry out stem cell research,
using imported stem cells, but not those from newly-created cell lines. Views on this
might change if a life-saving technique were to be developed from stem cell research.
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The Status of Stem Cell Research in Scandinavia
Professor Jan Helge Solbakk
Centre for Medical Ethics, University of Oslo
 Three different stories from Sweden, Denmark and Norway respectively, all originating
from the 1978 birth of ‘test tube baby’ Louise Brown and the birth 19 years later of the first
cloned animal, Dolly the sheep. There is the question of who might be responsible for any
lack of transparency and trust: the scientists, the lawyers, the ethicists, or Mother Nature?
Sweden
 In 1978, a system of medical research ethics committees (RECs) was set up, the majority
of whose members were recruited from the medical community, as this was seen as a
guarantee of professionalism. The fact that ethical regulation was being determined by
those positively biased towards medical research might explain why, since early 1980’s,
Swedish researchers have been able to work on fertilised human eggs and early embryos.
There are currently more than 30 research groups in Sweden working in the area.
 A law formally regulating embryo research was introduced in 1991, and further regulation
was not deemed necessary until January 2000, when researchers applied for approval of
research into characterisation of stem cells harvested from surplus IVF embryos (Note a).
After consultation with the Swedish National Council of Medical Ethics, the local REC
judged that such research probably did not violate the spirit of the 1991 law, but felt that
further clarification of the law was required. In addition, the medical branch of the National
Council of Science established a working party to consider the production of embryonic
stem cells solely for research purposes.
 The working party reported in 2001, highlighting the principles of informed consent and of
REC approval of each individual project, and the need for public scrutiny (Note b). The
group did not accept the production of embryos solely for research purposes, although
there was no suggestion that legislation to prevent this should be introduced. The working
party also did not accept the production of embryonic stem (ES) cells through cell nuclear
replacement (CNR), judging that there was no need for the technique to be used, and that
its use might add greatly to the risk of the instrumentalisation of human life and that it
might pave the way towards reproductive cloning. Although the National Council of
Medical Ethics agreed in large part with the working party’s findings (Note c), the National
Council of Science advised the Government to add an article to the 1991 law allowing
CNR, and this is in the process of being passed (Note d).
Denmark
 Research on embryos relating to IVF/PGD has been regulated since 1987, and individual
projects require approval by a scientific ethics committee (Note e). In December 2001, the
Danish Council of Ethics (Note f) published a report on cloning, including CNR. Council
Members were unanimous in their disapproval of reproductive cloning, though 11 out of
16 were in favour in principle of deriving ES cells from surplus embryos or by CNR as long
as there were potential medical benefits.
 Concern that the creation of embryos for non-reproductive purposes would lead to demise
of values (‘værdiskred’) elicited the recommendation that only surplus IVF embryos be
used for research purposes. A unanimous Council recommended that ES cells should not
become the subject of patents, and emphasised the need for research of adult stem cells.
(Note g)
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 In January 2002, the Danish Health Minister ruled that the law did not allow the donation
of fertilised eggs for non-reproductive purposes, such as stem cell production, but did not
govern the import of fertilised eggs from abroad for such purposes. An ad-hoc committee
on genetic technology set up by the Government is due to give its report this year. (Note h)
Norway (Note i)
 The current Norwegian Minister of Health has proposed a law, soon to be presented to
Parliament, which would ban all research on fertilised eggs or early embryos for any
purpose, including production of stem cells by CNR and importation of cells or cell lines
from abroad. This would replace the current law which had been passed in 1987. The law
would not cover ES cells derived from umbilical cord blood or aborted fetuses.
 The report (Note j) in February 2000 of a Working Party on ES cells established by the
Ministry of Social Affairs and Health reflected Members’ differing views on ethically
acceptable sources of ES cells. Two of the six Members felt that the only acceptable
sources of ES cells were from still-born babies, spontaneous abortions and umbilical cord
blood, but the other four felt more time was needed to consider the issues, and went on to
agree that the use of surplus IVF embryos and aborted foetuses for stem cell production
might be ethically acceptable, but that fertilised eggs created just for stem cell research
was not.
 The report was widely circulated, and though most institutions, including the National
Committee of Medical Research Ethics and the Norwegian Medical Association, agreed
with the Working Party’s majority view, the Minister for Health adopted the pro-life view
and reflected this in proposals presented to Parliament in 2000 (Note k). However, shortly
before Parliament was due to debate the issue, the Government was forced to resign, and
the new Government retracted the proposal and resubmitted one with an opposing view,
close to the position in the UK.
 Following elections in September 2001, a new minority Government was formed and the
debate scheduled for May/June 2002. Despite broad support for the Working Party’s
majority position, the current Heath Minister will place before Parliament proposals for an
almost total ban. Most parliamentarians have not really decided on the issue and are
likely to follow the lead of the Health Minister currently in office. Thus the Norwegian
regulation on stem cell research will probably be stricter than in Germany, whereas, given
a slightly different political outcome, it could have been similar to the UK position.
Discussion
 Members commented on how the political situation can affect scientific policy and advice
– for example in Italy, the newly elected Government completely changed the
composition of the National Bioethics Committee.
Scientific Fact and Fantasy
Dr. Harry Griffin
The Roslin Institute
 The Roslin Institute has used murine embryonic stem (ES) cells for some time, and for the
last two years has also used human ES cells, imported from Wincosin in a collaboration
with the American biotechnology company Geron. The Institute has no relationship with
PPL Therapeutics who were also based at the Roslin Institute. In 2000, Roslin was
granted patents concerning stem cells with the full approval of Government, some of
whose departments were co-owners of the intellectual property involved. It has been only
3 years since the human first embryonic stem cells were created.
7
 The public perception of the area is much influenced by its presentation in the media,
which can be misinforming. There is no distinction in the UK and Europe between
regulation of the public and private sectors, but the latter is concerned about overly
restrictive regulation; for example, potential rivals/competitors might benefit if cell lines
were required to be made freely available.
 Future major tasks include:
 making cell lines without use of mouse cells or of human fetuses if possible;
 integration of different tissues; for example, cardiac therapy would require the
combination of heart and nervous tissue into a functional structure;
 avoidance of immune rejection of stem cells. A bank of over 200 stem cells could be
established, but this might not match all tissue types. Genetic modification of human or
pig cells are other possibilities.
 Mouse and human ES cells are not necessarily interchangeable, and so a procedure
carried out with the former may not be possible using the latter. For example, the
conversion of human ES cells to one particular cell type usually results in a mixed cell
population rather than the monoculture seen with the murine cells.
 The cell nuclear replacement technique (CNR) is the most imaginative technique, but
currently large numbers of eggs are required for each patient. Is it ethical for scientists to
attempt to develop a therapy which could only benefit a certain proportion of people? This
aspect has not really been discussed. CNR would assist in understanding the
reprogramming process, or in establishing a stem cell line of a certain genotype, for
example to assist in the treatment of complex genetic disorders, but is still very expensive
to undertake.
 The US FDA has proposed rules for Current Good Tissue Practice (CGTP) which deals
with screening of donors, traceability of tissue samples and quality assurance. Safety
concerns include whether stored stem cells would remain consistent over time, what
adequate storage conditions would be and in determining appropriate expiry dates.
 Should stem cell therapy should be regulated as a surgical procedure, or as drug therapy?
If regulation were too strict, this might result in no treatment becoming available to clinical
practice. The technology brings challenges to ethicists, clinicians and regulators. The
theme is one of caution, and of progress being made slowly, but also of awareness of the
magnitude of the potential benefit. It was a challenge that was being responded to
enthusiastically by scientists but which also required support by the public, especially in
the trade-off between embryo protection and development of medical therapy.
Discussion
 A ban on embryonic stem cell research might induce researchers to explore other areas,
but researchers required consistency of regulation. Current understanding seemed to
indicate that stem cells found in umbilical cord blood could not be converted into different
cell type types and could only be collected in small quantities. Evidence with regard to the
utility of adult stem cells was still equivocal.
 On the question of consent with regard to surplus IVF embryos, the initial gamete donor
ended their interest once they had given permission for their own treatment, another's
treatment, or for research, but there were still ethical considerations, including informing
the patient about the potential research that might be carried out.
HGC Secretariat
September 2002
8
DRAFT
Notes
Note 1
In November 1998 James Thomson and colleagues from the University of Wisconsin, USA, published
for the first time the successful in vitro cultivation of human embryonic stem cell lines (ES cells)
(Thomson, J.A., Itskovitz-Eldor, J., Shapiro, S.S., Waknitz, M.A., Swiergiel, J.J., Marschall, V.S.,
Jones, J.M. Embryonic stem cell lines derived from human blastocysts. Science 1998; 282: 11451147).
Note 2
The fundamental ethical regulations behind the German constitution, the Basic Law, guarantees the
independence of research from any kind of political and social restrictions. The freedom of research
and the sciences, as established in Article 5, paragraph 3 of the Basic Law, follows from the
protection of human dignity guaranteed in Article 1. It can only be restricted if and where it conflicts
with other constitutional guarantees, such as the Right to Life and to Inviolability of the Person (Art. 2,
Par. 2).
Note 3
In March 1999 the major research foundation in Germany, Deutsche Forschungsgemeinschaft (DFG)
released a statement on the issue of human embryonic stem cell research (Deutsche
Forschungsgemeinschaft: DFG-Stellungnahme zum Problemkreis “Humane embryonale
Stammzellen”. 1999. In: Jahrbuch für Wissenschaft und Ethik, vol. 4. L. Honnefelder and C. Streffer,
eds. Berlin, New York. 393-399.)
The DFG is the self-governing body of the Sciences and Humanities in Germany and is funded by the
German Federal Government and the governments of the 16 states (Länder). Summarizing the
various methods of generating embryonic stem cells, i.e. from the inner cell mass of human
blastocysts (ES cells), from primordial germ cells isolated from aborted human fetuses (EG cells), and
from embryos produced by somatic nuclear transfer into a human oocyte, the statement reasoned
that the use of ES cells derived from human blastocysts, regardless of whether they were generated
by in vitro fertilisation or somatic nuclear transfer, should not be supported since they originated from
cells which are totipotent, i.e. are capable of becoming a fully developed human being. This statement
was in accordance with German legislation, particularly with the Embryo Protection Act, which
imposes a strict ban on any manipulation involving a human embryo if the manipulation does not aim
exclusively at the preservation of the embryo. Thus, the DFG opinion relied on the criteria of
totipotency as the basis of its ethical argument. Preferring the use of EG cells as a less problematic
alternative in ethical terms, the DFG statement also concluded that, for the success of stem cell
research, there was at present no need for changing the German law with regard to the protection of
human embryos.
Note 4
A medical scientist of the University of Bonn submitted a grant proposal to the Deutsche
Forschungsgemeinschaft, asking for financial support for a research project involving the use of
human embryonic stem cells, which he intended to import from abroad. The research project dealt
with in vitro differentiation of human ES cells into neural cells in the context of transplantation studies
in small animals. If successful, this approach is said to represent a model for potential therapeutic
strategies for neurological disorders such as multiple sclerosis and Parkinson’s disease.
This grant application fueled the already widening public debate in Germany and, challenged by that
grant application, the Deutsche Forschungsgemeinschaft in May 2001 published revised
recommendations regarding research on human stem cells (Deutsche Forschungsgemeinschaft:
Empfehlungen der Deutschen Forschungsgemeinschaft zur Forschung mit menschlichen
Stammzellen. 2001. In: Jahrbuch für Wissenschaft und Ethik, vol. 6. L. Honnefelder, C. Streffer, eds.
Berlin, New York 349-385 http://www.dfg.de/aktuell/stellungnahmen/empfehlungen_stammzellen_03_05_01.pdf,
http://www.dfg.de/aktuell/stellungnahmen/empfehlungen_stammzellen_hintergrund_03_05_01.pdf ).
In a second statement the DFG emphasized that the rapid worldwide progress in stem cell research
had produced such far reaching and promising results that the future exclusion of potential patients as
well as scientists in Germany from participating in this novel field in medical research could no longer
be justified. Referring to the German Embryo Protection Act, which only applies to embryos and
totipotent human cells, the DFG stated that ES cell lines are not totipotent, but pluripotent, and
therefore not subject to the Act. No restrictions exist in Germany with regard to the import and use of
cells which are not totipotent. On this basis the DFG now recommended a step-by-step process
starting with the import and use of pluripotent ES cells from abroad. Leaving previously held positions
behind, the DFG also recommended not to exclude scientists in Germany from the possibility of
isolating embryonic stem cells from human blastocysts if, in future, the imported ES cell lines should
turn out to be insufficient for achieving the intended research goals. In that case, the DFG
recommended that the German Parliament should consider changing the Act in a way that, under
certain conditions – outlined in detail in the statement – scientists in Germany should be allowed to
work actively on the derivation of ES cells from human embryos.
Note 5
In March 2001 the German Parliament established an Ad-hoc Study Commission on “Law and Ethics
in Modern Medicine”(Enquete-Kommission “Ethik und Recht in der modernen Medizin), consisting of
13 members of Parliament and 13 experts from different disciplines, which was commissioned to
prepare recommendations on the assessment of the ethical problems, social consequences and
potential law-making requirements associated with several different topics in the life sciences,
including stem cell research. In November 2001 that Ad-hoc Commission reported to the Parliament
on the issue of stem cell research (Deutscher Bundestag. 2001. Zweiter Zwischenbericht der
Enquete-Kommission Recht und Ethik in der modernen Medizin. Teilbericht Stammzellforschung.
Second Interim Report of the Commission on Law and Ethics in Modern Medicine - Subject Report on
Stem Cell Research. Berlin. Bundestagsdrucksache 14/7546,
http://www.bundestag.de/gremien/medi/medi_2zwisch.html).
Carefully weighing the arguments against and in favor of changing the Embryo Protection Act the
report came to the conclusion that lowering the standards of protection for embryonic life cannot be
justified and recommended not to allow in Germany the generation of ES cell lines from human
embryos. Also, the majority of the Ad-hoc Commission favored a total ban on the import of ES cells
arguing that their utilization was not morally distinguishable from an approval of the destruction of the
human embryos from which the cells were sourced. However, some members, while criticizing the
lack of legal restrictions on the import of ES cells, expressed their concern that a total ban on ES cell
imports might contravene the right to freedom of research as laid down in the German Basic Law.
They therefore recommended an in-principle ban on the import of ES cells that could be subject to an
exception under certain restrictive conditions.
Note 6
In May 2001, the German Federal Government established a second interdisciplinary advisory body.
It consists of 25 scientists named and appointed by the Federal Chancellor and is called National
Ethics Advisory Council (Nationaler Ethikrat). In December 2001, the Council issued an opinion on the
import of ES cells (Der Nationale Ethikrat. 2001. Stellungnahme zum Import menschlicher
embryonaler Stammzellen. Berlin. (http://www.nationalerethikrat.de/mitteilung20dez01.htm). Reflecting on
alternative options similar to those identified by the Ad-hoc Commission, the majority recommended
to introduce an in-principle ban on the import of ES cells with restricted exceptions. Early this year,
that recommendation became the basis for a draft of a Stem Cell Act.
In January 2002, a fundamental decision was made by a majority of Parliament voting in favor of the
import and use of ES cells under certain conditions designed to limit the number of cell lines eligible
for import, as outlined below. On the basis of this decision a draft Stem Cell Act was presented to
Parliament in April 2002 (Deutscher Bundestag. 2002. Entwurf eines Gesetzes zur Sicherstellung des
Embryonenschutzes im Zusammenhang mit Einfuhr und Verwendung menschlicher embryonaler
Stammzellen (Stammzellgesetz – StZG). Berlin. Bundestagsdrucksache 14/8394). The Act was
passed on April 25.
Note a
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In January 2000, a group of researchers at Huddinge University Hospital applied for ethical approval
of a project aimed at ‘early characterisation’ of stem cells harvested from surplus IVF embryos.
Note b
A revised version of the working party’s Ethical Guidelines for Stem Cell Research in Sweden is
available at: Arbetsgruppen för forskningsetik inom ämnesrådet för medicin, Vetenskapsrådet, «Etiska
riktlinjer för stamcellsforskning i Sverige» (The working party for research ethics within the subject
domain of medicine, The Council of Science, «Ethical guidelines for stem cell research in Sweden»,
Läkartidningen 2001; 98: 5890-5.)
The guidelines cover the harvesting of stem cells for research purposes from adults, from umbilical
cord blood, from aborted foetuses aged up till 14 weeks as well as from surplus IVF embryos.
Note c
Swedish National Council on Medical Ethics, Summary of «Statement of opinion on embryonic stem
cell research», Stockholm 2001: »
The Swedish National Council of Medical Ethics considered that there should be opportunities for
conducting research on embryonic stem cells and that under certain circumstances it can be ethically
acceptable to perform research on fertilised eggs, and that embryonic stem cell research in itself is
not more controversial than other research on embryos. There is every indication that stem cell
research should be pursued on a broad front, with adult, foetal and embryonic stem cells.
Therefore, the Council held that embryonic stem cell research:

is ethically defensible on the condition that it is conducted in controlled forms and under public
scrutiny, including legally regulated ethical examination of each individual project by a committee
of research ethics;

is permissible only if there are no scientifically well-founded and ethically acceptable alternatives
for attaining the same goals of knowledge;

may, after careful information to, and free informed consent from, both the woman and the man,
use fertilised eggs which are left after test-tube fertilisation and which have been donated explicitly
for this purpose;

does not justify the creation of embryos, through test-tube fertilisation, solely for research
purposes;

must be subject to continued evaluation and ethical discussion, in pace with the growth of
knowledge and the development of new techniques;

must be protected from unethical commercialisation.
The Council had not, at this stage, taken a position on the issue of cell nuclear transfer. The medicalethical and legal implications of allowing cell nuclear transfer to egg cells, or to fertilised eggs, are
insufficiently elucidated at present. Consequently, the issue should remain open until the level of
knowledge and understanding is adequate to provide a base for policy decision. For the time being, a
ban against creation of embryos for research purposes should not be introduced into Swedish law. As
a first important measure, the Council strongly recommended that reproductive cloning be forbidden
in Swedish law.
Note d
«Ja till terapeutisk kloning» (Yes to therapeutic cloning), Läkartidningen 2002; 99: 482
Note e
The original law from 1987 is now incorporated in Lægelig behandling, diagnostikk og forskning, Lov
nr. 460 av 10. Juni 1997 (Law no. 460, June 10 1997 on Medical treatment, diagnostics and research)
Research can only be performed within the first two weeks after fertilisation and each individual
project must be examined and approved by an independent science ethics committee
(‘videnskabsetisk komite’).
Note f
The Council was established by law in 1987 and its «task is to provide the Danish Parliament, official
authorities and the public with ongoing advice and information about ethical problems raised by
developments within the national health service and the field of biomedicine»
(http://www.etiskraad.dk)
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Note g
A report on therapeutic possibilities and problems related to adult stem cells (Stamceller fra voksne terapeutiske muligheder og problemer) written for the Council by its former member, professor Søren
Holm, is available on http://www.etiskraad.dk/dm/00011/000341.html.
Note h
The report of the committee on genetic technology, Genteknologi-utvalget, is available at
http://www.folketinget.dk/Samling/20012/spor-sc/S544.htm.
Note I
Professor Solbakk has published the following papers:
 Solbakk JH. Why is the human embryo considered persona non grata in medical research today?,
BioLaw, Volume 2 Nos. 41/42, Aug.-Sept 1990: 483-89.
 The Norwegian National Committee of Medical Research Ethics, Research on foetuses, Oslo
1990.
 Solbakk JH. Kloning og etikk (Cloning and ethics), Dagbladets kronikk, 15.03.97
 Solbakk JH. Klon en forsker (Clone a researcher), Dagbladets kronikk, 25.05.97
 Stamceller fra aborterte fostre og befruktede egg – medisinsk forskning, klinisk anvendelse og
mulige alternativer. Rapport fra arbeidsgruppe nedsatt av Sosial og helsedepartementet (Stem
cells from aborted foetuses and fertilised eggs - medical research, clinical applications and
possible alternatives. Report from a working party set up by the Norwegian ministry of social
affairs and health), Oslo 2000.
 Genterapi. Status og fremtidige muligheter innen klinisk medisin SMM-rapport 1/2000 (Genetic
therapy. Status and future possibilities in clinical medicine. Report from a committee of experts set
up by The National agency of medical technology assessment, Oslo 2000).
Note j
Stamceller fra aborterte fostre og befruktede egg – medisinsk forskning, klinisk anvendelse og mulige
alternativer (Stem cells from aborted foetuses and fertilised eggs - medical research, clinical
applications and possible alternatives)
Note k
Odelstingsproposisjon nr. 24 om endringer i transplantasjonsloven (Proposition no. 24 to the
Odelsting on changes in the Act on transplantation).
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