SUMMARY:
Discussion:
1-The state of the law concerning embryo
stem cells
2-The issue of consent and excess embryo
donation
3-Embryonic stem cells: the tiniest of
human beings or “just human cells”?
4-Analysis of the jurisprudence
surrounding excess embryos.
5-Embryo stem cells and organ donation.
6-The spectrum of the past: an obstacle
for embryonic stem cell research.
7-The alternative to embryonic stem cells:
fetal and adult stem cells.
8-European
member states legislations regarding research on embryos.
9-The birth of the Oviedo Convention.
10-Oviedo’s cornerstone principle: human dignity.
11-preservation of human dignity with the
Oviedo Convention.
Conclusion
__________________________________
INTRODUCTION:
“When the human body breaks down, it must
be repaired.” [1] Every
country is now experiencing a constant lack of organs available for
transplantation. Nothing leads to
believe that the general population is getting used to the idea of organ
donation, in fact it seems like the reverse is happening. The taking of organs on dead donors has
raised legal, ethical and medical issues regarding the moment of death and the
consent to retrieve the organs.
But the situation is far from ideal. The waiting list for organs is still growing
as the technology for transplants do.
The unavailability of organs has led research to find new ways of
obtaining organs. Research is
concentrating specially on two areas: xenotransplantation and stem cells research.
Xenotransplantation
from transgenic animal organs
Xenotransplantation is the transplantation into a human body
of an animal organ. The length of organ
transplantation waiting lists has long invited researchers to find new source
of organs besides artificial ones.
Through genetic modification, researchers try to fabric organs from transgenetics pigs and xenotransplant
them to humans.
There are however two main problems with
this new technique. First, there is an
immunological incompatibility between pigs and humans, leading to the rejection
of the pig’s organs transplanted.
Second, this technique could also bring the risk of introducing into the
human body new viruses. For all those
reasons, numerous researchers believe that the solution to the shortage of
human organs lies in the creation of new organs through the culture of human
cells.
Use
of human stem cells.
At the origin of most pathology affecting
industrialized populations, is the destruction of the architecture of the
organ’s tissue. One way to solve this
problem is to reconstruct the damaged tissue by transplanting new healthy
cells. Those new cells would then either
replace the cells destroyed or modified by the illness. This therapeutic strategy is mostly based on
the use organs from a dead donor, or in rare occasions, from a live donor[2].
Unfortunately, this technique has two
crucial limits: on the one hand, the scarcity of organs available, and on the
other hand, the chronic risks of immuno-suppression
to avoid the rejection of the new organ.
The therapeutic use of stem cells could very well turn out to be a
revolutionary way to treat those illnesses and lesions, at least this is the
hope.
The aim of stem cells research is to
develop cells and tissues intended to be later transplanted into patients
suffering from diabetes, Alzheimer’s disease, Parkinson’s’ disease, heart
failure… All those diseases do not have
yet any efficient treatment or way to cure, there lies the great hope of stem
cell research.
Stem cells are present at every stage of
human development, from children to adults.
Technology is now available to obtain stem cells from adult tissues,
fetal tissues, cells of the internal mass of the blastocyst,
from embryo.
“Excess embryos”, that is the embryos that
are no longer necessary to a parental project after a fertilization treatment
in vitro (FIV), might be used as a source of embryo stem cells. Stem cells may also be obtained from
naturally aborted fetuses and blood contained in the umbilical cord at the time
of birth. Adult stem cells are obtained
from tissues like bone marrow, skin, blood, and used for transplantation. One of the limits to the use of adult stem
cells is the difficulty to isolate adult stem cells and their weak
predisposition to differentiate themselves into different types of cells (this
point is still being debated over, as some studies seem to demonstrate that
adult stem cells might have the same differentiation potential as younger stem
cells[3].)
Stem cells research is torn between the
amazing potential of those cells and the deep moral and legal concerns about
the type of research that they involve.
One of the deepest issues is the use of human embryo stem cells.
The ethical
concerns about using human embryonic stem cells.
One of the most important issues raised by
the use of embryo stem cells is their method of removal. Removal and later use of tissues create a
difficult problem: those cells can only be obtained by in vitro culture of
embryos. Then, stem cells are removed from the embryo. This process means the end of the
implantation of the embryo for reproductive purposes. The embryo is “instrumentized”
before being disposed of. This technique
is troublesome when one thinks that the embryonic phase is one of the earliest
phases of human life.
Even if the use of embryo stem cells could
open the door to “science miracles”, curing Alzheimer’s disease, diabetes...we
cannot ignore that the benefit of curing some cannot justify everything. Moreover, the focus on the properties of
embryo stem cells should not lead scientists in forgetting research on adult
stem cells, which might very well reveal themselves as useful as the embryo
ones.
The fear is that research using human
embryo tissue could pull medicine down the slippery slope to a world where the
unborn human beings are harvested for the cells they could provide to another human
being. On the other hand, the human
embryo stem cells that have already been collected may be a sufficient source
of cells for future replacement tissue, so that no new embryos are required.
Preliminary:
what are embryo stem cells?
Shirley J. Wright recently[4]
answered this question. Embryo stem
cells form a very early stage in human development and remain in an
undifferentiated state for only a short period of time. They are first clearly recognizable about
five to seven days after fertilization, when a human embryo forms a structure
called a blastocyst.
Consisting of merely 140 cells, this hollow, fluid-filled sphere gives
little indication that it could develop into a complete person. There are two types of cells in the blastocyst at this stage.
Trophoblast cells, which form the “shell” of
the sphere, will become the supporting tissues of the fetus such as
placenta. Inner-cell-mass cells, which
are located at one end within the blastocyst, are the
undifferentiated cells that will divide and develop into the individual.
The inner-cell mass begins to
differentiate when it forms the three fundamental germ layers of the embryo,
known as the ectoderm, the mesoderm and the endoderm. Each of theses germ layers has a specific
destiny as a particular set of tissues in the mature individual, and all organs
are ultimately derived from them. The
ectoderm will form the skin, the eyes and the nervous system. The mesoderm will form bone, blood and muscle
tissue. And the endoderm will develop
into the lungs, liver and lining of the gut.
Because the inner-cell mass gives rise to a complete individual, these
cells are considered to be totipotent. When inner-cell mass cells are cultured in a
dish they are called embryo stem cells.
DISCUSSION:
In our discussion, we
will first describe the state of the law concerning human embryo stem cells
research and the issue of consent when giving embryos to research. Next, we will concentrate on trying to define
the status given to embryos, thereby rendering research on embryonic stem cells
sound or not. We will do so by looking
at the two extreme views concerning the embryo: the tiniest of human beings or
“just a cluster of cells”, and the organ donation analysis of the
research. Then, we will look at the main
criticisms, the spectrum of past science abuses and the possible alternatives
sources of stem cells. Finally, a short
analysis of the European Union’s dealing with the subject will also guide us
through our analysis of embryonic stem cells use.
1-The state of
the law concerning human embryonic stem cells.
The National Institutes of Health (NIH)
guidelines, announced in August 2000, allow federal funding for research with
stem cells that have been removed from human embryos. The rules forbid research on the embryo
itself, which is prohibited by federal law.
In 2001, federal funding of research using
embryonic stem cell lines was uphold by the new administration. In
According to President Bush’s statement
federal funding of medical research on the existing stem cell lines will
promote the sanctity of life “without undermining it[6]”
and will allow scientists to explore the potential of stem cells to benefit the
lives of millions of people who suffer from diseases so far with no known cure.
Federal funds will only be used for
research on existing stem cell lines that were derived: with the informed consent of the donors; from
excess embryos created solely for reproductive purposes; and without any
financial inducements to the donors.
In order to ensure that federal funds are
used to support only stem cell research in the determined parameters, the NIH
examines the derivation of all existing stem cell lines and created a registry[7]
of those lines that satisfy the federal criteria. No federal funds will be used for the
derivation or use of stem cell lines derived from newly destroyed embryos; the
creation of any human embryos for research purposes; or the cloning of human embryos
for any purpose.
2-The issue of
consent and excess embryo donation.
NIH draft guidelines so far require the
agreement of both gamete donors before the embryos are used in research. The draft requires that in vitro
fertilization clinics not only have special rules for obtaining consent for the
use of the excess embryos for research but also that there should be a clear
separation between the decision to create embryos for infertility treatment and
the decision to donate early human embryos in excess of clinical need for
research purposes. Moreover, only frozen
early human embryos should be used, and couples should be approached about
donation only at the time of deciding the disposition of excess embryos.
The issue of consent from the donor, basic
issue, is lead by the main concern regarding the donation of excess embryos,
that the couple might be vulnerable to pressure from the medical team to donate
embryos for research purposes. Indeed,
the in vitro fertilization (IVF) process might represent a couple’s last chance
at getting their own child.
Additionally, there are other candidate-couples to fertilization. This situation might leave a couple inclined
to please the medical team, in an effort to achieve their goal. If asked to donate eggs or embryos at the
time of their IVF, the chance of a couple to even be able to really make a free
choice in that important decision is slim.
3-Embryonic
stem cells: the tiniest of human beings or “just human cells”?
Senator Sam Brownback is quoted as saying
that embryonic stem cell research reminds him of Nazi experimentation: “they
used the same sort of argument, that they are going to be killed anyways.”
In the same trend of thoughts, one author[8]
was observing that it is not because we condemn criminal to be sentenced to
death that we collect their organs...
On the moral ethics of embryo stem cells
research, Roman Catholic Cardinal Bevilaqua of
All those arguments against the use of
embryo stem cells sound very compelling at first glance: the “killing” of human
beings, the reminder of the Nazi regime… However, those arguments fail to address
the more important question: what are really stem cells?
The arguments we just mentioned view the
embryo stem cells as the tiniest human being.
As is, it deserves the protection and respect of all human beings, among
its rights would be the right not be killed, and the right to live.
In response to that argument, the
co-author of the legislation in favor of federal funding[10]
explained that the cells are no longer embryos, but only stem cells extracted
from embryos, making experimentation with them not equivalent to experimenting
with embryos. This analysis of the
research seems however a little too rhetorical: “we are not experimenting on
embryos, just on cells taken from embryos.”
Moreover, the argument fails to address the fact that after the harvest
of its stem cells, the human embryo can longer be used for reproductive
purposes and therefore will eventually be disposed of.
More compelling in favor of the research
is the argument that embryo stem cells, at the research stage, resemble more to
a cluster of cells. Peter Singer[11],
in its analysis of the status of the embryo in the laboratory, answers the two
claims of opponents to research (1-the embryo is a human being. 2- the embryo
is a potential human being.)
First, Singer opposes the qualification of
human being for an embryo on scientific grounds. Singer’s proposition is based on the premise
that human beings are individuals. For
the embryo to be a human being, it would have to also be an individual. But an embryo might not be the precursor of
an individual. Indeed, up to about
fourteen days after fertilization, the embryo can still split into 2
genetically identical embryos. An
embryo, up to this point, may be the precursor of one or two individuals.
According to Singer, this scientific fact
poses a problem to the argument who stress the continuity of an existence from
conception to adulthood. The author
finally gives away with the “absurdity” stemming from the thought of the embryo
as an individual at the time at which it is “only a cluster of cells[12]”
by giving us a vivid case scenario.
“Considering the embryo as the first stage
of an individual human being, we might call it Mary. Now, suppose that the embryo divides itself
into two identical embryos. Is one of
them still Mary, and the other one Jane?
If so, which one is Mary? There
is nothing to distinguish the two, no way of saying that the one we call Jane
split off from the one we call Mary, rather than vice versa. So should we say that Mary is no longer with
us, and instead we have Jane and Helen?
But what happened to Mary? Did
she die? Should we grieve for her? There lies the absurdity of maintaining that
the embryo is an individual.”
Second, Singer questions the proposition
that an embryo is a “potential human being.”
The author then goes on to compare the potential of an embryo in the
uterus to the one of an embryo in the laboratory. An embryo, implanted in the uterus, is most
likely to realize its potential, unless we voluntary interfere with its natural
process. The “laboratory embryo”, on the
other hand, will only realize its potential to its most (i.e.: fetus and
eventually adult human being) provided that a deliberate human act is carried
out. And this need for positive action is
not the end of what the “laboratory embryo” needs. Probabilities are next in the way: the probability of a given embryo that has
been transferred to the uterus actually implanting there, and leading to a
continuing pregnancy is less than 20%.
In Singer’s demonstration, IVF technique
has only reduced the difference between the “embryo in a glass dish” and sperm
and egg considered together.
Specifically, the probability of a child resulting from a given IVF
embryo and the probability of a child resulting from an egg that has been
placed in a fluid to which sperm has been added are similar. So far, eggs and sperm can be disposed of and
no one is claiming that they should not be “killed” because of they have the
potential to become a human being.
This analysis raises the question of
whether it would be a good idea to treat embryo stem cells as we do sperm for
example. In the current state of the
law, sperm is treated as a replenishable tissue, just
like blood, and both statutes and jurisprudence refuse to recognize property
rights in replenishable tissues.
To better our
understanding of the issues raised by the use of embryo stem cells, an analysis
of the status of the same embryo in a different judicial setting might be most
useful.
4-Analysis
of the jurisprudence surrounding excess embryos.
The jurisprudence concerning excess
embryos has so far been limited to the future of embryos after a divorce, a
death and generally focusing on the reproductive rights stemming from the
existence of the frozen embryos. The
subject might be different from ours; however, it is a great indicator on the
court’s opinion of the status of embryos.
One of the most
interesting decisions is Davis v. Davis, a 1992 decision from the
Supreme Court of Tennessee[13]. This case is one of the few that address the
question of the disposition of cryogenically- preserved product of in vitro
fertilization, i.e. of “frozen embryos”, in case of the divorce of its
genitors. The
The divorce proceedings were only
complicated because of the issue of the disposition of the frozen embryos. Mrs. Davis then demanded the control over the
frozen embryos with the intent to have them transferred to her own uterus, in a
post-divorce effort to become pregnant.
Mr. Davis objected, saying that he preferred to leave the embryos in
their frozen state until he decided whether or not he wanted to become a parent
outside the bounds of marriage. Later,
in the litigation, Mrs. Davis, now remarried, no longer wished to utilize the
frozen embryos for herself, but wants authority to donate them to a childless
couple. Mr. Davis is adamantly opposed
to the idea of donation and would prefer to see the frozen embryos discarded.
The trial court originally decided that
the embryos were “human beings” from the moment of fertilization and thereupon
awarded custody to Mrs. Davis and directed that she “be permitted the
opportunity to bring these children to term through implantation[14].” The court of appeals reversed, finding that
Mr. Davis had a “constitutionally protected right not to beget a child where no
pregnancy has taken place[15].” The court of appeals further held that “the
parties share an interest in the seven fertilized ova[16]”
and remanded the case to the trial court for entry of an order vesting them
with “joint control… and equal voice over their disposition[17].” The Tennessee Supreme Court granted
certiorari.
The scientific testimony section of the
court’s decision is enlightening to our present issue of embryo stem cell
research as to the status of the frozen embryo.
The
Next, the court
discarded the expert testimony of a French genetist,
Dr. Jerome Lejeune, finding that his testimony “ revealed a profound confusion
between science and religion[19]. Indeed, Dr. Lejeune testified that he was
deeply moved by the mother wanting to rescue her babies from this
“concentration can[20]”,
and thereafter concluded that Mr. Davis had a moral duty to try to bring these
“tiny human beings[21]”
to term. Instead, the highest court of
Tennessee rather turned its attention to the testimony of Dr. Irving Ray King,
the gynecologist who performed the IVF procedures, so should we.
Dr. King testified that
the currently accepted term for the zygote immediately after division is “preembryos” and that this term applies up until fourteen
days after fertilization. This
fourteen-day period defines the accepted period for preembryos
research. At about fourteen days, he
testified that the group of cells begins to differentiate in a process that
permits the eventual development of the different body parts which will become
an individual. This proposition was
supported by the American Fertility Society[22],
stating that at the eight-cell stage, the developmental singleness of one
person has not been established. Indeed,
each blastomere, if separated from the others, has
the potential to develop into a complete adult.
Beyond the eight-cell stage, the production of the IVF procedure looks
more like a multicellular entity, rather than a
“loose packet of identical cells[23].”
The court next used as
a reasoning start point the legislation of abortion. The
The
Finally, the
Besides the
jurisprudence, stem cell research may also be problematic, regarding of its
line of funding in several States due to their legislation. So far, nine States statutes may be
interpreted as prohibiting embryo stem cell research.
In
As for
In
In Minnesota, the law
prohibits using or permitting the use of “a living human conceptus
for any type of scientific, laboratory research other experimentation except to
protect the life or health of the conceptus[37]...”
Earlier in the statute, “conceptus” is defined as
“any human organism, conceived either in the human body or produced in an
artificial environment other than the human body, from fertilization through
the first 265 days thereafter[38].” The
In
In
In
In
At least in those nine
States, we can observe a deep concern for the rights and protection of the
embryo. However, the vast majority of
States follows the Federal compromise and does not oppose the research on
embryo stem cells. Another way to view
the use of “excess embryos” is the organ donation approach. Under this later approach the use of those
embryos and their cells might take an entire new meaning.
5-Embryo
stem cells and organ donation.
If we take the position
that the cells no longer have the potential for developing into an independent
human life, then statutes concerning organs donation may be applicable to the
embryo stem cells. Indeed, organ donation
statutes address the question of who controls the disposition of human organs
and tissue with no further potential for autonomous human life. The area is governed by the Uniform
Anatomical Gift Act
Moreover, as some have noted, one could be attached to the principle of
dignity that should protect to some degree the embryo and still favor embryo
stem cell research. Indeed, it is
difficult to be convinced that defrosting an embryo and throwing it down the
drain is respecting its dignity.
Instead, integrating the embryo to a research protocol seems to be a
more acceptable proposition. This would
indeed translate in a actual form of solidarity, that one could compare to the
gift of organ from a dead man to a live one, thereby manifesting solidarity
beyond death, in the case of the embryo beyond development.
If considering the use
of embryo stem cells as a new way of organ donation would help strike the
ethical balance in favor of the research, some, on the other hand, bring the
spectrum of past abuses of science to argue in favor of its prohibition.
6-The spectrum
of the past: an obstacle for embryonic stem cell research.
One argument in favor
of embryonic stem cells states that the potential of this research is so great
that we cannot not pursue it, the greater good of the needy patients is at
stake and the promises of stem cells way to great to slow down. But the greater good cannot justify any means
to reach that good. International instruments
have recognized that very dilemma and stated that the means to those laudatory
ends may not include the harm or death of human subjects. The
Another powerful
argument against embryonic stem cell
research is the historical abuse that society has already committed on
weaker individuals, thereby sacrificing those individuals for the “greater good
of society or of science.” The
atrocities of the Nazi experiments with captive Jews in concentration camps are
often compared to embryo stem cell research.
In Nazi Germany, Jews were considered “sub-humans” and experiments on
them, even leading to death, were performed under the idea that they were going
to die anyway and so they might as well be of some use. Shadows of that idea are emerging from time
to time. In the Willowbrook
experiments, mentally retarded children were purposefully infected with
infectious diseases in order to study the diseases to later prevent later
populations from infections. In the Tuskeegee experiments, black males suffering from syphilis
were not administered penicillin, in order to observe the progression of the
diseases. Elderly male nursing home
patients were injected with cancer viruses to see if the would form
antibodies. Mentally retarded children
in state institutions were fed feces to study hepatitis. Most recently, the
As the American Bioethics Advisory
Commission[49] noted:
“It is interesting that many of such breeches of research ethics took place in
experiment involving vulnerable populations of human beings, whose
“personhood”, perhaps, was considered to be less than adequate. It is also interesting that much of it was
federally funded, and justified for “the greater good of society”, for the
advancement of scientific knowledge or for national security reasons.”
The threat of those
abuses seems a very compelling argument at first but this argument fails to
realize that embryo stem cells are not the “tiniest of human being” and have no
“personhood”, whether or not we consider it adequate. At the stage of research, the embryo has no
longer the capacity to become an embryo and therefore will never attain the
state of personhood. The justified fear
of research sacrificing human life for a greater good might be addressed in the
case of embryo stem cells research by a better definition of what are those stem
cells are and how they are harvested. As
we earlier mentioned, embryo stem cells do originate from excess embryo
donations for which the gametes donor no longer have a parenting project. Unlike later fetuses however, those embryo
are taken at a very early stage where they are more a cluster of human cells
than a fetus. Some have rightfully found
the embryo, even at this early stage, deserves some respect because of its
potential and symbolical value.
Expression of that respect may be found by ensuring that the research is
done by competent researchers and under strict research protocols.
If the spectrum of past
abuses can be overcome, the scientific questioning of the use of embryonic stem
cells might however be more difficult.
Indeed, alternatives to the use of embryo stem cells might very well be
possible and may even be more useful in curing awaiting patients.
7-The
alternative to embryonic stem cells: fetal and adult stem cells.
A number of advocates
against the use of embryonic stem cells in research argue that such are unnecessary
due to the numerous studies tending to show that stem cells derived from adults
are equally or more promising for medical research than those derived from
embryos. Already, adult stem cells have
been used successfully in clinical trials to treat cartilage defect in
children, restore vision to patients who were legally blind...
More precisely,
researchers already reported, that stem cells taken from adult tissues retain
the ability to become several different types of tissues: brain cells can
become blood cells and cells from bone marrow can become liver. The overwhelming evidence from the scientific
community is that the new discoveries in adult stem cell research rival the
development previously found only in embryo stem cells.
One of the most exiting aspects to adult
stem cell research is the advantage it may have over embryo cells, adult stem
cells may be harvested directly from the patient. Because those cells are retrieved from the
patient, any development of cells or tissue that may occur outside the body
would not be rejected if implanted back into the body. This technology would indeed be the “perfect”
answer in circumventing the risk of rejection that embryonic stem cells may
still pose. On the other hand, embryo
stem cells raise the amazing possibility of made-to-order, person-specific
cells or organs to transplant into a needy patient. With the technology used to produce the
cloned sheep Dolly, any human somatic cell could be fused with an enucleated
donor human egg cell that is then stimulated to develop into a blastocyst embryo.
The inner-cell mass could then be harvested from the blastocyst. A specific tissue could then be grown from
the embryonic stem cells, which could be implanted into the original
donor. The advantage of this cloning
method is that the embryonic stem cells would be compatible with the donor of
the somatic cell. This would prevent any
graft rejections due to immune-system incompatibility. To date, however, no one has derived
embryonic stem cells using this technique, but the feasibility of this
technique has been demonstrated.
Moreover, the technique used in cloning embryo stem cells is
unacceptable under the federal funding guidelines.
Another important
advantage of adult stem cells is the presence of “precursor” cells, cells that
have already been committed to becoming one type of cell. While precursor cell’s morphing potential is
narrower, many scientist believe that turning them into medical treatments will
be much easier, because they are further along in their development[50].
In favor of embryonic stem cells research,
in July of 2001, the National Institutes of Health released an internal report
touting several advantages of using stem cells formed in embryos within days of
fertilization, that is coming from excess embryos, over stem cells harbored in
the bodies of children and adults. The
report focused more on the scientific aspect of embryo stem cell research
rather than on its purely ethical aspects.
However, as we have already mentioned, our legal system does need
definitions before it can apply a legal status.
Adult, fetus, embryo and gamete have different characteristic and that
is the way the law will distinguish among them and each will be awarded a legal
status of its own.
The report cites several
advantages of using embryonic stem cells, specifically their ability to
transform themselves into virtually every type of cell in the body. The report concluded that: “[c]urrent evidence indicates that the capability of adult stem
cells to give rise to many different specialized cell types is more limited
than that of embryonic stem cells.” The
report also questioned whether sufficient supplies of adult stem cells could be
created to allow for therapeutic applications, such as using stem cells in transplants
to regenerate organs or tissue damaged by disease. NIH scientists noted, “adult stem cells are
rare” and “often are difficult to identify, isolate and purify.” Embryonic stem cells, on the other hand, “can
be generated in abundant quantities in the laboratory.” From a practical perspective in basic
research or eventual clinical application, it is significant that millions of
cells can be generated from one embryonic stem cell.
One question remains
however unclear: how about using embryo germ cells derived from fetal tissue
instead of embryo stem cells derived from excess embryos? Dr John Gearhart, from
In an effort to define
the limits of embryonic stem cells research, historical, ethical, medical and
legal arguments have thus far been our focus.
Now, we will turn to our neighbors and see if they have resolved the
conflict we are facing or at least how they address it.
8-European member states legislation
regarding research on embryos.[54]
Embryo stem cells research not only is a
controversial subject with the
While everyone seems concerned about the
research, it also seems that one of the argument for allowing it is that, “if
we do not pursue the research on embryo stem cells, some other country will and
we will be held back[55].” That same argument has been used in many
countries. This argument is less than
persuasive and can be refuted simply by remembering the common sense principle
that it is not because “everyone is doing it, that it is appropriate if I do
it.” Pursuing embryo stem cells cannot
be declared ethically and legally sound just because it is done. Moreover, “two wrongs do not make a right”
tell us the saying: embryo stem cells research must be analyzed on its
principles and not as a common practice.
When analyzing the issues raised, a quick
look at other countries’ legislation will help us.
|
Country |
Legislation |
Research |
limited length |
cryoconservation |
conditions and objectives of the research |
other restrictions |
ethics committee |
|
|
On
reproductive medecine (1992). |
not
allowed. |
|
one
year. |
embryo
donation is not allowed. |
Conditions
of access to reproductive medecine: stable heterosexual
relationship. Aim: procreation. Works only if an ovocyt
is implanted. |
|
|
|
There
is no specific legislation but a Royal decision that regulates IVF clinics.
(1999) A governmental proposition on embryo research is currently discussed. |
allowed
under certain conditions. |
|
|
In
authorized IVF clinic, need to obtain the approval of a Bioethics commission |
|
There
is a ethics commission at every institution capable of doing research (ie: universities…). Those commissions approved the
protocols of research. |
|
|
On
reproductive medecine (1997) |
allowed
under certain circumstances |
14
days from conception (excluding the cryoconservation
time) |
one
year with the authorization of the couple |
Conditions:
authorization of a regional ethics commission. Aim: improving IVF techniques, preemplantation diagnostic of the embryo. |
fusion
of genetically differents embryos or parts of
embryos is forbidden. Ova used for
research may not be transferred in utero |
national
Commission on Ethics for the health and Research ( consultation role) |
|
|
on
medical research (1999) |
allowed
under certain conditions. |
14
days from conception. |
15
years (then it must be destroyed). |
Conditions:research is only done by authorized
agencies and with the parents' consent. |
It
is forbidden to create embryos for the purpose of research. Research on fetus can only take place after
written consent from the pregnant women.
Research that modifies the genetic line is not allowed (unless it is
for the limited purpose of prevention a fatal disease.) |
The
National Authority of Medical and Legal matters give authorization to
research to the agencies. |
|
|
on
bioethics (1994). A modification of that law is currently debated on whether
to authorize research on embryos |
allowed
under certain conditions. |
7
days. |
5
years. During this time the couple may
donate the embryo to another sterile couple. |
Conditions:
must be useful directly to the embryo or to reproductive medecine;
authorization of both parents is needed; authorization of an independent commission
is also necessary. |
cloning,
creation of chimera and embryo for research purposes are not allowed.
Modification of a germinal line is also forbidden. |
National
Consultative Committee on science and biology ethics (1983). The Committee is opposed to the
incorporation of the European Directive 98/44/CE on patentability into
national law. |
|
|
on
protection of embryos (1992). |
allowed
if the embryo benefits from it |
|
not
allowed. |
non
therapeutic research on embryos is forbidden. |
The
Law expressly forbids human cloning. It is forbidden to destroy embryos.
Fertilization of an ovocyt not aimed at
reproduction is a misdemeanor. It is also forbidden to use embryonic stem
cells for research or diagnostic. A debate of the German Parliament is
expected on the subject. |
Central
Ethics Commission on Federal Ethics. |
|
|
There
is no regulation on embryo research.
The area is regulated by a declaration of the General Council on
Health (1988). |
allowed
under certain conditions. |
14
days after conception. |
|
Conditions:
research needs to be approved by the appropriate Ethics Committee. |
Cloning
is expressly forbidden. |
Different
Ethics Committees exist. |
|
Irland |
The
area is regulated by the 8 th Amendment of the
Irish Constitutional Law. |
not
allowed. |
|
|
|
|
|
|
|
Research
on embryos is not regulated by law. An
ordonnance from the Ministry of Health forbids
cloning (1997). |
|
|
|
|
|
The
National Bioethics Committee. There is
also a 2000 report on the use of stem cells for therapeutic purposes. The report is in favor of therapeutic
cloning and research on excess embryos. |
|
|
The
is no regulation. Only a proposed
legislation on IVF (1999). |
|
|
|
|
|
|
|
|
There
is no regulation. Only a proposed law on gametes and human embryos (2000). |
Research
protocols must be approved by a Central Research Commission on human
subjects. The Commission's approval is
based on 1995 memorandum excluding therapeutic research using embryos. |
|
|
|
In
September 2000, the Government presented Parliament with a proposed
legislation on sperm, ovocyts and embryos (used for
other purposes than reproduction). |
|
|
Portugual |
There
is no regulation. The Parliament approved a proposition of law but the
President has vetoed it in 1999. |
|
|
|
|
|
The
National Ethics Committee on life science published a report in 1995. |
|
|
On
reproductive techniques (1988). Human cloning is forbidden. |
allowed
under certain conditions. |
14
days with parental consent. |
5
years. |
Only
research with therapeutic or diagnostic aims; Non therapeutic research is
authorized only on non-viable embryos and with the condition that animals are
not used. |
|
|
|
|
on
in vitro fertilizaton (1988); Legislation also on
research and treatment with human fertilized ovas.
(1991) |
allowed
under certain conditions. |
14
days from fertilization. |
|
When
research is completed, the embryo must be destroyed. Implantation in utero
of the embryo for research purposes is forbidden. |
Research
aimed at genetically modifying an embryo is forbidden. |
|
|
|
on
human fertilization and embryology (1990). |
allowed
under certain conditions. |
14
days. |
5
years; 10 years with consent. |
Conditions:
licensing from the Authority on Human fetrilization
and embryology. |
Non-therapeutic
research must:promote the impovement
of the reproductive technologies, better the knowlegde
of congenital diseases, abortion, better contraceptive techniques, develop
methods to identify genes or abnormal chromosoms
before in utero implantation. |
Human
fertilization and embryology authority. It is a public and independent
authority in charging of regulatingembryo research,
IVF techniques and authorize therapeutic cloning research. |
As the chart shows us, even countries as
close as the European Union’s experience great divergence in their legislation
concerning embryo research. At the
international level also, the issue of embryo stem cells research has been
raised. The main concern at all levels (
The Oviedo Convention[56]
(under the aegis of the Council of Europe) and the Convention on the Human
Genome (under the aegis of UNESCO) have tried to address this concern. The Oviedo Convention is particularly
interesting because it had to reconcile national sensibilities sometimes diametrally opposed to one another. This Convention could therefore give us some
guidance on how to reconcile our internal oppositions.
The Convention first had to take into
account the trauma still affecting
The Convention started from the premise
that individual fundamental rights should not be sacrificed on behalf of
scientific progress, free from any moral or legal principle. This idea has been embodied in article 1 of
the Oviedo Convention: “ The parties to the present Convention protects the
human being in its dignity, identity and guarantee every person, without
discrimination, the respect of its integrity and of its other fundamental
rights and liberties toward the application of biology and medicine.”
The Convention may be
signed by the 40 member states of the European Council but also by
The underlying
principle of the Oviedo Convention is the preservation of human dignity. The notion of human dignity itself however is
based on traditional Christian thoughts[59]. Indeed, the idea of human dignity is at the
core of the Roman Catholic view concerning embryo stem cells research. The pope, jean Paul II, explained in Evangelium Vitae[60],
“the use of human embryos and fetuses as object of experiments constitutes a
crime against their dignity as human beings.”
The idea of human dignity, however, has not been applied for so long to
the area of science. Human dignity is
now the cornerstone of the Oviedo Convention.
The report following the Convention emphasizes
that human dignity designates “the essential value to maintain; the foundation
underlying most of the values protected by this Convention.[61]” Further, the Preamble states that all parties
signatory to the Convention recognize the “necessity to respect human beings as
an individual but also as a member of human species...”, that the progress of
biology and medicine must be used “for the benefit of present and future
generations.” The Convention then
reveals a dual approach of the principle of human dignity: the term encompasses
both the individual and the human species.
The individual’s protection resides in a protection against illicit
bodily invasions[62], an
equal access to medical care[63],
a guarantee against uncontrolled use of genetic testing[64],
use of his organs[65]. The human species, on the other hand, receive
protection essentially in the area of genetics and the research on the human
genome.
However, as in many
domestic legislations, the Oviedo Convention is lacking express definitions for
the terms it is using: neither the term human being nor person is defined. The rationale behind that gap resides in the
disagreement among the signatory parties, thereby leaving the definitions up to
each domestic legislation. Moreover, the
term “person” is not temporarily defined by the Convention: no article
expressly states the beginning of life as the starting point of the attribution
of rights. If the letter of the
Convention address a person dead or alive, a major issue remains unsolved: in
which form does that person appear? The
answer to this issue is crucial in determining whether the Convention would
support or not the research being done on human embryo stem cells. At which stage of human development is the
Convention considering the embryo a person?
How many hours, days, weeks or even months are necessary to be declared
a person under the Convention? In spite
of this issue, the embryo is not entitled to any rights under the
Convention. As a French author stated
it, this is “the impossible status of the embryo.”
In the
Faced with that issue,
Noelle Lenoir[67]
expressed her concern that the embryo will no more be considered as by its
potential to become a person but rather as a cluster of cells, “some kind of
material of human life”. If indeed the
embryo is no longer considered a potential person but only a “material of human
life”, the progresses of science will have impacted our traditional way of
thinking of life. This evolution alone
renders the study of human embryo stem cells worthy of a debate.
So far, the Oviedo
Convention deals with the research on in vitro embryos by stating: “when the
research on embryos is allowed by legislation, this legislation will insure an
adequate protection of the embryo.”
Further, the text prohibits “the making of human embryos for the sole
purpose of doing research.” Thus far,
the Convention’s language does not address the principle of research on in
vitro embryos; needless to say that it does not define the status of the
embryo. The Convention only proscribes
the creation of human embryos for the sole purpose of research. One could even argue that the Convention
implicitly sides on the side of allowing the research on excess embryos, since
the lack of a prohibition could be viewed as encouragement.
Indeed, the first draft
of the Oviedo Convention went as far as considering the research on embryos
ethically sound, thereby allowing research on excess embryos under fourteen
days. This provision, however, raised
such a passionate debate among the participating States that the final
Convention had to strike the balance we have seen between the two extremes
(i.e.: an absolute protection of the embryo, and the authorization of research
on embryos.)
CONCLUSION:
We have seen the two
extreme views concerning embryonic stem cells research: (1) the embryo is the
tiniest of human beings and therefore deserves the most basic right: the right
not to be killed. (2) the embryo is more
of a human tissue, a “cluster of cells.”
Intertwined to those views are the moral and medical issues of when life
begins, the doubts concerning the research and even possible alternatives
avoiding the conflicting we are now facing, the fear of the past.
An alternative thought
on the issue of embryo stem cells research is possible however: all agree that
no matter how the embryo is defined, that it deserves a “special respect” due
to its potential, even if very remote, and its value to human development.
The European Union has
tried to tackle the issue but finally avoided giving a clear answer because too
much passion surrounded the debate. In
the United States also, the National Institutes of Health interpretation of the
Federal funding criteria avoid the same issue by declaring that the research it
is allowing is not made on embryos.
Now, seems like a good
time for all countries to gather and decide once and for all what is the status
of the embryo and if research is permitted what the guidelines should be. The fear of the past, combined with the
promises of the future of embryo stem cells should not leave us in the uneasy
situation where research on embryo stem cells is done but without clearly
facing the issues raised by such a progress in science. As a French author suggested, so far we can
only describe the “impossible status of the embryo.”
[1] Francesco Fiori, report to the European
Parliament,
[2] Bone marrow, kidney…
[3] so far, mostly mice adult stem cells experiences.
[4] Shirley J. Wright, Assistant Professor of biology at the University of Dayton, Ohio “Human embryonic stem-cell research: science and ethics”, 1999 W L 3555448, July 1999.
[5] Office of the Press Secretary, President George W. Bush,
[6]
[7] Among the entities meeting President’s Bush criteria and therefore eligible for federal funding are: BresaGen, Inc, Georgia- CyThera, Inc, California- ES Cell International, Australia- Geron, Inc, California- Goteborg University, Sweden- Karolinska Institute, Sweden- National Centre for Biological Sciences/ Tata Institute of Fundamental Research, India- Reliance Life Sciences, India- Technion University, Israel- University of California, California- Wisconsin Alumni Research Foundation, Wisconsin.
[8] “On human embryos and medical research: an appeal for ethically responsible science and public policy.” 16 ISSULM 261 (spring 2001).
[9] Cardinal Bevilaqua is cited in “use of stem cells in biotechnological research.” 22 WTLR 1183 (2001).
[10] Senator Arlen Specter.
[11] Peter Singer, Practical Ethics, 2d edition, 1993.
[12] Id at page 157.
[13]
[14]
[15]
[16]
[17]
[18] Id at 592,593.
[19] Id at 593.
[20]
[21]
[22] The American Fertility Society is an organization of 10,000 physicians and scientists who specialize in problems of human infertility. The information presented at trial by the Society comes from its 1990 report on Ethical Considerations of the New Reproductive Technologies.
[23]
[24] Roe v. Wade, 410
[25] The
[26] Roe v. Wade at 162.
[27] Webster v. Reproductive Health Services, 492 U.S. 490 (1989) at 529 (concurrence).
[28]
[29]
[30] Report of the Ethics Committee of the American Fertility Society, Official Journal of the American Fertility Society, Volume 53,number 6, June 1990.
[31] La. Rev. Stat. tit. 9 § 123, 129 (2000).
[32] Id. section 122.
[33] Me. Rev. Stat. Tit. 22 § 1593 (1992).
[34] NBAC, “Ethical Issues in Human Stem Cell Research”, vol. II, p A-4, A-10.
[35] Mass. Gen. Laws ch. 112 section 12 J (a) I (1996).
[36]
[37] Min. Stat. Section 145.422 (1998)
[38]
[39] N.D. Cent. Code section 14-02.2-01 (1) (1997).
[40] NBAC, “Ethical Issues on Human Stem Cell Research”, vol. II, p. A-4.
[41] Pa.Cons.Stat. title 18 section 3216 (a) (2000).
[42]
[43] R.I.Gen.Laws section 11-54-1(a) (2000).
[44] NBAC, “Ethical Issues In Human Stem Cell research”, vol. II, p. A-4, A-10.
[45] S.D. Codified Laws sections 34-14-16,34-14-17 (2001).
[46]
[47]
[48] United States Government sponsored radiation experiments from 1945-1973.
[49] American Bioethics Advisory Commission, “NIH and human embryo research revisited: what is wronh with this picture?”, Dianne N. Irving, 2001.
[50] Laura Johannes, “Adult stem cells have advantage battling disease”,
The Wall Street Journal,
[51] Those are the cells obtained from aborted embryos.
[52] National Institutes of Health, “Opportunities and challenges: a focus on future stem cell applications”, executive summary at p. 4, www.nih.gov/news/stemcell/scireprt.htm
[53] id at p. 14.
[54] The information is coming from: “ Document de travail sur les implications socials, juridiques,
ethiques et economiques de
la genetique humanine”
presented by Franscesco Fiori
on
[55] Lastly, that argument was used by the French Minister of Health, Le Monde, November 2001.
[56] Convention on Human Rights and biomedicine, signed in
[57] Indeed, the birth of the infamous sheep, Dolly on
[58] The 4 Protocols deal with human cloning, organ transplantation and human tissues, biomedical research, protection of the human embryo and fetus and human genetics.
[59] “God created man to its image, to God’s image he created him, man and woman, he created them.” Old Testament, Genesis.
[60] Encyclique of 1995.
[61] Point 9 of the report following the Oviedo Convention.
[62] Article 5 of the
[63] Article 4 of the Convention.
[64] Article 11 and 12 of the Convention.
[65] Article 19 to 22 of the Convention.
[66] This technique is currently proscribed. This technique would produce be a “perfect” organ for transplantation since the patient and the embryo used to obtain the stem cells have the exact same genetic material.
[67] Noelle Lenoir is the President of the European Group on Ethics of science and new technologies.