Science, 25. Feb 2000, Vol 287, No. 5457, page 1425
Europe Confronts the Embryonic Stem Cell Research Challenge
Europe's historic plurality and the lack of a commonly accepted
definition of the moral status of the embryo have led to varying regulation in European
countries. Council of Europe and European Union legislation, based on fundamental ethical
principles, does exist for specific issues, such as prohibition against producing embryos
solely for research. Such principles have recently been elucidated by the European Group
on Ethics in Science and New Technologies. Newly emerging research techniques are
beginning to cause reconsideration of the regulation of embryo research in Europe.
Noëlle Lenoir
Is the culturing of human embryonic stem cells really creating a medical revolution?
Will it lead toward an entirely new way of practicing medicine in which diseased human
body parts can be regenerated with grafts derived from differentiated cells? Will this new
medicine of "regeneration" empower society to eliminate the vicissitudes of the
natural genetic "lottery," with everyone able to use his or her own cultured
cells as a source of new tissues and organs?
No one knows, of course. Nevertheless, the work on embryonic stem cells, reported in
Science at the end of 1998 (1), has given rise to unprecedented hopes, the direct result
of which has been new reflection on the status of the human embryo. Such reflection
involves reconciling "respect for human life" with "freedom of
inquiry," principles that both have constitutional grounds in Europe (2).
Throughout human history, the status of the human embryo has continually changed in
response to the transformation of cultural values and the acquisition of new scientific
knowledge. For the ancient Greek philosophers, for instance, human life per se did not
have any value. According to Aristotle, the fetus was deemed worthy of protection only
after 40 days for males and 90 days for females. The Catholic Church did not immediately
condemn abortion. In the 5th century A.D., Saint Augustine believed that the fetus was
part of a woman's body and was thus deprived of any sensation of its own (3). It was only
in the 13th century that abortion was condemned by the Church as against nature and
against a woman's duty to bear children. All the major monotheistic religions, such as
Judaism, Catholicism, Protestantism, and Islam, remain divided on the status of the human
embryo (4).
In today's more secular Europe, opposition continues between those who believe that the
human embryo should be respected as a person and those for whom it is essentially a
fertilized ovum. However, the principle of respect for human life is strongly rooted in
European traditions, and humankind's claim to absolute mastery of the universe is thus
often doubted. This is striking in Germany, where religion and a profound commitment to
respect for natural processes, combined with the need to reject the Hitler regime's
degradation of human life, contribute to a strict prohibition of embryo research (5).
Europe's pluralism must be taken into account in understanding the status of embryo
research and in predicting its future evolution. Until now, different European countries
have taken contrasting approaches, not only on embryo research but also on other subjects
such as abortion and new reproductive technologies. On the other hand, uniform European
legislation exists on specific issues, namely the prohibition against producing embryos
solely for research purposes and against any commercial exploitation, and the forbidding
of reproductive cloning and of modifications of the human germ line. Some of these points
of agreement seem nonetheless vulnerable in view of the complexity introduced by embryonic
stem cell research.
The standard among European countries has been to uphold the principle of respect for the
human being from the very beginning of life, and even before birth. This does not mean
that the right to life is automatically recognized in the case of the unborn child. The
Austrian Constitutional Court decided, for instance, that the right to life "cannot
be applied to the embryo" (6), whereas the German Constitutional Tribunal ruled to
the contrary that the human embryo is a human being fully possessing the dignity of a
person (7). This results in a great diversity of legislation in Europe with regard to
abortion. It ranges from Ireland, whose constitution establishes the "right to life
of the unborn child" and results in a strict prohibition against abortion, to France
and the United Kingdom, where abortion is generally permitted until die 10th or 12th week
of pregnancy.
Similar degrees of diversity exist in national legislation in Europe dealing with embryo
research. For instance, in France, although abortion rights are liberal and in vitro
fertilization (IVF) is commonly done, embryo research is legally forbidden. In addition,
although every European country has abortion legislation, only 7 of the 15 European Union
(EU) member states have legal provisions concerning embryo research (8): The United
Kingdom, which is at the forefront of research, has enacted very liberal legislation to
promote embryo research, whereas Belgium has left it unregulated.
None of the European countries has yet dared to define the human embryo or the notion of
human life. Thus, it would seem that legislators feel unable to fix in definite terms such
concepts that cannot be but arbitrary. The border between life and death is in fact
defined according to societal convention. This is made evident by the recent postulation
of brain death as the legally determinative event. This new legal standard is linked to
the harvesting of organs for transplantation. Similarly, the concept of
"pre-embryo" [not older than 14 days after the gametes are mixed (9)] has been
developed to defuse controversy concerning embryo research.
Does this mean that the definition of such fundamental concepts as human life is bound to
be based on fragile principles? In Europe, certainly not. Although it is up to each
European state to decide upon the legality of embryo research, in those countries that
authorize it, it must be conducted consistent with regulations imposed by European
authorities - that is, the Council of Europe (an organization bringing together Eastern
and Western European countries) (10) and the EU. However, some of these regulations now
appear controversial in the context of prospective embryonic stem cell production.
The first regulation is the Convention "on Human Rights and Biomedicine" of the
Council of Europe, effective 1 December 1999 (11). As already mentioned, although it
leaves up to each country the decision to allow or forbid embryo research, it nevertheless
requires that countries prohibit "the creation of human embryos for research
purposes." Up to now, this seemed sensible because embryo research was mainly
connected to new reproductive technologies, and researchers were enabled to experiment
with supernumerary embryos. Is this prohibition compatible with research on embryonic stem
cells derived by means of nuclear transfer? Apparently not, and this is probably one of
the reasons why certain European countries are hesitating to ratify the Convention.
At the EU level, the regulation "on the Legal Protection of Biotechnological
Inventions," dated 6 July 1998 (12), considers "the use of embryos for
industrial and commercial purposes" to be unpatentable inventions. Is this
prohibition, referring to the older European principle of "the noncommercialization
of the human body," in accordance with the patenting of cultured stem cells? That is
another question now being raised.
What is lacking is a clarification of the European values at stake in this field. It is a
void that the European Group on Ethics in Science and New Technologies (EGE) has
endeavored to fill, with half of its 14 Opinions to date touching on the ethics of embryo
research (8). The EGE, created in 1992, is an advisory committee to the European
Commission, the European Parliament, and the Council of Ministers of the EU. It is
independent, represented by 12 countries and several disciplines (philosophy, law,
medicine, biology, sociology, theology, and computer science) (8).
The EGE has taken into account the facts that there is no specific legislation at the EU
level concerning embryonic stem cell culturing and that there currently is no real will to
harmonize national laws. "Because of lack of consensus concerning the status of human
embryos, it would be inappropriate to impose one exclusive moral code," admits the
EGE in its opinion on "Human Embryo Research." Accordingly, the EGE has refused
to call for a ban on public funding for embryo research at the European Community level,
in contrast to the United States, where Congress has prohibited federal funding for embryo
research, leaving it in private hands. The EGE stressed that "it is crucial to place
human embryo research, in the countries where it is permitted, under strict public
control, while ensuring maximum transparency, whether the research in question is carried
out either by the public or by the private sector."
In this context, all solutions that might be adopted in Europe concerning embryonic stem
cell research will satisfy the following conditions:
First, the principle of human dignity is stronger in Europe than the principle of
unrestrained freedom of research. This explains why there is a general ban at the European
level on reproductive cloning and on human germ line modifications, both in the
aforementioned regulation "on the Legal Protection of Biotechnological
Inventions" and in the decision of the EU to refuse funding for such research (13).
The issue here is that embryo manipulation raises completely different ethical concerns,
depending on whether it is intended for research or for procreation. As the EGE said in
its opinion on cloning: "Considerations of instrumentalization and eugenics render
[reproductive cloning] ethically unacceptable," but this is not the case for human
embryo research, notwithstanding the fact that such research otherwise raises
"serious ethical controversies" (8).
Second, irreversible damage is possible unless strong emphasis is placed on the principle
of adequate caution ahead of the pursuit of economic interests. As a consequence, ethical
evaluation and open public debate must come before research in the most controversial
areas. Debate is all the more essential given the possibility of embryonic stem cells
being used on an industrial scale. The EGE stresses: "However promising the medical
perspectives, recent manipulations of human stem cell lines carried out in the U.S. raise
a number of ethical questions. These questions emphasize the urgency to enlarge the
debate.... European citizens have a right to be clearly informed ... as well as to be put
in a position to evaluate the responsibilities implied for society as a whole" (8).
In conclusion, embryonic stem cell research in Europe will ultimately depend on European
citizens' values. As Rabelais said in 1532, in his book Pantagruel (14), "Science
without conscience is but death of the soul." In. the light of today's preoccupations
in Europe, this statement should be understood as reflecting two cultural currents. First,
Europeans hold the view that public authorities must establish the principles according to
which research must be conducted. Second, because of Europe's experience of scientific
excess, there is a consensus that the scientific agenda should be congruent with
fundamental social values.