Global Bioethics

ISSN: 1128-7462 (Print) 1591-7398 (Online) Journal homepage: https://www.tandfonline.com/loi/rgbe20

The Place of Civil Law in Biotechnology

Carlos M. Romeo-Casabona

To cite this article: Carlos M. Romeo-Casabona (2004) The Place of Civil Law in Biotechnology,
Global Bioethics, 17:1, 125-130, DOI: 10.1080/11287462.2004.10800851

To link to this article: https://doi.org/10.1080/11287462.2004.10800851

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GLOBAL BIOETIIICS Vol. 17-2004

CarlosM. The Place of Civil Law

Romeo-Casabona
Dr.iur. Dr.med Dr h.c. mult. Profes-
sor in Criminal Law, Director, Inter-
University Chair BBVA Foundation
- Provincial Government of Biscay
in Law and the Human Genome.
University of Deusto, and University
of The Basque Country, Bilbao, Spai
in Biotechnology
Biolaw is an autonomous interdisciplinary legal discipline, with
great theoretical and practical relevance because of its possible
social effects. This contribution deal with the most relevant
different approaches to bioethical problems according to the
main juridical systems, as they are civil law and common law.
A main topic is also the relation between Biolaw, Bioethics and
Biopolitics

Biolaw as a new law for biomedicine and biotechnology

Biolaw or Biomedical - Sciences - Law encompasses the legal implications of the so-
called biomedical sciences and biotechnology as it affects the human being and, therefore,
all living things (animals and plants).
Biolaw has been enlarging its focus progressively, forced by the great development of
Biomedical Sciences, but probably also influenced by the development of Bioethics. Due
to the enlargement of its field, biolaw has substituted and absorbed traditional medical
law, which with a narrower point of view, is in charge of the legal aspects related to the
practice of medicine. Consequently, medical law has been dealing with the professional
relations between physicians and health organizations, patients, healthcare users (public
or private), with other health professionals, and, especially, with the legal responsibilities
that could be derived from such relations (generally due to carelessness or medical mal-
practice).
As we can see, biolaw reverses the perspective: the focus is on the human being as
the addressee (in all aspects of his origins and biological evolution) and, therefore, as the
potential receiver of the benefits or damages, in the affection of his rights and legal goods,
of biomedical sciences, that is, not only medicine but also, biology, biochemistry, biophy-
sics, as well as biotechnologies. On the other hand, in extending the field to all living
things, biolaw must also deal with the equilibrium of natural systems, the protections of
all living things (the manipulation of genetically modified micro organisms, animal expe-
rimentation, cloning, transgenic animal and plant production and so on) and specifically
126 C. M. ROMEO-CASABONA

with the security of biotechnological research and production and the legal protection of
the inventions derived therefrom.
Biolaw is, according to the above statement, an autonomous interdisciplinary legal
discipline, with great theoretical and practical relevance because of its possible social
effects. Therefore, its study cannot be completely satisfied from a unilateral perspective
offered by the classic legal sciences (constitutional law, administrative law, civil law,
criminal law and philosophy law).

Juridical approaches to bioethical problems: civlllaw v. common law

The starting point of biolaw was when the biomedical sciences began to pay closer
attention towards the especially vulnerable subjects, whatever the cause or circumstance
of such vulnerability. These subjects pose with greater frequency limit situations, which,
at times, are almost impossible to resolve from even the most established traditional legal
fields. On the one hand, this phenomenon requires constant rethinking of the way to ap-
proach and the possible solutions, having to recognise that the law cannot always provide
immediate and wholly satisfactory answers. On the other hand, this complexity has forced
lawyers to use, each time with a greater degree of frequency, biotechnological conflicts as
a testing ground to contrast the coherence and validity of their legal reasoning.
Indeed, it has not been uncommon for Law to face itself with the necessity to confront
new social situations, and with a greater degree of acceleration throughout the twentieth
century. These new situations have derived from changes in the control and production
of goods and services, changes in economic relations, discoveries and improvements in
science and technology, or from changes in inter-personal relations, which, in its entirety,
biomedical sciences is one of the most clear examples.
The answers provided by law have been focused in two main ways, according to the
two traditional legal systems: European Continental law (civil law) and Anglo-Saxon law
(common law). The tradition of Civil Law means that law is grounded in very specific
normative sources, from which Acts approved by national parliaments are the fundamental
way of that sources. This is a good way to get security to citizens in which they should
engage to avoid a confrontation against law and to reach a protection from it. At the same
time jurisdictional courts are submitted to the words of act being relevant for the case in
conflict, but because the words of law are broad enough to be applied to many specific
cases that can happen in everyday life, the courts frequently have to give their interpre-
tation on whether and in which way the law is relevant for the case in conflict. This opi-
nion, formed by superior courts, could also be relevant for similar situations, but not in
such a strong way as Common Law is (the precedent ruling).
Sometimes, the Law has resolved a new situation by accepting new emerging social
relations, either by establishing new regulations or by judicial recognition. Finally, the
matter has been resolved through the application of basic general and legally integrated
principles. That is, by providing a legal solution ahead of a social conception, introducing
through law development (legal or judicial) new axiological principles, although this has
been the exception.
THE PLACE OF CIVIL LAW IN BIOTECHNOLOGY 127

These ways have been established, either through legislation, through the legislators,
or - in the case of having competence for it - through the executive power, via judicial
rulings in relation to conflicts presented before the courts. The first system has been used
mainly by countries which are based on the European Continental law system (e.g. the so
called "Bioethics Laws" of France (1994 and 2004); the Embryo Protection Law and on
the Import and Use of Embryonic Stem cells of Germany (1990 and 2002); the Medically
Assisted Reproduction Techniques Law of Spain (1988 and 2003); meanwhile the second
system has been used in countries of the common law or judicial precedent system, espe-
cially in relation to biomedical conflicts in the USA, United Kingdom and Canada. Howe-
ver, in both legal systems a reciprocal influence can be observed.
According to this, in an strict sense, we cannot accept the occasional existence of
legal holes in connection with new social phenomena - scientific or technological - be-
cause it is always possible to find a legal principle more or less adapted to the demands
of the new reality. However, it is also true that in certain occasions, it is not possible
to extract from the current law - of a given legal system - regulatory and satisfactory
principles for the necessities of the community; i.e. it is not always possible to offer
valid answers for those new realities or new social phenomena. Something similar is
occurring with biotechnology, because it offers new perspectives on the human being's
understanding of such fundamental notions as the relation of humankind with other li-
ving beings and with the environment. In this way, society is forced to take part in these
changes, because they are going to have important consequences for present and future
generations.
In this case, the juridical problem (or one of them) consists of detecting the new
ethical and social values necessary to confront the new reality, in how they are integrated
in the juridical framework and (just as importantly) how those new social and ethical va-
lues are developed and created. Here lies the importance of bioethics inside law, helping
the law identify bioethical conflicts and suggest possible solutions. At this point we would
question the relation between law and ethics, and how this relation can help the judges in-
terpret, the experts define, and the legislator create new laws, keeping clear the difference
between the two and of the way in which law works.

Bioethics as conftuence for European Continental law and common law in the field
ofbiolaw

At least in the field of biomedicine and biotechnology I think that Bioethics now
plays a fundamental role: to act as a meeting point of the two traditional juridical systems.
The grounds of this meeting point lays in the fact that both European Continental law and
common law are using as their respective sources the new regulations from bioethics.
It is clear that bioethics and biolaw were born at the same time, as well as their object
of study, being different just in the way they focus each study. That is why, and as pointed
out above, it is impossible to deny the relation between bioethics and biolaw, once we
overcame the way of thinking from the seventeenth and eighteenth centuries (whose cli-
max was the French revolution) which tried to clearly separate law and religion (religious
128 C. M ROMEO-CASABONA

moral). Today there are neither ancient fears of mistaking/identifying between law and re-
ligion nor of intrusion of religious power into the civil one.
We can easily see the influence of bioethics in law, for example, in admitting persons
as living donors for organ transplants due to the beneficence principle and respect for
animals. Similarly, we cannot ignore the influence that law has in bioethics as happens,
for example in relation to the principle of "informed consent" used by bioethicists as an
expression of the autonomy principle. This had been secularly elaborated in the juridical
world in relation to the public law principle of freedom and the private law principle of
will development and expression. In reference to the field of biotechnology, the influence
of law on bioethics can be seen in matters relating to patents in a broad sense and to bio-
security, because patents specifically related to living matter could be taken as an example
of a meeting point between bioethics and law.
Nowadays, it is not possible to discuss the existence of a relationship between bioe-
thics and law and the fruitfulness of that relation; there is, however, a problem with esta-
blishing the limits of both. This is especially due to the influence of the practice of bioe-
thics - more than its conception - by some North American and European researchers.
They consider it a multidisciplinary subject whose object is not only the ethical aspects
(applied ethics) of biomedical sciences, but also the philosophical, legal and sociological
aspect. Furthermore, because of this, such researchers tend to consider ethical problems as
if they were legal problems, conflicts of interest and subjective values arise.
We can be sure that bioethics is a clear example of a multidisciplinary approach to
an object of study, where several sciences are represented, apart from ethics, with their
various perspectives and methodologies. In this wide sense of its empiric expression,
law would also fall within bioethics. All of these characteristics, together with its plural
and transnational ideological framework - because bioethics is not a moral system, nor
does it want to be one - tend to configure bioethics as a powerful intellectual reflexive
instrument. Its object being to elaborate guiding criteria and act as a starting point to
take an opposing stand to the State's excesses, to the diffuse pressure of public powers
(political, economical, industrial) and, if it were necessary, to researchers. Besides the
terribly negative experiences of recent decades, it is possible to assume today an opti-
mism that, as I have explained above, allows us to plot the biocratic society in the bioe-
thics person's favour.
Law, as well as ethics, also appear in the axiological world, where values are set
out, but there are differences between law and ethics. These are that the law is com-
pulsory and heteronomous in its character and the way in which law is manifested, or
created through regulations (e.g. through judicial decisions in the common law system),
which are legitimised when they have been created in a democratic state and thereby
plural. In this sense, such an ideological separation is only possible in the framework
of a democratic constitution, which adopts the dominant values of a society and the-
reby produces laws endorsed by a majority consensus. Nevertheless, it is certain that
the Constitution (any constitution) does not imply a standard of "minimum ethics" (we
have historical examples of this), but it is something that must be demonstrated in each
case. This is not to imply that it is necessary to establish a previous bond to a pre-con-
stituted legal order (the natural law), but at least a commonly-accepted notion of the
human being as autonomous from which we can derive a treatment based in equality
THE PLACE OF CIVIL LAW IN BIOTECHNOLOGY 129

and self-responsibility and from which human dignity can be deduced. Only in this way
can one avoid the arbitrariness of a decision to resolve each individual case, totally
separate from the others; and only in this way can the objective of generalisation that
characterises law be satisfied. But, once again, pluralism asks for a social agreement on
the content of those principles (or some other considered axis), their reach and limit and
their internal hierarchy. This aspect is discussed in the next section.

Relation between (Bio-)Law and (Bio-)Politics

Constitutions or modem fundamental laws of democratic States are shaped as the

appropriate instruments from which one can extract socially accepted values. In this
sense, we can assume that the Constitution frequently does contain not only a sole so-
lution but also a framework of answers, sometimes more precise and other times more
uncertain. This does not mean that an absolute indetermination exists, because there
are always some limits, although on occasions they are difficult to specify. It is also
possible to accept that although a certain interpretation neither finds support in a given
constitution nor opposes to it, it does not consequently mean that in that particular case
there can be a demand for a recognition of constitutionally-based pretence. Because one
cannot try to obtain explicit answers from the Constitution in all the cases, on occasions
it will be necessary to accept only interpretations or conceptions that are compatible
with it.
Nevertheless, in this constitutional normative constellation we find sufficient sup-
port so that the values that the constitution consecrates or that can be deduced from it
project their corresponding reflection in the interpretation of the juridical framework
whenever applicable to legal implications in biomedical advances or in the legislative
activity related to this matter. The judge's interpretative work, the applicability of ge-
neral principles of law, and the consensus in the legislative tasks are the most effective
instruments for the social incorporation of those new or revised perspectives. This hap-
pens with such principles as human dignity, individual autonomy, equality, tolerance,
self-responsibility, the person's inviolability, inalienability of the human body, solidarity.
Finally, the constitutions can look for another source of normative or interpretati-
ve inspiration: the UN's Universal Declaration on Human Rights. It is certain that the
Declaration, in spite of calling itself "Universal", is an achievement of Western cultural
conceptions. In order to be shared by different ideological conceptions, the drafters had
to compromise to find a common foundation to the rights recognized in it. However,
on the one hand, certain scepticism exists about its necessity by countries belonging
to other cultures, specially Oriental ones. On the other hand, theories of natural rights
seem to find a foundation and a meta-positive limit to law, mainly in reference to
human rights. It is from here that one try to could recapture the current existing discus-
sion that faces modernity and post-modernity. These trends, contrary to the universali-
ty of human rights and to the mere positivism of law, could perhaps reach a common
point. These may be consistent in the conversion to the field of law of Kant's principle
of the person's dignity, as a catalyser:
130 C. M. ROMEO-CASABONA

"Law has already obligatory force due to his mere positivism, for its virtue of
overcoming the bellum omnium contra omnes, the civil war, but in the event of a
serious infraction of the material principle ofjustice, the respect to the persons
dignity, its injustice will lack of obligatory force it will be necessary to deny him
the character of Law".

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