BIOLAW
I. theories: bioethics and biolaw
II. problems: beginning and of life
issues
III. case analysis
bioethics
Van Rensselaer Potter, Bioethics: bridge to the future,
1970
- the fact that the rapid advances in science had proceeded
without due attention being paid to values
- field of medicine, biology, environmental issues
bioethics, as a ‘bridge’ between ‘facts’ and ‘values’.
Potter said that he coined the word bioethics using two
Greek words, bíos, life, representing the facts of life and
life sciences, and éthos, morals, referring to values and
duties
bioethics
• not all that is technically possible is
morally right,
• some control of our intervention in nature
and the environment, on animals and on
human beings, is needed
• the future of life and of humankind is at
stake
BIOETHICS
• scientific and technological advance in the
biomedical field opens new possibilities of
intervention on life (human and nonhuman) and raises new moral questions
• anything that can be done, must be done
anyway? are there limits/which?
ethics
ethical pluralism: which ethics for bioethics?
• libertarian theory
• utilitarian theory
• personalism
• concept of person
liberal-libertarian theory
• non-existence and the impossibility to know a
common objective truth (non cognitivism)
• ‘strong’ pluralism of values: no unification of the
plurality of values is possible and desirable
1. principle of autonomy: self-determination
2. principle of tolerance: every subjective ethical
view must be accepted, passively tolerated and
indifferently legitimated in an equivalent way to
any other
utilitarianism
• an empirical/consequentialist moral theory
• priority to the sensation: ability to feel pleasure
and pain, the ability to prefer pleasure to pain
1. principle of utility: welfare (or happiness) = the
best optimal balance of benefits over costs, of
satisfactions over frustrations, of
preferences/interests (in terms of pleasure/joy)
over damage (pain/suffering)
2. principle of the maximisation of the interests of
all the individuals involved considered as a
whole
personalism
• possibility to know the common/objective truth:
recognition of the intrinsic dignity of the person
in every human being, irrespective of the phase
of physical-psychic development, the condition
of existence (health or illness) or of the
properties that they possess or the abilities that
they are able to show
• principle of physical integrity, therapeutic
principle, liberty/responsability, justice/solidarity
the concept of person
• most frequently used philosophical
concept
• evocative nature of the word
“person” = a subject worthy of some respect
and protection
philosophical ambiguities
• what is a person? (conceptual definition)
• who is a person? (factual identification)
• how should we treat a person? (definition
of rules of conduct)
pluralism (different answers to the
questions)
two trends:
• “personism”: separation of the concept of
person from the human being (not all
human beings are persons/some nonhuman beings may be considered
persons)
• “personalism”: an intrinsic identity between
person and human being
“personism”
(separation person/humans)
- the human being is not a person from the
moment of fertilization, but “becomes” a
person at some subsequent moment
- the person may end “before” the natural
biological death of the human being
boundaries of personal status:
1. personhood = relationship
person begins with the implantation of the
embryo in the uterus
person dies when the human being is no
more capable of relationship
objection: relationship does not constitute
“being” in ontological terms, but it
“presupposes” his/her existence
boundaries of personal status:
2. personhood = individuality
person begins at the 14th day of conception (end
of totipotentiality: possibility of twinning)
objections: recent studies support the hypothesis
that twinning is not a separation (one individual
becomes two individuals) but a “duplication”
(one individual gives birth to another individual)
boundaries of personal status:
3. personhood = sensibility (perception of pleasure
and pain)
person begins with the formation of the central
nervous system/with the capacity of maximizing
pleasure (human beings and animals)
person ends in condition of maximization of pain
objection: experience of pleasure or pain is
structurally subjective, cannot be quantified or
calculated
boundaries of personal status
4. personhood = rationality (possibility to exercise
rationality)
person begins with the formation of the cerebral
cortex (parallelism between “brain death” and
“brain life”; emergentism)
objection: no mirror-correspondence between life
and death (death is the negation of life)/
emergentism does not explain how conscience
“emerges” from matter
boundaries of personal status:
5. personhood = rationality (actual exercise),
selfconsciousness, selfdetermination
person begins with the capability of understanding,
reasoning evaluating (human beings and robots)
person ends with the incapability of understanding,
reasoning and evaluating
objection: the performance of a function is
inseparable from the ontological subject who is
the condition of its existence
consequences:
the ambiguous use of the concept of person
in bioethics opens the way
to new forms of discriminations in terms of
the degree of physical, psychological and
social development of the human
being/existential conditions
the concept of person
does it make sense any longer to use the concept
of person in bioethics and biolaw?
- the recognition of the dignity and rights of the
human being may, in principle, rule out the
discussion of the concept of person (human
rights)
- the notion of person was actually devised in
western philosophy for the precise purpose of
characterizing the human being
person = human being
the identification of the human being as a
person specifies the characteristics and
the constituent property of the human
being (explaining the basis of the person’s
values and rights)
personalism
justification of the identity between human
being and person
the definition of person was originally
devised to characterize the real human
being
definition, originally formulated by Boethius
“rationalis naturae individua substantia”
personalism
• substance = distinct subject who exists in
himeself/herself, not inherent to anything else, or
who belongs only to himeself/herself
the functions which the human being exercises do
not exist in themselves, but exist only as
functions and activities “of” a substantial human
individual, who is their singular and permanent
reference-point (real ontological condition)
personalism
• rational nature:
“nature” means what the person “is” by
virtue of birth
“rational” does not merely indicate
intelligence and rationality but it indicates
reason and thought, word, language,
communication, freedom and intention
ontological personalism
the human being “is” a person by virtue of his/her
rational nature
the human being doesn’t “become” a person by
virtue of the effective exercise of certain
functions (such as relationship, sensibility and
rationality)
the functions are “of” a person (in that they inhere
to his/her substantial nature), they are not “the”
person
ontological personalism
the presence of a substantial principle makes it
possible to recognize the actual status of the
person in the human being even in conditions of
“potentiality” or “privation”
the zygote, the embryo, and the fetus (and also the
newly born or the minor) are “already” persons
the moribund, the handicapped, people in comas,
are “still” persons
ontological personalism
• the ontological concept of person could relate to
the doctrine of human rights, which is universally
agreed and recognized
• recognition of our duty to respect all human
beings and the fundamental rights to life and
integrity of every human being at every stage of
physical, psychological and social development
• human being must always be recognized as an
end, and never just a means
BIOLAW
“biolaw”: the search for rules to discipline
human behaviour at a social level, in the
context of progress in scientific knowledge
and technological applications in biology
and medicine
biothics/biolaw
bioethics and biolaw do not overlap
• bioethics: good/bad; duty (non binding)
• biolaw: rules of behaviour in a binding way
(also foreseeing administrative or penal
sanctions for unlawful behaviour) so as to
guarantee social life
biolaw
• on the one hand, we perceive a urgent need for
biojuridical rules that make social life possible
and resolve disagreements (which appear to be
more and more difficult to resolve because of
ethical pluralism);
• on the other hand a juridical answer, or
systematic reflection, is delayed at a legislative,
doctrinal and jurisprudential level
biolaw
• reasons for the delay in biolaw:
- the asynchrony between the rapidity and dynamism of
the biomedical technical-scientific progress and the
slowness of the law (in the political debate, the
production of laws, the jurisprudential interpretation, the
elaboration of doctrines)
the risk of obsolescence (biolaw tends to arrive too late
when the problem is no longer felt, substantially
transformed or perceived differently),
the risk of hurried interventionism (with problems giving rise
to particular social alarm)
biolaw
- the interdisciplinary structure of bioethics
requires the continuous updating of the
operators and the opportunity for debate with the
experts of different disciplines, with
heterogeneous languages and methodologies
- the need of juridical categories to define and
classify phenomena that depart from the usual
context of analysis
- prudence (or precaution) of the legislator, in the
fear that certain techno-scientific intervention on
life may cause unforeseeable and irreversible
effects
models of biolaw
biojuridical pluralism
- model of abstension
- model of intervention
procedural, ‘soft’
substantive, ‘hard’
abstension
the libertarian model, in the name of the affirmation
of individual freedom, considers the absence of
law/regulation preferable in bioethics
intervention of law, perceived as an instrument of
oppression
a “space free from law/regulation”, supposing that
all that is neither prescribed nor forbidden by
laws is/may be considered allowed
.
abstension
movement of thought known as “Hil”, or “highly
inappropriate legislation”, which considers that
legislation in bioethics, in whatever way it may
be formulated, can only be ‘highly inadequate
a preference for regulations of deontological
codes, codes of professional practice codes of
conduct, or the opinions of ethical committees,
as indirect and flexible rules and regulations,
self-control of a community or the self-discipline
of single researchers
intervention ‘soft’
• intervention of the law in bioethics with the
function of guaranteeing freedom, understood as
individual self-determination
• biolaw should protect the external and formal
conditions allowing freedom to be concretely
manifested and should abolish the impediments,
ensuring the means for the translation of
intention into behaviour
• biolaw should strengthen subjective freedom,
broadening it with the multiplication of the
possibilities of choice (technologically possible)
intervention ‘soft’
• biolaw recognises ethical pluralism, seeking to elaborate
“neutral” rules, without taking sides in favour or against
any moral perspective, so that each single person is free
to express his/her individual option, with the only limit to
avoid damages to others (free individuals)
• “minimal legislation”, procedural rules to negotiate
controversies or flexible intervention of jurisprudence
• only if there is a justified fear of possible severe and
irreversible risks of society, temporary rules, to deal with
social emergencies, which may be reviewed and
eliminated if not necessary
intervention ‘hard’
• detailed, specific legislation, with specific
moral contents
• substantive intervention: specific moral
prespective
• deduction of law from morals
• limits of jurisprudence, protection of
certainty
biolaw
• the law can find ethics in it, inside it: it is not a question
of making a choice between the ethics in the context of
the plurality characterising the present debate (such a
choice would inevitably determine the privilege of one
set of ethics and the delegitimisation of another)
• the law is called upon to account for the internal meaning
of the law itself, as an instrument for the defence of
human coexistence and the dignity of each human
being, as a presupposition and condition of structural
possibility of the existence and human coexistence
biolaw
• fragmentation: phenomenon of “bioethical
tourism”, the displacement of individuals
claiming rights being prohibited in their
country to go to the country that allows the
implementation of those rights
• search for harmonization
International committees
Unesco:
- International Committee for Bioethics
- Intergovernmental Committee fro Bioethics
World Commission on the Ethics of Scientific
Knowledge and Technology (Comest)
WHO, Department of ethics and health
WHO, Global Summit
EU, International dialogue on bioethics
European committees
- European Group of Ethics in Science in
New Technologies EGE (European
Commission)
- Bioethics Committee (Council of Europe)
DH-BIO
European Commission, Nec Forum
National organism
Italian Committee for Bioethics
http://www.governo.it/BIOETICA/
born in 1990
35 members: interdisciplinar ans pluralistic
structure
advice to Parliament and Government;
information to society
opinions, motions
bioethics and culture
bioethical issues are strictly connected to
cultural belonging
- diverse level of development of scientific
knowledge and technological applications
in biomedicine
- different theoretical and practical contexts
bio-ethno-ethics
• the coexistence of different ethnic groups
in the same territory
• solutions to bioethical problems within a
culture often have implications outside
• health cooperation between advanced
countries and developing countries to
ensure equity in health
ethno-centric bioethics
• one’s own culture is superior to all others
in a hierarchical view (imposition of one
culture over other cultures, considered
inferior)
• bioethical
colonialism/imperialism/paternalism
ethno-centric bioethics
• “model of assimilation”: those belonging to
other cultures adapt and adjust to the
bioethics of the “mainstream” culture
• “model of subordination”: possible
exploitation
objection
• an arbitrary imposition of one culture as
superior (it is neither the bioethical place
of origin nor possession of advanced
technology that confers superior ranking
to bioethics)
• an attitude of unjustified intolerant
“arrogance”
multicultural bioethics
• relativist prospective: bioethics of each
culture is and must be placed on the same
level with regard to the bioethics of any
culture, all cultures being equivalent
• tolerance: passive and indulgent
acceptance of every culture/bioethics,
without making any ethical judgement
multicultural bioethics
• juxtaposition of multiple and diverse
bioethics: the search for common values is
futile and undesirable, considering plurality
better than unity as an expression of
richness and originality
multicultural bioethics
• “model of separation”: each culture is a
“closed” world (which internally affirms its
own values and preserves its own
traditions) and externally tolerates any
other bioethical culture
objections
• the principle of equivalence as neutral and
uncritical acceptance of every culture is
unable to avoid cultural conflict among
cultures which are opposing and
incompatible (allowing the stronger culture
to prevail over the weaker one)
• equivalence can lead to self-closure of
each culture in itself, resulting in
incommunicability
intercultural bioethics
• against hierarchy among cultures and
against equivalence
• all bioethics in every culture is judgeable: it
is a duty to express judgement on the
bioethics of different cultures: not a
judgement of superiority or inferiority, but a
judgement of truth in reference to human
dignity, considered as the minimum
common value
intercultural bioethics
• equality must ensure that all men, regardless of
cultural belonging, have the possibility of
knowing each other as human beings (before
realisation of their belonging to a specific cultural
group)
• affirming equality means assuming the
differences: equality is the precondition for
“recognition” of the “differences” as significant
interaction between human beings
bioethics
• the role of bioethics is not to impose a
vision as superior (negating and annulling
the others) nor is it to legitimise every
request from each cultural group
(uncritically), thereby creating a series of
‘separate islands’ that risk conflict
• the structural reference to human rights
acquires priority in ethnoethics: human
rights are the “units of meaning”
bioethics: communication
• negative paths:
- egalitarianisation (assimilation: all men of
diverse cultures should conform to the
dominant culture)
- differentiation (separation: the individuals
of different ethnic groups should be
guaranteed by the broadest possible
conservation of what makes them
different)
bioethics: communication
• intercultural bioethics
- critical search for continuous mediation
and integration of human rights and the
specific needs of diverse cultures
- affirming the relational logic of diversity in
equality
documents
• Convention for the Protection of Human
Rights and Biomedicine of the Council of
Europe (1997)
• Charter of Fundamental Rights of the
European Union (Nice, 2000)
• Universal Declaration on Bioethics and
Human Rights by Unesco (2005)
problems
1.
2.
3.
4.
5.
6.
7.
8.
9.
reproductive technologies
genetic tests
cloning
ascertainment of death
organ transplants
therapeutic obstinacy
euthanasia
living will, advance care directives
allocation of health care resources
reproductive technologies
• the increase in new technological possibilities
with regard to reproduction and the rise of
sterility and/or infertility of the individual and the
couple (despite the persistence of the desire to
have a child that is biologically one’s own),
• constitute the facts behind the emergence over
the last few decades of an increasingly pressing
social demand for access to medically assisted
procreation
reproductive technologies
• is the desire to have a child with the use of
technologies always and anyhow licit?
• what must the limits to the request for
access be?
• does the desire to have a child represent
the claiming of a “right”?
• do “reproduction rights” exist, choosing not
only if and when, but also how to
reproduce oneself?
reproductive technologies
• assisted/artifical insemination/fertilization:
intracorporeal insemination (in vivo) = taking of the
male gamete, its treatment and insertion into the
woman’s body
extracorporeal insemination (in vitro) = taking both
gametes, treating them, fertilising them,
transferring the embryo into the woman’s body
• homologous/heterologous
• surrogate motherhood
(ectogenesis; hibridation)
ethical issue: sexuality/generation
• the question of the separation between sexuality
and generation, mediated by the technical
intervention of the doctor
- libertarians and utilitarians consider the access
to reproduction technologies legitimate, even if
they require an invasive and substitutive
intervention by the doctor with respect to the
unifying act of the couple, appealing to
procreative freedom and the satisfaction of a
widespread social desire (individual and
collective)
sexuality/generation
- the personalist standpoint considers that
the excessive technicalisation and
medicalisation increasingly tends to
reduce procreation to being an impersonal
artificial procedure: the depersonalisation,
the impoverishment of the personal
significance of the generation
sexuality/generation
with intracorporeal artificial insemination: the
technical intervention is a concomitant
cause, insofar as it accompanies the
semen into the uterus; the doctor
intervenes in an auxiliary way with respect
to natural conception, limiting his action to
facilitating the meeting of the gametes,
overcoming the obstacle impeding natural
conception, which anyway takes place
inside the woman’s body
sexuality/generation
with extracorporeal artificial insemination,
greater manipulation is involved: the
doctor’s intervention substitutes the sexual
act: in this case it is not a facilitation but a
substitution
conscientious objection
given the possible ethical reserves towards
artificial extracorporeal insemination,
biolaw should, when legislating over such
practices, foresee the possibility for
conscientious objection by medical staff
biolaw should offer the doctor and medical
staff the possibility not to take part in the
use of certain techniques when they go
against their ethical conscience
main problems for biolaw
- status of the embryo: manipulation
(overproduction, crioconservation,
reduction, selection)
- value of the family
libertarian theory
• procreative freedom: positive reproductive
rights
no personal status of the embryo
family: product of society, or decision of the
individuals (relativistic conception)
libertarian theory
- lecit to access even in condition of fertility
- lecit the manipulation of embryos: priority
of the desires of individuals over the value
of the embryos
- lecit homologous/heterologous fertilization
(anonymity of the donors)
- lecit: acces of single, homosexuals, postmortem,
personalist perspective
• procreative responsability:
personal status of the embryo
value of the (natural) family
personalist perspective
- lecit to access only in condition of infertility
- illecit the manipulation of embryos: priority
of the dignity of the embryos over the
desires of adults (limitation of the number
of production, no reduction, no selection)
- lecit homologous; problems of
heterologous fertilization
- illecit: acces of single, homosexuals, postmortem,
personalist perspective
problems of heterologous fertilization:
- the right of the embryo to know his/her
origin
- asymmetry of the couple (possibile refusal
of fatherhood)
Summary
•
•
•
•
Historical background
Motives/aims of the Convention
Leading principles
Possible restrictions of the rights accorded
by the Convention
• Violations of the Convention
• Further developments
• Questions and discussion
Historical background
Council of Europe
• Council of Europe established in 1949
during the Cold War
• Its main aim: to defend western values
against Soviet Union
• 1989 : fall of the Berlin Wall
• New central and eastern European states
join the Council of Europe
• Second breath for the Council: bioethics
The Convention for Biomedicine
• Prepared between 1991 and 1996 by the
Comité Directeur de Bioéthique (CDBI)
• Adopted by the Committee of Ministers of
the CoE on 19 November 1996
• Opened for signature in Oviedo, Spain on
4 April 1997
• It entered into force on 1 December 1999,
after the fifth ratification (Spain)
Italy and the Convention
• Italy signed the Convention already in
1997
• On 28 March 2001 the Act N° 145
ratifying the Convention was approved by
the Italian Parliament with a majority of
386 votes for, 3 against and 13
abstentions although the Parliament was
already dissolved because of the
forthcoming elections
• However, the deposit of the instrument of
Ratifications
• 28 (of 47) member states have ratified the
Convention
• Mostly central/ eastern European countries
• No ratification by Belgium, France,
Germany, Netherlands, UK….
Motives/aims of the Convention
• a need to make a greater effort to
harmonise existing standards (EM, §4).
To prevent so called ‘bioethics’ paradises
• The Convention as a whole will provide a
common framework for the protection of
human rights and human dignity. Member
states may provide a higher level of
protection (article 27 Convention)
Motives/aims of the Convention
• Parties to this Convention shall see to it
that the fundamental questions raised by
the developments of biology and medicine
are the subject of appropriate public
discussion in the light, in particular, of
relevant medical, social, economic, ethical
and legal implications, and that their
possible application is made the subject of
appropriate consultation (article 28
Convention)
Leading principle A
A. The protection of the human being and of
everyone
•
CONVENTION FOR THE PROTECTION OF
HUMAN RIGHTS AND DIGNITY OF THE
HUMAN BEING WITH REGARD TO THE
APPLICATION OF BIOLOGY AND MEDICINE
•
Parties to this Convention shall protect the
dignity and identity of all human beings and
guarantee everyone, without discrimination,
respect for their integrity and other rights and
Human Being and Everyone
• The Convention does not define the term
‘everyone’ nor (‘human being’. In the
absence of a unanimous agreement on the
definition of these terms among member
States of the Council of Europe, it was
decided to allow domestic law to define
them for the purposes of the application of
the present Convention (EM § 18)
Protection of prenatal life
• Article 18 – Research on embryos in
vitro
1 Where the law allows research on
embryos in vitro, it shall ensure adequate
protection of the embryo.
2 The creation of human embryos for
research purposes is prohibited.
Leading principle B
B. The protection of the human dignity and
the identity of the human being
Parties to this Convention shall protect the
dignity and identity of all human beings
(article 1)
Leading principle B
The protection of human dignity is further
elaborated by the following articles:
• The interests and welfare of the human
being shall prevail over the sole interest of
society or science (article 2)
• The use of techniques of medically
assisted procreation shall not be allowed
for the purpose of choosing a future child's
sex, except where serious hereditary sexrelated disease is to be avoided (article 14)
Leading principle B
• The creation of human embryos for
research purposes is prohibited (article
18.2)
• The human body and its parts shall not, as
such, give rise to financial gain (article 21)
Leading principle B
• The protection of the identity of the human
being is of importance in light of the
growing possibilities to intervene in the
human genome.
An intervention seeking to modify the human
genome may only be undertaken for
preventive, diagnostic or therapeutic
purposes and only if its aim is not to
introduce any modification in the genome
of any descendants (article 13)
Leading principle C
C. The protection of the integrity of everyone
‘Parties to this Convention shall (...)
guarantee everyone, without
discrimination, respect for their integrity
(...) with regard to the application of
biology and medicine’ (article 1)
Leading principle C
The protection of the integrity is further
elaborated in article 5:
‘An intervention in the health field may only
be carried out after the person concerned
has given free and informed consent to it.
This person shall beforehand be given
appropriate information as to the purpose
and nature of the intervention as well as on
its consequences and risks.
The person concerned may freely withdraw
Leading principle C
‘The term "intervention" must be understood
here in a broad sense; it covers all medical
acts, in particular interventions performed
for the purpose of preventive care,
diagnosis, treatment or rehabilitation or in
a research context’ (EM §29)
Article 16 (medical research), 19 (removal of
organs for transplantation) and 22 (use of
human material) repeat the requirement of
consent for these particular interventions
Leading principle C
• Article 9 deals with the so called positive
and negative Advance declarations of will:
‘The previously expressed wishes relating to
a medical intervention by a patient who is
not, at the time of the intervention, in a
state to express his or her wishes shall be
taken into account’.
Leading principle D
D. Protection of other rights and
fundamental freedoms
Parties to this Convention (...) shall
guarantee everyone, without
discrimination, respect for their integrity
and other rights and fundamental
freedoms with regard to the application of
biology and medicine (article 1)
Leading principle D
The Convention explicitly refers to some of these
rights and fundamental freedoms:
- Article 10 –
Private life and right to
information
1 Everyone has the right to respect for
private life in relation to information about his or
her health.
2 Everyone is entitled to know any
information collected about his or her health.
However, the wishes of individuals not to be so
informed shall be observed.
Leading principle D
• Article 11 – Non-discrimination
Any form of discrimination against a person
on grounds of his or her genetic heritage is
prohibited.
• Article 24 –
damage
Compensation for undue
The person who has suffered undue
damage resulting from an intervention is
entitled to fair compensation according to the
conditions and procedures prescribed by law.
Leading principle D
• ‘The term "Human Rights" refers to the principles laid
down in the Convention for the Protection of Human
Rights and Fundamental Freedoms of
4 November 1950, which guarantee protection of such
rights. The two Conventions share not only the same
underlying approach but also many ethical principles
and legal concepts. Indeed, this Convention elaborates
some of the principles enshrined in the European
Convention for the Protection of Human Rights. The
concept of the human being has been used because of
its general character. The concept of human dignity,
which is also highlighted, constitutes the essential
value to be upheld. It is at the basis of most of the
values emphasised in the Convention’.
• The close link with the ‘mother Convention’ is also of
imprtance with regard of the enforcement of the
Biomedicine Convention
Leading principle E
• The protection of incompetent persons
The Convention contains 3 articles that
protect incompetent persons subjected to
a medical intervention : articles 6, 17 and
20
Leading principle E
• Article 6 –
Protection of persons not able to consent
1
Subject to Articles 17 and 20 below, an intervention may
only be carried out on a person who does not have the capacity
to consent, for his or her direct benefit.
2
Where, according to law, a minor does not have the
capacity to consent to an intervention, the intervention may only
be carried out with the authorisation of his or her representative
or an authority or a person or body provided for by law.
The opinion of the minor shall be taken into consideration as
an increasingly determining factor in proportion to his or her age
and degree of maturity.
Leading principle E
• Article 6 – Protection of persons not able to consent
3
Where, according to law, an adult does not have
the capacity to consent to an intervention because of a mental
disability, a disease or for similar reasons, the intervention may
only be carried out with the authorisation of his or her
representative or an authority or a person or body provided for by
law.
The individual concerned shall as far as possible take part in the
authorisation procedure.
4
The representative, the authority, the person or the body
mentioned in paragraphs 2 and 3 above shall be given, under the
same conditions, the information referred to in Article 5.
5
The authorisation referred to in paragraphs 2 and 3 above
may be withdrawn at any time in the best interests of the person
concerned.
Leading principle E
• Article 17 –
Protection of persons not able to consent to research
1
Research on a person without the capacity to consent as stipulated in
Article 5 may be undertaken only if all the following conditions are met:
i
to iv, are fulfilled;
the conditions laid down in Article 16, sub-paragraphs i
ii
the results of the research have the potential to produce real
and direct benefit to his or her health;
iii
research of comparable effectiveness cannot be carried out on
individuals capable of giving consent;
iv
the necessary authorisation provided for under Article 6 has
been given specifically and in writing; and
v
the person concerned does not object.
Leading principle E
• Article 20 – Protection of persons not
able to consent to organ removal
1 No organ or tissue removal may be
carried out on a person who does not have
the capacity to consent under Article 5.
Leading principle F
• Article 3 –
Equitable access to health
care
‘Parties, taking into account health needs
and available resources, shall take appropriate
measures with a view to providing, within their
jurisdiction, equitable access to health care of
appropriate quality’.
‘The purpose of this provision is not to create an
individual right on which each person may rely
in legal proceedings against the State, but
rather to prompt the latter to adopt the requisite
Leading principle G
• Respect for professional obligations and standards
‘Any intervention in the health field, including research,
must be carried out in accordance with relevant
professional obligations and standards’ (article 4)
‘The Article covers both written and unwritten rules’ (EM
§ 30)
‘The content of professional standards, obligations and
rules of conduct is not identical in all countries. The
same medical duties may vary slightly from one
society to another. However, the fundamental
principles of the practice of medicine apply in all
countries. Doctors and, in general, all professionals
who participate in a medical act are subject to legal
and ethical imperatives. They must act with care and
Leading principle H
• Freedom of scientific research
‘Scientific research in the field of biology and
medicine shall be carried out freely, subject to
the provisions of this Convention and the
other legal provisions ensuring the protection
of the human being’ (article 15)
‘Freedom of scientific research in the field of
biology and medicine is justified not only by
humanity's right to knowledge, but also by the
considerable progress its results may bring in
terms of the health and well-being of patients’
Possible restrictions and
exceptions
General restrictions
• Article 26 – Restrictions on the
exercise of the rights
1 No restrictions shall be placed on the
exercise of the rights and protective
provisions contained in this Convention
other than such as are prescribed by law
and are necessary in a democratic society
in the interest of public safety, for the
prevention of crime, for the protection of
public health or for the protection of the
General restrictions
Examples:
• EM § 150. Compulsory isolation of a patient
with a serious infectious disease, where
necessary, is a typical example of an exception
for reason of the protection of public health.
• EM § 151. A person who may, due to his or her
mental disorder, be a possible source of serious
harm to others may, according to the law, be
subjected to a measure of confinement or
treatment without his or her consent.
• EM § 152. Protection of the rights of others may
also, for example, justify an order by a judicial
authority for a test to be carried out to establish
parentage.
General restrictions
• Article 16. 2 ‘The restrictions
contemplated in the preceding paragraph
may not be placed on Articles 11, 13, 14,
16, 17, 19, 20 and 21’.
- Article 11 :
- Article 13 :
genome
- Article 14 :
Non-discrimination
Interventions on the human
Non-selection of sex
General restrictions
- Article 17 : Protection of persons not
able to consent to research
- Article 19:
Removal of organs from a
competent donor
- Article 20:
Protection of persons not
able to consent to organ removal
- Article 21 : Prohibition of financial gain
Specific restrictions
• Treatment without consent of a mental
disorder
‘Subject to protective conditions prescribed
by law, including supervisory, control and
appeal procedures, a person who has a
mental disorder of a serious nature may be
subjected, without his or her consent, to an
intervention aimed at treating his or her
mental disorder only where, without such
treatment, serious harm is likely to result to
Specific restrictions
• Treatment in urgent situations
‘When because of an emergency situation
the appropriate consent cannot be
obtained, any medically necessary
intervention may be carried out
immediately for the benefit of the health of
the individual concerned’ (article 8)
Specific restrictions
• Restrictions to the right to know and not to
know
Article 10.2 ‘Everyone is entitled to know any
information collected about his or her health.
However, the wishes of individuals not to be so
informed shall be observed’
Article 10.3
‘In exceptional cases,
restrictions may be placed by law on the
exercise of the rights contained in paragraph 2
in the interests of the patient’.
Specific restrictions
• Non-therapeutic research with incompetent persons
Article 17.2 ‘Exceptionally and under the protective conditions prescribed
by law, where the research has not the potential to produce results of
direct benefit to the health of the person concerned, such research may
be authorised subject to the conditions laid down in paragraph 1, subparagraphs i, iii, iv and v above, and to the following additional
conditions:
i
the research has the aim of contributing, through
significant improvement in the scientific understanding of the individual's
condition, disease or disorder, to the ultimate attainment of results
capable of conferring benefit to the person concerned or to other
persons in the same age category or afflicted with the same disease or
disorder or having the same condition;
ii
the research entails only minimal risk and minimal burden
for the individual concerned’.
Specific restrictions
• Removal of tissue from an incompetent person:
Article 20.2 ‘Exceptionally and under the protective conditions prescribed by law,
the removal of regenerative tissue from a person who does not have the
capacity to consent may be authorised provided the following conditions are met:
i
consent;
ii
iii
recipient;
there is no compatible donor available who has the capacity to
the recipient is a brother or sister of the donor;
the donation must have the potential to be life-saving for the
iv
the authorisation provided for under paragraphs 2 and 3 of
Article 6 has been given specifically and in writing, in accordance with the law
and with the approval of the competent body;
v
the potential donor concerned does not object’.
Specific restrictions
‘Any State and the European Community
may, when signing this Convention or
when depositing the instrument of
ratification, acceptance, approval or
accession, make a reservation in respect
of any particular provision of the
Convention to the extent that any law then
in force in its territory is not in conformity
with the provision. Reservations of a
general character shall not be permitted
Violations of the Conventions
• The Parties shall provide appropriate
judicial protection to prevent or to put a
stop to an unlawful infringement of the
rights and principles set forth in this
Convention at short notice(article 23)
• Parties shall provide for appropriate
sanctions to be applied in the event of
infringement of the provisions contained in
this Convention (article 25)
Violation of the Convention
• Cases of infringement of the provisions of
the so called ‘mother convention’ may
ultimatey be taken to the European Court
of Human Rights (Strasbourg). This is
however not the case for the Biomedicine
Convention.
• The European Court may only give
advisory opinions on legal questions
concerning the Convention, at the request
of a Member State and the Steering
Violation of the Convention
• In case the infringement also concerns a
provision of the ‘mother Convention’
(article 8 – protection of private and family
life), an individual has the right to institute
proceedings at the European Court
Violation of the Convention
• Increasingly, the European Court is
referring to the Convention itself
• Glass v. UK (9 March 2004), requirement
to seek the intervention of a court in the
event of parental objection is in any way
consistent with the standards laid down in
the Convention. UK did not sign nor ratify
the Convention
Violation of the Convention
• Vo v France, (ECtHR, 8 July 2004). The
Court made reference to the “Oviedo”
Convention with regard to the
interpretation of “everyone” and “human
being”. France has signed but not ratified
the Convention
• Evans v.UK, (ECtHR, 10 April 2007) :
reference to article 5 of the Convention (
Informed Consent)
• Özalp v.UK, (ECtHR, 11 October 2007).
Violation of the Convention
• Ada Rossi v. Italy, ( ECtHR, 16 December
2008; inadmissibilily decision – Eluana
Englaro – in which the Court indicated it
would take into account the Oviedo
Convention.
• The European Court imposes the
provisions of the Convention “through the
backdoor”
Further developments
• In order to monitor scientific developments,
the present Convention shall be examined
within the Committee no later than five
years from its entry into force and
thereafter at such intervals as the
Committee may determine (article 32.4)
• Protocols may be concluded in pursuance
of Article 32, with a view to developing, in
specific fields, the principles contained in
this Convention (article 31)
Further developments
• Protocol on the prohibition of cloning
human beings (1998)
• Protocol concerning transplantation of
organs and tissues of human origine
(2002)
• Protocol concerning biomedical research
(2005)
Questions and discussion
Embryo research in Italy:
the bioethical and biojuridical
debate
Laura Palazzani
the debate on the embryo before
the law
• the negation of rights to the human
embryo: human embryo is considered a
mere set or material aggregate of cells
belonging to the human species
(conventional rights)
• the recognition of the rights of the embryo
from the very moment of conception: the
embryo is ‘already’ human
(absolute rights of respect)
the so-called embryonic stem cells
• libertarians/utilitarians: licit (value of
freedom of reseach)
• intermediate position: licit only the use of
frozen non-implantable embryos
• personalism: illicit (absolute value of
human life)
the regulation in Italy
• embryo research is explicitly legally regulated in the
sense of prohibition
• Act 40 of 2004 (Rules on medically assisted procreation)
art. 1: the conceptus has rights analogous to all the
subjects involved in assisted fertilisation;
art. 13: any experimentation on the human embryo is
prohibited; the clinical and experimental research on the
human embryo is allowed on condition that exclusively
therapeutic and diagnostic purposes are pursued and
linked to the protection of the health and development of
the embryo itself and should alternative methods not be
available.
the regulation in Italy
art. 3 prohibits:
a) the production of human embryos for research
or experimental aims or for ends different from
those foreseen by the law;
b) every type of selection of embryos and gametes
for eugenic purposes or interventions;
c) cloning by means of the transfer of the nucleus
or early scission of the embryo or ectogenesis
both for procreation purposes and research;
referenda
On June 2005 four referenda were put to the
vote for the partial repeal of Act 40 of
2004:
one of the questions concerned embryo
research.
The referendum turnout did not reach the
necessary quorum to be valid.
jurisprudence
jurisprudence tends to distinguish the
protection of the embryo when related to
scientific research from the protection of
the embryo when related to the mother.
When the relationship between the life
expectancy of the embryo and the mother
is highlighted, the rules do not foresee
absolute protection for the embryo.
the use of imported embryonic
stem cells
to date, it is not clear whether this is allowed
or prohibited at a juridical level
One point of view: the law does not express
any prohibition with regard to the import of
embryonic stem cells (so it is licit)
Opposed point of view: as embryonic stem
cells are embryos, the law expresses a
prohibition (so it is illicit)
arguments in favor
• a) it is not a question of research on embryos
but on stem cells of embryonic origin which had
been extracted outside Italy; b) this kind of
research does not alter the genetic patrimony
• according to criminal law ‘implicit criminal
prohibitions’ cannot exist as they would breach
the constitutional principle of legality and
certainty of the punishment
• the Italian Constitution recognises the freedom
of research
arguments against:
• as the totipotent stem cells are susceptible to
embryonic development if implanted in the
womb, they are to be considered embryos
• since such cells or embryos are obtained by the
destruction of a human embryo, their use is to
be considered illicit and criminally sanctionable
• the Italian Constitution protects human dignity
an open problem: the use of frozen
and non-implantable embryos
The National Bioethics Committee
Opinion on the destiny of embryos resulting
from medically assisted procreation and
not complying with the conditions for
implantation (2007)
different positions
• the intention to donate embryos to research can
be justified, with the informed consent of the
biological parents, providing that the embryos
have not been abandoned, even if this results in
their destruction
• any exploitative use of the embryos with
destructive outcomes is never ethically
acceptable because it is against their intrinsic
dignity
different positions
• an analogy with organ donation ex-mortuo:
the removal of live blastomeres from a non
transferrable embryo can be compared to
the removal of organs and tissues from an
individual who has been declared dead. In
this sense it could be licit to use the
donated embryonic blastomeres in
research.
objections
a) it must be specified that we can strictly speak of
‘unsuitability for implantation’ only when referring
to embryos that are characterised by intrinsic
conditions and that this concept cannot properly
include extrinsic conditions
b) ‘not implanted’ is different from ‘not implantable’
c) there might be indications of ‘probability’ but not
‘certainties’
The debate in Italy now
• The philosophical issue of the debate
concerns the balance between freedom of
research and human dignity.
• Some consider that freedom is inscribed in
dignity and others, on the contrary,
consider that dignity has priority over
freedom.