Transcript From Bioethics to Biolaw - Universidade Nova de Lisboa

Helena Pereira de Melo
[email protected]
February 2012
1
Bioethics:
“ethics of life”;
term created by Van
Rensselear Potter, in
1970.
2
VAN RENSSELAER POTTER (1911-2001):
3
Van Potter published:
1970 – the article “Bioethics, the
Science
of
Survival”
in
Perspectives in Biology and
Medicine;
1971 – the book Bioethics: Bridge
to the Future.
4
Bioethics:
 a new philosophy that sought to
integrate biology, ecology, medicine,
and human values;
 “all the medical and natural issues that
allow the survival of man in this planet,
namely the preservation of an
ecosystem that turns the planet
inhabitable for human beings”.
5
Science:
a way of knowledge that is sectorial
and reduccionist;
“when it studies deeply, and more
and more disconnected from the
complex and heterogeneous nature,
it is potentially dangerous and
constitutes a threat to life, in all its
forms”.
6
This threat can be sustained by:
reflecting on the knowledge
with have;
Bioethics as a new discipline
that results from “the linkage
of biology with anthropology
and culture”.
7
Andre Hellgers creates:
six months after the publication of
Potter’s book;
in
Georgetown
University
(Washington d.C);
Joseph and Rose Kennedy Institute
for
the
Study
of
Human
Reproduction and Bioethics.
8
Bioethics:
 “the researches, discourses, practices that
are generally pluridisciplinar and aim at
solving ethical dilemmas caused by the
application of the new biomedical
technologies” (Gilbert Hottois);
 the transdisciplinar knowledge that guides
humanity when it interferes with birth,
death, life quality and the interpendence
among living beings (Luís Archer).
9
Bioethics’ History:
a) the public acknowledgment of the research
done, during World War II, by the Nazi
physicians;
b) the quick progress of biomedicine, posing
new ethical dilemmas;
c) the insufficiency of the traditional ethical
concepts to solve the problems raised by
biomedicine.
10
11
Human experimentations in Buchenwald:
a) inmates were used as test subjects for
vaccines against epidemic typhus, with 280
of them dying as a result;
b) hormones were given in order to cure
homosexuality;
c) prisoners were shot in order to study the
injuries caused by the bullets;
d) muscles were taken from women to see
how tissue regeneration occurred.
12
Auschwitz – Joseph Mengel:
sterilization
experiments
were
conducted in Jewish women, to
determine the effects of the injection of
caustic chemicals into the uterus;
b) blue ink was injected in children’s eyes
to determine if their eyes would turn
blue;
c) female twins had sex with male twins to
see if they had twins.
a)
13
The Angel of Death
14
1946 – Nuremberg trials:
 German physicians said that they had
not practised war crimes, but only
obeyed to orders;
 the Nuremberg Code was approved,
providing the standards against which
the practices of Nazis involved in
human experimentation were jugged.
15
16
Dr. Klaus Karl Schilling, a physician at the
Dachau concentration camp, defends
himself in at the Dachau trial. Schilling
was charged with infecting over one
thousand prisoners with malaria in his
experiments at the camp, resulting in
hundreds of deaths. He was condemned to
death and hanged.
17
December 1962: adoption of the Kidney
Centre's Admission and Policy, defining
the rules for the use of haemodialysis
equipment. The decisions of who benefits
from their use is taken not only by a
physician, but also by citizens.
2. 1966: Beecher publishes in the New
England Journal of Medicine an article in
which he describes 22 clinical trials done
without prior consent, that had been
published in scientific magazines.
1.
18
3. December
1967: Christian Bernard
performs the first heart transplantation at
Groote Schur in Cape City.
4. July 1972: Tuskegee Study is publicised as a
trial where natural history of syphilis was
observed in 399 afro-American who died
without treatment.
5. 1975: Karen Quilan’s parents ask the
administration of the hospital where she
was being taken care of, to turn off the
machines that kept her alive.
19
20
In 1932, the Public Health Service, working
with the Tuskegee Institute, began a study to
record the natural history of syphilis. It was
called the "Tuskegee Study of Untreated
Syphilis in the Negro Male."
21
How can we distinguish Bioethics /
/ Ethics
/ Deontology?
22
23
 rules followed by each human
being in his personal and social
life;
guides, according to chosen values
(religious, secular, relativist), the
human behaviour;
refers only to the individual.
24
25
Ethical responsibility:
not conditioned by any entity
external to the person;
sanction – the degradation of the
ethical being of the individual
 not external or coactive as the
juridical sanction is.
26
Deontology:
ethical rules that are specific of
a profession and are laid down
in a code of ethics;
rules of practice that guide the
physician’s,
the
nurse’s
professional behaviour.
27
Hippocrates (460 – 377 a.C.)
28
Medical ethics:
ethical statements subscribed by
the medical profession;
standards of conduct which define
the essentials of honourable
behaviour for the physician and
that must be upheld by all
physicians.
29
The traditional medical ethics:
 based in the Hippocratic Oath as a
summary of moral /medical wisdom;
 focuses on the relationship physician –
individual patient;
 is not enough to solve Bioethical
dilemmas that require concepts from
Law, Economics, Philosophy…
30
31
The complexity of bioethical dilemmas
requires the intervention:
of
professionals that work in
different disciplines;
of all society and not only of the
physicians.
32
33
34
The infraction of a deontological rule:
does not confer a legal claim to the
offended patient, unless there is a
legal rule with the same content;
the patient can only complain to
the medical association of the
country where the rule was broken.
35
Deontology:
lays down standards that are
specific to a profession;
not sufficient to assure the respect
of the rights of the person who
was offended by the action of a
professional that did not respect
medical ethics.
36
37
 in the intersection among different
disciplines – Medicine, Biology,
Philosophy, Law;
 transdisciplinar
dialogue
–
the
scientists have to become used to the
criteria of social sciences and vice
versa.
38
Form of dialogue that discusses “keythemes”:
 vg. – artificial procreation, euthanasia…
 constitutes a lasting set that is easy to
determine;
 the questions that are raised are
different if the person is a physician, a
lawyer, a nurse, that look at reality
from different points of view.
39
40
 it takes place in different institutions –
universities, ethic committees;
 plural and open – it has the
intervention of people that represent
the different ways of thinking present
in European societies;
 does not lead to one answer only, and
there is no bioethical method to have it.
41
42
No “bioethical method” exists since
Bioethics:
is a set of discourses and practices;
is open to the plurality of methods
as determined by the postmodern
paradigm
of
knowledge.
43
44
proposes
a synthesis between
natural and social sciences:
appeals to the policompetence of
the researcher;
is transdisciplinar.
45
Bioethics is an example of a
transdisciplinar field open to the
open
dialogue
between
specialists of different disciplines.
46
An open dialogue:
there is not a unique moral that
is shared by all citizens;
there are different bioethical
theories and their application
leads to different solutions.
47
For instance, Beauchamp and Childress:
 introduced in the book Principles of
Biomedical Ethics the approach of
balancing conflicting principles in
Bioethics;
 problems can be solved by reference to
the principles – beneficence, non
malficience, autonomy and justice.
48
49
What is Justice?
50
Questions:
 Why these principles and not other
ones?
 What do we exactly mean by each of
them?
 How can we order them?
 How can we solve conflicts among
competing principles?
51
In the analysis of the “ethical key-themes”
of Bioethics:
 the option for one method is very
important and leads to different
solutions;
 we can use at the same time several
methods since each of them represents
one of the moral views present in our
plural society.
52
53
Where are the frontiers
between
Bioethics
and
Biolaw?
54
Jean Bernard (1907 – 2006)
55
“The
frontiers between countries are,
sometimes, easy to devise: a river or a chain
of mountains. Sometimes those frontiers
have not yet been explored: a non-explored
sea or a desert. The frontiers between
Biolaw and Bioethics are of this kind. We do
not know were to mark them”.
56
a) it is difficult to determine what is
and what is not juridical when
we study a Bioethics keyquestion;
b) the determination of what is
juridical is done according to a
certain concept of Law.
57
There are several concepts of Law:
Positivism is no longer dominant in
European Countries;
juridical reasoning is in a
challenging situation, since there
are new problems that must be
solved.
58
Let us accept that Law:
rules external behaviours;
is coercive, since if broken
there can be a sanction;
aims at a virtue - Justice.
59
Ethics:
philosophical study of morality;
rules
individual
behaviour
according to what is morally
right;
breaking a moral rule leads to
no external sanction.
60
61
Law is linked to Ethics since:
human
relations
are
ruled
according to an ethical value –
justice;
law leads from ethics - a good law is
an ethical law rooted in the most
important values of each society.
62
Biolaw:
ethical
theories
play
an
important part in this branch of
law;
legal production is almost
always
a
posteriori,
and
dependent of progress in
Biomedicine.
63
64
Bioethics is a “science’s moral” that:
 tries to halt science - not all that is
technically possible is ethically
desirable;
 is an ethics of responsibility towards
actual and future generations;
 is rooted in the conception that
everyone has inherent dignity and the
right to have it respected.
65
Should
they
be
complemented by legal
rules?
66
Two positions in Europe:
Bioethics’ rules are enough to rule
this field and the legislator should
not adopt legal rules to govern it;
Legislator should adopt laws to
fulfil spaces that are without law.
67
First position:
a) human intelligence is part of
Nature and science must not
stop – law can not shut up a
priori certain fields of research;
b) the State is not competent to
determine who is able to
investigate or not.
68
69
70
scientific progress is so quick that the
legislator cannot adopt laws that will be
in force for a long period and the law after
being approved, may refer to an nonexistent reality;
d) the recent character and the broadness of
this field turn it impossible to adopt a
biolaw code and difficult to identify the
values that law has to protect.
c)
71
72
the way problems are solved in Bioethics
is different from country to country and
the adopted laws are frequently altered;
f) many practices in the Biolaw field are rare
and belong to fiction, so law should not
rule them before they really exist;
g) the existent legal rules are sufficient to
regulate the bioethical dilemmas.
e)
73
74
g) the resolution of ethical dilemmas is done
not by applying predefined rules, but by
balancing principles;
h) the Bioethics’ field is opened to ethical
discussion and so the ethical committees
should determine the rules to which
research obeys;
i) while there is no social agreement about
how to solve from a legal point of view the
dilemmas, the adoption of a law is
premature.
75
This position proposes a solution:
 of transferring the production of rules
from the legislator to the society;
 of not legislating - law can be replaced
by the consensus obtained in civil
society.
76
The other position:
a) the bioethical dilemmas are real –
the legislator has to rule them
because what is at stake is the
human person;
b) many of them are solved and now it
is time that they are ruled by the law.
77
Louise Brown
78
a) it is convenient that the bioethical rules are
assured by law since law is coercive;
b) if the law is not adopted, unethical
practices become “normal” and it will be
very difficult to eradicate them in the
future;
c) what one law determines another law can
alter - there is no reason not to legislate on
relevant bioethical issues.
79
How and when should we adopt
legislation on bioethical issues?
80
It its impossible to adopt a code:
 biomedical developments are recent
and quick;
 the issues that are to be ruled are
heterogeneous (from birth to death,
animal rights…), and it is impossible to
have a law that covers them all.
81
The legislator shall:
adopt laws for each issue or group of
bioethical issues;
b) avoid the problem of adopting too many
and unnecessary laws;
c) not rule what is still unknown since Law
does not aim at it;
d) only formulate guidelines that consider
the most important principles and the
borders that can not be transposed.
a)
82
Cesare Beccaria (1738 – 1794)
83
The law shall:
be clear, precise and determined,
since it may affect fundamental
rights;
contain only general clauses and
not clauses that rule all technical
questions, since the biomedical
progress is fast.
84
The legislator shall:
a) forbid
behaviours
that
are
prejudicial to society;
b) seek solutions that are the result of a
principles balancing, conditional
and transitory, since the biomedical
progress is accelerated.
85
86
Bioethics:
a) defines ethical norms according to
the moral principles present in
European societies;
b) as it refers to society as a whole it
differs from individual moral and
from deontology;
c) its norms can be disobeyed since
their are not binding.
87
Law:
a) is coercive;
b) turns the
bioethical norms
compulsory when the legislator
understands that they should be
binding and determines which
sanction shall be applied if they
are not obeyed.
88
Biolaw:
a) is rooted in the most important
values of European societies;
b) aims at ensuring the rights of
the human being that may be
endangered by the misuse of
biology and medicine.
89
lays down principles protecting the
dignity of the human being and human
rights in regards to the application of
Biomedicine;
d) harmonizes freedom of research with
the protection of fundamental rights;
e) solves problems that belong to different
branches of law (Constitutional, Civil,
Criminal Law).
c)
90
91
Health Care Law:
a) took the place of Medical Law in the
second half of the 20th century, as a
separate branch of law;
b) corresponds to the fundamental
reorientation in perspective caused
by the shift in focus from the
physician duties to the medical team
duties.
92
Which are provisions that in
European Law safeguard human
dignity and the fundamental rights
and freedoms of the individual
with regards to Biomedical
applications?
93
94
Human dignity:
a) everyone has the right to have their
dignity respected;
b) influenced by the ancient JudeoChristianity influence in Europe;
c) imposes the primacy of the human
being over the interests of science or
society.
95
96
Charter of the United Nations:
 adopted on 26 June 1945;
 the peoples of the United Nations are
determined “to reaffirm their faith in
fundamental human rights, in the
dignity and worth of the human person
(…)”.
97
Universal Declaration of Human Rights:
 adopted by the General Assembly of
the UN on December 10;
 “(…) recognition of the inherent dignity
of all members of the human family”
(preamble);
 “all human beings are born free and
equal in dignity and rights” (art. 1).
98
Índia:
99
International Covenant on Civil and Political
Rights:
 General Assembly of the UN
(16
December 1966);
 “the recognition of the inherent dignity
and of the equal and inalienable rights
of the human being” (preamble).
100
International Covenant on Economic, Social
and Cultural Rights:
 adopted by the General Assembly of
the UN on 16 December 1966;
 “the recognition of the inherent dignity
and of the equal and inalienable rights
of the human being” (preamble).
101
102
Universal Declaration on the Human
Genome and Human Rights:
 adopted by UNESCO on November
1997;
 “Everyone has a right to respect for
their dignity and for their rights
regardless
of
their
genetic
characteristics” (art. 2).
103
Down Syndrome
104
International
Genetic Data:
Declaration
on
Human
 adopted by the General Conference of
UNESCO on October 2003;
 “the aims of this Declaration are: to ensure
the respect of human dignity and protection
of human rights and fundamental freedoms
in the collection, processing, use and storage
of human genetic data (…)” (art. 1).
105
Universal Declaration on Bioethics and
Human Rights:
adopted by UNESCO on October
2005;
“the aims of this Declaration are: to
promote respect for human dignity
and protect human rights (…)” (art.
2).
106
107
Convention on
Biomedicine:
Human
Rights
and
adopted by the General Assembly
on November 1996;
“Parties to this Convention shall
protect the dignity and identity of
all human beings” (art. 1).
108
109
Charter of Fundamental Rights of the
European Union:
proclaimed
by the European
Parliament, the Council and the
Commission on December 2000;
“Human dignity is inviolable. It
must be protected and respected”
(art. 1).
110
The right to respect for one’s dignity:
 the right to be respected as one who
belongs to the class of human beings;
 the right against unwilled interventions
by others that are damaging to the
circumstances that are essential if one
is to flourish as a human.
111
112
The recognition of the:
absolute value of human dignity;
rights based in human dignity.
Turns legally unacceptable all
acts that can violate it.
113
International Law appeals to human
dignity as a constraint to some
practices:
114
Prohibition of financial gain raised by the human
body or its parts, as such:
 art. 21 of the Additional Protocol to the CHRB
concerning Transplantation of Organs and Tissues
of Human Origin (January 2002);
 art. 7 of Recommendation Rec.(2006)4 on
Research on Biological Materials of Human Origin
(March 2006);
 n.º 23 of the Appendix to Recommendation 1100
(1989) on the use of human embryos and foetuses
in scientific research.
115
116
The implantation of a human embryo in
the uterus of another animal or the
reverse:
 N.º 14 of Recommendation 1046(1986) o the Use of
Human Embryos and Foetuses for Diagnostic,
Therapeutic, Scientific, Industrial and Commercial
Purposes, adopted by the Parliamentary Assembly of
Council of Europe on September 1986.
117
The fusion of embryos or other operation which
might produce chimeras:
a) n.º 14 of Recommendation 1046
(1946) of Council of Europe;
b) n.º 42 of European Parliament’s
Resolution on the Ethical and Legal
Problems of Genetic Engineering,
adopted on April 1989.
118
Interventions seeking to create a human
being genetically identical to another
human being:
a) Additional Protocol to CHRB, on the Prohibition of
Cloning Human Beings, adopted on January 1998;
b) n.º 14 of Recommendation 1046 (1946) of Council of
Europe;
c) n.º 41 of European Parliament’s Resolution on the Ethical
and Legal Problems of Genetic Engineering;
d) art. 3 of ECHR.
119
The use of techniques of medically assisted
procreation for the purpose of choosing a future
child’s sex:
 except where serious hereditary sex-related
disease is to be avoided;
 it instrumentalises the offspring;
 art. 14 of CHRB;
 n.º 14 of Recommendation 1046 (1946) of
Council of Europe.
120
121
Surrogate motherhood:
a) n.º 11 of European Parliament’s
Resolution
on
Artificial
Insemination in vivo and in vitro,
adopted on April 1989;
b) principle 15.º of Council of
Europe’s Report on Human
Artificial Procreation adopted on
1999.
122
Post-mortem artificial procreation:
principle 7.º of Council of
Europe’s Report on Human
Artificial Procreation.
123
The transfer of an embryo from the
uterus of one woman to the uterus of
another:
principle
12 of Council of
Europe’s Report on Human
Artificial Procreation.
124
125
The creation of human embryos for
research:
a) art. 18 of CHRB;
b) principle 16 of Council of Europe’s Report on Human
Artificial Procreation;
c) n.º 21 of the Appendix to Recommendation 1100
(1989) of Council of Europe;
d) n.º 14 of Recommendation 1046 (1946) of Council of
Europe.
126
The creation and use of embryos or foetuses for
commercial or industrial purposes:
 point B) of the Appendix to Rec. 1046 (1946) of
Council of Europe;
 n.º 20 of the Appendix to Recommendation 1100
(1989) of Council of Europe;
 n.º 41 of European Parliament’s Resolution on the
Ethical and Legal Problems of Genetic
Engineering;
 n.º 11 of European Parliament’s Resolution on
Artificial Insemination in vivo and in vitro.
127
The importance of ensuring the dignity of
the human being determines:
 the principle of the primacy of the
human being;
 “The interests and welfare of the human
being shall prevail over the sole interest
of society or science” (art. 2 CHRB).
128
Right to life, to the integrity
of the person integrity, to
liberty, to personal identity
and to privacy.
129
130
Right to life:
 the most important rights one has –
the damage caused by death is the most
serious one a person may suffer;
 natural, universal, invariable, not
transmissible, almost absolute right –
no one shall be deprived of his life
intentionally.
131
Recognised by:
 art. 3 of UDHR;
 art. 6 of ICCPR;
 art. 6 of UN’s Convention on the Rights of the Child, of
November 1989;
 art. 2 of European Convention on Human Rights, of
November 1950,
 art. 2 of CFREU.
132
What protection is conferred to in
vitro human life, to the embryo
that
results
from
artificial
procreation?
133
134
For instance, the European Parliament:
 Resolution on Artificial Insemination in vivo and in
vitro;
 “aware of the need to protect the human embryo from
the moment of fertilisation”;
 “expresses concern at the ‘waste’ of embryos involved in
artificial insemination and calls for the use of
techniques that do not produce spare embryos”.
135
Council of Europe:
 Recommendation 1046(1986) on the Use of Human
Embryos and Foetuses for Diagnostic, Therapeutic,
Scientific, Industrial and Commercial Purposes;
 “human embryos and foetuses must be treated in all
circumstances with the respect due to human dignity”.
136
“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”.
137
The adequate protection of the
in vitro embryo determines:
138
1. Artificial insemination should
avoid the “waste” of embryos:
 n.º 5 of European Parliament’s
Resolution on Artificial Insemination
in vivo and in vitro.
139
2. Embryos should only be frozen when
absolutely necessary and if they are to be
implanted to produce a pregnancy in the
“biological” mother:
 n.º 8 of European Parliament’s
Resolution on Artificial Insemination
in vivo and in vitro.
140
3. Embryo donation, when permitted,
shall be for free:
 n.º 10 of European Parliament’s
Resolution on Artificial Insemination
in vivo and in vitro.
141
4. The embryo must not be subject to
arbitrary experimentation:
 principle 17 of Council of Europe’s Report on Human
Artificial Procreation;
 points A) and B) of the Appendix to Recommendation
1046 (1946) of Council of Europe;
 n.º 9 of the Appendix to Recommendation 1100 (1989)
of Council of Europe;
 N.º 32 of Resolution on Artificial Insemination in vivo
and in vitro.
142
These solutions aim at balancing:
a) the parents’ whish to have a child
by artificial procreation;
b) freedom of research;
c) the respect due to the dignity of
every human being since
fertilisation.
143
144
Right to the integrity of the person:
fundamental right;
assures the respect of
physical and mental
integrity.
145
Recognised by:
 art. 5 of UDHR;
 art. 7 of ICCPR;
 art. 19 of Convention on the Rights of
the Child;
 art. 3 of European Convention on
Human Rights, of November 1950,
 art. 3 of CFREU.
146
The respect for the person’s integrity
determines that, in the fields of medicine
and biology, an intervention has to be
preceded by the free and informed
consent of the person concerned.
147
This general rule can be found:
 art. 5 of CHRB;
 Recommendation 779 (1976) on the rights of the sick
and dying, adopted by the Parliamentary Assembly of
Council of Europe on January 1976;
 Recommendation 934 (1982) on genetic engineering,
adopted by the Parliamentary Assembly of the Council
of Europe on January 1982;
 art. 3 of CFREU.
148
149
Right to liberty:
respected by rules that prescribe
free and informed consent prior to
interventions in the health field;
right to self-determination in the
health field – to decide to undergo
or not undergo medical treatment.
150
It is recognised by:
art. 3 of UDHR;
art. 9 of ICCPR;
art. 5 of European Convention on
Human Rights.
art. 6 of CFREU.
151
It is related with the:
 right to be informed about her /his
health status, and about the diagnosis,
prognosis and progress of treatment;
 right not to be informed about the
medical facts about her /his condition;
 right to choose who should be
informed on her / his behalf;
152
 right of obtaining a second opinion;
 the right to self-determination;
 the right to refuse or halt a medical
intervention;
 the right to decide to participate or not
in scientific research.
153
154
Protects what identifies
each individual as a
unique person.
155
It is related with the:
a) right to have a name;
b) right to personal history;
c) right to be informed or not to
be informed about his/her
genes.
156
157
It relates also to the principle of equality
before the law recognised in:
art. 7 of UDHR;
art. 26 of ICCPR;
art. 14 of ECHR.
158
The respect of this principle determines:
1. Any form of discrimination against a
person on the grounds of her or his
genetic characteristics is prohibited
(art. 11 of CHRB);
2. Everyone has a right to respect for
their dignity and their rights
regardless their genetic heritage (art.
2 of UDHGUR).
159
3. Predictive genetic tests:
 which are predictive of genetic diseases or which serve
either to identify the subject as a carrier of a gene
responsible for a disease or to detect a genetic
predisposition or susceptibility to a disease;
 can only be preformed for health purposes and not, as
a general rule, insurance or labour purposes (art. 12 of
CHRB).
160
4. Everyone has the right to inherit a genetic
heritance which has not been artificially
interfered with (n.º 4 of Recommendation
934 (1982) of Council of Europe);
5. Interventions on the human genome that
aim at introducing modifications in the
genome of any descendents are forbidden
(art. 13 of CHRB).
161
A man’s castle is his home
162
Right to the protection of the
law
against
arbitrary
interference with his private
and family life.
163
It is recognised:
a) art. 12 of UDHR;
b) art. 17 of ICCPR;
c) art. 8 of ECHR;
d) art. 7 of CFREU;
e) art. 16 of Convention on the
Rights of the Child.
164
This right includes:
 respect
for
family
life,
home,
correspondence, honour and reputation;
 protection of information about health and
genetic data (art. 10 of CHRB and art. 13 of
International Declaration on Human
Genetic Data adopted by UNESCO in 2003).
165
The information about a person’s
health:
 is confidential;
 can not be disclosed or made accessible
to third parties except for an important
public interest reason or where the
prior consent of the person concerned
has been obtained (art. 14 of IDHGD).
166
The patient has the right to:
a) access to her / his medical files;
b) to obtain, rectificate or erasure health
personal data that have undergone
automatic processing if they are inaccurate
or not kept up to date (Convention for the
Protection of Individuals with regard to
Automatic Processing of Personal Data
adopted by Council of Europe in 1981).
167
Health professionals have the duty to:
a) respect the patient’s privacy when
providing him health care;
b) safeguard personal health data that
are stored in medical files against
unauthorised access (n.º 7 of
Recommendation 934 (1982) of
Council of Europe).
168
International Biolaw:
a) normative
decisions
of
international organisations (EU’s
directives);
b) International covenants (ICCPR);
c) soft law rules (UDUGHR).
169
The fundamental Biolaw principles
derive from:
Bioethics;
the
values most shared in
European societies – slowly the
Bioethics’ rules tend to turn into
legal rules.
170
Underlying all laws there is:
a compromise with a certain
ethical theory (deontological,
utilitarianism…);
an ethical option – law is
never ethically neutral.
171
In Bioethics and in Biolaw there are
rules:
a) ethical (like the ones adopted by the
International Bioethics Committee of
UNESCO);
b) deontological (v.g. the ones adopted by the
World Medical Association);
c) legal (that are binding for the citizens are
for the States).
172
“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.”
173
“The
ethical
objections
against cloning also rule out
any
attempt
to
make
genetically identical embryos
for clinical use in assisted
reproduction (…)”.
174
“The
subjects must be volunteers
and informed participants in the
research project.”
175