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BIO-LAW LECTURE NOTES

Bio-ethics
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First said by Potter in 1970 in the USA
Due to the rapid advancement in scientific progress without due consideration for ethics
Just because you can do it, doesn’t mean you should
o E
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manipulation of life
Need to intervene in life but how much?
Checks should be in place so technology isn’t used for bad things
o E
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atomic bomb and gene manipulation
Mostly applicable in the biomedical field
Bioethics works as a bridge between facts and values

Ethical pluralism
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g
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Problem e
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in EU there are many countries that have different regulations
o Creates issue of bioethical tourism
o No point in having national legislation if they just go somewhere else to do it –
always a loophole
o Inconsistency of penalties, as they don’t tend to apply to people who go somewhere
else and do it and come back
o Injustice in terms of social class/ money
Ideally need minimal international rules, and have some international documents
o Universal Declaration of Bioethics and Human Rights 2005 (by UNESCO), says human
rights are always the first point of reference
o Convention for the Protection of Human Rights in Biomedicine 1997 (by Council of
Europe)
o Charter of Fundamental Rights NICE 2000
Also have international organisations
o WHO Global Summits
o EU International Dialogue on Bioethics

Bioethics and culture
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Bioethical issues are strictly connected to cultural belonging
Diverse level of development of scientific knowledge and technological applications in
biomedicine
o E
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most advancement is in the western world, meaning their understanding of
bioethics will prevail over all other cultures
Different theoretical and practical contexts
Bio-ethno-ethics
o The coexistence of different ethnic groups in the same territory
o Solutions to bioethical problems within a culture often have implications outside
o Health cooperation between advanced countries and developing countries to ensure
equity in health

Ethno-centric bioethics
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One’s own culture is superior to all others in a hierarchical view, resulting in an imposition of
one culture over others
Bioethical colonialism
Model of assimilation – those belonging to other cultures adapt and adjust to the bioethics
of the mainstream culture
Model of subordination – possible exploitation
Objections
o This is an attitude of unjustified intolerant arrogance

Multicultural bioethics
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Relativist perspective – bioethics of each culture must be placed on the same level, since all
cultures are equal
Tolerance – passive and indulgent acceptance of every culture, without making any ethical
judgement
Juxtaposition of multiple and diverse bioethics means that the search for common values is
undesirable, since plurality is better than unity as an expression of richness and originality
Model of separation – each culture is a closed word, which internally affirms its own values
and preserves its own traditions, and externally tolerates other cultures
Objections
o Equivalence cannot be neutral and uncritical since cultural conflict will always
happen and the stronger culture will prevail over the weaker one
o Equivalence can lead to self-closure of each culture into itself, resulting in an
inability to communicate

Intercultural bioethics
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Against hierarchy among cultures and also against equivalence
All bioethics in every culture should and can be judged
o It is a duty to express judgement on the bioethics of different cultures
o Not a judgement of superiority, but a judgement of truth in reference to human
dignity, considered as the minimum common value
Affirming equality means assuming the differences, since equality is the precondition for
recognition of the difference between cultures as significant interaction between human
beings

Applying these to bioethics
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The role of bioethics is not to impose a vision as superior, nor is it to uncritically legitimise
every request from each cultural group
The structural reference to human rights acquires priority in ethno-ethics, since human
rights are the “units of meaning”

Bioethics and communication
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Negative paths
o Egalitarianism – assimilation in that all men of diverse cultures should conform to
the dominant culture
o Differentiation – separation meaning that the individuals of different ethnic groups
should be guaranteed by the broadest possible conservation of what makes them
different
Intercultural bioethics
o The critical search for continuous mediation and integration of human rights and the
specific needs of diverse cultures
o Affirming the relational logic of diversity in equality

PROBLEMS OF BIOETHICS
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
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Use of technologies to conceive a child that is not natural
Usually used by parents who are unable to have children naturally
People also use it when they can have kids however
o E
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to avoid illnesses like HIV or genetic illnesses
o Aim of selecting healthy children because they check if the embryos are healthy or
not before implantation
o E
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to achieve more control
o Can interrupt pregnancy when a child is not healthy
First child born like this was Louise Brown of the UK in 1978
Homologous:
o The gametes are purely from a couple
Heterologous:
o Have a donor outside the couple who donates a gamete
Surrogate motherhood:
o Using someone else’s uterus to give birth to a child for another couple (can implant
their own embryos)
o Usually used because someone doesn’t have a uterus, but has been used for reason
of not wanting to be pregnant before (Nicole Kidman)
Ectogenesis – artificial manmade womb
2 main ethical questions:
o What is the status of the embryo? Is it a subject or an object?
o What is the conception of family? Traditional family of mother and father, single
mother, homosexual couples, donor sperm families
o Different answers to these questions determine our type of bioethics

15/03/16
Reproductive technologies
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In vivo: inside the body
In vitro: outside the body
Homologous: the couples provide the genes
Heterologous: a donor provides the genes

Ethical issues: sexuality/generation
Extracorporeal (in vitro) reproduction:
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The libertarians and utilitarians think invasive technologies etc
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g
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o Procreative freedom – positive reproductive rights
o You can also have natural spontaneous miscarriages; you should overproduce to
increase chances of success; selection is allowed to ensure a healthy child
Personalists say the embryo is a person with intrinsic dignity
o Only people who are infertile can have IVF, and only heterosexual couples
o Limit use of reproductive technologies and strict guidelines to stop
manipulation/overproduction/selection of embryos – priority of the dignity of the
embryo over the desires of the adults
o Only allows heterologous fertilization, not donor gametes, since this can create
psychological effects within the family
o Principle of procreative responsibility

Family:
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Libertarians say the family is a product of society, but depends on the decisions of the
individual families
o Priority of individual choices
o Family is the free expression of will as a voluntary association or agreement
between individuals, or social convenience
Personalists say there is value only in the traditional (natural) family – heterosexual married
couple
o Natural because they can naturally give birth to children

Surrogate motherhood
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Use another woman’s uterus to be pregnant and give birth to your child (can be paid for or
done voluntarily)
Issue of fragmentation of motherhood
Different legislations have different rules for the right of the surrogate mother
o Right to end up keeping the child or change their mind (creates issues of genetic vs
...
)
Slippery slope – when you start allowing one thing, it head more and more towards positive
selection

Utilitarian perspective
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John Harris – should apply the principle of procreative beneficence, in the sense that there is
a duty to select in cases where there is a diagnosis of genetic illnesses/characteristics that
are not acceptable
o Have a duty to procreate the child with the best possibilities
Selection is allowed and mandatory in a certain way
People and embryos are not subjects until they can express their autonomy
John Harris says that sometimes prenatal selection and testing is too risky/expensive, and so
you can also test after birth and select then (infanticide)
o Blurring the line between abortion and infanticide
If the couple chooses to have the child anyway despite defects, then they have an economic
duty to pay for the cost of living and cure of the child – state shouldn’t have to pay because
they had a choice

Personalist perspective
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Starting idea that all embryos, foetuses and children are subject
Genetic testing on embryos is morally problematic due to the risk of damage and so should
not be allowed
o Further problem of totipotentiality – if you separate the cells for testing, you are
effectively cloning because both parts will become genetically identical twins
Problem that we are not certain of the results and their accuracy, and the margin of error is
unknown
Say that technology is not advanced enough to supersede the dignity of the embryo
During pregnancy (foetus), the risk is not as high and the technologies have improved more
o Risk of 4% of spontaneous abortion due to the tests, so have to have genetic
counselling and informed consent
Tests should be done only when there is already medical indication of illness
What do you do with the results of the test? Have to be sensitive with the information and
support the couple in their decision

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Cannot be directive with post-testing counselling – i
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cannot tell them what to do; whether
to abort or keep it – but equally cannot be completely neutral because then it stops being
counselling
o Have to inform them and help enable them to make a responsible choice
Despite all this, selection and interruption of pregnancy is NOT allowed due to the inherent
dignity of the foetus
o Tests should only be done to prepare for the life of the child and for things like gene
therapy

Other issues
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Direct to consumer genetic testing, where you send a biological sample to a lab and get the
results back directly
Huntingdon’s disease can be 100% diagnosed that you will get it in the future by the age of
14, which enables these people to know their future and that they will die earlier with no
available cure
o Issue of psychological effect for people
Can end up getting results that are unexpected, which can be psychologically damaging, but
also enables people to change their lives to prevent or deal with illnesses
o E
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Angelina Jolie having a double mastectomy because of her high risk of breast
cancer
People can also say they have the right to not know their genetic makeup
Problem of ending up getting a diagnosis when you didn’t ask for it, known as incidental
findings – is the doctor obliged or allowed to tell the patient the results?
o General solution is to allow people to choose whether or not they want to know any
incidental findings
o Generally, parents of a minor have a duty to know because of the priority of the
interests of the health of the child
Selection is problematic because each couple or person has different criteria, and so the
dignity of the embryo becomes arbitrary and extrinsic

05/04/16 – Cloning

What is cloning?
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When a set of individuals have the same genetic patrimony – making things genetically
identical replicas of each other
Two different techniques:
o The fission of the embryo – splitting an embryo when it is still totipotent
o The transfer of the nucleus – nucleus is taken out of a somatic (bodily; hair that
includes all DNA) cell of an adult, and transferred into an oocyte (female gamete;
only half of DNA) which has had its nucleus and DNA removed
Second technique is a very different way of reproduction, since the fusion of cells becomes
an embryo with only genetic patrimony (not female)

Vegetable and animal cloning
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3 main problems
1st one is that it is experimentation on animals
o Means you don’t have an approved risk-free procedure
o The clones could die or be damaged
2nd one is the lack of biodiversity
o You are risking a reduction of genetic variability, with the consequent loss of the
ability to naturally adapt to the environment
3rd is human’s health because we eat animals
o Don’t know if eating cloned animals is risk-free to our health

Human cloning – the libertarian theory
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Permissive – it allows it because of the principle of self-determination
o People say they want to reproduce by cloning
o Self-determination of scientists saying they want to clone things for the
advancement of science
Moderate permissive – allows it only under the 2 conditions of acceptance from society, and
having more experimentation
o In 1997 when Dolly the sheep happened there was a huge refusal from society
o Experiment more on animals to create a more risk-free procedure
o Temporary prohibition until the conditions are fulfilled
Current issues:
o High mortality rate (2086 sheep clones died before Dolly)
o The possibility of contracting clone pathologies
o The risks to the life and health of the woman carrying the clone
o Foreseeable social damage (biodiversity)
Attitude of caution and precaution

Ethical problems
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Life is produced in a laboratory without the use of male and female gametes
This involves the cancellation of the idea of family, since the clone is not really a child of the
subject from which the nucleus was taken, but a kind of twin deferred in time (a vertical
twin)
o Also only one parent since the DNA gets taken from one person
o Genetically identical twins can occur in nature, but it is very rare and would not
involve this shift in time
Distortion in the relationship between the sexes is created
o The man can only give the somatic cell and provide the genetic patrimony, can’t give
birth to it
o Women can provide the somatic cell, AND provide the oocyte and the womb to give
birth to it
Asymmetry between men and women, since men need women to clone, but women do not
need men – leads to predominance of women
There is a restriction of the freedom of the clone, since their genetic patrimony is integrally
predetermined instead of being an unpredictable amalgamation of mother and father
o With cloning there would be the possibility of a technical control of human nature,
and the genetic annulment of novelty – a sort of technological totalitarianism
o Birth would no longer be something new, but would be programmable
o Could decide exactly what kind of people are born, e
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scientists, Mozart, etc
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g
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)
Most scientifically reliable definition since it is an irreversible state

Organ transplants
Introduction
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A transplant consists in the transfer of organs and live tissues and cells from one individual
to another
This is with the aim of maintaining the functional integrity of the transferred organs, tissues
and cells in the recipient
The donor can be living (e
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kidney or liver transplants) or dead (e
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heart or pancreas)

Organ transplants from living people
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The main bioethical issues:
o The question of the physical integrity of the donor and the gratuitousness of their
act
o The non-damage or reasonable damage
o The proportionality (criteria referring to the donor’s psycho-physical integrity), i
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the donor shouldn’t have any illnesses
o The freedom and gratuitousness, referring to the donor’s intention
The lesion and impairment of the subject’s physical integrity, even if motivated by an
altruistic disinterested gesture, comes into conflict with the duty to preserve one’s own
physical health – should maintain the physical integrity of the donor
The reason for the donation of organs can be argued by referring to the principle of charity
and solidarity of a single person towards the community to which they belong – therefore
exposure to even mortal risk of donation in order to help those who are in a grave state of
need is legitimated
Donation should be without payment as a principle of non-commercialisation of the body

Organs from a corpse
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Main bioethical issues:
o The verification of the death
o The availability of the dead body
o The consent
Non-necessity of consent – the collectivist standpoint of those who maintain that the state
can decide what to do with the corpse, reduced to a mere disposable object, whatever may
have been the opinion of the subject when alive or the relatives
o Donation is substituted by coercion instead
The need for consent – the removal is justified only if the person has expressed a favourable
opinion when living, as a personal decision
The theory of family consent – maintains that in the absence of individual consent, family
consent is sufficient, or at least non-refusal from them
Theory of tacit/presumed consent or silent assent – maintains that it is legitimate to remove
the organs and tissues from a dead person is he has not expressed denial during his life
o This is based on the consideration that the corpse belongs to society and is available
for the common good, with the assumption that everyone would want to help
others by making their organs available after death

19/04/16 – Therapeutic obstinacy

Prolonged artificial life support
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The attempt by medicine to delay death beyond all limits
To indefinitely lengthen life by postponing death in the illusion of immortality
Opposite of euthanasia
Doesn’t follow the principle of proportionality:
o The risks and benefits of a treatment have to be proportional
Conditions for considering stopping the prolonging of life:
o 1st condition is ineffective cures in cases of terminal illness, incurable diseases, or
imminent death
o 2nd condition is putting the patient in unbearable pain (subjective)
o 3rd condition is the creation of difficulties for accessing cures (e
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limit of number of
beds in ICU in hospital)
o 4th condition is the high costs of treatments
o Different theories place these conditions in a different order (this is probably
personalist, utilitarians would put high cost first, and libertarians would put
unbearable pain first)
o Emerging condition of invasive technologies in the body causing the unbearable pain
is being used to allow the stopping of treatment, especially in US jurisprudence
This type of life support can also be very experimental, meaning the risks are generally
higher than the benefits

Different theories
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Libertarians – principle of self-determination means patients can choose when to live and
die themselves
Personalist – there is a duty to stop this kind of prolonged life support because of the dignity
of the person, and this is not considered euthanasia

Euthanasia
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The autonomous management of dying
Will to control death and exercise self-determination
Involves a relationship between the patient and physician (if there is no relationship then
this is simply suicide)
Different types of euthanasia by the physician:
o Active – the active action of killing someone e
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giving them a lethal injection
(killing)
o Passive – simply omitting to give someone treatment that by its nature and/or
intentions anticipates killing them to alleviate suffering (letting them die)
o Direct – the act of the physician who helps them to die
o Indirect – the assistance of the physician (assisted suicide) e
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getting a prescription
for lethal drugs which you then use yourself
Other options to alleviate suffering is palliative care, which cannot cure the problem but
stops them from suffering
Different types of euthanasia by the patient:
o Voluntary – by request or with informed consent
o Involuntary – without request or informed consent (new-born babies, elderly,
disabled)

Non-euthanasia
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The refusal of persistent therapy and extreme exceptional medical practice,
disproportionate to the condition
The refusal of treatment by a competent patient, even when they are aware that this refusal
will lead to death (e
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Jehovah’s witnesses refusing blood transfusions)
Even though refusal of therapy gives rise to an ethical problem of the recognition of the
value of human life, it is acceptable
Refusal should be taken seriously and respected

Different perspectives
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Libertarian
o Permissive principle – people have the right to die and self-determination
o Objections include the need to establish authentic autonomy (being of sound mind),
and the conflict of autonomies with the relationship between the patient and doctor
Utilitarian
o Permissive principle – based on the quality of life
o Objections include the subjectivity of the evaluation of quality of life, and the
slippery slope that leads to an establishment of varying degrees of dignity
Personalist
o Against euthanasia – maintain the right to live, to be cured and cared for

Palliative care
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Medical interventions which are no longer aimed at the patient’s recovery but at trying to
help the patient bear the pain caused by the illness

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Palliative medicine has developed at an astonishing rate over the last years, restraining more
and more efficiently one of the most common and most human motivations behind requests
for euthanasia
o Namely the desire to not suffer anymore, especially in cases of terminal illness

Humanisation of death
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The attention of the doctor and family close to the dying person
The accompanying of the dying person in alleviating pain

Living will, and advance care directives/indications

What are they?
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Previously expressed preferences and desires, showing the will of the subject
With regard to the various diagnostic and therapeutic choices proposed by the physician
Can be things like refusal of treatment
In advance – in the specific situation in which they were deprived of the possibility of
directly expressing their desires and will to the medical staff
A written document, done by a competent person (healthy or in initial stages of an illness),
in advance with respect to the possible discovery of certain pathological conditions, which
has a precise aim of authorising the doctor not to treat him
Can involve the patient’s choice concerning future arrangements with regard to religious
assistance before dying
Things showing intentions regarding allowing the use of their organs for transplants, or using
their body for experimental or didactic activity

Living will
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Can also make a request of euthanasia or persistent treatment
They are binding, and the physician is obliged to apply the will

Advance statements
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They are limited in that they cannot request euthanasia or therapeutic obstinacy
Can only request refusal of treatments, which may be refused by a competent person
They are not binding, but are simply wishes that are taken into consideration

03/05/16 – Distribution of healthcare resources

Determination of allocation
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Decision of what, how much (financially), and how to distribute among some subjects who
can benefit from this distribution
Assumption that there is a scarce amount of resources, and that there is an increasing need
for healthcare
Macro allocation
o Governmental allocation of finances to resources
o How much to invest compared to other sectors e
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education
o Planning decision/political decision
o Which area of healthcare do you privilege? Research, treatment, prevention, etc
...

Minimum state/maximum market – emphasis given to free choice of individuals
No one is responsible for natural and social inequalities
o The results of a natural/social lottery are not unjust, only unfortunate
o Society is not obliged to compensate for these differences or to repair damage
No right to healthcare and assistance
o E
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US where only people who can afford health insurance can get help
o Principle of autonomy over charity – charity is only voluntary
Minimising the involvement of the state, and no guarantee of public healthcare
In selection of treatment on a micro allocation level, the first people to be treated are those
who can pay
Objections:
o Doesn’t consider people who cannot exercise freedom
o Altruism is only a free choice
o Doesn’t adequately consider the social effects of individual free actions
o Logic of profit over the idea of helping the vulnerable

Social egalitarian theory
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Emphasis on social needs rather than individual freedom
Recognition of equality between individuals

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Maximum state/minimum market
Principle of equality and principle of difference
“Giving to each his own” – means giving to everyone equally simply because they belong to
society
Special recognition of the vulnerable and weak
Tries to compensate for natural/social inequalities and repairs these damages since they are
considered unjust
Maximum involvement of the state in healthcare policies, with greater involvement for the
needy
On a micro level, there is an effort to guarantee equal access to treatment and an equal
opportunity for everyone
o Giving less to those who are better off, and more to those who are worse off
Objections:
o No recognition of individual rights compared to the common good
o Expansion of the power of the state (heavy fiscal intervention and excessive
bureaucracy)

Natural law theory
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Tries to balance the previous two theories
Not causing harm and justice means protecting and respecting the life of every human being
Causing harm is every suppressive, experimental or manipulative intervention of human life
Defend life and health of each individual
Distribute resources according to equity
o Particular circumstances and needs of individuals
Considers the clinical evaluation of the needs of the patient first, not who can pay or
anything

Persampeiri lecture on the Italian National Bio-ethics Committee (CNB)

SEE SLIDES
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Balance between protecting human rights/dignity and allowing scientific/technological
progress
Committees had to adapt to ever-changing issues in the scientific and medical field
Works closely with parliament (prime minister and members of parliament) to give them
advice when they legislate
Their documents or opinions are not binding, only advisory, but can become binding law if
enacted upon by parliament
Mainly follow 2 important recommendations
o One is about research on embryos and foetuses (council of Europe)
o The other is about genetic engineering (European parliament)
Some bioethical issues were discussed as a matter of international and national
requirements
Deal with issues that require urgent intervention from government because of ethical
concerns
Bioethics is governed by society and how quickly it changes

Tasks
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Scientific advisory body
Expressing opinions and providing solutions – often controversial due to ethical pluralism
o One solution would slow down scientific progress, but no solution goes against
values, so usually there has to be a plurality of solutions
Raise awareness
Makes either motions (short) or opinions (longer)

Composition
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Not huge number of members (30-36)
Doesn’t have detailed rules regarding its composition (usually interdisciplinary and
encompassing different ethical positions in order to mirror society)
o Have to make sure all ethical opinions in society are also found in the committee
o Shown through use of personal remarks within draft documents
o Makes it democratic

Working methods
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Plenary meetings – monthly and private
Working groups – created for urgent issues with experts in that specific field (also monthly)
Can involve external experts not in the committee to make sure they make a truly informed
decision
Motions and opinions are usually by request of parliament/minister of health

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2 philosophical approaches: descriptive and prescriptive

Opinions
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Much broader view than motions, with more complete analysis and criticism
Goes through all the different ethical stances and legalities
Scientific, psychological, ethical and sociological issues are discussed where appropriate
Personal remarks are important for democracy, and they provide complexity and pluralism,
but can be negative since they can disrupt a concrete solution

Descriptive approach
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Philosophical assumption of non-existence of an absolute truth
Law should be separate from ethics – ethical subjectivism
Bio-ethics shouldn’t make decisions, only provide viewpoints, since the decisions are up to
the government (recipients)
Emphasises role of awareness
In this case opinions would provide an unbiased overview of different perspectives (should
reflect society as a whole, not just a reflection of the committee)
This means there is no need for personal remarks
Should remain rational and not emotional – but rationality doesn’t mean there is only one
solution

Prescriptive approach
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Duty of the commission to express a majority opinion
Philosophical assumption of the existence of an absolute truth
One solution is not, however, viable or useful a lot of the time since it lets too many opinions
fall aside

Minimum prescription/description approach
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Showing the complexity of views, and being subjective and aware, but also attempting to
come to some sort of solution
Synthesis between the two opposing approaches
Makes ethical and cultural recommendations in the end, which encompass the most
important elements of the document as a whole



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