MEDTECH LAWS AND BIOETHICS CONSEQUENTIALISM/TELEOLOGY

2ND
SEM | PRELIMS/MIDTERMS | MT2D rightness or wrongness of an
action depends on consequences

ETHICS UTILITARIANISM
definition: way of life Act utilitarianism – focuses on the utility of each
origin: greek word – ethos (way of living) action in achieving the most happiness.
french word – ethique What happens to the minority?
(moral/character) Rule utilitarianism – focuses on happiness
latin word – mores (customs) resulting from following rules
society has set of good norms and values Act is good if it comes from following rules and brings
good to greatest number.
Components and Types of Ethics
✓ PRINCIPLES JUDGEMENT DEONTOLOGY
✓ COMMON SENSE ⎯ Act only from a sense of
✓ VA L U E S ⎯ duty, not from inclinations and feelings
✓ PUBLIC INTEREST ✓ Kant
✓ RULES STANDARDS Rule deontology
Categorical imperative
✓ Ross
Approaches to Ethics Act deontology
✓ VIRTUE APPROACH
(morally good and right) Categorical Imperative
⎯ Rules should be universally binding for all
✓ DEONTOLOGICAL APPROACH people.
(duty or obligation) ⎯ All individuals should be treated as ends in
themselves and not means to an end.
✓ TELEOLOGY APPROACH ⎯ One person or group should not be privileged
(consequential – outcomes are good) over all others.

ETHICAL THEORIES
⎯ foundations of ethical analysis
⎯ provide guidance in the decision-making
⎯ process
Act deontology
⎯ When moral duties conflict, consider
⎯ individual situations
Prima facie duty vs Actual duty
⎯ Use ethical intuitionism.
⎯ Weigh evidence to decide course of action in a
particular case.

Ross’ Prima facie Duties

Fidelity: telling the truth, keeping promises
Reparation: righting the wrongs we have done
Gratitude: recognizing services others have done
Justice: distribution of pleasure or happiness
Beneficence: helping to better the condition of other
beings
Self-improvement: making ourselves better with
respect to virtue or intelligence
Non-malfeasance: avoiding or preventing

Natural Law Theory

⎯ Based on the religious philosophy of St. Thomas
⎯ Aquinas (morals)
⎯ morality is inherently determined by nature, not
by
⎯ customs and preferences
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 ⎯ basis for some religious prohibition ⎯ The 3 R's are the guiding principles for the
Divine Command Theory ethical treatment of animals used for testing and
⎯ sees what is right as the same as what God experimentation.
commands
⎯ following God’s will is seen as the very SUMMARY OF ANIMAL RIGHT
definition
what is ethical ✓ Respect Animal Dignity
✓ Responsibility for considering options (Replace)
Virtue Theory ✓ The principle of proportionality
⎯ agent-oriented rather than action or rule- ✓ Responsibility for considering reducing the
oriented ✓ number of animals
⎯ cultivation of good character (eudaimonia) ✓ Responsibility for minimizing the risk of
⎯ A morally virtuous person is one who does the ✓ suffering and improving animal welfare (Refine)
⎯ good and right thing by habit, not by a set of ✓ Responsibility for maintaining biological
rulesof conduct ✓ diversity
✓ Responsibility when intervening in a habitat
Virtue Theory ✓ Responsibility for openness and sharing of data
✓ Cardinal virtues ✓ and material
✓ prudence (wisdom) ✓ Requirement of expertise on animals
✓ fortitude (courage), ✓ Requirement of due care
✓ temperance (moderation)
✓ justice Environmental ethics
⎯ Environmental ethics is a branch of ethics that
Ethical Approaches studies the relation of human beings and the
✓ Principlism environment and how ethics play a role in this.
System of ethics based on the ⎯ Environmental ethics believe that humans are a
four principles of: part of society as well as other living creatures,
✓ Autonomy which includes plants and animals.
✓ Beneficence
✓ Nonmalficence PHILIPPINE LAW OF 1996
✓ Justice ➢ Mining Act(Republic Act No. 7942) which was
•Non-hierarchical; prima facie designed to revive the mining industry and attract
derived from the teachings of more foreign investment by defining the agreements
Hippocrates for mineral exploration, and provide the
✓ Causuistry requirements for acquiring mining rights.

Sub-discipline of BIOETHICS Principles of Environmental Ethics

Clearing House for Human Ethics
✓ PHREB – National
✓ IERB/REB/IERC – institutional
✓ IACUC – Institutional Animal Care and Use
Committee (UPManila)
Animal Ethics
⎯ is a term used in academe to name
⎯ the branch of ethics that examines human-
animal
⎯ relationships, the moral consideration of animals
and how they are treated/handled.
The practical purpose of environmental ethics, is to
provide moral grounds for social policies aimed at
protecting the earth's environment and
remedying environmental degradation
BASIC ETHICAL PRINCIPLE
✓ PRINCIPLE OF STEWARDSHIP
Grounded in the presupposition that God has
absolute Dominion over creation and human
beings, being made in God’s image and
likeness, have been given a limited dominion
over creation and are responsible for its care

Replacement, Reduction, and ✓ PRINCIPLE OF TOTALITY

Refinement The whole is greater than any of its parts
⎯ 3 R's were first introduced in 1959 by Russel
✓ PRINCIPLE OF DOUBLE EFFECT
and Burch
An action should be performed only if the
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 intention is to bring about the good effect and
the bad effect will be unintended or indirect
consequence.
PRINCIPLE OF COOPERATION
Discerning how to properly avoid, limit, or
distance one’s self from evil (especially
intrinsic evil) in order to avoid a worse evil or
to achieve an important good
✓ Establish cooperative and respectful working
relationships with other health care professional
Duty to Society
Contribute to the general well-being of the
community
comply with relevant laws and regulations
pertaining to the practice of clinical laboratory
science

THE CALLING OF A Concepts of Health and Disease

HEALTH CARE PROVIDER
Health care profession – vocation, or calling Definition of Health
that requires specialized knowledge and is a state of complete physical, mental
intensive academic preparation, training, and and social well-being and not merely the absence of
experience in the knowledge of health care disease or infirmity. (WHO, 1948)
along with its various specific scientific Physical – both structural & chemical
specializations and techniques. Mental – cognitive and emotional being
Wellness -Wellness is an active process of becoming
Professionalism – practice of an activity using aware of and making choices toward a more successful
the conduct, aims, and qualities based on a existencedimensions:
code of ethics for that profession Social/Occupational/Spiritual/Physical/
Intellectual/Emotional
MERTON’S PRINCIPLES
Knowing: Dimensions of Health
the value placed and well-being
upon systematic knowledge 1. Intellectual -interaction of the mind with the
and intellect environment (person learns how to solve problems and
Doing: learn to cope with stress)
the value placed upon 2. Environmental – intra and inter-relationship within a
technical skill and training community (social)
capacity 3. Financial - ability to save for future (occupational)
Helping: 4. Physical – good nutrition, regular exercise, healthy
the value placed lifestyle
upon putting this conjoint 5. Emotional – understand one’s feeling, accept one’s
knowledge and skill to work limitations to achieve emotional stability
in the service of others 6. Spiritual - commune with God to achieve peace

DUTIES OF A MEDICAL TECHNOLOGIST Disease/Illness

(Adapted from ASCLS COE)
✓ Duty to the Patient
✓ Quality and integrity of laboratory services
✓ Strict confidentiality of patient information and
testresults
✓ Duty to Colleagues and the Profession
✓ Uphold and maintain the dignity and respect of
the
A state or condition in which maladjustment
(physiological or psychological is present. It occurs
when there is an interaction among the host, agents
and environment. It is a pathological process
Synonym – disorder/illness/sickness
Concept of Disease
Ontological - positive concept such as things, events
and relations
Physiological – physical make up, system, organs and
its functions

✓ Contribute to the advancement of the profession

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Maslow Hierarchy of Needs ✓ Patient’s right to information
✓ Proxy consent

IMPORTANCE OF FREE, PRIOR

& INFORMED CONSENT
Protection of the subject
Right to refuse ---voluntary
Right to withdraw –at any point

7 detailed elements of Informed Consent

The Human Act and Its Characteristics
✓ Knowledge
✓ Freedom
✓ Willfulness
Conscience
An awareness of morality in regard to one's behavior; a
sense of right and wrong that urges one to act morally
Conscience as a Practical Judgment
Kinds of Conscience
✓ Correct or true- tells us when something is a
good
choice or a bad choice and that this decision is in
agreement with what that thing actually is according to
the objective law
✓ Erroneous or False -judges something
incorrectly, when
something is bad you think its good and when its good
you think its bad
✓ doubtful conscience - when you cannot choose
between good and bad
choices
✓ lax conscience -when you see no sin where there
actually is sin
✓ scrupulous sin -a conscience that judges that
there is sin where there
really is no sin, or that judges that something is a
mortal sin when it is only a venial sin
✓ delicate conscience- judges correctly and with
careful attention
concerning the acts that are about to be performed
1)patients role; 2)clinical issues & suggested
treatment; 3) alternative to suggested tx;
4) risks & benefits; 5) related uncertainties;
6) assessing patient’s understanding of the info;
7) patient preference (choice) consent
TYPES OF JUSTICE
Distributive Justice – economic justice : fairness/
equality is the fundamental principle; common
welfare by sharing what God has created
Procedural Justice – fair process use in deciding what it
is to be distributed
Restorative Justice – betrayal seeking restitution/
putting back as they should be
Retributive Justice – principle of punishment (emotional)
Commutative - based on the principle of equality.
Legal -the obligations of the government to it's
citizens and society; opposite of distributive
Social - everyone has a right to a fair say in society
BENEFICENCE
is defined as an act of charity, mercy, and kindness with
a strong connotation of doing good to others including
moral obligation. All professionals have the foundational
moral imperative of doing right
Inviolability of Life:
Crimes Against Human Life
✓ Suicide
✓ Mutilation
✓ Sterilization
✓ Euthanasia
✓ Drug Addiction
✓ Alcoholism
✓ Abortion
✓ Non-Maleficence

MAJOR BIOETHICAL PRINCIPLES

Respect for Person
Respect as a Value
Principle of Free and informed consent
Principle of Autonomy
Importance of Free and Informed Consent
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 History of bioethics
Tuskegee Syphilis Experiment
✓ conducted by the US
✓ Public Health Service
• Involved 600 black
✓ men, 399 with syphilis
• No informed consent
• Participants were
✓ denied with information and treatment
SUBDISCIPLINES OF BIOETHICS
✓ Medical Ethics
✓ Public Health Ethics
✓ Research Ethics
✓ Animal Ethics
✓ Environmental Ethics
RECENT ETHICAL/BIOETHICAL ISSUES IN
THE PHILIPPINES
✓ Dengvaxia
✓ ActRx Triact Trials
✓ Reproductive Health Law
✓ In vitro Fertilization
✓ HIV/AIDS Law
✓ Bt Talong
✓ Planned Construction of Kaliwa Dam
✓ Garbage shipment from Canada, Hongkong
STEM CELL
✓ Aka pluropotential or Multipotential
cell
✓ Has the ability to differentiate into any
cell line
Types of Stem Cell
Embryonic stem cells
⎯ Come from human embryos that are three to five
days old.
⎯ They are harvested during a process called in-
vitro fertilization. This involves fertilizing an
embryo in a laboratory instead of inside the
female body.
⎯ Embryonic stem cells are known as pluripotent
stem cells.These cells can give rise to virtually
any other type of cell in the body.
Non-embryonic (adult) stem cells
⎯ Adult stem cells have a misleading name,
because they are also found in infants and
children.
⎯ These stem cells come from developed organs
and tissues in the body. They’re used by the
body to repair and replace damaged tissue in the
same area in which they are found.
⎯ Adult stem cells can’t differentiate into as many
other types of cells as embryonic stem cells can.
Induced pluripotent stem cells (iPSCs)
⎯ Scientists have recently discovered how to turn
adult stem cells into pluripotent stem cells.
These new types of cells are called induced
pluripotent stem cells (iPSCs).
⎯ They can differentiate into all types of
specialized cells in the body. This means they
can potentially produce new cells for any organ
or tissue.
⎯ To create iPSCs, scientists genetically
reprogram the adult stem cells so they behave
like embryonic stem cells.
Cord blood stem cells and amniotic fluid stem cells
⎯ Cord blood stem cells are harvested from the
umbilical cord after childbirth. They can be
frozen in cell banks for use in the future.
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 ⎯ These cells have been successfully used to treat
children with blood cancers, such as leukemia,
and certain genetic blood disorders.Stem cells
have also been found in amniotic fluid
Only four hospitals in the Philippines are
accredited to perform stem cell procedures.
⎯ The Medical City Institute of
Personalized Medicine
⎯ Asian Stem Cell Institute
⎯ Makati Medical Center Cellular
Therapeutics Center
⎯ Lung Center of the Philippines
Molecular Diagnostics and
Cellular Therapeutics
Laboratory.\
GENE THERAPY
⎯ Experimental technique that uses genes to treat or
prevent disease
⎯ Replacing a mutated gene that causes disease with a
healthy copy of the gene.
⎯ Inactivating, or “knocking out,” a mutated gene that
is functioning improperly.
⎯ Introducing a new gene into the body to help fight a
disease
Genetically modified organisms
⎯ Living organisms whose genetic material has been
artificially manipulated in a laboratory through
genetic engineering.
⎯ Creates combinations of plant, animal, bacteria, and
virus genes that do not occur in nature or through
traditional crossbreeding methods.
BT TALONG
Eggplant that is spliced with “Bacillus thuringiensis”
(Bt).
A common soil bacterium, Bt produces a protein
that paralyzes the larvae of some harmful insects.
Benefit to human health from health cost savings in
growing Bt talong is equivalent to P2.49 million
yearly as risk from illnesses is avoided.
Golden rice
Golden rice is a genetically modified, biofortified
crop
Biofortification increases the nutritional value in
crops.
Genetically modified in order to produce beta
carotene
Beta carotene is convereted into Vitamin A when
metabolized by the human body. We need Vitamin
A for healthier skin, immune systems, and vision.
ROUND UP SOYBEANS
Genetically engineered varieties of glyphosate-
resistant soybeans produced by Monsanto in 1996
Glyphosate works by preventing plants from being
able to make the proteins they need to survive.
ORGAN DONATION
WHO CAN DONATE?
✓ Deceased person
✓ Living person
✓ May be related or non-related to patient
✓ Related donors until fourth-degree of
consanguinity only
WHAT CAN BE DONATED?
✓ For a deceased person, s/he can donate
ALL or ANY PART of their body
✓ For a living person, she can donate the
following
Organs: 1 lung, 1 kidney, 1 lobe of the
liver, a part of the pancreas or intestine.
Tissues: skin, bone, amnion after
childbirth, blood, cells from bone marrow,
and umbilical cord
ORGAN APPLICATION
✓ For organ application, donors must fill up
an organ donation for or a card
✓ Requirements vary per organ and donor
type (either deceased or living) and by
institution or hospital
✓ One of the most important requirement is
CONSENT to donate
✓ Family members of deceased donor must
give authorization to donate
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Prepared by:Queen Castillo Ramos