Bioethics and medical law

Genetics and biotechnology; Regenerative

medicine, Organ transplantation; Genetic
testing and screening
MARINA DARAKHVELIDZE,
MD, PH.D.(C)
SCHOOL OF HEALTH SCIENCES
UNIVERSITY OF GEORGIA, 2022
DEFINITION: BIOTECHNOLOGY

Biotechnology is the application of science and technology

to living organisms and their parts, or to products and
models of living organisms, in the hope of producing
understanding, goods or services.

Sequencing human DNA. # iStockphoto.com/dra schwartz.

BIOTECHNOLOGY

 Biotechnology is multidisciplinary in that it involves many

different disciplines, all the pure and applied sciences in fact
 Biotechnology is interdisciplinary in that all these sciences and
technologies work together to achieve biotechnological ends

 The “Bio” bit is important because, in biotechnology, these

different sciences and technologies are all applied to biological
organisms: to living organisms, their parts and products, and to
models such organisms.

 Biology is central to the pursuit of biotechnological ends because

biotechnology is the application of science and technology to
biological organisms.
BIOTECHNOLOGY
Human Genome Project involve attempts (many
already very successful) to:
 Discover the function of the various genes;
 Map the locations of common variations between
individuals;
 Correlate these bio-markers with phenotypical
traits of interest;
 Develop techniques to detect the presence of
important bio-markers; / Develop techniques by
which to manipulate gene expression.
BIOTECHNOLOGY AND BIOETHICS: WHAT IT’S ALL ABOUT

 Biotechnology is advancing at a breathtaking pace,

facilitating the development of numerous potentially
life-enhancing and life-saving techniques.

 But, the techniques of Biotechnology do not map

neatly onto the ethical issues that are generated by
biotechnology

 Bioethics is the discipline that studies the actions

permitted by biotechnology – actions like cloning
or genetic engineering – and asks whether or not
these actions are morally acceptable, and if so how
we should manage them socially in order to
promote citizens’ welfare, protect their rights and
treat them fairly
BIOINFORMATICS

 Bioinformatics involves the application of

information technology to the various fields of
molecular biology.
 Specifically, it involves developing methods for
storing, retrieving, comparing and analyzing
biological data.
PHARMACOGENETICS/PHARMACOGENOMICS

 The techniques grouped under these names, for

all practical purposes interchangeable,
comprise the study of the genetic variations that
determine an individual’s metabolism and response
to various drugs.
SYNTHETIC BIOLOGY

 A relative newcomer to the discipline of

biotechnology, synthetic biology involves the
re-design and fabrication of existing organisms, and
the design and fabrication of organisms that don’t
exist in nature.
 NANOTECHNOLOGY
 A “nanometre” is one billionth of a metre (1X
109).
 Nanotechnology exploits the properties and
behaviors of the very small.
 Nanotechnology is sometimes characterized

as “soft” or “hard” depending on whether it exploits

a biological system (‘soft’) or a mechanical system
(‘hard’).
MAPPING BIOTECHNOLOGIES ONTO ISSUES
 The techniques of assisted reproduction
Under this heading fall all the techniques by which
individuals and couples having trouble conceiving can
be helped to achieve a healthy baby.
There are many such techniques of which in vitro
fertilization – the mixing, in a Petri dish, of sperm and
egg in such a way as to ensure the fertilization of the
egg – is probably the best known.
MAPPING BIOTECHNOLOGIES ONTO ISSUES
Cloning
 Every time a cutting of a
plant successfully roots the
plant is cloned. We have
been cloning plants by such
means for centuries.
 In the late twentieth
century, however, a
mammal – Dolly the sheep
– was cloned for the first
time by means of somatic
cell nuclear transfer.
 GENETIC SCREENING/TESTING
 The techniques of genetic
screening/testing include any means
by which we can identify (some part
of) the genetic inheritance of an
individual.

 Genetic “testing” applies to the

determination of some genetic factor
in an individual, whereas “screening”
aims to ascertain the prevalence of
such a factor in a population or
population group where there is no
evidence in advance that any
particular individual has it.
 GENETIC SCREENING/TESTING
 Screening programs, although they
involve actual testing of individuals,
are typically part of a public health
program, for example in response to
a government-determined need to
address a given health issue.

 The term “genetic test” is not entirely

transparent. It has been defined as “a
test to detect the presence or absence
of or change in a particular gene or
chromosome”, but it may or may not
involve analysis of DNA
WHY IS GENETIC TESTING AND SCREENING IMPORTANT?

 The ethical issues arising in relation to genetic testing and

screening largely depend on the view that there is
something special about genetic information which makes
it different from other kinds of medical information

 The fact that genetic information is shared with family

members gives rise to issues about confidentiality and
sharing of information

 There is, therefore, an issue for the health professional as

to whether to disclose or not, if the patient is unwilling to
share the information
GENETIC SCREENING/TESTING - LAW
 The range of possible applications of genetic information is vast, and
there will be national differences in the ways in which different
countries regulate in this area.

 The Universal Declaration on the Human Genome and Human

Rights (UNESCO, 1997), although it has no legal force, lays down
certain principles such as the right of everyone to respect their
dignity and rights regardless of their genetic characteristics, and it
provides that genetic data must be held in conditions of confidence.

 The Convention for the Protection of Human Rights and Dignity of

the Human Being with Regard to the Application of Biology and
Medicine (Council of Europe, 1997) also enunciates some general
principles, that tests may be performed only for health purposes or
for scientific linked to health purposes
ORGAN TRANSPLANTATION
 Organ transplantation is both a life-extending and a life-saving
medical procedure in which a whole or partial organ (or cells in
cell therapy) from a deceased or living person is transplanted into
another individual, replacing the recipient’s non-functioning organ
with the donor’s functioning organ
CURRENT ETHICAL DEBATE ON TRANSPLANTATION

 The procurement of organs from family

members, from friends, and even from strangers;
 Patients, soliciting organs on the Internet;
 The compensation of living donors for related
expenses or even the bestowing of financial
rewards for donation;
 The experimental use of organs from animals
and atc.
WHY IS ORGAN TRANSPLANTATION IMPORTANT? - ETHICS

 Organ transplantation presents several ethical challenges.

Amongst these are issues related to the determination of
death, organ procurement, and organ allocation

 The vast majority maintain that organs belong to the

potential donor and thus the most prevalent deceased
donation model requires a person’s consent to donate
through signing a donor card while alive, or more
commonly, through the agency and consent of next-of-
kin, after death

 This model is based on respect for individual autonomy. 

WHY IS ORGAN TRANSPLANTATION IMPORTANT? - ETHICS

 Organ procurement from the living is more accepted in some parts

of the world than others.
 Donation is assessed by weighing the benefit to the recipient
against the physical harm and psychological benefit to the donor.

 Many agree that a donation between relatives is ethical because the

familial relationship appears to justify the risks involved. However,
some have expressed reservations about the propriety of living
donations from non-family members, especially from strangers

 Some further contend that, because a stranger’s offer to donate is

altruistically motivated, there is a greater chance that they are
acting autonomously and without undue pressure to donate.
ORGAN TRANSPLANTATION - LAW
 The laws enacted to regulate organ transplantation vary with
jurisdictions around the world. They generally cater to
definitions of death, donor consent, and, often, the prohibition
of the commercial trade in organs

 The laws in most countries require donor consent for

posthumous organ donation. "Opt-in” donor consent is
common internationally.

 Many countries have enacted legislation against commerce in

organs. Partly as a result of these legal prohibitions, the
phenomenon of transplant tourism has emerged.
  
HOW SHOULD I APPROACH ORGAN TRANSPLANTATION IN PRACTICE?

 A donor must be fully and

accurately informed about and
demonstrate an understanding of,
the risks and benefits of donation as
it affects themselves and the
recipient, as well as the different
treatment options available to the
recipient.

 The transplant center must ensure

that the donor’s decision to donate
is voluntary and is not influenced
unduly by material gain, coercion,
or other factors that may reduce
individual autonomy.
REGENERATIVE MEDICINE

 Regenerative medicine is an emerging interdisciplinary field

of research and clinical applications focused on the repair,
replacement, or regeneration of cells, tissues, or organs to
restore impaired function resulting from any cause, including
congenital defects, disease, trauma, and aging

 Regenerative medicine can be thought of as the next phase in

the evolution of organ transplantation and replacement
therapies.

 Disciplines, contributing to this field include: genetics and

molecular biology, materials science, stem cell biology,
transplantation, developmental biology, and tissue engineering
 REGENERATIVE MEDICINE

 It has been estimated that

stem cell-based therapies,
one aspect of regenerative
medicine, could potentially
benefit over a hundred
million patients in the USA
alone for conditions such as
diabetes mellitus,
autoimmune diseases,
cardiovascular disease,
cancer, and
neurodegenerative diseases
REGENERATIVE MEDICINE - ETHICS

 Regenerative medicine raises a number of ethical issues

 Firstly, regenerative medicine presents new challenges
to the process of informed consent.
 Regenerative medicine also presents
challenges to the informed consent process
because of its innovative nature
 Regenerative medicine can raise issues
related to a patient’s capacity to consent to
treatment.
 Ethical issues have been raised as a field of traditional
transplantation.
REGENERATIVE MEDICINE - LAW
 The law relevant to regenerative medicine is primarily
focused on the regulation of stem cell research

 As such, legislation varies broadly worldwide, from

permissive to flexible, to restrictive policies

 In countries with permissive policies on stem cell research

stem cells may be derived from a wide variety of sources

 Countries with flexible (USA) legislation limit the methods of

acceptable stem cell procurement

 Countries with restrictive (Italy) stem cell legislation vary

widely - it is allowed in part or all embryonic stem cell
research is banned
REGENERATIVE MEDICINE - POLICY
 From a policy perspective, regenerative medicine presents
new challenges in regulating emerging products to ensure
quality control and patient safety

 Clinicians faced with the question of whether they should

recommend patients for clinical trials of regenerative
medicine therapies should take extra care to ensure that
informed consent is a top priority

 Clinicians should disclose all areas of potential risk.

 Throughout this process, clinicians should be sensitive to

the fact that patients seeking experimental therapy may
be particularly vulnerable because of severe illness or
because they have exhausted all other treatment options
THANKS FOR
ATTENTION