gene expression - Center for Ethics of Science and Technology ...

Towards Good Governance in

Biotechnology and Life Sciences

Yongyuth Yuthavong

BIOTEC, National Science and
Technology Develolpment
Agency, Thailand

Biotechnology Feeds on New
Paradigms of Bi
oscience


1953
:

Structure of DNA as genetic material.


1973
:

Genetic engineering (gene splicing)achieved.


Mid 90’s:

Widespread genetically modified (GM) crops in
market.


1997
:

Animal cloning achieved.


2001
:

Human genome unveiled.


New Millennium:

Maturing of stem cell research
and genomics (gene chips, proteomics,
“transcriptomics”).


Technology is moving faster than
understanding of implications to society.

Issues for the New Millennium


Cloning:



Therapeutic organ cloning (cost and equity>
technical>moral)


Whole organism cloning (moral>technical)


Deciding factors: embryonic vs adult stem cells, failure
rates, long
-
term issues


Genomics:


Pharmacogenomics (cost and equity)


GMOs (biosafety vs benefits)


Deciding factors: consumer benefits vs costs,
understanding of long
-
term effects of GMOs on the
environment

Technical Implications:

Agricultural Biotechnology


DNA information as guide to selective
breeding:
“Molecular markers”.


Development of transgenic plants and
animals (Genetically modified organisms,
GMOs
).


Insect resistance (eg. Bt cotton), herbicide resistance
(eg. round
-
up ready):
gene expression


Genetic Use Restriction Technologies (GURT,
“terminator”):
control of gene expression

(by genes
and chemicals).

Ethical, Social and Legal Implications:
Agricultural Biotechnology


Is it
against “nature”?
Risks vs benefits?


Relative lack of
religious objections
.


Transgenics intrinsically harmful to the
environment?
Environmental biosafety concerns.


Harmful to consumers?
Health biosafety concerns.


Gap

between haves and have
-
nots increased.


Intellectual property system

in favour of already
developed countries (eg. gene patents).


Production system

in favour of the already efficient.

Ethical, Social and Legal Implications:
Risk management


Types of risks


Technical

risks (environment, consumers).


Public perception

risk.


Market

risk.


Principle of Substantial Equivalence:

Equivalent product regardless of process.


Precautionary Principle:

Err on the side of
caution.

Ethical, Social and Legal Implications:
Intellectual Property Management


Ownership

of, and
soverignty

over,
genetic resources: natural and developed
further by human efforts
.


Indigenous people (
Farmers’ rights
).



Countries (
Biodiversity Convention
).


“Common property of mankind” (
free

use of natural resources, but restricted
by
patents
for modifications).

Technical Implications:

Medical Biotechnology


Gene
-
based dignostics

can give
prenatal and long
-
range predictions of
illness and other human characteristics.


Genes of humans and other organisms
are
targets

leading to therapeutics.


Stem cells (embryonic and adult) can lead
to spare organs or tissues, or whole
humans through
cloning
.

Ethical, Social and Legal Implications:
Gene
-
based diagnostics


The need to know

vs.
the right to privacy.


Illness is a burden to both
individuals

and
society
.


The
right to life

of the unborn child.


The need (right) of the society, employer,
insurer to know (
social contract issues
).


The right of the individuals to privacy, and
the right not to know (
human rights issue
).

Ethical, Social and Legal Implications:

Intellectual Property Rights


Should genes be patentable?


Who

own the genes (biological
materials)?


Who has the
right to use

the genes?


Special considerations

for developing
countries/poor communities who cannot
afford the treatment (eg. compare with
AIDS drugs).


Ethical, Social and Legal Implications:

Cloning


Is it ethical to use
embryonic stem cells
?
In what circumstances?


Is it ethical to
clone spare organs
? From
oneself? From another individual?


Is it ethical to
clone human beings
? Under
what circumstances?


The
legal status

of a human clone?

Fukuyama’s Concerns


F. Fukuyama:
How far do we let biotech go?


Current
regulatory bodies are inadequate

to
deal with future choices, eg.


Manipulating
genes which

modify behaviour
.


Using
drugs which alter moral character
.


Extending life
, impacting on economies,
international relations, and new ideas generation.


Creating “
designer babies
”
.

Future Directions:
Towards Good
Governance in Biotechnology


More concerns and discussions on bioethics by
laypeople and scientists

alike.


Voluntary Codes of Conduct

on issues involving
risks or ethics by bioindustries, professional
societies, etc. (cf. 1973 voluntary moratorium
on genetic engineering).


New
laws

may be enacted, but a good sense of
balance is needed.


Role of government:


Oversees development and capability strengthening in both
technical and social, ethical issues in biotechnology and life
sciences.


Set up regulations and laws as necesssary, making sure of
having a healthy balance.


Role of civil societies (NGOs)


Help to make the public understand issues in various aspects,
not just lobby on single issues.


Role of education/research institutes


Acquire knowledge and understanding on issues interfacing
between technology and society.


Help to generate healthy debates among various stakeholders
and the public.

Future Directions:
Towards Good
Governance in Biotechnolog
y (contd)