Transcript Biotechnology Today: Technical Progress and Societal Feedback

Towards Good Governance in
Biotechnology and Life Sciences
Yongyuth Yuthavong
BIOTEC, National Science and
Technology Develolpment Agency,
Thailand
Biotechnology Feeds on New
Paradigms of Bioscience
 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.
Future Directions: Towards Good
Governance in Biotechnology (contd)
 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.