Towards Good Governance in Biotechnology and Life Sciences

1
Towards Good Governance in Biotechnology and Life
Sciences

• Yongyuth Yuthavong
• BIOTEC, National Science and Technology
  Develolpment Agency, Thailand

2
Biotechnology Feeds on New Paradigms of Bioscience

• 1953 Structure of DNA as genetic material.
• 1973 Genetic engineering (gene
  splicing)achieved.
• Mid 90s 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.

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Issues for the New Millennium

• Cloning
• Therapeutic organ cloning (cost and equitygt
  technicalgtmoral)
• Whole organism cloning (moralgttechnical)
• 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

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Technical ImplicationsAgricultural 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).

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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.

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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.

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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).

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Technical ImplicationsMedical 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.

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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).

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Ethical, Social and Legal ImplicationsIntellectu
al 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).

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Ethical, Social and Legal ImplicationsCloning

• 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?

12
Fukuyamas Concerns

• F. FukuyamaHow 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.

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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.

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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.