Towards Good Governance in Biotechnology and Life Sciences

1. Towards Good Governance inBiotechnology 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 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.

3. 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

4. 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).

5. 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.

6. 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.

7. 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).

8. 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.

9. 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).

10. 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).

11. 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?

12. 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 whichmodify behaviour. • Using drugs which alter moral character. • Extending life, impacting on economies, international relations, and new ideas generation. • Creating “designer babies”.

13. 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.

14. 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.