UNESCO Bangkok
Regional Unit for Social and Human Sciencein Asia and the PacificAsia Pacific Perspectives
on Biotechnology
and Bioethics

Asia-Pacific Perspectives on Biotechnology and Bioethics. Bangkok: UNESCO Bangkok, 2008.
v + 147 pp.
1. Ethics of science. 2. Biotechnology. 3. Genetics. 4. Bioethics. 5. Asia and the Pacific.

ISBN 978-92-9223-220-7 (Electronic version)© UNESCO 2008
Published by the
UNESCO Asia and Pacific Regional Bureau for Education
920 Sukhumvit Rd., Prakanong
Bangkok 10110, Thailand
Chief Editor: Daniel Calderbank
Editor: Darryl R.J. Macer
Cover design: Alessandra Blasi
Design/Layout: Celia H Thorheim
Printed in Thailand
The designations employed and the presentation of material throughout the publication do not imply theexpression of any opinion whatsoever on the part of UNESCO concerning the legal status of any country, territory,
city or area or of its authorities, or concerning its frontiers or boundaries.

SHS/08/EP/003-1

CONTENTS
iii
ACRONYMS
iv
PREFACEv
Is there a need or space for gene technology ethics: An Australian perspective
1
Governance of biotechnology in the state of Victoria, Australia
6
The Transgenic Thai Papaya story: A Milestone Towards Thailand Becoming a Biotech Crop Country 11
Benefits and ethical limits of biotechnology
16
An analytical framework for understanding the ethics of agricultural biotechnology
24
Ethics of the use of genetic control methods for infectious disease
33
Japanese attitudes towards genetically modified mosquitoes
48
Benefits and ethical limits of transgenic animals
58
Biobanking and ethnic monitoring
65
Human biobanks - trustees and some aspects of the current discussion, especially in Germany
70
Protection of genetic data in medical genetics: A legal analysis in the European framework73
Biobanks and the Notion of Justice in Health92
Is the era of the therapy by tailor-made stem cell coming?
100
The regulation of stem cell technology - international approaches to restriction or permission
105
Ethical issues in ‘ethical guidelines for research on human embryonic stem cells’ in China
110
What are the points in the human cloning debate? A view from the Buddhist religion
118
Shareholder-focused utilitarianism support for corporate social responsibility
123
Discussion
132
Wichai Kositratana (Thailand) - Biosafety study of GM-papaya in Thailand
134
Pahol Kosiyachinda (Thailand) - The Transgenic Thai Papaya Story – A Milestone of Thailand toward a
Biotech Crop Country134
Don Chalmers (Australia) – Is there a Need or Space for Gene Technology Ethics: An Australian
Perspective
136
Voravit Siripholvat (Thailand) - Description of Thai indigenous chicken plumage colour and broodinessusing classical and molecular genetics
136
Kazuo Watanabe et al. (Japan) - Ethics in Public Communication on Agricultural Biotechnology
138
Minakshi Bhardwaj (UK) - Constituting ethics into biotechnology policies and developing international
relations.
138
Tomiko Yamaguchi (Japan) - An Analytical Framework for Understanding Agricultural Biotechnology
Controversies
139
Darryl Macer (UNESCO): Ethics of use of genetic control methods for Infectious Disease140
Naoko Kimura and Darryl Macer (UNESCO): Japanese attitudes towards geneticallymodified mosquitoes
140
Mary Josephine Rani and M. Selvanayagam (India): Benefits and Ethical Limits to Transgenic Animals 142
Juergen Simon (Germany): Chances and Risks of Biobanks: Problems of Ethnic Monitoring142
Miyako Okada-Takagi (Japan): Is the era of the therapy by tailor-made stem cells coming?
143
Ivo Kwon (Republic of Korea): The Current State of Embryonic Stem Cell Research in Korea
144
Yanguang Wang (China): Ethical Issues on Human Embryonic Stem Cell Research in China
145
About the contributors
146

Asia-Pacific Perspectives on Biotechnology and Bioethics

CONTENTSiii

iv

Asia-Pacific Perspectives on Biotechnology and Bioethics

ACRONYMS
AEBC: Agriculture and Environment Biotechnology Commission
BBRC: Biotechnology and Biological Reseach Council
BIOTEC: Thailand’s National Centre for Genetic Engineering and Biotechnology
CHRB: Convention on Human Rights and Biomedicine
CIOMS: Council for International Organizations of Medical Sciences
COMEST: World Commission on the Ethics of Science and Technology
CSR: Corporate Social Responsibility
GM: Genetically Modified
ELSI: Ethical, Legal and Social Impact
GMOs: Genetically Modified Organisms
GTCCC: Gene Technology Commuity Consultative Committee
GTEC: Gene Technology Ethics Commitee
GTMC: Gene Technology Ministerial Council
HES: Human Embryonic StemHUGO: Human Genome Organization Ethics Commitee
IBC: UNESCO International Bioethics Committee
IDHDG: Internal Declaration on Human Genetic Data
IVF: In Vito Fertilization
LMOs: Living Modified Organisms
NGOs: Non-Governmental Organizations
NHMRC: National Health and Mecial Research Council (Australia)
OECD: Organization for Economic Cooperation and Development
OGTR: Office of the Gene Technology Regulator
PAH: Polycyclic Aromatic Hydrocarbons
PCB: Pentachlorobenzenes
PCP: Pentachlorophenyl
PRV: Papaya Ringspot Virus
RUSHSAP: Regional Unit for Social and Human Sciences in Asia and the Pacific
SFU: Shareholder Focused Utilitarianism
TNT: Trinitrotoluene
UNESCO : United Nations Educational, Scientific and Cultural Organization
US-APHIS: US Animal and Plant Health Inspection Service
US-EPA: US Environmental Protection Agency
US-FDA: US-Food and Drug Administration
VBEAC: Victorian Biotechnology Ethics Advisory Commitee

PREFACE

UNESCO’s programme in this area aims to strengthen the ethical link between scientific advancement
and the cultural, legal, philosophical and religious context in which it occurs. UNESCO’s strategy inbioethics has been to act as a standard-setter on emerging ethical issues, to disseminate informationand knowledge and to help Member States build their human and institutional capacities. The standards
include the Universal Declaration on the Human Genome and Human Rights, adopted by UNESCO’s
General Conference in 1997 and subsequently endorsed by the United Nations General Assembly in
1998. This was followed by the International Declaration on Human Genetic Data, adopted in 2003;
and the Universal Declaration on Bioethics and Human Rights, adopted by UNESCO’s 33rd General
Conference in 2005.
This collection of papers is second in a series of books from RUSHSAP, UNESCO Bangkok offering
perspectives on ethics in Asia and the Pacific region, with each focusing on a specific theme. Thesepapers were originally presented during conferences on ethics in science and technology which
UNESCO’s Regional Unit for Social and Human Sciences (RUSHSAP) has been convening since 2005.
Since intercultural communication and information sharing are essential components of thesedeliberations on ethics of science and technology, the books also provide theme-related discourse fromthe conferences.
The First UNESCO Bangkok Bioethics Roundtable was held between 11-15 September, 2005 - the firstevent in Bangkok to celebrate UNESCO’s 60th anniversary. The UNESCO Bangkok office is the largest
UNESCO branch office in the Asia-Pacific region, encompassing 46 member countries. RUSHSAP isdesignated as the regional office for coordinating implementation of UNESCO programmes in the socialand human sciences sector in Asia and the Pacific region, which includes programmes on ethics ofscience with the Division of Ethics of Science and Technology in Paris.
I would like to thank the active discussion and participation of all those who attended the UNESCO
Bangkok meetings. A special thank you is due to Heather McClellan, Silvie Poeth and Daniel Calderbank
for help in editing the papers, and to Frankie Keller for transcribing the discussion. The cover design isthanks to Alessandro Blasi and the book text layout was prepared by Celia Thorheim. We look forward toincreased discourse on these papers not to be seen as the final word on these topics, but rather as ways
to catalyze a greater regional discussion of the ethics of science and technology.

Darryl Macer
Regional Advisor for Social and Human Sciences in Asia and the Pacific
UNESCO Bangkok

Asia-Pacific Perspectives on Biotechnology and Bioethics

Biotechnology has been with humankind since the beginning of our existence as we modify theenvironment around us for shelter, food and tools. Modern biotechnology has been a stimulus fordiscussion of many bioethical issues, and continues to be so as evident in the papers assembled inthis volume. While ensuring the right of scientific investigation, there is also a necessity to ensure thatscientific progress is ethically acceptable. Reflecting this concern, UNESCO (United Nations Educational,
Scientific and Cultural Organization) has made ethics of science and technology one of its five priority
areas. This volume offers perspectives from persons in a range of countries across Asia and the Pacificon some ethical issues related to biotechnology, many of whom are actively involved as members of the
UNESCO Asia-Pacific School of Ethics.

vIs there a need or space for gene technology ethics: An
Australian perspective*
Don Chalmers, Ph.D.
Gene Technology Ethics
Committee,
Australia

Biotechnology is a classical example of a knowledge-value industry that is widely supported by theOECD (Organization for Economic Cooperation and Development) as a basis for future employment andwealth for advanced nations. Australia has drawn up its own Biotechnology: National Strategy, in which itstates that it shall be “consistent in safeguarding human health and ensuring environmental protection,that Australia capture the benefits of biotechnology for the community, industry and environment”. The
National Strategy was developed with regard to international standards. Equally, the National Strategy
acknowledges the emergence and development of environmental ethics. The environmental ethicalprinciples that have emerged are expressed in both familiar and new terms, such as care and protectionof the environment, respect for biodiversity, the precautionary approach (see Article 15, Convention on
Biological Diversity), and sustainability and natural ecosystems (Graham, 2004).

Gene Technology Act 2000: Australian regulation of GMOs
The Gene Technology Act 2000. This Act established the regulatory framework for the licensing of dealings
with genetically modified organisms (GMOs) in Australia. Reflecting the sentiments of the National
Strategy, the Act aims “To protect the health and safety of people, and to protect the environment,by identifying risks posed by, or as a result of, gene technology and by managing those risks throughregulating certain dealings with GMOs”.
The aims of the Act are to achieve:• national consistency in regulation within the federal system;• transparency and accountability in GMO dealings;• responsiveness to stakeholder’s views;• scientifically-based risk assessment;• independent decision making;• avoidance of duplication in regulation;• improvement in the coordination of agencies.
The Act established the Office of the Gene Technology Regulator (OGTR)1, which regulates dealings
with GMOs, including exempt dealings, accreditation of facilities and organizations, and licensingof intentional releases of GMOs into the environment (see: www.ogtr.gov.au). The Act sets down
a comprehensive and rigorous system of the scientific assessment of risks involved in dealings with
GMOs. The Gene Technology Regulator is required to develop a Risk Assessment and Management Plan
to address any identified risks. The Regulator principally examines the scientific risks involved, and is not
required to consider issues of:• cost/benefit economic considerations;
1 See www.ogtr.gov.au*

Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Biotechnology and Ethical Principles

1• comparisons with alternative technologies;• marketing and trade impacts of any granted licence
The Act does include comprehensive consultation processes that are required by the Regulator for theissue of a licence. At the end of September 2005, the Regulator had approved 35 field trial licences,approved 303 contained dealings licences, and received notification of 1,809 low-risk dealings. One
commercial licence has been issued for a carnation (blue colour) and a cholera vaccine (cholera toxin
removed), three were issued for cottons (herbicide tolerant and/or insecticidal), and two for canolas(hybrid and /or herbicide tolerant).2

Gene Technology Ethics Committee (GTEC)

2

Asia-Pacific Perspectives on Biotechnology and Bioethics

The Gene Technology Regulator has three advisory committees under the terms of this Act. The Gene
Technology Technical Advisory Committee advises on the scientific and technical aspects of applications
for licences. The Act also recognizes that, as well as strict compliance with the legal requirements of theAct, there may be ethical and social issues that require consideration. These ethical and social issues
surrounding genetically modified organisms (GMOs) were recognized by the creation of the Gene
Technology Ethics Committee (GTEC) and the Gene Technology Community Consultative Committee(GTCCC).
The Gene Technology Ethics Committee (GTEC) was established to provide advice to the Regulator or
the Ministerial Council on:• ethical issues relating to gene technology;• the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with
GMOs;
• the need for, and content of, policy principles in relation to dealings with GMOs, which should be
conducted for ethical reasons (section 112).
The Gene Technology Ministerial Council may issue policy principles in relation to: ethical issues;recognizing non-GM or GM zones designated under State law for marketing purposes; and matters
dealings with GMOs prescribed by the Gene Technology Regulations of 2001.
The GTEC is a multi-disciplinary committee with members with skills or experience in areas such asenvironmental ethics, law, religious practices, agricultural practices, and animal health and welfare(section 111, (5).

Are environmental ethics needed?
In the area of research involving humans, the basic regulatory framework depends on well-established
codes of ethical practice, such as the key international reference point of the Declaration of Helsinki(WMA, 1996), or, within Australia, the National Statement of Ethical Conduct in Research Involving
Humans (NHMRC, 1999), or the CIOMS Guidelines (1997). In the case of research involving animals,
there are established ethical and legal standards (for example, BBRC, UK, 2000) that provide astatutory framework within State and Territory Animal Welfare Acts. The statutory framework has been
supplemented gradually by Codes of Practice and ethical principles developed by the National Healthand Medical Research Council (NHMRC), in particular the 7th edition of the 2004 Australian Code ofPractice for the Care and Use of Animals for Scientific Purposes (NHMRC, 2004).
There are no gene technology or environmental equivalents of the Human Research Ethics Committees
or Animal Welfare Committees. Similarly, while codes of medical research ethics contain statements ofbroadly agreed and consistent principles, there are no equivalent international statements in relation
2 Updates in Quarterly Report of the Gene Technology Regulator

to agreed environmental ethical principles. At this stage, environmental ethics are significantly lessdeveloped and formalized (Smith, 1997; Sylvan, 1994).
The GTEC is developing a National Framework Statement on environmental ethics, and on the ethics
of gene technology. Other countries (for example, New Zealand (2004) and the Vatican (2002) havealso examined the ethical aspects of genetic manipulation. GTEC notes the excellent work done by thetwo states of Queensland (Queensland, 2001) and Victoria in developing their ethical statements in thisarea. The GTEC, in developing the draft National Framework Statement, took the following matters into
account:

GTEC has identified the following set of 10 core principles that apply to the environment in general, andto gene technology, GMOs, and GM products:(1) Integrity is the guiding value for researchers and all others involved in gene technology and
GMOs in their search for knowledge. It is crucial in their commitment to the obligations and spiritof the national regulatory system;(2) Researchers and all others involved in gene technology and dealings with GMOs have thelegal and ethical responsibility to ensure that activities within their control do not cause damage
to the Australian environment or in areas beyond the limits of national jurisdiction. In so doing,
there must be a thorough assessment of the extended side effects of practical applications ingene technology and dealings with GMOs;(3) Gene technology and dealings with GMOs should be conducted with consideration of theenvironmental and health needs of present and future generations;(4) Gene technology and dealings with GMOs should be conducted in a manner that integrates
environmental and health protection into the research and development process;(5) Researchers and all others involved in gene technology and dealings with GMOs should
demonstrate respect for persons in all acts, including obtaining appropriate consent. Respect for
persons is expressed as regard for the welfare, rights, beliefs, perceptions, customs, and cultural
heritage (both individual and collective) of persons likely to be affected by the gene technology
and GMO dealings;(6) Researchers and all others involved in gene technology and dealings with GMOs should
demonstrate respect for all living things and the environment on which they depend in every
act when dealing with gene technology;(7) Researchers and all others involved in gene technology and dealings with GMOs should
minimise risks of harm or discomfort to the persons (or living things) affected by the dealing;(8) Researchers and all others involved in gene technology and dealings with GMOs should act
with compassion, reciprocity, and solidarity with others and with future generations;(9) There is a challenge to promote an equitable distribution of benefits from the biotechnology
revolution to developing nations. This may include promoting equal access to scientificdevelopments, sharing knowledge, and recognising the value of benefit sharing.

Asia-Pacific Perspectives on Biotechnology and Bioethics• relevant provisions/objects of the Act;• relevant International Conventions (UNESCO 1 and 2);• concerns about GMO technology (AEBC, 2003ab; Nuffield Council, 2003);• development of environmental ethics as a distinct branch of ethics;• codes of ethics dealing with human and animal research;• social responsibility of scientists to act ethically/with integrity;• scientific endeavours and the pursuit of knowledge3(10) Researchers and all others involved in gene technology and dealings with GMOs should
carry through the values and principles set out in this framework in a practical, informed way,without sacrificing one value while attempting to realise another value.
These core principles aim to assist scientists and the community to identify and follow the correct
conduct in relation to the environment in general, and gene technology, GMOs, and GM products inparticular. The GTEC considered that these principles were grounded in certain core values identifiablein the Australian community (knowledge; reason and wisdom; trust; integrity and courage; respect forlife and equity; freedom of choice; and respect for the environment). These principles are for guidance
and, at this stage, are not intended to be prescriptive. These principles may form the basis upon whichcodes of practice or policy principles (under the relevant provisions of the Gene Technology Act 2000
and the corresponding state and territory acts) may be developed at a later stage.

4

Asia-Pacific Perspectives on Biotechnology and Bioethics

Concluding remarks
Public trust in science and biotechnology is a major issue. The Novartis Foundation, for example, hasnoted that deficits of trust are and were a general rule, rather than advances of trust. This was similarly
recognized by the U.K. House of Lords Select Committee, which said there was a “new mood for dialogue
where scientists were beginning to understand the impact of [their] work in society and public opinion”.
This trend is towards greater public scrutiny through legislation, which places the responsibility for the
scrutiny of biotechnology squarely within parliamentary responsibility. But, of course, this is not to deny
the importance of the social responsibilities of the scientists themselves.

References
Agricultural and Environment Biotechnology Commission (AEBC (1)), United Kingdom. 2003. GM Crops?
Co-existence and Liability.
Agricultural and Environment Biotechnology Commission (AEBC (2)), United Kingdom. 2003. GM Nation?
The Findings of the Public Debate..
Australia, National Health and Medical Research Council (NHMRC). 1999. National Framework Statement
on Ethical Conduct in Research Involving Humans.
Australia, National Health and Medical Research Council (NHMRC). 2004. Australian Code of Practice for
the Care and Use of Animals for Scientific Purposes. 7th ed.
Biotechnology and Biological Research Council (BBRC), United Kingdom. 2000. Ethics Morality andAnimal Biotechnology.
Convention on Biological Diversity, Rio de Janeiro. 5 June 1992, 31 International Legal Materials 818[entered into force 29 December 1993].
Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the Joint
NHMRC/AVCC. 1997. Statement and Guidelines on Research Practice.
Graham, J. 2004. The Perils of the Precautionary Principle: Lessons from the American and European
Experience. The Heritage Foundation.
Human Genome Organisation Ethics Committee (HUGO). 2000. Statement on Benefit Sharing. http://
www.hugo-international.org/hugo/ethics.html.
New Zealand, New Zealand Bioethics Council. 2004. Toi te taiao. The Cultural, Ethical and SpiritualDimensions of the Use of Human Genes in Other Organisms. August 2004.
Nuffield Council on Bioethics, United Kingdom, 2003. The Use of Genetically Modified Crops in Developing
Countries.
Queensland, Australia. 2001. Code of Ethical Practice for Biotechnology in Queensland. September 2001.

The Royal Society, United Kingdom. 2001. The Use of Genetically Modified Animals.
Smith, P. 1997. Environmental Ethics? New Jersey, Paulist Press.
Sylvan, R., Bennett, D. 1994. The Greening of Ethics. United Kingdom, Whitehorse Press.
UNESCO, Universal Declaration on the Human Genome and Human Rights. 1997.
UNESCO, Declaration on Universal Norms in Bioethics. 2005.
Vatican. 2002. Common Declaration on Environmental Ethics: Common Declaration of John Paul II and the
Ecumenical Patriarch his Holiness Bartholomew I. Monday 10 June, Rome–Venice.

Asia-Pacific Perspectives on Biotechnology and Bioethics

World Medical Association. Declaration of Helsinki. 1996.

5Governance of biotechnology in the state ofVictoria, Australia*
Ellen M Kittson, Ph.D.
Australia

Introduction

6

Asia-Pacific Perspectives on Biotechnology and Bioethics

In April of 2004, the Government of Victoria asked the Victorian Biotechnology Ethics Advisory
Committee (VBEAC) to convene a meeting of community and industry stakeholders to consider theneed for a “Code of Ethical Practice for Biotechnology” to guide the behaviours, actions, and decisionmaking of individuals using biotechnology in the State of Victoria.
The VBEAC is an independent committee established by the government to provide advice on ethicalissues in relation to biotechnology in Victoria. Its members are appointed in their own right for having
relevant expertise in areas such as: biomedical research; applications of biotechnology in agriculture;religion and ethics; consumer advocacy; animal welfare; law; and environmental advocacy. In addition,
the VBEAC has lay representatives drawn from the community, who have no affiliation with thebiotechnology industry.
The meeting attendees were largely individuals who use biotechnology in the continuum from research
to commercialisation. Representatives from civil society and the lay community also participated. Afterconsidering existing and proposed models for biotechnology governance, the meeting recommended
that the government develop a voluntary document to provide guidance, rather than enact anenforceable code.
Subsequently, the Statement of Ethical Principles for Biotechnology in Victoria (the Statement) was
developed by VBEAC and received the state government’s endorsement. As a government-endorsed
document, the Statement allows individuals and institutions to adopt it and customize its use in theirrelated activities.
The Statement is intended to be reviewed and updated on a regular basis, and information about its
usefulness and relevance to the users of biotechnology will be gathered to inform this process.

Code versus statement of principle
The field and applications of biotechnology are broad. Numerous statutory and non-statutory
instruments currently in place were identified as providing guidance and setting standards for the
ethical behaviour of scientists and others using biotechnology.
VBEAC’s interest in identifying gaps in the current scheme required a parallel process to develop a mapof existing instruments that provide ethical guidance and governance. The map was tabled with theStatement and is the basis for stakeholder meetings to develop strategies to address any gaps.
An enforceable Code of Ethical Practice was not the preferred approach of stakeholders. They expressedfears that the resulting duplication in coverage between state and national-governance instruments
could potentially cause confusion and inconsistency in practice for users of biotechnology. Because
Australia has a central national licensing system for gene technology yet no administrative structuresin place to enforce additional legislation in this area, it was viewed that enforcement of a Code of
Ethical Practice would have required significant input of resources without any notable advance in the*

Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005.

protection of public health and safety or the environment.
The industry and, in particular, research institutions also highlighted the already substantial administrative
burden of compliance with existing governance and regulatory schemes.
Finally, it was suggested that the development of a statement of ethical principles for biotechnology
would have an additional benefit in its usefulness as an educative tool for the wider community — theethical principles applicable in science and technology activities are not easily available or accessible forindividuals outside of the science community.

Process for development of the Statement
The VBEAC’s development of the Statement and the mapping exercise was carried out in a systematicand consultative manner.
Similar examples of codes of conduct and practice were reviewed. For example, ideas were sourced fromboth the UNESCO Preliminary Draft Declaration on Universal Norms on Bioethics as well as Australianlegislation and guidance documents relating to the ethical review of research involving humans.

Two rounds of publicly advertised comment were sought — initially interested parties were asked what
elements were important to include in such a statement, and an initial draft of the Statement and themapping document were circulated for comment. A total of 78 submissions were received and reviewed
by the VBEAC before the document was finalized and presented to the Government.
In addition, the VBEAC convened a secondary school student forum, in which 30 schools participated.
The student forum was organized by a group of students from senior years 10 to 12. Students constructed
a questionnaire looking at the applications of the draft ethical principles, which was then discussed insmall breakout groups and again in a plenary forum. The students also considered how adherence to
the Statement could be monitored, and they suggested strategies for its dissemination.

The statement of ethical principles for biotechnology in Victoria
The Statement of Ethical Principles for Biotechnology in Victoria is contained within a seven-page
document that defines “ethical principles”, “biotechnology”, and the environment in which the Statement
operates.
The map of existing ethical guidance and controls accompanies the Statement but is formatted as aready reference poster.
The Statement puts forward the following eight ethical principles as fundamental to all activities using
biotechnology:
Respect for Persons: The recognition that persons have an inherent dignity and the welfare,rights, beliefs, perceptions, customs, and cultural heritage of individuals should be taken into
account;
Respect for Animals: The recognition that animals have a value both in their being and in relation
to human culture; the welfare and humane treatment of animals should be taken into account;
Respect for the Natural Environment: The recognition that the natural environment is ourcommon heritage and sustains all life and human culture. The natural environment is more thana means to satisfy human ends. The safeguarding of biodiversity, ecosystems, and the beautyof the natural environment should be taken into account now and in the interests of future
generations;
Respect for the Public Good: The recognition that individual activities take place in a context

Asia-Pacific Perspectives on Biotechnology and Bioethics

Given that the Statement is directed towards business practice as well as scientific conduct, the VBEAC
included principles drawn from the fields of business ethics and governance within the public sector.

7

of social and institutional relationships. The “public good” is a collective good to be taken into
account along with individual interests. Our understanding of the “public good” shapes thesociety in which we live;
Benefit and Harm: The recognition that human activities have an impact and should promote
good and avoid harm. The use of risk assessments, as a tool to ensure health and well-being,
should be considered;
Justice and Equity: The recognition that the benefits and burdens from biotechnology activities
should be distributed equitably through society such that no particular group is inequitably
advantaged or disadvantaged now or in future generations;
Probity: The recognition that activities should be conducted honestly, truthfully, lawfully,
impartially, competently and with considered regard for transparency of process;Accountability: The recognition that persons and institutions are inherently responsible both fortheir actions and the justification, the purpose and the consequence of their actions.

8

Asia-Pacific Perspectives on Biotechnology and Bioethics

Interpreting the ethical principles
In addition to the stated ethical principles, the VBEAC document includes a set of questions to assist
individuals integrating the ethical principles into institutional and individual practice and governancesystems.
In Relation to Respect for Persons:• Have persons likely to be affected by decisions been informed and consulted about the proposed
biotechnology activity?;• Has this biotechnology activity been undertaken with regard to the safety, welfare, rights and beliefs ofresearch staff, research participants and those impacted by the activity?;• Has individual autonomy been respected through the provision of accurate information presenting boththe benefits and the risks likely to occur from undertaking the activity that will allow individuals to makeinformed decisions?;• Has the privacy of personal information been protected?;• Will genetic information arising from biotechnological activity potentially be used in a manner that may
lead to discrimination?;• Does this biotechnology activity contribute to an identified need by improving human health orotherwise enhancing the quality of human life?;• Has a properly constituted Human Research Ethics Committee approved any biotechnology research
proposal involving humans?
In Relation to Respect for Animals:• Have alternatives to the use of animals in biotechnology research been sought wherever possible?
• Have the minimum possible number of research animals needed to produce valid results been used anda justification provided for the determined number?
• Has biotechnology research been designed with regard to the biological• characteristics of research animals, including their behaviour, species, genetic attributes, and theirnutritional and general health status, so that potential pain and distress to the research animals is
avoided or minimized?
• Has a properly constituted Animal Ethics Committee approved the biotechnology• research proposal involving animals?
• Where the biotechnology activity may result in the creation of a transgenic or• genetically modified animal, has regard been given to minimize any suffering of the animal, including thedeprivation of its natural expressions?
In Relation to Respect for the Natural Environment:• Will the benefits from the application of biotechnology be achieved at the expense of damaging thenatural environment for future generations?;• Has humanity’s stewardship of the splendour and inherent value of the natural environment been taken
into account via the neutral impact of the biotechnology activities?;• Does the biotechnology activity support environmental sustainability?;• Does the biotechnology activity preserve and foster biodiversity and avoid serious side effects to species
present in the surrounding environment?;• Have suitably qualified persons undertaken an environmental impact assessment wherever there is
uncertainty or lack of information regarding the effects of proposed biotechnology activities?;• Is environmental degradation reduced or avoided as a result of the biotechnology activity?

• Has balanced information been made available to the public so as to foster informed public discussionof biotechnology-related issues and to allow for the expression of any public concerns about a particulardevelopment?;• Does the biotechnology activity lead to an overall benefit for the public, with consideration given to thesocial and environmental benefits as well as expected economic benefits?;• Is the biotechnology activity consistent with the accepted ethical standards of professional practice?;• Is the proposed biotechnology research activity of sufficient scientific merit that it does not produce
results of questionable validity or duplicate other research unnecessarily?;• Have the results of biotechnology research been published within a reasonable time frame (given
consideration of any commercial-in-confidence restrictions)?;• Has this biotechnology activity been carried out in a manner that recognizes and protects the cultural
heritage and rights of indigenous populations?;• Is the biotechnology activity adequately secured so that it will not be used or applied to destructive
ends, such as in biotechnological weaponry?;• Have research staff and research ethics committees undertaken training in ethics and researchgovernance to ensure that biotechnology activities are conducted according to accepted ethicalstandards?;• Where appropriate, has a social impact study been undertaken for this biotechnology activity?
In Relation to Benefit and Harm:• Is the biotechnology research carried out by individuals who have the relevant technical knowledge andskills for such activities?;• Do risk assessments of the biotechnology activity identify the possible long-term effects so these may betaken into account in risk management strategies?;• Is the biotechnology activity undertaken in a way that causes harm to, or puts at risk the safety of,
persons, animals, or the natural environment, where such harm or risk is disproportional to the expected
benefits?;• Are there systems in place to ensure the recall or ceased production of any biotechnology activity or GM
product that exhibits negative effects on human health, safety, or the environment?
In Relation to Justice and Equity:• Have the interests been taken into account of those most likely to be affected by this biotechnology
activity?;• Have groups been identified who are potentially disadvantaged by the biotechnology activity?;• Have steps been taken to ensure that the biotechnology activity does not expose any particular group to

Asia-Pacific Perspectives on Biotechnology and Bioethics

In Relation to Respect for the Public Good:9

a risk or burden disproportionate to the benefit that may be expected to flow to them?;• Will the biotechnology activity result in obtaining benefits for the present generation to the detriment of
future generations?;• Will this biotechnology activity adversely impact efforts to foster a society where risks, burdens, andbenefits are distributed equitably?

10

Asia-Pacific Perspectives on Biotechnology and Bioethics

In Relation to Probity:• Are biotechnology activities undertaken with intellectual honesty and in accordance with professional
standards?;• Have processes been put in place to identify and resolve actual or perceived users’ conflicts of interest
relating to biotechnology product development?;• Are public statements made by biotechnology users or organizations tested to ensure that they do not
misrepresent the biotechnology product or the process of its development?;• Do biotechnology research results undergo peer review before being published?;• Are responses to information requests from the community met promptly and accurately, subject tospecific privacy or commercial-in-confidence restrictions?;• Have biotechnology users and organizations put in place processes to monitor their adherence to andcompliance with the Statement of Ethical Principles?;• Are there mechanisms in place for dealing with conflicts of interest as well as conflicting interests,
especially for persons responsible for public statements?
In Relation to Accountability:• Is the biotechnology activity carried out in a transparent and open way with public scrutiny as far as ispossible given the constraints of commercial-in-confidence requirements?;• Are the outcomes of publicly funded biotechnology research and development publicly reported?;• Will biotechnology users and organizations adopting the Statement of Ethical Principles put in placetransparent processes that report on compliance with the Statement?;• Where a biotechnology activity has inadvertently resulted in harm or loss to a third party, will thebiotechnology user or organization act to remediate the loss or harm?;• Has a properly constituted Institutional Biosafety Committee reviewed the biotechnology activity andestablished a monitoring process relative to the level of risk?
External bodies such as Human Research Ethics Committees, Institutional Biosafety Committees andAnimal Ethics Committees have defined roles within the Australian ethical governance system. Further
information on their roles and function are noted in the map.

Conclusions
The State Government endorsed the Statement of Ethical Principles for Biotechnology in Victoria. The
VBEAC held further stakeholder meetings to identify gaps in the existing system of ethical guidance andcontrols and suggest ways in which these gaps may be addressed. Further documentation providing
individuals and institutions with a framework for recognizing ethical issues associated with the use of
biotechnology has subsequently been distributed as well as the statement and map. The VBEAC also
provided the Statement to other government jurisdictions with an aim to support the development of anational Australian Statement, and to mitigate potential inconsistency in practice across jurisdictions.
Further information on the Statement and VBEAC activities may be found at http://www.health.vic.
gov.au/biotechnology
Information on the Victorian Government’s Strategic Development Plan for Biotechnology (2005)
may be found at http://www.biotechnology.vic.gov.au

The Transgenic Thai Papaya story: A Milestone Towards
Thailand Becoming a Biotech Crop Country*
Pahol Kosiyachinda, Ph.D.
Mahidol University,
ThailandMetinee Srivatanakul, Ph.D.
Ministry of Agriculture andCooperative,
Thailand

Papaya ringspot virus (PRSV) is one of the limiting factors in growing papaya in many regions of theworld, including Thailand. PRSV stunts the infected plant and reduces the size of its fruits, sugar content,
and yield. After the plants become infected by the virus, curative measures are not available. Some
control measures are aimed at removing virus sources, providing certified virus-free plant materials,
reducing the spread of the virus, breeding for virus resistance, and cultural practice. Althoughconventional breeding has developed a number of virus-tolerant papaya varieties (DOA, 1997), thesetolerant papayas may serve as reservoirs of the virus and may be attributable to subsequent epidemicsof the ringspot disease. Currently, no natural virus-resistant genes against PRSV have been identified or
are readily available for conventional breeding. Thus, genetically engineered virus resistance became aprimary interest of researchers.
A virus-resistant transgenic papaya was the first genetically modified fruit crop launched on themarket (Gonsalves, 1998). The first transgenic papaya resistant to PRSV was produced in a laboratory
in a joint experiment between Cornel University and the University of Hawaii (Fitch et al., 1992). The
pathogen-derived resistance mechanism in transgenic papaya has been reported as an RNA-mediatedmechanism (Souza, 1999). On May 1st, 1998, after the completion of research, testing, deregulation, andcommercialization procedures, the transgenic papaya seeds became available to the farmers of Hawaii(Gonsalves, 1998). Development of the virus-resistant transgenic papaya line 55-1 has been reviewed
in detail by Gonsalves (1998). The success of transgenic papaya has been well evidenced and served
as a model for technology transfer for many countries, such as Jamaica, Brazil, Venezuela, Bangladesh,and Thailand. Since then, farmers in Hawaii have been able to reclaim their land for papaya production.
(Gonsalves et al., 2004).

Papaya Ringspot Virus in papaya in Thailand
Destruction of papaya plantations by PRSV has been reported worldwide (Gonsalves, 1998; Kiritaniand Su, 1999; Wolfenbarger and Walker, 1974). Papaya ringspot virus (PRSV) is a flexous rod-shaped
single-stranded positive sense RNA virus belonging to the Potyviridae strain. Its host range is limited to
Caricaceae, Cucurbitaceae, and Chenopodiaceae (Purcifull et al., 1996). Conventional control methodsof the virus, including sanitation, cultural practices, cross protection, and control of aphid vectors, havenot been very successful (Gonsalves, 1998; Kiritani and Su, 1999).
PRSV can kill young susceptible papaya seedlings. It causes mottled patterns of the leaves, reductionof the laminar area, and water-soaked ringspot lesions on stems and fruits (Wolfenbarger and Walker,
1974). When severely infected with PRSV, the palm-like papaya tree is reduced to only a stem (Kiritaniand Su, 1999; Tennant et al., 1994). In addition, yields of the infected plants are mostly unmarketable.
PRSV causes one of the most destructive diseases in papaya (Carica papaya L.). It is a major limiting factor
to papaya production in many tropical and subtropical countries, including the United States (Hawaii
and Florida), tropical Africa, Australia, and South and Southeast Asia (Ali and Lazan, 1998; Gonsalves,
1998; Kiritani and Su, 1999).
* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Asia-Pacific Perspectives on Biotechnology and Bioethics

Transgenic papaya resistant to Papaya Ringspot Virus

11

In Thailand, the first report of PRSV was in 1975. Measures used to combat the infestation of PRSV
included instigating quarantine controls, burning all infected plants, and using virus-tolerant varietiesand pesticides. Nevertheless, all these measures just seemed to delay the real destruction. In 2002, up
to 80% of papaya production was severely damaged by the infestation of PRSV (Sangruksawong, 2004).
From a report by the Thailand Department of Agriculture, the production of papaya between the years
1997 and 2002 was 461,179 metric tons, or approximately 17.437 metric tons/hectare/year, which isconsidered very low. When virus-resistant transgenic papayas were deployed in a disease management
programme, the 2002 production of papaya in Hawaii was approximately 29.037 metric tons/hectare.
(Gonsalves et al., 2004).

Development of the virus-resistant transgenic Thai papaya

12

Asia-Pacific Perspectives on Biotechnology and Bioethics

Due to an urgent need for effective control measures against PRSV, several governmental agencies
have been working to alleviate a common problem: the epidemics of ringspot disease in papaya.
These agencies include Mahidol University, Kasetsart University, and the Department of Agriculture.
Researchers at Mahidol University study molecular resistance mechanisms. Those at Kasetsart University
are working on resistance against PRSV and delayed-ripening traits. The Department of Agriculture had
established collaboration with researchers at Cornell University, USA, to develop virus-resistant Thai
papayas. Here we will cover the works related to the Department of Agriculture only.
In 1995, the Department of Agriculture sent Thai researchers to produce virus-resistant Thai papayas
with a group led by Professor Dennis Gonsalves at Cornell University, where the first virus-resistanttransgenic papaya was developed. In 1997, the first Thai papayas were transformed by Thai researcherswith technical assistance provided at Cornell University and brought back to Thailand. As a result of thistechnology transfer, two lines of transgenic Thai papayas, namely Khak Dam and Khak Nuan varieties,
were rendered. These transgenic papayas were transformed with constructs of non-translatable versionsof a coat protein gene of a PRSV isolate from Thailand. Thus, similar to the transgenic papayas in Hawaii,
these transgenic Thai papayas do not express a viral coat protein. The resistance mechanism is RNAmediated, commonly known as a process called post-transcriptional gene silencing.
Thailand’s Department of Agriculture set up the Khon Kaen Horticultural Station with the aim of making
Thailand a centre of excellence in the study of transgenic papayas. These papayas were subjected to atest for their resistance against Thai strains of PRSV and for biosafety, both nutritional and environmental.
The testing was divided into three levels, i.e., in laboratory or under greenhouse conditions, in a confined
field site of the Department of Agriculture, and in a field site under real orchard conditions.
Several tests have been conducted to clarify biosafety concerns (Sangruksawong, 2004). The tests underlaboratory and greenhouse conditions showed that both lines of the transgenic Thai papayas exhibited
97-100% resistance against PRSV infection compared to the non-transgenic papayas. Under confined
field conditions, the average yield of transgenic Thai papayas was over 293 metric tons/hectare. In cocultivation experiments, transgenic Thai papayas were grown in close proximity with several locallygrown plant species and weeds, such as ground nuts, maize, lettuce, string bean and water morning
glory. In this experiment, all plants exhibited normal growth and development. Also, the numberof microorganism species in the soil and compost of transgenic Thai papayas was not significantly
different from the number of microorganism species in those of non-transgenic papayas. Those species
included Rhizobium. and mycorrhiza. In addition, the development and growth of bees and mice were
not affected by consumption of transgenic Thai papaya, compared to those fed with non-transgenic
papayas.

Risk assessment and deregulation of genetically-modified crops
Genetically engineered plants and products derived from genetically engineered plants have reachedmarkets in several countries, including the United States, Canada, China, and Australia. However, acommon apprehension is that transgenic plants can be harmful to human consumption and theenvironment. Since nutritional aspects and allergenicity are major concerns to human consumption,
guidelines to determine the allergenicity of food products derived from genetically engineeredplants are available (FAO/WHO, 2001; Wal, 1997). For instance, comparisons of amino acid sequences
and protein structures of known allergens are made with the food products derived from geneticallyengineered plants to determine their similarity. Reactions of antibodies to known food antigens aretested. In addition, animal testing and digestion assays can determine relative digestibility of thegenetically engineered protein in mammalian gastrointestinal tracts.

In the USA, deregulation of transgenic papayas was conducted by the US Animal and Plant HealthInspection Service (US-APHIS), the US-Food and Drug Administration (US-FDA), and the US Environmental
Protection Agency (US-EPA) before releasing transgenic papaya into the environment. US-APHIS, withits mission to monitor and safeguard resources and the environment, was concerned with the potential
ecological risks of the transgenic papaya. APHIS deregulated transgenic papaya line 55-1 in Hawaii andits derivatives in 1996 (USDA/APHIS, 2002). A petition to the US-EPA for an exemption from tolerance
levels of the coat protein produced in the transgenic papaya was submitted in 1997 (EPA, 2002). The
mission of the US-EPA is to protect human health and to safeguard the natural environment. The
Hawaiian transgenic papaya line 55-1 and its derivatives, including ‘SunUp’ and ‘Rainbow’ varieties, were
granted an exemption by US-EPA in 1997. US-FDA, which regulates food safety of transgenic products,
approved the papaya line 55-1 and its derivatives in 1997 (FDA/CFSAN, 2002). Data showed that line
55-1 is not materially different in composition from non-transgenic ‘Sunset’ (Gonsalves, 1998). ‘SunUp’
and ‘Rainbow’ were commercialized in May 1998.
In other countries such as Japan, the development and application of living modified organisms (LMOs)
are regulated under specific laws. Japan has “The Law Concerning the Conservation and Sustainable
Use of Biological Diversity Procedures”. They are classified into two types: Type One is for the use of
LMOs where no preventative measures are required against their dispersal into the environment; TypeTwo is for the use of LMOs with preventive measures. During the period of development, the Ministry of
Education, Culture, Science, Sports, and Technology is responsible for the risk assessment of LMOs.
For Thailand, specific laws and regulations concerning the release of LMOs are still to be established.
Currently, the Department of Agriculture has been following the Quarantine Regulations that have beenused to quarantine and handle any importation of plants and living materials since 1964. Thus far, there
has been no distribution of transgenic materials to the public. Besides, the Department of Agriculture
has been conducting the test on biosafety with the highest security level. For instance, the confined
field sites have been double fenced and guarded 24 hours a day. The non-transgenic papaya production
facility is located approximately 150 metres away from the confined field experiment location. These
measurements have been employed to minimize the risk of cross-contamination from the fields oftransgenic papayas to other crops.
At the time of printing this paper no commercialization or distribution of transgenic Thai papaya seeds
is allowed (Sangruksawong, 2004). Any importation of genetically modified organisms can only be done
for research purposes. Therefore, any procedures involving transgenic papayas must be conducted withgreat care. Detailed biosafety laws have been undergoing drafting for years by the Ministry of Natural
Resources and Environment, in conjunction with an expert panel from Thailand’s National Centre for
Genetic Engineering and Biotechnology (BIOTEC), the researchers must conduct experiments by taking
precautionary measures for biosafety concerns.
Because of a need for a legal framework to deal with transboundary movement of LMOs, the Cartagena

Asia-Pacific Perspectives on Biotechnology and Bioethics

The environmental concerns over virus-resistant plants are mainly ecological. These include
transcapsidation, synergism, transgene flow or introgression, and recombination (Tepfer, 2002).
Nonetheless, we need to delineate actual risks from perceived risks. It is difficult to generalize whether
transgenic plants are likely to pose ecological risks because each transgenic plant may be transformed
with different genes and derived from different techniques. Each component provides idiosyncrasy toa transgenic plant. Many of the concerns are not only specific to the gene and the host plant, but also
to the environment in which the plant is released. Thus, it is important to consider the concerns on acase-by-case basis.

13

Protocol on genetically modified crops or other LMOs has been ratified by 147 countries as of May 2008.1
Initially, the Cartagena Protocol was drafted to protect biodiversity resources against any deliberate
release of LMOs. Currently, it is also used to provide consistent and unbiased guidelines to a country
that, for whatever reason, might need to deal with the importation and release of LMOs (Watanabe
et al., 2004). Thailand signed up to the Cartagena Protocol soon after BBRT1, acceding to it in February
2006.

Summary

14

Asia-Pacific Perspectives on Biotechnology and Bioethics

The devastation caused by PRSV on papaya production has been documented extensively. The impacts
could be both economical and sociological to both farmers and local communities. In Thailand, thefarmers either rotate their crop species or move to another area where the virus infestation has not
arrived, and some markets have started to import papayas to substitute production losses. These
temporary solutions have not only had negative impacts on the local economy but also affected theminds and dignity of the local people, because they need to import a staple food that was once grownin their own backyards. These are definitely not good solutions to the problem. The urgency of measures
to alleviate the ringspot disease on papaya is apparent in Thailand. While several governmental agencies
are taking efforts to deregulate the virus-resistant transgenic Thai papayas, stakeholders should work
towards a practical and sound resolution based on scientific evidence in a timely manner.
The transgenic papayas in Hawaii provide an excellent example to objectively determine how a transgenic
product may affect the farmers and local community. The project was started on a humanitarian basis,
without investments from large multinational companies. The genetically engineered papaya cultivars
have successfully demonstrated resistance to PRSV in laboratory, greenhouse, and long-term field trials.
They have been in the open field for almost a decade now and there is no single report of any catastrophic
event from the release of the transgenic papayas in Hawaii. However, for Thailand, it appears that the
deregulation process will take more time than it did in Hawaii. This seems to be due to the controversies
over generalization of transgenic technology.
Concerns over biosafety issues should attest to justified assessment experiments for the actual risks,and on a case-by-case basis. At this point in time, Thailand has no biotech crop that is grown by local
farmers. To bring Thailand towards being a biotech crop country, it is essential for the scientists andthose who know and understand this technology to speak up and educate the uninformed. After
joining the Cartagena Protocol, the interim regulatory agencies are working on agreements on the
deregulation process of LMOs. A high demand for virus-resistant transgenic papayas from local farmers,
and the established regulations of the government may propel the speed of deregulation. Then, withthe regulatory approval to the virus-resistant transgenic Thai papayas, Thailand will set its milestone
towards becoming a biotech crop country. The transgenic Thai papaya will pave a path and become thepractical pilot case for other fruits of biotechnology to follow.

Disclaimer
This article only reflects the opinions of the authors. It does not provide any implication or any relation
to the Thailand Department of Agriculture or any other mentioned agencies. Should further clarification
be required, please contact the corresponding author.

References
Ali, Z.M. and Lazan, H. 1998. Papaya in Tropical and Subtropical Fruits. Edited by P. E. Shaw, J. H.T. Chan,and S. Nagy. Florida, USA. AgScience Inc., pp. 401-445.
DOA. 1997. Papaya Var. Khak Dam Tha Phra: A Variety Tolerant to Papaya Ringspot Virus Infection. Thailand
Department of Agriculture.

1 http://www.cbd.int/biosafety/signinglist.shtml

EPA. 1997. Coat Protein of Papaya Ringspot Virus and the Genetic Material Necessary for its Production:
Exemption From the Requirement of a Tolerance. United States Environmental Protection Agency, 22
August 1997. Accessed on 12 April 2002. Available from http://www.epa.gov/fedrgstr/EPA-PEST/1997/
August/Day-22/p22395.htm.
FAO/WHO. 2001. Evaluation of Allergenicity of Genetically Modified Foods. In Report of a joint FAO/WHO
expert consultation on allergenicity of foods derived from biotechnology (Rome). Food and Agriculture
Organization of the United Nations.
FDA/CFSAN. 2002. List of Completed Consultations on Bioengineered Foods.
United States Food and Drug Administration. This document is available by accessing: http://www.
cfsan.fda.gov/~acrobat2/bnfM042.pdf.
Fitch, M. M. M., Manshardt, R. M., Gonsalves, D., Slightom, J. L., and Sanford, J. C. 1992. Virus Resistant
Papaya Plants Derived From Tissues Bombarded With the Coat Protein Gene of Papaya Ringspot Virus.
Biotechnology. Vol. 10, pp. 1466-1472.

Gonsalves, D., Gonsalves, C., Ferreira, S., Pitz, K., Fitch, M., Manshardt, R., and Slightom, J. 2004. Transgenic
Virus Resistant Papaya: From Hope to Reality for Controlling Papaya Ringspot Virus in Hawaii. American
Phytopathological Society. July 2004.
Kiritani, K. and Su, H.J. 1999. Papaya Ringspot, Banana Bunchy Top, and Citrus Greening in the Asia andPacific Region: Occurrence and Control Strategy. JARQ 33, pp. 23-30.
Purcifull, D. E., Edwardson, J. R., Hiebert, E., and Gonsalves, D. 1996. Papaya Ringspot Potyvirus. In Virusesof Plants: Description and Lists from VIDE Database. Edited by A. Brunt, K. Crabtree, M. Dallwitz, A. Gibbs,
and L. Watson. Oxon, UK. CAB International. pp. 874-877.
Sangruksawong, C. 2004. Research on Genetically Modified Papayas at Department of Agriculture. Bangkok,
Thailand’s Department of Agriculture. pp. 1-8.
Souza, M. T. 1999. Analysis of Sunset Solo Line 55-1: Assessment of the Role of Plant Developmental Stageand Inoculum Strength in the PRSV: Transgenic Papaya Resistance System. Department of Plant Pathology(Geneva), Cornell University, pp. 164-199
Tennant, P., Gonsalves, C., Ling, K., Fitch, M., Manshardt, R., Slightom, J., and Gonsalves, D. 1994.
Differential Protection Against Papaya Ringspot Virus Isolates in Coat Protein Transgenic Papaya andClassically Cross-Protected Papaya. Phytopathology. Vol. 84, pp. 1359-1366.
Tepfer, M. 2002. Risk Assessment of Virus-Resistant Transgenic Plants. Annual Review of Phytopathology.
Vol. 40, pp. 467-491.
USDA/APHIS. 2002. Petition 96-051-01P for the determination of nonregulated status for transgenic “Sunset”
papaya lines 55-1 and 63-1: United States Animal and Plant Health Inspection Service. This document
is available by accessing the following: http://www.aphis.usda.gov/biotech/dec_docs/9605101p_
ea.HTM.
Wal, J. M. 1997. Evaluation of the Safety of Foods Derived From Genetically Modified Organisms. Revue
Francaise D’Allergologie Et D’Immunologie Clinique. Vol. 37, pp. 326-333.
Watanabe, K. N., Taeb, M., and Okusu, H. 2004. Putting Cartagena into Practice. Nature Biotechnology. Vol.
22, pp. 1207-1208.
Wolfenbarger, D. O., and Walker, S. D. 1974. Two Major Pest Problems of Papayas. Proceedings of Florida
State Horticultural Society. Vol. 87, pp. 384-385.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Gonsalves, D. 1998. Control of Papaya Ringspot Virus in Papaya: A Case Study. Annual Review of
Phytopathology. Vol. 36, pp. 415-437.

15

Benefits and ethical limits of biotechnology*
A. Mary Saral
Vellore Institute of Technology,
India
M. Selvanayagam
Loyola College Chennai, India

Introduction

16

Asia-Pacific Perspectives on Biotechnology and Bioethics

Consideration of the ethics of science, technology and the environment require a multidisciplinary
perspective.
Biotechnology is the most controversial scientific discovery of recent times and hit the headlines ofnewspapers throughout the world because of potential positive and negative effects on the ethicaland social aspects of present day civilized society. There are innumerable biotechnical, agricultural,industrial and medical applications in the biotechnological approach. In the field of medical andchemical biotechnology, biotechnologists have triumphed in producing some special chemicals suchas amino acids, vitamins and enzymes which are essential for normal biological functions. (Organizationof Economic Cooperation and Development, 2001).
Biotechnologists have made remarkable contributions in the fields of agriculture and food in areas
like pest control and animal foodstuffs. The food processing industry has a constant demand for
acceptable additives such as colorants, sweeteners and sauces, including soy sauce, novel catalysts andpreservatives. They have developed plants resistant to pollution, insects, pests and even pesticides.
Biotechnologists are trying to transfer the genes of the neem tree for insect and pest resistance. Using
biotechnological methods, scientists have succeeded in enhancing the production of secondary
products such as wood, leaves, resins and also improving other products such as fatty acids, organic
acids, vanilla and pigments.
In the fields of energy and the environment, plants are the most efficient energy stores used bybiotechnologists to produce fuels such as biodiesel directly from plants. Biotechnologists have efficiently
produced alcohol from biogas. Waste treatment has also improved as a larger scale fermentationindustry requires new catalysts and improved reactors to treat toxic waste.

Examples of the benefits of biotechnology
Biotechnology is the application of biological systems in technology that can only be achieved throughan integration of the biological, physical and engineering sciences. In this paper I wish to give someexamples that relate to life in developing countries.
The current approach of biotechnology in the environment is to apply biological products such as
enzymes rather than live cultures. Enzymatic action is very specific and also easy to control. This paper
discusses biotechnological applications in different operations including: i). Waste water treatment; ii).
Removal of specific pollutants by bioremediation;iii). Biotechnology for hazardous waste management; iv). Biotechnology for the pesticide industry; v).
Biotechnology for food and allied industries, and; vi). Biotechniques for air pollution abatement andodour control, where the roles of chemical and environmental scientists are involved.

* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Waste water treatment
Biological processes for industrial effluent treatment includes aerobic biological treatment, anaerobic
biological treatment, membrane bioreactors, the use of immobilized enzymes and microbial cells.
Biotechnology process changes in the production and bleaching of pulp for paper reduce the amountof chlorine chemicals necessary for bleaching by 10-15%. The use of biotechnology processes also cut
bleaching–related energy use by 40%. This is a saving that can create additional pollution reductions. This
process also lowers wastewater toxicity. The yeasts, like Candida tropicalis, Saccharomyces cerevisiae,
S. carlbergensis and Candida utilis are important in clearing industrial effluents of unwanted chemicals.
Agaricus bisporus and Lentinus oloides are important in lignocellulose decomposition. Corius versicolor
is important in cleaning up pulp and paper mill waste.

Phenolic waste treatment by specialized microbes

Specialized microbes however have the capacity to transform these chemicals into non-toxic entities. A
list of such microbes is given in Table One. The techniques consist of growing the cultures in a synthetic
medium with the organic pollutant as the carbon source to the organisms along with other essential
nutrients. Several investigations have employed this technique to detoxify phenolic wastes for a longtime (Kumaran and Shivaraman 1968).
Table 1: Microorganisms known to degrade phenols and other related aromatic compounds throughaerobic/anoxic routes
Organic Compounds

Micro-organisms

Hydrocarbons- Aromatic hydrocarbons

Psendomonas putida, P aeruginosa, P.
Stutzeri, Flavobacterium, Achromobacter,
Bacillius, Vibrio, Spirillum, Candida, Nocardia

Naphthalene salicylate, phthalates, parafinins

Beijerinkia B 836, P. Aeruginosa, P. Putida,
Micrococcus, Nocardia, Arthrobacterparaffineus

Phenols, Chlorophenols, Nitrophenols, AminophenolsCatechol, Alkyl substituted cresols,
Reseorcinol, Hydroquinne, Pyridines, Pycholines,
Benzoates

Alcaligenes, acinetobacotr, Achromobacter,
Azotobacter, Bacillus subtilis, B. Cerus,
Brevibacterium, Flavobacterium,
Pseudomonas aeruginosa, P. Cepecia,P.
Flurescens,P.strutzeri,P.putida,Candida
tropicalis, Trichosporon cutanenum, Nocardia

Catechuic acid, tannin

Pseudomonas

Catechin

Bradyrhizobium japonicum

Lignin and lignin derivaties

Aspergillus niger, Phanerochaetechrysosporium, Polycysticus versicolor;
Plurotus ostreatus, coriolus versicolor,
Chaetomeum piluliferum, nocardia sp.,
Fusarium, P. fluorescens, P. putida FK-2, P.
testosterone,P. acidovorans, bacillus subtilis,
Acinetobacter sp., Candiada albicans,
Alcaligens sp., Trametes sp., Penicillium sp.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Biological treatment of waste water containing organic pollutants has been universally accepted as acost efficient method for the prevention of environmental pollution. Phenols and other aromatics aredischarged from a variety of chemical industries, including the petrochemical refining and manufacturingindustries, pharmaceuticals, coal refining, basic organic chemical manufacturing, textiles and pulp andpaper milling.

17Removal of metals
Heavy metal contamination causes direct toxicity to most living beings due to their presence beyond
specified limits (Jamode et al., 2003). Several past disasters were due to the contamination of heavy
metals in the aquatic environment. Consequentially all effluents need to be assessed and require
integrated pollution documentation before their final discharge.

Bioremediation
Bioremediation is a pollution control technology that uses biological systems to catalyze the degradation
or transformation of various toxic chemicals to less harmful forms. The general approaches tobioremediation are to enhance natural biodegradation by native organisms (intrinsic bioremediation),
to carry out environmental modification by applying nutrients or aeration (biostimulation) or throughaddition of microorganisms (bioaugmentation). Unlike conventional technologies, bioremediation canbe carried out on-site. Bioremediation is limited in the number of toxic materials it can handle, butwhere applicable, it is cost-effective (Atlas and Unterman, 1999).

18

Asia-Pacific Perspectives on Biotechnology and Bioethics

Bioremediation refers to the use of biological systems to degrade toxic compounds in the environment.
Bioaccumulation or biosorption is the accumulation of the toxic compounds inside the cell without any
degradation of the toxic molecule. This method can be effective in aquatic environments where theorganisms can be removed after being loaded with the toxic substance.

Fungi in bioremediation
Fungi are good in the accumulation of heavy metals such as cadmium, copper, mercury, lead and zinc.
Systems using Rhizopus arrhizus have been developed for treating uranium and thorium. The abilityof fungi to transform a wide variety of hazardous chemicals has created interest in using them inbioremediation (Alexander, 1994). The white rot fungi are unique among eukaryotes for having evolved
nonspecific methods for the degradation of lignin; curiously they do not use lignin as a carbon source
for their growth (Kirk et al., 1976). Lignin degradation is, therefore, essentially a secondary metabolic
process, not required for the main growth process. Lamar et al. (1993) compared the abilities of threelignin-degrading fungi, Phanerochaete chrysosporium, P. sordida and Tramates hirsute to degrade PCP(Pentachlorophenyl) and creosote in soil. Inoculation of soil with 10% (wt/wt) Phanerochaete sordid
resulted in the greatest decrease of PCP and creosote. P. sordida was also most useful in the degradationof PAHs (Polycyclic aromatic hydrocarbons) from soil. Davis et al. (1993) showed that P. sordida wascapable of degrading efficiently the three ring PAHs, but less efficiently the four-ring PAHs.

Removal of dye
In many developing countries large areas of land, and water tables, are polluted by the dye industry.
Consortia of fungi and bacteria (usually uncharacterised) are used in composting dye, the most usefulwaste disposal practice. Phenolic azo dyes have been shown to be oxidized by the enzyme laccase
produced by Pyricularia oryzae (Chivukula and Renganathan, 1995). Bacteria such as Pseudomonas
and Bacillus have been shown to degrade the azo or reactive dyes from textile industry effluents. The
process is often referred to as biobleaching. The bacteria are often used in consortia for biobleaching(Ashoka et al., 2002).
Phanerochaete chrysosporium has been shown to affect the biobleaching of organic dyes (Nigam et al.,1995). Pauli et al. (1993) have also shown the decolourization of azo-triphenyl methane dyes by lignin
peroxidase produced by P. chrysosporium. Sami and Radhaune (1995) have demonstrated the role oflignin peroxidase and manganese peroxidase from P. chrysosporium in the decolourization of olive millwaste water. The work carried out by Asoka et al. (2002) revealed that Phanerochaete chrysosporium andmicrobial consortia were effective in colour removal from textile dye effluents. The fungus caused 80%
decolourization in broth containing 2.5% of effluent. There was a reduction in BOD and COD values. A
local isolate of Fusarium caused various degrees of decolourization ranging from 35 to 85%.

Biotechnology for hazardous waste
Several bacteria have been found to be good degraders of toxic pesticides such as halocarbons.
Some sulfate reducing bacteria transform tetrachloroethane to cis-1,2-dichloroethene by anarobic
dehalogenation of halocarbons. Methanogenic bacterial consortium has been shown to degrade
perchloroethene. Mono and dichlorobenzenes are degraded aerobically by various Pseudomonasand Alcaligenes strains. Pentachlorobenzenes (PCBs) are degraded by strains of Acinetobacter andAlcaligenes the same way as Phanerochaete chrysosporium, the fungus.
Several soil-inhabiting bacteria have been reported to degrade chlorophenols under both aerobic andanaerobic conditions. Pentachlorophenol is degraded by a monoxygenase enzyme which removes
chlorine from the molecule making it nontoxic, and this enzyme is found in some soil bacteria.

Petroleum products contain a mixture of several hydrocarbons which are difficult to degrade by any
one bacterium. Short-chain alkanes are toxic to many microorganisms and are difficult to degrade.
Intermediate chain length (C10-C24) are degraded most rapidly. Very long chain alkanes become
increasingly resistant to biodegradation. Monoxygenases and dioxygenases are the enzymes involvedin the degradation of alkanes. The aromatic hydrocarbons present in petroleum are also difficult
to degrade. Some aromatic compounds such as benzene and toluene can be degraded by bacteria,
especially species of Pseudomonas.
Biodegradation of oil spills is a major problem because it usually occurs on marine water surfaces andseeding with bacteria becomes difficult. Besides, there is no single bacterium that can degrade all thecomponents of the oils which are petroleum products. A genetically engineered strain of Pseudomonas
putida has been reported by Anand Chakrabarty, an Indian-born scientist working in the USA, which
can degrade more than three to four components of petroleum. Other bacteria used in the treatmentof oil spills are strains of Alcaligenes eutropus, Rhodococcus, Bacillus and several unidentified bacteria.
Nutrients like nitrogen and phosphate enhance the potential of microorganisms for biodegradation.
The oleophilic fertilizer Inipol EAP-22 is used extensively to stimulate degradation of oil spills.

Biotechnology for the pesticide industry
With industrialization and the extensive use of pesticides in agriculture, the pollution of the environment
with human-made (synthetic) organic compounds has become a major problem. Many of these novelcompounds introduced into nature are called xenobiotics, and a large number of them are not easily
degraded by the indigenous microflora and fauna. The list of xenobiotics is very long and some of them
are directly applied to nature in the form of pesticides or fertilizers, some others are released as industrial
waste products (effluents). Other than the above compounds, the xenobiotics would also include awide variety of dumped materials such as plastics, detergents and oil spills, either inadvertently ordeliberately disposed of.
The chemical pollutants such as toxic pesticides are of two types, biodegradable and nonbiodegradable(recalcitrant). A biodegradable pesticide may be converted by microbial action into a nontoxic compound
within a few months whereas a recalcitrant chemical may remain in nature for several years in the toxic
form. The duration of persistence of some of the common pesticides is given in Table Two.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Nitroaromatics are highly recalictrant because of the strong aromatic rings. Under anaerobic andmicroaerophilic conditions, the nitro groups of trinitrotoluene (TNT) can be reduced to amino groups
but each subsequent step is slower.

19

Table 2: Persistence of some pesticides in the environment

20

Asia-Pacific Perspectives on Biotechnology and Bioethics

Common Name
AldrinChlordane
DDT
DiuronEndrinMonuronParathion
PCP
Simazine

Chemical name
Hexahydro dimetanonaphthalene
Octacholoro hexahydro methano-indene
Dichloro diphenyl trichlro ethane
Dichlorophenyl dimethyl urea
Hexachloro dimethanonaphthalene
Parachlorphenyl dimethyl urea
Diethyl paranitrophenyl phosphorodithioate
Pentachlorophenol
Cholro ethyl amino triazene

Persistence (Years)
15
15
15
15
14
3
16
5
2

Phanerochaete chrysosporium has been shown to degrade a number of toxic xenobiotics such asaromatic hydrocarbons (Benzo alpha pyrene, Phenanthrene, Pyrene), chlorinated organics (Alkyl halide
insecticides, Chloroanilines, DDT, Pentachlorophenols, Trichlorophenol, Polychlorinated biphenyls,
Trichlorophenoxyacetic acid), nitrogen aromatics (2,4-Dinitrotoluene, 2,4,6-Trinitrotoluene-TNT) andseveral miscellaneous compounds such as sulfonated azodyes. Several enzymes which are releasedsuch as laccases, polyphenol oxidases, lignin peroxidases etc. play a role in the degradative process.
In addition, a variety of intracellular enzymes such as reductases, methyl transferases and cytochromeoxygenases are known to play a role in xenobiotic degradation (Barr and Aust, 1994).
Biodegradability or recalcitrance depends on the nature of the chemical molecule. Often a simple
change in the substituents of a chemical molecule may make the difference between recalcitrance
and biodegradability. The herbicide 2,4-D (2,4 dichlorophenoxy acetic acid) is biodegraded withindays but 2,4,5-T differs only by the addition of a chlorine molecule in the meta-position. The additional
substitution interferes with the hydroxylation and cleavage of the aromatic ring. Similarly methoxychloris less persistent than DDT which has great stability.

Biotechnology for food and allied industries
Classical biotechnological processes have been used for a long time in the production of food andbeverages such as bread, cheese, beer and wine. These process are characterized by the direct applicationof live organisms and the in sitar production of enzymes and other products (Table 3).
Table 3: Examples of biotechnology in food
Product

Old Manufactering
Process

New Industrial Biotech Process

Deter
-gent

Phosphates added
as a brightening andcleaning agent

Addition of biotechnology
enzymes as brightening andcleaning agents- Proteases remove protein stains-Lipases remove grease stains-Amylases remove starch stains

Genetically enhanced
microbes or fungi
engineered to makeenzymes

Bread

Potassium bromate,a suspected cancercausing agent at
certain levels, added
as a preservative and adough strengthening
agent
Polyester* produced
chemically frompetroleum feedstock

Addition of biotechnology
enzymes to

Microorganisms geneticallyenhanced to produce
baking enzymes ( directed
evolution and recombinant
DNA)

Polyester
Bedding* any synthetic fibre-enhance rising-strengthen dough-prolong freshness
Biotech polyester (PLA)
produced from corn starchfeedstock

Biotech Enabling
Technology

Existing bacillus microbe
used to ferment cornsugar to lactic acid; lactic
acid converted to abiodegradable polymer
by heating; polymer madeinto plastic products andpolyester

Benefits-Elimination ofwater pollution from
phosphates-Brighter, cleaner
clothes with lower
temperature water-Energy savings-High-quality bread-Longer shelf life
-No potassium
bromate
PLA Polyester does
not hold body odour
like other fibres-Biodegradable-Not made frompetroleum-Does not giveoff toxic smoke ifburnedToxic chemicals, suchas aniline, used in anine step chemical
synthesis process

One-step fermentation processuses vegetable oil and glucose asa feedstock

Wood chips boiled
in a harsh chemicalsolution thenbleached with chlorine
to yield pulp for paper
makingEnzymes selectively degrade
lignin and break down wood cell
walls during pulping

Ethanol
Fuel

Food and feed grains
fermented intoethanol ( a technologythat is thousands ofyears old)

Cellulase enzyme technology
allows conversion of crop
residues (stems, leaves, straw,
and hulls) to sugars that are thenconverted to ethanol

Genetically enhanced
organism developed to
produce enzymes thatconvert agricultural wastes
into fermentable sugars(directed evolution, gene
shuffling)Anti-biotics

Chlorinated solventsand hazardous
chemicals used to
produce antibiotics
through chemical
synthesis
Surfactants and / orsaline solutions (donot remove protein
deposits) used to cleanlenses

One-step biological process uses
direct fermentation to produce
antibiotic intermediate

Genetically enhanced
organism developed
to produce the key
intermediate of certain
antibiotics (recombinantDNA)
Genetically enhanced
microbes engineered tomake protease enzymes(directed evolution)

Paper
Bleach-ing

Contact
Lens
SolutionProtease enzymes remove
protein deposits from thecontact lensGenetically enhanced
microbe developed to
produce vitamin B2 (directed
evolution)

Wood-bleaching enzymes
produced by geneticallyenhanced microbes(recombinant DNA)

Biologically
produced withoutchemicals
Greatly reduces
hazardous waste
generation anddisposal
Reduces use ofchlorine bleach andreduces toxic dioxinin the environment
Cost savings due tolower energy andchemical costs-Renewable
feedstock-Reduces green
house gas emissions-Increases domesticenergy production-Is more energy
efficient to produce
than old process
65% reduction inenergy consumption
Overall cost savings

More effective
contact lenscleaning
Less eye irritationand fever infections

Microbiological purification of wine distillery wastewaters
Wine alcohol distilleries produce the waste that has no acidic character and a high organic content.
The adequate microbial treatments (acrobic, mesophilic anaerobic and thermophilic anaerobic) for the
purification of vinasses were examined. Ninety percent biodegradable COD removals were achieved inevery treatment.

Biotechnology for air pollution abatement and odour control
With advances in biotechnology, it is feasible to modify plants for a wider range of phytomonitoringand phytoremediation applications. It is proved that it is possible to produce pollution resistant plant
species, through biotechnology (Linderman, 1997; Baker, 1997).

Ethical limits of biotechnology
As biotechnology has become widely used, questions and concerns have also been raised. One of themain areas of concern is the safety of genetically engineered food (American Dietetic Association, 1995).
In assessing the benefits and risks involved in the use of modern biotechnology, there are a series ofissues to be addressed so that informed decisions can be made. The health effects of foods grown fromgenetically engineered crop depend on the composition of the food itself. Any new product may have
either beneficial or occasional harmful effects on human health. What we know from our understandingof science and more than a decade of experience with biotech-derived plants is that they appear to besafe (FDA, 1993). There is no evidence that genetic transfers between unrelated organisms pose humanhealth concerns that are different from those encountered with any new plant or animal variety. The risk
associated with biotechnology are the same as those associated with plants and microbes developed byconventional methods. Consumers find biotechnology acceptable when they believe it offers benefits
and it is safe.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Vitamin
B2

21

Conclusion
The applications of biotechnology are so broad, and the advantages compelling that virtually every
industry is using this technology. Developments are underway in areas as diverse as pharmaceuticals,
textiles, chemicals, cleaning the environment, food processing and forensics to name but a few.
Biotechnology holds a significant promise to the future but a certain amount of risk is associated withany area. Biotechnology must continue to be carefully regulated so that the maximum benefits arereceived with the least risk.

References
Alexander, M. 1994. Biodegradation and Bioremediation. Academy Press, San Diego, Calif.
Kumaran, P. and Shivaraman, N. 1968. Biological treatment of toxic industrial wastes in bio-treatment
system (Donald L. Wise, Editor) CRC Press, Boca Raton, USA, p. 242.

22

Asia-Pacific Perspectives on Biotechnology and Bioethics

American Dietetic Association. 1995. “Position of the American Dietetic Association: Biotechnology andthe Future of Food. J Am Diet Assoc., 95:1429-1432.
Asoka, C. , Geetha, M.S. and Sullia, S.B. 2002. Bioleaching of composite textile dye effluent using bacterial
consortia. Asian Jr. Microbial Biotech. Env. Sci., 4:65-68.
Atlas, R.M. and Unterman, R. 1999. Bioremediation. In: Industrial Microbiology & Biotechnology, 2nd Ed.,ASM Press, Washington, pp. 666-681.
Baker K.F. 1987. Evolving concepts of biological control of plant pathogens. Ann. Rev. Phytopathol. 25,
pp. 67 – 85.
Barr, D.P. and Aust, S.D. 1994. Mechanisms the white rot fungi use to degrade pollutants. Environmental
Science & Technology, 28: 79A-87A.
Chivukula, M. and Renganathan, V. 1995. Phenolic azo dye oxidation by laccase from Pyricularia oryzae.
Appl. Environ. Microbiol., 61:4374-4377.
Davis, M.W., Glaser, J.A., Evans, J.W. and Lamar, R.T. 1993. Field evaluation of lignin degrading fungu
Phanerochaete sordida to treat creosote contaminated soil. Environmental Science & Technology, 27:2572-76.
Food and Drug Administration (USA) FDA. 1993. Genetically Engineered Foods, Fears and Facts: FDA
Consumer 27(1). January/February 1993, pp. 11-14.
Jamode et al. 2003. Applications of the inexpensive adsorbents for the removal of heavy metals fromindustrial waste water: A brief review. J. Industrial Pollution Control 19(1), pp. 114-134.
Kirk, T.K., Connors, W.J. and Zeikus, J.G. 1976. Requirement of growth substrate during lignin degradationby two wood rotting fungi. Appl. Eviron. Microbiol., 32: 192-194.
Lamar, R.T. Evans, J.W. and Glaser, J. 1993. Solid phase treatment of pentachlorophenol-contaminatedsoil using lignin degrading fungi. Environmental Science & Technology, 27: 2566-71.
Linderman R.G. 1997. Vesicular-Arbuscular Mycorrhizal (VAM) fungi In: The Mycota V Part B. Plant
relationships (Carroll & Tudzynski, Eds.) pp.117-127. Springer Verlag.
Nigam, P., Banat, I.M., McMullan, G., Dalel Singh, and Marchant, R. 1995. Microbial degradation of textile
effluent containing Azo, Diazo and reactive dyes by aerobic and anaerobic bacterial and fungal cultures.
36th Annual Conference AMI, Hisar, pp. 37-38.
Organisation for Economic Co-operation and Development. 2001. The Application of Biotechnology toIndustrial Sustainability, Sustainable Development, Paris, France.
Ollikka, P., Kirsi Alhonmaki, Veli-Matti Leppanen, Tuomo Glumoff, Timo Raigola and Hari Suominen
1993. Decolorization of Azo Triphenyl Methane Heterocyclic and Polymeric dyes by lignin peroxidase,
isoenzymes from Phanerochaete chrysosporium. Appl. Environ. Microbiol., 59: 4010-4016.

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Sami and Radhaune. 1995. Role of lignin peroxidase and manganese peroxidase from Phanerochaetechrysosporium in the decolorization of olive mill waste water. Appl. Envron. Microbiol., 61: 1098-1103.

23

An analytical framework for understanding the ethics
of agricultural biotechnology*
Tomiko Yamaguchi, Ph.D.
International Christian University,
Japan

24

Asia-Pacific Perspectives on Biotechnology and Bioethics

Introduction
Several years before the Indian government decided to introduce transgenic cotton (Bt cotton) to theIndian market, social controversy erupted. Bt cotton has been genetically engineered to produce a toxin
which protects the plants from certain insect pests. The inserted genetic material is taken from Bacillus
thuringiensis, a bacterial pest that occurs naturally in the soil and is widely used to control insect pests.
The controversy arose in the late 1990s, when the State government of Andhra Pradesh halted the open
field trials of Bt cotton, which were then being conducted by a joint venture between a local firm and amultinational corporation. Concerns about ethical issues including: how the benefits of biotechnology
will reach developing countries; how the benefits will be distributed to growers of different social andeconomic strata; and how the environmental and health risks will be distributed and redistributed; havegiven rise to a social movement opposing the efforts of the Indian government and the cotton industry
to introduce state of the art agricultural technology. The controversy has taken place in the spheres
where only professional elite groups participate, such as government hearings, as well as in the publicspheres of non-elite mass groups, such as farmers’ groups who have staged demonstrations and burned
test plots for Bt cotton. Since the eruption of the controversy, many groups, including farmers, scientists,industrialists, NGOs, and various government agencies, have become actively involved in discussions
concerning the commercialization of transgenic cotton.

Problem statements
Against this backdrop, the aim of this study was to understand the opportunities and challenges involvedin collective decisions about controversial science and technology (Busch et al., 1991). The project also
explores how ethics and values enter into disputes over science and technology (Burkhardt, 2001;
Thompson, 1997). In addition, the study considers how actors are empowered to participate in decisionmaking processes through the use of science or are rendered less able to participate by not using science.
With these questions in mind, this paper will outline a specific analytical framework used for the project
so as to demonstrate a sociological approach to the study of the ethics of science and technology. It will
make clear that assessing and understanding the ethics of science and technology requires a complex,
multi-faceted approach that takes into account the different backgrounds, motivations, assumptions,and worldviews that the various parties bring to bear on the problem, and that finding a path throughthe complexity in a coherent and unified way is possible with the use of certain analytical tools. The
paper will not present actual findings of the study, but those can be found elsewhere (Yamaguchi etal., 2001; Yamaguchi and Harris, 2004). After a brief introduction to the Bt cotton controversies in India,
I will describe the theoretical and conceptual foundation and methodologies, and then summarize thekey ethical issues in agricultural biotechnology controversies. I will end by suggesting a theoreticallycompelling premise on which to conduct research on ethics of controversial science and technology.

* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Bt cotton controversies

In response to the controversy, the Ministry of Agriculture imposed a ban on the import of terminatorseeds. At the same time, the director-general of the Indian Council of Agricultural Research, the key
agency in charge of public agricultural research in India, announced that the government would be“gearing up for a single-point entry for all imports of seeds”,4 implying increased governmental control ofimports of genetically modified seeds. In July of 2000, the MAHYCO received permission for large-scale
trials to generate biosafety data for the Genetic Engineering Approval Committee (GEAC). Although the
Department of Biotechnology of the Ministry of Science and Technology expected the open field trials
to be completed by mid-2001, the committee postponed its approval, requiring additional data forfurther scrutiny of the environmental impact of the transgenic cotton seeds developed by MAHYCO andMonsanto. Meanwhile, some 10,000 hectares of standing crops of pirated Bt cotton seeds were foundin Gujarat, India’s western state. Farmers had purchased and planted the pirated Bt cotton seeds. It waslater found that Cry1Ac, a gene owned by Monsanto, had been inserted into the seeds. Subsequently,
the GEAC ordered the destruction of the standing crops in Gujarat, because those seeds were illegal.5
The order for removal of the standing crops of pirated Bt cotton provoked a strong reaction from farmers’groups who were eager to use transgenic seeds. Following the issuance of that order, Sharad Joshi, theleader of the Kisan Coordination Committee, announced the Committee's plan to resort to large-scaleprotests if the government insisted on removing the standing crops. Furthermore, he criticized the slow
process by which transgenic crops were reviewed. In March 2002, a decade after the government had
announced obtaining Bt technology from the US, GEAC gave approval for the commercial distribution
and cultivation of three varieties of genetically modified cotton.

Theoretical foundation
The social constructionist approach to social problems provides a theoretical foundation forunderstanding the social processes leading to a social condition defined as problematic (Best, 1995;
Kitsuse and Spector, 1973). These studies suggest that a set of seemingly objective conditions actuallyconstitutes just one of many perceived realities, which suggests that perceived social problems are thesocial constructs of actors. The emphasis is on how actors interpret and define problems, rather than on
an objective description of the particulars of a problem. For instance, let’s look at the issues concerning
environmental risks related to transgenic crops. To date, even within the scientific community there
1 Business Line, 5 December 5 1998.
2 Business Line, 11 January 1999.
3 Business Line, 3 December 1999.
4 Business Line, 14 January 1999.
5 The Times of India, 19 October 2002.

Asia-Pacific Perspectives on Biotechnology and Bioethics

In late 1998, a farmers’ group, the Karnataka Rajya Raitha Sangha (KRRS), began protesting against fieldtrials being conducted under a joint venture between an Indian seed company, Maharashtra Hybrid Seed
Company (MAHYCO), and the transnational agrichemical company Monsanto, which holds the licence
for this technology. They uprooted the crops and set fire to the trial fields (The Hindu, 29 November
1998). Subsequently, the Andhra Pradesh government halted the field trials of Bt cotton. The Andhra
Pradesh government claimed that the decision was made because farmers were agitated over the tests,
which were said to involve testing the “terminator gene” under the guise of the Bt cotton seed trials.1
Terminator technology is a gene protection technology inserted in plants that blocks the productionof fertile seeds. Use of the gene provides seed producers security against the unauthorized use of newplant varieties. Critics point out that the terminator gene would force farmers to purchase seeds frompatent holders who own the rights to the new crop varieties. The leader of the KRRS said in a publicstatement that the gene incorporated in Bt cotton had contaminated all the crops in the vicinity of the
field trial plots and was jeopardizing the biodiversity of the area. He also pointed out that the firm had
undertaken trials without obtaining government permission.2 At the same time, various commentaries
appeared in the newspapers. An editorial3 strongly criticized such vandalism and condemned KRRS’s
activities. The editorial suggested that such activities and the government’s inability to control themwould send negative signals to prospective investors in India.

25

has been no consensus concerning the degree and extent of environmental risks posed by transgenic
crops. For some scientists who oppose transgenic crops, the commercialization of transgenic crops is
problematic because transgenic technology has been in open field use for a relatively short period oftime, making it extremely difficult to identify where the risks lie or even to determine the appropriate
methods of risk assessment and management (The Royal Society, 1998). Thus, they may recommend thatIndia adopt a precautionary approach to the technology or that India continue to conduct experiments
until sufficient evidence of risk is collected. On the other hand, those actors who support transgenic
crops may use scientific data from the US cotton industry which shows that the number of needed
pesticide applications is reduced (James, 1998). These examples demonstrate that when science cannot
offer definitive answers to issues and concerns, seemingly objective environmental risks become subject
to various interpretations.

Key Concepts
In order to discover the ways in which individuals and groups define problems associated with thecommercialization of genetically modified crops, I have used several key concepts, of which the mostimportant for our purposes here are the concepts actor and frame.

26

Asia-Pacific Perspectives on Biotechnology and Bioethics

ActorsIndian society, characterized by “division and hierarchy” (Shah, 1982), consists of actors with diverse
norms, values, and cultures. This diversity, combined with the impacts of capitalism and industrialization,
has divided actors in India into an enormous number of subgroups according to their socio-economic
and cultural backgrounds, their professions and positions, and their interests and agendas. The diverse
norms, values, and cultures of contemporary India, combined with a newly-emergent partly-Western
biological technology (Swaminathan, 1996), have created a space in which actors, both individuals andgroups, can debate not only the scientific dimension of transgenic crops but also the non-scientificdimensions. Actors are capable of reworking values, norms, and cultural orientations, and then of
disseminating these revised understandings through their actions and interactions with other actors(Touraine, 2000).
In order to understand the complex divisions and alliances of actor groups, I have identified five majorgroups:(1) actors in non-governmental organizations (NGOs);(2) industrialists;(3) government officials;(4) scientists; and(5) farmers
Actors in NGOs include individuals and organizations specializing in advocacy activities on such
issues as environment, agriculture, population, gender, and development. In the case of agricultural
biotechnology, environmental advocacy groups and think-tanks dealing with issues related to gender,
development, and agricultural policies have been vocal participants in the disputes. “Industrialists”
include seed companies and dealers, pesticide formulators and dealers, agrichemical companies, andassociations of industrial or commercial organizations. “Government” refers to both elected officials andbureaucrats in both the central and state governments. “Scientists” are people holding scientific positionsin the public research system, in the private sector, or in NGOs. “Farmers” refer to actors engaged in thecultivation of crops, and those in farmers’ unions and associations. These categories are not mutually
exclusive, and field data confirm that there are overlaps between them; nonetheless, delineating actor
groups will help us to gain insights into diverse interpretations related to transgenic crops and to see
the complex and constantly changing perceptions of agricultural biotechnology.
FramesSocial processes, such as those described above, which lead to a particular understanding of a social
condition involve “frames”. Drawing on Goffman (1986), I use the notion of frames as a foundation forFrames can be used to examine interactions among actors as well. As demonstrated by Snow
and Benford (1988), some actors use frames to mobilize other actors. This concept will allow me tocharacterize interactions and negotiations in the race to define key issues in the deployment oftransgenic crops. For instance, a purposeful selection of frames results in two different interpretationsof modern biotechnologies. On the one hand, within a technology-oriented frame of agriculturaldevelopment, agricultural biotechnology becomes a useful tool for solving the problems of production
and cultivation of crops; on the other hand, within a frame which emphasizes the importance ofsustainable agriculture, agricultural biotechnology becomes a hindrance to such efforts. Some argue
that the scientific approach to agriculture is the best one for an arid region of India, where crops arevulnerable to natural calamities related to weather and pests. Others argue that Western science
will compete with traditional knowledge for the cultural and ecological resource base, subverting
indigenous agricultural knowledge and adversely affecting biodiversity. Given that different frames
lead to different evaluations of a technology, and that lay interpretations of controversial technology
tend to closely relate to how the story is framed in the newspapers (Friedman et al., 1999, Gamsonand Modigliani, 1989; Mazur, 1981), actors could adopt a strategy of influencing mass media frames toinfluence opinions on a large scale. Framing literature has significant analytical utility in understanding
agricultural biotechnology discourse by virtue of its system for analyzing the content of claims in relation
to interested actors. Framing theory has helped me engage in a substantive analysis of the content ofdisputes over genetically modified crops by providing an analytic scheme to organize a range of claims,
experiences, and events reported in newspapers and obtained in interviews. I organized the content ofclaims about Bt cotton into five different frames at the outset of this research, obtaining results which
later became a basis for understanding actors’ framing strategies and for understanding the nature ofinteractions among actors.

Methods
The project focused on understanding empirical social processes of interpretation and interactions
among actors involved in the Bt cotton controversy. For that purpose, the project used three types of data:
newspaper articles, interviews, and policy documents. Collected data was coded and categorized.
First, newspaper articles shed light on the nature of disputes in the public sphere. Prior to the fieldstudy, Indian newspaper articles were collected through Lexis-Nexis, an online database of full-text
newspaper articles. In India, the English-language dailies are the most influential mass media (Jeffrey,2000). In addition, I collected articles from two Gujarati-language newspapers and the major Gujarati
farm newspaper.
Newspaper articles were collected by searching for the words Bt cotton, India, terminator technology,
and field trials. Articles from the three Gujarati newspapers were collected by visually searching for thesame key words, and were translated into English. Articles were identified beginning in 1992 in the
English-language newspapers, and coverage of Bt cotton was found beginning in 1999 in the Gujarati
newspapers.
Second, in-depth interviews were conducted with actors identified in the mass media coverage:
industrialists, scientists, policy-makers, journalists, and activists. In-depth interviews allowed interviewees
to freely express their perceptions of the issues and maximized variations in responses.
In addition, structured interviews were done with cotton growers in south Gujarat; interview subjects
were identified through referrals by a local farmer leader, whose name appeared in the English-language
and Gujarati dailies. When the interviews needed to be conducted in Hindi or Gujarati, trained local
research associates conducted structured interviews.
Structured interviews allowed me to monitor the interview situation, and helped me to maintain

Asia-Pacific Perspectives on Biotechnology and Bioethics

analyzing interpretations of Bt cotton. Frames are packages of social values and norms which shapepeople’s evaluations of an issue such as a new technology (Benford and Snow, 2000). A frame embracing
certain values and norms becomes a template for a range of positions (Gamson and Modigliani, 1989).
Thus, by exploring the frame of reference actors use, we will learn how actors are involved subjectively
in social phenomena

27

consistency in the ways in which the interviews were carried out. Interviews were taped, transcribed,
and translated into English. I also observed the interviews.
Third, documents such as policy documents, corporate brochures, annual reports of research institutes,
and leaflets of NGOs were collected as background information for understanding the regulatory
framework in India and the current state of the research on, and development of, transgenic crops.
All the articles from the newspapers and the transcripts of interviews were coded into categories
representing key concepts used for the analysis, including such concepts as actors, actions, claims, andframes. I then attempted to identify emergent concepts and categories from the coded texts.

Emergent ethical issues
Let me now turn to a brief description of certain ethical themes that have emerged in agricultural
biotechnology discourse.

28

Asia-Pacific Perspectives on Biotechnology and Bioethics

Exclusion/Inclusion
Broadly stated, the ethical dimensions of agricultural biotechnology echo philosophical discussionsof utilitarian, rights, and virtues approaches to social justice (Thompson, 1997). Some of the actors
supporting the introduction of genetically modified crops base their arguments on a utilitarian
approach by saying the technology will help increase the productivity of agriculture, which in turnwill improve the profits for the grower. Opponents use the same utilitarian frame and argue that the
introduction of Bt cotton will cause pest resistance to Bt. Proponents bring in a rights-based claim that
it is morally imperative to make genetically modified crops readily available to developing countries(Nuffield Council on Bioethics, 1999).
Opponents bring in a rights-based claim that the interests of small and landless farmers will not be
represented fairly. From a virtues approach, some frame Bt cotton as the essence of modernization(Monsanto, 1997), while others argue that biotechnology violates the laws of nature (Shiva, 1991).
The concerns expressed by all of the actors described above focus on the question of the exclusion or
inclusion of certain groups from the benefits and costs of agricultural biotechnology. The issues here arewhich groups are included in, or excluded from, the benefits of agricultural biotechnology, and whichgroups bear the costs of agricultural biotechnology. While inclusion in the benefits and/or exclusionfrom the costs will favour some groups, exclusion from the benefits and/or inclusion in the costs will be
detrimental to others. Some actors argue that agricultural biotechnology will exclude small and landlessfarmers from benefiting economically, while the benefits will go to commercial farmers with significant
landholdings or go to industries (Buttel and Barker, 1985; Shiva et al., 1999).
Others claim that prohibiting agricultural biotechnology is preventing India from getting access to apromising scientific tool that might become a key to meet rising food demands in coming years or a key
to shift towards sustainable agricultural practices (Monsanto, 1997). The idea of exclusion/inclusion isassociated with the potential risks and hazards of introducing agricultural biotechnology.
Risk
Some argue that risk can be estimated by multiplying the probability of occurrence with the severity ofharm (Campbell, 1980), while others define risk in terms of how actors interpret a potential harm (Adam,
2000). For instance, while both opponents and proponents list as potential risks the possibility of geneflow to closely related plants, possible effects on non-target organisms, and increased pest resistance,interpretations vary.
Some scientists who oppose this new technology argue that because this technology has been in open
field use for a relatively short period of time, it is extremely difficult to identify where the risks lie, andeven to determine the appropriate methods of risk assessment (Royal Society, 1998). They conclude
that India should adopt a precautionary approach to the technology, or that India should continue toconduct scientific research until sufficient evidence is collected.
Scientists supporting the new technology use data from the US cotton industry, which shows that theneeded number of pesticide applications has been reduced from four to six per crop to zero (James,
1998), and they argue that this proves that Bt cotton is a promising tool to alleviate pesticide stress on
soil.
They argue that particularly in India, where many of the problems related to cotton (productivity andproduction costs) derive from excessive use of pesticides, Bt cotton, which has built-in pest resistancetraits, will be a promising crop management tool.
Some actors in NGOs who oppose agricultural biotechnology argue that, although there is no biologicalevidence that genetically modified crops (GMOs) are detrimental as compared to non-GMOs, such crops
should be banned because there are no science-based protocols to assess the risks. Those who support
the introduction of GMOs use the same reasoning but argue for GMOs on the basis of the non-existenceof scientific facts showing any hazards from agricultural biotechnology. They claim that, given expected
rapid population growth, producing a sufficient amount of food to meet the rising food demand is more
important than the, as yet, hypothetical impacts of GMOs.

The third theme concerns the contrasting ways in which knowledge is generated in two approaches
to science — Western and indigenous science. First, some scientists and policymakers claim that the
adoption of Western scientific approaches to agriculture is most appropriate in the case of a crop suchas cotton, which tends to be vulnerable to natural disasters, and in a country in which the production ofsuch cash crops is required to provide a stable flow of foreign currency. They claim that Western science
will allow us to manipulate the natural environment in accordance with our needs.
Contrary to that view, both theorists and activists argue that the introduction of agricultural
biotechnology (Western science) will negatively impact indigenous science and knowledge systems(Bebbington, 1994; Richards, 1985; Sharma, 2001). They argue that Western science will compete withtraditional knowledge for the cultural resource base (Boef et al., 1993; Perlas, 1994; Shiva, 1993).
Second, indigenous science is discussed through the rights of the holders of indigenous knowledge,
innovations, and practices. The importance of indigenous science and knowledge is recognized inboth international and national discourse. Internationally, its importance is institutionalized within
the Convention on Biological Diversity (CBD), signed in 1992, which states that the knowledge,
innovations, and practices of indigenous and local communities are entitled to respect, preservation,and maintenance as a right of the indigenous people.
Nationally, within India, indigenous science and its knowledge generation is discussed in connection
with the Protection of Plant Varieties and Farmers’ Rights Bill (PPV Bill). Some argue that the PPV Bill will
not protect farmers and will take indigenous science and knowledge away from them (Cleveland et al.,
1997; Damodaran, 1999; Kothari, 2000; Swaminathan, 1998), while others argue that the PPV Bill will
help promote the rights of farmers (Morris et al., 2001).
Domination
The fourth theme concerns domination. Domination is defined as the extent to which lives are dominatedby external factors (Gramsci et al., 1971). Domination is interpreted in various ways in the discourse of
agricultural biotechnology. One form of domination is the integration of the Indian cotton commodity
chain with the global agriculture and food regime, wherein the Indian agricultural sector becomes partand parcel of the global regime and will be dominated by economic and political factors external to
India (Goonatilake, 1984; Shiva et al., 1999).
A Marxist paradigm would assert that an introduction of technology could act as a dominating force
facilitating the extraction and accumulation of value to the detriment of labour (small and landlessfarmers) (Kloppenburg, 1988; Ramamurthy, 2000). Some actors have taken the idea of domination in the

Asia-Pacific Perspectives on Biotechnology and Bioethics

Western versus indigenous science and knowledge generation29

reverse direction, saying that Indian cotton is facing serious global market competition in the presenceof other cotton-producing countries such as China and the US, where Bt cotton is already extensively
used.
In order for India to maintain and expand its global market share, the introduction of cutting-edge
technology such as Bt cotton is argued to be indispensable (Krishna Iyer, 1999).

Conclusion
Decision-making processes involving controversial science and technology are not simple but involve
rather complex social elements such as ethical and moral concerns. This project sheds light on the ethics
involved in technological innovations in agriculture specifically. However, the analytical frameworksuggested in this paper can also be used for the study of other innovations. The framework will help us
gain insights into not only the ethical concerns but also the ethical reasoning of a range of people ofdiverse social backgrounds as they grapple with the complex questions posed by the introduction ofcontroversial science and technology. Through such efforts, we will get a glimpse of the ethical concerns
experienced by people as they confront technological change.

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Asia-Pacific Perspectives on Biotechnology and Bioethics

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Ethics of the use of genetic control methods for
infectious disease*
Darryl Macer, Ph.D.
UNESCO Bangkok,
ThailandThe ethics of disease prevention

We can debate what are the most ethical measures for achieving these goals, including the extent towhich risks to human health, damage to the environment and other living organisms, and economic
costs are balanced in societies that have a range of worldviews and social structures. Certain principles
basic to resolving ethical dilemmas can help decision makers make more informed policy decisions.
The principle that we should love the life given to us (self-love) implies that each person should begiven autonomy (self-rule) to work out how to balance the ethical dilemmas and choices themselves.
The Universal Declaration of Human Rights of 1948 specifically set as a baseline that all human beings
possess equal rights, and should be given a chance to exercise their autonomy. One of the fundamental
human rights is a right to health, and working towards giving every person a chance to grow up freeof disease is the ethical foundation of public health. If a person does not possess some basic level ofhealth, he/she cannot even face many of the choices commonly accepted as normal.
Poverty also restricts the choices of many people (Azevedo and de Moraes, 2002), especially in areas
faced with infectious insect borne diseases. Justice simply means that if we want others to recognize
our autonomy, we have to recognize theirs as well. There are at least three different meanings of theconcept of justice: compensatory justice - meaning that the individual, group, or community, should
receive recompense in return for contribution; procedural justice - meaning that the procedure bywhich decisions about compensation and distribution are made is impartial and includes the majorityof stakeholders; and distributive justice - meaning an equitable allocation of, and access to, resourcesand goods (Macer, 2003). There are ethical questions about how a society should represent procedural
justice when there are major divisions within the society on particular issues, as we find in many countries
with debates over the use of genetic engineering.
The process of consensus building and reaching common ground may be preferable for many cultures
rather than confrontations.
At present there is great inequality between rich and poor nations in the direction and priorities ofresearch, and in the distribution of and access to benefits that might come from this research. Under
any ethical theory, the presence of diseases that threaten the lives of not just one but more than abillion people worldwide provides a compelling need for efforts to eradicate the diseases. There is wide
diversity in the risks that members of each community face from infectious diseases due to: individual
genetic variation in resistance to infectious disease agents; a person’s nutritional state and immediate
environment; a family’s economic situation with respect to providing barriers to vectors and disease
and access to both preventative and therapeutic medicines.
These variations can be regarded as a type of lottery. Working towards better global equity is a goal that
attempts to even out the lottery that people are born into. This is ethically mandated by Rawlsian justice(Rawls, 1971), which argues that efforts should be made to minimize the variation in all social factors* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Asia-Pacific Perspectives on Biotechnology and Bioethics

This paper will examine the ethical issues that underlie efforts to control human disease, modify vectors,
modify the environment, and methods to seek community support. There is global support for the efforts
to improve existing and develop new approaches for preventing, diagnosing, treating and controlling
infectious diseases that cause loss of human life (Macer, 2003). The ethical principle that lies behind theidea of preventing, treating and controlling disease is that human life should be protected.

33

because no one knows before they are born into which situation they will be born, so everyone would
wish for equal opportunity and equal exposure to risk. All should have a chance to be born and grow up
in an environment free of infectious diseases, if that can be achieved.
The ethical principle of beneficence supports the development of science and medicine, and its
provision to those who suffer. A universal ideal found throughout human history is that it is better tolove doing good things than bad things, and to love our neighbour as ourselves. Humans have usedtechnology in efforts to make their lives easier and better for thousands of years, and the ethical principleof beneficence argues that we should continue to make life better. This ethical principle is based on thegeneral motivation inside people to love doing good rather than harm, and may be expressed as loveor compassion (Boyd et al., 1998).

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Asia-Pacific Perspectives on Biotechnology and Bioethics

Efforts that work for the betterment of others in society have a universal moral mandate. The ethicalprinciple of non-maleficence, or do no harm, would make us reasonably cautious about premature useof a technology when the risks are not understood. Recently some have advocated a total precautionary
principle for genetic engineering, which would mean that no technology with more than 0% risk should
ever be attempted (Ho, 1998).
This has also entered the Cartegena Protocol on Biosafety, which is an International Legally Binding
Agreement that regulates international movement of living modified organisms (LMOs) (CBD, 2000;
Kurokawa and Macer, 2005). Because no human action has 0% risk, the principles of both benefit and risk
are used to assess technology and are central to any public health programme (Callahan and Jennings,
2002).
The ethical issues raised by biotechnology are commonly termed bioethics dilemmas, although when
we examine the actual moral questions they may not be so novel and are often related to areas ofapplied ethics that were debated long before we had modern biotechnology (Comstock, 2000). There
are several basic theories of ethics.
The simplest distinction that can be made is whether they focus on consequences, actions or motives.
Consequential arguments are criteria such as whether they contribute to the greater good by improving
the well-being of all. Consequential arguments state that the outcome can be used to judge whether
an action was ethically correct or not. An action-based argument looks at the morality of the act itself,
so that the actual action to cause harm itself is an unethical action regardless of the consequences ormotives.
Motive-based theories of ethics, including virtue-based ethics, judge an action based on the motivationof the action. For example, if the act was done with good intentions or not. Another separation thatis used is between deontological theories, which examine the concepts of rights and duties, andteleological ones, which are based on effects and consequences. If we use the image of walking along
the path of life, a teleologist tries to look where decisions lead, whereas a deontologist follows a planned
direction.
The objects and subjects of ethics can be viewed in terms of ecocentric, biocentric or anthropocentric
concerns. Ecocentric concerns, that value the ecosystem as a whole, are used when expressing
environmental concerns. The reverence for all of life (Schweitzer, 1966) can apply to the whole ecosystemor to every member of it. Biocentric thinking puts value on the individual organism, for example onetree or one animal. Anthropocentric thinking is focused on the human individual.
There is a trend for more ecocentric views to be included in recent legislation, with protection of
ecosystems for their own value. Almost all of human life is a social activity, involving many relationships
with people and the ecosystem. Different ethics are implied when human activity, e.g. agriculture or
urbanization, attempts to dominate nature or to be in harmony with the environment.
Despite the fact that there are a variety of definitions of health, disease, disability, and what is a meaningful
human life, working to alleviate disease and empower individuals to reach their potential are universal
goals for the progress of humankind. The basic ethical principles of autonomy, justice, beneficence andnon-maleficence can be applied to help decision-making in a range of bioethical dilemmas in medical

and environmental ethics.
There is some debate over whether further principles can always be derived from these over the precise
terminologies in each field (Weed and McKeown, 2001), but the general consensus is that these four
principles are fundamental in a range of cultures (Beauchamp and Childress, 1994; Tsai, 1999). The
emphasis on individuals may be questioned more in developing countries. There are also theories of
ethics based on community, which argue that individuality, autonomy or rights of a person are notsuited to the community structure of society.

Ethics of genetic manipulation

There is a long history of altering the behaviour of disease vectors so that they cannot transmit pathogens
to humans (Spielman and D’Antonio, 2001). Insects have also long been the targets of attention inagriculture as well as in medicine. While there are few intrinsic ethical concerns about killing insect
pests, as discussed below, ecocentric approaches to ethics do raise some objections to modification of
ecosystem components, and these need to be taken more seriously.
People of all cultures have developed biotechnologies as they live together with many species in
the wider biological and social community. A simple definition of biotechnology is the use of livingorganisms (or parts of them) to provide goods or services.
Over five millennia of classical plant and animal breeding have seen the emergence of agriculturalsocieties, and modern biotechnology is built on that. Since the mid 1990s, foods produced fromgenetically modified organisms (GMOs) have been sold in a growing number of countries (James C,2001).
There has been fierce international debate over the environmental and human health aspects of GM
foods, but no harmful effects of GM foods on human health have been shown scientifically (FDA, 2001).
There is greater concern over the environmental impact of gene transfer in the environment.
A number of governments have considered the issues and concerns people have raised about genetic
engineering, and there is a wealth of useful material in the reports and submissions made to them
(United Kingdom Royal Commission, 1989; New Zealand Royal Commission, 2002). Reports have also
been made by independent organizations on the ethical issues (Nuffield Council on Bioethics, 1999a).
With the emergence of genomic sequencing, we now have the DNA sequence of human beings, dozens
of pathogens, and some disease vectors e.g. Anopheles gambiae (Holt et al., 2002; Morel et al., 2002).
It is therefore not surprising that molecular entomology, the study of DNA and the proteins it encodes
in insects, is emerging as a serious scientific approach for insect control (TDR, 2002; Robinson et al.,2004).
Social factors need to be carefully considered (TDR, 2000; Macer, 2003). While there is debate over the useof funds to combat infectious disease using genomics and biotechnology as opposed to implementing
practical measures to curb vectors and pathogens in the field (Curtis, 2000), it is hoped that the former
approach will be a major strategy in the future (Hoffman, 2000; James et al., 2001).
A common way to insert DNA for genetic transformation of insects is to use transposons or viruses(O'Brochta and Atkinson, 1998). Most attention has been given to efforts to genetically transform insects
in the laboratory, and to test their behaviour before releasing them into the environment.
A mechanism that would safely spread the gene among vectors in the wild is the objective of thesestudies, except for the approach using sterile insects. Effector mechanisms are needed to drive theeffector system into the vector population (Beaty, 2000), which raises more ethical issues about the

Asia-Pacific Perspectives on Biotechnology and Bioethics

This paper will focus on genetic control of the vectors of disease, although we can also envisage genetic
modification of other organisms that might affect disease transmission by indirect effects on vectors,
such as through GM plants in the environment, GM pathogens of insects such as Wolhbacter, or othermethods (Macer, 2003).

35

safety and desirability of changing the entire vector population, and possibly related species.
The conclusions of studies of ethical issues inherent to the process of genetic engineering compared to
traditional methods of animal and plant breeding, are that the only significant differences in the process
are the more precise control of genetic engineering and whether the DNA involves cross-species genetransfer that does not occur in nature (Nuffield Council on Bioethics, 1999a; Comstock, 2000; Macer,2003).

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Asia-Pacific Perspectives on Biotechnology and Bioethics

One of the key questions is whether there is an intrinsic value of genetic integrity at an organism andecosystem level that humans should not change. There are some persons in some communities thatplace intrinsic value upon native fauna including insects, however the way that they do would require
well designed research to investigate.
We should also note that cross-species DNA transfer does occur in nature between all species, evenof different kingdoms, and that the genomes of insects are subject to genetic flux in nature. In thissense, because the DNA change can be precisely designed, an actual targeted genetic change throughgenetic engineering should be safer than a natural change because it is more under control. Given
the results of public opinion surveys that find opposition to cross species gene transfer (Macer, 1994;
Macer and Ng, 2000), if the DNA change is made using DNA within the same species entirely, then thisconcern can be removed. In this way of thinking there may not be any new intrinsic ethical dilemma
from the modification of DNA structure in genetic engineering as it simply mimics the natural ways
organisms use to change genetic structure. However, the scientific details of the targeting process, andthe intentional nature (the issue of control of nature) are important for some persons.

Mosquitoes and animal rights
Another concern in ethics when discussing animals is their capacity to suffer or feel pain. If insects do
not feel pain or sense feelings, then the most prevalent ethical approach for animals would argue that
there is nothing intrinsically wrong in manipulating them (Singer, 1976).
Given what we know about mosquitoes in this approach they would have no moral rights. However, if we
consider the idea of making so-called vegemals, animals that do not feel pain, we are still manipulating
life for human purposes without considering the interests of the animal (Macer, 1989). The concern isthat living organisms should not merely be treated as a means to the ends desired by humans. There arealso extrinsic values placed on some animals by human society, but I do not know of any which place
special value upon mosquitoes. There are biodiversity concerns about endangered animals in general,
some of which are expressed in the Convention on Biological Diversity (CBD).
Another argument used in these discussions concerns the telos (purpose) of an organism. A teleologicalexplanation describes phenomena by their design, purpose, or final cause. Teleology is the branch ofmoral philosophy dealing with the cause and effect of an action, the belief that there is purpose anddesign in nature, and consequently, with the belief in the existence of a Creator.
There are concerns that the ability to alter the telos of an animal has profound implications (Munro,2001). If one believes that every organism has a purpose, then the telos is an intrinsic concern, andgenetic engineering alters the telos or ‘being-ness’ of an organism. However, it is debatable whether
changes and control through genetic engineering are significantly different from changes made byhumans to animals and plants in farming and modern life. It is basically an issue of human control ofnature, and there is debate over the extent to which humans should control nature (Reiss and Straughan,
1996; Bruce and Bruce, 1998; Comstock, 2000). If we consider this issue in a historical context, we seethat humans in many affluent cultures have controlled nature in significant ways, e.g. by concrete riverbanks, irrigation and sanitation projects. However, especially in some developing countries, limited
resources have meant that control of nature has been less.
However, sociological evidence has found that a number of people object to human control of nature,
regardless of whether it poses a risk (Macer, 1994).
While perhaps only followers of the Jain religion in India regularly refrain from killing insects thatare human pests, there are still some people who may object to killing mosquitoes. It is not known if
manipulating the insects so that they would not be a human pest would be more acceptable to persons
with these ecocentric world views than traditional methods of insect control that attempt to eradicate
a whole insect population.
Those who subscribe to an ecocentric viewpoint might argue that the ecosystem as a whole would
benefit from an intervention that left the mosquitoes in the ecological community, with the eliminationof the disease-causing pathogen from the vector, if the alternative was eradication of the vector
species.
In this case, the total number of species affected by this type of genetic modification of vectors would
be significantly less than the number of species affected by use of insecticides (Macer, 2003). However,there are still those who believe there should be no human modification of the ecosystem. This actuallyshould argue that there should be no direct or planned modification of an ecosystem by humans,
since human activity modifies almost all ecosystems, including those where humans are not directly acomponent member.

The process of community engagement has several goals, as developed recently in human genetic
studies (International HapMap Consortium, 2004). It should approach a broad range of members of thecommunities for participation in a two-way process of information exchange to share with investigators
their views about the ethical, social, and cultural issues the scientific project raises for them, their
immediate communities, and the broader communities and populations of which they are a part.
It should provide input that may modify the disease control mechanisms and approaches that will be
adopted. It should provide extensive information about the project so that the decisions of individuals
about whether or not to support their community involvement would be better informed. It also will be
expected to continue throughout the trials, including sharing findings from studies conducted.
There will be expected to be negligible human risks from the trials of GM insect vectors, but still consent
should be considered. Firstly, let us consider environmental risks of a trial because the GM insect vectors
may represent potential harm to other members of the biological community as well as other membersof the human community.
Globally people vary in the importance they ascribe to the environment, or parts of it. Especially inareas where more traditional world views are found, we may see greater value given to parts of theenvironment that are forgotten in the modern industrial mindset. We also see variations between
persons in all cultures as to their images of nature and what is life (Macer, 1994). Some people arewilling to sacrifice themselves for the broader environment. Examples such as the preservation of sacredgroves in India for thousands of years, even during times of severe crisis and human death (Gupta andGuha, 2002), show that in some cultures almost all people are willing to die rather than damage thatpart of the environment they cherish. This behaviour is often linked to religious beliefs in the afterlife.
A variety of potential broader ecological, environmental and health risks are associated with the releaseof GMOs. Environmental risks can be considered from both anthropocentric and ecocentric-based
approaches. The risks identified include the possibility of horizontal transfer of the transgene to nontarget organisms, and possible disturbance of insect ecology (Hoy, 1995; Nuffield Council of Bioethics,
1999a). There have also been concerns expressed in some cultures, e.g. New Zealand, over the need tovalue the native fauna and flora, which is considered by many in the Maori community to be something
not to modify, or at least any modification should be endorsed by the Maori community (New ZealandRoyal Commission, 2002). While human beings cannot consent for other organisms to be modified, very
few persons suggest that any consent is required except for possibly sentient animals.
One of the main concerns of releasing GMOs is environmental risk (FAO, 2001; Aultman, et al. 2002).
This risk has been successfully controlled in over 10,000 international field trials of GMOs (USDA, 2002).
Whilst the methods used for monitoring field trials are argued to be inadequate by those campaigningagainst GMOs, to date there has not been a significant adverse event from GMO release for the health of

Asia-Pacific Perspectives on Biotechnology and Bioethics

Community engagement and environmental risks37any non-target organism, including humans, in the ecosystem (Comstock, 2000).
In the year 2001, the first US field test of a genetically modified pink bollworm, a cotton pest, wasconducted. It followed very soon after the development of methods to transform the bollworm(Peloquin, et al. 2000). This type of trial had an important consequence of preparing regulatory systems
for oversight of GMOs/ Living Modified Organisms (LMOs), but still most countries in the world have notestablished systems for oversight of GM insect field releases (Pew, 2004). The American Committee ofMedical Entomology has also produced guidelines (ACME, 2002).
New ethical issues about GM arthropod vectors and their symbionts and/or pathogens should be
subject to extensive open discussions and forums.
Any risks to the agricultural systems of rural communities also require assessment, as animal diseases
transmitted by vectors are important to farming families. In addition, there may also be risks to wild
animals in surrounding areas, which in some ecocentric environmental views have more intrinsic rights
to be left undisturbed than farm animals (Rolston, 1994).

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Asia-Pacific Perspectives on Biotechnology and Bioethics

This calls for broad ecological understanding of the impact, beyond public health. There is also thepossibility for GM vectors to spread to areas beyond the initial expectations, which needs to beconsidered when planning the geographical extent of information and communication programmes.
Although there have been numerous public opinion surveys on the release of different GMOs, there
have been few surveys asking people their views on introducing GM vectors or pathogens for disease
control.
One general feature of the surveys is that GM plants are considered less threatening than GM microbes,
animals and humans. In a 2003 national sample in Japan, one third thought it would be acceptable touse genetic engineering to make mosquitoes unable to be a vector for human diseases like malaria orJapanese encephalophy, and only 16% said it would not, while half said they did not know.
There was 54% approval for environmental release of mosquitoes that do not transmit human disease,which is the same as the support for release of GM disease resistant crops, with 19% disagreeing (Inaba
and Macer, 2003).
Although knowledge is important for acceptance of biotechnology, it is not a predictor of acceptance.
In surveys of scientists and the public in Japan in 1991-2000, for example, well-educated scientists were
often just as sceptical of biotechnology as the general public, and shared the same types of concerns(Macer and Ng, 2000).
The failure of the government authorities in public health has led to higher public trust in NGOs,
including environmental groups. The media has also disproportionately reported negative aspects ofgenetic engineering because these appeal to people (Durant, 1995). Thus the late 1990s saw a dramatic
drop in public support for biotechnology in every country surveyed. It is therefore important thatscientific knowledge be accurately shared with all, that this process be open, and that all opponents are
involved in discussion.
Issues include the ethics behind research into, and later financing of, technological products that
attempt to “fix” a problem rather than invest in increasing the ecological knowledge base to “prevent”
the problem. There is considerable preference for deterministic science over "softer" educational
systems like flexible learning.
It is clear that not all local communities will share the modern scientific world view that technical healing
is better for them, so there needs to be flexibility in the approaches available to eradicate disease. In thepast, paternalistic interventions were taken on the behalf of citizens; however, civil rights movements
have empowered people to take these decisions themselves.
A number of ethical issues have been raised in international debates over the morality of patents, andthere have been strong calls against the patenting of medical innovations.
Laws on intellectual property vary between countries, despite attempts to harmonize these laws amongindustrialized countries and members of the World Trade Organization (WTO). A number of developing
countries are not members of the WTO, and often the major controversies over whether a country will
join WTO is related to intellectual property rights (IPR).
Practical guidance for ethics committees needs to be clarified for public health interventions. One key
problem is identifying who is specifically at risk, and what the particular risk is. In vector release studies,everyone in the area may be at risk. These complex questions are made more manageable throughbreaking down the concerns people have into manageable issues.
Defining a minimum standard of protection for research participants in trial and control populations for
GMO interventions is the key point. This question is not specific to GM vectors and pathogens, but it is
crucial to consider the benefit/risk equation.
Most concerns can be the subject of better information and education. Gathering satisfactory scientific
data by conducting field trials, and understanding ecological issues (Scott et al. 2002), are the main
criteria required prior to release for most people. The remaining concern, and one which is also found inscientists as well as the public, is that genetic engineering is somehow unnatural.

Given that most mosquitoes do not transmit disease to humans, it is, arguably, not unnatural to changea mosquito that does transmit diseases into one that does not. There is a need for public opinion studies
in the communities before the release, during the process of community engagement, and after the
study, if we wish to really understand the opinions and concerns that people have.

Consent from trial participants
Recognition of the ethical principle of autonomy means that all participants need to give informed
consent to an intervention that has a reasonable risk of causing harm (Annas, 1989). There are significant
difficulties in obtaining individual informed consent in some developing countries (Ekunwe and Kessel,
1984; Angell, 2000; Alvarez-Castillo, 2002), but by adequate investment of time and provision of suitablematerials, it should be possible to obtain informed consent from individuals at direct risk, even though
the exact cultural interpretation of the informed consent process may vary between countries (Nuffield
Council on Bioethics, 1999b). There are risks of direct or indirect harm to human beings from the original
pathogen-transmitting vector, so a trial needs to be done to show that there is greatly reduced risk ofharm from the modified vector.
Until a trial is conducted we cannot be sure that there will be no risk and that the whole enterprise has
been successful. The risks may not just be those that arise directly from the ability of the vector to carry
the target pathogen. There could be a negative impact on human health by altering the behaviour ofblood-feeding insects.
In the case of insects that cannot be confined to a particular population, whether they fly or float to newplaces, notions of “human subject” and “informed consent” need to be extended.
There are basic ethical issues involved in vector collection and studies in the field.
Firstly, many such studies have relied on a researcher waiting for the vector to land on a human host,and then capturing it hopefully before the vector has transmitted the pathogen to the "bait". In fact, any
field studies in which human beings are exposed to the pathogens raise the question as to why someother intervention is not used in that area.
The approach developed for population genetics studies may be useful where the community and local
authorities are involved in the decision-making process. Informed consent requires information to beprovided, so disseminating information about the plans and progress of the project, and obtaining theconsent of any person potentially affected by the release of the transgenic insect, is important for the

Asia-Pacific Perspectives on Biotechnology and Bioethics

This is an issue that needs greater social discussion. However, if presented with the threat of contracting
disease, most people have few concerns about using other "unnatural" remedies such as pesticides andmedical drugs.

39ethical conduct of research trials, whether or not national guidelines require this, or even exist.
Other lessons show us that people who lack the means to express their preferences may have been
abused by the lack of individual or community consent for research in anthropology (Fine, 1993;
Kleinman, 1999) and epidemiology (Capron, 1991; Dickens, 1991; Gostin, 1991; Chee et al., 1996).
If a study involves humans, oversight by an ethics committee or institutional review board (IRB)
is necessary. In an increasing number of countries, such committees are established by law and arecharged with certain legal responsibilities, typically about the conduct of research or clinical practice at
local or national level.
An IRB is a group of persons from a range of disciplines who meet to discuss the ethical issues of particularsubmitted procedures and review the benefits, risks and scientific merit of the application. The IRB
usually requires that each human subject in a medical trial gives informed consent to be involved in the
project. Model ethical guidelines on the establishment and procedures for an IRB have been produced
by an international consultative committee for TDR (WHO, 2000).

40

Asia-Pacific Perspectives on Biotechnology and Bioethics

These guidelines however are not sufficient for the broad question of how to obtain informed consent fora public health intervention involving thousands of persons where the benefits are not demonstrated.
Ethics or bioethics committees include groups of people set up to adjudicate about bioethical matters.
A typical IRB works through a large number of applications and often excludes the broader social
discussion and representation that is seen in a regional or national bioethics committee. There are also
national variations in the laws to define membership and scope of work, and terms used.
The project to introduce transgenic insects will need an ethics committee with a broad overview, andspecific regional ethics committees to consider the local issues.
To consider the issue at a local level, as required for obtaining appropriate informed consent, it is essentialthat a local ethics committee (and/or IRB if associated with an institution) open to the communities
involved is established. There are cultural differences in the way informed consent should be taken(Levine, 2001; Alvarez-Castillo, 2002). The accepted norm in international ethical guidelines is seenfor example in the modified Helsinki Declaration (WMA, 2001) and the draft Council for International
Organizations of Medical Sciences (CIOMS, 2001) guidelines.
In cases involving bilateral research collaboration, the most stringent ethical standards of the twocountries should be applied. This creates problems for non-literate populations, and for populations
whose common sense social assumptions are different.
It is desirable that internationally agreed standards are applied, and that there are few points of difference
between these standards even for simple clinical trials of drugs. The ultimate decision procedure should
be decided by the local ethics committee, but international consistency and guidance will be essential.
Although the control population for the study may continue to face the same high risk of contracting
the disease, recent trends in research ethics debate whether we can leave control groups without any
treatment. Therefore, ethically there may need to be some other vector reduction measures given if
making any interventional study in an area.
While those designing ethical guidelines on placebo-controlled trials (e.g. Helsinki Declaration) werethinking of placebo controls on clinical trials of potential medical drugs, we can ask the ethical question
whether researchers have an obligation to the local population to use the best available means ofdisease control whenever they enter an area for a study.
This practically means that, as well as studying the new method, a researcher may ethically be compelled
to also provide the best available proven alternative to the study population.
There may be times when the provision of the proven alternative to the area of study alters the dynamics
of the disease so that the results of the vector field trial differ from what the results would have been had
no established alternative been provided.

Before and during the intervention, there may be privacy concerns when questionnaires are administeredand personal data are stored. For public health purposes, it is essential that all information about
individuals involved is linked to other data, but to ensure privacy, the data should only be identifiable toa specific person by a coding frame that is not in a computer linked to a network.
Children are one of the targets of public health interventions, with presumed consent from thetherapeutic imperative that they want to be involved in programmes that will avoid disease.
Some compulsory vaccination programmes have faced criticism that consent is not obtained even fromthe surrogate decision-maker, the child's parents. In each family there may several adults, and morechildren, which raises questions of whether consent is required from every individual. The local cultural
norms need also to be considered.
However, an appropriate mechanism may be one in which the views of everyone who have reachedreproductive age (let us call this the level of adult maturity) are gathered, and consent sought fromthese persons both as individuals and as a family.

On a more positive note, children in fact could be a very powerful means to involve the community ina process of community engagement through schools. Since children are at a higher risk from many ofthe diseases in question, they stand to benefit more, and most parents may want to be involved in thetrial because of the potential benefit to their children rather than themselves.
If the trial covers an area with a local population of 100,000 persons or more, it is unrealistic and unlikelythat informed consent can be given by all people in the area. There will always be some people who areagainst any proposition, no matter how much others value it, but the opponents cannot be moved fromtheir houses for the period of the trial.
So a procedure that is neither paternalistic nor paralytic needs to be developed. After the process of
consultation and dialogue to seek informed consent, there still needs to be a procedure to supply
relevant information to all persons in the area so that the minority who disagree with the trial have theoption to leave. In developing countries, many may not realistically be in either a position to achievesocial consensus or for persons to actually leave the area. It is even doubtful that truly "informed"
consent can be obtained in communities with high levels of illiteracy.
Other options may be to provide additional insecticide resources to households that object to the study
and are afraid of the presence of GM insects. The mechanisms for social consensus in biotechnology are
not well understood in the affluent countries that have been debating GMOs, and even less is known indeveloping countries.
Public opinion studies suggest that people may respond differently to theoretical and real situations.
Recognizing the autonomy of people as a group demands that we apply the consent model to morethan isolated individuals. The introduction of GM vectors and pathogens requires community consent,
so a process for seeking group consent needs to be developed for each community (Kleinman, 1999).
The question of whether every citizen has to consent to public health interventions is not a new one(Kass, 2001), but with the current social transition from a paternalistic society to informed consent andinformed choice, this key concern is appearing in all societies, although at different speeds.
Any initial trial may be subject to the philosophy “not in my backyard”. Socially powerful persons are
generally more effective at preventing trials they perceive to be risky in their area, or, conversely, atattracting social resources towards themselves and away from weaker persons in the community.
Ethically it is important that risks and benefits are shared equally, and one way to ensure this would be
a commitment to the local community that, if the trial is successful, the full-scale intervention would

Asia-Pacific Perspectives on Biotechnology and Bioethics

The agreement and understanding of children in the community should be sought through suitablematerials. However, children should not be exposed to direct risk from therapeutic trials unless there
is no alternative. In the case of a child living in a community that was involved in a GM vector trial, nodirect risks to the human population would be expected so the consent issue is not a major hurdle.

41

include them from the beginning. In this way, any risks borne by a local population would subsequently
be rewarded by that population being the first group to benefit from the knowledge gained when the
full-scale safe and effective control programme is implemented. The field trial must therefore come witha commitment to the local community that financial resources will be available and that sustainable useof the control tool will be affordable.

Regulation and Biosafety
The internationally accepted principles of risk assessment for GMOs take into account: relevant technicaland scientific details of the recipient or parental organism, the donor organism(s), the vector, the insert(s)and/or characteristics of modification, the GMO, and the methods for detection and identification of the
GMO including specificity, sensitivity and reliability; as well as information relating to intended use,
information on location and geographical, climatic and ecological characteristics, and the foreseen
health impact of the intervention (Macer, 2003).
The ethical principle of non-maleficence is the underlying basis for attempting to avoid harm and theregulation of human activity.

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Asia-Pacific Perspectives on Biotechnology and Bioethics

What is a particularly relevant point in the development of GM insect vectors unless it is based on sterile
insect methods (Alphey, 2002; Robinson et al., 2004), is that in order for a vector programme to be
successful, the modification must spread throughout the wild population of a vector.
This means that deliberate infection with the transgene may be the target of introducing the GMO.
In order to define the parameters associated with the speed and extent of spread of the genetic
modification under real conditions, extensive trials are necessary. Some vectors may transmit more than
one pathogen, so any intervention programme may have complicated effects on the distribution of
disease.
The International Centre for Genetic Engineering and Biotechnology (ICGEB) provides assistance inbiosafety training for the development of genetic engineering in many countries (ICGEB, 2002). Some
issues also relate to the proposed Code of Conduct in Biotechnology being developed under theCommission on Genetic Resources for Food and Agriculture (CGRFA). UNDP and FAO generally support
the development of genetic technology while considering the benefits and risks of the organisms.
The capacity of countries to establish committees to adequately address ethical, social and scientificconcerns needs to be strengthened.
The Scientists' Working Group on Biosafety of the Edmonds Institute (1998) in Washington D.C., USA,recommended that field trials of vectors genetically engineered to reduce disease should be small scalein terms of the area of dispersal of the vector.
"In the case of an anti-malaria or anti-dengue intervention, such a field trial could involve a single
village or an isolated cluster of adjacent villages. No large-scale release should be attempted until theeffectiveness is shown in the first trial".
Thus, while there is general international consensus in the UN system that selected use of GMOs should
proceed, there are groups within society that continue to be cautious. There are also countries whose
political regimes do not accept GMOs, and these attitudes depend on political elections, including theprinciple of democracy.
National sovereignty should of course be respected, but GM vectors may spread beyond a national
border. The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an advance
informed agreement procedure on the safe transport, handling and use of living modified organisms(LMOs) resulting from modern biotechnology that specifically focuses on transboundary movementsof LMOs. The parties to this protocol agreed to ensure that "the development, handling, transport,
use, transfer and release of any living modified organisms are undertaken in a manner that prevents or
reduces the risks to biological diversity, taking also into account risks to human health".
It was also noted that "the parties are encouraged to take into account, as appropriate, available

expertise, instruments and work undertaken in international forums with competence in the area of therisks to human health" (CBD, 2000).
In the Cartegena Protocol, "a living modified organism means any living organism that possesses anovel combination of genetic material obtained through the use of modern biotechnology. Modern
biotechnology means the application of either in vitro nucleic acid techniques, including the recombinant
DNA and direct injection of the nucleic acid into cells or organelles, or the fusion of cells beyond thetaxonomic family, that overcome natural physiological reproductive or recombination barriers and thatare not techniques used in traditional breeding and selection".
This definition of LMOs is now accepted in international law in general because of the Protocol. The
actual term “living modified organism” is still not as widely used as “genetically modified organism”, theterm that has been used for two decades in academic and media debates.

Many developing countries do not have the economic or scientific capacity needed to examine theproducts of modern biotechnology (Chinsembu and Kambikambi, 2001). Information related to GM
vectors should be linked to the same biosafety clearing houses.

Conclusion
There are a variety of ethical issues that are raised from the use of GM insects, but the most challenging
may be the process of informed consent for individuals and communities.
Each community or society needs to be given a chance to set consensus values on risk assessment.
This two-way process of community engagement is evolving and appropriate procedures for each
community need to be developed. A universal minimal standard of risk assessment applicable to disease
vectors needs to be defined, as diseases cross national and continental borders.
Before field release of transgenic insects, researchers must assess all the scientific and social issues
associated with GM vectors and develop safety precautions to address potential risks. The scientificand social risks should be minimized through careful design of the vector system, relevant laboratory
experience, and careful choice of the site including considering appropriate social and cultural factors.
Even if there are not perceived to be any realistic risks, a procedure for their evaluation should be set
up so that new information can be gathered and interpreted. This procedure may involve establishinga specialized ethical review committee under the auspices of an international body such as TDR to offer
advice to researchers on the ethics of projects.
There should be prior environmental, medical and social studies for site selection, and the mostappropriate site should be chosen on the basis of this data. Information should be exchanged as broadly
as possible with community leaders, members of the local community, and the mass media. Consent
should be obtained from the communities involved. Specific mechanisms to obtain individual andgroup consent need to be developed for public health interventions. A contingency plan for aborting afield trial needs to be developed.
Commitment to the local communities involved in field trials should be made such that they will be thefirst beneficiaries of more permanent use of a GM vector should results indicate that this is appropriate.
Intellectual property concerns should not be barriers to implementing public health measures using
GM vectors or their symbionts and/or pathogens.
Prior negotiation, including possible involvement to allow access to the latest technology, is preferable
to confrontation. The data should be made available to all in order to benefit from global expertise anddevelop international consensus.

Asia-Pacific Perspectives on Biotechnology and Bioethics

One useful development of the Cartegena Protocol umbrella is the establishment of biosafety clearing
houses, which are contact points in each member country. The Protocol also includes risk assessment
and risk management once agreement is reached, as well as development of capacity building inbiotechnology research.

43

There is a need for an ongoing and active process of ethical analysis, through a variety of forums, thatwill provide us with the conclusions about where it is ethical to conduct these type of studies.
Ethically, we have to consider what are core ethical values for modification of nature for human needs.
The ethical principle of beneficence demands action to eliminate hunger and disease. We must do
this while preserving the environment for the future and respecting the cultural diversity that each
community in endemic areas possesses.

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Japanese attitudes towards genetically modified
mosquitoes*
Naoko Kimura and Darryl Macer
RUSHSAP, UNESCO Bangkok,
Thailand

Vector-borne diseases

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In the fight to reduce human suffering, there is an urgent need for the control of vector-borne diseases
such as malaria and dengue fever. The use of genetically modified (GM) insects is one of the methods
that has been supported by the WHO as a new measure for disease control. It is also being supportedby the Grand Challenges to Global Health initiative as a method to control vectors transmitting dengue
fever. However, there is much controversy surrounding the procedures of such research, especiallyconcerning field trial studies of all types of GM organisms (GMOs).
Malaria is reported to cause one million deaths annually, mainly taking the lives of young children. It is
known to be one of the leading causes of death in children under the age of five. Between 300 million
to 500 million people suffer from acute cases of this mosquito-borne disease each year with about 90
percent of the cases occurring in Africa.
In 1997 where nine out of 10 cases occurred in sub-Saharan Africa, it is estimated that malaria caused
more than $2 billion of losses in the economy. Although prophylactics and various antimalarial drugs
exist, the overuse of antimalarial drugs in recent years has led to a widespread resistance to conventional
therapies leading to an increase of malaria morbidity and mortality (Breman, 2001; UNICEF, 1999;
WHO).
In addition to malaria, dengue and the more virulent form of dengue virus infection, dengue hemorrhagic
fever (DHF), are also international health concerns, being endemic in Africa, the Americas, the Eastern
Mediterranean, Southeast Asia and the Western Pacific. It is estimated that two-fifths of the world’s
population is at risk from dengue, but due to there being four different viruses causing the disease,vaccine development has been difficult and there is no specific treatment for dengue fever (WHO).
To control insect vector diseases, the most common and effective measure at present is transmission
prevention at both individual and area-wide levels. Preventive methods such as insect repellents andbed nets are commonly practiced and have proven to be successful in reducing the risk of infection. On
the other hand, the usage of pesticides to control larvae and adult populations in a more wide-spreadarea is a common approach as well, but has in fact caused higher incidences of malaria in some cases
once again mainly due to mosquitoes acquiring resistance to insecticides (Eldridge, 2004; WHO).
As mosquitoes grow increasingly resistant to existent insecticides and with the general use of
insecticides, especially those containing DDT, being questioned by some because of the environmental
and health risks, conventional vector disease control methods are facing an exigency with many
voicing the need for alternative futuristic approaches. The complete genome sequence of the malaria
mosquito Anopheles gambiae has been obtained with researchers optimistic about the genomic data
contributing to combating malaria (Holt et al, 2002). To hinder vector disease transmission by releasingmosquitoes that have been genetically modified to be refractory to pathogen infection could be a new
method of mosquito-vector disease prevention and eradication (Alphey et al, 2002; Lycett et al, 2002;
Scott et al, 2002; Enserink, 2000).

Views on biotechnology
To carry out a field trial in an ethical manner, it is necessary to understand the concerns held by thegeneral public of each particular community as well as those of various stakeholders, and to ensure that
* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

there is open dialogue and continued involvement of communities throughout each trial.
In order to gauge the attitudes that people have concerning bioethics, two surveys were conducted inJapan, one in 2003, and the second in 2004 to both the general public and to farmers. These surveys
contained a few questions relating to GMOs, with one question focused specifically on whether using
genetic modification techniques to make mosquitoes incapable of vectoring diseases such as malaria
and Japanese encephalitis in their opinion is acceptable or not. The questions were given in an open
response format, thus the returned comments were analyzed and categorized into concept categories
which express the ideas in the responses given.
Several public surveys have been conducted to ask for people’s views on biotechnology in the US,
Europe, and in Japan (Gaskell, 2000; Macer and Ng, 2000; Hoban, 1998; Macer et al, 1997; Macer, 1994;
Macer, 1992). In the U.S., according to three surveys conducted in 1992, 1994, and 1998, just over 70%of the respondents were positive about plant biotechnology with the results remaining stable over theperiod.

Surveys that were conducted in Japan reveal that the Japanese population is highly interested in scienceand technology including biotechnology. Over half of the respondents were favourable to genetic
engineering. However, possibly due to bad publicity, there has been a decline in the overall acceptanceof the application of biotechnology, even for areas such as environmental applications where support
dropped 9% from 1997 to 2000.
Parallel to the surveys of public attitudes to biotechnology, scientists were also surveyed throughout
Japan in 1991 (Macer, 1992) and in 2000 (Macer and Ng, 2000). More scientists than the general publicbelieve that genetic engineering will improve the quality of life. Saying this however, scientists were justas sceptical about the application of genetic engineering as non-scientists Macer and Ng, 2000).
There have been few surveys conducted to find out the views of people towards genetically modifying
vectors, specifically mosquitoes, and pathogens for the purpose of disease control. GM microbes andanimals are generally not as accepted as well by the public as GM plants (Macer, 1994). This may be dueto the fact that GM plants are possibly more conceptually attainable because of their wide usage in foodwhereas GM microbes and animals are often linked with images derived from fantastical stories.
The issue of horizontal gene transfer between species is an ongoing polarized debate prodded bysporadic reports of gene transfer occurring which often lack substantial evidence of its actuality. Thosein support of genetic engineering argue that gene transfer occurs naturally without human intervention,and in the case of genetic engineering, the genes being manipulated would be under better control
compared to that of the random occurrences in nature (Macer, 2003). This suggests that a different wayof thinking could relieve some people of their concerns.

Methodology
The 2003 survey was randomly distributed to households across all prefectures of Japan using a random
sampling method (Inaba & Macer, 2003). Due to a low response rate when surveys were distributed
anonymously in previous similar surveys, for the 2003 survey, the questionnaires were distributed
personally to randomly selected households and left behind with the householders to complete andreturn by mail to their discretion. Consequently, the response rate was at around 20%, a significant
increase compared to that of 2000 where the response rate was a mere 12%. Of the total 1900 distributed
questionnaires, 376 were returned.
The 2004 survey was conducted in the Kanto area and some other prefectures across Japan in OctoberNovember of 2004 (Macer et al., 2006). Six hundred questionnaires were randomly distributed to theAsia-Pacific Perspectives on Biotechnology and Bioethics

The support has also been reported to be the highest among men and people with a more formal
education. Surveys carried out in Europe show that only German and Austrian consumers were clearly
opposed to plant biotechnology (Hoban, 1998). In general, perceptions of Europeans towards medical
biotechnologies and environmental biotechnologies are very positive where they were most negative
towards GM foods and the cloning of animals (Gaskell, 2000).

49

public of which 128 were returned. 200 questionnaires were distributed to farmers of which 65 werereturned. The response rate was 21% and 33%, respectively.
The collected responses were categorized according to standard qualitative research methodology. For
this particular question concerning GM mosquitoes, the comments were categorized into 23 categories
that can be grouped as being a positive feeling, mixed feeling, or a negative feeling. The keywords andconcepts expressed in the comments were the bases for categorization following the methods of Macer(1992, 1994). Some of the comments were categorized into up to three categories when more than one
feeling was expressed.
Japanese attitudes towards the use of genetic modification techniques to make mosquitoes incapableof vectoring diseases such as malaria or Japanese encephalitis
Of the total number of comments made, 31% expressed positive feelings, 19% mixed feelings, and 50%
negative feelings towards using genetic modification techniques on mosquitoes vectoring diseases.
The mean acceptance rate for all of the respondents from both years was 36% whereas 17% responded
that the technique is unacceptable. The majority (of 47%) were unable to decide whether it is acceptablenor unacceptable.

50

Asia-Pacific Perspectives on Biotechnology and Bioethics

Perceived benefits
Slightly more than one fifth of the entire sample population responded with a comment that expressed
their feelings that benefits would arise from curing or preventing disease. Some of the sample comments
were:“For this kind of purpose, genetic modification should be used enthusiastically”.
“Due to global warming, there is concern of new mosquito vector viruses entering form foreigncountries. Preventive measures are necessary”.
“Children in developing countries will be less in danger of contracting malaria and other diseases”.
One farmer stated:“It’s good if it’s only to eradicate diseases. However, I am against the genetic modification of plants[food]”.
Nearly 40% of the farmer respondents commented that curing and preventing disease was a benefitof genetically modified mosquitoes, compared to the 20% of the general public of 2003 and 27% of
the general public in 2004. A number of people expressed little or no concern towards the use of thistechnique to genetically modify mosquitoes. Some of the comments were:“Necessary”.
“It is very much welcome”.
“As long as safety can be assured, there is no problem with reducing diseases”.
Vector-borne diseases such as malaria and Japanese encephalitis are critical global health issues, andmalaria in particular is both a major economic and health detriment in many developing countries.
Some people expressed their hopes of bettering this situation by making statements such as:“It’s beneficial to humankind”.
“For the happiness of humankind”.
“Because it will especially contribute to the improvement of the quality of living in developing
countries”.
“Because there are many people troubled by malaria”.

Table 1: The concepts associated with the reasons given for thinking that using genetic modification
techniques to make mosquitoes incapable of vectoring diseases such as malaria or Japanese
encephalitis (results for public 2003, 2004; farmers in 2004; and total; N, %).
Sample:2003

Public2004

Public2004

Farmers

Acceptable

124

32.9%

54

42.9%

24

39.3%

Unacceptable

61

16.2%

25

19.8%

10

16.4%

Don’t know

186

49.3%

47

37.3%

27

44.3%

Total Number

371

126

61

189

67

21

277

182

59

40

-

Number withcomments
Not stated

Total

Cure/Prevent Disease

38

20.1%

18

26.9%

8

38.1%

64

23.1%

No problem

14

7.4%

2

3.0%

0

0.0%

16

5.8%

Humanity benefits

7

3.7%

5

7.5%

2

9.5%

14

5.1%

Better

10

5.3%

4

6.0%

0

0.0%

14

5.1%

Medicine/Health

5

2.6%

3

4.5%

2

9.5%

10

3.6%

Science/Knowledge

0

0.0%

1

1.5%

0

0.0%

1

0.4%

Conditional benefit

23

12.2%

14

20.9%

8

38.1%

45

16.2%

Don't know

24

12.7%

3

4.5%

0

0.0%

27

9.7%

Disaster

31

16.4%

3

4.5%

1

4.8%

35

12.6%

Fear of unknown

21

11.1%

9

13.4%

1

4.8%

31

11.2%

Ecological concerns

13

6.9%

14

20.9%

3

14.3%

30

10.8%

Interfere with nature

16

8.5%

3

4.5%

1

4.8%

20

7.2%

Don't need

11

5.8%

5

7.5%

2

9.5%

18

6.5%

Insufficient control

10

5.3%

2

3.0%

1

4.8%

13

4.7%

Playing God

9

4.8%

2

3.0%

0

0.0%

11

4.0%

Need more research

4

2.1%

1

1.5%

3

14.3%

8

2.9%

Human health

3

1.6%

3

4.5%

2

9.5%

8

2.9%

Humanity changed

1

0.5%

2

3.0%

1

4.8%

4

1.4%

Animal concerns

3

1.6%

1

1.5%

0

0.0%

4

1.4%

Unethical

3

1.6%

0

0.0%

0

0.0%

3

1.1%

Feeling

1

0.5%

1

1.5%

0

0.0%

2

0.7%

Deformities

0

0.0%

0

0.0%

1

4.8%

1

0.4%

Economic loss

1

0.5%

0

0.0%

0

0.0%

1

0.4%

Mixed

Negative

Asia-Pacific Perspectives on Biotechnology and Bioethics

Positive

51

Genetically modifying mosquitoes in order to make them incapable of vectoring diseases such as
malaria and Japanese encephalitis can be perceived as simply a better option than the current situation.
A few of the comments that were made were:“I think it’s better than getting sick”.
“Because the dangers of malaria and Japanese encephalitis are far greater than those of genetic
modification”.
“It’s better if epidemic diseases are eradicated”.
Medicine and health are general concerns for most humans. A few people conveyed their views that thistechnology is beneficial from a medicinal and health-related standpoint:“Because I want to remain healthy”.
“For health”.
“Because it is something that concerns human bodies”.

52

Asia-Pacific Perspectives on Biotechnology and Bioethics

There was one comment made that hinted at the potential benefit towards the development of scienceand knowledge:“It’s an obvious option that doesn’t even need to be questioned. (Hideo Noguchi endeavored singly)”.
Mixed Feelings
Many people viewed genetically modifying mosquitoes as beneficial, but only under certain conditions.
Concerns for the safety of the procedure and its effects on the ecosystem, along with the actual benefitsof the technique for curing and preventing diseases, were stated by many of the respondents. Some ofthe sample comments were:“It’s acceptable if social problems and environmental pollution are prevented as much as possible.”“As long as safety can be assured, there is no problem with reducing diseases”.
“The balance of the natural world not being destroyed is the condition”.
“Under the condition that there are no other effective prevention/treatment methods (especiallyconcerning malaria). If this method is considered to cause little harm and be effective, then it can beapplied”.
“I accept if it is a technique that will benefit the development of humankind”.
Some people did not know enough about genetic modification techniques to answer the question ofwhether or not they could accept it. Listed below are a few of the statements:“I don’t know about vectoring (no knowledge)”.
“I have no idea what kind of technique this is so I can’t say anything”.
“I’ve never thought about it”.
Perceived risks
The public often receives any new progressive scientific technique with ambiguous feelings towards
the possibility of disaster and risks that might be posed by application of the technique. Although
new procedures are evaluated for potential risks before their application (usually by several regulatorycommittees) public opinion over GMOs tends to be negatively focused. Generally, more time andinformation are needed to alleviate this uneasiness and for the public to be accepting of such novel
techniques. Some of the respondents replied that:

“Other disasters are worrisome”.
“There aren’t any answers to the comparative analysis of real disasters and futuristic disasters”.
“I can’t completely disagree, but I can’t completely agree, either. Because the possibility of theecosystem being destructed and other harms occurring can be highly considered”.
Apart from concerns of disaster, fear of the unknown was a noticeable concern for many. To be more
specific, the unknown can be attributed to areas of concern such as side effects, new diseases emerging,
unexpected problems, etc. A few of the comments were:“Because even if we prevent diseases using genetic modification, the possibility of contracting diseases
that were unknown until now is thinkable”.
“Because the range of connections in nature is not understood. Also, I am worried of the danger of
new diseases being vectored”.
“I am worried that there may be new unexpected problems”.

Concerns for the effects on the ecosystem and to the environment were mentioned in many of thecomments. Because the proposed technique involves the genetic modification of mosquitoes, which
are more difficult to contain than, say, genetically modified plants, the effects on the ecosystem can beperceived as a significant concern. Some of the opinions that were voiced were:“Because I don’t know whether or not there are worries of the ecosystem being destroyed due togenetic modification”.
“Same as humans, manipulating genes of organisms will destroy the balance of all livingorganisms”.
“Having fewer diseases is a good thing, but I don’t know if it’s right to destroy the natural system”.
“[T]here are benefits for humans, but it will disrupt the balance of the animal world”.
A number of people expressed their concerns that such a technique might interfere with nature. The
progress of science and technology can be seen as a means to manipulate nature, or to interfere withnatural ways. In Japan, a recent trend to choose “nature-friendly” products and methods is noticeable.
This could possibly be due to the increased publicity of environmental issues. A few of the comments
were:“I feel awkward about the providence of nature being easily destroyed”.
“Genetic modification might go against nature”.
“I can’t decide whether it is acceptable to manipulate nature”.
“I am against unnecessary intervention of nature, but I don’t like mosquitoes”.
Some of the respondents simply found the genetic modification of mosquitoes unnecessary for the
purpose of vector disease control, or considered that other methods of control and prevention were
better options. There were comments such as:“[The need for] the development of insecticide that will stop [population booms] of mosquitoes”.
“[They] were made as mosquitoes by nature. Humans should not manipulate. Medicine effective formalaria and Japanese encephalitis should be developed and mass produced”.
“Considering that it has been overcome with conventional methods, I cannot agree yet to applying
genetic modification techniques of which the side effects have not yet been clarified”.

Asia-Pacific Perspectives on Biotechnology and Bioethics“Because the effects on the ecosystem and environment are unknown when genetically modified
mosquitoes are released into the natural world”.

53

“Diseases are stoppable without doing such a thing”.
Uneasiness towards insufficient control of both the technique itself and the application of the technique
was expressed by some of the people.
There is a similar connotation to the categories of “disaster” and “fear of unknown”, but comments that
expressed such apprehensions to a lesser degree were categorized under “insufficient control”. Some of
the comments made were:“I am worried that only apparent concerns will be dealt with”.
“Even if [the disease] is stopped, the possibility of a different virus emerging and attacking humans
cannot be denied”.
“I am afraid of new trouble due to genetic modification”.
“I think it’s good, but I feel that there will be more side effects. After all, it is genetic modification”.
Several people felt that genetic modification is a technique that exceeds the moral boundaries of themany privileges humans are capable of taking advantage of; it is considered synonymous to humans
playing God. A few of the comments were:54

Asia-Pacific Perspectives on Biotechnology and Bioethics“Humans manipulating the life system is unacceptable”.
“I feel it is wrong to manipulate mosquitoes and things for human conveniences, but if people whowill suffer from diseases will decrease even slightly, I accept”.
“There is nothing better than getting rid of diseases, but I can’t help feeling that humans are being
arrogant by doing so”.
“Stopping the transmission of diseases is a good thing, but it’s difficult to judge whether it’s an area
which humans should interfere with”.
Lack of sufficient research was another cause of doubt among the respondents who did not accept theuse of genetic modification techniques on disease-vector mosquitoes. The people feeling that more
research is necessary can be inferred through comments such as:“It’s questionable until there is proof of no side effects when bitten by the specified mosquitoes”.
“Because the ecosystem is not fully understood, it is necessary to confirm that there are no othereffects”.
“There are many things that have initially been said to be safe but have subsequently been claimed to
be dangerous, so I cannot trust anything unless it has been thoroughly researched”.
There were two comments made that indicated concern that reducing diseases will be detrimental tothe immune system of humans:“Getting diseases (the possibility) is what makes humans stronger”.
“Because by using genetic modification techniques, it seems like humans will lose their naturalresistance among other things towards diseases”.
As with any novel scientific procedure, there is always a possibility of humanity being changed. This was
expressed as a concern by a few of the respondents, as can be seen from the following comments:“Humankind as it was born should be succeeded as it is”.
“I am worried about how humankind will become in the future”.
There were a few comments stating concern for the well being of mosquitoes and of animals in general.
Although general concern for mosquitoes and other insects is often not as significant as that for various
mammals and birds, the remarks below are a few of the comments made that do express concern formosquitoes as well as for the animal world:“What about the effects to the cycle of the animal world?”“I think that maybe it is okay if there are few bad aspects to the mosquito”.
“[I accept.] However, so long as mosquitoes themselves are not changed”.
The genetic modification of mosquitoes was considered by a few to be unethical. The comments madewere:
“I am against changing the genes of organisms”.
“Researching anything is good, but I am against using it as a technique”.
“[I don’t know,] because mosquitoes are also living organisms and humans have no right tomanipulate them. (Ethics of nature.) However, [I don’t know] because humans don’t want to get
Japanese encephalitis”.
One person stated concern that a new species might result:

There was one comment expressing a negative economic concern:“The numbers are too big, the cost too high. It should be done more ecosystematically”.

Increased support of the genetic modification of mosquitoes
In the 2003 survey, one third of the people answered that they thought genetically modifying mosquitoes
to make them incapable of vectoring diseases such as malaria and Japanese encephalitis would be
acceptable.
Nearly half answered that they did not know, and only 16% said they did not find the technology
acceptable. Comparatively, in the 2004 survey to the general public, the number of respondents
accepting GM technology rose by 10% to 43%.
However, the proportion of the respondents not accepting also rose by 4% to 20% of the total with thepercentage of respondents answering not knowing decreasing to 37%. There was also an increase inacceptance by the farmer respondents, with 39% answering they would accept. As was the case in 2003,
16% responded that they would not accept, and 44% answered they did not know.
It is difficult to pinpoint exactly why there was an increase in the proportion of respondents accepting thegenetic engineering from 2003 to 2004. Japan is not endemic for malaria, and the previously compulsory
childhood vaccination for Japanese encephalitis since 1994 was announced to be discontinued in May
2005 due to the number of cases dropping to just a few per year. Given this, it is unlikely that a stronger
sense of need for disease control was evoked among the respondents within a year.
Several studies conclude that the support for biotechnology applications in general is declining(Gaskell, 2000; Macer, 2000). In this light, it is conceivable that there is some other intrinsic factor forsupporting the use of GM technology for disease control that outweighs the general attitude towards
biotechnology.
Possibly worthy of mention is that a new 1,000 yen bill picturing Hideo Noguchi, a heroic figure in
Japan who developed the yellow fever vaccine, which began circulation in November 2004. Prior tothis occasion, the Japanese public was reminded of his achievements and contribution to the fieldof epidemiology. No specific campaigns were carried out to evoke public awareness for malaria andother tropical infectious diseases, but the overlapping timing of this particular event and the timing of
the surveys may have affected the respondents to be subconsciously sensitive towards the subject ofinfectious diseases.

Asia-Pacific Perspectives on Biotechnology and Bioethics“I feel that a stronger new species will be generated”.

55Views on GM technology
The categorization of the returned comments revealed that although there was little disparity among
the comments made in 2003 and 2004, nor in the proportions of persons that accepted GM mosquitoes.
In 2003, the proportion of positively inclined comments was 30%.
In 2004 among the general public, this figure was 34% and 33% among the comments from farmer
respondents. 19% of the comments made in 2003 were comments conveying mixed feelings. There wasan insignificant difference in 2004 with the percentage being 17% among the general public and 22%
with farmers’ comments.
As for comments that perceived the particular GM technology negatively, half of the comments fromthe surveys (2003, 51%; 2004, 48% of the comments from the general public and 44% of the commentsfrom the farmers) were categorized as so. Compiled together, 31% of the total comments were of apositive nature, 19% of them revealed ambivalent feelings, and 50% had a negative connotation to
them.

56

Asia-Pacific Perspectives on Biotechnology and Bioethics

The total percentage of the respondents that thought the genetic modification of mosquitoes to makethem incapable of vectoring diseases is acceptable was 36%.
Only 17% found the procedure to be unacceptable and 47% answered that they did not know. This is
an interesting finding when taking into account that half of the comments returned contained negative
perceptions of the procedure, yet only 17% of the total respondents answered that the actual procedure
to be unacceptable.
It seems that the respondents were accepting of the purpose of the procedure, but still had doubts
over the technique itself. One quarter, 23%, of the total comments mentioned some association withcuring and/or preventing disease. The second highest proportion of comments was categorized under“conditional benefit”.
These comments contained what the respondents perceived as being both positive and negative
aspects of the procedure. Preventing vector borne diseases such as malaria and Japanese encephalitis
are considered important concepts for the Japanese people even if Japan is not endemic for suchdiseases. Malaria is ubiquitously known as a tropical disease to the Japanese public. However, theyclearly were wary of the possible hazardous consequences of the procedure, implying that the public
was more or less informed of GM technology due to the fact that they were capable of expressing theirconcerns.
Survey results of scientists in Japan in 1991 and in 2000 show that even though they are just as cynicalof certain applications of GM technology, overall, scientists are more inclined to believe that genetic
engineering will improve the quality of life (Macer and Ng, 2000).
This suggests that information that is quantitative in nature influences a supportive stance towards GM
technology, but the relative level of the qualitative information received by the more formally educatedcompared to the general public is unknown. Distinguishing this would be informative of just how muchthe media predisposes public opinion as well as being helpful to compile objective information to bedisseminated for the purpose of encouraging an informed opinion of GM technology and biotechnology
in general.

References
Alphey, L. et al. 2002. Malaria Control with Genetically Manipulated Insect Vectors. Science, Vol. 298, No.
5591, 4 October 2002, pp. 119-121.
Bremen, J.G., Egan, A., Keusch, G.T. 2001. The Intolerable Burden of Malaria: A New Look at the Numbers.
Am J Trop Med Hyg., Vol. 64, suppl. 1.
Eldridge, B.F. 2004. In: Biology of Disease Vectors. 2nd ed, Marquardt, W.C., et al (eds). Elsevier Academic
Press, pp. 107-110.

Enserink, M. 2000. Building A Disease-Fighting Mosquito. Science, Vol. 290, No. 5491, 20 October 2000,
pp. 440-441.
Gaskell, G. 2000. Agricultural Biotechnology and Public Attitudes in the European Union. AgBioForum,Vol. 3, No. 2-3, pp. 87-96. http://www.agbioforum.org/v3n23/v3n23a04-gaskell.htm.
Hoban, T.J. 1998. Trends in Consumer Attitudes About Agricultural Biotechnology. AgBioForum, Vol. 1,
No. 1, pp. 3-7. http://www.agbioforum.org/v1n1/v1n1a02-hoban.htm.
Holt, R.A., et al. 2002. The Genome Sequence of the Malaria Mosquito Anopheles gambiae. Science, Vol.
298, No. 5591, 4 October 2002, pp. 129-149.
Inaba, M., Macer, D.R.J. 2003. Attitudes to Biotechnology in Japan in 2003. Eubios Journal of Asian andInternational Bioethics, Vol. 13, pp. 78-89.
Lycett, G.J., Kafatos, F.C. 2002. Anti-malarial Mosquitoes? Nature, Vol. 417, No. 6887, 23 May 2002, pp.
387-388.
Macer, D.R.J. et al. 2006. Publication in preparation.

Macer, D.R.J. 1994. Bioethics For the People by the People. Christchurch, Eubios Ethics Institute.
Macer, D.R.J. 1998. Bioethics is Love of Life. Christchurch, Eubios Ethics Institute.
Macer, D.R.J. 2003. Ethical, Legal and Social Issues of Genetically Modified Disease Vectors in Public Health.
UNDP/World Bank/WHO, special program for Research and Training in Tropical Diseases (TDR), Geneva.
www.who.int/tdr/publications/publications/seb_topic1.htm.
Macer, D.R.J., Bezar, H., Harman, N., Kamada, H., Macer, N. 1997. Attitudes to Biotechnology in Japan and
New Zealand in 1997, with International Comparisons. Eubios J. Asian Int. Bioethics, Vol. 7, pp. 137-151.
Macer, D.R.J., Ng, MN. 2000. Changing Attitudes to Biotechnology in Japan. Nat Biotechnol., Vol. 18, No.
9, September 2000, pp. 945-947.
Scott, T.W., Takken, W., Knols, B.G.J., Boëte, C. 2002. The Ecology of Genetically Modified Mosquitoes.
Science, Vol. 298, No. 5591, 4 October 2002, pp. 117-119.
UNICEF. 1999. Rolling Back Malaria. March 1999. www.unicef.org/publications/files/pub_rollback_malaria_en.pdf
WHO. Resources available online: www.who.int/en/

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Macer, D.R.J. 1992. Attitudes to Genetic Engineering: Japanese and International Comparisons. Christchurch,
Eubios Ethics Institute.

57

Benefits and ethical limits of transgenic animals*
Mary Josephine Rani
Auxillium College,
Vellore, India
M. Selvanayagam
Loyola College,
Chennai, India.

Introduction
The growing awareness of the human and social implications of progress in life science is certainly oneof the most significant developments of the 21st Century (Melchias, 2005).

58

Asia-Pacific Perspectives on Biotechnology and Bioethics

In the last few decades, there has been a growing feeling that technology has brought with it both problems
and benefits, thus leading to a strong anti-technology trend (Sullia, 2003). Modern biotechnology has
the potential to bring up a wide range of “moral and ethical concerns”. “Ethical concerns” are a set ofstandards by which a particular group or community decides to regulate its behaviour, to distinguishwhat is legitimate or acceptable in pursuit of their aims from what is not (Straughann, 1996).
The genetic modification of living beings raises special ethical concerns that go beyond a general
discussion of animal rights or welfare. Although the goals may be similar, biotechnology has accelerated
the process of modification of “types” traditionally carried out by crossbreeding (Nuffield Council,
2005).
While there has been a downward trend in the number of genetically normal animals used in research,
the use of genetically modified animals has increased tenfold in the last decade (Almond, 2000).

Genetic Modification
Genetic modification, or genetic engineering, of animals involves the addition and/or deletion of partof the DNA of an animal in order to change that animal’s characteristics. Genetically modified animals
are widely preferred as the source of animal experimentation, as they can be of uniform quality and canbe mass-produced (Boyd Group, 1999). Genetically modified animals have been produced for several
reasons, including:• To help scientists to identify, isolate, and characterize genes in order to understand more about theirfunction and regulation;• To provide research models of human diseases and help develop new drugs and new strategies forrepairing defective genes (gene therapy);• To provide organs and tissues for use in human transplant surgery;• To produce milk that contains therapeutic proteins, or to alter the composition of the milk to improve its
nutritional value for human infants;• To enhance live stock improvement programmes (Straughan, 1996).

Production of genetically modified animals
The techniques used in the genetic manipulation of animals include the administration of drugs todonor female animals in order to induce super ovulation, followed by timed mating and collection offertilized eggs (by killing the donor animals in the case of mice, or by laparotomy in larger animals).
After they have been genetically manipulated in vitro, the modified embryos are then implanted into
surrogate mothers by laparotomy. Both induction of super ovulation and laparotomy are establishedtechniques which, increasingly, are employed in the selective breeding of farm and laboratory animals.
Laparotomy is carried out under general anesthetic. Nevertheless, laparotomy can cause post-operative*

Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

pain, and super ovulation can cause discomfort.
In both cases, appropriate analgesia should be administered. Preparation of surrogate mothers involves
mating them with sterile males to produce a 'pseudopregnancy', and the males must therefore undergo
vasectomy under general anesthetic.
Sometimes, the donor female animals are mated when very young, and this can be stressful (Hubrecht,
1994). Aside from the direct effects of the techniques involved, foetal death can occur during
development in utero, and some additional deaths can occur post-natally.

Such proportions are likely to vary considerably from case to case. It is uncertain at what stage indevelopment foetuses can experience pain and distress, or how much the welfare of the mother iscompromised by foetal death. But with larger farm animals, it is known that miscarriages cause distress tothe mother. Losses during production mean that relatively large numbers of donor and recipient animals
must usually be used, in order to produce a relatively low yield of genetically modified animals.

The contribution of transgenic animals to human welfare
There are a number of examples of how transgenic animals can contribute to human benefit. Scientists
are attempting to produce disease-resistant animals such as influenza-resistant pigs.
In 2002, two scientists at Nexia Biotechnologies in Canada spliced spider genes into the cells of lactatinggoats. The goats began to manufacture silk along with their milk and secrete tiny silk strands from theirbody. By extracting polymer strands from the milk and weaving them into thread, the scientist is able
to create a light, tough and flexible material that can be used in such applications as military uniforms,
medical microsuture and tennis racket strings.
Toxicity-sensitive transgenic animals have been produced for chemical safety testing. Microorganisms
have been engineered to produce a wide verity of enzyme-yielding proteins; the enzymes, in turn, canspeed up industrial chemical reactions (Margawathi, 2005).
Genes can be inserted or deleted in the genome, and mice have been used extensively to study complex
developmental processes in which genes are switched on and off.
Many different mice models mimicking human disease or possessing relevant human receptor sites areused in studying the mechanisms by which disorders are caused, and to work towards developing more
effective treatments such as a pharmaceutical or gene therapy (Bedell, 1997). Human gene therapy
involves adding a normal copy of gene (transgene) to the genome of a person carrying defective copiesof that gene.
The potential for treatments for the thousands of genetic diseases is huge, and transgenic animals could
play a role in the development of human therapy. For example, the A.I. Virtanen Institute in Finland
produced a calf with a gene that makes the substance that promotes red blood cell growth in humans.
Selective inbreeding has produced several strains of animal that are considered reasonable models oftype 1 diabetes, type 2 diabetes, and related phenotypes such as obesity and insulin resistance. Apartfrom their use in studying the pathogenesis of the disease and its complications, all new treatments
for diabetes, including islet cell transplantation and preventive strategies, are initially investigated inanimals.
In recent years, molecular biology techniques have produced a large number of new animal models
for the study of diabetes, including so-called "knockin", generalized "knockout", and tissue-specificknockout mice (Rees, 2005).

Asia-Pacific Perspectives on Biotechnology and Bioethics

A study (Wight, 1994) found that, in experiments involving pro-nuclear microinjection of seven different
gene constructs into mouse embryos, 1360 out of a total of 1585 embryos survived micro-injection(and in some cases overnight culture) and were implanted into pseudopregnant females. 29% of theimplanted embryos survived to weaning (with a range of 21% to 42% between the seven experiments).
Just under a quarter of these pups proved to be successfully genetically manipulated (that is, 7% of theimplanted embryos, with a range of 3% to 11% across the experiments) (Hubrecht, 1994; Wight, 1994).

59

Biopharming
Transgenic animal bioreactors represent a powerful tool to address the growing need for therapeutic
recombinant proteins. The ability of transgenic animals to produce complex, biologically-active
recombinant proteins in an efficient and economic manner has stimulated a great deal of interest in
this area.
As a result, genetically modified animals of several species, which express foreign proteins in various
tissues, are currently being developed (Dyck, 2003). Production of pharmaceuticals in milk (for instance,
production in sheep’s milk of human blood clotting factor IX, human α-1-antitrypsin) can be used totreat hereditary emphysema and cystic fibrosis (Nuffield Council, 2005).

Xenotransplantation
The use of animal organs for human transplantation is being seriously considered as a viable option
for organ donation. Two groups of animals have been considered as donors: non-human primates andlarge non-primates such as pigs (Ravelingien, 2004).

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Asia-Pacific Perspectives on Biotechnology and Bioethics

The chances of successful xenotransplants in the future can be improved by genetically modifying pigs
so that, for example, they carry human-complement regulating proteins on the surfaces of their cells,
which will help to inhibit hyper acute rejection when such organs are transplanted into humans.

Improving Productivity
Genetically modified cows can be bioengineered to produce several verities of milk:• milk with a lower level of a protein that can be allergenic to infants;• milk that is more easily digested by people who are lactose intolerant;• milk that has more naturally occurring anti-microbial enzyme and therefore has a longer shelf life;• milk that makes better cheese because it has altered the distribution of caseins or less fat
There are a wide range of genetically modified animals. A tropical fish was genetically modified toglow in the dark and was called the “Glofish”. A company called Transgenic Pets started work in 2001 to
remove the allergen gene from cats in a bid to make allergy-free cats. Shellfish have also been modified
for reduced allergenicity and faster growth. Salmon, catfish, and tilapia have been modified for fasterand more efficient growth in aquaculture.

Ethical Concerns
Alongside potential benefits, genetic modification of animals raises a variety of ethical concerns. Ethics
can be defined as a set of standards by which a particular group or community decides to regulate its
behaviour; to distinguish what is legitimate or acceptable in pursuit of their aims from what is not.
Bioethics can be defined as the systematic study of human conduct in the areas of life sciences andhealth sciences, keeping in view the moral values and principles existing during a particular period(Sullia, 2003).
The debate over animal use brings up difficult ethical questions, such as: Do we as humans have theright to alter the genetic composition of other animals? And what is the point of researching on animals
when they are so different from us?
The concern for animal welfare is sometimes portrayed and dismissed as a matter of purely emotional
response (Mani, 2003). Animal biotechnology is a morally sensitive issue, because many people haveconcerns about not only the treatment of animals but also about the nature of biotechnology itself.
Other concerns include the nature of the act of genetic engineering, involving broad issues such asgenetic integrity, the idea of unnatural intervention in the natural world, and the co-modification ofanimals (Macer, 2006).
It might be argued that genetic engineering currently includes the transfer of only one or two genes andas such has little difference to evolution or selective breeding. But this modern technology is limitlessand has the capacity of crossing species boundaries drastically.
Ultimately, all of these objections are debatable, as views vary widely regarding the moral basis ofgenetic modification. Transgenic animals can create particular problems for some religious groups, forexample, Muslims, Sikhs, and Hindus are forbidden to eat the flesh of specific animals and thus a conflictarises in eating foods containing genetic material from those animals.
Many people appear to be uneasy about the transfer of genetic material from and into animals, though
there seems to be little concern that insulin for treating diabetics is now produced by inserting copies
of human genes into microorganisms. This suggests that it is the involvement of animals rather than the
crossing of species' boundaries that is regarded as morally problematic.

Consequences of genetic manipulation and animal welfare
Though opinions differ on the fundamental objections, the consequences of genetic manipulation
cannot be denied or explained away without considering suitable precautionary measures.
This enormously promising science is in its infancy - despite a wealth of amassed knowledge, weknow very little. The consequences of genetic modification on animals as well as human life and theenvironment at large must be considered.
Animals undergo various procedures during genetic modification. In some cases, genetic modification
appears to have no impact on the welfare of resulting animals; in certain cases, it could theoreticallybenefit animal welfare, and in other cases, there are certainly adverse welfare effects in a range ofseverities, both during and after the procedures (Moore, 1995; Van Zutphen, 1996).
Welfare can be compromised in two main ways:(a) For research purposes, gene deletions (“knock-outs”), mutations, or defective genes may
be introduced in order to deliberately cause or simulate a wide range of genetic diseases, ordevelopmental or gene function abnormalities;(b) In any case of genetic manipulation, unintended adverse side effects can occur. Such side
effects may be caused when the new genetic material is expressed and unpredicted physiologicalchanges occur, or they may be caused when the introduced DNA disrupts the function of one ormore of the animals’ own genes.
The latter is a result of randomness of integration of the new genetic material into the recipient animal's
genome, in particular when the pro-nuclear microinjection technique is used. Many such disruptions
prove fatal to the developing embryo.
When the effect is not lethal, the welfare of the resulting animal can be seriously compromised (e.g., mice
have been born with deformed limbs or kidney malfunction) (Sullia, 2003; Dyck, 2003). For example, anumber of species of hoofed animals produced by in vitro culture or nuclear transfer methods, whether
or not they carry a transgene, tend to have higher birth weights and longer gestation times than offspringproduced by artificial insemination. Additional health and welfare problems include respiratory distress,
lack of suckling reflex, and a variety of pathological conditions (Vandenberg, 2002).
There are a few instances where genetic modification led to substantially ill effects even with survival
beyond foetal stages. Some super pigs engineered with a human growth hormone gene were arthritic,
ulcerous, blind, and impotent (Catholic Study Circle, 2004).

Asia-Pacific Perspectives on Biotechnology and Bioethics

The deliberate production of genetically identical animals is dangerous because it fails to respect genetic
diversity, particularly if the aim is a production-line uniformity (Catholic Study Circle, 2004).

61

A super salmon engineered with genes from another fish for fast growth had a bulbous head anddied as a result of not being able to breathe, see, or hear properly. Clones of Dolly the sheep, “the big
success story”, were eight times more likely to die at birth than a normal lamb (Hubrecht, 1994). Amongtransgenic animals that survive, many don’t express the inserted gene properly, often resulting in
anatomical, physiological, and behavioural abnormalities.

Potential risks to humans, animals and the environment
A utilitarian justification for producing and using genetically modified animals must take into accountpotential risks to humans and other animals, as well as to the wider environment. While risk management
is a major concern of regulatory bodies, it varies in scope and efficacy between countries, and much
more research on safety aspects is needed.
There is a concern about the risks from the use of retroviruses as DNA vectors during production ofgenetically modified animals: e.g., risks that genes might inadvertently be transferred to other individuals
or species, or that retroviruses might infect other organisms.

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Asia-Pacific Perspectives on Biotechnology and Bioethics

There is also a concern that drug resistance gene markers used in some genetic engineering procedures
might inadvertently be transferred and expressed. There is also an ecological concern that the creationof disease-resistant animals may threaten the entire environment.
There are concerns that animal biotechnology might narrow the gene pool and reduce genetic diversity,
thereby producing a monoculture that could be vulnerable to new diseases or other environmental
threats. If animals bioengineered in biomedical research to be models of human diseases escape they
may infect the human (and animal) population, or might generate new and more resistant strains of
the disease. There are also concerns that organs from genetically modified animals might transmit vital
diseases if used in human transplant surgery. Particularly in xenotransplantation, there is a concern thata human recipient of animal organs might become infected with animal viral diseases, which mightthen infect the wider population.
Genetically engineered salmon could induce the widespread introduction of new genes into wild fishruns and they could, for example, introduce new vulnerabilities to disease or disrupt the predator-prey
relationship because they might grow larger than normal.
Cats, goats, fish, insects, and other animals that pose the greatest risk of escaping and cross-breeding
would be difficult to quarantine or capture, and could yield unforeseen consequences for the genetic
future of these species.
Animals bioengineered for food purposes might produce proteins that would cause allergies or otherhypersensitive reactions. The applications of biotechnology may someday reduce the number ofanimals needed for food and fibre production, but they also can have adverse effects on the welfareof the animals: for example, calves and lambs produced through in vitro fertilization or cloning tend tohave higher birth weights and longer gestation periods, which leads to difficult births, resulting in manycases in caesarian sections.
There is a concern that proteins designed to produce a pharmaceutical product in an animal’s milk may
find their way into other parts of the animal’s body and cause adverse effects (Carroll, 2002). While mostgenetic modifications tend to not benefit the animals concerned, genetic modification might also aim
to benefit animal welfare, for example by producing better disease resistance. In other cases, genetic
modification might be welfare “neutral”. This might be the case if there is “no change from the averagefor unmodified animals” (as for example in most, but not all, animals modified to produce medicallyimportant proteins in their milk) (Moore, 1995); or welfare is no different from that of animals produced
by selective breeding (Straughan, 1996). This last point again raises the question of how significant thedifferences are in the effects of direct genetic modification versus conventional selective breeding.

Conclusions
We need more detailed analysis about welfare problems caused during the production of geneticallymodified animals. Directly modifying an animal's genetic material can produce unpredictableconsequences, while most genetic modifications tend to not benefit the animals concerned.
Genetic modification could aim to benefit animal welfare: for example, by producing better disease
resistance. To take a hypothetical example, if all pigs in the world were resistant to foot and mouthdisease, there would be enormous benefits for the welfare of pigs.
In other cases, genetic modification might be welfare “neutral”. This might be the case if there is nochange from the average for unmodified animals (as for example in most, but not all, animals thatare modified to produce medically important proteins in their milk) (Moore, 1995), or if welfare is nodifferent from that of selectively bred animals (Straughann, 1996).

It is therefore crucial that the justification for the work is reassessed as it progresses. There is a need for
greater commitment to monitoring, collecting, and reporting data on the adverse side effects of genetic
manipulations.
Good practices should be followed, in that adverse effects should be looked for actively, and data
gathering should involve those responsible for the husbandry of the animals.
Welfare problems should be recorded in databases on the characteristics of genetically modified
animals, and journals should require scientists reporting novel genetic manipulations to fully document
the effects on the animals of their procedures. Reporting should include aspects such as deaths in utero
occurring during production of genetically modified animals, as well as adverse effects experienced by
the resulting animals. The latter should include any morbidity or mortality, changes in health status,changes in weight/growth of the animals, behavioural changes, changes in breeding success, andresults of post mortem examinations of gross morphology.
The use of genetic modification to increase productivity in farm animals by enhancing growth rate,or related factors such as muscling, is particularly controversial. In large-scale production and longterm use of genetically modified animals in agriculture, negative welfare effects caused by genetic
modification should not be tolerated, and every effort should be made to minimize such effects.
The process of ethical review of research involving animals should satisfy the following objectives:• It should ensure the ethical acceptability of all research projects involving animals. In practice, this means
ensuring:(a) That they are scientifically necessary and of high quality; and(b) That, wherever possible, the use of animals is replaced, refined, or
reduced• It should improve public confidence in the review process;• It should enable those responsible for ensuring the acceptability of work in their institutions to carry out
their duties as effectively and efficiently as possible (Boyd Group, 1999);• We have no right to use the animals in any way that suits us just because we are members of a different
species: we should take into account their feelings, interests, and capacity for pain and pleasure(Straughan, 1996)
Human beings are challenged to make ethical decisions and to balance the benefits and risks ofalternatives. The benefits of genetic modifications are great, but there are many possible risks. The more
possibilities we have, the more decisions we must make. People need to be taught more about how to

Asia-Pacific Perspectives on Biotechnology and Bioethics

This last point again raises the question of whether there are significant differences in the effects ofdirect genetic modification versus selective breeding. Wide-ranging effects and thus potential harms
and benefits of such procedures are often uncertain.

63

make ethical decisions, and the educational system should accommodate this need of modern society.
Bioethics shouldn’t be allowed to strangle technical research, while at the same time research shouldn’t
be allowed to proceed unscrutinized. Let us not forget that the moral goodness of any progress ismeasured by its net benefits to humankind, and the benefits of biotechnology must outweigh theburdens (Melchias, 2005).

References
Almond, B. 20000. Health Risk Soc., Vol. 1, pp. 95-105.
Bedell, M.A., Largaespada, D.A., Jenkins, N.A., and Copeland, N.G. 1997. Mouse Models of Human Disease
II: Recent Progress and Future Directions. Genes and Development. Vol. 11, pp.11-43.
Boyd Group. 1999. Animal Welfare and Ethics: A Discussion Paper From Boyd Group. Genetic
Engineering.
Carroll, J. and Regalado, A. 2002. Genetically Modified Animals May Pose Environmental Risks. National
Academy of Sciences.

64

Asia-Pacific Perspectives on Biotechnology and Bioethics

The Catholic Study Circle for Animal Welfare. 2004. The Prospect of Xenotransplants: Scientific Aspects
and Ethical Consideration.
CSIRO Animal Health Laboratory. 2005. Animals Under the Knife.
David, M. 2002. Genetically Modified Organisms. University of Pennsylvania Philadelphia.
Dyck, M.K. Lacroix, D., Pothier, F., and Sirard, M.A. 2003. Making Recombinant Proteins in Animals—
Different Systems, Different Applications. Trends Biotechnology, Vol. 9, pp. 394-399.
Hubrecht, R . 1994. Genetically Modified Animals, Welfare and UK Legislation. Animal Welfare, Vol. 4, pp.
163-170.
Mani, V., Mathew, R., and Homer-Vanniasinkam, S. 2003. Xenotransplantation: Animal Rights and HumanWrongs. Ethics Med., Vol. 9, No. 1, pp. 55-61.
Margawathi, E.T. Trangenics Animals: Their Benefits to Human Welfare.
Melchias, G. 2005. National Symposium on Microbial and Plant Biotechnology. Loyola College, Chennai,
pp. 15-17.
Moore, C.J. and Mepham, T.B. 1995. Transgenesis and Animal Welfare. Alternatives to Laboratory Animals,Vol. 23, pp. 380-397.
Nuffield Council of Ethics. 2005. Ethics of Research Involving Animals. London.
Ravelingien, A. and Braeckman, J. 2004. Xenotransplantation. Ethics Med., Vol. 4, pp. 371-375.
Rees, D.A. and Alcolado, J.C. 2005. Animal Models for Diabetes. Diabet Med., Vol. 4, pp. 359-370.
Rehm, H.J. and Reed, G., in corporation with Puhler, A. and Stadler, P. Biotechnology and Bioethics., Vol.
12, pp. 122.
Straughan, R., Reiss, M. 1996. Ethics, Morality and Animal Biotechnology. Biotechnology and BiologicalResearch Council.
Sullia, S.B. 2003. Foundation for Biotechnology Awareness and Education.
Wight, D.C. and Wagner, T.E. 1994. Transgenic Mice: A Decade of Progress in Technology and Research.
Mutation Research, Vol. 307, pp. 429-440.
Vandenberg, J.G. 2002. Animal Biotechnology: Science-Based Concerns. National Research Council.
Van Zutphen, L.F.M. and Van den Meer, M., eds. 1996. Welfare Aspects of Transgenic Animals. SpringerVerlag.

Biobanking and ethnic monitoring*
Jürgen Simon, Ph.D. and Cristina
Blohm-Seewald, Ph.D.
University of Lueneburg,
Germany

Introduction

Scientists have much hope in the collection, treatment, storing, and distribution of human tissues fromdifferent populations. However, what opportunities do those projects offer for the donors? We havelearned from the very famous Icelandic and the UK biobanks that donor benefit is often not taken
into account, apart from a potential indirect benefit due to the development of medicines for donorpatients.
For this situation, we can find many examples. We would like to present some not-so-well-known but
highly current cases. The first two are biobanks: one is the "Macedonian Biobank", and the second isthe "Genographic Project". The third one is the Hungarian project for ethnic monitoring. Lastly, we will
analyse chances and risks for involved populations in these projects, with special attention to theirimpact on minorities.

The Macedonian DNA bank1
It is little known that Macedonia has set up a DNA Bank.2 This human biobank is operated by the
University of Skopje, the Institute for Immune Biology, and the Institute for Human Genetics. The
biobank of genealogical data has various goals: the genetic diversity of the Macedonian population andits minorities will be studied, and any correlations between genetic diversity and genetic diseases are to
be examined. This biobank is financed by the Macedonian government. It encompasses three different
research and project areas, as shown in Table 1.
Table 1: Project areas, number of existing DNA samples. December 20023
Project
Anthropology (ethnic groups)
Patients without reference*
Patients with reference**
Total

2002
46
111
19
176

DNA: stored samples
2001
2002
279
652
249
75
159
103
687
831

2000-2002
978
435
281
1694

*"Patients without reference" refers to data and materials, etc., from different medical projects outside of the two
institutes, where no family data are recorded. To date, this bank only has 409 samples. Main focal points are 10 diseasesof various types like heumatism, heart disease, and diabetes mellitus 1 and 2, and others.
**"Patients with reference" means projects where DNA samples are stored to include family and patient data. The main
focus of this bank is bone marrow transplantations, related renal transplantation, and autism. At this time, the bankcomprises 232 samples of 232 persons.

1This part of the paper refers to B. Jansen, Rechtliche undethische Asperte von DNA – Datenbaken in Internationalen
Vergleich, Lueneburg, 2005
2 http://www.hdnamkd.org.mk/index.html
3 Source: www.hdnamkd.org.mk* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Asia-Pacific Perspectives on Biotechnology and Bioethics

This paper will discuss the "Chances and Risks of Biobanks" and “Ethnic Monitoring” of different
population groups, in our case, minorities.

65Defining populations and samples of human genetic material as done in this anthropological research
is problematic, because the samples are structured and defined according to the criteria of population,nationality, language (mother tongue and second language, and religion, as Table 2 shows.

Table 2: Definition of the Macedonian population and samples4
Population

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Asia-Pacific Perspectives on Biotechnology and Bioethics

Macedonian

Nationality

Other National.

Macedonian Macedonian

Mother tongue 2nd Language

Religion

DNA Samples

Macedonian

Macedonian

Orthodox
Catholic
ProtestantMuslim353
00
4MKDAlbanian Albanian

Macedonian

Albanian

Macedonian

MuslimCatholic

50
0

MKD ROMA

Roma

Macedonian

Roma
Macedonian
TurkishMacedonian

Muslim82

MKD Turks

TurkishMacedonian

TurkishMacedonian

Muslim8

MKD Serbs

SerbianMacedonian

SerbicMacedonian

Orthodox

9

MKD Valchs

Vlach

Macedonia

VlachsMacedonian

Orthodox

2

MKD Mixed

Mixed

Macedonia

Mixed

Macedonian

Mixed

6

Yug Gorans

Goa

SerbianMacedonian

SerbicMuslim

80

Total

594

Particularly from an ethical point of view, to use the above criteria could be problematic, because no
information is given if the concepts of these criteria are in accordance with the concepts of the involved
ethnic groups, because the research results may be abused with regard to ethnic groups. The selfidentification of individuals and groups is problematic, and using the above criteria, the results of theanalysis of the research may be abused to discriminate ethnic groups.
With regard to this project, the question of protecting the personality rights of the individual is entirely
unanswered. Although the Macedonian constitution generally protects personality rights, it is unclear
whether or not DNA issues are covered. Furthermore, other crucial matters like informed consent,
duration of storage, etc., are not mentioned in the project information material. Macedonia does
have a 1994 law for the protection of person-related data; however, it is not available in a new English
translation, and it is not included in their law texts on the internet.5
Abusing tissues and data for discrimination purposes with regard to unwanted groups of the populationis, therefore, not legally prohibited. This is particularly of concern since, until quite recently, Albanianminorities have been persecuted.

4 “MKD Valchs”= This minority is largely not known, “MKD Mixed”= people of Montenegro, Jews, and others, “YugGorans”= people who live in the region Gora (southwest of Kosovo, Muslims).
5 http://www.mlrc.org.mk/list.htm

The Genographic Project6
The Genographic Project has the goal to take human genetic samples from all over the world in order tocreate a world atlas of human migration. The project was announced to the public on 13 April 2005 andwas initiated by the National Geographic Society, IBM, the geneticist Spencer Wells, and the Waitt Family
Foundation. Referring to information published on the internet, an advisory board with ten members
provides advice and consultation on matters such as funding priorities and ethical and legal complianceover the course of the project. This ensures that all national and international laws concerning human
genetic sampling and anthropological research are followed before starting. An external control ismanaged by the Social and Behavioural Sciences Institutional Review Board (IRB).7

Scientists have taken samples also from indigenous people. There is still some mystery of how samplingis managed: it is just mentioned that participation is voluntary and that advice and counsel from leadersand members of indigenous communities is sought. The samples are analysed in regional labs, and theencoded results are sent to the central database at the Arizona Research Lab for analysis. The origin of
the sample and the donor are kept on file in the regional research lab. Published information states thatany further research on the samples and any patenting on the results are banned. The samples are to becompletely destroyed by the end of the project. The net proceeds from the sale of the participation kits
will be directed towards cultural preservation efforts for participating indigenous populations.
According to the lack of transparency in this project, it is not clear if and when consultations are to
be enacted with indigenous people concerning the implementation and methodology of the project.
This lack of transparency links the project to scientific paternalism. Also, any possible economic
exploitation is unknown. And as mentioned above, the security of the indigenous participants' data is
not guaranteed.
In addition, the Arizona Research Lab, which is in charge of the analysis of the collected data, wasdiscredited due to the exploitation of human genetic material of the native American tribe theHavasupai8 a couple of years ago. Also, members of the research group participated in a previous projectthat resulted in discord between some of the indigenous people and the scientific community. The
discharged Human Genome Diversity Project collected the genetic data of ethnic minorities and almost
all the chosen indigenous peoples refused to participate because they felt it treated them as scientificobjects rather than as human beings.
The respect for human dignity and the respect for the rights of each human being, "regardless of
their genetic characteristics" (Art. 2,a)9 and the imperative not "to reduce individuals to their genetic
characteristics" (Art. 2,b)10 were acknowledged through the UNESCO Universal Declaration on the uman
Genome and Human Rights11 in 1997.
For this reason, some are concerned that human genetic projects are violations against international law
agreements; for example, Article 7.1 of the ILO Convention 169 demands that: "The peoples concerned
6 The following has been worked out in the context of a seminar of the University of Lüneburg, and it was presented
as a statement during the twenty-third session of the Working Group on Indigenous Populations, Commission on
Human Rights, Sub-Commission on the Promotion and Protection of Human Rights (UNESCO), Geneva, 18.-22. July
2005 (Anna Böhme, Cristina Blohm-Seewald, Ingeburg Annelie Fincke, Robin Gläß, Jürgen Simon).
7 Which is situated at the University of Pennsylvania, Office of Regulatory Affairs.
8 http://www.havasupaitribe.com/
9 Article 2, (a): Everyone has a right to respect for their dignity and for their rights regardless of their genetic
characteristics.
10 That dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect theiruniqueness and diversity.
11 UNESCO. 1997. Universal Declaration on the Human Genome and Human Rights. Gen. Conf. Res. 29 C/Res. 16,
reprinted in Records of the General conference, UNESCO, 29th Sess. 29/C/Resolution 19, at 41. Adopted by the UN
General Assembly, G.A. res. 152, U.N.GAOR, 53rd Sess. U.N.Doc. A/RES/53/152, 1999.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Even non-indigenous people can participate in this project by purchasing a "participation kit" for aminimum of $100. Those participants are called upon to do a cheek swab and anonymously send it to
the Arizona Research Lab at the University of Arizona.

67

shall . . . participate in the formulation, implementation and evaluation of plans and programmes fornational and regional development which may affect them directly."
In this context, the criticism given by the Indigenous Peoples Council on biocolonialism is indeed
understandable, the concern is that via the intended genetic analysis within the scope of the Genographic
Project, the integrity and sacredness of the indigenous bodies and their ancestors are violated, and as aconsequence to this, the project should not be supported.
In both of the above mentioned projects, the risks for the minorities are more or less evident, and one
should avoid violating the “rules” that should be taken into account in these cases. Considering biobank
projects in general, we also recognize opportunities for antidiscrimination of minorities, and we should
use them for the benefit of these groups. We refer to the point that biobanks do collect, store, anddistribute human genetic materials and data, and they even produce statistical data which can be used
for antidiscrimination purposes, as illustrated by the following example.

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The Hungarian ethnic monitoring case
The Ethnic Statistics and Data Protection project was inaugurated in 2000 and directed by the Hungarian
Rights Information and Documentation Centre (INDOK). It was funded by the Centre for Policy Studiesof the Central European University in Budapest. Lawyers worked in the proposal group, in conjunction
with human rights activists and NGO representatives. The project was instigated to respond to Romarights lawyers working at and with the European Roma Rights Centre who routinely noted that one of
the most significant obstacles to effective anti-discrimination litigation was the absence of statistics
showing disparate treatment of Roma and other minorities in most areas of public life. This group,
together with representatives from the Open Society Institute, Budapest, the Constitutional and Legal
Policy Institute and other NGOs, later served as the Steering Committee of the project (Krizsan and
Szekely, 2001).
Generally, we have to observe the right to information and the right to privacy, and the difficulty ofreconciling these interests is nowhere more pronounced than in the field of race discrimination(Goldstone, 2001): Fundamental to the task of promoting civil rights and non-discrimination throughEurope is accurate documentation of the subordinated position of racial and ethnic minorities in many
areas of public life. Statistical information is a prerequisite for the formulation of government policy aswell as it could be in the [health] sector.
In spite of this, historical experiences regarding the abusive purposes of statistics lend to mistrust
toward the willingness or capacity of governments to maintain confidentiality, thereby contributing to
non-cooperation.
One of the most important European steps for race antidiscrimination is the adoption of the directive
implementing the principle of equal treatment between persons irrespective of racial or ethnic origin
by the Council of the European Union in June 2000.12 And in the future, it will mainly depend on how
far governmental authorities can produce trust in ethnic monitoring, statistics, and the future means ofbiobanks.

Results
What can we learn from the Hungarian ethnic monitoring case? We must carefully wage the chancesand risks for ethnic groups resulting from material and data monitoring. Biobanks could provide
statistical data and also support against antidiscrimination. However, in Germany in particular we have
had bad historical experiences in the case of observing and destroying the Roma and Sinti people. At
the end of the last century, the police, especially in Bavaria, termed the Roma “Landfahrer [vagrant]

12 Council Directive 2000/43/EC of 29 June 2000.

observing rather than Roma monitoring". Perhaps this data does not exist anymore.13 But in contrast
to the National Ethics Council of Germany and other authors who do not seem to be able to recognize
any discrimination of minorities in Germany, we would say: We do have the minorities of Roma, Sinti,
and others, and we should be very cautious. However, if different interest groups of civil society andthe tissue-and-data-donors themselves do agree, monitoring should be considered as being useful for
anti-discrimination purposes.
For the anti-discriminating purposes of ethnic monitoring, we must follow the rules of Convention
number 169 from the International Labour Organization (ILO) from 1989, concerning the rights ofindigenous peoples and minorities; we must arrange public hearings (also on the internet) for such
purposes and projects; we must insure the participation of all involved populations at all stages of the
project development; and we must especially consider the principle of prior, free, and informed consent
in order to find out the will of the potential donors. In case consent is given on behalf of a community,
the consideration of the expressed will of every potential donor has to be an ethical imperative for thoseprojects.

References

Krizsan, Andrea, Szekely, Ivan. 2001. About the Background of this Volume. In: Ethnic Monitoring andData Protection: The European Context. A. Krizsan, ed. Budapest, p. 12.

13 The annual report of the United Nations Special Rapporteur on Racism noted: "That Sinti and Roma minorities arebeing specially registered in the data-bases and records of the Bavarian police as Roma/Sinti type, gypsy type or
the old Nazi term Landfahrer [vagrant[. The Central Council of German Sinti and Roma has been informed of thereport of the Bavarian Data Protection Commissioner of 16 December 1998, which states that Sinti and Romaare being registered generally on special police files without reason or legal basis by their personal details andeven the number plates of their cars and further data. The police justify this storage as supposedly vorbeugende
Verbrechenbekämpfung [preventive crime combat] and explain that Sinti and Roma could be a public danger. […]the Federal Government [of Germany, sic] stated that […] doing away with such classifications altogether does notcome into consideration because of their indispensable nature for police work […]” (24.E/CN.4/2000/16, 10 February
2000: paragraph 37); see also, Goldstone.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Goldstone, James A. 2001. Race and Ethnic data: A Missing Resource in the Fight Against Discrimination,
in Ethnic Monitoring, pp. 19-41.

69

Human biobanks - trustees and some aspects of thecurrent discussion, especially in Germany*
Brigitte Jansen, Ph.D.
BioEthics Law,
Germany

If one observes all the factors that concern the organisation of a biobank, the aspect of acceptancetakes on an exceptional role. Every plan to successfully reorganise a biobank depends on a high level ofagreement by all participants.

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Asia-Pacific Perspectives on Biotechnology and Bioethics

A trusteeship represents an interesting possibility for the organisation and administration of genetic
data. What remains to be considered is what kind of trusteeship is appropriate. This often depends on
the situation in which the initiators of a biobank find themselves.
For example, a private sector trusteeship tries to optimize the profit aspects of research. However, thisprofit orientation should not, under any circumstances, lead to a neglect of the rules for data protection,
as this danger in the international transfer of data is already quite high. Also, the acceptance of allparties concerned is not exactly the rule in private sector organisations. This indicates that private sector
trusteeship is in a field of tension regarding common welfare.
If a public trustee is delegated to administer a biobank, one can assume, at least in the Western industrial
nations, that sufficient control measures are guaranteed and therefore common welfare is not neglected.
Therefore, it seems meaningful to strive for a co-operative form of public and private sector trusteeships
or a commission form of public and/or private organizations. A natural alternative would be a credible
private sector organization such as the First Genetic Trust.
On 2 October 2003, the German and French ethics councils emphasized in a joint statement that there
must be an overriding authority to supervise compliance with the relevant rules: “A suitable model forthis role is that of a special delegate or trustee whose functions and duties are to be determined indetail.”Therefore, the views of the ethics councils are in accordance with the internationally highly esteemed
proposal of the introduction of a type of trustee who, besides supervising organic banks, would provide
additional legitimacy. The trusteeships could also be organized in different levels of hierarchy; this would
allow private trustees to join up with commissions and, at higher levels, perhaps with the government.
Regardless of what organizational form the trusteeship takes, one of the main functions of the trustee ispublic reports. The German Research Foundation also urges setting up internet sites in such cases. This
includes regular feedback about the (commercial) utilization and the actual medical benefits resulting
from the research with donor data. If this reporting involves permanent communication, it leads toincreased transparency about the work of a biobank and therefore promotes general acceptance within
the population.
The Administration for Data Protection in Germany has provided an exceptional example of such work,and has gained great recognition on the international stage. To be sure, not all functions required of thetrusteeships of biobanks are covered, but the orientation towards the four procedural steps of biobanks,
in any case, corresponds to the direction of extant data protection. The German data protection system
has also been outstanding for its transparency, excellent public relations and development of legal
issues pertaining to bioethics law. These positive developments should help the continuity of biobanks
regarding insolvency and other problems - if the measures could be relevantly adapted.

* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Results and perspectives
Biobanks are booming worldwide. However, one should distinguish between the organizations
that collect, administer, and utilize large amounts of material and data centrally (including lifestyleand environmental data) and those who do this on a smaller level and are thus more decentralized(specialized biobanks). The latter are the norm in Germany; this is less a matter of biobanks in the senseof this work (which corresponds to the normally accepted definition), but, rather, these are entirely
normal material banks constructed according to scientific criteria. I have included these since they canalso be connected with other organizations according to the above criteria.

However, it is not implied in the above statement that one should curtail the requirements for consent
of the extraction of bodily substances. It is merely a matter of how (as the National Ethics Council
formulates it): “In consideration of the public interest, research is to take precedence above the personal
interest of the donors to decide over the fate of their body substances and data” (page 34 in the Joint
Statement). Therefore, these concerns precisely further the research of substances separated from thedonor body where the donor has no specific lasting interest in the use thereof and without his declaredconsent.
This carte blanche authority would be primarily relevant to completely anonymous samples and data,and especially for material without relevance to individuals. Consent should be obtained in any case forthe external utilization of human samples and data.
In agreement with the National Ethics Council, the utilization of human samples and data should bepossible, in exceptional cases, without consent where there is a predominantly scientific interest in the
research goal, and if the purpose of the research cannot be reached in any other manner.
That means that in these cases, to a degree, the direct connection to a concrete research project must
be abandoned. Similarly, the principle of mandatory destruction of personal data after the end of acertain time (as required by German data protection law) should be given up. However, in the case oftransmission to a third party, the samples must either be made completely anonymous or at least be
encoded.
In this context of personal consent, transmission of the stored samples and data plays a role as far as thelegal successor to the biobank is concerned. Furthermore, in this case, the permission of the donor is asine qua non unless the samples/data are made anonymous.
As mentioned above, the trust mode, with its various forms of private, private/public, and purely public(cooperative) efforts are being tested at the moment. One should especially mention patient collectives
here, who administer and utilize their samples and data themselves. But one should also mention purely
private corporations, such as the First Trust in the United States.
In Germany, the ombudsman is discussed as a model for the supervision of biobanks. This system isviewed as very successful. The model of an administrator (as in the case of the data protection officials)
who is autonomous in his powers would be a good export to the rest of Europe in order to formulatecompelling rules and concomitant measures for the protection of the donor. To be sure, the dataprotection laws already foresee the use of data protection personnel, so some framework is in place.
The use of commercial organizations “lent” to the government is just as functional as is the use of civicorganizations. In both cases, supervision is necessary to ensure that a balance is struck between private
and public interests. In this sense, the question arises as to whether, in the framework of the planned
genetic test law, more consideration should be given to research by individuals. Such regulations are

Asia-Pacific Perspectives on Biotechnology and Bioethics

Here, one is confronted with the problem of an appropriate way of dealing with the “phenomenon” ofbiobanks in order to meet the challenge of balancing their potential benefits and risks. This is especiallytrue for healing illnesses more effectively, with: (i) the accompanying risk for the patients, and; (ii) the
possible discrimination of an entire population group. This potential threat is treated not only generally(and for Germany, more specifically), but also in detail in an international comparison. Therefore, it isespecially important to broaden perspectives for the protection and the utilization of biodata in both
the Federal Republic of Germany and the European Union.

71

urgently required for the realization of the utility of organic banks as well as the control of risks. This
also applies to an intensive discussion about possible restrictions of data protection in regard to carte
blanche authorizations, as stated above. Unfortunately, such discussion has barely started in Germany.

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The cited examples clearly show that the discussion in Germany has begun only recently and so far is
not thriving as well as in places such as the USA, Iceland, Estonia, the UK, Canada, and the Scandinavian
countries. This need to catch up is extremely serious, because one needs public discussion of biobanking
ethics in order to protect the rights of citizens, advance the utility of the biobanks, and to not lose publictrust (for example, in the case of green genetic engineering).

Protection of genetic data in medical genetics: A legal
analysis in the European framework*
Sergio Romeo-Malanda, LL.B.,
Ph.D.
University of Tasmania,
Australia

Introduction

Thanks to these advances in genetics, doctors now have the tools to understand how certain illnesses,
or increased risks for developing certain illnesses, pass from generation to generation. According tosome health experts, the definition of an inherited or genetic illness should be expanded beyond theclassic inherited disorders (such as hemophilia and sickle cell anaemia) to include many types of cancer,
Alzheimer's disease, and other illnesses.
They look toward a future where genetic test results are an important part of every healthy person's
medical file. Currently, genetic testing has developed enough so that doctors can pinpoint missing or
defective genes. However, in some cases, treatments for those diseases are still far off.
The term “genetic testing” refers to analysis which serve1: a) to diagnose and classify a genetic disease;b) to identify unaffected carriers of a defective gene in order to counsel them about the risk of having
affected children; c) to detect a serious genetic disease before the clinical onset of symptoms in order toimprove the quality of life by using secondary preventive measures and/or avoid giving birth to affected
offspring; d) to identify persons at risk of contracting a disease where both a defective gene and acertain lifestyle are important as causes of the disease.
According to this, genetic testing of individuals can bring to light important personal and family
information, such as biological information on a person´s current and future health, including mental
health, even though this may be limited to giving advance warning of a propensity or predisposition tocertain disorders, or information on reproductive capacity and the future health of offspring.
The information which can be obtained from genetic testing raises problems associated with theinformation itself, access thereto, and the uses of such data, given that the interests of the person towhom these data refer (data subject) may be in conflict with those of other persons (including thebiological family), with collective health and safety interests, and even with interests of an entirely
different kind (for example, economic).
Access to such information provides knowledge of highly important aspects of the tested individualand directly affects his or her innermost sphere2. However, the information is also highly valuable for
1 Recommendation No. R (92) 3 on genetic testing and screening for health care purposes, of 10 February 1992.
2 Nevertheless, Margaret Otlowski, “Protecting genetic privacy in the research context: Where to from here?” Macquarie
Law Journal, 2002, page. 91 notes: ‘‘The availability of human genetic information is not of itself new [as noted earlier,some genetic information has long been available through family history of genetic disease] – what has changed isthe means by which genetic information is available and also the extent of information which can now potentiallybe obtained as a result of the advancements in relation to genetic testing’’.
* Paper first presented at the Second UNESCO Bangkok Bioethics Roundtable/Eighth Asian Bioethics Conference,
March 2007

Asia-Pacific Perspectives on Biotechnology and Bioethics

One of the short and medium term goals of human genome research is to gain a knowledge of thecharacteristics of human DNA and its components, particularly genes. There is particular interest in
learning how genes function and what their role is in the transmission of biological heredity. Progress inthe field of biomedical science has made it possible to obtain greater knowledge of the human genome
and the nature of genetic disorders.

73protecting his or her health or that of any offspring.
The aim of this article is to point out the main questions and dilemmas that have arisen in the field of theprocessing of genetic data in medical genetics3 and to examine the solutions that have been offered in
the European framework. In this respect, at the European level, several legal and non-legal documents
dealing with this issue must be taken into account.
Firstly, documents of international organizations such as UNESCO4 have a repercussion world-wide andshould be respected both by the European Union and by other countries. In this group, the International
Declaration on Human Genetic Data (IDHGD), of 16 October 2003, is particularly important.

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Asia-Pacific Perspectives on Biotechnology and Bioethics

Secondly, there are some documents of the Council of Europe5, namely, the European Convention
on Human Rights, of 4 November 1950; Convention for the Protection of Individuals with regard to
Automatic Processing of Personal Data, of 28 January 19816; Recommendation No. R (92) 3 on Genetic
Testing and Screening for Health Care Purposes, of 10 February 1992; Convention for the Protection of
Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine:
Convention on Human Rights and Biomedicine (CHRB), of 4 April 19977; Recommendation No. R (97) 5
on the Protection of Medical Data, of 13 February 1997.
Thirdly, also noteworthy is the legislation of European Union, such as the Charter of Fundamental Rightsof the European Union, of 7 December 2000, or the Directive 95/46/EC of the European Parliament andof the Council, on the Protection of Individuals with Regard to the Processing of Personal Data andon the Free Movement of Such Data, of 24 October 1995. The latter is especially relevant because it
generates in all the EU Member States an effective obligation to act according to the terms stipulated
in it8.
Finally, we cannot overlook the legislation of every European country. At the regulatory level the situation
across Europe appears to be uneven. Indeed, while some countries either have explicitly listed genetic
data as sensitive data in their Data Protection law with all the safeguards and restrictions associated3 That means that the possibility of misusing genetic information for non-medical purposes (i.e. insurance, employment,commercial transactions), or even its use with other social and legally admissible aims (i.e. DNA fingerprint in forensic
or criminal justice, determination in parentage, etc.) is beyond the scope of this article.
4 UNESCO (United Nations Educational, Scientific and Cultural Organization) is a specialized agency of the United
Nations established in 1945. Its stated purpose is to contribute to peace and security by promoting international
collaboration through education, science, and culture in order to further universal respect for justice, the rule of law,and the human rights and fundamental freedoms proclaimed in the UN Charter.
5 The Council of Europe is an international organization of 46 member states in the European region. Its main success
was the European Convention on Human Rights in 1950, which serves as the basis for the European Court of Human
Rights. The Council of Europe is not to be mistaken with the Council of the European Union or the European Council,
as it is a separate organization and not part of the European Union.
6 This Convention was the first international legally binding text on data confidentiality.
7 Unlike the European Convention on Human Rights which applies to all EU Member States, the Convention on Human
Rights and Biomedicine has not been signed or ratified by many States, including most of the larger States. In spiteof it not applying directly to many EU States, it is nevertheless significant in that it has been drawn upon by theEuropean Court of Human Rights in making judgments involving States who are not parties to this Convention. Seein this respect, Glass v. The United Kingdom, 9 March 2004 (paragraph 58); Evans v. The United Kingdom, 7 March
2006 (paragraph 40).
8 Directives are a legislative act of the European Union which requires member states to achieve a particular result
without dictating the means of achieving that result. It can be distinguished from European Union regulations which
are self-executing and do not require any implementing measures. Directives normally leave member states witha certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety oflegislative procedures depending on the subject matter of the directive. Of course, this legal text is only applicableto EU member States (currently 27: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom).

(Italy9, Poland10), or have passed specific legislation on protection of genetic data (Switzerland11,
France12), in most member states the issue of the processing of genetic data is not as such regulated by
specific legislation. However, as national authorities become increasingly aware of the risks associatedwith the processing of genetic data, a general trend towards new initiatives at the national regulatorylevel is anticipated (that is the case of Spain13, for instance).
Apart from these legislative sources, several guidelines and reports have been elaborated both at theinternational and national level. It is beyond the scope of this work to discuss all of these instruments.
However, special attention will be paid to, on the one hand, the “Working Document on Genetic
Data”, adopted on 17 March 2004 by the Data Protection Working Party14; and on the other hand,
the report entitled “Ethical, Legal and Social Aspects of Genetic Testing: Research, Development andClinical Applications”, elaborated by the Expert Group on Genetic Data at the request of the European
Commission, also in 2004.

As stated above, the most significative legal text related to the protection of personal data in theEuropean Framework is the Directive 95/46/EC. Its object is, as stated in Article 1.1, to “protect thefundamental rights and freedoms of natural persons, and in particular their right to privacy with respect
to the processing of personal data”.
This directive states that personal data: “Shall mean any information relating to an identified or
identifiable natural person (‘data subject’)”, (Article 2, a). In the same sense, Recommendation R (97) 5
states that “the expression ‘medical data’ covers any information relating to an identified or identifiable
individual” (Principle 1).This definition of personal data allows one to include any information regarding
a person, whatever his or her nature or origin, being intimate or not, even if it affects several people atthe same time or a family group (an aspect that can be of great importance in relation to data concerning
ealth and genetics)15.
Thus, data can be classified into one of three categories, according to the greater or smaller possibilityof identification of the person from whom the data is obtained: a) data relating to an identified person;b) data relating to an identifiable person; and c) anonymous data. However, the nomenclature may varyfrom one text to another and from one author to another, so it is more important to pay attention to theconcept than to the wording.
Data relating to an identified person (“identified data”) is data that appears clearly and is directly linked
9 Personal Data Protection Code (Codice in materia di protezione dei dati personali). Legislative Decree No. 196, of 30
June 2003. Section 90 deals with the “processing of genetic data and bone marrow donors”.
10 Act on the Protection of Personal Data, of 29 August 1997, Article 27.
11 Human Genetic Testing Act (Loi fédérale sur l’analyse génétique humaine), of 8 October 2004.
12 Public Health Code (Code de la Sante Publique), amended by Law No. 2004-800 on bioethics, of 6 August 2004,
Article L1131.
13 Biomedical Research Bill (Proyecto de Ley de Investigación Biomédica), 2006.
14 The Working Party has been established by Article 29 of Directive 95/46/EC. It is the independent EU Advisory Body
on Data Protection and Privacy. Its tasks are laid down in Article 30 of Directive 95/46/EC and in Article 14 of Directive
97/66/EC, of 15 December 1997, concerning the processing of personal data and the protection of privacy in thetelecommunications sector. The Working Party was set up to achieve several primary objectives: a) To provide expert
opinion from member state level to the Commission on questions of data protection; b) To promote the uniform
application of the general principles of the Directives in all Member States through co-operation between dataprotection supervisory authorities; c) To advise the Commission on any Community measures affecting the rights
and freedoms of natural persons, and in particular to Community institutions on matters relating to the protectionof persons with regard to the processing of personal data and privacy in the European Community.
15 Carlos M. Romeo-Casabona. 2004. “Anonymization and Pseudonymization: The Legal Framework at a European Level”,
in D. Beyleveld/D. Townend/S. Rouillé-Mirza/J. Wright (Eds.), The Data Protection Directive and Medical Research
Across Europe, Ashgate, England, pp. 36 f. The Data Protection Working Party, Working Document on Genetic Data,
p. 5, also notes that «there is no doubt that genetic information content is covered by this definition».

Asia-Pacific Perspectives on Biotechnology and Bioethics

Personal genetic data and protection of privacy. The meaning of“personal data” in the European context

75

with the person from whom it was obtained (data subject). The IDHGD refers to data linked to an
identifiable person, meaning “data that contains information, such as name, birth date and address, bywhich the person from whom the data was derived can be identified” (Article 2.ix).
Data relating to an identifiable person (known as ‘‘dissociated data’’) is data that seems not to be directly
attributable to a certain person, since he or she does not appear to be identified or there is no link
between the data and the person. However, the linking of such data to the person is possible by diverse
procedures, which can normally be easily carried out16.

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Asia-Pacific Perspectives on Biotechnology and Bioethics

Directive 95/46/EC gives a definition of identifiable data in the following terms: “An identifiable person is
one who can be identified, directly or indirectly, in particular by reference to an identification number orto one or more factors specific to his or her physical, physiological, mental, economic, cultural or social
identity”. (Article 2 a). According to this, the directive considers a person identifiable in connection withhis or her data, if the data is identifiable by means of an identification number (coded data)17. In suchcases it is possible to use the code to re-identify the person to whom the data relates so that the processof de-identification is reversible.
Finally, anonymous data can be considered as data where the identity of the data subject is not known,
and identification is not possible because the data was collected as such, or because although collectedwith identification, the data has later been anonymized18. For this second type of anonymous data, theidentifiable data of a person is subjected to a process of dissociation from the data that refers to that
person, in such a way that it no longer allows the person’s identification. Consequently, it is necessarythat such a dissociation process should be irreversible, that is to say, that the data cannot return to theform taken previously.
IDHGD speaks of data irretrievably unlinked to an identifiable person, this refers to data that cannot belinked to an identifiable person, through destruction of the link to any identifying information about
the person who provided the sample (Article 2.xi). However, Directive 95/46/EC does not mention thiscategory of data explicitly. It only sets down that “an identifiable person is one who can be identified,directly or indirectly”, without mentioning the level of difficulty of the identification. But Recital 26
specifies the reach of Article 2, a) since it points out that “to determine whether a person is identifiable,account should be taken of all the means likely reasonably to be used either by controller or by anyother person to identify the said person”19 (emphasis added).
Thus, Recital 26 has restrictive effects on what should be understood as “identifiable people’s data”,
because it adds that “account should be taken of all the means likely reasonably to be used” to identify
a person. When those means are not reasonable, the person will no longer be considered legally
identifiable and the data will move into the category of anonymous data. What “reasonable” means is
not easy to say. Recommendation R (97) 5 is a little more concrete in this respect, as it states that “anindividual shall not be regarded as ‘identifiable’ if identification requires an unreasonable amount oftime and manpower” (principle 1)20.

16	 In these cases, as Romeo-Casabona, “Anonymization and Pseudonymization”, page 38 points out, “the connection of
the data with the person to whom it belongs can also be obtained by other indirect procedures, such as, for example
when the data reveals certain personal or social characteristics that only one person or a small group of people
possesses, and those characteristics could be known by others”.
17 Article 2.x IDHGD names data unlinked to an identifiable person those data that are not linked to an identifiable
person, through the replacement of, or separation from, all identifying information about that person by use of acode.
18 Carlos M. Romeo-Casabona. 2004. “Anonymization and Pseudonymization: The Legal Framework at a European Level”,
in D. Beyleveld/D. Townend/S. Rouillé-Mirza/J. Wright (Eds.), The Data Protection Directive and Medical Research
Across Europe, Ashgate, England, page 38.
19 	 It should be noted that the recitals in the directives do not have a statutory value, but they are very useful to interpretthe rules contained in the legal text.
20 In the same sense, the German Federal Data Protection Act, of 20 December 1990, gives a definition of“despersonalization” as follows: “Modification of personal data so that the information concerning personal or material
circumstances can no longer or only with a disproportionate amount of time, expense and labour be attributed toan identified or identifiable individual.” (Section 3.6).

Thus, the principles of data protection shall not apply to data rendered anonymous in such a way thatthe data subject is no longer identifiable. This statement implies that protection will not be given topersonal data that have been subjected to an anonymization process21. However, if these anonymized
data were processed and it became possible to identify the data subject again, they would regain thestatus of personal data and the principles of data protection would be applicable to them again22.

Medical data and genetic data: genetic exceptionalism?

The expression medical data refers to all personal data concerning the health of an individual. It refers
also to data with a clear and close link with health as well as to genetic data.25 But genetic data aresubject to a specific definition. Genetic data are: “All data, of whatever type, concerning the hereditarycharacteristics of an individual or concerning the pattern of inheritance of such characteristics withina related group of individuals. The definition also includes all data on the carrying of any genetic
information [genes] in an individual or genetic line relating to any aspect of health or disease, whether
present as identifiable characteristics or not. The genetic line is the line constituted by genetic similarities
resulting from procreation and shared by two or more individuals”.26
Thus, the term “human genetic data” (or “human genetic information”) is used to describe information
about an individual’s genetic make-up. However, there is ongoing debate about the real reach of theterm “genetic information”27.
In the light of the major biotechnological developments in the field of genetics, there is a tendency toassume that acquiring human genetic information necessarily entails genetic testing. Nevertheless theterm is broad enough to also cover genetic information available through other means (for instance,family history)28. In this sense, Article 2.i) IDHGD describes human genetic data as “Information about
heritable characteristics of individuals obtained by analysis of nucleic acids or by other scientificanalysis”.
In a nutshell, medical data refers to data concerning health and information about a person’s genetic

21 Romeo-Casabona, “Anonymization and Pseudonymization”, page 34.
22 Ibid., p. 42.
23 Cf. Directive 95/46/EC, Recitals 34 an 70.
24 Romeo-Casabona, “Anonymization and Pseudonymization”, p. 37.
25 Recommendation R (97) 5, Principle 1.
26 Ibid.
27 See Pilar Nicolás Jiménez. 2006. La protección jurídica de los datos genéticos de carácter personal, CátedraInteruniversitaria de Derecho y Genoma Humano-Comares, Bilbao-Granada, pp. 66 ff.; Janneke H. Gerards/Heleen L.
Jansen. 2006. “Regulation of Genetic and Other Health Information in a Comparative Perspective”, European Journalof Health Law, No 13, pp. 347 ff.
28 Otlowski, “Protecting Genetic Privacy in the Research Context”, p. 89. The National Consultative Ethics Committee
for Health and Life Sciences (France), 2003, Opinion nº 76 regarding the obligation to disclose genetic informationof concern to the family in the event of medical necessity, p. 2 f., also points out that a test is not the only way of
diagnosing a genetic disease, putting as examples the haemoglobin electrophoresis (for sickle cell disease andthalassemia), renal ultrasound (polycystic kidney disease), coloscopy (polyposis of the colon), or cholesterol assays,
and affirms that “all of these diagnostic criteria would well generate the same legal consequences as a genetic
test”. See also, Gerards/Jansen, “Regulation of Genetic and Other Health Information in a Comparative Perspective”,
page 349. («Genetic information may be derived from family medical history, from testing (tests either directed
immediately to genetic information or tests that are directed to others health information but that may also yield
genetic information, such as blood tests or urine tests) but also from information derived from observance of anindividual’s behaviour»).

Asia-Pacific Perspectives on Biotechnology and Bioethics

Within the category of personal data, there are some data that have special protection - the so called
sensitive data23. Sensitive data have been defined as “data in connection with which the data subject
is more vulnerable when the data is known or used by a third party because of its potential forcausing discrimination and other misuse, especially when accessed, used, or illicitly disclosed”24. As aconsequence, this category of data is regarded as needing more intensive protection.

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make-up and obviously comes within the meaning of “health” or “medical” information29. As aconsequence, genetic data is considered to belong to this category30.
The concern that genetic data may be particularly prone to misuse has fuelled public perceptionthat genetic information is fundamentally different from other forms of medical data, and has led
to calls for policies to treat such information differently from all other medical information (“genetic
exceptionalism”)31.
The report, Ethical, Legal and Social Aspects of Genetic Testing: Research, Development and ClinicalApplications, affirms that “genetic information is not, as such, different from any other personal medical
data, and should therefore be treated in the same way”32.
However, the potential information obtained from genetic tests conducted on a person is different fromany other information - its source is indestructible since it is present in almost all the cells of the bodywhile alive and usually even when dead; it is permanent and unalterable, save for spontaneous genetic
mutations or ones triggered through genetic engineering or as the result of other external agents (forexample, radioactive ones).
In any case, such mutations will always be partial and limited. Lastly, genetic tests give information not
only about the subject, but also about his or her biological family.

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Likewise, according the IDHGD (Article 4.a)), human genetic data have a special status because:• They can be predictive of genetic predispositions concerning individuals;• They may have a significant impact on the family, including offspring, extending over generations, and insome instances on the whole group to which the person concerned belongs;• They may contain information the significance of which is not necessarily known at the time of thecollection of the biological samples;• They may have cultural significance for persons or groups.
Certainly, the aforementioned features may, in themselves, not be unique to genetic information,
but may also be relevant to certain types of non-genetic health information. Nevertheless, genetic
information can be considered different from other health information, as all factors mentioned above
appear in combination33.

29 Data Protection Working Party, Working Document on Genetic Data, p. 5; Otlowski, “Protecting Genetic Privacy in the
Research Context”, page 92.
30 It has been discussed if information provided by non-coded DNA (for instance, in order to obtain the DNA fingerprint
with forensic or paternity purposes) can also be considered as health data. As scientists still do not have a greatknowledge of the purpose of this non-coding DNA, the Agencia Española de Protección de Datos (“Spanish Data
Protection Authority”) has set out that this information must be processed as health data. Cf. Agencia Españolade Protección de Datos, Tratamiento de datos genéticos para la localización de personas desaparecidas o en
investigación criminal, 2000. See also, Nicolás Jiménez, La protección jurídica de los datos genéticos de carácter
personal, pp. 85 ff.
31 According to Thomas H. Murray, “Genetic Exceptionalism and ‘Future Diary’: Is Genetic Information Different from
Other Medical Information?”, in Mark A. Rothstein (Ed.), Genetic Secrets: Protecting privacy and Confidentiality in the
Genetic Era, Yale University Press, New Haven, 1997, pp. 60 f., genetic exceptionalism means «the claim that genetic
information is sufficiently different from other kinds of health-related information that is deserves special protection
or other exceptional measures». See also, Koichi Setoyama. 2005. “Privacy of Genetic Information”, Osaka University
Law Review, No 52, pp. 94 ff.; Gerards/Jansen, “Regulation of Genetic and Other Health Information in a Comparative
Perspective”, pp. 341 ff.
32 Expert Group on Genetic Data, Ethical, legal and social aspects of genetic testing: research, development and clinicalapplications, page 42. The Group believes, therefore, “that genetic exceptionalism is both scientifically unjustified andnot helpful in addressing ethical and societal issues” (page 43). In the same sense, Murray, “Genetic Exceptionalismand ‘Future Diary’”, pp. 64 ff.
33 Cf. Gerards/Jansen, “Regulation of Genetic and Other Health Information in a Comparative Perspective”, p. 352, where
they affirm that «genetic information in exceptional in that it shows a unique combination of features».

Thus, genetic data, although medical data (and for that reason, part of medical information), seem tohave specific dimensions which are not necessarily common to all medical information34. Therefore,
it has been argued that genetic information should be treated differently and given special legal
protection35. However, it cannot be flatly rejected that similar protection should also be given to otherkinds of predictive health information36.

Genetic testing and genetic counselling. The duty to provide ‘nondirective’ counselling

According to Article 12 CHRB: “Tests which are predictive of genetic diseases or which serve either to
identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predispositionor susceptibility to a disease may be performed only for health purposes or for scientific research linked
to health purposes, and subject to appropriate genetic counselling.”
This is not new. Recommendation R (92) 3 also states that:“Any genetic testing and screening procedure
should be accompanied by appropriate counselling, both before and after the procedure” (Principle 3).
Genetic counselling can be defined as “a procedure to explain the possible implications of the findingsof genetic testing or screening, its advantages and risks and where applicable to assist the individualin the long-term handling of the consequences; It takes place before and after genetic testing andscreening” (Article 2.xiv IDHGD).
The development of new diagnostic methods has resulted in major advances in our ability to detectmicroscopic and submicroscopic chromosome abnormalities as well as single gene disorders. This
often allows to provide a person with accurate information regarding the aetiology, prognosis, therisk of recurrence and the options available to deal with such finding. Genetic counselling is importantbecause this information should be communicated in simple language, with care and sensitivity, so thatthe person or the family can make decisions that are fully informed.
Thus, the main goal of genetic counselling is to help individuals or families understand or cope withgenetic disease, not to decrease the incidence of genetic disease38. In addition, the counsellor should
adopt a non-directive approach.
In this respect, Principle 3 of the Recommendation R (92) 3 states that “such counselling must be nondirective”39. The information to be given should include the pertinent medical facts, the results of tests,
as well as the consequences and choices. It should explain the purpose and the nature of the tests
34	 See Data Protection Working Party. 1997. Working Document on Genetic Data, pp. 4 f.; Guilherme Freire Falcâo de
Oliveira, “Juridical implications of genome knowledge (Part II)”, Law and the Human Genome Review, No 7, p. 88;
Loane Skene. 1998. “Patients’ Rights or Family Responsibilities? Two Approaches to genetic Testing”, Medical Law
Review, No 6, pp. 5 ff.; Otlowski, “Protecting Genetic Privacy in the Research Context”, p. 92 f.;
35 Data Protection Working Party. 1999. Working Document on Genetic Data, p. 4; George Annas, “Genetic Privacy: There
Ought to Be a Law,” Texas Review of Law and Politics, No 4, pp. 9 ff. According to Freire Falcâo de Oliveira, “Juridical
implications of genome knowledge”, page 88, «in view of these special characteristics, tighter confidentiality mustbe guaranteed».
36 Cf. Gerards/Jansen, “Regulation of Genetic and Other Health Information in a Comparative Perspective”, pp. 351 f.
37 Vid. Barbara Bowles Biesecker/Theresa M. Marteau. 1999. “The future of genetic counselling: an international
perspective”, Nature Genetics, No 22, p. 133.
38	 Expert Group on Genetic Data, Ethical, legal and social aspects of genetic testing: research, development and clinicalapplications, p. 78.
39 See also IDHGD, Article 11.

Asia-Pacific Perspectives on Biotechnology and Bioethics

It is important to distinguish genetic counselling from clinical genetics services and genetic testing or
screening37. The former is a communication and, in some cases, a psychotherapeutic process, while thelatter are diagnostic or prognostic services. Current clinical genetics services and accompanying genetic
counselling commonly involve the diagnosis (and prediction) of what are for the most part rare anduntreatable conditions in foetuses, children and adults. Genetic diagnosis has traditionally been basedon physical examination or family history but increasingly relies on molecular testing.

79and point out possible risks. It must be adapted to the circumstances in which individuals and families
receive genetic information40.

Right to privacy and the right to data protection
Privacy refers to the general interest in control of one’s private sphere broadly conceived. The conceptof “privacy” is huge and complex and has many meanings. Allen identifies four dimensions of privacy41:a) informational privacy; b) physical privacy; c) decisional privacy; and d) proprietary privacy. In
summary, informational privacy concerns access to personal information; physical privacy concerns
access to persons and personal spaces; decisional privacy concerns governmental and other third party
interferences with personal choices; and proprietary privacy relates to the appropriation and ownershipof interests in human personality.

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This work focuses on “informational privacy” interests, that is, the interest a person has in controlling
access to and the use of their personal information42. This is the aspect of privacy which is mostcommonly referred to in the discussions about genetic privacy. As I will mention later, this sphere of theright to privacy has turned towards a specific right - the right to data protection.
The right to privacy is a well established right in the European tradition. From a European perspective,
we should begin by quoting Article 8 of the European Convention on Human Rights (which has its
precedent in Article 12 of the Universal Declaration of Human Rights, of 10 December 1948)43: “1.
Everyone has the right to respect for his private and family life, his home and his correspondence. 2.
There shall be no interference by a public authority with the exercise of this right except such as is inaccordance with the law and is necessary in a democratic society in the interests of national security,
public safety or the economic well-being of the country, for the prevention of disorder or crime, for theprotection of health or morals, or for the protection of the rights and freedoms of others”.
Here we have all the essentials concerning the right to privacy: on the one hand, society must guarantee
respect for privacy as essential to the individual’s development. On the other hand, many limitations
are listed in the Convention itself, so that privacy is not an absolute but a relative right. In particular, theprotection of health is mentioned.
40	 The Expert Group on Genetic Data, Ethical, legal and social aspects of genetic testing: research, development andclinical applications, p. 79, notes that “[t]he most difficult task for the counsellor is to communicate the precise meaningof genetic risk … Different methods – verbal, numerical and graphical – have been developed to communicate riskin an understandable way to the person being counselled … [T]he provision of simple, printed information that canbe consulted by the individual after leaving the counselling session has been shown to be essential. Moreover, theexistence of genetic support groups for the particular disease or problem, to which the person can be referred will,in many cases, provide information complementary to that given during the counselling session and can provide
further support in the understanding of, or the coping with, a genetic problem”. See also, Carlos M. Romeo Casabona.
1994. “Legal Aspects of Genetic Counselling”, Law and Human Genome Review, No 1, pp. 164 ff.
41 Anita L. Allen, “Genetic Privacy: Emerging Concepts and Values”, in Mark A. Rothstein (Ed.), Genetic Secrets: Protecting
privacy and Confidentiality in the Genetic Era, Yale University Press, New Haven, 1997, pp. 41 ff. This sorting is also
accepted by Otlowski, “Protecting Genetic Privacy in the Research Context”, p. 88; Setoyama, “Privacy of Genetic
Information”, pp. 81 ff.
42 Mark A. Rothstein, “Genetic Secret: A Policy Framework”, in Mark A. Rothstein (Ed.), Genetic Secrets: Protecting privacy
and Confidentiality in the Genetic Era, Yale University Press, New Haven, 1997, p. 453; Margaret Otlowski, “Protecting
Genetic Privacy in the Research Context: Where to From Here?” Macquarie Law Journal, 2002, p. 88.
43 Article 12 of the Universal Declaration of Human Rights states that: “No one shall be subjected to arbitrary interferencewith his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has theright to the protection of the law against such interference or attacks”. In addition, other international documents
on human rights also deal with this issue. For instance, the International Covenant on Civil and Political Rights, of
16 December 1966, according to which: (1) ‘‘No one shall be subjected to arbitrary or unlawful interference with his
privacy, family, home or correspondence, nor to unlawful attacks on his honour and reputation. (2). Everyone has
the right to the protection of the law against such interference or attacks” (Article 17). And more recently, UNESCO’s
Universal Declaration on Bioethics and Human Rights, of 19 October 2005, states in its Article 9 that: “The privacy ofthe persons concerned and the confidentiality of their personal information should be respected. To the greatest
extent possible, such information should not be used or disclosed for purposes other than those for which it wascollected or consented to, consistent with international law, in particular international human rights law”.

The right to privacy in relation to health was established in Article 10 CHRB, in the following terms:“Everyone has the right to respect for private life in relation to information about his or her health.”
In similar terms, Recommendation R (97) 5 states that: “The respect of rights and fundamental freedoms,
and in particular of the right to privacy, shall be guaranteed during the collection and processing of
medical data” (Principle 3.1).
More recently, the right to data protection, considered as a right linked but different to the right privacy
has been recognized at the European level. While the Convention for the Protection of Individuals withregard to Automatic Processing of Personal Data, refers to the “right to privacy, with regard to automatic
processing of personal data relating to him”, the Charter of Fundamental Rights of the European Union
recognizes the “protection of personal data” as a right in itself (Article 8)44. And Directive 95/46/EC
develops this right extensively.
Several principles of data protection come from this right45. Among them, in relation to genetic data, thefollowing will be considered: a) the principle of self-determination, that is, freedom and autonomy of theindividual, which also implies initial freedom of choice and consent before undergoing genetic testingand even before providing biological samples for the test46; b) the right of access to information.

Each person is entitled to decide to whom, when, and to what extent personal information relating tohim or her can be processed. Thus, the processing on the information obtained by means of genetic
testing should be prohibited unless consent is given by the data subject.
According to Article 8.2.a) of Directive 95/46/EC, the data subject must give his or her explicit consent to
the processing of personal data concerning health47. Considering the extremely singular characteristics
of genetic data and their link to information that may reveal the health condition or the ethnic origin of
the subject, they can be considered as falling within the scope of Article 8 Directive 95/46/EC48.
Equally, Principle 5 of Recommendation R (92) 3 states that “the provision of genetic services should
be based on respect for the principle of self-determination of the persons concerned. For this reason,
any genetic testing, even when offered systematically, should be subject to their express, free andinformed consent”. And Article 8 IDHGD states that “prior, free, informed and express consent, without
inducement by financial or other personal gain, should be obtained for the collection of human
genetic data, human proteomic data or biological samples, whether through invasive or non-invasive
procedures, and for their subsequent processing, use and storage, whether carried out by public or
private institutions”49. When a person is incapable of giving informed consent, authorization should
be obtained from the legal representative50. The legal representative should have regard to the bestinterest of the person concerned51. In any case, an adult not able to consent should as far as possible
44 Charter of Fundamental Rights of the European Union, Article 8: “1. Everyone has the right to the protection of
personal data concerning him or her. 2. Such data must be processed fairly for specified purposes and on the basisof the consent of the person concerned or some other legitimate basis laid down by law. Everyone has the right ofaccess to data which has been collected concerning him or her, and the right to have it rectified. 3. Compliance withthese rules shall be subject to control by an independent authority”. The more general “right to respect for his or her
private and family life, home and communications” is recognized in Article 7.
45 See Nicolás Jiménez, La protección jurídica de los datos genéticos de carácter personal, pp. 176 ff.
46 See Recommendation No. R (92) 3, Principle 8; IDHGD, Article 8; Recommendation Rec (2006) 4 on research on
biological materials of human origin, of 15 March 2006;
47 However, domestic legislation of the Member States can foresee some exceptions to this principle. For instance,
when the processing is necessary to protect the vital interests of the data subject or of another person where thedata subject is physically or legally incapable of giving his consent. See Directive 95/46/EC, Article 8.2 and 3.
48 See Data Protection Working Party, Working Document on Genetic Data, pp. 5 and 7.
49	 See also Recommendation (97) 5, Principle 6.1.
50 “Legal representative” refers to a person provided for by law to represent the interests of, and/or take decisions onbehalf of, a person who does not have the capacity to consent. That is the case of a parent o guardian, for instance.
51	 See IDHGD, Article 8.b); and Recommendation (97) 5, Principle 5.5; Charter of Fundamental Rights of the European
Union, Article 8.2.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Right to self-determination and consent

81take part in the authorization procedure52.
In regard to Recommendation R (92) 3, its Principle 5 states that the testing of minors, persons sufferingfrom mental disorders and adults placed under limited guardianship should be subject to special
safeguards. In particular, testing of these persons for diagnostic purposes should be permitted only
when this is necessary for their own health53 or if the information is imperatively needed to diagnose theexistence of a genetic disease in family members54. That means that genetic testing on newborns andchildren should be confined to treatable disorders, for which early treatment has a substantial positive
impact on the health status and where delay would reduce benefits55.

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Asia-Pacific Perspectives on Biotechnology and Bioethics

When human genetic data are collected for medical purposes, consent may be withdrawn by the person
concerned unless such data are irretrievably unlinked to an identifiable person (Article 9. a) IDHGD).
When a person withdraws consent, the person’s genetic data should no longer be used (Article 9. b)
IDHGD).
There is some debate as to whether the anonymization process of itself requires the affected person’s
prior consent or whether it is necessary at least to inform him or her of this process. According to Directive
95/46/EC, processing of personal data “shall mean any operation or set of operations which is performed
upon personal data, whether or not by automatic means, such as collection, recording, organization,
storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, disseminationor otherwise making available, alignment or combination, blocking, erasure or destruction” (Article 2.
b) (emphasis added).
There is no doubt that this paragraph includes the process of anonymization, since personal data issubjected to an alteration or mutilation in order to avoid the identification of the person from whom
this data originates. The process of anonymization itself is therefore still an act of data processing56. Thismeans that, until anonymization is carried out in fact, the data will still be considered as personal dataso the principles of data protection will be applicable.
Right of access to information
Articles 10 and 11 Directive 95/46/EC state that the data subject has a right to receive information fromthe controller57 (or his representative), both when the data is collected directly from the said data subject
and when the data has not been obtained from the said data subject.

52	 Cf. Explanatory Report on CHRB, paragraphs 45 and 46 (“the participation of adults not able to consent in decisions
must not be totally ruled out. This idea is reflected in the obligation to involve the adult in the authorisation
procedure whenever possible. Thus, it will be necessary to explain to them the significance and circumstances of
the intervention and then obtain their opinion”).
53 One good example of this is the genetic testing of newborn babies (neonatal screening) for treatable diseases suchas phenylketonuria and hypothyroidism (available in all UE countries). As I said above, the testing of children must be
strictly limited to those cases in which a diagnosis is important for disease management or therapy. See Expert Groupon Genetic Data, Ethical, legal and social aspects of genetic testing: research, development and clinical applications,p. 75 (“susceptibility screening is not justified as the benefit is remote and often uncertain. Carrier screening can also
wait ultil the child can make his or her own decision”).
54	 See also, IDHGD, Article 8. c) and d).
55	 H.D.C. Roscam Abbing, “Genetic Information and third party interests. How to find the right balance?”, Law and the
Human Genome Review, No 2 (1995), p. 37.
56 Romeo-Casabona, “Anonymization and Pseudonymization”, p. 43. See also the document entitled European Standards
on Confidentiality and Privacy in Healthcare (2006), whose paragraph 3.3.5 sets out that “the Data Protection
Directive requires data subjects to be informed of the purposes of all processing of personal data and rendering data
anonymous is itself a process performed on personal data”. These European Standards on Confidentiality and Privacy
in Healthcare were developed through the work of the EuroSOCAP Project (funded by European Commission).
Document available in: www.eurosocap.org.
57	 According to Article 2 (d) of Directive 95/46/EC, “controller” shall mean the natural or legal person, public authority,
agency or any other body which alone or jointly with others determines the purposes and means of the processingof personal data.

This right is exercised through the so-called right of access58, that is, the right to obtain from the controller
without constraint at reasonable intervals and without excessive delay or expense: a) confirmation as towhether or not data relating to the person is being processed; and b) communication in an intelligible
form of the data undergoing processing and of any available information as to their source59. Given thesensitivity of genetic data, the right to information is particularly relevant in the context of processing
such data60.

The right to know and the right not to know
Article 10.2 CHRB, provides that “everyone is entitled to know any information collected about his or her
health…” However, the last paragraph of Article 10 sets out that in exceptional cases, domestic law may
place restrictions on the right to know or not to know in the interests of the patient's health61.

In respect of the right to know, special mention should be made of unexpected findings. It is notuncommon in medicine, during operations or tests, for personal data of varying importance to bediscovered in addition to the information actively sought.
For example, a person may be tested for one disease and found to be suffering from another; or a
genetic test carried out for medical purposes may reveal that the genetic relationship is not the sameas the legal one.
In conformity with the right to know, subjects should be informed of “unexpected findings” when they
are of medical relevance63. However, except in some clear situations, the physician will face important
doubts in taking a decision and whether to inform the patient about any unexpected findings. In thisdecision not only objective factors must be taken into account, such as the possibility of therapy, but also
subjective ones, such as the personality of the patient, the consequences of receiving this information,and other familiar circumstances.
Recommendation R (92) 3 points out that: “In conformity with national legislation, unexpected findings
may be communicated to the person tested only if they are of direct clinical importance to the personor the family. Communication of unexpected findings to family members of the person tested should
only be authorised by national law if the person tested refuses expressly to inform them even though
their lives are in danger.” (Principle 11).
This position has been developed by Principle 8.4 of Recommendation R (97) 5. According to this Principle,
the person subjected to genetic analysis must be informed of unexpected findings if the domestic law
does not prohibit the giving of such information; or the person himself has asked for this information; orthe information is not likely to cause serious harm to his/her health; or to his/her consanguine or uterine
kin, to a member of his/her social family, or to a person who has a direct link with his/her genetic line,
unless domestic law provides other appropriate safeguards. The person should also be informed if thisinformation is of direct importance to him/her for treatment or prevention.

58	 Carlos de Sola, “Privacy and Genetic Data. Cases of Conflict (I)”, Law and the Human Genome Review, No 1 (1994), p.
177.
59	 Cf. Directive 95/46/EC, Article 12. See also Recommendation R (97) 5, Principle 8.1; IDHGD, Article 13; Charter ofFundamental Rights of the European Union, Article 8.2.
60	 Data Protection Working Party, Working Document on Genetic Data, page 6.
61 Article 10.3 CHRB: “In exceptional cases, restrictions may be placed by law on the exercise of the rights contained inparagraph 2 in the interests of the patient”.
62 Roscam Abbing, “Genetic Information and third party interests”, page 39. In general, such a therapeutic exception is
only justifiable in very exceptional circumstances.
63 Cf. de Sola, “Privacy and Genetic Data”, p. 178.

Asia-Pacific Perspectives on Biotechnology and Bioethics

There might be a situation where the harm to the data subject which is expected to be caused by
the information is such that it clearly justifies withholding the information or part of it (for example
a prognosis of death which might, in certain cases if immediately passed on to the patient, seriously
worsen his or her condition). This is the so-called “therapeutic exception”62.

83Thus, Recommendation R (97) 5 restricts the circumstances in which unexpected findings should not be
communicated. In conclusion, the doubtful cases that remain at the moment of deciding on whether
to report or not of an unexpected finding are very limited. The cases are those in which this information
does not have health repercussions because the mutation found does not have a great significance orthere is no therapy or prevention known, or it is not going to be transmitted to the offspring.
In these cases, it is not necessary to inform. That means that this duty to inform would not extend todata which were not directly medical, such as the discovery of the lack of a genetic link between father
and son. But it must not be forgotten that these data can also be medically relevant and may be of
considerable importance to the subject when taking important decisions of other kinds (for instance,
when a donor for a transplant is required)64.

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In fact, the information provided at the time of the consent should indicate the possibility of revealing
unexpected findings and the right of the person concerned to decide if he or she wants to be informed
about them or not. In this respect, Recommendation R (97) 5 also states that “before a genetic analysis iscarried out, the data subject should be informed about the objectives and the possibility of unexpected
findings” (Principle 5.4).
In addition to the right to information, or the right to know, which also covers individual genetic
information, reference tends to also be made to the reverse, i.e., the right “not to know”. According to
Article 10 IDHGD, “the person concerned has the right to decide whether or not to be informed of theresults”. In the same sense, Article 10.2 CHRB states that “the wishes of individuals not to be so informed
shall be observed”. Patients may have their own reasons for not wishing to know about certain aspectsof their health. A wish of this kind must be observed.
The right not to know includes the right not to undergo genetic testing, so that the subject can avoid
knowing whether he or she is carrying a genetic condition or whether he or she might do so in the
future. This right is important because not every hereditary disease can be treated or even prevented
at present. In many cases, the only certain prediction is that diseases will develop and that nothingwhatever can be done to prevent or delay them. If there is no medical technique to cure a specificgenetic disease, such as Huntington’s disease, some people may not want to know their future fate andshort life span65.
For this reason, a genetic test should be performed or offered only where the expected benefits forthe individual outweight the potential risks66. That is to say, some kind of action must be available(treatment, prevention, reproductive choices). In effect, to make a person conscious of a genetic disease
can help him or her to take important measures in the field of reproduction. That is specially significant
in some populations highly affected by any concrete illness. In effect, some populations are known tohave a higher frequency of a gene that is known to be associated with a disease. Genetic testing of
couples in such populations would permit them to take their carrier status into account before planning

64 Vid. Nicolás Jiménez, La protección jurídica de los datos genéticos de carácter personal, pp. 289 f.
65	 A study developed in the US concludes that the suicide rate for Huntington’s disease sufferers is much greater than
the national average. See Jane S. Paulsen/Karin Ferneyhough Hoth/Carissa Nehl/Laura Stierman, “Critical Periodsof Suicide Risk in Huntington’s Disease”, American Journal of Psychiatry, No 162 (2005), pp 725–731 (http://www.
huntington-assoc.com/Critical%20ab05.pdf ).
66 Expert Group on Genetic Data, Ethical, legal and social aspects of genetic testing: research, development and clinicalapplications, page 75.

a family67.
However, in some circumstances, the right to know or not to know can be restricted in the patient's own
interest or else on the basis of Articles 10.3 (“In exceptional cases, restrictions may be placed by law on
the exercise of the rights contained in paragraph 2 in the interests of the patient”) and 26.1 CHRB68.

67 One example of population-based testing is the screening for the carrier status of ‘thalasemia’ in certain Mediterranean
communities, where genes for this disease appear to be more frequent. While this testing is not technicallymandatory, individuals are not permitted to marry without a pre-marriage certificate. And a pre-marriage certificate
is not issued without the requisite of genetic testing. See Minas G. Hadjiminas, “The cyprus experience-screening tocombat a serious genetic disease”, Ethics and Human Genetics, Council of Europe Press, Strasbourg, 1994, pp. 26-48;
Ann Cavoukian, “Confidentiality issues in genetics: the need for privacy and the right ‘not to know’”, Law and the
Human Genome Review, No 2 (1995), pp. 62 ff.; Luis Zarraluqui Sánchez-Eznarriaga, “Genetic testing and matrimony”,
in The Human Genome Project: Legal Aspects, Vol. I, Fundación BBV, Bilbao, 1995, pp. 391 ff.; Barbara Prainsack, “TheRise of Genetic Couplehood? A Comparative View of Premarital Genetic Testing”, BioSocieties, No 1 (2006), pp. 17 ff. In
this respect, according to Recommendation No. R (92) 3 on genetic testing and screening for health care purposes,“(…) marriage requirements (…) should not be made dependent on the undergoing of genetic tests or screening”(principle 6.a)).
68 Article 26.1 CHRB: “No restrictions shall be placed on the exercise of the rights and protective provisions contained inthis Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of
public safety, for the prevention of crime, for the protection of public health or for the protection of the rights andfreedoms of others”. Therefore to be compatible with the CHRB, any interference with the right to privacy must meetcertain conditions. It must be “in accordance with the law”, which means that any interference must have some basis
in national law, and the law must be precise enough so that people can reasonably understand its requirements andconsequences. It must be “necessary in a democratic society”, which means that the interference must also bothcorrespond to a “pressing social need” and be “proportionate to the legitimate aim pursued”. See further, Sergio Romeo
Malanda, “Relación del presente Convenio con otras disposiciones (Capitulo IX)”, en Carlos María Romeo Casabona(ed.), El Convenio de Derechos Humanos y Biomedicina: su entrada en vigor en el ordenamiento jurídico español,
Cátedra de Derecho y Genoma Humano-Comares, Bilbao-Granada, 2002, pp. 387 ff. According to the Explanatory
Report on CHRB, “The reasons mentioned in Article 26.1 should not be regarded as justifying an absolute exception
to the rights secured by the Convention. To be admissible, restrictions must be prescribed by law and be necessary
in a democratic society for the protection of the collective interest in question or for the protection of individualinterests, that is the rights and freedom of others. These conditions must be interpreted in the light of the criteria
established with regard to the same concepts by the case-law of the European Court of Human Rights. In particular,
the restrictions must meet the criteria of necessity, proportionality and subsidiarity, taking into account the socialand cultural conditions proper to each State. The term "prescribed by law" should be interpreted in accordance withthe meaning usually given to it by the European Court of Human Rights, that is a formal law is not required and eachState may adopt the form of domestic law it considers most appropriate” (paragraph 159).
69 See also Expert Group on Genetic Data, Ethical, legal and social aspects of genetic testing: research, development andclinical applications, page 81. For example, if a deceased grandparent is known to have suffered from Huntington’schorea and his grandchild asks to be tested for carrier status (with a view to making decisions about his reproductive
choices, for example), the information that he is a carrier will also be information about the parent who did not wantto know.

Asia-Pacific Perspectives on Biotechnology and Bioethics

The Explanatory Report CHRB points out that it may be of vital importance for patients to know certain
facts about their health, even though they have expressed the wish not to know about them. For
example, the knowledge that they have a predisposition to a disease might be the only way to enable
them to take potentially effective (preventive) measures. In this case, a doctor's duty to provide care,as laid down in Article 4 [CHRB], might conflict with the patient's right not to know. It could also beappropriate to inform an individual that he or she has a particular condition when there is a risk not only
to that person but also to others. At the same time, certain facts concerning the health of a person who
has expressed a wish not to be told about them may be of special interest to a third party69. In such acase, the possibility for prevention of the risk to the third party might, on the basis of Article 26, warrant
his or her right taking precedence over the patient's right to privacy, as laid down in paragraph 1, andas a result the right not to know, as laid down in paragraph 2. In any case, the right not to know of theperson concerned may be opposed to the interest to be informed of another person70.

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Right to privacy and (the corresponding) duty of confidentiality
Privacy and confidentiality
First of all, it is important to distinguish the terms “privacy” and “confidentiality”. Although they areconnected in some sense, they are not synonyms71. Privacy is a much broader concept, involving the rightto be free from intrusions, or simply to be left alone. It involves the right to control one’s own personal
information (this perspective is also known as “informational self-determination”)72. Confidentiality,
however, is only one means of protecting information, usually in the form of keeping that information
protected from disclosure73. Actually, we can say that confidentiality is still the standard safeguard toprotect privacy and medical information74.

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Each person is entitled to decide to whom, when, and to what extent personal information relating tohim or her can be disclosed. Thus, the passing on of information obtained by means of genetic testingshould be prohibited unless consent is given by the data subject or legal representative in the case ofminors or legally incapacitated persons75.
In some cases, it may be necessary to share some information of a patient with other professionals
involved (directly or indirectly) in his or her care. In this respect, Recommendation R (97) 5 states that“medical data may only be communicated to a person who is subject to the rules of confidentiality
incumbent upon a health-care professional, or to comparable rules of confidentiality…” (Principle
7.2). It refers to the so-called “shared confidentiality”76, which means that the processing of medical
data may only be performed by health-care professionals77, who are bound by the profession’s rule ofconfidentiality78.
According to this, genetic data must also be protected from other persons even in the case of a biologicalrelative who seeks information concerning the possible presence in him or her of a pathological genesimilar to that discovered in the data subject79. It is necessary to maintain confidentiality in these cases.
Since the person disclosing the information will be the doctor, the answer is complicated by the very
high value that our societies have placed on medical secrecy since time immemorial.
Doctor-patient relations are based on trust, guaranteed by the doctor's duty not to disclose informationof any kind about his or her patients. The latter would not confide in their doctor if they were afraid that71	 See, for instance, Ann Cavoukian, “Confidentiality issues in genetics: the need for privacy and the right ‘not to know’”,
Law and the Human Genome Review, No 2 (1995), page 53.
72	 Felix Thiele, “Genetic tests in the insurance system: criteria for a moral evaluation”, Poiesis Prax (2003), pp. 193 f. («Theright to informational self-determination (…) should enable an individual to make decisions concerning personal
data without being exposed to the coercion of a third party»). See also Nicolás Jiménez, La protección jurídica de losdatos genéticos de carácter personal, pp. 163 ff.
73 Margaret Otlowski, “Protecting Genetic Privacy: An Overview”, in Regulating the New Frontiers: Legal issues in
Biotechnology, Centre for Law and Genetics, Hobart-Melbourne, 2001, pp. 66 and 72, defines confidentiality as “aspecific obligation arising in certain relationships whereby the recipient of personal information about another isunder an obligation not to use that information for any purpose other than that for which the information wasgiven”
74 José Elizalde, “Confidentiality, Privacy and Genetic Data”, in The Human Genome Project: Legal Aspects, Vol. I,
Fundación BBV, Bilbao, 1995, page 307.
75 Carlos M. Romeo Casabona, “Genetic Information: Collection, Access and Use”, in Baltimore (Ed.), Frontiers of Life, Vol.
IV: The Living World, Academic Press, San Diego, 2001, page 781.
76 Ibid., page 780.
77 Directive 95/46/EC authorizes the processing of the data if it is required for the purposes of preventive medicine,
medical diagnosis, the provision of care or treatment or the management of health-care services, and where thosedata are processed by a health professional (Article 8.3).
78 See Santiago Ripol Carulla, “The protection of medical and genetic data in the Council of Europe’s normative texts(Part I)’”, Law and the Human Genome Review, No 5 (1996), p. 116.
79 Romeo Casabona, “Genetic Information”, p. 781; Roscam Abbing, “Genetic Information and third party interests”, p.40.

he or she might then reveal their secrets80. So disclosure of confidential information not only breaches
individual rights but undermines the very foundations of medical practice and therefore endangers ageneral interest81.
In this respect, The European Court of Human Rights has held that “the protection of personal data,
not least medical data, is of fundamental importance to a person's enjoyment of his or her right torespect for private and family life as guaranteed by Article 8 of the Convention (art. 8). Respecting theconfidentiality of health data is a vital principle in the legal systems of all the Contracting Parties to theConvention.

According to Article 14. b) IDHGD, human genetic data should not be disclosed or made accessible
to third parties, in particular, employers, insurance companies, educational institutions and the family,
except for an important public interest reason in cases restrictively provided for by domestic law or
where the prior, free, informed and express consent of the person concerned has been obtained83.
“Public interest” should be here understood in the sense of Article 26.1 CHRB, that is to say, for reasonsof public safety, for the prevention of crime, for the protection of public health or for the protection of
the rights and freedoms of others.
In practice, it is likely that the subject will consent to the disclosure of the information to members of thefamily or may even provide the information himself or herself84. However, it is important in the genetic
counselling process to stress to the subject the importance for others to partially relieve the doctor of
his or her professional duty of secrecy for the subject to give the information.
Conflicts of duties and interests. Privacy and intra-family communication of genetic information
Genetic medicine can give rise to a variety of conflicts of interests. On the one hand, the data subject
will have an interest in their protection. On the other hand, certain legal entities or individuals may show
an interest of apparently equal legitimacy, although in conflict with the first, in gaining knowledge

80 de Sola, “Privacy and Genetic Data”, p. 182; Freire Falcâo de Oliveira, “Juridical implications of genome knowledge”, p.
90; Ismini Kriari-Catranis, “Genetic data and confidentiality, the Estonian experiment”, Revista de Derecho y Genoma
Humano/Law and the Human Genome Review, No 19 (2003), p. 148.
81 In addition, Madison Powers, “Justice and Genetics: Privacy Protection and the Moral Basis of Public Policy”, in MarkA. Rothstein (Ed.), Genetic Secrets: Protecting privacy and Confidentiality in the Genetic Era, Yale University Press,
New Haven, 1997, p. 358, notes that when genetic information obtained from one patient or subject is revealed toother family members without his/her consent, «the ability of persons to shape their most intimate relationship iscompromised, and the trust and patterns of usual communication within families can be compromised».
82 Z. v. Finland, 25 February 1997 (paragraph 95). Cf. also, M.S. v. Sweden, 27 August 1997 (paragraph 41).
83 See also Principle 9 of Recommendation R (92) 3: “Persons handling genetic information should be bound byprofessional rules of conduct and rules laid down by national legislation aimed at preventing the misuse of suchinformation and, in particular, by the duty to observe strict confidentiality. Personal information obtained by genetic
testing is protected on the same basis as other medical data by the rules of medical data protection”.
84 Cf. National Consultative Ethics Committee for Health and Life Sciences (France), Opinion nº 76 regarding theobligation to disclose genetic information of concern to the family in the event of medical necessity (2003), page 5;
Moniz, “Privacy and intra-family communication of genetic information”, page 108.

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It is crucial not only to respect the sense of privacy of a patient but also to preserve his or her confidence
in the medical profession and in the health services in general. Without such protection, those in needof medical assistance may be deterred from revealing such information of a personal and intimate
nature as may be necessary in order to receive appropriate treatment and, even, from seeking suchassistance, thereby endangering their own health and, in the case of transmissible diseases, that of thecommunity”82.

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or making use of the very data which the subject would like to safeguard85. In the field of medical
genetics, the most obvious situation of conflict is probably that between a subject and his, or her blood
relatives.
Genetic features are transmissible from one generation to another. If a person carries a gene responsible
for a certain disease it is virtually certain that the gene will also be found in other members of that
person's close family. From the medical standpoint, the patient is the entire family rather than just one
single person86. Whenever a gene is discovered in a given individual, therefore, the question arises as
to whether this information should be communicated to the individual's relatives for the purposes ofdiagnosis, prevention or therapy, etc. However, from a legal point of view, the data subject is only theindividual person whose DNA is being analysed87.

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In the huge majority of cases, information can be passed on without much difficulty. As noted above, thesubject himself or herself will agree to inform close family members. In some circumstances, however,problems will arise if the subject refuses to do so88. Although infrequent, such cases do occasionallyarise, sometimes because the subject does not get on with his or her family or, more often, because thesubject would prefer that his or her relatives do not find out that he or she is a carrier of the gene89.
If an individual refuses to inform relatives of any relevant genetic data, we can wonder whether adoctor has a duty to inform the interested parties. This is a frequent dilemma in medicine and there
is no universal answer to it. In fact, there are two different approaches relating to the passing on of
information to relatives90: the legal model and the medical model. The legal model is based on thepatients’ right to privacy, based on the idea that each person has the right to control their own bodyand genetic information; while the medical model rejects the language of individual rights and instead
stresses the need to treat patients who have risks of a genetic nature.
The so-called legal model has prevailed in Europe so far, based on the preservation of human rights,
particularly the right to privacy, in defence of the principle of patient autonomy and self-determination.
As mentioned above, in the countries that have adopted the “legal model” (most of them), doctors may
only disclose such information with the express consent of the patient, even if a family member is at

85 These conflicts may be classified in the following categories, according to the person or institution seeking access tothe data: a) Biological relatives might unknowingly be healthy carriers of the same genetic anomaly as the subject
and consequently have a direct interest in the information; b) Legal entities or individuals have entered or plan
to enter into a contractual relationship with the subject, especially an employment, service-related or insurance
contract; c) The use of genetic data may be required by society as a whole (collective interest), for example as a vitalclue in identifying the perpetrator of a crime; d) The advancement of medical research may be dependent on thegreatest possible knowledge of data relating to subjects belonging to families within certain hereditary diseases
occur. See Carlos de Sola, “Privacy and Genetic Data. Cases of Conflict (I)”, Law and the Human Genome Review, No
1 (1994), p. 175.
86 De Sola, “Privacy and Genetic Data. Cases of Conflict”, pp. 179 f.; Freire Falcâo de Oliveira, “Juridical implications ofgenome knowledge”, p. 88; Helena Moniz, “Privacy and intra-family communication of genetic information”, Revista
de Derecho y Genoma Humano/Law and the Human Law Review, No. 21 (2004), p. 109.
87 See Freire Falcâo de Oliveira, “Juridical implications of genome knowledge”, p. 89 («[genetic] information refers only
to the subject and hence the right to privacy can be assured»).
88 Actually, given the nature of genetic information, it has been argued as to whether there is an obligation (legal duty
imposed by civil law or even criminal law) to notify genetic information to members of the family. See in this respect,
Freire Falcâo de Oliveira, “Juridical implications of genome knowledge”, pp. 89 f., according to whom, a «recognitionof a legal duty to notify family members would (…) be a curtailment of the individual’s right to privacy»; Harold
Edgar, “Is there a legal duty to disclose genetic characteristics to a future spouse?”, in The Human Genome Project:
Legal Aspects, Vol. I, Fundación BBV, Bilbao, 1995, pp. 360 ff.; National Consultative Ethics Committee for Health andLife Sciences (France), Opinion nº 76 regarding the obligation to disclose genetic information of concern to thefamily in the event of medical necessity (2003).
89 De Sola, “Privacy and Genetic Data”, p. 180.
90 Skene, “Patients’ Rights or Family Responsibilities”, pp. 1 ff.

risk91. This does not mean that doctors do not have the possibility of disclosing this information in very
closely defined circumstances. In fact, they are allowed to. This is not because a duty to forewarn exists,
but because there is a justification for the breach of confidentiality92.
The CHRB offers no precise solution to this dilemma. It only provides the general guidance set out in
Article 10.1 in conjunction with Article 26. The former lays down the right to privacy (“Everyone has theright to respect for private life in relation to information about his or her health”), whereas Article 26.1
states that there may be exceptions to this right when necessary to protect the rights of others.
The question of when these exceptions are justified and when they are not remains unanswered. Since
there is no general answer, all that can be said is that the solution will depend on the circumstances
surrounding each case93. The only possible criterion is an assessment of the respective consequences ofeach solution, bearing in mind in particular the seriousness of the disease in question94,95.

In other words, before deciding whether or not to pass on the subject's personal information to therest of the family against his or her wishes, doctors must not only weigh up the private interests atstake (the subject's right to privacy versus the family members' right to health) but must also take into
consideration the loss of confidence in the medical profession that their action could cause.
Thus, having established that a person has rights over his or her own genetic information, and that said

91 On the contrary, when we refer to the medical model, the general principle is not respect for the right to privacy, but
respect for each person’s health. Consequently, genetic information must be shared between family members andunder no circumstances can this be prevented by the patient. According to this model, a person does not have theright to control his o her own genetic information, and doctors have a duty to disclose it.
92 Moniz, “Privacy and intra-family communication of genetic information”, p. 111. Cf. European Standards on
Confidentiality and Privacy in Healthcare (2006), paragraph 3.4.2. The National Consultative Ethics Committee for
Health and Life Sciences (France), Opinion nº 76 regarding the obligation to disclose genetic information of concern
to the family in the event of medical necessity (2003), maintains a much more strict position with regard to theduty of confidentiality. It says that “the doctor will never take the initiative of warning family members unless theproband [the data subject] request him to do so” (page. 8), although he or she must do everything in his power toconvince a patient that his or her family should be informed “but he must not step in personally and breach medical
confidentiality” (page 6). Cf. also, Virgine Commin/Emmanuelle Rial-Sebbag, “UNESCO and Council of Europe’s
contribution to the question of the confidentiality of the genetic information of an individual towards his family, inthe case of genetic tests”, in Marcelo Palacios (Ed.), IV World Conference on Bioethics: summary of Lectures and oralpresentations, Sociedad Internacional de Bioética, Gijón, 2005, p. 474.
93 Data Protection Working Party, Working Document on Genetic Data, p. 9 (“Given the complexity of the issues
described above, the Working Party takes the view at this stage that consideration should be given to a case by caseapproach in deciding how to address possible conflicts between the interests of the data subjects and those of their
biological family”).
94 De Sola, “Privacy and Genetic Data”, p. 182
95 A case was addressed in this respect in Italy, in 1999, through a decision issued by the Garante per la Protezione dei
Dati Personali (Personal Data Protection Authority), which granted a lady the possibility to access her father’s genetic
data although the latter had denied his consent. This request was granted by considering that the father’s rightto privacy was to be overridden by the lady’s right to health – the latter meaning her “psychological and physicalwell-being”. The lady had requested disclosure of the data to carry out a genetic test and subsequently take a fully
informed reproductive decision – upon assessing the risk of transmitting a genetic disease that affected her father.
See Data Protection Working Party, Working Document on Genetic Data, p. 9.
96 Expert Group on Genetic Data, Ethical, legal and social aspects of genetic testing: research, development and clinicalapplications, p. 80. See also, Recommendation No. R (92) 3, Principle 9 (“In the case of a severe genetic risk forother family members, consideration should be given, in accordance with national legislation and professional rulesof conduct, to informing family members about matters relevant to their health or that of their future children”);
Recommendation No. R (97) 5 on the Protection of Medical Data, principle 7.3. However, the right to privacy will not
be necessarily at stake because it is not always necessary to reveal the identity of the data subject when there arecontacts with relatives. See in this respect, Roscam Abbing, “Genetic Information and third party interests”, p. 39

Asia-Pacific Perspectives on Biotechnology and Bioethics

Thus, “exceptional circumstances, whereby disclosure could prevent serious harm to the health of therelative, and provided there are no other less-intrusive alternatives with respect to the privacy of thepatient, may justify a breach of confidentiality in the doctor-patient relationship, and disclosure of theinformation by the health professional against the wishes of a patient”96.

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rights must prevail over the interests of others, it is nevertheless possible to consider the rights of others
when their health or lives are seriously affected. Specific regulation is not required for this. Rather, it canbe achieved on the grounds of the conflict (or collision) of duties97 or, as the case may be, the state ofnecessity98, institutions which exist in the majority of legislation99.
In an attempt to establish a balance between the interest in preserving privacy, on the one hand, andthe need to disclose confidential information, on the other (and assuming that the tests performed arereliable, the severity of the illness diagnosed and the availability of preventive treatment or cure), thedoctor may violate confidentiality by communicating that genetic information to family members100.

Conclusion

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In medical genetics, the information that derives from genetic testing presents several dilemmas related
to the information itself, access thereto, and the uses of such data, given that the interests of the data
subject may be in conflict with those of the biological family. The term “human genetic information”
must be understood broadly, so that it should encompass data also available through means other thana genetic testing, namely medical history or information derived from observance of an individual’s
behaviour.
Genetic data seem to have specific dimensions which are not necessarily common to all medical
information. Therefore, it is necessary to treat genetic information differently and give it special legal
protection. For example, tests should be performed only for health purposes or for scientific researchlinked to health purposes, and genetic counselling should be provided to help individuals or families
understand or cope with genetic disease.
Medical genetics also raises particular privacy concerns. The aspect of privacy which is most commonlyreferred to in the discussions about genetic privacy is called “informational” privacy. In recent
times, especially in Europe, the right to privacy has turned towards a specific right, the right to dataprotection.
The principles of data protection (such as the need of consent to the processing of personal genetic
data or the right of access to personal genetic information) do not apply to data rendered anonymousin such a way that the data subject is no longer identifiable. This means that protection will not be given
to personal data that have been subjected to an anonymization process. The process of anonymization
itself is therefore still an act of data processing. This means that, until anonymization is carried out in fact,
the data will still be considered as personal data so the principles of data protection will be applicable.

97 In order to use the conflict of duties solution, it is necessary to first determine the obligation of information towards
others on the part of the person who performed or proposed the tests (e.g. a doctor in relation to his or her patient).
That is to say, if the doctor is simultaneously doctor to other family members of the patient in question, then he or
she may have the duty to communicate the fact to them.
98 When the clinician is doctor only to the patient having the test. In these cases, the doctor does not have to violate
confidentiality, but when he or she does so, taking into account certain clearly defined circumstances, his or her
conduct is not considered illicit.
99 Romeo Casabona, “Genetic Information”, p. 784. See also Herman Nys/Carlos M. Romeo Casabona/Christophe Desmet,“Legal aspects of prenatal testing for late-onset neurological diseases”, in G. Evers-Kiebooms/M. W. Zoetewelj/P. S.
Harper (Eds), Prenatal testing for late-onset neurological diseases, Bios, UK, 2002, p. 98; Roscam Abbing, “Genetic
Information and third party interests”, pp. 40 ff.
100 According to this, Moniz, “Privacy and intra-family communication of genetic information”, page 109, considers thatthe breach of confidentiality can be justified provided that: 1) the doctor has done everything possible to persuade
the patient to communicate the information him/herself; 2) there is a strong chance of serious risk to the healthof a relative; and 3) there exists some preventive treatment or cure. In addition, she also thinks that, in order toavoid problems, the best solution would be the clear and express stipulation of the circumstances that justify thedisclosure of information, with a precise indication of the presuppositions underlying the justification. The following
provision has been proposed: “The breach of confidentiality by a doctor is not punishable when, according to thecurrent state of knowledge and medical experience, it constitutes the only adequate way of preventing serious andirreversible damage to the physical or psychic health of a third party, taking into account the reliability of the tests,
the severity of the disease diagnosed and the possibility of preventive or curative treatment”.

Every person has the right to decide whether or not to be informed of the results. Before a genetic
analysis is carried out, the data subject should be informed about the objectives and the possibility of
unexpected findings.
If they occur, they should not be communicated if they have no bearing on the health of the individual
because the mutation found does not have great significance, or there is no therapy or prevention
known, or it is not going to be transmitted to the offspring.
The right to privacy involves a corresponding duty of confidentiality. This means that genetic data mustalso be protected from other persons even in the case of a biological relative who seeks information
concerning the possible presence in him or her of a pathological gene similar to that discovered in thedata subject. However, this does not imply that doctors do not have the possibility of disclosing thisinformation in very closely defined circumstances.
Exceptional circumstances, whereby disclosure could prevent serious harm to the health of the relative,
and provided there are no other less-intrusive alternatives with respect to the privacy of the patient, mayjustify a breach of confidentiality in the doctor-patient relationship, and disclosure of the information by
the health professional against the wishes of a patient.

I would like to thank Prof Margaret Otlowski and Assoc. Prof. Dianne Nicol for their insightful comments
on earlier drafts of this article. Responsibility for ignoring their best advice, and making mistakes anyhow
is, of course, mine alone.

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Acknowledgments

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Biobanks and the Notion of Justice in Health*
Minakshi Bhardwaj, Ph.D.
CESAGEN, Lancaster University,
UK

Introduction

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The aim of this paper is to examine and describe some ethical issues that arise with the developmentof population-based genetics research and the establishment of large-scale biobanks, with specialreference to the notion of justice.
“Justice” is not only interpreted in the system of governance, but also in the ethical conception of justicein biobanks. This paper will examine what justice means at the individual as well as at social levels;
what complexities ethical principles bring out in balancing the interests of all stakeholders; and whatkinds of governance and regulatory mechanisms are employed to ensure operational effectivenessand prevent ethical concerns from actualizing. This paper is divided into two major sections, with afocus on understanding the term “biobanks” and its international perspectives, followed by a study on
conceptualising justice in biobanks.

Understanding Biobanking
Functional genomics has brought a new shift to genomics research, with a focus on the applications ofgenomics research at the level of populations. Although still in its embryonic stage, research focus isgradually shifting from the identification and treatment of rare single gene disorders to more common,complex diseases that effect large populations.
Advances in genetics, genomics, and bioinformatics have led to their merger into large-scale population
biobanks. However: there are different understandings of biobanks, and at the international level,
different research communities and several countries plan to pursue their own biobanks objectives.
“Biobanking”, which implies a systematic collection of biological material, is not a new concept inscientific research. In medicine and clinical practice, there have been several examples of tissue
collections and maintenance of health records for research and therapeutic purposes. Family genetic
registers have been in practice for over thirty years now; for example, the Register for the Ascertainment
and Prevention of Inherited Disease in Edinburgh, Scotland, offers active counselling to members offamilies with a history of genetic disorders, and a register centred at the University of Utah in the US,
based on the family register of the Mormon Church, was used to identify individuals with dominant
hypercholesterolemia. (Modell et al., 2001).
The integration of computational tools and applications has led to the development of bioinformatics.
The use of bioinformatics in genomics research has diverted focus from traditional research biobanking tostudies relying on Human Genetic Research Databases (HGRDs) (Knoppers, 2004). These modern genetic
databases are depositories of DNA, other biological materials, and a collection of genetic information thatis linked and organized in a systematic way for research purposes, with future possibilities for therapeutic
purposes —especially for genetic and other associated conditions. Several terminologies are used forthese systematic collections, including biobanks, cohorts, gene banks, population collections/studies,and genetic/genome databases. These biobanks are diverse in terms of criteria/selection of collections,healthy or affected groups, age groups, homogenous or heterogeneous representations, operationaland governance mechanisms, research agendas, and underlying scientific purposes. These differences
raise various ethical questions on the overriding philosophy of biobanking.

* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Population Biobanks
Lately, proposals have been put forward for the genetic understanding and study of entire populations
or subsets of populations, which in popular discourses and debates are referred to as biobanks. These
population-based biobanks are unique in their nature, since they are not only collections of biologicalmaterials and genetic information, but they also intend to collect personal information, histories of
diseases and treatments, and lifestyle information, including health, nutrition, and family histories.
It is envisaged that many of the collections will be permanently stored. Since the development of
the Icelandic Health Sector Database (HSD), several countries initiated the task to bring governing
mechanisms of medical, health, and research infrastructures under one umbrella to create a complex
but robust research and therapeutic environment. These databases focus on social and community
benefits rather than individual benefits.
The benefits are expected for all the stakeholders including patients, participants, the general public,
research communities, health authorities and the private sector. The interests of future generations andproviding better health for the present generation are a leading argument for establishing biobanks.

In countries where biobanks are established, there are varying expectations. According to John Newton,
the CEO of UK Biobank Ltd., the UK Biobank will allow the risk of disease to be predicted. Knowing
differences in risk in the population will help determine the scope of prevention. Information from UK
Biobank will help specify meaningful subgroups of illness and improve the specificity and effectivenessof all kinds of care, not only drugs [sic], but also social and emotional.
Hence, it is a long-term investment to create a resource and a framework for future studies looking into
the complexities of gene-gene interactions, genotype-phenotype interactions, and the separate andcombined effects of genetic, environmental, and lifestyle factors on the development of multi-factorialdiseases in adults (UK Biobank Ltd., 2004).
The Icelandic Health Sector Database can be considered a pioneer in starting the concept of populationbased genetic databases. The purpose of the Icelandic database, as mentioned in their Act on HSD, isvery general, with an aim of increasing knowledge in order to improve health and health services.
It became ethically challenging not because of the aims of the database, but due to the nature of its
constitution, governing framework and involvement with the private sector (Ministry of Health andSocial Security, Iceland 1998). The justification for the Estonian biobank initiative was that a small
country that is genetically heterogeneous makes the Estonian biobank a useful tool for targeting theincreasing number of drugs with efficacy problems and issues of adverse reactions.
We can see the diversity of expectations from biobanks from similar initiatives in Sweden, Norway,
Latvia, Tonga, Canada, USA, and also some countries of Asia, namely China, Singapore, Japan, andTaiwan. Given the wide variety of databases, there are different governing mechanisms adopted bydifferent countries, depending on the existing infrastructures, governing frameworks, and mechanismsof ethical oversights.

Legislation and Regulation of HGRDs: A Matter of Justification and
Trust
When considering the governance of databases, most countries have opted for pre-existing mechanisms,
and some have passed new legislation. Again, we can see different regulatory approaches taken.
The Icelandic government passed the Act on Biobanks of the Iceland Parliament, with sections on theestablishment and operation of biobanks; collection, handling, and access; monitoring and obligation
to supply information; and penalties. A similar approach is seen in Estonia in the form of the Human
Genes Research Act (HGRA); these cases are more firmly grounded in the “legislative approach” (2003).

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Biobanks and health expectations

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The projects in Iceland and Estonia are a creation of statutory bodies and, hence, a fundamental
mechanism for the structure, operation, and regulation of the projects was established based on theseregulations.
In these countries where the biobanks are firmly grounded in legislation, there is strong public support
for biobanks, and public trust is an important criterion for such large-scale genomic studies. Thesebiobanks are also ethically justified as a “common good” model with strong public acceptance. The
question of “biobanks as common good” is considered in a separate section later in this paper. However,formal public control over the biobanks for safeguarding the interests of all participants represents a
unique example of a general desire to use genomic technologies for health care and clinical practice.
Therefore, it also has a greater power of enforcement.

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In the case of the UK Biobank and Cartagena project, ethical operation of the biobanks is the responsibilityof the instigators. The Ethics and Governance Council (EGC) of the UK biobank was established by theinterim advisory board of the UK Biobank. As mentioned on the UK biobank website: “The role of the
EGC is to act as an independent guardian of UK Biobank’s Ethics and Governance Framework (EGF), toadvise the board on the conformance of UK Biobank's activities with this framework and to safeguard
the interests of participants and the public. The council will also advise UK Biobank on the future
development of the Ethics and Governance Framework”.
The Quebec network for Applied Genetic Medicine (RMGA) has documented two papers on theStatement of Principles of Human Genome Research (2000) and the statement of Principles on the
Ethical Conduct of Human Research Involving Populations (2003). These documents outline the relevant
principles to be followed when conducting research. However, in some cases, policies and committees
are referred to, but they are yet to be drawn up, and the terms of references have not been set up. This
raises concerns over paradigms of trust and confidence of the stakeholders in the biobanks. It is also a
reason that, before recruiting volunteers to donate samples, the UK has a rigorous public consultation
process. The process encompasses more than “informing” people about the project when the decisions
have been made in advance: it is an interaction with the public from the beginning of and during theprocess, when required. But is public consultation enough for ensuring the legitimacy of biobanks,
or does independence from legislation provides inherent flexibility to the projects, and hence leave
opportunities for changes when needed?

Abandoning individual choice for community benefits?
The construction of favourable arguments for biobanks are largely based on the theory that they canprovide possibilities for better health and nutrition, for affected and non-affected individuals, specificgroups, or general communities.
While individual choice and autonomy is paramount in clinical ethics, biobanks draw our attention
to the ethical complexities of a person’s social identity and puts group interests on the agenda while
invoking the concept of beneficence. Ironically, if we look at the proposed benefits of genetics researchwith biobanks, there is an increasing trend in the “individualisation” of medicine and health benefits,
thus promising more individual choice.
The scientific research in pharmacogenomics and nutrigenomics is based on the premise that people
differ in their genetic variants and, hence, respond differently to different diseases, medicine, and food.
The Department of Health (DoH) UK’s White Paper on “Our inheritance, Our future” illustrates thisconcept by stating that “the way external factors and genes interact to cause disease or protect us from
disease will be understood. This information will allow people with certain genetic profiles to avoid
foods, chemicals and environmental factors, such as smoking, which are particularly risky for them.
(DoH, 2003).
Arguably, individualising benefits will yield a community benefit. These benefits are made available
in the form of providing information and knowledge to the people so that people can make informed
decisions about their future health. Note that people also have the right to not know and the choiceof not utilizing the benefits. As Ruth Chadwick argues, individual autonomy consists of making aresponsible choice as a rational agent, and that there is a duty to be well informed in order to makeinformed decisions for oneself and out of duty to others (Chadwick, 2004).
The concept of duty to others is based on the ethical principle of beneficence, which would demandthat each healthy individual has an ethical obligation to donate to the research for good, as it will leadto the benefit of all humankind. The principles of solidarity and equity that are argued in the biobanks
debates insist on the concept of beneficence in genomic research. The duty to contribute is also argued,
based on the concept of the “common heritage of humankind”.
Biobanks envisage linking genetic factors with environmental factors and behavioural characteristics,
which are also constituents of the “society” we live in, as any decisions made by one individual have an
impact on society and vice versa. We make choices not only as individuals but also as members of aparticular group or a community. This is very important in relation to biobanks, and it is also recognisedby the WHO, which, in their draft statement on genetic databases, states that “the justification for a
database is more likely to be grounded in communal value, and less on individual gain . . . it leads to aquestion whether [sic] individual can remain of paramount importance in this context” (WHO, 2001).
Hence, we can see a gradual shift away from the importance of individuals in favour of community
interests.

The benefit sharing concept in genomics research in medicine and health care is derived from debates
surrounding the protection of traditional knowledge and property rights of indigenous people in plant
genomics. The purpose of benefit sharing in medical research is multifold. The HUGO statement on
benefit sharing states “that all humanity share in, and have access to, the benefits of genetic research. . . that benefits not be limited to those individuals who participated in such research”, based on thearguments for distributive justice in health, and that the human genome is a common inheritance ofhumanity (HUGO, 2000).
At the same time there is a need to identify what the immediate and future benefits from biobanks
are, whose interests should be taken into account, and how best we can distribute these benefits. The
potential recipients of the benefits from biobanks include the general population, sub-populations,specific groups (affected individuals, ethnic groups), families, single patients with rare diseases,
researchers, hospitals, institutions, etc.
The immediate health benefits may include improved diagnostics or preventative medicine, and an
indirect health benefit for small groups of people with genetic conditions, in terms of easy accessand better health care deliveries and inexpensive or free treatments, as seen in Iceland with deCODE
Genetics.
The long-term benefits are based on the “common good” argument: that the better understanding of
disease mechanisms will help in improving therapies on an individual basis. We can also argue thatcreation of “knowledge” and advancement in medicine is good in itself, as it benefits humanity at large.
However, it is a matter of consideration that existence of a “common public good” does not necessarily
imply that the applications and impact of a public good is also “common”.
Therefore, we can argue that regarding the human genome as the “common heritage of humankind”
alone is not a sufficient principle to ensure justice, especially with regards to distributing the benefits ofgenomics research at a global level; especially in the poorer regions of the world.
The HUGO statement on Genetic Databases mentions that “the fair and equitable distribution of benefits
from research using databases should be encouraged” (HUGO, 2003). The distribution of benefits caneither be at the level of each individual, or at the community level. Benefits can be distributed: equally,
regardless of contribution, which is based on the principle of equity and human dignity; according
to the needs of each person, prioritising individual choice; or, at more subtle level, according to thecontribution, which is based on the notion of compensatory justice, wherein benefit is provided as a‘reward’ for participation based on benefit-risk assessment.

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Benefit sharing/sharing of benefits and common good95

This is also seen as a recommendation in the HUGO Benefit Sharing statement: “Profit-making entities[should] dedicate a percentage, for example 1-3% of their annual net profit to health care infrastructure
and/or to humanitarian efforts”. Nevertheless, the question of whose responsibility it is to ensure benefit
sharing remains to be analysed.

Complexities of individual rights and social justice
Individualism in biobanks raises intrinsic ethical concerns from the participants. One of the main
complexities in biobanks is how to determine confidentiality and privacy of the data. We also needto consider which kind of privacy is under question, and what we mean by “genetic privacy”. Granting
rights for the protection of genetic privacy is the basis for limiting access to available information andrestricting misuse and exploitation, as there is potential to generate information from genetic researchbeyond what was originally sought, thus provoking issues of commercialisation.

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In some cases, samples were made anonymous, but for parallel epidemiology studies, where individuals
are likely to be followed through periods of their lives, it is questionable how the privacy of individuals
will be maintained over time without destroying data.
Sometimes information about the patients is encoded into serial numbers or other codes correlating totheir genetic makeup. Nevertheless, for follow up, studies needed to be carried out in different setups,
and in the case of “novel” findings, where a disclosure might be needed for third party researchers, weneed a method of acquiring secondary consent from the donors. Data encryption is often used, andsometimes includes personal identifiers — but for commercially attractive databases, it may not be
sufficient to prevent unauthorised access (GeneWatch UK, 2004).
Another database issue is granting ownerships rights. UNESCO’s Declaration on Human Genome andHuman Rights states that DNA is a common heritage that is shared by all. The HUGO ethics committee
describes genetic databases as global public goods. This implies that all human beings, regardless of
their participation in research, share the ownership of data and should have equal rights to it. It is aconceptual issue, but at the level of applicability in both research and governance, ownership of data islegally bound and used as a measuring tool for determining benefit sharing and control over the data.
But if each individual had ownership rights and control of the data, it would be extremely difficult todetermine a balanced approach in ensuring the claims of each individual over their individual tissue
as well as the information derived from it. Also, would massive collections lead to a proliferation ofindividual rights, or should the approach be more “social” and “community based” (Bovenberg, 2004)?
When comparing social interests and individual interests, it is important to consider what social factors
will be influenced by biobanks, for example family, community, environment and lifestyle (Wilson,2004).
Social justice demands recognition of the rights and responsibilities of human beings as individuals andmembers of society. The utilitarian argument claims that improvements in health care are in everyone’s
interests, and understanding the genetic factors relating to multifactorial conditions, for example heartdisease and diabetes, will lead to better individual health and thus better public health in terms of theprovision of health care and the development of robust health care systems.
Health care is a definite priority, as seen by the generally large allocations of state funds to health caresystems. However, these arguments override or ignore the disadvantages and burdens that might occur
in seeking genetic information. Not everyone might be willing to sacrifice privacy and individual rights
for a common good. Previous instances of possible discrimination and unequal treatment based onhealth and genetic make-up has led to mistrust of genetic research on humans. Arguably, provision ofhealth and genetic information does not force individual obligation to use the resources and options
available. But duty to safeguard the interests of future generations and the ideal of sustainability is
crucial, and it demands social cooperation.

Commercialisation issues
The controversies surrounding the ownership of data, information, and tissue samples are complicatedby the involvement of private sectors. The Iceland Health Sector database is an ideal example: In Iceland,
genealogies date back centuries, and have a significant contribution. The government of Iceland agreed
with Decode on granting an exclusive licence to establish and operate the Icelandic Health Sector
Database (HSD), and they gave access to medical and health records of the people through a universal
presumed consent.

In the case of some large-scale databases like the UK Biobank, there is some provision for the repatriationof accrued profits to the community, but this does not always occur (WHO, 2002). In Iceland, following
heated public debate and international criticism, the universal presumed consent bill was revised to
add an “opt-out” system that requires citizens to register if they do not want to be on the database. But
this raises questions of how much people trust their chosen governments, and it highlights dissonancebetween the concept of “genetic property” and the shared nature of economic and cultural assets, whichis integral to most indigenous societies (Committee on Human Genome Diversity, 1997).
Iceland aside, many international biobank projects have ties with commercial companies. Autogen Ltd.,a leading Australian pharmaceutical company, signed an agreement with Tonga’s Ministry of Health to“establish a major research initiative aimed at identifying genes that cause common diseases using theunique population resources in the Kingdom of Tonga”(Autogen Ltd., 2000).
The agreement included access to data and the samples in return for providing annual researchfunding to the Ministry of Health, in addition to paying net royalties on revenues generated fromany commercialized discoveries. But there was no public consultation process. Other countries withbiobanks tied to commercial companies include Estonia with EGeen Incorporation and Sweden with
UmanGenomics. Is private sector involvement an unavoidable requisite for genomics research? And
how can we balance the conflicting interests of society, science, and industry?

Developing Countries
Genomics research demands investment, innovation, and a capacity to produce. Genetic databases arean “add on” in genomics research, and they have their own implications and importance to developing
countries. Genetic databases in the public domain provide opportunities for developing countries togain access to a huge amount of available information and gain deeper knowledge at the basic researchlevel.
Technological innovation is an essential tool for growth and development. It would help developing
countries to develop their own research methodologies and therapies for epidemic diseases such as
thalassaemia and sickle cell anaemia. There is also the question of which kinds of databases might be of
immediate use for developing countries.
But it might not be of immediate use to invest in large-scale population biobanks. Rather, resources
need to be allocated to extract the existing information in the public domain and utilize it for purposesof primary health care, genetic testing, and counselling. The issue of resource allocation is crucial fordeveloping countries, and at the global level, it is central to the issue of health inequity in the world(Bhardwaj, 2004).
In debates on the gap between the developing and the developed world, capacity building is an issue.
Regarding capacity building in genomics research, biobanks pose a concern of exploitation of genetic
diversity in both public and private domains. The well-known Harvard Anhui case and issues from theinternational HapMap Project are examples of such exploitation.

Asia-Pacific Perspectives on Biotechnology and Bioethics

The database will contain medical records of the whole population, but it will also be a structure throughwhich a genealogical database and a DNA database can be linked to medical records. The intentionof the company to exploit information for commercial profit by selling access to the database, which
can be used for research in epidemiology and genetics research, has been ethically condemned; it has
raised several complex issues of informed consent and ownership of the data.

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Conclusions
Different notions of justice are apparent on the levels of practice and policy development. The issues ofindividual choice and social justice raise important philosophical concepts that are sometimes difficult
to apply in practical ethics, but they help to facilitate discussions and options. For example, it helps toanalyse what is “good” in the notion of genetic databases as global public goods, and whether duties
and responsibilities in research change if the database is private or public. This paper does not look into
the more philosophical approaches in studying the principle of justice, but focuses on the conceptionsof justice as raised in the application of databases for general health care on local and global scales. The
thrust to global justice is paramount in biobanks because of its implications for individuals as well as
communities, who shape the decisions made by and for them.

Acknowledgement
The support of the Economic and Social Research Council (ESRC) is gratefully acknowledged. This work
was part of the programme of the ESRC Research Centre for Economic and Social Aspects of Genomics.

References98

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Autogen Ltd.: media announcement. 17 November 2000.
Bhardwaj, M. 2004. Rich Databases and Poor People: Opportunities for Developing Countries.
TRAMES, Vol. 8, No. 1-2.
Bovenberg, J. 2004. Ownership and Commercialisation in Charitable Trust. PropEur Workshop on
Models of Regulations for IPR in Population-Based Research. Cardiff, 7−8 July 2004.
Chadwick, R. 2004. Genetic Databases: Individual Choice and Community Benefits. Invited lecture at
Chinese Academy of Social Sciences.
Estonian Genome Project. www.geenivaranu.ee. (Accessed 2 January, 2005)
HUGO. 2000. Statement on Benefit Sharing. HUGO Ethics Committee.
HUGO. 2003. Statement on Genetic Databases. HUGO Ethics Committee.
Iceland, Ministry of Health & Social Security. Act on Health Sector Database 139/1998. http://brunnur.
stjr.is/interpro/htr/htr.nsf/pages/gagngr-log-ensk. (Accessed 4 January, 2005)
Modell, B., et. al. 2005. A National Register for Surveillance of Inherited Disorders: Beta Thalassaemia
in the United Kingdom. Bulletin of the World Health Organisation, Vol. 79, pp. 1006-1013.
National Research Council, Committee on Human Genome Diversity. 1997. Evaluating Human
Genome Diversity. National Academy Press.
Sallee, C. Background Paper on Existing Human Genetic Research Databases: Context. Tokyo.
OECD, Health Canada, and the Japanese Association of Legal Medicine Workshop on Human Genetic
Research Databases, February 2004.
Statement of Principles on the Ethical Conduct of Human Research Involving Populations. 2003. http://
www.rmga.qc.ca/doc/pop/statement_ANG_.pdf.
United Kingdom, Biobank Ltd. 2004. www.ukbiobank.ac.uk. (Accessed 2 January, 2005)
United Kingdom, Department of Health. 2003. Our Inheritance, Our Future. White paper on Future
Health Care.
United Kingdom, Genewatch. 2004. UK Biobank Database. http://www.genewatch.org/www.
genewatch.org/humangen/biobanks/dbaseint.htm
Wilson, S. 2004. Biobanks and the “Social” in Social Justice. Iceland, Presentation in the ELSAGen
conference.

WHO. 2001. Genetic Databases: Assessing the Benefits and the Impact on Human and Patient
Rights.

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WHO. 2002. Genomics and World Health. Report.

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Is the era of the therapy by tailor-madestem cell coming?*
Miyako Okada-Takagi, Ph.D.
Nihon University,
Japan

Introduction

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Therapeutic cloning may result in the production of immunologically compatible replacement tissues
in severe degenerative or inherited diseases like Huntington’s, Parkinson’s, cystic fibrosis and otherdiseases. There are two types of stem cells: Embryonic stem (ES) cells can proliferate indefinitely inculture, they could potentially provide an unlimited source of clinically important adult cells. But ES cells
are controversial because they involve destruction of human embryos. While adult stem cells, derived
from bone marrow, blood, skin, hair follicles, nasal passages and the brain, come without the ethicalquandary, some scientists doubt they have as much potential as ES cells.
A successful attempt to freely control the growth of ES cells means that sufferers of a wide range of
diseases could be treated via regenerative medicine. Film star Christopher Reeve, who died on October
10th 2004, had been paralyzed from a spinal cord injury since 1995. He saw ES cells as the best hope forpeople like him, as do sufferers of obstinate disease. In June 2004, former US President Ronald Reagan
died from Alzheimer's disease, and Nancy Reagan announced in public that she was in favour of ES cellresearch.
Each year in Japan, about 5,000 people suffer spinal cord trauma in car crashes and other types ofaccidents. Estimates suggest that over 100,000 people in the country are afflicted with physical paralysis.
In July 2004, it was found that nine Japanese people who suffer from spinal cord injuries travelled toChina to undergo transplants of cells from aborted foetuses.
Such transplants are believed by some to aid the regeneration of nerve cells in the injured spinal cord,possibly enabling patients to regain feeling in their arms and legs, and eventually restore movement.
But the effectiveness and safety of the treatment has yet to be verified.
The United States has no laws banning such research, but in 2001, President Bush declared that nofederal funds could be spent on ES cell lines developed after that date. Since then, many states havetaken on funding efforts. At first California decided to fund three billion dollars of state money into ES
cell research over the next 10 years. Other states then expressed the fear that they would lose their top
researchers to California. Wisconsin's governor recently earmarked $750 million for ES cell research andfacilities and New Jersey and several other states are also doling out cash.

Regulation of human ES cell and cloned Embryos research in Japan
In Japan, the Council for Science and Technology Policy's bioethics subcommittee recommended inJune 2004 that scientists be conditionally allowed to use cloned human embryos for research purposes.
The creation and use of cloned human embryos are banned under cloning technology legislation thattook effect in 2001, but the law was slated to be reviewed three years after its implementation.
The panel held 29 meetings to review the use of cloning technology. Giving serious consideration to theopinions of those cautious about the research, members of the panel agreed to set up rigid conditions
for such research. As a result, the research was approved by a vote of 10 to five.

* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

The potentiality of the embryo
The moral legitimacy of performing research on the human embryo depends on the status of theembryo. The issue of how we define and categorize the embryo at its different developmental stages is
crucial to the question of what we can do with it.
If the embryo is a human being, then our treatment of it is limited to what we are allowed to do to otherhuman beings. By contrast, if it is no more than a collection of human cells, then there are far fewer
restraints on our handling of it. In the area of stem cell research, much of the moral debate in various
countries has focused on the question of just what the embryo is, in particular at the pre-implantation
stage.

There is an argument focus on the biological status of the embryo. One line of argument examines
the capacity of the embryo for conscious thought. As the nervous system does not begin to develop
until after implantation, according to this view there is no objection to the use of pre-implantationembryos.
When does a human formulate in a biological view? The ordinary human form correlates with theproperties of the human brain, in particular cognitive and emotional infrastructures. Hence, a humanwould form when significant parts of that infrastructure develop in the foetal brain during pregnancy.
This may be the third trimester of pregnancy. Accordingly, a younger embryo should be treated withappropriate respect but not as a person.
One debate is how to consider the potentiality of the embryo. The defenders of the protected embryo
status argue that it is wrong to do anything to the embryo that will prevent it from fulfilling this potential
because the embryo has the potential to become a person even if it is not yet a person. On the other
hand, one may argue that the potential to become a human being does not endow the developing
embryo with the status of a human being.
Egg and sperm are components of the gamete that becomes a foetus. In the case of IVF, the concept ofembryo potential is further complicated since direct medical intervention is needed for the embryo’s
implantation in a uterus. The rate of IVF embryos that develop into blastocysts is still low, between 20
to 30%. If there are extra embryos, the couple has the option of freezing the remaining embryos forthawing and transferring in a later cycle. Approximately 30 % of embryos do not survive the freeze-thawprocess.

Cultural and religious views on human ES cell research
The bioethical debate on human ES cell research occurs in a context of cultural and religious reflection.
The strongest opposition to the use of embryo for research purpose is expressed by the Roman Catholic
Church. In August 2000, regarding ES cell and the status of the embryo, the Catholic Church’s PontificalCouncil announced, in their view, that a human being comes into existence at the time of fertilization.
They believe that there is a continuum from the conception to the human being, and that development
continues during all stages of life, giving sanctity to all stages of development. Therefore every embryoshould be given the opportunity to develop to a human being. In contrast, Protestant theology does notfollow a single source of authority. It is part of the Protestant ethos that moral questions are determinedby the individual conscience.
Therefore in Protestant thought, Christians may have very differing views on the issue of ES cell

Asia-Pacific Perspectives on Biotechnology and Bioethics

It is clear that the embryo has a unique status in biological terms. Unlike any other cluster of living
cells, this cluster has the capacity to develop into a functioning complex organism. This difference
may be described as the embryo’s potential to become a human being. This biological fact has moral
implications. So far as our moral notions depend on the value of human life, the human embryo demands
respect as being related to human beings who deserve the utmost respect and have human rights. But
how far should this respect go when considering the human embryo? In other words, at what point ofembryonic development do we consider it a human being?

101research. Jewish Biblical Law determines that human status is acquired progressively during embryonicdevelopment, and not at fertilization. The status of the embryo outside the womb is comparable to thatof gametes, sperm and eggs. With regard to the pre-implantation embryo, genetic materials outside
the uterus have no legal status since they are not even part of a human being until implanted in thewomb.
In Islam, the use of embryos for research purposes may be acceptable provided that it occurs before
the point at which the embryo is ensouled, i.e. from the 40th day after fertilization. Therefore, ES cellresearch in Islam is allowed in the early stages of life, as long as such an intervention is undertaken withthe purpose of improving human health.

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However in Japanese Buddhism or Shintoism, there is no clearly defined doctrine on which stage of theprocess of development from fertilization to foetus life begins. The issue of producing ES cells throughthe destruction of embryos has not generated major opposition in Japan. The difference between Japanand other countries concerning ES cells could probably be explained from the viewpoint of differencesin the cultural backgrounds.
In farming communities during the Edo period (1603-1868), poor farmers who could not afford to raisechildren killed newborn babies, a practice known as mabiki. Mabiki originally referred to the thinningout of rice paddies by pulling out poorly growing seedlings. Of course, mabiki occurred in the distant
past. Today, each baby is raised as a priceless individual. However, the idea that life comes into existence
when fertilization is complete is not the majority view in Japan. Therefore our definition of fertilized
eggs contradicts such that we clearly give eggs a dignity as humans but do not agree that their right tolive is equal to ours. In Western countries, abortion and the destruction of the embryo incite trouble, yettheir culture allows brain death and organ transplants to be moved through quite fast.
Japanese Organ Transplantation Law was established in 1997. Since then, the organs have been donatedby only 37 brain dead patients with family consent. The survey, conducted in Aug 2004, covered over2000 people and revealed that the Japanese are still hesitant about becoming donors. In Japan, death
is a socially determined event, a process, not a moment. We Japanese could not depend on organtransplants.

Creating embryos for research
ES cell research seems to be arousing wide attention and due consideration in connection with cloning
technology. There is a practical problem when ES cells from supernumerary embryos of the fertility
treatment are used to differentiate into particular cell or tissue types for transplantations and therapeutic
effects. Because these cells will not be derived from the patients, they will be rejected by the patient
immune system.
Therapeutic cloning uses the same method that created the Dolly the sheep. Somatic cell nuclear
transfer (SCNT) removes the nucleus of an unfertilized egg, which contains 23 human chromosomes
and replaces it with the nucleus of a somatic cell from the donor to be cloned, which contains 46
human chromosomes and the donor’s genetic code. The rest of the cellular material is cytoplasm, which
provides nutrients for the eggs’ survival. The tissues derived from such ES cells would be autologous to
the recipient and not subject to immune rejection.
In Asian countries, South Korea adopted a law in late 2004 to pave the way for research using cloned
human embryos. Also in Singapore and Thailand, the law allows the harvesting of stem cells from cloned
human embryos. The international community has been divided over the ethics of therapeutic cloning.
The United Nations tried to weigh in on the divisive issue by proposing universal research regulations,but was unable to have consensus.
Advocates list the development in regenerative medicine as a major benefit of allowing the cloning of
human embryos, while opponents argue that it can be used to clone humans and that using embryos asa research tool is wrong. “Declaration" condemns all forms of human cloning but is not legally binding.
The declaration was passed by 84 votes to 34, with 37 abstentions. Many industrialised nations, including
the UK, France, Norway, Japan, China and South Korea, voted against the declaration.

In May 2005, a South Korean scientist announced that he had created the first ES cells that geneticallymatch injured or sick patients. The match means ES cells are unlikely to be rejected by the body's
immune system. Researchers hope the cells eventually can be used to repair damage from disease. In
order to accomplish this experiment, the eggs were retrieved from 18 volunteers, and total of 185 eggs
were donated.
Researchers got 31 embryos from which they tried to extract stem cells and managed to produce 11 ES
cell lines. When Dr. Hwang claimed to have derived the first human stem cell line from a cloned embryo
in February 2004, he used 242 eggs donated from women to create only one ES cell line. However,this research has now been judged fraudulent and thus false. However we can still discuss the ethics
involved in egg donation.

If egg donation is the pain of the procedure, bone marrow donation is very painful as well. Yet somepeople donate bone marrow to complete strangers all the time. In those cases, the benefits may
outweigh the risks.

Discussion
Such technology raises a concern over egg donation. There is a concern that disadvantaged women
will be targeted to provide eggs, putting their health at risk. Even if future studies decrease the amountof eggs necessary, this is still going to put women on some sort of “production line” as part of the
production process.
Moreover, as the technique brings the therapy much closer to reality, it will actually increase the demandfor eggs. We have to recognize the need to establish systems to protect women who will provide theireggs for research. Scientists have already succeeded in turning ES cells into egg cells. It was achieved
with ES cells from mice, but most experts see no reason why the same should not work in humans. If so,
this opens the possibility that human eggs could be made in large numbers in a culture dish, instead of
relying on donors.
Nuclear transfer of this sort may be opposed by those who see it as the first steps towards humanreproductive cloning. It should be explained and has been understood in public that therapeutic cloning
is not the sense of human reproductive cloning. It is certain that ES cell technology will become key
aspects of various treatments and regenerative medicine will soon be employed in treating intractablediseases once their safety is guaranteed. As scientific technology advances, we are increasingly forced tomake difficult decisions. Although new technology can potentially be a solution to unsolved problems,
it can lead to unexpected side effects when applied. Therefore bioethics becomes a more essential
component of science.

References
Bioethics & Security guide section, Ministry of Education, Culture, Sports, Science and Technology inJapan.http://www.mext.go.jp/a_menu/shinkou/seimei/index.htm
Daily Yomiuri (Jul 22.2004) Nine Japanese had transplants using foetal cells in China,
Database of Global Policies on Human Cloning and Germ-line Engineering: http://www.glphr.org/
genetic/genetic.htm.
Holland, S., Lebacqz, K. & Zoloth, L. 2002. The human embryonic stem cell debate. The MIT Press.

Asia-Pacific Perspectives on Biotechnology and Bioethics

In order to minimize the ethical problem of the egg donor, one can manage to produce embryos only
when the person to be cloned was also the donor of the egg used. If that remained the case, it would
mean that therapeutic cloning would not be of benefit to men, or to women past menopause. In some
aspects, we would say egg donation is similar to bone marrow donation. If a family member contracts
a severe disease, a daughter or sister or mother may help the treatment by donating eggs through one
cycle or two cycles.

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Hubner, K. et al. 2003. [DOI:10.1126/science.1083452] Derivation of Oocytes from Mouse Embryonic
Stem Cells. Science.
Japan Times, Oct 24.2004, Public mixed on brain death transplant. Japan Times.
Korea Times, May 27.2005, Stem Cell Pioneer Opens Doors to Therapeutic Cloning.
Ministry of Education, Culture, Sports, Science and Technology (2001) The guidelines for derivation andutilization of human embryonic stem cells in Japan. Tokyo.
National Academy of Sciences (USA). 2002. Stem cells and the future of regenerative medicine. National
Academy Press. Washington DC.

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Welcome to BioethicsWeb http://www.bioethicsweb.ac.uk/.

The regulation of stem cell technology - international
approaches to restriction or permission*
Donald Chalmers, Ph.D.
Deputy-Chair, NHMRC Licensing
Committee, Australia

Cloning and embryo research

The former has been condemned universally. Both expressions are in any case imprecise and misleading.
A preferable expression for the latter is stem cell technology or somatic cell nuclear transfer (SCNT). The
UNESCO Declaration on the Human Genome and Human Rights 1997 stated in Article 11 “[p]ractices
which are contrary to human dignity, (Harris, 1997) such as reproductive cloning of human beings shallnot be permitted”.
More recently, the United Nations passed a non-binding resolution opposing reproductive cloning aftersome two years of debate, in which agreement could not be reached on a form of words that would not
impact on stem cell work in member nations (Mayor, 2005).
The Australian Health Ethics Committee developed a report on cloning and stem cells (Scientific, Ethicaland Regulatory Considerations Relevant to Cloning of Human Beings NHMRC, 1999) that was presented
to the Australian Parliament which prepared a report entitled Human Cloning: Scientific, Ethical andRegulatory Aspects of Human Cloning and Stem Cell Research 2001. This report recommended legislationin the area. The Research involving Human Embryos Act 2003 established a Licensing Committee, as acommittee of the National Health and Medical Research Council, to handle these matters.
This paper will examine the regulatory scheme established in Australia to deal with embryo researchand the development of stem cell technology.

Stem cell technology
There has been a prolific publication of literature on the science and ethics of stem cell technology(Jaenisch, 2004). Stem cell technology involves the extraction of cells from the developing embryo
blastocyst (and now from single cells at the eight cell stage) or other “adult” cells, which have the qualityof self-replication.
Stem cell technology relies on the regenerative qualities of these cells. The regenerative characteristics
of stem cells are not unique and are manifested in other “adult” cells, such as bone marrow, cord blood,skin, and foetal tissue. Stem cells derived from human embryos have generated considerable moral
controversy. The expectations of stem cells and regenerative medicine are considerable, with high hopes
for disease prevention and, even life extension (Rosenthal, 2005). There have been fairly audacious claimsin Australia describing stem cell research to be ‘‘the greatest and most exciting medical breakthrough’’and ‘‘one of the biggest breakthroughs in human medicine’’, promising ‘‘very great potential benefits’’(House of Representatives Report, 2001).
Stem cell technology may address shortages of organs for transplants in developed countries, stem
* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Asia-Pacific Perspectives on Biotechnology and Bioethics

UNESCO, along with other organisations such as the WHO, Council of Europe and National Bioethics
Advisory Commission (USA), responded to the Dolly cloning announcement in the late 1990s withethical opinions, public policy directions or regulation (Macklin 2004). The succession of internationaland national inquiries drew a sharp boundary between the unacceptable cloning of a human being(“reproductive cloning”) and possible “therapeutic” applications (USA President’s Council on Bioethics,
2002).

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cell technology is seen as a potential source of compatible organs for transplantation; stem cells may
produce tissue for to replace damaged nerve, muscle, liver, pancreas and heart cells (Nature (2001) 414:
87-138). This technology is being promoted as a potential treatment for diseases of the ageing such as
Parkinson’s disease and Alzheimer’s disease. There are promises of stem cells as a source of safe bloodand blood products.
However, some of the optimism may prove premature or overstated. In spite of the considerable
public investment in this research, embryonic stem cell technology is at a preliminary research stage.
The reported breakthroughs have been modest. Despite the promise, the therapeutic applications ofhuman stem cell technology in transplantation or any other therapy have been very few.
Interestingly, the international debates about human embryo research have revived philosophic
discussion on arguments based on human dignity. Arguments based on human dignity allow discussion
on areas outside simple claims to human rights. For example, the embryo may not have human rights
but still deserve to be treated with dignity.

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Similarly, some have argued that reproductive cloning is part of the right to procreate. However,reproductive human cloning offends human dignity because the fundamental nature and values ofa society are as important and may transcend individual rights. Human dignity also underpins humanrights themselves and places proper limits on the idea of autonomy. Professor Brownsword has alsosuggested human dignity is necessary to avoid the trivialisation of genetics for cosmetic purposes.

Towards legislation in Australia
The passage of the Research Involving Embryos Act 2002 provided the longest ever debate in the historyof the Australian Parliament (Australian Parliament, 2002). In summary, the key arguments raised in thedebates can be divided into eight broad themes:• potential therapeutic benefits of stem cell technology;• use of surplus IVF embryos for research was a better use to destruction;• moral status of the embryo prevented its use as a means to an end;
• adult stem cell research was equally promising and offered a preferable alternative;• private interest commercialisation of the research and potential exploitation of couples in IVF
programmes;• the slippery slope to more contentious embryo research;• economic benefits and scientific implications for Australia; and• imperative for national legislation
The Research Involving Human Embryos Act creates a national licensing scheme for embryo research inthe private and public sector. The Act allows the use of “excess ART (IVF) embryos” to carry out licensed
research that may lead to the destruction of the embryo. Criminal offences apply when excess ART
embryos are used without a valid licence.
The national regulatory scheme (Chalmers and Nicol, 2003) has two steps before a licence can be issued.
First, the research institution must consider ethics of the embryo research application then the Licensing
Committee considers the application.
Step 1: Approval by the Applicant’s Intitution.
At the first step, an applicant for a research licence must present the research proposal to the institution
and to their Human Research Ethics Committee (HREC). Under the Act, the HREC must be satisfied thatthey approve the research activity and the project. In particular the HREC must approve that:• The embryos are excess to the needs of the couple in the ART programme. The Act provides thatthe couple in an ART programme must declare their embryos to be surplus to their needs, andconsent to the embryos being classified as excess under the terms of the Act. These embryos may
be then used for research, in strictly limited circumstances. An embryo can only be “excess” if each
responsible person (S 8) has authorised in writing the use of the embryo for a purpose other than the
ART treatment of the woman concerned (S9 (2)(a)). or has determined in writing that the embryo isexcess to their needs (s9 (2)(b)).

• All the consents have been obtained. In particular, s24 (1) provides that, before an excess ART embryo
is used as authorised by the licence each responsible person (i.e. all those involved in providing
the egg or sperm for the creation of the embryo and any spouses) must declare the embryos to be
excess and that the embryo may be used for an approved research purpose. In effect, the legislationprescribes two separate consents - a consent that the embryos are no longer required for their ART
treatment and also consent to the research. Consent forms in ART clinics had to be redrafted to reflect
these two stages.

Step 2 Embryo Research Licensing Committee

The Licensing Committee must first be satisfied (s21(3) that all the required consents have beenobtained and that the applicant has obtained approval for the project by the properly constituted
Human Research Ethics Committee, (s23(3)(c). Secondly, the Licensing Committee is directed to haveregard to the following matters in deciding whether to issue the licence (s21(4):(a) restricting the number of excess ART embryos to that likely to be necessary to achieve thegoals of the activity or project proposed in the application;(b) the likelihood of significant advance in knowledge or improvement in technologies fortreatment as a result of the use of excess ART embryos proposed in the application, which could
not be reasonably achieved by other means;(c) any relevant guidelines, or relevant parts of guidelines, issued by the the NHMRC under the
National Health and Medical Research Council Act 1992 and prescribed by the regulations for the
purposes of this paragraph;(d) the HREC assessment of the application mentioned in paragraph (3)(c);(e) such additional matters (if any) as are prescribed by the regulations.
In practice, the Licensing Committee’s deliberations have concentrated with regard to the firsttwo issues, namely restricting the number of excess ART embryos and the likelihood of significant
advancement in knowledge or improvement in technologies. The Licensing Committee has developed
additional guidance on how it treats the interpretation of the issue of “likelihood of significant advance”.
In addition, the Licensing Committee drafted a guidance note on the consent requirements of the Act.
The consent guidance has been drawn up with reference to the Ethical Guidelines on the Use of Assisted
Reproductive Technology in Clinical Practice and Research (2004).1
If the Licensing Committee is satisfied with all matters a licence can be issued. So far, the Committee
has issued nine licences. Licences so far issued have included standard and special conditions (S 24),
particularly about the numbers of embryos allowed to be used.
The Act establishes an inspectorate and a system of monitoring not only of licensed research but also
any possible breaches of the cloning legislation. The Act creates a series of criminal offences for failure
to follow the conditions in the licence. The inspections and monitoring consist of document inspections
as well as site audits with checks on all licensed activity.

1 See http://www7.health.gov.au/nhmrc/embryo/index.htm

Asia-Pacific Perspectives on Biotechnology and Bioethics

If the HREC approves, the application can be referred to the Licensing Committee for consideration. The
Licensing Committee (see http://www7.health.gov.au/nhmrc/embryo/index.htm) is set up within the
National Health and Medical Research Council (s12), and grants licences to conduct research on excess
human embryos in the private and public sector (s20).

107International approaches
This framework system of regulation of embryo research based on the use of surplus embryos from
IVF (sometimes referred to Assisted Reproductive Technology - ART) is by far the most common modelwith a number of countries having introduced legislation. Amongst this group are the UK, Finland,
Greece, Israel, The Netherlands, Sweden, South Korea, the American States of California and New Jersey
and Australia (Isasi, 2004). Other countries have also followed the surplus embryos approach but havepreferred to use guidelines with approval by a national committee, such as Singapore, China, Spain andJapan. Guidelines can be more flexible in a fast-moving research environment.

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The legislation and guidelines introduced to permit embryo research have usually placed many otherrestrictions on embryo research. For example:• Only surplus IVF embryos allowed to be used except in the UK;• The consent of the parties creating the embryos is required at two stages - a consent that the embryos
are no longer required for their IVF treatment and also consent to the research;• The purposes of the research must be explained and mostly the research purposes are limited andrequire careful justification;• Research purposes must be approved by an Ethics Review Committee;• The research is generally required to be reported and the research results published;• Finally, some countries have set up national committees to licence the research with power to impose
further conditions in the licence.
Overall, the legislation and guidelines allowing research on excess ART embryos have a clear “restrictive
tilt” and not a permissive one. Such restrictions are usual in relation to the purpose of the research. No
country has allowed, as yet, undefined research on embryos.
In Australia the researcher has to show there is a “likelihood of significant advancement of knowledge
or improvement in technologies for treatment”. Similarly in Japan, the researcher may only use ES cells
for basic research and cannot use them reproductively.
The USA is in the company of countries that have maintained a ban on research, such as Austria, Ireland,
Canada, Philippines and Germany (Heinemann and Honnefelder, 2002). The US federal funding ban only
applies to research involving applications for federal funding support. Some American states, principally
California and New Jersey, have allocated state funds to this kind of research. Interestingly, Germanybans embryo research but still allows stem cells to be imported.

Conclusion
Regulation may be in place in some countries but the science is in its infancy. For example, there is noaccepted scientific standard for certifying that a stem cell is “established”, that is having the capacity tocontinue replication. At the time of writing, researchers are trying to set standards for stem cell line byreference to the number of times the lines should be able to be frozen, thawed and still demonstrate
their capacity to replicate and also allow a number of genetic tests to be conducted.
Secondly, standards for Good Manufacturing Practice are a necessary precondition to the use ofembryonic stem cells in a clinical setting as part of “established” clinical practice (BioNews, 2005).
Thirdly, stem cell lines may be unstable and exhibit genetic mutations and the possibility of tumour
development. Overall the reports in the press tend to substantially exaggerate the state of the science;
the researchers cannot be blamed for this over-optimistic reporting. At this stage, the science should be
as much of a driver of the debates as the ethics and regulation.

References
Australian Parliament: The Research Involving Embryos and Prohibition of Human Cloning Bill 2002 to
ban human cloning and other unacceptable practices associated with reproductive technology andto regulate research involving the use of excess human embryos created by assisted reproductive
technology. This bill was later split into two separate bills: the Research Involving Embryos Bill (Cth) 2002
and the Prohibition of Human Cloning Bill (Cth) 2002 respectively. The Prohibition of Human Cloning Bill
received unanimous support and passed very quickly with reference to the fact that cloning was anaffront to human dignity. House of Representatives: June: 27 Research Involving Embryos and Prohibitionof Human Cloning Bill 2002 read a First and Second time. August 20 debate begins and continues on the22, 22,26, 27, 28and 29th (Commonwealth, House of Representatives, Parliamentary Debates (Hansard),
29 August 2002 at 6115-6116).
(Commonwealth, House of Representatives, Parliamentary Debates (Hansard), 16 September 2002 at
6291-6292). Commonwealth, House of Representatives, Parliamentary Debates (Hansard), 25 September
2002 at 7233-7234).

(Commonwealth, Senate, Parliamentary Debates (Hansard), 14 November 2002 at 6342). The Research
Involving Embryos Bill 2002 debate continued December: 2, 3, 4, 5 and read a third time and passed(Ayes 45 with Noes 26).
BioNews “Stem cell lines available to US state researchers are contaminated” (2005) 292 BioNews week
17/1/05 at 8-12
Chalmers, D. and Nicol, D. 2003. “Embryonic stem cell research: can the law balance ethical, scientific andeconomic values”, Law and the Human Genome Review Vol. 18, Part 2 at 101-106.
Harris, J. 1997. “Goodbye Dolly? The Ethics of Human Cloning”, Journal of Medical Ethics, Vol. 23, p.
353, on the vagueness of term dignity.
House of Representatives Standing Committee on Legal and Constitutional Affairs. 2001. Human Cloning:
Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research, AGPS at paras 3.233.34.
Heinemann, T. and Honnefelder, L. 2002. “Principles in Ethical decision-making”, Bioethics, Vol. 16, p.
530-543 at 541.
Isasi, R., et al. 2004. “ Legal and Ethical Approaches to Stem Cell and Cloning Research: A comparative
analysis of policies in Latin America, Asia and Africa”, Journal of Law and Medical Ethics, Vol. 32, p. 626640.
Jaenisch, R. 2004. “Human cloning - The science and ethics of nuclear transplantation”, New England J.
Medicine, Vol. 351, 27: 2787-2791.
Macklin, R. 2004. “Cloning and Public Policy” in J Burley and J Harris, eds., A Companion to Genethics,
Blackwell Publishing UK, pp.206-215.
Mayor, S. 2005. “UN committee approves declaration on human cloning”, 330 BMJ 496; and, “Un calls forban on all forms of human cloning” (2005)149 BioEdge 8/3/05 at 3-5
USA President’s Council on Bioethics Human Cloning and Human Dignity: An Ethical Inquiry Washington
DC, July 2002 at Chapter Three The terms were questioned as early as 1997 by the UK Human Genetics
Advisory Committee but entered the lexicon.
Rosenthal, N. 2005. “Youthful prospects for human stem-cell therapy”. EMBO reports: special issue, Vol.
6, s30-s34.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Senate (Commonwealth, Senate, Parliamentary Debates (Hansard), 18 September 2002 at 4421).
(Commonwealth, Senate, Parliamentary Debates (Hansard), 15 October 2002 at 5142) with debate on
November: 11, 12, 13, 14

109

Ethical issues in ‘ethical guidelines for research on
human embryonic stem cells’ in China*
Yanguang Wang, Ph.D.
Centre for Applied Ethics, Chinese
Academy of Social Sciences,
China

The situation of embryonic stem cell research in China

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Asia-Pacific Perspectives on Biotechnology and Bioethics

Human embryonic stem cell (ES) research is developing quickly in China. From the first International
Symposium on Stem Cell Research held in Beijing, at the end of May, 2002, we discovered that there
are many institutes engaged in ES cell research in China and more than twenty leading individuals are
devoting themselves to stem cell research in their institutes in ten major cities.
During The second International Symposium on Stem Cell Research held in Beijing, between
December 16-19, 2003 – an event organized by the Chinese Academy of Medical Sciences and Peking
Union Medical College, with the involvement of the Stem Cell Research Centre, Beijing University;
National Centre of Stem Cell Research and Engineering; The National High Technology Research andDevelopment Programme of China; and the Beijing Tianxiangyuan Bio-Tech Investment Corporation,
we discovered that significantly more personnel and institutes are engaged in stem cell research thaninitially thought.
The Chinese presenters attending the first and second International Symposium on Stem Cell Researchcame from: Shanghai Jiao Tong University of Medicine; The Chinese University of Hong Kong; Chinese
Academy of Medical Sciences and Peking Union Medical College; Chang Gung Memorial Hospitaland Industrial Technology Research Institute, Taiwan; Academy of Military Medical Sciences; Guiyang
Medical College; Sun Yat-sen University, Guangzhou; Jiangsu Province Hospital, Nanjing; Fourth Military
Medical University, Xian; Peking University; Nanjing First Hospital; Capital University of Medical Sciences,
Beijing; Shandong University, Jinan; Dalian University of Technology; Zhujiang Hospital, Guangzhou;
Fudan University, Shanghai; Chinese Academy of Sciences, Beijing; Pediatric Department of the Naval
General Hospital, Beijing; Second Military Medical University, Shanghai; First Military Medical University,
Guangzhou; Run Run Shaw Hospital, Hangzhou; Central South University, Changsha; Xi’an Jiaotong
University, Xi’an; Third Military Medical University, Chongqing; Northwest Sci-tech University ofAgriculture and Forestry and Shanghai Second Medical University.
Most of the topics presented by the Chinese scientists involved in research on stem cells in the first andthe second international symposiums were on adult stem cells, for example, adult bone marrow, andalso the use of animals in research, most notably, mice, goats and pigs. Some research involved the useof human stem cells, such as a study of human/goat stem cell chimera. Other research involving the useof human stem cells including the finding that flk-1+ stem cells from a variety of human foetal tissues
reveal multiple differentiation potential. Scientists have also worked on enrichment and characterizationof human foetal epidermal stem cells; the isolation and in vitro cultivation of the human embryonicgerm cells; transplantation of human embryonic cortical neural stem cells into rats (with the spinal
cord being transected); a human/goat hematopoietic xenogeneic model (human hematopoietic stemline-cells purified from umbilical cord blood were transplanted in utero into foetal goats at 45-65 daysof gestation); as well as the primary establishment of Chinese embryonic stem cell lines. The research
included theory and the technology of stem cell research and its application. Scientists collectively
expressed the opinion that the development of embryonic stem cell research in China is at the samelevel as in other developed countries.

* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

Background to ‘‘ethical guidelines for research on human embryonicstem cells’’
We Chinese hope such technology can be developed healthily and ethically by government regulation.
Since the first case reports appeared in the media, an ethical discussion on human stem cell research
has occupied a major position in the public domain in China, as well as in the media over the past few
years.
It also has played a significant role in international discussions. In the aftermath of cloning reports
from other countries, some attention was focused on China as well. The public, scientists, bioethicists,and government officials discussed ethical disputes, the cultural background, ethical principles,
recommendations, guidelines, regulations, policies, and the different perspectives and the laws on stem
cell research in China and the rest of the world.

In January 2004, the widely anticipated written regulation of ‘‘guidelines for research on humanembryonic stem cells’’ was jointly released by the Ministry of Science and Technology (MST, Beijing) andthe Ministry of Health (MOH, Beijing), China. The Beijing draft of the ethical principle and regulatory
recommendation on HES cell research was issued by the Centre for Applied Ethics of the Chinese
Academy of Social Sciences, the ELSI Committee of Human Genome Project China and the Centre for
Bioethics of the Chinese Academy of Medical Sciences/Peking Union Medical College in September
2001.
It includes four ethical principles: The principle of respect; the principle of informed consent; theprinciple of safety and efficacy; and the principle of non-commercialization - plus eight regulatory
recommendations. In November 2001, the first draft was revised by the Ethical Committee of Ministryof Health and was submitted to the Ministry of Health, China (Wang, 2003).
The Shanghai draft of the ethical code on HES cell research was issued by the Ethics Committee of theChinese National Human Genome South Centre in October 2001. It was revised in August 2002 andsubmitted to the Bureau for Science and Technology, Shanghai Municipal Government and the Ministry
Of Health/Ministry of Science and Technology of China. Most points are similar to the Beijing draft (Qiu,
2001).
“Guidelines for research on human embryonic stem cells’’ codified the interpretation and reconfirmed
some earlier ethical and political statement. It is less binding as an announcement then many earlier
regulations or proposals, and thus fills a gap, since the revision of the regulation on reproductive
medicine since 2002 does not deal with research on ‘‘therapeutic cloning’’.

Ethical Guidelines for Research on Human Embryonic Stem Cells
This guideline is a regulation that allows therapeutic cloning and prohibits any research on humanreproductive cloning. According to the regulation, the stem cells used for research can be obtained
either from spare embryos from in vitro fertilization (IVF) or from naturally aborted embryos, with theinformed consent of the donor. The regulation specifically forbids the trade of human gametes, germ
cells and embryos. The regulation also prohibits the implantation of human embryos into reproductive
systems of human beings or animals.
Here is an English translation of the major articles of ‘‘ethical guidelines for research on human embryonicstem cells’’:
Article 1: Research must comply with international bioethical guidelines and Chinese bioethicalguidelines or regulations, and also promote the healthy development of human embryonic stem
cell research.

Asia-Pacific Perspectives on Biotechnology and Bioethics

This prompted the Chinese government to voice an opinion on the issue. A representative of theChinese government at a UNESCO meeting on human cloning declared in his presentation that the
Chinese government opposes human reproductive cloning and supports therapeutic cloning. (Ying,
October 2001).

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Article 2: In the guideline, the concept of the human embryonic stem cells includes: the stem
cell derived from human embryos; the stem cell derived from human germ cells; the stem cell
derived from human germ cells; the stem cell derived from human blastula or monosexual split
blastula by the somatic cell nucleus transfer technique.
Article 3: Any research on the human embryonic stem cells inside the boundary of China should
be done in accordance with this guideline.
Article 4: Any research on human reproductive cloning shall be prohibited.

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Asia-Pacific Perspectives on Biotechnology and Bioethics

Article 5: The human embryonic stem cell used for research can be derived from: (1) spared
gamete or blastula remaining after IVF; (2) foetal cells after natural or voluntarily selective
abortion; (3) blastula or mono-sexual split blastula by somatic cell nucleus transfer technique;and (4) germ cells voluntarily donated.
Article 6: The conduct of human embryonic stem cell research must comply with the following
norms:(1) any blastula obtained by IVF, somatic cell nucleus transfer technique, mono-sexual
reproduction technique or genetic modification cannot be cultured in ex vivo for longer than 14days, since fertilization or nucleus transfer; (2) the implantation of any human blastula obtainedby IVF, somatic cell nucleus transfer technique to the human and other animal’s reproductive
system are prohibited; (3) the hybrid between human germ cells and other species germ cells is
prohibited.
Article 7: Buying and selling human gamete, fertilized egg, embryo and foetal tissue areprohibited.
Article 8: The principle of informed consent and informed choice, the signing of informed consent
and informed form and the protection of the subject’s privacy must be adhered to in the conductof human embryonic stem cell research.
Article 9: An ethics committee should be established in any institute which engages in humanembryonic stem cell research. Members of ethics committees must come from the fields of
biology, medicine, law, and social science. The main role of the ethics committee is to do scientificand ethical reviewing, counselling and surveillance on human embryonic stem cell research.
Article 10: Any institute which engages in human embryonic stem cell research should formulate
their own conduct guidelines and administration procedures in detail following this ethicalguideline (Chinese Health, Jan 14, 2004).

Disputes over ethical guidelines or regulations regarding HES cellresearch
Article one and Article three in the guidelines state: In order to comply the research of human embryonicstem cell in the field of biomedicine in China with the international bioethical guidelines and Chinese
bioethical guidelines or regulations, and to promote the healthy development of human embryonicstem cell research, this guideline was issued. Article three states: Any research on the human embryonicstem cells inside the boundary of China should be done in accord with this guideline. But a dispute didarise about whether or not to issue an ethical guideline for HES cell research in China.
In China the concern for ethical guidelines and the regulation on HES cell research came after a hybrid
embryo case in ES cell research which was reported widely in the Chinese media in September 2001.
At the same time there was a concern about whether HES cell research should be subjected to ethicalstandards. From the proceedings of the Xiangshan conference on life science policy and ethics andother meetings that address these issues, we know that some Chinese bioethicists and government
officials made great effort in description and prescription of the ethical issues, drafted the regulatory
recommendations and ethical guidelines, but some bioethicists, government officials and scientists andthe public voiced strong arguments against it.

An argument put forward was to respect the freedom of scientific research in any condition. Some
Chinese scientists in the field of life science argued that the freedom of scientific research should not
be violated. They said the freedom of the sciences, in a certain sense, could be proved by the historyof science. A scholar made his argument stronger by using the theory of Marxism that the moral
declaration should be based on the developing level of science and technology - that the moral values
should be changed following the development of science and technology. He pointed out that the
moral doctrines are results of historical processes and subject to scrutiny or revision.

Many life scientists, mainly researchers, supported this view, arguing for freedom of research. For the
majority of leading researchers in the field of stem cell research, both for the research reason and for its
value, the general opinion seems to be quite optimistic in supporting any kind of research on embryos.
Some Chinese scientists claimed that at the beginning of the scientific research when the benefit andrisks were not very clear, the scientific research should be without any extreme forbidden areas. But a few
leading Chinese scientists who have studied in foreign countries in the field of stem cell research agreed
that the stem cell scientific research should be conducted in conformity with ethical requirements, andhelp the bioethicists to understand ethical issues they have met in the practice.
The counter argument stated that there are dilemmas between scientific freedom and ethical constraints.
Science or technology is a double-edged sword, which could benefit humanity and at the same time
could do harm to humanity. There is no absolute scientific freedom, any scientific research should begiven an appropriate benefit/risk assessment to any involved elements.
Moral values do change following the development of science and technology, but the principles ofrespect, do-no-harm and beneficence will not change. Stem cell scientific research has to be conductedthat conforms to international ethical guidelines and requirements.

Ethical issues on the source of human embryonic stem cells
Article 5 in “ethical guidelines for research on human embryonic stem cells states: The human embryonicstem cell used for research can be derived from: (1) spared gamete or blastula remaining after In Vitro
Fertilization (IVF); (2) foetal cells after natural or voluntarily selective abortion; (3) blastula or monosexual
split blastula by somatic cell nucleus transfer technique; and (4) germ cells voluntarily donated.
Ethical issues on the source of human embryonic stem cells in China focus on how to protect thedonors, and how to execute the principle of informed consent in Chinese clinics. We have no exact
statistical figures about abortion rates, but it a fact that there have been many abortion cases in China
and the physicians could get the cadaver foetal tissue without the mother’s informed consent in certain
cases. Also, physicians could use frozen embryos or gametes remaining after IVF without the mother’s
informed consent. Such a situation should be outlawed.
There are a few government administrative documents relating to ES cell, cloning or human embryo
research in general. They are: “Procedures on safety of gene engineering” issued by the Ministry of
Science andTechnology, China, 1993; “Procedures of the Administration on IVF Technology” issued
by Ministry of Health, China, 2001; and “Procedures of the Administration on Sperm Bank” issued by
Ministry of Health, China, 2001.
In order to protect the donors of the source of human embryonic stem cells, surveys should be carriedout on units engaged in HES cell research and also on the current practice of IVF in China. We haveto know where these researchers and others get their biomaterial from. Where they taken from IVF
clinics, from early abortions, or donated by women with informed consent? Did the donors receive anycompensation? Who was in charge of obtaining the material (researchers themselves, IVF clinicians,
other parties?) Deliberately causing pregnancy for deriving stem cells, controlling of abortion of donors

Asia-Pacific Perspectives on Biotechnology and Bioethics

Some scientists involved in the 181st high policy meeting were outspoken supporters of freedom of
research on human embryos. They supported a strategy to adopt less restrictive guidelines such as inuse in the British, Australian, or Israeli regulations for embryo research. They mainly emphasized thepragmatic urge to obey the dictate of the global markets as well as to aggressively probe the economic
and medical promises of stem cell therapy and Chinese cultural integrity and national identity.

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or methods, and timing of artificial abortion by any means etc, should be prohibited. The voluntary
donation of reproductive cells should be done without economic compensation.

Ethical issues about the researched embryos
Article 6 in “ethical guidelines for research on human embryonic stem cells” states: The conduct ofhuman embryonic stem cell research must comply with the following norms: (1) any blastula obtainedby IVF somatic cell nucleus transfer technique, mono-sexual reproduction technique or genetic
modification cannot be cultured in ex vivo longer than 14 days, since fertilization or nucleus transfer;(2) the implantation of any human blastula obtained by IVF, somatic cell nucleus transfer technique tothe human and other animal’s reproductive system are prohibited; (3) the hybrid between human germ
cells and other species germ cells is also prohibited.
During the issue of this guideline, we know the Chinese government was aware of the benefit and valueof ES cell research. Human embryonic stem cell research has great potential value in effectively treating
various human diseases, maintaining and promoting human health and114

Asia-Pacific Perspectives on Biotechnology and Bioethics

it is good for millions of patients, families and society. Therapeutic cloning is a potentially important areaof research, particularly with regard to circumventing the problem of rejection of cell or tissue grafts.
Some leading stem cell researchers also expressed a concern that if embryo stem cell research is limitedby the government, the development of Chinese stem cell research will be held back. To back up thisassertion, the researchers cited the double standard used in both Germany and the USA. The double
standard is such that in the USA federal institutes observe one standard, but private institutes do not.
German law prohibits embryo research and embryo cloning within the state, but permits the import ofstem cells which are derived from human embryos outside the country.
The support given to research on embryos from the somatic cell nucleus transfer technique, and support
for human embryonic stem cell research under the condition that the embryo must be researched within
14 days is similar to UK standards which allow researchers to create embryos from IVF and cloning for
ES cell research. Also the Human Genome Organisation (HUGO) supported therapeutic cloning, but it isencountering objections from people in different countries.
Many Westerners think that such research is a very controversial issue. They believe that life is sacredand it is God's creation and that creation begins at conception. They believe that no scientist or person
can define the official day when life begins on the basis of physical progression. To separate a spirit froma physical body (in other words, to say that something is not “alive” yet) is something best left to God's
hands, in their view.
The Catholic Church and Right to Life organizations in Australia oppose the creation of embryos forresearch. They said it is the same as dismembering embryos, embryo farming, cannibalising embryos,
etc. Marcia Riordan of the Catholic Archdioceses of Melbourne said: “There is no need to kill somepeople to cure others.” 1 In May 2002, at the Council of Australian Governments’ Conference, the prime
minister and state premiers decided to legislate that Australia adopted the most conservative of the
defensible positions to only allow derivation of new ES cell from spare embryos but not from IVF or
cloning, because there is no creation of embryos by IVF for research.
There were some objections from scientists and scholars in China. They argued that HES cell researchshould be forbidden because if human beings go against natural law, human beings will be punished bynature. HES cell research violates human dignity and this is a big challenge to human life, they argued.
But the majority of bioethicists from China argued that an embryo is not a person. They said an embryo
has a certain value and it still deserves due respect, but if there are enough valid reasons, it can be used
for research.
The majority of bioethicists from China argued that a human embryo cannot be manipulated or
1 Herald Sun December 4, 2001, p.17

damaged without sufficient reason and it is wrong to deliberately create and destroy embryos forresearch. Destructive embryo research should only be approved in exceptional circumstances, theysaid. They also put forward the view that stem cell research has the potential to revolutionise medicine
and save millions of lives and they said scientists are responsible for people who die while research isdelayed.
Some bioethicists claimed that a 14 day old embryo can be used for research. They argued that a 14 day
old embryo is a cluster of cells without bones and organs and that an embryo only has consciousness
after around 20 weeks.
Some scientists supported using embryos to do research within 14 days, and they even said that toobject to embryo research is inconsistent with values implicit in society, because there are so many
abortions in mainland China.

Regarding the public view in China, ethical issues about embryo research was not an issue about
supporting or objecting to researched embryos within 14 days or not, nor an issue about the statusof embryo, foetus or infant. What made them supportive was the view that the research is valuable
and worthy to protect patients. They thought a sufficient reason was that human embryonic stem cellresearch has potential value in treating various human diseases and relieving millions from suffering.

Ethical issues about the hybrid research between human cells andother species cells
Article 6 in “ethical guidelines for research on human embryonic stem cells” states: The hybrid between
human germ cells and other species germ cells is prohibited. But this Article does not say the hybrid
research between human somatic cells and other species cells is prohibited.
One famous case of the hybrid embryos research occurred in China in 2001. On September 7, 2001,
a report was published in the Beijing Youth Daily: Professor Chen Xigu in the Experimental AnimalCentre of Sun Yat-sen University, transferred a skin cell nucleus from a seven-year-old-boy into a rabbit’s
denucleated egg, and created an embryo. He had been able to grow the hybrid embryos only to thestage at which they remain a cluster of undifferentiated cells; he was far from his goal of extracting stem
cells from the embryos and turning them into treatments. For some reasons, he stopped his researchsoon after the report was printed in the newspaper.
This was the most controversial case at that time. After Professor Chen’s case, stem cell research occupied
a prominent position in the Chinese media. Two days after the case was reported, four scientists fromThe Chinese National Human Genome South Centre published their views in the newspaper. They
pointed out that Professor Chen’s case violated human dignity and this was a big challenge to human
life. A director of the Chinese Academy of Medical Sciences told the media that such a mixed embryo
would harm the safety of human beings and violate social ethics.
A senior scientist said that when we are not able to respond to biomedical selection, we are not able torespond to the social and moral difficulties connected with bioengineering in any responsible way. If we
do something we do not really understand, this is dangerous to human beings in the future.
Regarding the hybrid or chimera issue, there is a difference between the Beijing draft of ethical principle
and regulatory recommendation on HES cell research, and the Shanghai draft of ethical code on HES
cell research. The Beijing draft said that on the basis of human dignity arguments, creating a hybrid orchimera by the use of the fusion of human and animal embryo, or the hybrid between human and animal
gamete should be strictly rejected and can only be done if there are sufficient reasons, permissible bygovernment guidelines.
However, the Shanghai draft allows creating a hybrid within 14 days for non-clinical treatment research.

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Also, opposition to the use of spare embryos from IVF is the same as opposition to IVF, because frozen
embryos could be destroyed. Infertile couples are permitted to destroy unwanted embryos rather thandonate them to other couples.

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The Shanghai draft said the chimera between human nucleus and animal mitochondria is permissive if
it is an embryo produced within 14 days for basic scientific research, if it is for the patient’s benefit andit is not an embryo produced by reproduction cloning. However, production derived from hybrid orchimera research and used in clinical treatment is prohibited (Qiu, 2001).
We found existence of hybrid embryo research in China. Some scientists attributed this to insufficienthuman eggs to meet the needs of the proposed research. Now, if the hybrid research and egg donation
are allowed by the “guideline for future stem cell research”, the ethical issue of hybrid turns to how
to guarantee the protection of women rights who donate the germ cells voluntarily. Unlike sperm
donation, donating eggs is an invasive medical procedure with physical, psychological and social risks
for women.
From some Western perspectives, the profit made from women's eggs by third parties makes thisinvasive medical procedure unacceptable. When we know that donated egg cells are already short in
supply for research, we worry that incentive issues will be created in order to gain enough egg cells fortherapeutic cloning, even for a hybrid or a human embryo. So when this guideline is executed, how toprotect the women’s body and rights in society must be taken into account.

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Issues on IRB (Institutional Review Boards) or Ethics Committees
Article 9 in “ethical guidelines for research on human embryonic stem cells” states: An ethics committee
should be established in any institute which engages in human embryonic stem cell research. The
members of the ethics committee must come from the fields of biology, medicine, law or social science,etc. The duties of an ethical committee are to carry out scientific and ethical reviews, counselling andsurveillance on human embryonic stem cell research. Article 10 in the guidelines states: Any institute,which engages in human embryonic stem cell research should make the own conduct guidances andadministration procedures following this ethical guidances.
In reference to Article 9 and 10, we agree that “the ethics committee should be established in any institute,which engages in human embryonic stem cell research” and “any institute which engages in humanembryonic stem cell research should make the own conduct guidances and administration proceduers
in detail following this ethical guidances”, but considering the situation of Chinese ethics committees, if
stem cell research is only a review by their own IRB, we bioethicists question how to guarantee stem cellresearch? We think there is not only an urgent need to create such ethic committees, or the IRB, but alsoa need to establish a central institutional review board.
The central IRB or ethics committee should authorize and give approval to institutes which engage inhuman embryonic stem cell research and review the conduct guidelines and administration procedures
made by the institutes which engages in human embryonic stem cell research. The institutes, which
engage in human embryonic stem cell research should submit an application to a central institutional
ethics committee or the Ethical Committee of the Ministry of Health China for approval.
Few units engaged in HES cell research have an IRB, so the situation of Chinese ethics committees
is a mixed bag. The Beijing and Shanghai ELSI committee of the Human Genome Project has beenworking well and has produced recommendations on some issues. The Ministry of Health has an ethics
committee, which has worked on administrative ethical guidelines on IVF, sperm banks, stem cell andthe use of genetic material.
But other ethics committees may be in a different situation. There are ethics committees in large medical
universities and big hospitals. Many of these committees only review operated proposals and do nothave much deep discussion of medical ethics issues. They have little involvement in medical encounters.
Many members also have insufficient training in ethics to analyze the issues.
An issue has arisen over Article 9: “The members of the ethics committee must come from the field of
biology, medicine, law or social science, etc.” Why are bioethicists absent in the stated members of the
ethics committee? And there are no articles in the guideline about certain requisites on the qualification
requirements of research personnel, technological equipment, administration in HES cell research
institutes, etc. Also, there are no penalties imposed on researchers or institutes that disobey ethicalguidelines on stem cell research. We bioethicists have posed such questions to the Ministry of Scienceand Technology and the Ministry of Health, China. We are hopeful that the guideline will be revisedsoon.
We hope that the ethical guideline issued by Chinese ministries can be operational and meaningful forcontrolling stem cell research in China. Because the ethical guideline is not a law, ethical guidelines haveno legal force, but as a regulation, it seems to have power to force scientists to follow the guidelines. But
if there is no punishment and there are no bioethicists within the ethics committee the guidelines andrequirements can only create a moral pressure on the scientists involved in research.
In view of the rapid development of stem cell research in China, it is noteworthy that only a few
bioethicists were invited to the 2002 and 2003 international symposiums on stem cell research. Amongthe nearly 400 leading scientists who attended both symposiums, very few scientists paid attention to
ethical principles. So we bioethicists must call for all researchers to follow the ethical guidelines.

References
Xiangxing Qiu. 2001. Studies on Human stem cells and some Related Ethical Issues, Medical andPhilosophy, Dalian, October 2001, Vol.22, No. 10, pp. 54-58.
Yanguang, Wang. 2003. A Study on Genetic Ethics in Contemporary China, Beijing Institute of Technology
Press, Beijing, November 2003, pp. 199-201.
Yanguang, Wang. 2003. Chinese Ethical Views on Embryo Stem (ES) Cell Research”,Asian Bioethics in the
21st Century, Eubios Ethics Institute, Japan, pp.49-56，2003b.
Xiaoyan, Ying. 2001. “Chinese Government objects Human Cloning Clearly.” Beijing Evening News (3),Beijing, 13 November 2001.

Asia-Pacific Perspectives on Biotechnology and Bioethics

We hope the Ministry of Science and Technology, and the Ministry of Health, China will work out quickly
about how to revise the guideline, how to plan the creation of a central and unit IRB and how to train
IRB members ethically. The most important thing is how the “ethical guidelines for research on humanembryonic stem cells” is implemented in detail.

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What are the points in the human cloning debate? Aview from the Buddhist religion*
Somparn Promta, Ph.D.
Chulalongkorn University,
ThailandOne of the most basic beliefs of Buddhism is that proper questioning leads to proper answers. From
this principle, the ethics of Buddhism can be viewed as the ethics of questioning. So, to get answers to
ethical questions we must post the question: What is a proper approach to the given subject? In thispaper, the debate over human cloning will be explored through the principle of Buddhism as follows:

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1. ‘Naturality’ or ‘unnaturality’ is not the problem
The debate over human cloning (or any kind of cloning) normally involves a discussion about its
unnaturality. Some of the arguments against human cloning state that it is “unnatural” in a sense that
it is not provided by nature. Some people who believe in God might think that anything unnatural isdangerous. They might believe that human cloning is immoral, as it is not provided by God, and thathumans who clone humans are “playing God”. This is considered dangerous because man has limited
knowledge compared to the omniscience of God. So, it is seen that human cloning is done on the basisof ignorance and could thus greatly harm the future of humanity.
Some scientists who support human cloning state that it should not be viewed as unnatural because
there is a form of cloning permitted by nature — identical twins. According to these scientists, humancloning performed by scientists can be viewed as the making of identical twins. The difference is merelythat natural identical twins are those who carry the same ages, while artificial identical twins are ofdifferent ages. From this view, human cloning is not an immoral action because it is natural, in the sensethat it follows the law of nature as found in the case of natural identical twins.
For Buddhism, morality can be separated from the issue of “natural” versus “unnatural”. Buddhism breaks
it down such that if any action is attributed to be morally good or bad, that attribution depends solely on
the moral properties within. Actually, nothing is unnatural according to Buddhism. Buddhism believes
that nothing is beyond the Five Laws of Nature.
Humans, according to Buddhism, are a natural thing. When a person creates something, it is counted by
Buddhism as natural. So, natural things could be categorized as: (1) Things not created by humans, and(2) things created my humans. Between these two categories, there is no difference in terms of ethics.
That is, some natural things are good, and some are bad; likewise, some of what was created by humans
is good, and some is bad. “Good” and “bad” does not correlate to “natural” and “unnatural”.
Moreover, Buddhism accepts that nature has a long history and that humans, in their present form,
have a comparatively short history. However, there is some potentiality in man that cannot be found innature: Consciousness and intelligence (a.k.a. wisdom).
Through consciousness, man learns to solve problems that would otherwise take a long time or be
impossible for nature alone to solve. If a person breaks an arm, surgery is done to heal it — the surgery
is performed by humans, but nature actually joins the broken bone. So, it can be said that in the joiningof the broken arm, two things are equally needed: humans and nature. Thus, the two work together.
According to Buddhism, the view that only “natural” phenomena can be trusted is an extreme stance.
Likewise, the view that humans can dominate nature or do anything unconditionally is also extreme.

* Paper first presented at the First UNESCO Bangkok Bioethics Roundtable, September 2005

2. The harm principle
The harm (a Pali word is: vihimsa) principle is one of the major criterion used by Buddhism to assess
moral events. This principle states that any action that harms oneself and/or others is counted as
morally wrong. Human cloning is a complex issue that should be explored on a case-by-case basis.
What follows is a Buddhist view on the matter, via the harm principle. Human cloning involves action
from man and nature. The next point to be considered is: under what circumstances can the cloning of ahuman being be viewed as morally permissible, and under what circumstances can it be viewed morally
impermissible. At this point, the Buddhist principle of harm can serve the problem.

The second kind of harm (harm to another) can also be of the two above types. Normally, in a free society
such as a liberal democratic one, some personal harmful actions can be tolerated by the law of the given
society. Drinking beer, for example, is a harmful action in the first category; but this kind of action istolerated by the law in Buddhist countries because it is viewed that the law should focus on only serious
harmful actions. Using drugs is prohibited by law in Buddhist countries because the harm caused bydrug use is more serious than caused by beer consumption. So it can be said that, according to Buddhist
morality, “personal freedom” does not cover personally serious harmful actions in terms of both physicaldamage and damage in the dimension of human dignity. Harm to another is more obviously viewed asa wrong action, no matter if it is in the realm of physical damage or human dignity damage. However,
the intention behind an action plays a significant role in the Buddhist system of moral judgment; any
investigation of harm to another cannot be done without considering the doer’s intention.
To apply the harm principle to the issue of human cloning: it seems that the first thing to be questioned
is: can human cloning be interpreted in terms of harm? It is clear that the cloning of a human being inmany cases is open to question. For example, a man clones himself to use the embryonic stem cell. In
such a case, can we say that it is really a personal matter, implying that the harm principle which canbe used for this case is the harm to oneself only? According to Buddhism, a clone is a person at the first
moment of fertilization, so it is very difficult or impossible to locate human cloning within the area of
personal activity. It seems obvious that the harm in the case of human cloning is the harm to others.
However, this does not mean that any case of human cloning is viewed by Buddhism as the harm toanother individual. Buddhism merely says that if human cloning possibly causes the harm, the kind ofharm in this case is the harm to the other party. Simply speaking, Buddhism does not accept that humancloning can be understood in terms of personal activity.

3. The principle of analysis
Sometimes the Buddha identifies Buddhism as ‘‘a religion that teaches analytical morality.’’ The term‘‘analytical morality’’ is roughly a translation of the Pali word vibhajja. The term, as understood among
Buddhist scholars, denotes a system of thought that does not look at the world through ‘‘black or white
separation.’’ Actually, Buddhist logic or Buddhist epistemological outlook has criticized the ‘‘black orwhite logic’’ as found in the work of the great thinkers such as Aristotle. Applying the principle of analysis
to the case of human cloning, the advice from Buddhism is: Firstly, to assume that all kinds of humancloning are solely right or wrong is not valid. Buddhism considers any events in the world in terms ofcomplicated things; some may be less complicated while some events are much more complicated.
Analysis will reveal the proper way to deal with specific events. The idea of cloning a human being
originated from the human mind, and the human mind must always hide some reasons for thinking insuch a way. Looking at it from this point of view, it could be that in some cases the human mind’s role in

Asia-Pacific Perspectives on Biotechnology and Bioethics“The harm” in Buddhist teaching can be divided into two main categories: to harm oneself and to harm
another. Harm to oneself means the action intentionally performed by a person. That action harms the
person in two ways - physically, and dignity-wise. Taking intoxicants is prohibited by the fifth preceptof Buddhism. It is prohibited on the grounds that ingesting alcohol causes physical harm. Selling bodyorgans, such as a kidney, could be viewed as harm in terms of dignity. The person who does such a thing,no matter what the reason, could be viewed as not respecting their own status as a human being. They
treat their life as if it were a product that can be sold. This interpretation makes it possible to state thatthe sale of human organs is harm in the second meaning, as stated above.

119the bid to clone human beings comes from good intentions, while in some cases everything is directedby bad intentions. So, what we must do is analyze the given case and find the details inside.
As said previously, Buddhist ethics are the same as analytical ethics. After a process of investigation
it could be argued that the cloning of a human being is not harmful to anyone and in such a casethe cloning of a human being is tolerated by Buddhist ethics. The problem is when we talk about theconcept of harm in the Buddhist view, such harm is involved only with the person, or the harm can beextended to a society. This question is important because some arguments against the cloning of humanbeings state that it could be possible that we cannot find the obvious victim of harm in the cloning of
human beings in terms of the individual, but it could be said that society is harmed by allowing such apractice.

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Legal moralism, as presented by legal philosophers such as Patric Devlin, is of the view that one of the
major structures that support the existence of society is the moral structure. Mr Devlin argues that eventhough drinking intoxicants can be viewed as a personal freedom, we should take the view that if the
majority of members of a society habitually take intoxicants, then that society must be weak. In thiscase, intoxicants cannot be viewed in terms of freedom only. It can be related to the moral structure ofsociety as well. Human cloning considered in this light of thought could be viewed as a harmful action
to the society, even in the case where we think that everyone involved is happy and no individual isharmed at all.
One of the Five Laws of Nature taught in Buddhism, the Law of Dhamma (a Pali word is: Dhammaniyama),
partly seems to share the latter view. In Buddhism, moral tendencies found in a society affect the wellbeing (or not) of people in that society. In short, Buddhism promotes the view that human society is notjust a place where people gather and produce only what is mutually beneficial - on the contrary, society
has the spirit and the common ideal to meet certain moral standards. We are not just living, but we areliving a good life as a noble human being. However, the moral structure that supports the existence of asociety in the Buddhist perspective must be identifiable, not merely an abstract imagination. One thingthat helps us to reduce the degree of abstract imagination is to relate the moral structure of the society
to what individuals do. The cloning of human being in terms of totally free business can be viewed as
something that points out the level of morality in the minds of the people. So, in this case we can saythat allowing human cloning affects the moral structure of society. As the actions of individuals in asociety are related to law in a sense that the law must determine what kind of actions can and can’t bedone, so the law followed in the society can be partly viewed as an indicator of the moral structure ofthat society as well.
Social necessity is a norm Buddhist ethics tolerates in certain cases. For example, Buddhism teaches usthat killing is evil; but Buddhism never teaches against having an army. Reasonable capital punishment
is sometimes interpreted by Buddhist thinkers as a social necessity, implying that it is tolerated to exist
or be legal in a Buddhist community.
Suppose we can rationally prove that the cloning of a human being is a social necessity, Buddhist ethics
seems to tolerate it as revealed in the cases already discussed. The analysis of the context and surrounding
data will help us to classify the various categories of human cloning, of which some categories can meetthe properties tolerated by Buddhist ethics.
At this point, we will find that human cloning is an open-end subject in the Buddhist community,
meaning that some doors are open to the possibility of allowing human cloning in a Buddhist society.
We must determine the reasons as to why this should be allowed?

4. Social and individual dimensions of ethical problems
However, if we accept that a community is shared by different members, of which some are bad andsome are good; the understanding of Buddhist ethics in terms of personal dimension only will leavesome problems remaining. How to judge the cloning of a human being may not be a problem for theenlightened members of a community, but it may be greatly different for the unenlightened ones.
Without the rule or law, it can be possible that sometimes the unenlightened members of a community

will harm others intentionally or unintentionally. The word “other” in this context certainly covers theembryo or the child to be cloned.
Summarily speaking, Buddhism admits that the issue of human cloning, viewed from the two approaches
already discussed, needs an understanding of two dimensions of ethics. Basically, Buddhism takes
the view that ethical problems given to an enlightened person will be properly solved; so this is why
moral education is highly prized by Buddhist ethics more than the attempt to set up the rule of law.
Even though the law is accepted by Buddhism as something important, it is also viewed by Buddhism
as something that should be critically examined as much as possible before it is put into practice. In
Buddhism, to have a law that totally prohibits any kind of human cloning does not mean that all the
problems are solved. Likewise, it does not mean that between two societies, one of them allowing thecloning of a human being and one not, the former is bad while the latter is good. The point is the reason
and explanation behind allowance or non-allowance. This concept is very important.

One of the basic features of Buddhism is that freedom is highly valued. The principle of freedom in
Buddhism is closely related to its humanistic tendencies, which is generally found in Buddhist texts.
There are two meanings of freedom. The first is positive meaning and the second is negative meaning.
The positive freedom means freedom to do something. The negative freedom is freedom from theprevention that does not allow us to do something. Ultimately these two meanings are undividedly
related to each other. Buddhism does not think that all forms of freedom are right. It is merely some kindof freedom that is valuable. Freedom in the Buddhist perspective can be both the means and the end.
An enlightened person in the Buddhist view is the free one. He is free in two senses. Firstly, he is free ina sense that he is not under the influence of anything especially the desires which Buddhism considers
to be the blind forces that push sentient beings into the struggle for things.
Secondly, he is free in a sense that his actions are totally pure. This kind of person can never harm
anything. We will see that freedom as the highest quality of life is the end. In the Buddhist perspective,the end and the means must share some basic nature. Freedom as the means will support freedom as
the end. This is why in Buddhism the religious dogmas are less influential. The Buddha gives the freedom
to his disciples even to argue against what he has said. It could be said that the first kind of freedom(methodological freedom) is required to attain the second kind of freedom (ultimate freedom).
In the Buddhist community, personal freedom of the believers is accepted through social tolerance oversome kinds of evil. For example, even though the Fifth Precept says that taking intoxicants is wrong,
intoxicants still can be sold in the Buddhist community. This does not mean that Buddhist ethics accept
that it is freedom of Buddhists to take these things. It just means that to have freedom to freely learn
about moral lessons in one’s life is needed to be a free person in the future. Taking intoxicants is always
wrong, but it might be worse if a society does not give freedom to members of the society to learn
lessons by themselves.
Applying the principle of freedom to the cloning of human beings, two things should be considered.
The cloning can be viewed both as an activity and an object. Cloning in terms of activity means thatit reflects an attempt by scientists to search for something which aims to advance scientific research.
Cloning in terms of the object means that it produces something and puts that thing into society. It
seems that the debate over human cloning stresses the second meaning of the term. We look at the
product resulting from the process (the clone) and say: Should we tolerate this kind of thing? It may bepossible that the most important meaning of the term is the first one. The serious question then arises:
Should we tolerate an attempt to search for something valuable in terms of scientific advancement in
the name of human cloning?
The history of science has recorded that something we had feared at the beginning was proved by time
not to be wrong. The technique of fertilization (IVF) was initially feared because some thought it would
produce a monster without a human soul. Nowadays, such a fear becomes dust in the wind. The processof learning something does not necessarily end up with pleasurable results. But if we are not free tolearn, how shall we know what is right and what is wrong?

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5. Principle of freedom

121Conclusion

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Buddhism believes in human wisdom and considers the history of humankind in terms of the learning
process. Wisdom includes knowing to stop at the point which the inner moral whisper advises theindividual to stop. However, the inner moral whisper about something never occurs without serious
study of that subject. The serious study of any subject can never occur without freedom to study. Today
we have many views about human cloning, some of them are negative and some are positive. The
problem is: Should some kind of imagination be the dominant idea, under which the real study of thesubject must be aborted? There can be different answers to this question. But it seems the view of
Buddhism is that a study should not be aborted just on the grounds of negative views beforehand.

Shareholder-focused utilitarianism support forcorporate social responsibility*
Glen Kurokawa, J.D.
CanadaCorporate social responsibility (CSR) is a frequently heard and used term. Although somewhat ill-defined,
it is roughly taken to be “an expression used to describe what some see as a company’s obligation to
be sensitive to the needs of all the stakeholders in its business operations” (Wikipedia, 2006). A broader
definition is a “company’s commitment to minimizing or eliminating any harmful effects and maximizing
its long-run beneficial impact on society” (Mohr, et al., 2001). Thus, CSR can include a wide spectrumof activities: human rights, labour standards, environmental management, consumer protection, anticorruption, and corporate philanthropy, to name but a few.
One of the issues in CSR is over its ethical justification. Conservative perspectives generally shunactions which are not profitable for the corporation, while liberal ones provide ethical justification formany unprofitable CSR activities. This paper introduces a shareholder-utilitarian perspective to thedebate, which addresses the concerns of conservatives, yet may provide justification for liberal CSR
prescriptions.
The organization of this paper is as follows. The first part of the paper reviews conservative and liberal
stances on CSR. Next, shareholder-focused utilitarianism is introduced and justified for ethical analysis.
The final part examines implications of this perspective.

Conservative and Liberal views of CSR
The conservative view takes a more pro-shareholder position in relation to the liberal view. Twoconservative views are those of Friedman and Lantos. Milton Friedman’s Capitalism as Freedom, frequently
cited as the epitome of this view, is summed thus: “There is one and only one social responsibility ofbusiness – to use its resources and engage in activities designed to increase its profits as long as it stays
within the rules of the game.” The “rules of the game” are “those embodied in law and those embodiedin ethical custom.” More recently, Lantos (2001) argued that purely altruistic CSR, or “interest in doing
good for society regardless of its impact on the bottom line”, is unethical. In the conservative view,
actions which are taken to benefit society and profit the corporation are ethically permissible, but
actions that are taken solely to benefit society without providing profitability are considered unethical.
The conservative view is one that is very concerned about the shareholders; actions that lead to greater
shareholder returns are encouraged, and those that do not are discouraged.
Several reasons have been cited in support of conservatives – some are summarised here. First, byengaging in unprofitable CSR activity, “The corporate exec­utive would be spending someone else's
money [the shareholder’s] for a general social interest” (Friedman). Second, individual shareholders
could spend their portion of corporate dividends in a manner most satisfying for each shareholder,rather than through the corporation, which would have to balance the interests of all company
shareholders. Third, the corporation must decide how “to spend the proceeds – all this guided only
by general exhortations from on high to restrain inflation, improve the environment, fight poverty
and so on” – a difficult decision compounded by the corporation’s lack of expertise in general welfare
issues. Fourth, in democratic welfare states, mechanisms already exist for dealing with many CSR issues.
Elections provide an inlet for citizen participation and public choice in welfare issues; taxes provide a
wealth-redistributive mechanism; and laws and regulations, with democratic input, provide rules to* Paper first presented at the Second UNESCO Bangkok Bioethics Roundtable/Eighth Asian Bioethics Conference,
March 2007

Asia-Pacific Perspectives on Biotechnology and Bioethics

Introduction

123constrain corporate behaviour.
The liberal view adopts a more pro-society perspective. Three liberal views are those of Bowen, Prestonand Post, and Sacconi. Howard Bowen, in Social Responsibilities of the Businessman, triggered a push for
greater CSR. The rationale was simple: businesses were influential; with influence came responsibility. “Itrefers to the obligations of businessmen to pursue those policies, to make those decisions, or to follow
those lines of action which are desirable in terms of the objectives and values of our society” (Bowen,1953).

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A further push for CSR is given by Preston and Post, in The Principle of Public Responsibility (1979), who
employ a “public policy” rationale: “Public policy includes not only the letter but also the spirit of thelaw, as well as the societal values and commitments reflected in that spirit” (Preston and Post, 1979).
The values that Bowen, Preston and Post refer to may be beneficence, justice, altruism and others that
may or may not be derived from social norms. The third liberal perspective emerges as a version of
stakeholder theory. Sacconi (2006) uses game-theoretics to derive a social contract for the firm:
It is evident that if fiduciary duties attach only to ownership, those stakeholders without residual
right of control will not be protected by the fiduciary duties of those who run the firm… Various
stakeholders will ex ante have a reduced incentive to invest (if they foresee the risk of abuse),
while ex post they will resort to conflicting or disloyal behaviour….in the belief that they arebeing subjected to abuse of authority. In the economist’s jargon, this is a ‘second best’ state ofaffairs (less than optimum): all governance solutions based on the allocation of property rights toa single party may approximate social efficiency, but they can never fully achieve it.
While the ethical positions reviewed here are often complicated, it is possible to envision a unidimensional ethical spectrum of CSR, with a “purely” conservative position on one end, and a “purely”
liberal view on the other. The purely conservative position is deduced from the collection of conservative
positions reviewed above: It prescribes pure profit-maximization. Any and all business activities
must be profit-maximizing to be ethical. The purely liberal position is deduced from the collection ofliberal positions. It prescribes mandatory activities for social benefit, regardless of whether it is profitmaximizing or even profitable.

Shareholder-focused utilitarianism (“SFU”)
Utilitarianism is one of the major ethical theories and there are several variations that can be applied.
Different versions may prescribe different outcomes. The utilitarian perspective used in this paper(“shareholder-focused utilitarianism” or SFU) assumes four features in addition to the common utilitymaximization imperative.
First, SFU’s concern is with maximizing shareholder utility, rather than that of society (hence:“shareholder-focused”). While it is more conventional to use societal utility, this is not done for several
reasons. First, SFU assumes the most distinguishing criterion of the conservative position, that of strong
private property rights. Second, it is designed to make the utility calculus more manageable in the restof the analysis. Third, SFU avoids the criticism that the corporation spends money for society at theexpense of shareholders. Fourth, societal utilitarianism would need to explain the inadequacy of laws
and institutions (e.g. securities laws, corporate taxation, tax-funded governments and programmes)
which are already designed to handle societal utility given political realities. SFU avoids this difficulty.
Basically, the shareholder-orientation of SFU allows us to accept relevant laws/institutions as they are,without revision.
Second, preference utilitarianism is used. Utility is to be preference satisfaction. That is, utility increases
when the preferences, rather than happiness or other measures, are advanced. In non-preference
utilitarianism, shareholders, if unaware of CSR activities in their companies, do not benefit even if theywould have liked the company to have carried out (in other words, prefer) those CSR activities. In contrast,
preference would measure CSR activity as a benefit to shareholders, (1) if they prefer it, (2) even if they
are unaware of the CSR action. This creates a deeper link between shareholder utility and CSR, because
it adds/subtracts to shareholder utility regardless of whether it is reported or whether shareholders areaware of such actions. Moral philosophers Singer and Hare (Wikipedia 2006) supported this feature ofutilitarianism.
Third, rule utilitarianism is observed to collapse into act utilitarianism. More specifically, rule utilitarianism
may be a subset of, or equivalent to, act utilitarianism.
Fourth, negative utilitarianism is incorporated. Negative utilitarianism “requires us to promote the least
amount of evil or harm, or to prevent the greatest amount of harm for the greatest number” (Wikipedia,
2006). It is not incorporated wholesale, as it still keeps the positive utility aspect, i.e. positive utility is
still part of SFU. However, relatively greater weight is given to harm vis-à-vis benefits than in “normal”
utilitarianism. The prevalence of risk-aversion indicates relatively greater weight is given to negative
utility than positive utility.

Justifying SFU

Second, other ethical perspectives (especially those used in business ethics) can be reduced to, or
found to be the equivalent of, SFU. For instance, the business perspective of CSR is framed in terms
of profitability (Capaldi, 2005; Prout, 2006), rather than utility. Yet, profitability is an approximation ofutility. While it may be a very effective approximation, it is still only an approximation. We can frame thedifference between profitability and utility as one between rule and act utilitarianism, respectively. Thatis, profitability is the rule, and utility the act. By approaching business with SFU, we approach CSR froma more fundamental perspective1. Another example concerns societal duties, such as those cited by theliberal perspective, which may also be reduced to SFU. If they are formulated as ‘rules’ such as values (i.e.
beneficence, justice, altruism), then they may be reducible to rule utilitarianism, thus being formulated
in terms of SFU. These values can also be formulated in terms of act utilitarianism as preferences.
SFU is not without criticism, however. First, utilitarianism involves unquantifiable values and utilitariancalculus is difficult. However, the same kind of issues are involved in financial accounting. Numericalvalues being sought in financial accounting, such as profitability of enhanced corporate reputation, may
not be quantifiable or involve large statistical uncertainties. In most – if not nearly all – cases, CSR deals
with such difficult-to-quantify variables. Often, only opinions and estimates are available; yet these arewhat utilitarianism also employ. If such variables are difficult to quantify, the calculations for them also
become difficult to accurately quantify; thus, financial accounting – the best alternative to utilitariancalculus – may not offer significant advantages over SFU.
Second, there may be decreased transparency from using utility rather than profit. With the latter,shareholders can see the estimated values for variables such as the ‘benefits from enhanced corporate
reputation’’; they may disagree with the estimated values and use this as information for further action(e.g. voting or selling/keeping shares), however imprecise or inaccurate such values are. With utility,
there may not be transparent accounting. However, annual reports and sustainability reports contain
information that can allow each investor to estimate utilities. For instance, the amount and variety ofenvironmental pollutants emitted by a company, described in its sustainability report, may allow eachshareholder to decide whether or not to change their voting behaviour or whether to sell or keep theirshares. Thus, utility approaches like SFU may not suffer from decreased transparency.
Third, the “stockholders or the customers or the employees could separately spend their own money on
the particular action if they wished to do so” if dividends were distributed. This may increase shareholder

1This is not to say that business is exclusively concerned with profit; indeed in many instances business does take autility perspective. However, the predominant concern of business is assumed to be that of profit, while the nearexclusive perspective of utilitarianism is that of utility. Thus, business concerns are more fundamentally approached,relatively speaking, from a utilitarian perspective.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Reasons exist to justify SFU as a valid ethical perspective. First, the core moral theory is utilitarianism,
which is a long-established moral theory. Most of the concepts used in the SFU assumptions, including
preference, the relationship between rule and act utilitarianism, and negative utilitarianism, are drawn
from prominent moral philosophers.

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utility to a level higher than in the resolutions above. The subset of shareholders who want a specific
CSR action (e.g. environmentalism) could setup their own non-profit association or fund an existing
one that already deals with their concerns, without imposing negative utility on unwilling shareholders.
However, there are many cases where such dividend distributions are not SUM, as explained in thefollowing paragraphs.
Shareholders may prefer CSR which can only be obtained through their invested company. For instance,
they may prefer stringent human and labour rights for their company. Such actions lead to SUM andwould be ethically prescribed under SFU.

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Tax laws and regulations may provide incentives to favour company-coordinated CSR. Dividends may beheavily taxed; some countries impose such taxes so that corporations re-invest their profits. There may
be corporate tax breaks on charitable giving; many countries wish to promote such CSR. If shareholder
utility is maximized as a set for a given corporation (i.e. negative preference utilities outweighed bypositive preference utilities) for a given CSR action, shareholder utility can be maximized. Shareholder
utility is maximized despite dividends not being distributed.
The company could be engaged in CSR activities that lower coordination and information costs.
For instance, there may not currently exist a CSR philanthropy programme that shareholders prefer,
but for which coordination costs are large for individual shareholders yet smaller for each individual
shareholder if coordinated by the company. Such advantages are numerous for companies, which would
require time and effort on the part of shareholders to overcome. For instance, they may have numerous
connections with charity organizations and expertise that can be “borrowed” from the company for its
CSR purposes.
Fourth, there may be concerns that corporations that use SFU may be subject to takeovers. Corporations
which engage in altruistic CSR may, despite SUM, have un-maximized share prices. That is, corporations
or private entities such as corporate raiders may find profitable opportunity in purchasing such “altruistic”
target companies and make them more profitable, increasing their share prices, and possibly sellingthem off. In very efficient markets, the argument goes, altruistic (or any non profit-maximizing) CSR may
cease to exist because such companies will either be taken over, or pressured to maximize profitability
to prevent takeovers.
While altruistic companies that do not follow something similar to SFU by appealing to the interests ofshareholders may be subject, SFU is not. SFU prioritizes shareholder interests, and any “SFU corporation”
engaged in altruistic CSR is actually optimizing shareholder interests through SUM. Thus, any takeoverbid will not be approved by shareholders, unless SFU has not been strictly adhered to. Exogenous forces
such as laws (i.e. securities and mergers and acquisitions) may alter incentives, but we assume here
market-oriented rules. And of course, takeover bids could still occur on the basis of perceived inefficiency
elsewhere in the corporation.
This argument can be strengthened. Shifts in corporate ownership distribution occur if corporations
were to adhere to SFU. Corporations which engage in more purely altruistic CSR, for instance, will attract
more investors interested in CSR. These investors’ individual utilities increase with share purchase.
Other investors of the company, whose individual utilities decrease, will sell their shares. The result is achange in corporate ownership distribution. Furthermore, this change leads to greater SUM potential
due to more shareholders who are receptive to altruistic CSR. To actualize SUM then, the corporation
will undertake slightly further altruistic CSR actions. This repeats until a stable (and more efficient)distribution is achieved.
The result of this process is that corporations which are engaged in altruistic CSR will not only havea set of shareholders who are in favour of its CSR actions, but also a greater proportion of individual
shareholders who are in favour of it. Without this shift in ownership, individual shareholders who do notsupport altruistic CSR may have been negatively affected by the corporation’s CSR actions. With the shiftthen, corporate takeovers of “altruistic corporations” are even less likely to occur.

Altruistic, strategic, and ethical CSRWith SFU, the ethical implications are different from those of conservatives and liberals; they are likely
somewhere between these two perspectives. To explicitly show how SFU finds itself in the ‘middle
ground’, we adopt Lantos’ (2001) classification of CSR into altruistic, strategic, and ethical and show how
the three perspectives deal with each CSR type.
Altruistic CSR is defined as “interest in doing good for society regardless of its impact on the bottomline” (Lantos, 2001). Conservatives argue that altruistic CSR is unethical. Liberals think it is ethicallypermissible.

The result is that SFU may find altruistic CSR as unethical as conservatives, but it may also allow for
altruistic CSR. Generalizing where it falls between conservatives and liberals on altruistic CSR is moredifficult: it depends on the utility calculus for each issue, with the ultimate criterion being SUM.
Ethical CSR is where “a corporation is morally responsible to any individuals or groups where it might
inflict actual or potential injury (physical, mental, economic, sprirtual and emotional) from a particular
course of action” (Lantos, 2001). This includes CSR actions such as human rights, labour standards,
consumer safety, employee health, and anti-corruption. Both conservatives and liberals argue that thisform of CSR is mandatory, assuming we can agree on a common “ethical custom” or “ethical CSR”.
Thus in this case the ‘‘middle ground’’, if one conceptually exists, is one that mandates ethical CSR sinceconservatives and liberals agree. SFU, too, mandates ethical CSR. Rather than accepting ethical actiona priori however, SFU uses SUM as the fundamental justification for mandating ethical CSR. Suppose achemical company can legally and inexpensively dump chemical by-products in a developing world
country. There exists a more expensive, yet cleaner, method of disposing of the by-products in thehome developed country. Further suppose that the company has no pro-environment or pro-“green”
shareholders. If by-products need to be addressed, the SUM course of action is to dispose of waste withthe “clean” method as the risk of a public outcry may be large if consumers, civil society, and the rest ofsociety were to find out about this practice. The prescribed outcome is conditional, as it depends on theamount of pressure the company thinks will result if there were public outrage. However, if the ethicalcustom is breached (as it is in this case), and it is ethical custom, there is likely to be some attention
directed at the company. Further, the conscience of these shareholders, however non pro-environment
they are, must be factored into the utility calculus: while they are indifferent about the environment,
they will care about the harm it causes to other human beings. Thus, SUM will be realized only if thecompany disposes waste with the clean method.
What if, however, the shareholders have no “conscience” to speak of? The response to this fringe scenario
is three-fold. First, this is a very unlikely scenario. Second, the public pressure may still be sufficient tocause SUM to be realized only if the chemical company disposes of its waste with the clean method.
Indeed, if the public discovered the lack of conscience in the company, public pressure would be evengreater, and this is a calculation that these conscience-less shareholders would need to consider before
taking action. Furthermore, since negative utility is given relatively larger weight than positive utility,
the risk may not be justifiable. Third, it may be difficult for the corporate agents who actually make thedecision and carry it out to do things contrary to ethical custom or ethical CSR.
It is, however, impossible to show 100% that SFU leads to ethical CSR. Either that or re-define ethical CSR

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SFU would, in the context of pure (i.e. not ethical nor strategic CSR) altruistic CSR, prescribe a ‘middle
ground’. In some cases, SFU will prescribe purely altruistic CSR because it will maximize the utility
preferences of shareholders, without significant negative effects (e.g. take money away from) on any
individual shareholder. The ethical prescription really depends on whether SUM can be realized. For
instance, if a corporation has a significant percentage of shareholders who want to battle poverty,
SFU may be maximized if a certain percentage of profits, on occasion, were used for unprofitable, yetpoverty-fighting, causes. It will not allow poverty motives to be the sole consideration for altruistic CSR
actions, but nevertheless we would find some altruistic CSR. However, if negative utilities are significant
due to, say, only minor pro-equality sentiment among shareholders, SFU would not prescribe altruistic
CSR since SUM is not realized.

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for conservatives: custom/law/cause bad, while liberals: absolute values.
Strategic CSR is specifically defined to occur when profit intention is aligned with societal interests(Lantos, 2001; Carroll, 2001). Conservatives basically argue that CSR, if not ethical CSR, must be strategic
since altruistic CSR is unethical. Liberals do not have an ethical issue with strategic CSR; it is also ethicallypermissible for them. The difference is that the liberal perspective of “ethically permissible” is notcoterminus with the conservative prescription that CSR must be strategic (at least in the case of profitmaximization, but it may not be in the case of profitability) if not a part of “ethical CSR”; otherwise, thecorporation would be “spending someone else's money for a general social interest” (Friedman).
SFU differs from both views. The conservative perspective prescribes profitability or profit-maximization
under strategic CSR (if not ethical CSR). However, when profitability, and more fundamentally numericalcurrency, ceases to be the metric, a different prescription can arise. SFU’s utility metric can be independentof profitability, even if in most cases the two will be causally linked. In many cases, one or both of theother CSR types, altruistic and ethical, will be involved. The pro-poverty shareholders example used
above shows how unprofitable CSR can be.
CSR that actualizes SUM.

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This shows interconnectedness.
While conservative and liberal perspectives can fully compartmentalize CSR into the altruistic,
strategic, and ethical, the same cannot be done with SFU. It can be compartmentalized for certain
examples, as done above with the environmentalist shareholders and conflict diamond examples, but
compartmentalization can break down in many cases. This occurs because SFU does not mandate or
prohibit CSR actions on the basis of CSR types. In most realistic examples, elements of all three Lantosian
CSR types will exist, and SFU does not simplify the ethical analysis on the basis of types.

CSR departments
Specialized CSR bureaucracies in companies may come in different forms: As public relations departments,
occupational health and safety divisions, regulatory affairs departments, and others. Here, using the
CSR definition cited in the introduction (a “company’s commitment to minimizing or eliminating any
harmful effects and maximizing its long-run beneficial impact on society”,) we collectively refer to themas “CSR departments”. A profit-oriented perspective and SFU differ in many respects for issues related to
CSR departments; here, we discuss whether to create one, and how to direct it.
The decision of whether to create an internal CSR department is viewed differently by the profit andutility (i.e. SFU) perspectives, and they prescribe differing results. The former perspective uses netpresent value, or simply “profit” to determine whether or not a department should be created. If the firm’s
profit can be increased through such specialization, there will be a “business case”. SFU may prescribe adifferent outcome. For instance, the profitability of a firm may increase 0.5% if a CSR department works
on corporate philanthropy programmes designed to increase corporate reputation, and hence, sales
and profits. There is a business case if this is the most profitable, and at least profitable, investment. Yet,as has been seen elsewhere, if SUM is not realized, the CSR department will not be prescribed under
SFU. This may occur because, for instance, certain shareholders disagree with creating such specialized
departments.
A different scenario with different results can also emerge. For instance, if the company determines that
CSR departments are not profitable (e.g. if the CSR department would consume resources more than the
0.5% profit it would generate), there would be no business case. However, if the shareholders as a groupprefer to have one, perhaps because they believe in well-considered altruistic responses, this result may
actualize SUM. In such cases, SFU prescribes creating CSR departments, regardless of profitability.
CSR Department Exists
Despite the complex utility calculus for a CSR department, if a decision has been made to carry throughwith one, the range of ethical responses can vary. Most interestingly, it is possible that shareholder

preferences can indicate no preference for any particular approach to CSR. In other words, there canbe the equivalent of an ethical “wild west” or anarchy. We apply utilitarianism to situations: (a) Where
there are shareholder preferences; (b) when there is only shareholder preference for complete CSR
department independence, and; (c) to illustrate some ethical difficulties encountered when (b) occurs.
First, where there are shareholder preferences expressed to CSR departments, utilitarianism would
obviously prescribe actions in accordance with them. The most likely sources of these preferences are
signals such as directives directly or indirectly (the latter through elected corporate directors) and norms(e.g. for profit-maximization or commitment to some level of corporate citizenship or philanthropy) thatshareholders acquiesce to.

Second, and most interestingly, there can be a case where shareholders as a set adopt a “hands-off”
approach to CSR. They leave CSR matters completely to specialised and independent CSR departments.
For instance, signals such as directives or norms may not exist, there may be directive to be independent.
Shareholders may want to do this to, say, to leave such issues to “CSR professionals” who may be
acquainted with optimal decisions for both companies and society. This is perhaps where the businessand utilitarian perspectives most differ: the latter can prescribe a “hands-off” neutral approach to CSR
actions in a CSR department, but the former may not. Suppose a hypothetical where the preference
utilities of shareholders are for complete CSR department independence. A business perspective canprescribe profit-maximization. However, a utility-maximization perspective could not prescribe any
action, because the utility is already maximized if the CSR department is acting independently. Thus,
the utilitarian perspective may give rise to an ethical “wild west” or anarchy.
Third, we illustrate some ethical difficulties encountered with this ethical “wild west” situation. There
are a series of seemingly appropriate ethical frameworks that can be applied in this case. For instance,
Sacconi’s game-theoretical model, which is akin to a social contract theory applied to the firm, may befound applicable since it may be viewed as ultimately utilitarian. However, there are two issues here. We
cited earlier that any perspective that attempts to include stakeholders such as greater society would
need to overcome institutions that may be shareholder-oriented, such as securities laws, that do notcurrently incorporate such elements of society.
Overcoming these requires a utility-cost calculus, evaluating for societal utility. While not impossible
to do, this is not considered here. Perhaps an even larger setback is that it simply is not shareholder
preference utilitarianism assumed and espoused in this paper. That is, the Sacconi perspective assumes
that there is further utility to maximize for shareholders – for instance, increasing the utility to society
somehow maximizes or increases the utility to shareholders as a set. However, we have previously
stated that, if shareholders were to provide complete independence to CSR departments, that there isno further utility to maximize since CSR department independence is utility-maximization. This analysis
can be extended to other kinds of ethical perspectives.
For instance, virtue ethics, Kantian and other deontological perspectives, the ethics of care, welfare
economics perspectives, and other value-based ethical approaches (e.g. altruism, beneficence,autonomy, justice, and non-maleficence) can be argued to be non shareholder preference utilitarianism.
While they can or may be applied, this is a different question from whether they can applied logicallyfollowing the utilitarian perspective presented in this paper.

Asia-Pacific Perspectives on Biotechnology and Bioethics

While impossible to precisely and accurately gauge the preference utilities of shareholders, if such
sources exist, they represent utilitarian sources for prescription(s). For instance, suppose there is anaccepted norm in the corporate culture of a firm ‘‘A’’ which expects corporate philanthropy to yield
some, but not the highest NPV benefits to the shareholders. This is the utility-maximizing preference
for shareholders as a set because the latter want to have CSR, but not sacrifice too much of their otherutility preference, profit. In essence, this is the maximal preference utility for the CSR funds devoted to
the CSR department (in economic jargon, this is the point at which the diminishing marginal rates ofreturn are equal on these two goods). It follows this is what our utilitarian perspective would prescribe
to the department.

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Conclusion
This paper outlines a shareholder utility-based approach for normative and prescriptive CSR ethics. A
justification could be found to move ahead and apply this to CSR ethics. The ethical analysis prescribes
results different than the traditional and predominant profit or wealth perspectives. In particular, we findopportunity for greater CSR levels to be justified than currently exists under a conservative shareholderoriented view. It was shown that it could yield prescriptions that are more favourable, and likely morefaithful, to the desires of shareholders than other conservative views. Further, there may be increases
and/or decreases in CSR activities if this approach is adopted. However, there is ultimately room for
optimism, because there are cooperative utility-maximizing solutions and the possibly “open” nature ofCSR departments leaves room for a variety of approaches to participate in CSR ethics.

Acknowledgements
I would like to acknowledge the institutional support of UNESCO Bangkok and guidance of Darryl Macer.
Any views expressed in this article do not necessarily reflect those of UNESCO.

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132

Discussion
Discussion and discourse at the conferences account for a significant part of the meetings. They areoften wide-ranging and equally thought-provoking. Excerpts from some of the discussions are, thus,
provided in the following pages. They are identified by the titles of the presentations after when theyoccurred.

Kanokwan Romayanon (Thailand) - GM papaya for PRSV resistance
Parichart Burns (Thailand) - GM papaya for delayed ripening
Morgan Pollard (Australia): I have a general question. What is your philosophical idea on the ecologicalprinciple of maximizing biodiversity. Do you think that the out of control ring spot disease might bea result of monoculture rather than multiculture? My specific question is that you mentioned you are
specialised in microbiology, so I wonder whether your institute also employs macrobiologists, or inother words ecologists?
Parichart Burns (Thailand): In Thailand papaya is not grown in large numbers, unlike Australia. Also
papaya is not native to Thailand, it was introduced. Papaya Ring Spot virus (PRSV) has other hosts, suchas cucumber and pumpkins. I think it may be actually due to other plants, because of mixed culture in
the Thai case. It is the other way around. As for ecology, ecology is the main concern for us. That is why
we are investigating the best possible way to control PRSV.

Kanokwan Romayanon (Thailand): We collected viruses throughout Thailand in all major areas ofcultivation. We inoculate all strains. We combine the sequences of different viruses and we chose themost suitable strain for making it resistant.
Miyako Takagi (Japan): I would like to know if GM fruits are well accepted by people, because in Japan,
for example Tofu made as GMO foods from soybeans are not well accepted. People do not buy it. So
companies label tofu that is not GMO. I wonder, therefore, even if you make GM foods will they be
accepted by Thai persons or not?
Parichart Burns (Thailand): Peoples’ perceptions change all the time.
Kanokwan Romayanon (Thailand): Actually there is no other way to grow papaya, and currently people
move from field to field to escape PRSV. They have to cut down more forest and make new fields toescape the virus. People fear what they do not know. We are trying to educate people to say that there
is no scientific evidence that it is harmful to eat. We try to provide more evidence on this. Also we try
to do protein studies to confirm safety. We want to use the new varieties that we have developed as agovernment agency to solve a problem that is facing our farmers now.
Ellen Clayton (Australia): I enjoyed eating papaya every morning here. Did you make any cultivars withboth gene changes, or do you intend to? Also you mentioned that aphids are the vehicle of transmissionof the virus. Have you done any studies on aphid response to transgenic papaya?
Kanokwan Romayanon (Thailand): In answer to the second question, this is part of the biosafety study
that Dr. Wichai will give a talk on. We have some concerns on horizontal gene transfer with aphids, or
microbes for example. We have not made a double gene changed GM papaya.
Parichart Burns (Thailand): The technology to develop both sides comes from different companies sothat is one issue in our research that we are overcoming.
Subrata Chattopadhyay (Nepal): Who holds the patent on GM papaya, is it the university, state orcompany? Also, will you make a deal with the patent holder? The second question is if we consider that
GM papaya is in a supermarket, what is the position of a villager? What is the use of doing something
against a virus that has been there in the whole history of agriculture. I ask you to think from the view ofa lay villager, looking at agricultural scientists looking at this?
Parichart Burns (Thailand): The patent over all technology is in the same big companies. At the researchscale it is OK to use this technology. We work for the government so the government will own everything.
Now let us consider from the perspective of a lay farmer? In Thailand everyone grows papaya, as backyard
papaya. Some are growing freely to sell. If we can harvest for longer, than you can get more crops. It
does not mean you need to get more, but rather the plants keep growing much longer. It is not to get

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Abnik Gupta (India): You are selecting the PRSV resistant gene. How do you get these genes? Is it fromwild varieties of papaya? The second is at what stage in the field trials are you at?

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millions of dollars, but rather to generate a stable income for persons. That is a good start for us, to help
the farmers. Papaya also has many applications, not just selling the fruit in the market.
Mamun – I would like to raise food safety as an issue. You mentioned there is evidence that it is safe?
Because there are so many debates over GM papayas.
Kanokwan Romayanon (Thailand): The food safety is being investigated. Dr. Wichai will report on thesestudies.
Darryl Macer (UNESCO): As a closing comment before the next speaker we can observe that GM papaya
is eaten widely already in the USA and some other countries.

Wichai Kositratana (Thailand) - Biosafety study of GM-papaya in
Thailand
Pahol Kosiyachinda (Thailand) - The Transgenic Thai Papaya Story –A Milestone of Thailand toward a Biotech Crop Country134

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Darryl Macer (UNESCO): When was papaya first introduced into Thailand?
Pahol Kosiyachinda (Thailand): 200 years ago.
Darryl Macer (UNESCO): So it was only introduced into Thai culture from then?
Wichai Kositratana (Thailand): Yes, we can see in a journal that it came about 200 years ago. It may
have come from Sri Lanka and Malacca. The variety called Malacca came by ship, from Malacca Islandin Malaysia.
Tomiko – I understood that there is a committee inside Thailand that gives final approval to commercial
transgenic crops. My question is which government authority is in charge of that? Who heads that, andwhich government department are they from?
Wichai Kositratana (Thailand): We have a procedure that the researcher starts from the institutional
biosafety committee approval, it is then approved by the National Biosafety Committee. Then step bystep through the laboratory to the greenhouse, to larger fields, and then the data is subject to the
Ministry of Agriculture. The Ministry of Agriculture can approve immediately to grow GM crops, but the
Ministry will first ask the prime minister for a decision. That is why it takes a longer time. The first cases
involved five years of Bt cotton, but the government was still not decided. Even now the policy is not tocommercialise GM foods.
Aruna Sivakami (India): I wonder whether GM crops can also be similar to the regulation of pharmaceuticaldrugs. On drugs we see the “best before use” date, and negative effects after a certain date?
Wichai Kositratana (Thailand): We follow international standards. In our view, food should follow foodguidelines. The papaya has been shown to be safe, by protein expression and animal testing. We will dosimilar things as the FDA does with drugs. We need not listen to just bad or good, or that this is food likeFrankenstein. Rather we need to be based on science. Maybe the picture in Europe ten years ago is thesame as now in Thailand. Protesters wear space suits for media impact.
Minakshi Bhardwaj (UK): I have a philosophical question of whether scientists’ concerns are the sameas the public concern. However, since the majority of people do not know what scientists do in the lab,then their concerns may be different? This leads us to consider our responsibility to the public. Was
there any public debate held to lessen the concerns.
Wichai Kositratana (Thailand): It is a good point. We had no public concern at the beginning. Peoplebuild a car before society tells us whether it is good or bad. People do not ask before building or riding
in a car, or on a plane, so we have to later prove if the thing is good or not.

Pahol Kosiyachinda (Thailand): I would like to add that this research project was prompted by thefarmers. Farmers who are members of the papaya growing association went to the University of Hawaii
to ask for control measures against the virus. The devastation was so severe that peoples’ lifestyles werechanged. They had to stop being farmers and be a taxi driver for example. The virus has no cure, butsince we have a solution it will provide a choice.
Irene Taafaki (Marshall Islands): We have both local papaya and also imported papaya. Locals know thatthe Hawaiian papaya seeds will not grow new papayas after throwing it out. I would like to ask about
the seeds and how a person in a rural area can propagate transgenic papayas? Can they do it?

Kazuo Watanabe (Japan): I was involved in the first phase of plant biotechnology transfer from Cornell
University to Thailand. I will give a simple response to the discussion on public communication materials.
Your materials are copied from Thai to English to be used in the EU. Even children can understand them.
On specific issues of environmental and food biosafety, the transgenic plants have an established safety
history of 15 years and nothing happened. There are many studies reported in scientific journals. Foodsafety it is the same as coat protein protection used in many commercially grown crops, and you havea good monitoring system. Thailand is a good example having a national and institutional framework.
On the biosafety issues you have used the annex of the Cartegena Protocol, and you have a feedback
system. I think Thailand is well developed on biosafety issues. On IPR issues, many components are free,and companies have made these components free providing it is used in domestic varieties for domestic
consumption. Around 20-30 patents are involved and many components are free. The government had
many expectations and it has a good safety check system.
Mohammad Hasan Ghadiani(Iran): What is the major medical use of papaya?
Parichart Burns (Thailand): It is the use of papain. Papain is good for digestion. Also it is a softener. I said
it is our responsibility to give the public understanding of the knowledge.
Subrata Chattopadhyay (Nepal): Papaya also has beta carotene which has been shown to have anticancer properties.
Sarinya Sophia (Thailand): I heard we did GM for potato too?
Kanokwan Romayanon (Thailand): Too my knowledge there is no GM potato made.
Sarinya Sophia (Thailand): Most Thai people eat papaya every day, so I worry about biosafety. Still thatquestion can be answered by science. Do farmers get the plants free to grow? Who controls the priceof GM papaya?
Kanokwan Romayanon (Thailand): There are several groups. In Kasertsart University we have publicfunding and so everything will go out free of charge. We worked on this since 1975. This is a real trouble
for Thai farmers. We want farmers to come back to grow along the side of the road. We want it for local
production. We want to avoid deforestation caused by this virus.
Elise Huffer (Fiji): Who owns the Papaya industry in Hawaii, as you mentioned it was the second largest
export after pineapple? How many individual farmers are involved?
Pahol Kosiyachinda (Thailand): Dole has a monopoly in pineapple, but in the case of papaya there is no
single company that has a monopoly. Usually for small farmers they come together as a small unit, as acooperative, then they have a GM test for marketing purposes and labelling.
Ellen Clayton (Australia): What is containment in an open field?
Pahol Kosiyachinda (Thailand): The Department of Agriculture did experiments under contained
conditions. Based on scientific research we did research on pollen distance, for example, 50 metres, andAsia-Pacific Perspectives on Biotechnology and Bioethics

Pahol Kosiyachinda (Thailand): So far the biosafety committee has not allowed people to grow transgenic
papayas at all. In the same way as in Hawaii, people have their own rights to grow the seeds and maketheir own cultivars. This project was started upon the request of the farmers. Officially however thetransgenic papayas can only be grown in Hawaii.

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they made a secure field. They have 24 hour guards and double gates. When we compare the situation
to Hawaii they grow transgenic papaya and non-transgenic papaya very close to each other. They use
random checks to set standards.
Tran han Giang (Viet Nam): I saw many large fruits in Thailand, and they are much better than Viet Nam.
Why did you bring the seeds from Hawaii, as already the papaya here seems very good.
Pahol Kosiyachinda (Thailand): For example most fruits in a shopping centre like the Emporium areimported, and some are very large in size. However they are not GM.

Don Chalmers (Australia) – Is there a Need or Space for Gene
Technology Ethics: An Australian Perspective
Abnik Gupta (India): On the need for environmental ethics, it is very important. I would like to raise
the point of protecting the integrity of the ecosystem, or the macrosystem level? Can we look after
macrolevel systems withoutn distinct environmental ethics. Also we can include non-living organisms
in the ethical framework.

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Don Chalmers (Australia): That is a comment, and better than I can answer. We are trying to make amodest start, when you consider Morgan’s description in the first morning. We have had concerns about
pollution also. The science will always be interlinked and we need to go further still as you say.
Charn Mayot (Thailand): Can you clarify the last point about public trust? It is a problem in this country.
In my personal opinion GMOs are not terrible. But there are so many things where the governmentchanges what it had said. How about private corporations, and companies? What do you do in yourgovernment to generate trust?
Don Chalmers (Australia): There is lots of evidence, e.g. the UK House of Lords report on Science andTechnology three years ago, which said that the advance of science has been marked with deficits oftrust. Biotechnology Australia has done a lot of research to say that once a commercial interest is involved
people lose their trust. There is much data to show that the community is becoming more sceptical.
Another concern is that companies are not subject to the freedom of information acts that are seen
in many countries. Thirdly, governments are now coming in, as universities, and entering agreementswith companies that the government will keep the information confidential. It is the responsibility of all
involved, including the gene technology regulators, that public trust is in the public interest.
Aruna Sivakami (India): We eat papaya in India when it is green as it is good for health, and also when
it is ripe, when people say it is important to increase hemoglobin. In India it is eaten at every meal for
inducing abortion, so they eat papaya every meal. There are therefore many health questions in India.
In Australia it is possible to legislate about biological dioversity and biosafety, but in India, laws cause all
the problems. The 2002 Biodiversity Act and 2004 Biodiversity rules only stop foreigners from exploiting,but locals can continue to exploit. Thus we cannot do anything only by legislation in our countries.
Don Chalmers (Australia): I do not know how to respond. This use of papaya would be interesting to an
ethics committee. Australia set up a very strong welfare state and always looks to legislation.

Voravit Siripholvat (Thailand) - Description of Thai indigenous
chicken plumage colour and broodiness using classical andmolecular genetics
Darryl Macer (New Zealand): What is the average lifespan of chickens in the village?
Voravit Siripholvat (Thailand): Some papers say that the lifespan is about 10 years. That does not meanthat the meat can be eaten at that stage, as it will be very tough. They also may not be laying eggs
efficiently then.
Darryl Macer (New Zealand): Yesterday we had a paper on factory farming, and we can see that the

lifespan is much shorter in such farms.
Ellen Clayton (Australia): With the identification of the broodiness gene, can it be applied for farming?
For example, could we genetically engineer the chicken with the broodiness gene?
Voravit Siripholvat (Thailand): To modify the chicken gene is very difficult. I submitted some research
papers on indirect cloning. The chicken follicles include a blastoderm, which makes it very difficult.
When the newly hatched eggs come out it includes more than 4000-6000 cells. Thus it is impossible fordirect transgenic research. However, some researchers try to use retroviruses to transfer the transgene.
Or else use direct cloning. Currently there are some projects to research this.
Masato Motoki (Japan): My concern is about the picture where it seemed like the cockerels were bred
for fighting? Is there any movement against cock fighting?

Kalairari (India): I think if genetically engineered chickens are desired then one particular variety
will be eliminated from the community and the gene frequency may be affected. Please explain themechanism?
Voravit Siripholvat (Thailand): I think the first selection for genetic engineering is disease resistance,
related to avian flu. I do not to worry about gene equilibrium, they were adapted a long time ago. The
commercial chicken gene equilibrium is not affected. There has already been a long process of selection
in commercial broilers. The genetic selection is for fighting in these chickens but other genes are notaffected.

Ellen M Kittson (Australia) – Victorian Governance of Biotechnology
Abnik Gupta (India): It is significant that you have used the term respect for animals and respect for theenvironment, it is higher than just using the word concern in ethics. I do not know if you have taken
steps to commercialise transgenic crops or plants. If so, how has the “respect” been preserved?
Ellen M Kittson (Australia): In our national regulatory scheme there have been approvals for threedifferent types of genetically modified plants, the blue carnation, which is grown in Victoria; cotton,
which is not a crop we have in Victoria; and canola, which is a crop also grown in Victoria. At this time
the Victorian government has passed another law in addition to the regulation scheme, which prevents
its commercial growing. They still feel that they want to be more cautious even if the federal regulator
has approved this. I do not know if caution relates to respect. Rather it may be to give people the ideathat in their consideration there is something more than just the scientific risk assessment. It is meant
to be inspirational.
Peggy Fairbun-Dunlop (Samoa): Could you tell something more about the youth response you referredto.
Ellen M Kittson (Australia): When the youth considered their survey, they had actually written a series ofquestions which reflect a lot of our discussion at this meeting too, including all sorts of different topics.
There were some important themes that came from the youth. First they thought that ethical principles
were universal. They were comfortable that what was an ethical principle for agricultural biotechnology
would also be a principle for medical applications of biotechnology.
Irina Pollard (Australia): In the year 2000 I was invited to give a lecture in Chennai and I gave aquestionnaire to examine the cultural differences that could be found between those students and mystudents in Australia. The Indian groups ranked the concerns the same and the results were similar inthat they both rankled concern with environmental matters.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Voravit Siripholvat (Thailand): These cocks are not only for fighting but also for fowl beauty contests.
Their value is very high. The people who are interested in fighting will kill the lines to ensure a very highprice. Some people want to purchase the expensive female chicken lines, and they can fetch a very highprice. The ancient king of Thailand used fighting cocks in Burma. The chickens have been selected for avery long time. The style of fighting is very excellent compared to some other chickens.

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Kazuo Watanabe et al. (Japan) - Ethics in Public Communication on
Agricultural Biotechnology
Irene Taafaki (Marshall Islands): Please hypothesise why those who oppose are using unscientific claims?
Might it be they do not have the benefit of research dollars the companies have in this? Is it some otherreason?
Kazuo Watanabe (Japan): The specific case in Japan it is related to other economic activities, like theorganic farming industry. Other groups are based on their creed, like religious groups. They are to berespected, but not if they misrepresent scientific opinion.

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Jasdev Rai (UK): Among the weaknesses in the whole postdoctoral system is that there is a lot of emphasis
on ethics in governments and universities. But the MNCs are much more powerful, and they are abusing
the ethics. There is no oversight system for how to control them. In Geneva six years ago NGOs tried
to set up a voluntary code. Unfortunately it was taken over by the interests of persons in the USA, and
MNCs persuaded that it only needed a voluntary code. While we can discuss ethics for academics andsociety, there needs to be some sort of independent international ethical oversight. MNCs have a lot ofmoney to buy the media and can miscommunicate on these issues.
Kazuo Watanabe (Japan): The international regulation is controlled by different sectors, WTO, CBD andvarious environment laws. Each contains methods for strong participation of concerned groups. They
are not small groups, so independently they are spread out. They are quite visible, but I am not sure how
we can make a synergy between them. Even inside the United Nations they cannot sort out an overall
framework.
Nacanieli Tuivavalagi (Samoa): I want to share an experience related to one of your slides where 80%of people were not responding. In agriculture we have a lot of experience about non-responders,
and we found that people may have various reasons for not responding. The people may not like tocommunicate their feelings to each other. As we heard from Ellen Clayton, there are ways to get people
involved.
Pahol Kosiyachinda (Thailand): One question I have is about the activist that raided the farm and wasit a court case?
Kazuo Watanabe (Japan): This case concerned the first planting of GM soybean in Japan. The police filed
a report for property damage and trespass. It is still pending, but unlikely to proceed.
Mary Josephine Rani (India): I would like to know what are the benefits and risks of GMOs. The publicshould be well informed of the adverse effects. Do we label the products GMOs and what is your viewof gene pollution?
Kazuo Watanabe (Japan): It is important to show that it could be controlled or maintained. Yesterday
we also discussed some of these issues and risk management. Unless explained well, those GMOs
should not be used. Labelling is important to protect the right of the people to know, not because
it is harmful. If it is harmful it cannot be used. The labelling is because it is a product made from newtechnology. Gene contamination is an important component of these issues and risk assessment. Geneflow depends on the biological characters of the crop. In potatoes it does not produce viable pollen.
A potato grower in Peru should be very careful as it is the motherland of potatoes, but a place like thenorthern island of Japan regarding the potato they have no native species so the risk assessment should
be different. There are important issues when considering GM rice in Asia, as there can be influences on
weedy species surrounding GM rice crops.

Minakshi Bhardwaj (UK) - Constituting ethics into biotechnology
policies and developing international relations.
Subrata Chattopadhyay (Nepal): You talked about autonomy as a guiding principle of bioethics. In
the global community, China and India constitute the majority of humankind in terms of numbers,and the concept of autonomy does not apply the same way as it does in the West. In terms of theindividual how can autonomy be the guiding principle universally? When you say maximum good forthe maximum people, let me give you an example of a nuclear power plant in the Bay of Bengal. It isgood for individuals to have more jobs, it is good for the community to have more energy, and it is goodfor the state because they will have more power generation. But the problem is for the environment, or
nature. In the long term vision for future generations it will be a guiding principle that the environment
may suffer. Is it possible that the good for the short time is not good for the individual, community orstate when considering a long term perspective?
Minakshi Bhardwaj (UK): On the concept of autonomy of states, we could consider the right to exercise
at governance level and international levels, states can opt out to sign a treaty or not. In those terms
states have autonomy to reject, or adopt an agreement. Regarding the community, individual and state,
we can think of conservation of natural resources. Which holds more weight as a guiding principle? For
example in some states you exercise your autonomy to drive a car, but some states limit car use to acertain number of minimum persons for environmental reasons.
Ken Daniels (New Zealand): The papers this afternoon, have brought a real relevance between bioethics
and policy, in our conference.

Minakshi Bhardwaj (UK): When I talk about equity I think it comes when we think about access toresources and their availability. Equity cannot be available without enough, and access to resources.
There also needs to be intellectual resources to allow exploitation of resources for the good. We need
to use technology transfer for empowerment. In many developing countries they have resources
but they do not have equity. We have to provide equity, and need to have capability which requires
participation.
Tran Han Giang (Viet Nam): Sometimes equity is not equality and vice versa.
Minakshi Bhardwaj (UK): Equity will be needed as a guiding principle for equality. Then transformation
into policy is important.

Tomiko Yamaguchi (Japan) - An Analytical Framework for
Understanding Agricultural Biotechnology Controversies
Mamun (Bangladesh): I would like to make a comment on this paper. This paper includes ethnography,
analysis of newspapers and qualitative interviews. When you combined these methods with thecollection of data, this integration has made the analysis very meaningful. I would like to ask about thequantitative data analysis in your research.
Tomiko Yamaguchi (Japan): When I began the study in 1998 it was just when the controversy wasdeveloping. Triangulation between qualitative and quantitative data is very important to see thesituation in a broader picture. My next step is to link this into an even bigger picture.
Ellen M Kittson (Australia): When you were defining the social constructivist approach you talkedof defining the social condition that is problematic. Then you described the problem as being thecommercialization of GMOs. Is there a particular area that was lacking, that you identified in your analysis
such as lack of empowerment or participation?
Tomiko Yamaguchi (Japan): This social constructionist approach to problems looks at the processes
where people define or perceive certain social issues as problematic. The focus of the study is whatsort of processes people went through in their mind that has led to the problem that Bt cotton was a
problem.
Ellen M Kittson (Australia): Yes that is clearer. I wonder if you could describe some of the particularconcerns people had about the commercialisation of GMOs?

Asia-Pacific Perspectives on Biotechnology and Bioethics

Tran Han Giang (Viet Nam): I want to ask about the difference between welfare and equity.

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Tomiko Yamaguchi (Japan): I am concerned about how they perceived this. How do people define thecommercialization of Bt cotton, and why they thought that it was problematic.
Darryl Macer (New Zealand): The discussion of different methodologies has been very interesting. WhenI wrote the report of the subcommittee of the UNESCO International Bioethics Committee in 1996 on“Bioethics, food and plant biotechnology”, there was a conclusion that overall biotechnology will help
society. However, there are many issues that are important, and we have discussed some of these here.

Darryl Macer (UNESCO): Ethics of use of genetic control methods for
Infectious Disease140

Asia-Pacific Perspectives on Biotechnology and Bioethics

Irina Pollard (Australia): With genetically modified mosquitoes they will modify the females, which suckblood. Eventually are they planning also to sterilize the males so that the population would go downeven though the genetically modified female does not allow the development of the pathogen once
it’s infected?
Darryl Macer (UNESCO): There are a number of strategies, some can utilise biology when Aedes aegypti
mosquitoes suck blood from a person with dengue, it then takes approximately 14 days for the dengue toreproduce and go to the salivary glands. So the mosquito needs 14 days. So there are several strategies.
The approach they are trying to use involves about three independent genetic mechanisms that willstop the transmission of dengue fever into mosquitoes. So the chance of natural selection to revert
back, one transformation is a chance, but if there are more independent transformations, there is almost
no chance they could revert back. Because they would be targeting different stages in the dengue
lifecycle and different organs in the mosquito, so that’s one strategy. Overall in molecular entomology,
the idea is, there are about 4,000 species of mosquito, but only about one dozen can transmit humandisease. Dengue is transmitted only by around two different species and for many localities it’s only
Aedes aegypti. So the idea is that, instead of spraying with pesticides to destroy all the insects, it isbetter on the ecology to have the insect surviving in the community. So the population is not intended
to go down. That is one strategy. Another strategy that is being developed is to make geneticallysterile mosquitoes, but it requires a larger number of mosquitoes. So there are different strategies. The
genetically sterile mosquito doesn’t reproduce, but you have to make a large number. Another strategy
is to introduce these modifications on a transposable element so that they’ll be slowly moved throughthe wild population. This is an approach being considered. We don’t really know what will work until
there are trials and we know which one is best.
Morgan Pollard (Australia): I just wanted to comment that the mosquito is a keystone species which isvery important to the ecosystem especially in the larval stage. It is integral to the ecology. The aim of thisstrategy is health and the method is ecological. I suggest you need ELESI, the Ethical, Legal, Ecologicaland Social Impact to be considered.

Naoko Kimura and Darryl Macer (UNESCO): Japanese attitudes
towards genetically modified mosquitoes
Peggy Fairbun-Dunlop (Samoa): One of the things which has come through very strongly yesterday andtoday is the participation of community people in research. I was just wondering in the surveys Darryl
will be conducting, how much you have looked at community participatory research?
Naoko Kimura (Japan): In terms of community engagement, we would like to inform all citizens of
the community, or of the island. So the question was: Have we made considerations for community
engagement?
Darryl Macer (UNESCO): At first there is an initial phase for case studies and I think you are right inpointing out how long it does take. Also, as mentioned on the slides, we will probably have to conductongoing dialogue and modification based on what the community chooses through community ethics
boards. It’s possible after three or four years the communities may have extra concerns that need tobe met. For example, in this case it is needed to make it clear to people that these trials are cage trials

of GM mosquitoes. Therefore, there is no benefit to reducing dengue immediately because they aren’t
going outside of their cages for five years at least. But despite the best efforts and intentions that we’ve
made, it is still likely that, if it happens to be a bad year for dengue, the people will say: ‘‘Well what arethese guys doing, they cages are here, we’re meant to not have dengue anymore.’’ And people will find
it difficult to understand that. So an active and dynamic two-way process is required.
Le Dinh Luong (Viet Nam): I have some questions about the way we conduct surveys or interviews
because an important part about any surveys or interviews is the questions. We should put the rightquestions first after getting information back from the community. For example, according to one poll
we get that 70 % of European people do not know what is ‘G’ (a nucleotide base of DNA). In such a case,
if we ask a question like: ‘‘How do you consider the GMO is harmful or useful?’’, I would not be sure thatthe information would be useful for any information or conclusion. Perhaps in this case we should posethe question to the Japanese people what and how do they consider or understand the benefit or theharm of GM mosquitoes first. Afterwards we can get more information about that.
Ellen Kittson (Australia): Did you have any other demographics about the people who answered thesurvey? That is important in understanding the answers, for example, gender and education.

Ellen Kittson (Australia): But were there any differences in attitudes due to age of the participant?
Darryl Macer (UNESCO): No, as in most of the surveys that were done in Asia or the Pacific over the last
decade, I think it’s clear to say there is no demographic predictor for the attitudes people have to genetic
engineering questions. This is also now a common conclusion in European research as well. There’s nosingle demographic predictor of a person’s views about these dilemmas. I’ve also done surveys on thenatural sciences where there are also very similar universal ideas regarding the concerns people have.
The sample size here is not really large enough to make quantitative conclusions about that.
Subrata Chattopadhyay (India): I have a couple of questions but with the time constraint I will limit
these to just two. One is that we generally don’t hear the voice of the other world in the sense that if thecommunity ethics board are in one platform, what about the concerns which are expressed by groups
like NGOs such as Greenpeace or the PETA? The problem is in the scientific world there is generalmisconception about the other world and things were flushed out. In many parts of the world where thesociety or the system is unethical, how do you really think the community ethics board will be working inan ethical manner? I can tell you two examples. It could be really good in Washington DC or Europe but
realistically at the ground level in Asian countries, how do you ensure that it will be done in a very ethicalmanner when the question of economics and the jobs is the priority? Secondly, in the real third world,
we generally are concerned about the World Bank and the WHO because of their interest in all things.
It scares me when I hear that the World Bank is developed, I mean it is implementing development. So
how do you address that when psychologically it creates a sense of distrust when I find the World Bankor IMF or UNDP, and international organizations abroad, who are doing something good in the third
world where they are partly responsible for the misery in the third world?
Darryl Macer (UNESCO): Firstly, there are many pilot projects independent from the Tropical Disease
Research Programme of the WHO (TDR). TDR, this Tropical Disease Research Programme, is based in
Geneva, WHO Headquarters as a joint programme of three agencies, WHO, UNDP and the World Bank.
The project I gave as an example is led by a principal investigator at the University of California at Irvine,
funded by the Foundation for NIH, which is set up especially to administer the Gates Foundation Grand
Challenges for Global Health programme to be independent of an independent foundation. Its projects
are independent of the work of WHO. Concretely about the community ethics boards, I have mentioned
them as structures which I propose may meet once a month. It is essential that those coordinating thiswork are very careful to try to ensure very broad representation. There may be multiple ethics boards
depending on the local site. For example in Trinidad among the meetings I had planned in three villages
along the proposed experimental site were in a church, in a Hindu temple and in a cricket club. Thus
we may establish groups so that they have active participation. I think it is also part of community
engagement ideas now to pay people to come along to discuss these issues or otherwise they will lose

Asia-Pacific Perspectives on Biotechnology and Bioethics

Naoko Kimura (Japan): Yes, the demographics were analyzed and we found that it did represent thecommunity.

141interest. This is another issue with genetics ethics boards. If we want community participation, to get
ordinary people in these groups you have to compensate them in some way for taking the time awayfrom their work or other activities. These are all components of community engagement projects.
Naoko Kimura (Japan): In terms of the opposition voices, we are for various reasons obviously very
concerned about these opposing voices. We need to correspond with Greenpeace and experts who
disagree with the merits and risks of the research. Some comments convey their concerns.

Mary Josephine Rani and M. Selvanayagam (India): Benefits andEthical Limits to Transgenic Animals

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Aamir Jafarey (Pakistan): Certainly I agree that we are only caretakers, but every time science tries totake over, the question of the balance between playing God and being a caretaker, comes up. Whenthe universe began, we were playing with nature, also, but that was happening in the fields and notin the genetics lab. But the question of ethics in the altering of nature was happening was there? It
was happening in the fields but not in sterile labs. So what is the difference now that it is happening
according to scientific principle and in our own ways? People have been using nature for a long time.
We have been using animals, using plants and people seem to be adapting to that, accepting that. So
when we do that in genetic labs, why is that different?
Mary Josephine Rani (India): Even in the past we had lots of abuse but as time goes on there is a lot of
improvement. The same thing can be said with the use of technology and science. Now, for example,
can we grow headless embryos? Some say if the head is not present, if the brain is not present, they
have no rights. So they can produce now headless embryos. After the production we could take out theorgans, like the heart, kidney, and then donate as a business. This is not ethical, I believe. This type ofadvancement is not advertised in this field.
Maude Phipps (Malaysia): That was quite interesting. I am glad you put up the last slide where you
cautioned that there has to be a balance between technological advancements and the fear thatbioethics and a lot of these considerations will strangle the procedures. As regards headless embryos,
I think that’s more conceptual than actually happening. So at the moment there is a lot of controversy
about stem cell technology and the use of embryos and just scenarios where there have been debates
for a long time. What does one do with the excess embryos that are created artificially for ART? Doesit just go down the sink or can they be put to better use? We had a dialogue in Malaysia some time
ago about this, rather than creating headless embryos, about the embryos that existed. You would be
surprised as to the opinions that people were giving. There was an invitation to people from the NGOs,
from the scientific community, from the clinical/medical community, lawyers as well as religious groups.
And over all quite a number of religious groups or individuals felt why would you prohibit using embryos
for therapeutic cloning, when the process of “ensoulment,” when the soul actually is put into that being,
is at 120 days for Muslims, for example. So if it’s an excess embryo and it can be actually utilized as longas it is used before 120 days, then it is allowable. So there may be different ways, rather than having tocreate something that you can harvest organs from.

Juergen Simon (Germany): Chances and Risks of Biobanks: Problemsof Ethnic Monitoring
Alireza Bagheri (Iran): you mentioned about the need for community consent, I wonder if you canprovide us any practical definition and how to obtain community consent. Actually I am concerned
about the community of people who live in another country and how to have their own consent.
Juergen Simon (Germany): Well, that is a very important…? I think it is not possible to give you ananswer now about what is community consent because it is discussed in different ways. If you takegroups in Venezuela or Thailand or somewhere else, I think you have a lot of definitions for community
consent. Another issue is how we can see it, which is one we can talk about for a month. So I have given
you a statement from our group, we have discussed this. This was agreed upon by the members of thegroup in the UNESCO meeting.

Brigitte Jansen (Germany): Human Biobanks- Trustees and Some
Aspects of the Current Dicussion, especially in Germany
Darryl Macer (New Zealand): What is your opinion on the genographic project, do you agree that it isagainst norms of international law?
Brigitte Jansen (Germany): Yes, I think in some cases I have spent several times fighting about this topic
because each group may have a special idea of a group consent. I think this is also a possibility to misuseindigenous people for politics. So I dislike this form of consent because I prefer, also in indigenous
groups, more of an individual consent.
Juergen Simon (Germany): I agree that we need community consent, but it is indeed very difficult.
There is much discussion on community consent and also over the role of the donor which is the mostimportant thing. There are also discussions on the internet about such projects.

Brigitte Jansen (Germany): I think that for developing countries it can be interesting to have such abiobank. But before establishing them it is important to have legal rules of how to govern it and how
to provide the information. If you look at the Indian law, for example, you have also a data protection
law but I have the impression that in the medical field this law is not well known in the case of gathering
the genetic information. It was established in 1986 and it focused on the IT sector. In many cases I think
there is a gap between the different fields in India to recognize the existing law. This is not yet working
because nobody knows it. While I think in this case it is a good thing to establish something like abiobank to have the possibility to do something for the local community, but it is very important to haveproper legal rules and to apply them.

Miyako Okada-Takagi (Japan): Is the era of the therapy by tailormade stem cells coming?
Ivo Kwon (Republic of Korea): Your title is “Is the era of the therapy by tailor-made stem cells coming? I
think as do many medical experts that this time is far away from an era of therapy from tailor-made stem
cells because we have many obstacles and so many hard problems to solve to do therapy to the patient
by stem cell and made by stem cell research. If we reinsert embryonic stem cells into the patient, thepossibility of cancer may not be able to be detected by science, and this is a big problem. We have noidea what is happening after the stem cells are injected into the patients. In Korea we have some ideasof where stem cell therapy is going right now. We have very serious monitoring for the patient. So many
people think it is possible to use stem cell therapy very soon but I want to point out that this is far fromthe fact.
Miyako Okada-Takagi (Japan): Yes, of course, therapeutic cloning is in the very future of medicine andwe Japanese now are forming the research in human cloning for research purposes and now we cannot
do that yet. However, next year we will probably do that. We will change the regulation for humancloning research and already a lot of the researchers say that there is also, genetically, a lot of difference
between the natural embryo and cloned embryo. So it is not easy to use as therapeutic cloning, but weshould start to experiment.
Yanguang Wang (China): There may be other potential sources of human genetic material besides eggs,
such as aborted foetuses.
Miyako Okada-Takagi (Japan): While we are discussing now how to get eggs for the research, already
we are not permitted to have donations from the young women because the health risk is very high.
So people say that we should not, but many members of families with severely diseased patients may
want to donate the eggs for the research purposes, in which case probably we should accept them for

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D.S. Sheriff (India): What is the utility of such human biobanks in developing nations?

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Ivo Kwon (Republic of Korea): The Current State of Embryonic Stem
Cell Research in Korea
Noritoshi Tanida (Japan): It was a very interesting story. Would you mind telling me something more
about the attitude of people towards fertilized eggs or embryonic cells in Korea? Because in Japan,
the Japanese ad hoc committee officially employs the Christian ideology, which means life starts at
fertilization, so I would like to know more about the concept of your country.
Aamir Jafarey (Pakistan): You said that egg fertilization is for patriotic reasons, that is a very noble cause
but patriotism usually surfaces in times of crisis, and there is no war going on right now, there’s nofamine, tsunami, etc. Are there any other manifestations of this patriotism rather than egg donation by
only females happening in Korea at this time?

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Ivo Kwon (Republic of Korea): There is no case such as that in Korea. In clinical trials, many Koreansregularly want to be involved and some people wait for the notices of clinical trials in hospitals. But they
will readily sacrifice their bodies for a more noble approach.
Heiko Zude (Germany): I am Protestant Christian and I like your oppositional stance point very much. I
would like to know when you write over 90% of the Koreans praise the success of Dr. Hwang1, what is
the source of your opposition? Where is your oppositional stance point grounded?
Ivo Kwon (Republic of Korea): Generally speaking I am not opposed to his research, and I agree thattherapeutic cloning is necessary for our medical purposes this is my position. It is very hard to talkabout the human rights involved, and the procedural justification. Many procedures we have to keep inresearch for social utility. I think my point is that I am arguing to keep the right procedures when doingsocial research, which is very difficult in such a nationalistic condition.
Wang Yanguang (China): I know most of views from the public about stem cell research; I would like toknow more about the ethical field and how many bioethicists think about this. Also, I know that in yourcountry there are many Catholics. Nearly more than half of the population go to church, how do they
think about the embryo as a person, or as a human being or as something?
Ivo Kwon (Republic of Korea): We have very few bioethicists in Korea, and a group of them are againstsocial utility research like therapeutic cloning. However, a small group of bioethicists, including myself
are really for therapeutic cloning, but we cannot position all the bioethicists in Korea. For clarification,
many Koreans believe in Christianity, but they go to church to pray for their health and their wealth intheir current life. Many people are not interested in heaven after life. So many Korean people although
they believe they are Christian or Catholic, they will agree there is a very different cultural situation fromthe other western Christian countries.

Don Chalmers (Australia): The Regulation of Stem Cell TechnologyInternational Approaches to Restriction or Permission
Aamir Jafarey (Pakistan): My question is regarding the frozen embryos, you mentioned they are frozen,
and frozen indefinitely. I assume they are owned by the parents, but is there a deadline by when they
have to make some sort of a decision? Who pays for this period in which they are spent frozen?
Don Chalmers (Australia): The position in Australia is that before this national legislation, there weredifferent regimes in different states. Generally it was five years or ten years, now it is standardized atten years. After ten years, the parent must make a decision. If they have not made a decision thenthey should be allowed to succumb. The second question is who pays? Most of this is done througha private scheme, though we are one of the only countries that allow public access under our public
1This discussion occurred prior to the scientific fraud case brought in Korea over Dr. Hwang, and the withdrawal of his
scientific papers from several international journals, including Science.

health scheme, but if they are stored it is paid for by the couple. There is always a regular mail out by the
ART centres asking what you want to do. An interesting point was there was this feeling that once thecouples were invited to enter into the research, and I think really so far the experience of our licensing is I
think they’ve overestimated. I think some of the couples are deciding, but it’s not to go into the research
track.
D.S. Sheriff (India): It is interesting to see how different types of people in the county are going to regulate
your medical council. How do you select them? Do they have any corporate affiliations, because thisalso can influence the decision making process?

Yanguang Wang (China): Ethical Issues on Human Embryonic Stem
Cell Research in China
Heiko Zude (Germany): This impressive presentation helped me to understand better what mycolleagues in Eastern Germany think. You said that there was some discussion about the value of thehuman embryo, so I would like to know, who are the persons who argue and refer to the natural law?
Who are the persons and to what group do they sociologically refer to? Can you say these persons are
Christians for example? To what group do they belong?
Yanguang Wang (China): To my knowledge all bioethicists agree that up until 14 days we can doresearch. This is based on medicine, medical reasons and I don’t question about the nature at all in mypresentation. From the ethical reasons we think that cells are embryos and cells have no consciousness
before that line. So they think about so many patients who need help, and the need for research for
medical development, we think we can use the embryo, as the best option. We insist to forbid someone
from using cells from some women without obtaining informed consent. However, we think it is better
to use the embryo obtained from the abortion or from the spare embryos left after IVF.
Sarinya Sophia (Thailand): I just have one question, because it seems to me from your presentation thatin China you do a lot of the research on stem cells and this kind of bioethics. Do you do research related
to organ donations after people are dead for example? For example can you use the eggs of women
who just passed away within 24 hours, because the eggs are still okay? For me it is about respecting
living beings both animals and human, not only the human.
Yanguang Wang (China): We do respect the value of the embryo. We try to find many ways to find theembryo, so your suggestion is good. You will find in China that many scientists and ethicists have done
something. They try to use the adult tissue resources also for research.
Mary Kalaiarasi (India) I would like to have a little clarification. Why do you limit protection to 14 day
old embryos? Why not believe to respect them from the time of conception? I believe that life has to berespected from the time of conception itself. Secondly, you mentioned about volunteers. Are they paid?
What is the ethical limit to call them volunteers? What are the ethical limits that are followed?
Yanguang Wang (China): You want to know whether we use the embryos before 14 days. Many persons
ask us this question. From the first time of stem cell research, we read a lot of materials from the UK andfrom the USA. We followed the UK standards to limit to 14 days. The reason is that many Chinese people
think that the Chinese should not develop too quickly, we don’t want to, but if the USA or UK can, we
should follow them. This is one reason, but for bioethicists, we really think this 14 day embryo rule isquite appropriate. If embryos are to be destroyed, before they are destroyed society can use them.

Asia-Pacific Perspectives on Biotechnology and Bioethics

Don Chalmers (Australia): They are appointed by the commonwealth (federal government) but ourpoints are subject to consultation with all of the states, and there are a number of bodies which havethe capacity to make comments about the membership. The second question was conflict of interest
through financial association. Yes, that has actually happened, in the legislation there is a specific rule
which says if you are receiving any direct financial benefit from an ART centre, you must end it. So theparticular colleague that was from ART was initially attached to a university working in the RT, so he
was receiving his funds from the university. He’s now changed his position, it’s not a question of any
discretion, he’s had to resign from the committee and I think it is going to be quite challenging in his
area to find a replacement that is not tied up with the actual RT procedures. Because the legislation’squite clear, you have got to be absolutely independent of the procedure.

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Another reason is that, from Chinese theory, for example, in Confucianism, a person begins after birth,
after delivery, so there are so many reasons to support this stance.

About the Contributors

Minakshi Bhardwaj is Research Associate at the ESRC Centre for Economic and Social Aspects ofGenomics (CESAGen), Cardiff, United Kingdom [bhardwajm@cardiff.ac.uk].
Donald Chalmers is Head and Professor of the Faculty of Law, University of Tasmania, Hobart, Tasmania[Gayle.McElwee@utas.edu.au]
Ellen M Kittson is in the Directorate for Research Integrity, Quality and Regulation, at the National Healthand Medical Research Council in Canberra, Australia [Ellen.Kittson@nhmrc.gov.au]
Pahol Kosiyachinda is a lecturer in the Department of Biology and Centre for Vectors and Vector-Borne
Diseases Faculty of Science, Mahidol University, Bangkok, Thailand [tepkx@mahidol.ac.th]

Tomiko Yamaguchi is Assistant Professor, Division of International Studies, International Christian
University, Tokyo, Japan [tyamaguc@icu.ac.jp]
Naoko Kimura was a volunteer in RUSHSAP, UNESCO Bangkok from Japan, and is currently pursuing
graduate studies in USA.
J. Mary Vimalakumari Kalaiarasi is employed in the Department of Zoology Loyola College, Chennai,
Tamil Nadu 600034, India.
Glen Kurokawa was a consultant to RUSHSAP, UNESCO Bangkok, and is now working in a legal firm in
Canada [gskurokawa@hotmail.com]
Brigitte Jansen is Director, Bioethics Law e.v., Strasbourg, France [jansen@bioethicslaw.net]
Darryl Macer is Regional Adviser in Social and Human Sciences for Asia and the Pacific, at the Regional
Unit for Social and Human Sciences in Asia and the Pacific (RUSHSAP), UNESCO Bangkok, Thailand[d.macer@unesco.org]
Sergio Romeo-Malanda is from Spain, but currently a Research Fellow, Centre for Law and Genetics,
Law Faculty, University of Tasmania, Hobart, Australia [sergioromeo@hotmail.com].
Miyako Okada-Takagi is teaching bioethics at Nihon University, University Research Centre, Tokyo,
Japan [takagi.miyako@nihon-u.ac.jp]
Somparn Promta is a lecturer in the Department of Philosophy, Chulalongkorn University, Bangkok,
Thailand [somparn.p@chula.ac.th]
M. Selvanayagam is Director, Loyola Institute of Frontier Energy (LIFE), Loyola College, Nungambakkam,
Chennai [drmssel@yahoo.co.in]
Jürgen Simon is Professor of Bioethics and Law, University of Lüneburg, Lüneburg, Germany [simon@
bioethicslaw.net]
Yanguang Wang is Vice-Director of the Centre for Applied Ethics, and a Professor at the Institute ofPhilosophy, Chinese Academy of Social Sciences, Beijing, China [ameliawyg@sohu.com]

Asia-Pacific Perspectives on Biotechnology and Bioethics

A. Mary Saral is a lecturer at the Vellore Institute of Technology, Vellore 6, Tamil Nadu, India [jaya_saral@
yahoo.com]

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UNESCO Bangkok
Regional Unit for Social and Human Sciencein Asia and the Pacific