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ASIA

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BIOTECHNOLOGY AND DEVELOPMENT

REVIEW

ISSN: 0972-7566 Vol. 15 No. 2 July 2013

Bioscience and Innovation Research: Examining the GM Animals Case with Indian Researchers Using the Ethical Matrix

Scott Bremer, G. Pakki Reddy and Kate Millar

Patenting of Naturally Occurring 'isolated' Biological Materials Luigi Palombi

Genetically Modified Crops and Sustainability of Farm Livelihoods: A Compartive Analysis of India, China and Brazil Asmita Bhardwaj

Agricultural Biotechnology, Intellectual Property Rights and Seed Industry in India Vikas Kumar and Kunal Sinha

Perspectives

Bio-based Production in a Bioeconomy

Jim C. Philp and Krishna C. Pavanan

Asian Biotechnology and Development Review

Editorial BoardEditorsBiswajit Dhar Director-General, Research and Information System (RIS)

Sachin Chaturvedi Senior Fellow, Research and Information System (RIS)

Managing EditorK. Ravi Srinivas Associate Fellow, Research and Information System (RIS)

International Editorial Advisory Board

P. Balaram Director, Indian Institute of Science, Bangalore and Editor, Current Science

V. S. Chauhan Director, International Centre for Genetic Engineering and Biotechnology (ICGEB)

Nares Damrogchai National Science Technology and Innovation Policy Office (STI), Thailand

Vibha Dhawan Executive Director, The Energy & Resources Institute (TERI), New Delhi

Reynaldo V. Ebora Executive Director, Philippine Council for Advanced Science and Technology Research and Development (PCASTRD), The Philippines

Jikun Huang Professor and Director, Centre for Chinese Agricultural Policy (CCAP), China

Dongsoon Lim Dong-EUI University, College of Commerce and Economics, Korea

William G. Padolina Deputy Director General, International Rice Research Institute (IRRI), Manila, Philippines

Govindan Parayil Vice-Rector, United Nations University, Director, UNU-Institute of Advanced Studies, Japan.

Ajay Parida Programme Director-Biotechnology, M S Swaminathan Research Foundation, Chennai

Balakrishna Pisupati Chairperson, National Biodiversity Authority, Chennai

Bambang Purwantara Director, Southeast Asian Regional Centre for Tropical Biology, Indonesia

Sudip K. Rakshit Canada Research Chair - Bioenergy and Biorefining, Lakehead University

S R Rao Adviser, Department of Biotechnology (DBT), Government of India

M S Swaminathan Chairman, M S Swaminathan Research Foundation, Chennai

Halla Thorsteinsdóttir Assistant Professor, University of Toronto, Canada.

The editorial correspondence should be addressed to the Managing Editor, Asian Biotechnology and Development Review, Research and Information System for Developing Countries (RIS). Zone IV-B, Fourth Floor, India Habitat Centre, Lodhi Road, New Delhi-110003, India. Telephones: 24682177-80. Fax: 91-11-24682173-74. E.mail: [email protected] Website: http://www.ris.org.in

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Citation should be first alphabetical and then chronological–for example ‘Rao 1999a, 1999b’.

More than one reference of the same date for one author should be cited as ‘Shand 1999a, 1999b’.

The following examples illustrate the detailed style of referencing:

(a) Books: Hirschman, A. O. 1961. Strategy of Economic Development. New Haven: Yale University Press.

(b) Edited volumes: Shand, Ric (ed.). 1999. Economic Liberalisation in South Asia. Delhi: Macmillan.

(c) Articles from edited volumes: Lakshman, W. D. 1989. “Lineages of Dependent Development: From State Control to the Open

Economy in Sri Lanka” in Ponna Wignaraja and Akmal Hussain (eds) The Challenge in South Asia: Development, Democracy and Regional Cooperation, pp. 105-63. New Delhi: Sage.

(d) Articles from Journals: Rao, M.G., K. P. Kalirajan and R. T. Shand. 1999. “Convergence of Income across Indian States:

A Divergent View”. Economic and Political Weekly, 34(13): pp. 769-78.

(e) Unpublished Work: Sandee, H. 1995. “Innovations in Production”. Unpublished Ph.D thesis. Amsterdam: Free University.

(f) Online Reference: World Health Organisation. 2000. “Development of National Policy on Traditional Medicine”.

Retrieved on March 31, 2011 from http://www.wpro.who.int/sites/trm/documents/Development+of+National+Policy+on+Traditional+Medicine.htm

AsianBiotechnologyDevelopment Review

and

AsianBiotechnologyDevelopment Reviewand

Vol. 15 No. 2 July 2013 ISSN: 0972-7566

Bioscience and Innovation Research: Examining the GM Animals Case with Indian Researchers Using the Ethical Matrix ....................................................1Scott Bremer, G. Pakki Reddy and Kate Millar

Patenting of Naturally Occurring ‘isolated’ Biological Materials ....................................19Luigi Palombi

Genetically Modified Crops and Sustainability of Farm Livelihoods: A Compartive Analysis of India, China and Brazil ...........................................................31Asmita Bhardwaj

Agricultural Biotechnology, Intellectual Property Rights and Seed Industry in India ................................................................................................61Vikas Kumar and Kunal Sinha

PerspectivesBio-based Production in a Bioeconomy ...........................................................................81Jim C. Philp and Krishna C. Pavanan

Book ReviewsAgrobiodiversity and the Law: Regulating Genetic Resources, Food Security and Cultural Diversity ...............................................................................89Krishna Ravi Srinivas

Regulating Next Generation Agri-Food Biotechnologies: Lessons from European, North American and Asian Experiences ...................................93Amit Kumar

RISResearch and Information Systemfor Developing Countries

Asian Biotechnology and Development ReviewVol. 15 No.2, pp 1-17

© 2013, RIS.

Scott Bremer*, G. Pakki Reddy** and Kate Millar***

Bioscience and Innovation Research: Examining the GM Animals Case with Indian Researchers Using the Ethical Matrix

Abstract: Scientists working in the biosciences are increasingly required to consider the ethical issues of their research, for example due to government oversight and international research council funding requirements. The translation of ethics into practical processes is an ongoing area of research and several tools have been developed to help scientists identify and consider the ethical dimensions of their research. This article presents the results from a workshop with early-career Indian scientists as they apply a deliberation support tool, viz. the ‘Ethical Matrix’, to examine the ethical aspects of the development and use of genetically modified (GM) animals.

The results are presented in terms of: (i) a completed ethical matrix; (ii) the participants’ most significant ethical concerns or priorities regarding GM animals; and (iii) their views on their role as scientific researchers in responding to concerns. The workshop, supported by the ethical matrix, proved useful in nurturing interdisciplinary deliberation on ethical issues. Participants were able to map a diversity of ethical considerations, and recognise the dilemma posed by trading off between these. The findings from this work imply that this method may be a useful approach for structuring ethical analyses processes outside of a European context.

Key words: GM animals, Ethical Matrix, Research ethics, Animal biotechnology, Responsible innovation.

* Centre for the Study of Sciences and Humanities, University of Bergen, Bergen, Norway. Email: [email protected] (Corresponding Author)

** Agri Biotech Foundation, Acharya N.G. Ranga Agricultural University Campus, Rajendranagar, Hyderabad, India. Email: [email protected]

*** Centre for Applied Bioethics, School of Biosciences and School of Veterinary Medicine and Science, Sutton Bonington Campus, Sutton Bonington, Leicestershire, United Kingdom. Email: [email protected]

The authors would like to thank the workshop participants for their time and contribution. This work was supported through an EU 7th Framework Programme project grant; PEGASUS (Public Perception of Genetically modified Animals – Science, Utility and Society). Grant number: 226465 (Support Action).

2 Asian Biotechnology and Development Review

Encouraging Ethical Reflection amongst ScientistsGlobally, scientists are increasingly required to examine and discuss their professional responsibilities and the implications of their science. Requirements to engage in these research ethics activities are a result of government oversight and often a prerequisite of national and international research council funding. In addition, science research institutes are developing and embedding codes of conduct and promoting greater reflection on aspects of scientific integrity at an early stage of the research and innovation process.

The translation of ethics into practical processes is an ongoing area of research and the different forms of ethics present within bioscience research and technology development have previously been described (Millar et al. 2007). Several tools, such as ethical review processes, checklist and ethical reflection tools (such as the Ethical Matrix), have been developed to help researchers identify and manage the ethical dimensions that can emerge in their research and other processes have been outlined to encourage reflexivity more broadly in everyday practice. It has been proposed that ethics within research and technology can be identified in five forms (Millar et al. 2007). These forms are: (1) regulation (such as external ethics committee); (2) engagement (e.g. involving external stakeholders) (3) analysis (of a specific activity by an individual or group); (4) scoping (e.g. exploring ethical dimensions of future strategies or options); and (5) reflection (facilitated through internal value-based discourse).

This article reports on an experience of engaging early-career Indian scientists as they apply a deliberation support tool when discussing the ethical aspects of bioscience research, specifically the development and use of genetically modified (GM) animals. The process is structured according to the Ethical Matrix framework.

The application of genetic modification and other forms of biotechnology continue to represent prominent debates in the public sphere. These technologies remain characterised by significant degrees of uncertainty, particularly relative to the long-term consequences of this technology and what positive or negative outcomes may result for society. GM animals also draw into the debate the plurality of society’s values and ethical positions on the appropriateness of this technology, with this normative dimension often having the greatest influence in shaping decision-making processes,

3

while at the same time reducing the potential for consensus in a high-stakes politicised arena.

Beekman and Brom (2007) highlight two important ways in which the plurality of perspectives complicate decision-making for biotechnology, noting (i) society’s diverse values and ethical positions may be fundamentally irreconcilable; and (ii) that there is no ‘one’ societal debate within which GM animals are discussed. Rather there are several inter-twined debates, with different actors participating in different discourse in different institutional settings. These debates differ in character according to time, space and scale; with a debate at the local scale likely to be fundamentally different from one at the international scale for instance, or the debate in Europe likely to be quite different to related debates in Asia. Moreover, facilitating ethical discourse is difficult owing to the complex melange of values, beliefs, and knowledge that constitute actors’ individual perspectives, and the diverse vocabulary used to express perspectives. This has seen the increasing popularity of a number of tools and frameworks grouped under the heading of ‘deliberation support tools’ for structuring a systematic deliberation of plural ethical perspectives for biotechnology (Beekman and Brom 2007).

One important ethical discourse for GM animals is within the scientific community of Asia, where GM research has found increasing attention and public funding. While North American-European (NAE) science has often been depicted as a value-free and ‘disinterested’ exercise, it has latterly been argued by philosophers of science for instance, that scientists should reflect on their own value-bias and ethical standpoint, and recognise its influence on their research projects. This becomes particularly interesting when the NAE scientific approach is nested within the context of Asian societies, with their own unique value and ethical basis. With the emergence of GM animal technologies, to what extent do scientists in Asia engage with the ethical debate in undertaking their research? And how do Asian scientists view their contribution to society’s wider GM debate relative to other legitimate perspectives put forward by other sectors of society; such as from religious figures, or animal welfare groups?

This article follows one specific deliberative initiative which brought together young Indian scientists working within the field and associated studies of GM animals to draw out the diverse ethical aspects associated with their research, using the support of the Ethical Matrix deliberation support

Bioscience and Innovation Research


framework. This workshop was held in Hyderabad in late 2010, and aimed to empower young scientists to collectively explore and discuss the plurality of ethical standpoints that provide a context to their research. Relative to this workshop, this article has three aims. Firstly, it seeks to present the particular approach used for engaging early career Indian scientists in deliberation over the ethical considerations of GM animals. Secondly, it summarises the results of the workshop analysis; highlighting the key ethical issues that participants foresaw for GM animal research. And finally, it discusses the merits of the approach relative to supporting ethical reflexivity in research, specifically examining: (a) participation and interaction; (b) participant self-appraisal; and (c) awareness of ethical aspects.

Ethical Matrix ApproachThe initiative described by this article was undertaken under the auspices of the European Union 7th Framework Programme PEGASUS Project ‘Public Perception of Genetically modified (GM) Animals – Science, Utility and Society.’ The Project sought to present “the pros and cons” regarding GM animals and derivative foods and pharmaceutical products to support European decision-making by integrating existing social, environmental and economic knowledge. This includes an exploration of European ethical perspectives on GM animals accessed through four deliberative workshops in Belgium, Germany, Norway and the United Kingdom. As part of PEGASUS it was proposed to undertake a similar workshop with scientists in India to explore their ethical discourse, with a pilot event focusing on early career scientists and their early, formative perspectives on ethics in research. There were three reasons for this workshop:

i. To explore the degree to which earlier career Indian scientists engage with the ethical debate surrounding GM animals, and the perceived influence of ethical considerations on shaping their research, as interesting in its own right; while

ii. Methodologically revealing how a deliberation support tool previously used exclusively in Europe would operate in an Indian context to support further work in this area; and

iii. To provide Indian perspectives as a comparison to the perspectives arising from the workshops in Europe.

5

The Ethical Matrix (the ‘matrix’) was developed by Ben Mepham at the University of Nottingham in the mid-1990s (1996; 2000) as a framework to enable a diversity of stakeholders to present their plural ethical concerns relative to a specific issue. In creating the matrix, Mepham recognised that the discourse surrounding the assessment of novel technologies is complex and often opaque. Mepham also recognised a plural society could rarely arrive at agreement on one single frame or theory by which to measure the ethical appropriateness of its actions; no single concern such as maximising net benefits across society, or respecting human rights, overrides all others. Therefore, the matrix is designed so that a broad range of ethical concerns is (i) ‘mapped’; and (ii) differences of perspective openly discussed, and then the weighting of each concern against the others can be made explicit, if the framework is being used to support final decision-making. The matrix has been further developed as a participatory tool (Forsberg 2009; Millar 2011). For the PEGASUS Project’s purposes this tool was used only to aid a more informed societal debate through a rigorous and transparent mapping process.

Structured as a matrix, it takes a ‘principled’ approach to ethics, and allows each category of stakeholder (including those representing ‘voiceless’ stakeholders such as animals or the environment) to express their concerns relative to multiple ethical principles, considered relative to each other in parallel (see Table 1).

Typically the matrix incorporates three broad ethical principles: (i) wellbeing, (ii) autonomy, and (iii) justice (or fairness). These three principles are neither mutually exclusive, nor represent the totality of ethical concerns, though in European practice most concerns have been able to be expressed according to these principles (Kaiser et al. 2007; Mepham, 2000; Mepham et al. 2006; and Millar 2011). It has been argued that these three principles represent a ‘common morality,’ as the social norms that underpin contemporary European society. To this end, there has been no documented experience with using the matrix outside of a European context, where these principles may not hold as so self-evident. Since its inception in the mid-1990s, the Ethical Matrix has found widespread practical application in Europe, particularly in supporting deliberation over the ethical aspects of agriculture and biotechnology. To this extent, applications of the matrix across different topics have been widely reported in the academic literature (see e.g.



England and Millar 2007, Kaiser and Forsberg, 2001; and Kaiser et al. 2007) and it has been endorsed by European NGOs (e.g. The Food Ethic Council1).

Table 1: Example of a Generic Ethical Matrix

Generic Ethical Matrix (Translation of the ethical principles for the corresponding interest group)

WELLBEING AUTONOMY FAIRNESS

TREATED ANIMAL(Fish, Cattle, etc)

Animal Welfare

BehaviouralFreedom

IntrinsicValue

PRODUCERSSatisfactory incomeand workingconditions

Managerial Freedom

Equitable standards ofpractice

CONSUMERS / PATIENTS

Food Safety / Product Safety and Quality Of life

ChoiceAffordability of products

SOCIETY Safety and socialharmony

Democratic choice

Fair resource allocation

ENVIRONMENTConservation and protection

Biodiversity Sustainability

Source: Authors’ compilation.

Researchers’ WorkshopThe workshop was convened by the Agri-Biotech Foundation (PEGASUS partner), and held in a meeting-room at the Foundation for a full day in November 2010. Sixteen early-career Indian scientists took part in the workshop, with ten male participants and six female. Participants came from universities and research groups from around Hyderabad, and were all either enrolled in PhD programmes or were post-doctorate researchers, with some experience on the subject of genetic modification. The participants came from a diversity of disciplinary backgrounds. The majority worked within natural or life sciences, with a large portion of these participants actively engaged with research in the biosciences, including on genetic modification. Five participants came from the social sciences, and researched such diverse interests as sustainability, science and technology studies (STS) and media studies with interest in science studies. Most participants’ experience with genetic modification was related to plants, rather than animals. Beyond the Indian convener and the participants, two PEGASUS partners from Europe were present to facilitate the workshop and observe.

7

The workshop composition represented a strategy to bring together a heterogeneous group of young researchers from across several disciplines linked to scientific research and science studies, for three key reasons. First, a diversity of perspectives in the group was hoped to unpack a diversity of different ethical and social considerations of GM animals. Second, it was hoped that this diversity would encourage participants to challenge each other’s perspectives, as a collective appraisal of the considerations put forward. Third, by being confronted by other perspectives it was hoped that participants would reflect on their own perspective. Indeed, a heterogeneous workshop provides an important point of departure for many participatory approaches to bioethics that attempt to lay bare the plurality of ethical standpoints in society. Such heterogeneity can support the processes that are used in discussions structured by the Ethical Matrix, which is tailored to teasing out society’s plurality according to categories of ‘interest groups’ (Mepham et al. 2006). However, this noted, a recent study by Jensen et al. (2011) indicates that the process of applying this Ethical Matrix tool can encourage a reflective process without the need for heterogeneous participation or multi-stakeholder involvement. Tools such as the matrix may facilitate examination of the ethically pertinent issues as “ethical reflection evolves if subjects engage in ‘putting themselves in the shoes of others’ and hence reflect on key issues from the point of view of various affected parties” (Jensen et al. 2011). Therefore, although recruiting a heterogeneous group of researchers from across several disciplines is likely to benefit any structured process, this may not be imperative to stimulate valuable ethical reflection with science community groups when using the Ethical Matrix.

The workshop discussion was targeted to three case studies of GM animals being explored by the PEGASUS Project in Europe, to focus the research work. The first case study looked at an application of GM animals for food, presented by growth-enhanced salmon that grow to market size in almost half the time as conventional salmon and accordingly require less feed. The second case study looked at the pharmaceutical use of GM animals, with rabbits that produce poly-clonal antibodies in their blood. The rabbit’s own antibody genes are replaced by human antibody genes, before being immunised against targeted antigens and bled to distil polyclonal antibodies. The third case study looked at using GM animals to produce



food product enhancement, with transgenic cows that produce recombinant human lactoferrin in their milk. Lactoferrin has anti-bacterial properties and is present in high concentrations in human milk, but in low concentrations in cow’s milk. By transferring the constructs for producing lactoferrin into transgenic cows, this produces milk that may help people living in poor sanitary conditions to resist bacterial infection (further details of these case studies can be found in Vàzquez-Salat and Houdebine (2013)).

The workshop opened with a round of introductions; with participants all seated around one large table for the day’s discussion. Following these introductions, the facilitator gave a one-hour presentation, including (i) a simple introduction to concepts in bioethics; (ii) a brief overview of the three case studies that were to focus the discussion; and (iii) instruction in the use of the Ethical Matrix that was to structure the discussion. The facilitator then opened up the discussion, inviting participants to discuss the ethical concerns arising from the case studies or broader issues, and encouraging the participants to reflect on aspects according to the interest groups and three broad principles employed for the matrix, as they saw fit. Concurrently, the note-taker took notes on an empty matrix template (showing just the interest groups and ethical principles) which was projected onto a large screen above the group, and the discussion was recorded in real time allowing participants to comment on any notes taken. The workshop ran as a loosely structured discussion among all participants over three separate sessions separated by lunch and ‘tea’ breaks. Participants decided themselves to which degree that drew on the case studies, or structured their reasoning according to the matrix. This saw some participants specifically situating their thinking relative to a cell of the matrix, while others preferred to speak more generally. It equally saw participants sometimes speaking to the case studies, while other times they reverted back to their experience with other biotechnologies, such as GM plants. Notwithstanding this, all of the discussion was registered on the projected screen, with participants able to interject and modify what the note taker wrote, or which cell of the matrix a note was written in. The workshop finished with participants filling in an anonymous ‘feedback form’.

In this way, the matrix was used as a tool for stimulating, supporting and recording the workshop discussion, while not constraining a broader discussion. It is important to recognise this ‘supporting role’ of the matrix

9

in facilitating a rich and meaningful workshop discussion. As cautioned by Mepham and others (2006), the matrix does not work as a stand-alone balance sheet to be filled out. Its usefulness is contingent on its use in a deliberative setting, where it has been demonstrated to improve the quality of deliberation.

By way of critical appraisal, it deserves noting two particular criticisms of the workshop. Firstly, the specifics of the case studies did not prove fully engaging for a discussion between participants at the beginning of the workshop. This appeared to stem from a lack of direct research experience from most participants with the ethical dimensions of specific GM animal cases, and the necessarily short presentation given for each of the three cases at the start of the workshop. As such, few participants could claim adequate knowledge to steer a discussion focussed on the specifics of the case studies, and discussion usually retreated to more overarching ethical perspectives and claims about animals and GM per se. Secondly, participants were presented with a pre-structured Ethical Matrix based in the ‘European-model,’ with stakeholders and principles pre-defined. Given time constraints, participants were not asked to ‘re-build’ the matrix according to their own collectively agreed stakeholders and principles. While presenting a pre-defined deliberation support framework may affect the nature of the discussion in any case, the bias it may have introduced in this case might have been particularly important, because it represents a framework derived from a ‘Eurocentric worldview.’ Keeping in mind these caveats, the workshop did present some interesting results, and did prove successful according to a number of measures.

Summarising the Results As noted above, while the workshop began as focussed on the ethical concerns associated with three specific GM animal case studies, discussion tended toward an appreciation for the ethical concerns associated with GM animals in general. Indeed, often participants deviated from discussing GM animals to draw on their experience with GM plants, and the ethical issues that arose. As such, this article will present the results in terms of more general ethical concerns raised by participants regarding GM animals, rather than those ethical concerns specific to the case studies. These results can be split in three: (i) the completed matrix; (ii) the participants’ most



significant ethical concerns or priorities; and (iii) their role as scientific researchers in responding to concerns.

The Completed Ethical Matrix: Mapping the Ethical Terrain for GM Animals in IndiaThe workshop set out to facilitate a collective exploration and discussion by allowing participants to assume the perspective of different stakeholders and ‘map the ethical terrain’ regarding GM animals in India. This mapping exercise was structured according to five broad ‘stakeholders’ or interest groups, including the producers (farmers) of GM animals, consumers and society in general, as well as the treated animals themselves and the natural environment. For each stakeholder, the discussion registered different ethical concerns relative to three broad principles: well-being, autonomy and justice. The resultant matrix (see Table 2) provided a rich map of the ethical context within which GM researchers conducted their research in India.

The workshop saw an advanced discussion on the treated animal, and particularly the protection of their intrinsic value and ‘natural behaviour,’ which was considered vital to an animal’s well-being. Broadening the discussion to the natural environment, some participants discussed GM technology as one technological solution to reducing humanity’s adverse environmental impacts, though they urged a holistic and precautionary approach to ensure against long-term and irreversible externalities. However, while acknowledging the importance of the natural world, workshop participants stressed the well-being of humans and society as the over-riding ethical imperative, including issues of food security in India. Here again a clear distinction was made between short- and long-term effects. In the short term GM was seen to present an additional tool for ensuring more equitable access to food and healthcare, more choice for consumers, and improved profitability for producers or farmers. Over the long-term, however, GM was characterised as presenting a number of risks with potentially significant consequences for consumers/patients and producers alike. For example, with reference to the Indian experience with GM plants, there was a discussion on whether GM animals would see the monopolistic dominance of small producers by the large international corporations developing and promoting GM technology.

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se c

hoic

e fo

r co

nsum

ers.

Cho

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sho

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be b

ased

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kn

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int

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cing

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ies

to

info

rm c

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mer

s.

GM

ani

mal

s m

ay i

mpr

ove

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for t

he p

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tors

of s

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uita

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ness

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to

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and

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.

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and

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.

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iety

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bly

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cts

on t

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atur

al

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ronm

ent,

but t

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ell-

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g of

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iety

m

ust p

reva

il.

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ploy

men

t an

d ec

onom

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row

th t

o su

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t poo

rer

sect

ors

of s

ocie

ty.

EN

VIR

ON

ME

NT

Tech

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gy a

nd i

nnov

atio

n ar

e so

luti

ons

to t

he e

nvir

onm

enta

l im

pact

of s

ocie

ty, a

nd w

ill e

nsur

e su

stai

nabi

lity

.

Tech

nolo

gies

may

cre

ate

long

-te

rm e

xter

nali

ties

whi

ch a

re

irre

ver

sib

le;

nec

essi

tati

ng

prec

auti

on a

nd ‘

lear

ning

-by-

doin

g.’

Thr

ough

GM

, ani

mal

s m

ay n

ot b

e ab

le

to b

ehav

e in

a ‘n

atur

al’ o

r tel

eolo

gica

l m

anne

r, w

ith

impl

icat

ions

for

lin

ked

anim

als

and

othe

r co

mpo

nent

s in

the

ecos

yste

m, w

hich

wil

l als

o be

for

ced

to c

hang

e th

eir

beha

viou

r.

The

env

iron

men

t su

ppor

ts u

s an

d ha

s in

trin

sic

and

spir

itua

l va

lue

that

mus

t be

re

spec

ted.

We

shou

ld n

ot ‘

play

God

.’

We

need

to

cons

ider

the

env

iron

men

t ho

list

ical

ly,

and

cons

ider

flo

w-o

n ef

fect

s to

oth

er p

lant

and

ani

mal

spe

cies

.

Sour

ce: A

utho

rs’ c

ompi

lati

on.

Tabl

e 2

cont

inue

d...

13

Priority Ethical Concerns of GM AnimalsHaving mapped the ethical concerns regarding GM animals via the matrix, participants were asked to identify their priority ethical concerns, or the ethical ‘peaks’ of this terrain. Participants were both asked about ethical priorities within the workshop, and within the confidential feedback form. There emerged five key ethical concerns.

For participants, the most significant ethical consideration is the promotion of the health and well-being of human-kind, with this the only consideration raised both in the open discussion, and with five participants making special note of it in their feedback forms. This ethical consideration was both expressed in terms of “the maximum benefits to the maximum population with minimum risk to all,” and in terms of intra-generational equity, with healthcare and food accessible for even the most impoverished member of society. Part of this ethical claim was, however, that GM research should be focussed on food security and healthcare, rather than on more ‘ornamental’ uses of the technology.

The second priority ethical consideration, according to the frequency it was noted in the feedback forms, is to ensure that GM animals do not have an adverse impact on the natural environment, with a particular concern for the long-term sustainability of natural resources for future generations; notions of inter-generational equity. Thirdly, animal welfare was considered important with reference to the pain, suffering and sacrifice of animals in the GM animal research process. This also extended fourthly to the intrinsic and indeed spiritual value of animals and the broader natural environment, which was raised as important consideration. This concern was voiced both in terms of offering animals and the environment an ethical standing such that they are not considered only as ‘means’ but as ‘ends’ in themselves, and in terms of the spiritual essence that pervades Nature and that must be respected; humans must not ‘play God.’ Finally, a fifth ethical consideration noted by some participants was relative to how society collectively makes decisions on whether to advance toward the wider use of GM animals, and the role of science in supporting this ‘social choice.’ Specifically, participants engendered principles of participatory democracy, and scientific transparency.



The Role of Scientists in Responding to Ethical ConcernsHaving mapped the ethical terrain of GM animals, including its ‘peaks,’ participants were asked what they thought to be the main responsibility of scientists and researchers in the field of GM animals relative to these ethical considerations and their understanding of professional responsibilities. Again, this was raised as a point of discussion within the workshop, but was also included as a question in participants’ confidential feedback forms. For a few participants, the responsibilities of the scientific community begin and end with an ‘objective’ exploration of GM technology, and the timely progressing of this technology; “if we think about ethical issues we will not go ahead; benefits are more [numerous than risks] so let’s forget ethical issues”, was one participant’s response. However, most participants were quick to challenge this view and to identify other responsibilities placed on scientists by the ethical claims mapped in the workshop.

In their feed-back forms, participants identified the scientific community’s role as trading off between three over-arching responsibilities: (i) first and foremost, a responsibility to attend to the needs, health and well-being of society; (ii) secondly, a responsibility to protect the health of the natural environment; and (iii) thirdly, a responsibility to have regard for animal welfare. In designing research on GM animals, some participants described scientists as continually in a process of trading-off between these three perceived irreconcilable responsibilities.

Most frequently raised in feedback forms and vigorously discussed by participants in the workshop, were the responsibilities of science to remain accountable to society, and play a role in supporting society’s decision-making. Foremost amongst these responsibilities was to remain accountable to society through transparency, including the open and honest communication of GM animal science to wider society to encourage widespread awareness and understanding. In this way consumers, for instance, will individually be better informed to make decisions relative to products derived from GM animals. Another related responsibility of science is to provide knowledge, alongside that knowledge provided by other stakeholder groups, in support of society’s collective decision-making; expressed by participants as communicating an assessment of the pros and cons of GM animals to policy-makers across a science-policy interface.

15

Another related responsibility of the scientific community was to break down the barriers that it had placed around its disciplines, to allow access by scientists from other disciplinary backgrounds as well as non-scientists, to enable an extended critique of the GM animal science produced, and a constructive dialogue.

Changing Awareness of Ethical Considerations in ResearchEmbedded within the feedback forms were two questions which asked participants: (a) ‘To what extent had you thought about the ethical issues in advance of the workshop?’ and (b) ‘Do you think that the inclusion of ethical engagement processes in transgenic animal research projects is valuable?’ From the answers to these questions, some comment can be made on the way in which the workshop changed the awareness of participants toward ethical issues in GM animal research.

Most participants reported that they had given little thought to ethical issues in their research prior to the workshop, and almost none reported any formal attention to ethics as part of their research projects. Ten participants professed to moderate or very little knowledge of the ethical considerations of GM animal research prior to the workshop. As a result of the workshop many respondents explicitly noted that they had learnt much more about the diverse ethical issues surround GM animals, and some felt motivated to learn more.

With the exception of one participant, all who took part in the workshop agreed that it was valuable to include an ethical engagement process within GM animal research. For some this was important to appreciate the diversity of cultures, religious views, values and beliefs of society, within which scientists and their research are nested. For others this was as much about the promotion of GM animal research; once scientists and wider society are made aware of the significant benefits that can accrue from GM animals, then it was proposed that the path for GM animal research will be cleared.

ConclusionWhile Europe and North America have seen a growth in published research on the ethical considerations of biotechnology, there has by comparison been relatively little published on the experience in developing countries, including within India. Given the research that is being conducted outside



of NAE areas and that GM technologies are put forward as one tool for addressing such pressing issues as food security, it is important that we engage with the ethical debate in the developing world, where these issues are arguably most acute. It is within this context that this research aimed to make a small contribution to the understanding the types of tools that may facilitate engagement with the wider societal issues raised by this research; focussing on young scientists in India, and how they view these ethical considerations in light of these daunting issues.

The workshop, supported by the Ethical Matrix, proved useful in nurturing interdisciplinary deliberation on ethical issues. Participants were able to map a diversity of ethical considerations, and recognise the dilemma posed by trading off between these. That noted, there was an overwhelming sense of duty to society voiced by participants, with easing the suffering of fellow citizens the priority for most, and for some out-weighing other considerations of environment and animal welfare for instance. Another influence was seen to come from cultural and religious norms, with participants very comfortably engaging in a discussion on the need to respect ‘the spiritual essence’ of animals and the wider environment. The ease with which there was interchange amongst participants when scientific and spiritual aspects were discussed, or indeed their apparent reluctance to distinguish the two as mutually exclusive, marked the workshop discussion as characteristically different from most published experiences with the matrix in Europe or North America. While bio-scientists in Europe and North America may be increasingly comfortable with discussing the ethical, legal and social aspects (ELSA) of their work, as published ‘ELSA’ studies may indicate, few studies have explored reflections and discussion regarding spiritual perspectives on the biosciences research. For this reason, future research in India on the ethical aspects of bioscience may benefit from allowing the time for participants to collectively examine the interest groups and ethical principles proposed in the matrix, so allowing them to consider what they think are most appropriate for the specific Indian context. This may give rise to different packages of ethical principles to guide an Ethical Matrix deliberation. With that said, the Ethical Matrix tool was demonstrated to be a useful tool helping researchers identify and examine the ethical dimensions that can emerge in their research, and work further developing these types of tools would undoubtedly be beneficial.

17

Endnote1 www.foodethicscouncil.org (accessed on 14 May 2013)

ReferencesBeekman, V. and Brom, F.W.A. 2007. “Ethical Tools to Support Systematic Public Deliberations

about the Ethical Aspects of Agricultural Biotechnologies.” Journal of Agricultural and Environmental Ethics, 20, pp. 3-12.

England, G. and Millar, K. 2008. “The Ethics and Role of AI with Fresh and Frozen Semen in Dogs.” Reproduction in Domestic Animals, 43:165-171.

Forsberg, E-M. 2007. “Pluralism, the Ethical Matrix, and Coming to Conclusions.” Journal of Agricultural and Environmental Ethics, 20:455-468.

Jensen, K.K., Forsberg, E., Gamborg, C., Millar, K. and Sandøe, P. 2011. “Facilitating Ethical Reflection Among Scientists Using the Ethical Matrix”. Science and Engineering Ethics, 17(3), 425-445.

Kaiser, M. and Forsberg, E-M. 2001. “Assessing Fisheries – Using an Ethical Matrix in a Participatory Process.” Journal of Agricultural and Environmental Ethics, 14, pp. 192-200.

Kaiser, M., Millar, K., Thortensen, E., and Tomkins, S. 2007. “Developing the Ethical Matrix as a Decision Support Framework: GM Fish as a Case Study.” Journal of Agricultural and Environmental Ethics, 20, pp. 65-80.

Mepham, B. 1996. “Ethical Analysis of Food Biotechnologies: An Evaluative Framework,” in B. Mepham (ed.) Food Ethics, pp. 101-119. London: Routledge.

Mepham, B. 2000. “A Framework for the Ethical Analysis of Novel Foods: The Ethical Matrix.” Journal of Agricultural and Environmental Ethics, 12, pp. 165-176.

Mepham, B., Kaiser, M., Thorstensen, E., Tomkins, S. and Millar, K. 2006. Ethical Matrix: Manual. Agricultural Economics Research Institute (LEI), The Hague, The Netherlands.

Millar, K., Gamborg, C. and Sandoe, P. 2007 “Using Participatory Methods to Explore the Social and Ethical Issues Raised by Bioscience Research Programmes: The Case of Animal Genomics Research.” in W. Zollitisch, C. Winckler, S. Waiblinger and A. Haslberger (eds) Sustainable Food Production and Ethics. Pp. 354-359. Wageningen, the Netherlands: Wageningen Academic Publishers.

Millar, K. 2011. “Ethics and Ethical Analysis in Veterinary Science: The Development and Application of the Ethical Matrix Method,” in Wathes, C.M., Corr, S.A., May, S.A., McCulloch, S.P. and Whiting, M.C. (eds) Veterinary and Animal Ethics. Pp 100-112. Chichester, UK: Wiley-Blackwell.

Vàzquez-Salat, N. and Houdebine, L-M. 2013. “Will GM Animals Follow the GM Plant Fate?” Transgenic Research, 22 (1), pp. 5-13.




© 2013, RIS.

Luigi Palombi*

Patenting of Naturally Occurring ‘isolated’ Biological Materials

Abstract: The US Supreme Court in American Molecular Pathology v. Myriad Genetics has unanimously held that naturally occurring biological materials that have been isolated, that is, removed, from their natural environments are not patentable subject matter under US patent law. The decision not only overrules two decisions of the US Court of Appeals for the Federal Circuit (CAFC) directly on point, but overturns 30 years of US Patent and Trademark Office practice. The implications of the decision transcend the US patent law and impacts upon international law in so far as international agreements and conventions concerning patents are concerned. The two most important are the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the European Patent Convention (EPC) with specific emphasis on the Biotechnology Directive 98/44/EC (Directive). The decision means that the US patent law and the European patent law are inconsistent. The word ‘invention’ in Art. 27.1 TRIPS is not defined, yet the apparent trans-Atlantic inconsistency on such an important issue as the patentability of naturally occurring ‘isolated’ biological materials, leads inevitably to the conclusion that the basic premise upon which the Directive is constructed is not only fundamentally flawed but that it is in violation of TRIPS. Moreover, the decision brings into question the propriety of national patent laws of the member countries of the European Union to the extent that they are permissive of the patenting of naturally occurring biological materials isolated from their natural environments.

Key words: BRCA, Genes, DNA, Isolated, Patentable subject matter, TRIPS, Biotech Directive.

* Intellectual Property Advisor, Sydney, Australia. Formerly Adjunct Professor of Law, The National University of Sydney and Visiting Fellow, The Regulatory Institutions Network, The Australian National University, Canberra, Australia. Email: [email protected]

Facts, Stated Simply and BrieflyDeoxyribonucleic acid (DNA) is the biological carrier of genetic information for most living things on this planet. Think of it as the equivalent of digital information on a DVD.


In humans, DNA (nucleic acids) is housed in genes which are in turn housed in chromosomes. Humans have about 23,000 genes contained within 46 chromosomes. Every cell in the human body contains a nucleus in which these 46 chromosomes are contained. The genetic information is unique to every human because it is inherited. Human development commences with a fertilised ovum (human conception). DNA regulates the production of proteins (amino acids) during the process of cell division from conception, initially producing a foetus (in utero), and, eventually, an infant (ex utero). Cell division continues throughout human life and DNA regulates the cell division. Indeed, cell division is essential to human life. Think of genes as chapters of digital information and chromosomes as DVDs on which the digital information is contained. And just as a DVD produces sound and images on the television when it is played through a DVD player, so the human body produces proteins as the machinery of the human body uses the genetic information contained within the genes to enable cell division, growth and development.

The double-helical structure of DNA, first elucidated by Drs. James Watson and Francis Crick in 1953, helps to ensure that the process of cell division produces an accurate and faithful copy of that DNA and the protein that the DNA codes for. However, it is possible for some DNA to be altered or damaged (genetic mutations) by the environment. And, genetic mutations can also be inherited. Genetic mutations in humans can lead to deformities and disease, both of which can adversely impact on the quality and longevity of human life. Returning to the DVD analogy, just as the DVD player produces sound and images through a television, so the human body uses the genetic information contained in our chromosomes, through the process of cellular division, to produce proteins that eventually make us who we are. Equally errors in the digital information will result in poor sound and images and, if the data is badly corrupted, the DVD may not even play at all.

BRCA 1: From Breakthrough to Creation Scientific knowledge of the association between BRCA1 and BRCA2 mutations and breast/ovarian cancer risk began with Prof Mary-Claire King’s genetic research on families with very strong family histories of these cancers, King demonstrated in 1990 that a single region on chromosome 17, later known to contain the BRCA1 gene, was responsible for the high

21

risk of breast and ovarian cancers in some of those families. It took King 16 years of publicly funded research to make this discovery. For all intents and purposes, King’s breakthrough heralded a new tool for researchers to help combat these cancers. However, this discovery was not destined to be given to humanity, instead it was patented and commercialised. Although King mapped the general location of a gene related to breast cancer there was then a “race” among a few rival scientific teams to actually isolate the gene. That “prize” was won in 1994 by Dr. Mark Skolnick and the private biotechnology company, Myriad. Myriad applied for patents on the “discovery”, including a patent on the gene itself and a method-of-use patent for the application of BRCA 1 (and the next gene to be found BRCA 2) in diagnostic and therapeutic uses.

At the time, the United States Patent and Trademark Office (USPTO) classified isolated biological materials, such as genetic mutations to be patentable subject matter. This practice, which had been operating since the late 1970s, was well entrenched in the United States.

Myriad’s patenting of the BRCA 1 (and eventually BRCA 2) gene sequence and genetic mutations was claimed as they ‘isolated’ the gene sequence from the human body. And it was this process of ‘isolation’, that is, their extraction from human chromosomes 17 and 13, that enabled Myriad to patent them. Once the “discovery” had been made, their isolation was nothing more than applying standard techniques, like removing a leaf from a tree. The leaf has been ‘isolated’ from the tree, but the leaf is otherwise exactly the same as it was on the tree.

Patenting Isolated Biological Materials: Europe’s Biotechnology DirectiveBy this time, according to the practice of the USPTO, isolated biological materials, such as genetic mutations, were deemed to be patentable subject matter. This practice, which had been operating for about a decade, was well entrenched in the United States and was becoming so throughout Europe and most of the world. And by 1998, the European Biotechnology Directive 98/44/EC (Directive) had codified the practice into law. From July 2000 all members of the European Union would be required to amend their patent laws so that:

Art 3.2: Biological material which is isolated from its natural environment or produced by means of a technical process may be



the subject of an invention even if it previously occurred in nature.

Art 5.2: An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

The key word is ‘isolated’ and so long as the biological material has been removed from its natural environment, such as from the nucleus of a human cell, the proximity in structure or function of that isolated biological material ex situ to the corresponding biological material in situ is irrelevant. For all practical and legal purposes, an isolated biological material was considered to be something capable of being an ‘invention’.

Relevant Political Developments and the Formation of the World Trade OrganisationIn the meantime, the World Trade Organisation was established in 1995. A foundational document is the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). At the time this Agreement was a milestone in global trade in that it provided a comprehensive set of minimum standards for the creation, recognition and enforcement of intellectual property rights across the world and placed intellectual property rights within the scope of multilateral trade negotiations.

In regards to patents, Art 27.1 TRIPS mandates that patents be made available for “any inventions” that are “new, involve an inventive step and are capable of industrial application.” Arts 27.2 and 27.3 provide exceptions to this rule, namely, where it is “necessary to protect ordre public” or if the invention is a “diagnostic, therapeutic and surgical method for the treatment of humans or animals” or is a plant or animal (excluding microorganisms, such as viruses and bacteria).

It is unclear whether the TRIPS negotiators had a collective concept of the word ‘inventions’, but it is likely that the absence of a definition in the final document reflected a concern among key negotiators that any attempt to define the word would be counterproductive to the interests of the United States, the members of the European Union and Japan. It is, therefore, likely, given the close scrutiny given to the negotiations by the

23

pharmaceutical and biotechnology industry (Drahos 2002), that the absence of a definition provided one less point of contention in the finalisation of a complex document that was seen as pivotal to the future of global trade.

This said, during the negotiations between 1986 and 1995, the law regarding the ‘invention’ threshold in so far as the ‘isolation’ of naturally occurring biological materials is concerned was not settled either in Europe or the United States. While both the European Patent Office (EPO) and the USPTO may have been trailblasing a patenting policy agreed upon in 1988, as will become clear, the mere isolation of naturally occurring biological materials was contentious as a point of law.

Therefore, despite the agreed trans-Atlantic policy between two of the world’s most important patent granting organisations, it is arguable that the true meaning of the word ‘invention’ in Art 27.1 TRIPS was inconsistent with that policy in view of the established legal principles developed over hundreds of years, one of which was already enshrined in the European Patent Convention (EPC):

Art 52(2): The following in particular shall not be regarded as inventions within the meaning of paragraph 1:

(a) discoveries ...

BRCA Patents in EuropeMyriad obtained various patents over ‘isolated’ BRCA 1 and BRCA 2 genetic mutations and to their use in the diagnosis of breast and ovarian cancers. The patents were opposed, but the issue of patentable subject matter, though raised in the Opposition to European patent 0,705,902 was never seriously considered (T1213/05). And although the patent was upheld, the scope was severely narrowed on the basis of a technicality, namely, a lack of novelty caused by a sequencing error in the original patent application. The other European patents 0,699,754 (T0080/05) and 0,705,903 (T0666/05) were also upheld, although again, in amended and narrower forms. The result, according to Dr. Dominique Stoppa-Lyonnet, a clinician from the Curie Institute, one of the opposing parties, was: “disappointing after our 7-year fight ... (Abbott 2008).” By the end of 2008, the opposing parties had exhausted all available avenues to challenge these patents before the EPO.



BRCA Patents in the United States of AmericaIn the United States of America the concern over gene patents had been growing for some time. In March 2000, President Clinton and British Prime Minister Tony Blair issued a joint statement acknowledging the “important role” that “gene-based inventions will play in stimulating the development of important new healthcare products”, but warned that in order to “realize the full promise of this research, raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere.”1 Five years later a study published in the Science claimed that “nearly 20 per cent of human genes are explicitly claimed as US IP (Jensen and Murray 2005).”

Despite these concerns and the growing trend in the number of gene patents granted by the USPTO, nothing was being done to stop the grant of gene patents. However, in May 2009 twenty plaintiffs, with the backing of the American Civil Liberties Union (ACLU), brought a challenge to various US patents granted to Myriad over BRCA 1 and BRCA 2 genes. The primary attack, on the ground of lack of patentable subject matter, was directed to four claims in US patent 5,747,282 and one claim in US patent 5,837,492. According to the plaintiffs, claim 1 of US patent 5,747,282 covered “the DNA that includes the BRCA 1 gene in its “wild-type” or non-mutated form”, while claim 1 of US patent 5,837,492 covered “the DNA that includes the BRCA 2 gene in its “wild-type” or non-mutated form”. There were also claims to specific genetic mutations in both the ‘isolated’ BRCA 1 and BRCA 2 genes that the plaintiffs attacked on the same ground.

Myriad’s reaction to this attack-an attack that drew worldwide attention-was to challenge the plaintiffs’ standing to bring the proceedings. Under the US patent law only parties with a juridical interest in a US patent have the right of challenge. US patents are also presumed to be valid by the act of grant. Myriad was successful against all but one of the plaintiffs – Dr. Harry Ostrer, a clinician and Professor of Paediatrics at the New York University School of Medicine. That, however, was enough to maintain the challenge.

At first instance before the US District Court, Southern District of New York, Judge Sweet held that all the patent claims to ‘isolated’ DNA were invalid because “the isolated DNA is not markedly different from native DNA as it exists in nature.”2 Myriad appealed the decision to the US Court of Appeals for the Federal Circuit (CAFC) and before a panel

25

of three judges urged them to reverse this ruling. The Court, 2:1, obliged and overruled Judge Sweet. Judge Lourie, a senior member of the Court, was joined by Judge Moore, who for different reasons, agreed with Myriad that ‘isolated’ DNA was patentable subject matter. The plaintiffs then sought leave to appeal to the US Supreme Court. The Supreme Court was favourably disposed and granted leave. However, the application did not proceed to a oral hearing because having handed down its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc3, the Court simply vacated the CAFC’s decision and ordered the CAFC to rehear the appeal taking the Mayo decision into account. The CAFC, with the same judges reheard the appeal, but the result of the first appeal was repeated. Again the CAFC held 2:1 that the ‘isolated’ DNA was patentable subject matter. The second CAFC decision was brought before the US Supreme Court, which not only granted leave to appeal but, this time, also heard oral argument.

Case Related to BRCA Patents The Court heard oral argument on 15 April 2013. The question to be addressed was: “Are human genes patentable?”

The prevailing opinion of the biotechnology industry and patent attorneys, and with respect to which Myriad concurred, is neatly summarised in the amicus curiae brief filed by the American Intellectual Property Law Association (AIPLA). According to the AIPLA:

Myriad’s patents do not claim “human genes” as they exist in the body. Rather, the claims cover “isolated” DNA molecules - man-made, discrete chemical entitles that differ markedly from genes as they exist in the human body. Those inventions, not any human genes, are the proper focus of the section 101 analysis in this appeal. Genes in their native form, as part of human chromosomes, build and maintain cells. Myriad’s isolated DNA molecules do not and cannot perform the functions of native genes. Rather they can serve as functional biological tools that allow health care practitioners to identify individuals at significant risk of breast and ovarian cancer to tailor existing treatment options for highest likelihood of therapeutic success, and to develop new anti-cancer treatments specifically designed to combat these devastating diseases.4



The US Government, invited to participate in the oral hearing, disagreed. Donald Verrilli, the US Solicitor General, Department of Justice urged the Court to accept that:

Isolated DNA falls on the ineligible side [of patentability] because it is simply native DNA extracted from the body.5

The ‘native’ DNA to which he referred was identical in every way to the corresponding ‘isolated’ DNA except that in former it was contained within a human cell whereas in the latter it was outside of a human cell. The AIPLA was arguing that the isolation involved human manipulation of the native DNA, whereas the US Government was arguing that even so, that kind of manipulation did not change the DNA itself. In other words, the genetic sequence was identical and also the protein that it coded for. The mere act of extraction or isolation neither changed the DNA sequence nor the function it would perform.

Chief Justice Roberts drew upon an analogy using a baseball bat to simplify the argument. He accepted that the isolation of native DNA from a human cell was achieved through the use of “scientific processes”, but he said:

... we’re not talking about process. Here what’s involved is snipping. You’ve got the thing there and you snip -snip off the top and you snip off the bottom and there you’ve got it. The baseball bat is quite different. You don’t look at a tree and say, well, I’ve cut the branch here and cut it here and all of a sudden I’ve got a baseball bat. You have to invent it, if you will.6

US Supreme Court DecisionIn a unanimous decision delivered by Justice Thomas on 13 June 2013 the Court held that ‘isolated’ DNA is not patentable subject matter making it clear that:

Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [section] 101 inquiry [the patentability threshold under the US patent law].7

The Court applied its precedent in Diamond v. Chakrabarty to emphasise the distinction between an act of discovery and an act of invention.

27

In Chakrabarty, scientists added four plasmids to a bacterium, which enabled it to break down various components of crude oil. ... The Court held that the modified bacterium was patentable. It explained that the patent claim was “not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter—a product of human ingenuity ‘having a distinctive name, character [and] use.’” The Chakrabarty bacterium was new “with markedly different characteristics from any found in nature,” due to the additional plasmids and resultant “capacity for degrading oil.” In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.8

ImplicationsWhile the ramifications of the decision are being considered and debated, it is evident that aspects of the Directive are inconsistent with it. This much is clear given the distinction which the Court makes between discovery and invention in the context of ‘isolated’ DNA. Moreover, it is now arguable that Arts. 3.2 and 5.2 of the Directive are inconsistent with Art. 27.1 TRIPS and Art. 52(2) EPC in as much as the word ‘invention’ in the former is mutually exclusive to the word ‘discovery’ in the latter. The dichotomy between ‘invention’ and ‘discovery’ is irreconcilable and it is impossible for the Directive to remain unchallenged.

That it has taken 25 years to overturn a flawed patent policy, one that the USPTO developed in collaboration with the EPO, should be a reminder to politicians, policymakers and patent bureaucrats that it is incumbent upon them to draw upon basic principles of patent law and established legal precedent before developing and employing such policies without due regard to their consequences on the broader community. Their role is not to merely facilitate the creation of patent rights. It is all well and good to make the case that patents are vital to the process of invention and technological progress; however, it must be remembered that patents, being a monopolistic device, can only be allowed to tamper with the rights of the broader community to free competition if there is a demonstrable



net social benefit to that community. Patent offices are gatekeepers upon which the broader community places it trust. Unfortunately, as this example demonstrates, the USPTO failed the American people in this instance. And there is a very good reason why this duty is imposed upon patent offices, as the Court explained:

As we have recognised before, patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.”9

The adverse impacts of the control which the patents in issue gave to Myriad are significant. Besides the high cost of the BRCA genetic tests, reputed to be about USD 4,000, is how Myriad has collected and retained genetic data from those women who could afford its genetic test. Myriad now treats this data as a ‘trade secret’ and is not sharing it with other clinicians and medical researchers.10 Then there is the problem over the reliability of Myriad’s BRCA tests. Indeed, this was one of the concerns that prompted the Curie Institute to participate in the Opposition to Myriad’s European patents (Butler and Goodman 2001).

ConclusionHad the ACLU not backed the twenty US plaintiffs in challenging the Myriad BRCA patents, the policy that has now been so convincingly exposed and overturned would continue to apply in the United States. As Prof. Robert Cook-Deegan observed: “When it comes to gene patenting, policy makers may be responding more to high-profile media controversies than to systematic data about the issues” (Caufield 2006).The EU law and policymakers now have an opportunity to reassess the EPC and the Directive and the impact that gene patents granted by the EPO have had and are having within the EU. Interestingly, as a result of the EPO decisions, Myriad continues to have patent rights over specific BRCA genetic mutations whereas it no longer does in the United States. Whether this is good result for the EU, the European biotechnology industry and medical and clinical service providers should be a matter of consideration.

29

Endnotes1 Joint Statement - President Clinton and Prime Minister Blair - The White House, March 14,

2000.2 American Molecular Pathology et al. v. Myriad Genetics, Inc. et al. 702 F. Supp. 2d 181

(2010), p. 232.3 132 S.Ct 1289 (2012).4 Amicus Curiae Brief for the American Intellectual Property Lawyers Association, p. 2.5 Transcript in American Molecular Pathology et al. v. Myriad Genetics, Inc. et al. 15 April

2013, p. 24.6 Ibid, p. 417 Ibid, p. 128 Ibid.9 American Molecular Pathology et al. v. Myriad Genetics, Inc. et al. p. 11.10 Cook-Deegan, R. Genomic Law Report - How will Myriad respond to the next generation

of BRCA testing? http://www.genomicslawreport.com/index.php/2011/03/01/how-will-myriad-respond-to-the-next-generation-of-brca-testing/ (accessed on 28 June 2013).

ReferencesAbbott, A. 2008. “Europe to Pay Royalties for Cancer Gene.” Nature, 456, 556.

Butler, D. and Goodman, S. 2001 “French Researchers Take a Stand Against Cancer Gene Patent,” Nature, 413, 95-96.

Caufield, T., Cook-Deegan, R., Kieff., F.S. and Walsh, J.P. 2006. “Evidence and Anecdotes: an

Analysis of Human Gene Patent Controversies.” Nature Biotechnology, 24 (9), 1091-1094.

Jensen, K. and Murray, F. 2005. “Intellectual Property Landscape of the Human Genome.” Science, 310, 239-240.

Peter, Drahos. 2002. Information Feudalism, Chapter 4. London: Earthscan Publications.




© 2013, RIS.

Asmita Bhardwaj*

Genetically Modified Crops and Sustainability of Farm Livelihoods: A Comparative Analysis of India, China and Brazil

Abstract: Genetically modified (GM) crops have been adopted widely by farmers of developing countries, including India, China and Brazil. The proponents of GM crops assert that GM crops have led to increased productivity and farmers’ profits; GM crops will usher in a second Green Revolution. The critics of biotechnology continue to doubt its usefulness, particularly for small farmers in developing countries, suggesting that they pose environmental risks. This article argues that both proponents and opponents discuss benefits and risks of GM cotton in a narrow technological framework. It tries to analyse what are the impacts of GM crops on farm livelihoods in three different socio-political country or regional contexts, which differ widely in factors such as state regimes and non state actors, land size distribution and ownership patterns, and ecological resources. It compares the introduction of GM crops in India, China, and Brazil, the leading adopters of GM crops. It finds that in the Indian case, cotton farmers are besieged by problems such as poor regulation of seed quality, high seed prices, inadequate agricultural extension, water scarcity, crop failures, and pesticide pollution, and market integration making the technology a risky proposition. The Chinese case is more successful due to the strong role of the state, and the more egalitarian nature of land distribution despite environmental problems. In Brazil, the inadequate state intervention, and inegalitarian land distribution makes substantive gains from technology suspectable for small farmers.

Key words: Green Revolution, Genetically modified cotton, GM soya, India, China, Brazil, Sustainability.

* Assistant Professor-III and International Programme Coordinator, Amity School of Planning and Architecture, Amity University, Noida, Uttar Pradesh. Email: [email protected]; and: [email protected]

Introduction Genetically modified (GM) crops have been adopted by farmers in India, China and many developing and developed countries. International agencies claim that the adoption of GM crops or the Gene Revolution will redefine the success of the Green Revolution and will create gains for areas left out


by the first Green Revolution. For instance, Fukuda Parr (2006) writes that “the high-yielding selective breeding technology of ‘the Green Revolution’ of the 1960s and 1970s is now being overtaken by ‘the Gene Revolution.’” Gordon Conway, former President of the Ford Foundation writes in his book the Doubly Green Revolution:

The technologies of the Green Revolution were developed on experiment stations that were favoured with fertile soils, well-controlled water resources and other factors suitable for natural production. There was little perception of the complexity and diversity of farmer’s physical environment, let alone the diversity of farmer’s physical environments let alone the diversity of the social and physical environment. The new Green Revolution must not only benefit the poor directly but must be replicable in highly diverse conditions and be environmentally sustainable. In effect, we require a Doubly Green Revolution, a revolution that is more productive than the first Green Revolution, and even more green and we must try to repeat the successes of the Green Revolution. (Conway 1997, 22)

Technology is considered essential to agricultural progress: “through biotechnology, productivity gains could have the same poverty reducing impact as those of the Green revolution” (Pinstrup-Anderson and Cohen 2000).

The importance of GM crops is stressed by country governments as well. For instance, the approach paper to the 12th Five Year Plan of the Indian government suggests: “Technology is the main mover towards crop productivity where natural resources are fixed. At least one third of the future growth agriculture should come through new technologies. Significant breakthroughs are required to improve production technologies in predominantly rainfed areas.”1 (Planning Commission XII Five Year Plan). According to Huang Dafang, former director of the Biotechnology Research Institute of the Chinese Academy of Agricultural Sciences (CAAS), confronted with land degradation, chronic water shortages, and a growing population that already numbers 1.3 billion, China is looking to a transgenic Green Revolution to secure its food supply, and win the race against the West to identify and patent genes of high value. Once intellectual property rights are in place, says Huang, transgenic technology could transform Chinese farming “from high-input and extensive cultivation

33Genetically Modified Crops and Sustainability of Farm Livelihoods

to high-tech and intensive cultivation.2 Premier Wen Jiabao declared in the annual gathering of the Chinese Academy of Sciences (CAS) and the Chinese Academy of Engineering that to solve the food problem, “We have to rely on big science and technology measures, rely on biotechnology, rely on GM.”

The proponents of GM crops also claim that superior technology of GM crops has led to increased productivity, increase in acreage under GM crops and farmers’ profits. According to International Service for Acquisition of Agribiotech applications, 170.3 million hectares of land was under GM crops in 2012 worldwide, and this area is expanding at an annual growth rate of 6 per cent. There was an unprecedented 100 fold increase in 2012 in area under GM crops globally, which makes biotech crops the fastest adopted crop technology in current times. Of the 28 countries which planted biotech crops in 2012, 20 were developing and eight were industrial countries. The five leading developing countries are China and India in Asia, Brazil and Argentina in Latin America, and South Africa on the continent of Africa, after USA.3

It is claimed that fact that farmers have adopted the technology with enthusiasm, often through stealth, shows its success and popularity. For instance, in the case of India, even before its official release in 2002, illegal seeds were found growing in the western state of Gujarat 1998, possibly stolen through a gene from Monsanto. The unauthorised seeds have then spread to other states as well through an underground market, which developed in parallel to the formal market.

The critics of biotechnology continue to doubt its usefulness, particularly for small farmers in developing countries, suggesting that it poses significant environmental risks.4 GM crops have drawn, and continue to draw, criticism at both global and local levels, particularly because of the risk they pose to biodiversity on forests and farms, to farmers’ rights and to human health. Sanvido, Romies and Bigler (2007) suggest that because GM crops are manufactured through genetic manipulation, a risk is present that genes in GM crops could unintentionally flow from transgenic gene species to wild species, which could lead to the extinction of the sexually compatible wild species. The use of GM crops could also lead to contamination of the non-GM crops, and that would lead to problems for those farming organic crops,


for their organic certification could be revoked (Thies and Devare 2007). The researchers also hypothesise that gene products persist in the environment itself with deleterious effects because GM technologies have been proved to harm unintended and beneficiary organisms. Other deleterious effects have been noted too. GM crops are also hypothesised to make crops weedier, and create resistance in the pests that they are intended to target. GM crops could also have other negative effects on the larger environment. Anti-GM activists also claim that the GM crops that require the presence of a harmonised set of intellectual property rights (IPRs) are incompatible with farmers’ rights: “IPRs are an important part of agri-business controlled agriculture in which farmers no longer grow native seeds but grow seeds supplied by the transnational corporation industry. IPRs become a monopoly that wipes out farmer’s rights to save and exchange the seeds” (Shiva 2005).

GM crops allow seed monopolies to gather profits even though it is the farmers whose practice has preserved plant and seed biodiversity for centuries. The gathering of profits by seed monopolies is facilitated by international trade and finance institutions such as the World Trade Organization (WTO). “The state is under siege,” writes Vandana Shiva (2005). “New IPRs are being introduced in the area of plant genetic resources under the pressure of the U.S. government in the Trade Related Intellectual Property Rights (TRIPs) regime, under the WTO.”

This article argues that often both proponents and opponents of GM crops discuss benefits and risks of GM crops in a narrow technological framework. They do not give credence to the settings where GM crops are being introduced in. What are the impacts of new technology when it is introduced in two different socio-political country or regional contexts, such as widely different state regimes and policies, land size distribution and ownership patterns, societal factors, ecology? Since it is difficult to include the vast gamut of above-mentioned factors, this article will largely concentrate on the political and social factors.

GM Crops in India: State, Judiciary, and Non State Actors Produced by the transnational agro-corporation, Monsanto, Bt cotton has been adopted widely in India’s cotton belt. Even before their official release, “illegal” or unofficial GM seeds were found growing in the state of Gujarat in 1998. Monsanto’s Bt varieties that were officially approved in 2002

35Genetically Modified Crops and Sustainability of Farm Livelihoods

have made a dramatic acreage gain since then in the cotton regions of India (ISAAA 2006). According to GM crops proponents, the popularity of GM crops necessitates their introduction on a wider basis. Bt cotton, and GM crops, will increase agricultural productivity and usher in a “second Green Revolution” (Sibal 2008; Singh 2005; Rai 2006; and Patil 2008). Calling for the need for a second Green Revolution, the Five Year Plan paper notes: “The supply side of increasing agricultural growth is really formidable. This is especially so because no dramatic technological breakthrough comparable to the Green Revolution is presently in sight. We are also not exploiting the potential of existing technology.”

Policy MakingThe Indian state which has already been a premier state in the adoption of the green revolution technologies already boasted of a strong conventional plant breeding establishment. Global trends in biotechnology had since then been closely watched by the Indian state. In 1986, to build indigenous capacities for biotechnology development in line with international trends, the Indian government established the Department of Biotechnology in 1986.5

Despite the Indian state’s positive stance towards biotechnology development and the establishment of Department of Biotechnology, there was no national level policy per se as on biotechnology and its relation to the problems of the agrarian sector.

The advent of liberal policies towards foreign firms and investments, post-1985 and gaining momentum after 1991, facilitated agro-transnational Monsanto forming a collaboration with the Indian seed company Mahyco, a big seed company established in India since 1964. Already the 1988 National Seeds Act encouraged the entry of foreign-owned and large Indian firms in the seed sector and easing regulations on technology transfer (Pray and Ramaswami 2003).

Meanwhile, in 1993 itself the opposition to transgenic seeds started coalescing and occupying various protest forums. The environmental movement most prominently led by Vandana Shiva, provided significant opposition against GM crops.6 Opposition constituted by a section of farmers movements, primarily the Karnataka Rajya Ryotha Sangha (KRRS), occupied other forums for protest such as burning of field trial plots of Bt cotton in 1998 in Karnataka, destroying the seed company Cargill’s office in


Bangalore in 1993, uprooting trial fields and staging demonstrations against GM crops and multinationals (Herring 2005). Citizen’s juries and workshops that discussed principles of locally led rural development, initiated by groups such as Deccan Development Society, were also held in Andhra Pradesh and Karnataka (Scoones 2006). Small groups practicing organic and sustainable agriculture formed other forms of protest against GM crops.7

On the other hand, the pro-biotech alliance, which included a segment of the farmer’s movement, the seed industry, multinational seed companies, bio-pharma entrepreneurs, the central government, and federal states8 led a strong campaign, holding workshops, initiating policy dialogues and large conferences.

GM seeds were promoted, embedded in the liberal discourse of “making Indian agriculture competitive in the global market”; “India should shed its conservative stance on GM crops”; and “Bt cotton is providing the right policy signals for global venture capitalists to invest in India” (Scoones 2006).

The Indian seed industry formed a number of associations with alliances developing within the seed industry and with seed MNCs such as the All India Crop Biotech Association.

Using strategies such as public interest litigations and petitioning the Genetically Engineering Approval Committee (GEAC)9 the environmental movement made important interventions in the creation of the hitherto non-existent biotechnology policy and the formulation of bio-safety policy.10 After substantial hue and cry was raised by organisations such as Gene Campaign (see Sahai 2004) a Task Force for evaluating agricultural biotechnology was formulated in 200311 and a biotechnology policy in 2004. Overall, the movement has been successful in creating only a discursive space (Scoones 2006) providing an “enhanced sense of democracy in policymaking”12 and delaying the regulatory process (Scoones 2006).

Scholars such as Herring (2006) attribute the failure of these movements to the non-representativeness of the movements of the farmers and their class position. “Farmers are driven by necessity, unlike the activists for whom controversy is the mode of production.” However, the power of the seed industry that has been increasing due to the government support to the industry since the 1980s is the real reason why GM crops have been introduced in India in 2002.

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Cotton in India is grown in nine states, most prominently, Gujarat, Andhra Pradesh and Maharashtra. Documenting the events in these three states can give a representative picture of adoption of Bt cotton in India.

The case of Gujarat has been much cited in literature, in terms of the agency of farmers in using unauthorised seeds vis-a-vis a victimised portrait of the farmers under corporate control (Shiva 2000). Reports suggest that Bt gene had been inserted in a hybrid cotton that has been grown for several years using public germplasm and a gene stolen from Monsanto by a local firm called Navbharat. While the central state ordered the state of Gujarat to destroy the seeds, the state government and farmers refused to follow suit, leading to the formal introduction of Bt cotton created by Mahyco-Monsanto combine in 2002.13

Literature also suggests that Gujarat farmers are more privileged than their counterparts, in steadily increasingly the productivity of cotton and capturing the profits. Roy (2007) notes that farmers have been able to take advantage of the technology despite the fact that it is unauthorised because of trust bonds developed between farmers over years.

Gujarat is also unique in terms of the role of cooperatives, which have allowed farmers unlike in other states, to be independent in purchase of inputs like fertilisers from the government. Cooperatives have given them better bargaining power to negotiate for better prices with textile mills. Cooperatives and trust bonds amongst farmers also allow farmers to eliminate the need for extension information from government or private seed agents, atleast in the case of larger farmers.

Cotton in Gujarat is grown under irrigated conditions unlike the state of Maharashtra and Andhra Pradesh. These are some of the factors that have played a role in increased productivity of cotton in the case of Gujarat.

The state of Gujarat after experimenting with large-scale use of Bt cotton, is set to produce and distribute genetically modified seeds across India at competitive rates vis-a-vis private players.14

In the case of Maharashtra, the adoption of Bt cotton was at first largely unauthorised, through seeds being supplied from Gujarat via small private sector seed agencies. With the approval of the Mahyco-Monsanto produced MECH cotton in 2002, the sale of GM cotton in Maharashtra also became authorised. However, at the same time, an epidemic of farm suicides was

Genetically Modified Crops and Sustainability of Farm Livelihoods


noted in Maharashtra, that led to a number of court cases, including studies by the Tata Institute of Social Sciences (2005), Indira Gandhi Institute of Development Research (2006), and Planning Commission (2006). Reasons cited were indebtedness to local moneylenders, the removal of the State run Cotton Monopoly Procurement Scheme, and the higher cost of cultivation vis-a-vis Minimum Support Prices. Other reasons included, the absence of irrigation systems in drought-prone areas (especially in Maharashtra), combined with specialisation in high-cost crops, low market and support prices, and the absence or failure of the credit system specially after the economic reforms of 1992. It is also possible that under the conditions in which it was introduced, that Bt cotton might have played a role in the overall indebtedness of certain farmers in some of the suicide-prone areas of these two states, particularly in its initial years.15 The farm suicides led to the provision of a number of relief packages on part of the central and state government to Maharashtra and other states.

Analysing the farm suicides, social movement literature suggests the rise of a alliance of new social movements that have brought the material reality of farm crisis into national and international limelight. The state of Maharashtra had witnessed the rise of the Shetakari Sangathana, a nation wide farmers’ movement. The current farm movement is a fragment of the Sangathana, which has allowed the percolation of relief packages for the suicidal farmers, working in close alliance with the environmental movement, with the help of media (Author’s observation 2007).

Andhra Pradesh, is also another state where there have been multiple farm suicides. The state of Andhra Pradesh has been unique in the activist role played by the judiciary in regulating Bt cotton prices, a problem nationwide. The seed prices that Monsanto-Mahyco had put forth were too high because of the technology fee and the monopoly that Monsanto had over the Indian GM seed market. However, the state of Andhra Pradesh filed a case in the Supreme Court regarding the high prices, which led to a reduction of seed prices by half which was applied nation-wide. The initial seed prices that were around Rs. 1800 per 450 gm were reduced to Rs. 950 per 450 gram.16 Later, the government of Andhra Pradesh also entered into agreements with seed firms and farmers, which bypasses the certification of cotton seeds for quality and yield. Under the agreement, if farmers suffer any losses, farmers can approach a tripartite body comprising

39

government officials, and representatives of the seed companies and farmers for compensation.

Ecology Cotton in India is largely grown under rainfed conditions except in parts of Punjab and Gujarat. This leads to a low productivity in cotton despite the fact that India has the largest area under cotton in the world. Many of the areas growing cotton such as Maharashtra, lie in the semi arid zone of the Deccan Plateau, where groundwater recharge and surface water development are difficult, making irrigation difficult, which could lead to higher productivity in cotton. Remarkable difference was seen in the productivity of cotton when it was grown under irrigated conditions in the lab and under rainfed conditions on farms. According to the Planning Commission Report on Farmers Suicides (2006), “while Bt cotton, in fact, does quite well in irrigated conditions, it does not do as well in rainfed conditions.”

The fact that subsidies of fertlisers, power and pesticides are tied to irrigation and irrigated agriculture, also creates a constraint to farmers located in rainfed areas making gains from GM crops.

Land Ownership, Farm Size and Tenure in India Land is a critical asset in rural development. The overall Gini coefficient in India for land distribution is 0.73 showing that there is high inequality of land ownership in India.17 The proportion of landless labourers in the overall agrarian structure is 31 per cent. Landlessness in the case of the abovementioned three states is high, with Maharashtra at 38 per cent, Andhra Pradesh at 49 per cent and Gujarat at 35 per cent much higher than the Indian national average at 31 per cent.18 Similarly, inequality of land ownership is high in Andhra Pradesh (0.8 Gini coefficient), followed by Gujarat and Maharashtra. Land ownership shows that land is concentrated maximum between 0.4 hectare and 2 hectare overall in India.

Land systems are complicated in a large country like India, differing from state to state. Lease markets are of great importance in rural areas − households in all categories lease out and lease in land.19 In states like Andhra Pradesh, Gujarat, and Maharashtra, on non-operational fields, small operators lease out land while working as wage labourers, and rest are operated by absentee landlords. In case of Maharashtra and Andhra Pradesh



tenancy is low. The land lord tenant relationships give an indication of the nature of profits sharing, as the calculation of which class gains and which class does not from the GM crops is an easy one. Greater empirical studies will have to be conducted to understand the nature and spread of gains.

Cotton Fibre and TextilesLast but not the least, in India cotton is used mainly in textiles that form primary export of India vis-a-vis Indian cotton. With the economic reforms, textile exports have been given impetus, while eliminating the import duties for cotton, which will allow textile industry to purchase cotton from the international market. This can have significant repercussions on profits that cotton farmers get despite the adoption of Bt cotton.

Thus, overall, there are many constraints that affect the gains that small and medium farmers can make from Bt cotton. Conflicting empirical studies exist regarding the benefits of Bt cotton. For instance, in the case of Maharashtra, a study conducted in 2006 found that yield advantages differed for the same hybrid by region and within regions, by hybrid. Another study in 2004 and 2005, confirmed the spatial and temporal variation in partial productivity of Bt cotton. In some areas, they found that farmers did not benefit at all. A third study in Andhra Pradesh found that Bt cotton was found inferior to non-Bt cotton in terms of yields, pesticide use was negligible for both types of cotton, non-Bt farmers had higher profits and lower costs of cultivation, and suspected Bt cotton of a root rot that affected their soils for subsequent crops. Concerns exist that highlight the importance of host germplasm for Bt effectiveness. It was suggested that host germplasm was not broadly adapted to Indian growing conditions given the high degree of heterogeneity among farmers in terms of agro-ecological, social, and economic conditions and the better adaptation of local non-Bt hybrids compared to Bt hybrids (germplasm effect) influenced farm level benefits. Studies also report that black market sales of unapproved cultivars and sales of F2 seed at lower prices explain some crop losses.20

It is highly unlikely in the Indian case that GM crops will lead to sustainability of farm livelihoods overall. This is because not only is there ecological stress but also economic stress that affect farmers livelihoods but also the weaker role played by the Indian state in terms of dissemination and development of GM crops, maintaining price and quality and presence of strong credit, marketing and insurance systems.

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GM Cotton in China China grows 25 per cent of the global cotton constituting 45 per cent of world trade in cotton. Cotton industry has played a pivotal role in China, in developing its rural and industrial economies and driving textile trade,21 with 300 million people dependent on cotton.22

Due to heavy investment by the Chinese state starting mid 1980s, the Chinese biotech programme is one of the biotech research programmes in the world. Insect pests, mainly bollworm are a major threat to cotton production in China. Cotton producers have to struggle against many pests and resort to spraying pesticides. Despite an increasing use of pesticides, cotton productivity on Chinese farms was declining.23 Concerned about the pest problems, in early 1990s, with government funding a group of public research institutes, led by the Chinese Academy of Agricultural Sciences (CAAS), China developed Bt cotton varieties using a modified Bt fusion gene (Cry1ab and Cry 1Ac). The gene was transformed into major Chinese cotton varieties using China’s own methods (pollen-tube pathways), releasing them for commercial use in 1997.

Meanwhile, in mid-1990s, Monsanto entered into collaboration with the Chinese National Cotton Research Institute of CAAS. As Bt cotton spread in Chinese provinces, government research institutes at the province and prefecture levels also produced new Bt varieties, breeding CAAS varieties into their own local varieties and back-crossing with Monsanto varieties. In 2001, such practices became widespread in almost every province in North China.

At present, CAAS has permission from the Biosafety Committee to sell 22 Bt cotton varieties in all provinces of China. The Biosafety Committee has approved the sale of five Monsanto Bt varieties in four provinces. Many other varieties from national institutes (such as the Cotton Research Institute, Anyang) and from provincial institutes are being grown, but some of these local varieties do not go through the official approval procedure set by the Chinese Biosafety Committee.24

The main difference between the Chinese experiences from other countries is the major role of the public sector in providing GM technology in development, commercialisation and dissemination of Bt cotton. The fact that Bt cotton was developed by government researchers at about the same



time that international companies were introducing it into China clearly made it more palatable to the government, and ensured a strong lobby in favour of the technology, leading to its adoption without much opposition. In addition, the competition between local government firms and foreign firms in providing Bt cotton varieties is one of the critical reasons why the price of Chinese GM cotton seed is lower than other countries. That the Bt gene was bred into local varieties also led to a reduced price.

Between 1995 and 1999 the biotech funding in China more than doubled, and which is slated to increase by 400 per cent in the near future. While more foreign sector firms will be entering China after accession into the World Trade Organization (WTO),25 China is accelerating its investments in agricultural biotechnology research focusing on commodities that have been ignored in western laboratories.

Agrarian Structure While the spread of Bt cotton has relied on the varieties introduced by the public research system and seeds sold (at least initially) by the state-run seed network, the adoption of Bt varieties has been the result of decisions by millions of small-scale farmers.

Examining the history of Chinese agrarian structure, Chinese farms have gone through 20 years of collectivisation in the post Mao era, wherein farms were owned by a village commune or collective in the form of a village administration. In 1980s efforts were made towards de-collectivisation and communes were transformed into a system of individual farms, which are leased out for a time period 15 years via contracts, a system known as household responsibility system. While households were given land contracts the land was still owned and allocated by the collective (and not the state).26 Until 1985 households were given pre-specified production quotas and had tax obligations but were allowed to keep surplus for themselves or sell it to the government at higher prices.

Although in this system, rural landlessness had become non-existent and the distribution of land became more egalitarian, extensive de-collectivisation led to creation of farms that were small, even smaller than other Asian countries. On average, China’s cotton farmers have even smaller farms than those in other countries. In areas such as Eastern China, 63 per cent of the landholdings were small landholdings. Such small landholdings

43

are not conducive to mechanisation or capital intensive methods of farming; or might not lead to greater returns of scale as large farms might do.27 Small farmers also face significant problems of credit, insurance and marketing. Further, while farms have greater incentive to invest in farms and increased profits due to de-collectivisation, the fact that the land might not be reallocated to them after the contract expires, or there might be a lack of proper contract creates a disincentive for investment.28 Several constraints such as land readjustment as household composition remain an obstacle to farm investment. Many claim that perhaps a western style system of property rights would create greater incentive for investment and hence higher productivity. Studies have also found that farmers prefer the commune system, as when they leave the village for non farm work, they can get their land back upon return.29

Thus, while GM crops have been available in China at a cost lower than GM crops in other countries, the nature of agrarian structure can prove to be a constraint to productivity which has been achieved in case of farms in the West.

Ecological ConditionsCotton in China is grown in three main regions: Yangtze (Jiangsu, Anhui, Heibei, Hunan, Jianxi, Sichuan, Zhezang/Middle and Lower Reaches), Yellow River (Hebei, Shandong, Henan, Shangtzi, Shangtzi province), and Xinjiang (Northwestern Inland Cotton Region), with the largest volume of cotton grown in Xinjiang (42 per cent). In terms of water availability, there are relatively rich water resources in Yellow River and Yangtze River basin but there are insufficient resources in the inland cotton area in Northwest specially the Xinjiang region. Yields are highest in the Northwest region, significantly lower in the Yangtze Basin and lowest in the Yellow River Watershed. The Xinjiang region, however, has large agricultural plots but low income due to high dependence on cotton. In contrast, though both Yangtze and Yellow River have scattered landholdings, they are close to the centers of textile industry.30

There are great differences in climate, soil, quality, ecological conditions and the incidence of plant diseases and insect pests in the three main cotton-growing regions of China. The Yangtze River Watershed cotton region has suitable temperatures and soil fertility, and a sufficient water supply for



growing cotton but experiences frequent summer drought and floods (Xu 2007). The Yellow River Watershed cotton region has abundant sunshine in the spring and fall but drought often occurs in the winter and the spring; its soil is poor and its ecological conditions are fragile. The Xinjiang cotton region has abundant sunlight in summer and a dry climate; and big differences occur between day and night temperatures. The Xinjiang Cotton Region is characterised by drought in spring, flood in summer, water shortage in fall and low water in winter.

Due to irrigation works and its utilisation of both surface water and groundwater, the irrigated area of Xinjiang has expanded and it can be irrigated even in drought years. Because this region has little rainfall in normal years, its cotton production depends completely on irrigation. The construction of irrigation works and the adoption of water-saving irrigation technology make Xinjiang an important cotton producing region.31 Nevertheless, rain water availability is a constraint on the expansion of cotton production in Xinjiang.

Overall, water availability exerts a major influence on the sustainability of China’s cotton supplies and the issues involved vary according to the region in China where cotton is grown. Drought, floods and the unsustainable use of available water supplies (especially groundwater) are of concern. Groundwater is the main source of water for northern China. In some of the provinces in northern China, the rate of withdrawal of underground water exceeds its rate of replacement and, therefore, the water-tables are falling leading to an unsustainable situation. Even in other provinces, this is a problem in some areas. Falling underground water-tables add to the cost of extracting water and lower the availability of surface water. The overuse of groundwater (as well as surface water) can have many adverse ecological consequences.32 While droughts, floods and unsustainable use of water are also issues of concern, continuous cotton cultivation for more than 10 years in the same plot is reducing soil quality in China.

Despite the fact that Chinese cotton production has displayed an upward trend, China will face issues of sustaining its cotton production in the future. There is little scope of increasing area under cotton, one of the major strategies adopted could be the introduction of more water tolerant

45

varieties. A second strategy is the use of transgenic technologies, which will be used for a longer period of time.33

Cotton Subsidies The Chinese state unlike the Indian state, has given substantial subsidies to its cotton farmers putting China’s cotton exports second only to the US in the world. Along with domestic interventions and price quotas, domestic cotton prices in China are higher than international prices. China maintains significant reserves of cotton, which it releases in the market when there is shortage. It also helps farmers by setting minimum support prices, supporting farmers for growing high quality seeds, providing subsidies for transportation to mills, and by auctioning reserves to textile mills.34 This is an additional factor that can lead to the success of Bt cotton, unlike in the case of India, where the government favours the textile industry vis-a-vis cotton growers.

Cotton TextilesCotton in China, like India, is also an important raw material for the textile industry. The cotton textile industry is an important sector in national GDP, with over 10 million workers in China, while textiles and garments are important export commodities. China’s WTO accession brought favourable opportunity to the textile industry. China is both exporter and importer of cotton. Although commercialisation of cotton markets began in the late 1990s, most cotton was still purchased by the state Cotton and Jute Corporation at a price fixed by the government. Cotton mills are now allowed to buy cotton directly from growers.

However, since the market has been opened, there is a danger that low quality cheaper foreign cotton will flood the market. Although given that cost of cotton production is low, farmers can still make gains.35 China strictly controls cotton imports to support local growers, making it difficult for some textile firms to source the high-quality cotton they need to make fabric for global clothing brands, with limited amounts of the grade grown locally.36

Benefits from Bt Cotton Bt cotton was first introduced in Hebei and Shandong provinces (Yellow River, North China region). Before Bt cotton was introduced, cotton



production was at its highest level in 1991 when the region produced more than 3 million tonnes. Production then plunged to 1.4 million tonnes two years later in 1993. This was largely due to a severe bollworm infestation, as well as increased labour costs in the region and changes in relative crop returns. When Bt cotton started to spread extensively in the region in 1999, area under cotton increased. Farmers were responding to the pest-resistant characteristics of Bt cotton which allowed them to grow cotton successfully despite the bollworms, reduced their production costs and saved labour. Controversy exists whether Bt cotton has benefitted farmers or not in the long run, as secondary pests seemed to emerge, after use of Bt cotton. Concerns also exist whether there exists sustained productivity of Bt cotton. Yet other reports affirm the success of Bt cotton in the Yellow River region of China where resistance to insecticides had evolved and farmers applied 10 to 12 treatments, as compared to 2 to 4 in most countries. However, contrary evidence exists in the Yangtze river valley (Jiangsu) and other provinces, where pest pressures are lower and the germplasm is not as well adapted to local conditions.

At the same time, cotton production in the Yangtze region (south China) has remained steady, while cotton production has risen gradually in the north-west. The north-west cotton region is an irrigated desert. As a result there are fewer pest problems, higher yields, and higher fibre quality than in other regions of the country. The major problem is being so far away from cotton markets, which are primarily in the Yangtze region and to a lesser extent in the Yellow River region. Thus Bt cotton does not play a great role here in increasing cotton production in this region.37

Overall, studies conducted in 2001, found that Bt cotton adoption leads to a significant decrease in pesticide use (82 per cent). Chinese scientists tested bollworm pest with Bt cotton and concluded that bollworms found in China’s cotton fields had not yet become resistant to Bt cotton (in 2007). Reports (2008) have also shown that populations of bollworm larvae and bollworm eggs have continually decreased from 1997 to 2007. Though the bollworm’s lack of resistance to Bt cotton is encouraging, significant problems still exist. Primarily, Chinese cotton farmers are well known for using excessive amounts of highly toxic pesticides, and this practice has continued even after the adoption of Bt cotton. This is so because of

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the farmers’ uncertainty about the quality of Bt cotton seeds which varies dramatically. Some varieties do not contain the Bt trait. Due to high demand for Bt cotton seeds, some individuals are trying to exploit the situation for profit through illegal means. Some lower-quality seeds have permeated the market through different channels. Not only do local firms release seeds before approval farmers also reproduce the trademarked Bt cotton seeds via on-farm propagation. Some seed companies simply repackage their conventional cotton seeds to sell as authentic Bt cotton seeds with brand labels.

Last but not the least, there are a number of institutional factors, that might precipitate success of Bt cotton vis-a-vis other countries such as: 1) the decentralisation of breeding efforts in China; 2) the low seed costs for both the newly released cotton hybrids and varieties; 3) the competitive nature of the seed market; and 4) despite the elimination of support prices and subsidies, there is an effective price premium due to import controls in the domestic cotton industry.

Despite constraints there is a high possibility that GM crops can lead to greater sustainability of farm livelihoods in the case of China. This is because not only are there positive policy and institutional factors such as a strong presence of the welfare state, but also an egalitarian distribution of land that allows benefits to be available across classes.

GM Crops in Brazil: Foreign Multinationals, Judiciary and Farmers Transgenic technology in Brazil has been used in the case of soybean, maize and cotton. Soybean is grown in the Amazon and Cerrado regions of Brazil, which have high availability of water and produce a high quantity of soya, making soybean the number two export item in Brazil’s agricultural exports and 18 per cent of the global economy.38 About 85 per cent of Brazil’s massive soybean crop output is produced from genetically engineered seeds. Brazil exports about $24.1 billion worth of soybeans annually, more than a quarter of its total agri-exports.39 The US share of world soybean exports fell to 43 per cent in 2013 from 60 per cent in 1997 as competition increased from Argentina and Brazil, according to the U.S. International Trade Commission.40 China is one of the biggest buyers of soybean.41



Policy Making In terms of biotech research, while Brazil has a well established biotech programme, the agricultural state agency EMBRAPA (Empresa Brasileira de Pesquisa Agropecuária − Brazilian Enterprise for Agricultural Research) is only able to spend 1-2 million in biotech research vis-a-vis foreign companies which spend many times more on biotech research. EMBRAPA has struggled with limited finances since economic reforms.

The first GM soya seeds, however, were neither supplied by the government or the foreign companies in Brazil. In fact, soya farmers from RioGrande Sul region, for several years since 199842 have smuggled GM soya from the neighbouring country of Argentina.43 The smuggled crop already accounts for 10-20 per cent of Brazil’s total production.44

In the process of introduction of GM crops, the Brazilian state was divided over the decision to introduce GM crops. The political struggle for legitimacy to rule on transgenics engaged different levels of the court system, divisions within the federal government and disputes between the states and Brasilia.45 Brazil’s Biosafety Law was passed by the National Congress in 1994. It granted authority over both pharmaceutical and agricultural GMOs to a National Technical Biosafety Commission (CTNBio). Transgenics are also regulated by the Industrial Property Code of 1996, which explicitly responded to new requirements of WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS), granting legal protection to inventions related to pharmaceuticals, food processes, and biotechnology. CTNBio approved commercial release of three varieties of Monsanto’s Roundup Ready (RR) soybeans in September 1998.

GM crops were declared legal despite several years of protests by environmental groups such as Greenpeace. The government took this decision partly because it realised that it is going to be difficult to convince the farmers who had been smuggling GM seeds from Argentina.46 In protest, both Greenpeace and Commission from the Institute for Consumer Defense (IDEC) filed legal appeals in l999. Commercial cultivation of Roundup Ready soybeans was legally banned, on grounds that they had not been adequately tested for human health and environmental impacts. The authority of CTNBio was challenged by a law suit in 2000, seeking an injunction against decisions on transgenic-crop releases before the

49

government formulated rules for assessing bio-safety. A third decision, issued in 2002 in response to a suit brought by the federal Public Ministry, suspended all further field tests of ‘biopesticide’ transgenics until Brazil’s pesticide legislation is enforced. These decisions combined to produce a ‘judicial moratorium’ on the commercial release of transgenic crops in Brazil.

As the government banned the use of GM cotton, protests also ensued on part of the farmers against foreign MNCs. Brazilian soya producers had reportedly paid one billion Brazilian reals (US$ 530 billion) for the use of Roundup Ready soybeans.47 Five million Brazilian farmers have taken on US based biotech company Monsanto through a lawsuit demanding return of about 6.2 billion euros taken as royalties from them. The farmers are claiming that the powerful company has unfairly extracted these royalties from poor farmers because they were using seeds produced from crops grown from Monsanto’s genetically engineered seeds.48 Monsanto previously obtained patent protection in Brazil for its first-generation Roundup Ready soybean products.

However, the court in the southern Brazilian state of Rio Grande do Sul, ruled in favour of the farmers and ordered Monsanto to return royalties paid since 2004 or a minimum of $2 billion. The ruling said that the business practices of seed multinational Monsanto violate the rules of the Brazilian Cultivars Act. Monsanto has appealed against the order.49 In 2011, Monsanto had also made a parallel legal bid to the Brazilian Supreme Court of Justice. The company argued that the syndicates had no legal status to bring their case, and also that any final ruling should be limited to Rio Grande do Sul, fearing that its losses would be even greater if it applied to the whole country. The Brazilian Supreme Court ruled against Monsanto, deciding unanimously that the ruling by the Justice Tribune of Rio Grande do Sul, once it is made, should apply nationwide.50

Further, the Brazilian government is of the opinion that it will let those crops be sold rather than pay the cost of compensating farmers for destroying the plants. Brazil relies heavily on export revenue to pay its $300 billion debt.51 The ban has since been lifted and now 85 per cent of the country’s soybean crop (25 million hectares or 62 million acres) is genetically modified.



Fears still exist in EMBRAPA that Monsanto might withdraw its support, as part of the funds for EMBRAPA come from Monsanto.

Thus, farmers in general have benefitted by the activist role played by judiciary and the agency of the farmers themselves.

Soya production in Brazil is undertaken under rainfed conditions, thus the only way to meet the global demand of soya is to expand the area in the Brazilian Amazon. Thus while Bt crops might bring benefit to farmers, its ecological impacts might outweigh its gains in the long run. This is because the expansion of soya farms is a leading cause in the deforestation in Amazon.

Land Tenure, Ownership and Distribution in Rural BrazilHighly unequal distribution of landholdings is a unique feature of Brazil’s agrarian society and is quite unlike India and China (Gini Coefficient: 0.86). In Brazil, an archaic system of property or land rights supports one of the world’s most iniquitous and inefficient land distribution systems.52 Brazil has had a long troubled history of land distribution problems. While farms have been modernised, the conservative modernisation of the latifundia or large farms vis-a-vis minifundia or small farms, has reinforced concentrated land ownership and the exclusionary character of the “farming development model.” The state has played an active role in allowing foreign firms in leading to further concentration of land. Land concentration is as high as 0.871 in the southern state of Mato Grosso do Sul where cattle ranching and soybean production is encouraged and in northeastern state of Alagoas, it is 0.871, where sugarcane is grown.53 If landless families are included then gini coefficient becomes 0.91.54

Land conflict and the lack of more equitable land policies encouraged important social movements to employ land occupation as a third way. MST, a landless workers movement, is the largest social movement in Brazil, formed by the poor who have been pushed out of the land by large landowners.55 The Workers Without Land Movement (MST for its acronym in Portuguese) that gathers near 1 million families, has done controversial occupations of landowner’s properties.56

Despite the fact that both Brazilian government and non-state actors, for example social movements agree to the need for land reform, land

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concentration in Brazil has increased as the number of small farms has been reduced from three million in 1985 to less than one million in 2000s. The MST estimates that over 60 per cent of the farm land in Brazil is idle, while 25 million peasants struggle to survive.57

According to the 1996 census data, there are a total of 4.8 million farms in the country, covering 353.6 million hectares. Of the total number of farms, 89.1 per cent are minifundia (smaller than one fiscal module the minimum deemed necessary to support a family) and farms less than 100 hectares, yet these account for only 20 per cent of the land area. At the other extreme of the landholding structure, large holdings (over 1,000 hectares) account for 1 per cent of the total number of farms and 45 per cent of the farmland area. Sometimes, these large land estates that are used for cattle ranching are with absentee landlordism. These large landholdings make up a sector that includes over 35,000 farms classified as unproductive latifundia covering a total land area of 166 million hectares.58 This results in a dual agricultural system made up of medium- and large-scale commercial operations, and small subsistence farms. This system is capital-intensive but inefficient, resulting in low productivity with reduced levels of agricultural employment and self-employment.59

The poorest and most vulnerable groups among Brazil’s rural poor people are women, young people and indigenous people. Households headed by women account for 27 per cent of poor rural people. Either because their husbands migrate to other parts of the country in search of work, or because they are single parents, women bear responsibility for running the family farm as well as their households. And child labour is still common among poor households in Brazil. In the semi-arid North-East, landless people and smallholder farmers are severely affected by poverty. In this region, low incomes, adverse climatic conditions, the limited natural resource base characteristic of a semi-arid region, and limited access to public services have led to the migration of large number of people to urban areas, mainly to big cities in south-east Brazil.60

Environmentally, land tenure security also has a significant detrimental effect on deforesetation.61 Planting soyabean for animal feed and biofuel drives forest conversion indirectly by displacing cattle ranchers to forested areas where land is cheap. Land tenure issues have been explosive in parts of Amazon.62



Benefits from GM Crops Land concentration will critically influence the gains that farmers will make and the distribution of those gains between different land holding sizes. An issue of concern is the effects of profit making soya industry on the small farmers who cannot afford to grow GM soya and might be forced of the land by large estates as cost of production of farming might increase. Already land tenure is insecure and there is inadequate access of land to the poor,63 which makes sustainability of farm livelihoods a difficult proposition.

Conclusion: Comparing India, China and Brazil GM crops have been introduced under different political and economic circumstances in all the three countries, with varied roles played by non-state actors and farmers themselves. In the case of India, with the advent of 1991 economic reforms, an uneasy partnership exists between the state and public sector, and judicial intervention is required to define the context of adoption of new seeds by smallholder cotton farmers in India. Farmers benefit where strong farmers cooperatives or social capital exists. Scant evidence exists whether GM crops have played a positive role in ameliorating the condition of areas suffering from farm crisis. In the case of China, a strong role is played by the state in developing and diffusing Bt cotton amongst smallholder farmers in cotton growing regions, which has allowed the price of cotton to be low, thus promising greater gains for the farmers in comparison to other countries. In Brazil, farmers who had already been smuggling seeds from neighbouring Argentina played a major role in influencing the state in eliminating royalties charged by Monsanto. Since the role played by the Brazilian state was weak as compared to China, it is the judiciary that has played an active role in preventing Monsanto in collecting royalties from the farmers. Yet given that the policies of Brazilian state have been influenced by international capital as part of its economic development historically, the gains will be unequally shared between foreign multinationals and farmers.

Ecologically, cotton in India is grown under rainfed conditions, while in China, a significant area of cotton is under irrigation. In Brazil, soya is grown under rainfed conditions. Thus, China and Brazil gain more from GM crops than India, although other environmental factors such as rainfall or soil condition are also important. Economics is tied to ecology, by way

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of subsidies or market prices for agricultural commodities. Can GM crops circumvent these hurdles? This is a subject that demands greater analysis.

Regarding distribution of gains amongst agrarian classes, in case of both China and India, cotton farmers are smallholder farmers. However, in India, the Gini coefficient of rural land distribution is much higher than China where there are no landless labourers and decollectivisation and land redistribution has led to greater egalitarianism, which will lead to an equal spread of gains across classes in China. Access to irrigation, information and resources still remain as constraints to gains from Bt cotton. Brazil is a highly unequal society in terms of distribution of land resources, which suggests that the profits of GM soya are not equally accessible to all sections of agrarian society.

Given the different social, political, economic and ecological contexts, it is doubtful that GM crops can ensure equitable farm sustainability. It is thus equally important to consider alternative rural development pathways as well, which might ensure greater economic, ecological and social benefits making farmers livelihoods secure.

These alternative pathways could be integrated pest management, organic farming, supported by rainwater harvesting (CSE-NCF 2006), drip irrigation (Narayanmoorthy 2004; and Edward Coward 1988), soil improvement, stronger credit and insurance networks, local cooperatives, and better MSPs and marketing networks. While these take a long time to mature, they are ecologically sounder and create sustainable benefits.

Endnotes1 Planning Commission (2011). Faster, Sustainable and More Inclusive Growth: An Approach

to the Twelfth Five Year Plan (2012-17), Government of India, New Delhi. Accessed at: http://planningcommission.gov.in/plans/planrel/12appdrft/appraoch_12plan.pdf2 Stone, R (2008). “China Plans $3.5 Billion GM Crops Initiative.” Science, Vol. 321, The

American Association for Advancement of Science (AAAS). http://www.brown.edu/ce/adult/arise/resources/docs/China%20-%20GM%20foods.PDF-3 ISAAA (2012). Global Status of Commercialized Biotech/GM Crops: 2012, ISAAA

Brief 44, USA. http://www.isaaa.org/resources/publications/briefs/44/executivesummary/default.asp

4 Pray, C. E., Huang, J., Hu, R. and Rozelle, S. (2002). Five years of Bt cotton in China-the benefits continue, The Plant Journal, 31(4), pp. 423-430. http://onlinelibrary.wiley.com/doi/10.1046/j.1365-313X.2002.01401.x/full

5 Govind Rajan (1996) provides a North-south angle to the development of the biotechnology industry. He notes that aware of the developments in the North, the Indian state became



concerned that the lack of access to this technology would further widen the development gap between the North and South. In the negotiations for the Convention for Biological Diversity, the Indian state argued for technological transfer and location of gene banks in India.

6 For instance, see: Navdanya: Dr. Vandana Shiva’s Blog, http://www.navdanya.org/, or http://www.gmwatch.org/archive2.asp?arcid=4245 or http://www.genecampaign.org/News/news-gmcrops.html

7 These groups include Deccan Development Society located in Andhra Pradesh. See http://www.ddsindia.com/www/default.asp

8 The success of the information technology sector formed the basis of the political discourse of states in promoting biotechnology. For instance, the Chief Minister of Karnataka in his budget speech for the year 2000-2001 noted, “While Karnataka is the acknowledged leader in IT, I would like the State to lead the next revolution in Biotechnology.” See: “B for Bangalore and Biotech” in Hindu Business Line (2001). http://www.hindu.com/businessline/2001/05/07/stories/100767g1.htm

9 GEAC is a central level body constituted under the Ministry of Environment and Forests that approves GM trials.

10 For instance, see: “India needs a biosafety policy” at http://www.hinduonnet.com/fline/fl2110/stories/20040521001708200.htm and “Biotech Policy: Secretive and Hasty” at http://www.indiatogether.org/2006/apr/agr-btpolicy.htm#continue

11 Interview, Bhagirath Chaudhari, ISAAA, Delhi, April 2006.12 Comment, Shiv Vishwanathan, Social Scientist, CSDS, Delhi, July 2006. This stands in

stark contrast to the policy making during the green revolution period when the policies were more closed door but were created prior to the introduction of the new seeds.

13 Scoones, I. (2003). Regulatory Manoeuvres: the Bt cotton Controversy in India, IDS Working Paper 197, Institute of Development Studies, Brighton, Sussex, England. Accessed at: http://www.ids.ac.uk/files/Wp197.pdf

14 For See more: “In a first, state govt set to sell Bt cotton seeds”, The Indian Express, 16 February 2013. http://www.indianexpress.com/news/in-a-first-state-govt-set-to-sell-bt-cottoneeds/1075170/#sthash.FnVUTiug.dpuf

15 Gruère, G. and Sengupta, D. (2011). “Bt Cotton and Farmer Suicides in India: An Evidence-based Assessment.” Journal of Development Studies, Vol. 47, No. 2, pp. 316–337.http://sap.einaudi.cornell.edu/sites/sap.einaudi.cornell.edu/files/Suicides%20Bt%20cotton%20JDS%20great.pdf

16 Interview (2006), Pankaj Shiras, JK Seeds, Nagpur.17 Rawal, V. (2008). “Ownership Holdings of Land in Rural India: Putting the Record

Straight.” Economic and Political Weekly, pp. 43-47. http://www.agrarianstudies.org/UserFiles/File/Rawal_Ownership_Holdings_of_Land_in_Rural_India.pdf

18 Ibid.19 Mearns, R. (1999). Access to Land in Rural India: Policy Issues and Options. World Bank

Policy Research Working Paper 2123. Accessed at:http://www.cpahq.org/cpahq/cpadocs/Access%20to%20Land%20in%20India.pdf

20 Smale, M., Zambrano, P. and Cartel, M. (2006). “Bales and Balance: A Review of the Methods Used to Assess the Economic Impact of Bt Cotton on Farmers in Developing Economies.” AgBioForum, Vol. 9, No. 3, pp. 195-212. Accessed at: http://www.agbioforum.org/v9n3/v9n3a06-zambrano.htm

21 Solidaridad. (2010). Better Cotton Initiative, China Scoping Study Version 2.0. Accessed at: http://www.bettercotton.org/files/Regions/China/BCI_Solidaridad_Scoping_Study_China_final.pdf

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22 The Cotton Sector in China. UNEP Country Projects − Round II − A Synthesis Report, UNEP. Accessed at: http://www.unep.ch/etu/publications/Synth_China.PDF

23 Dong, H., Li, W., Tang, W. and Zhang, D. (2004). “Development of Hybrid Bt Cotton in China.” Current Science, Vol. 86, No. 6, pp. 778-782. Accessed at:http://www.currentscience.ac.in/Downloads/article_id_086_06_0778_0782_0.pdf

24 Pray, C. E., Huang, J., Hu, R. and Rozelle, S. (2002). “Five years of Bt cotton in China − the Benefits Continue.” The Plant Journal, 31(4), pp. 423-430. Accessed at: http://onlinelibrary.wiley.com/doi/10.1046/j.1365-313X.2002.01401.x/full

25 Gale, F., Lin, W., Lohmar, B. and Tuan, F. “Is Biotechnology in China’s Future?” China’s Food and Agriculture: Issues for the 21st Century / AIB-775, Economic Research Service, USDA. http://www.ers.usda.gov/media/303360/aib775m_1_.pdf

26 Hairong, Y. (2008) “The Myth of Private Ownership.” China Left Review, No. 1. http://chinaleftreview.org/?p=37

27 Feder, G., Lau, L.J., Lin, J. and Luo, X. (1990). The Determinants of Farm Investment and Residential Construction in Post-Reform China. PRE Working Paper 471, Agriculture and Rural Development Department, The World Bank. Accessed at: http://www-wds.worldbank.org/servlet/WDSContentServer/WDSP/IB/1990/08/01/000009265_3960929165242/ Rendered/PDF/multi_page.pdf

28 The good points of the policy include that the policy allows farmers to transfer the farming rights to others if they no longer wish to farm. A study of farmers preferences notes that affluent farmers who have non farm income prefer the small term contracts while those who depend solely on farming prefer long term contracts.

29 Kung, J. K.. and Liu, S. (1997). “Farmers’ Preferences Regarding Ownership and Land Tenure in Post-Mao China.” The China Journal, No. 38. Accessed at: http://www.jstor.org/discover/10.2307/2950334?uid=2129&uid=2&uid=70&uid=4&sid=21102533249423

30 Solidaridad (2010). Better Cotton Initiative, China Scoping Study Version 2.0. Accessed at: http://www.bettercotton.org/files/Regions/China/BCI_Solidaridad_Scoping_Study_China_final.pdf

31 Due to irrigation works and its utilisation of both surface water and groundwater, the irrigated area of Xinjiang has expanded and it can be irrigated even in drought years.

32 Zhao, X and Tisdell, C. (2009). The Sustainability of Cotton Production in China and in Australia: Comparative Economic and Environmental Issues, Working Paper No. 157, The University of Queensland, Australia. http://ageconsearch.umn.edu/bitstream/55338/2/WP%20157.pdf

33 Ibid.34 Secretariat of the International Cotton Advisory Committee Report. (2012). Production

and Trade Policies Affecting The Cotton Industry. USA. https://www.icac.org/cotton_info/publications/statistics/stats_wtd/gm-e_2012.pdf

35 The Cotton Sector in China. UNEP Country Projects − Round II − A Synthesis Report, UNEP. Accessed at: http://www.unep.ch/etu/publications/Synth_China.PDF

36 “China textile mills lobby to boost cotton imports, cut local prices,” Daily Times, 5 July 2013. http://www.dailytimes.com.pk/default.asp?page=2013\07\05\story_5-7-2013_pg5_23

37 To offset the costs of transportation and encourage more production in this region, the Chinese government provides subsidies for important inputs such as irrigation, mechanised tillage, planting and harvesting. See Pray, C. E., Huang, J., Hu, R. and Rozelle, S. (2002). “Five years of Bt cotton in China − the benefits continue,” The Plant Journal, 31 (4), pp. 423-430. Accessed at: http://onlinelibrary.wiley.com/doi/10.1046/j.1365-313X.2002.01401.x/full



38 Brighter Green. (2011). Cattle, Soyanization and Climate Change: Brazil’s Agricultural Revolution, Brighter Green, USA. Accessed at: http://www.brightergreen.org/files/brazil_bg_pp_2011.pdf

39 For more see “Brazilian farmers win $2 billion judgment against Monsanto.” QW, 15 June 2012. http://www.qwmagazine.com/2012/06/15/brazilian-farmers-win-2-billion-judgment-against-monsanto-2/#sthash.Wn055cMd.dpuf

40 U.S. Farmers Say Brazilians Pirate Monsanto’s Gene-Altered Soy, Bloomberg, 2 May 2003. http://www.bloomberg.com/apps/news?pid=newsarchive&sid=al4QLtjW1ci4

41 For more see “Brazilian farmers win $2 billion judgment against Monsanto.” QW, 15 June 2012. http://www.qwmagazine.com/2012/06/15/brazilian-farmers-win-2-billion-judgment-against-monsanto-2/#sthash.Wn055cMd.dpuf

42 Ibid.43 “Brazil agrees to grow GM crops.” The Guardian, 26 September 2003. http://www.

guardian.co.uk/science/2003/sep/26/gm.food 44 “GM crops in Brazil: An amber light for agri-business.” The Economist, 2 October 2003. http://www.economist.com/node/210200145 Herring, R. J. (2007) “Stealth Seeds: Bioproperty, Biosafety, Biopolitics.” Journal of

Development Studies, Vol. 43, No. 1, pp. 130–157. http://government.arts.cornell.edu/assets/faculty/docs/herring/JDS_HerringStealthSeeds.pdf

46 “Brazil agrees to grow GM crops.” The Guardian, 26 September 2003. http://www.guardian.co.uk/science/2003/sep/26/gm.food

47 Zacune, J. (2012). Combatting Monsanto: Grassroots Resistance to the Corporate Power of Agribusiness in the Era of the ‘Green Economy’ and a Changing Climate, Friends of the Earth International.http://www.viacampesina.org/downloads/pdf/en/Monsanto-Publication-EN-Final-Version.pdf

48 “Brazilian farmers win $2 billion judgment against Monsanto.” QW, 15 June 2012. http://www.qwmagazine.com/2012/06/15/brazilian-farmers-win-2-billion-judgment-against-monsanto-2/

49 Ibid.50 Massarani, L. (2012). “Monsanto may lose GM soya royalties throughout Brazil.” Nature,

15th June. http://www.nature.com/news/monsanto-may-lose-gm-soya-royalties-throughout-brazil-1.10837

51 Parker, J. (2003). “Patent battle lives on: Schmeiser to take fight against Monsanto to High Court.” The StarPhoenix (Saskatoon). Accessed at: http://www.grain.org/article/entries/1990-monsanto-s-seed-wars-several-updates

52 Teofilo, E. and Garcia, D.P. (2003) “Brazil: land politics, poverty and rural development.” Land Reform - Land Settlement and Cooperatives - Special Edition, pp. 19-39, FAO. http://www.fao.org/docrep/006/y5026e/y5026e04.htm

53 Frayssinet, F. (2009). “BRAZIL: Agribusiness Driving Land Concentration.” Inter Press Service News Agency, 5 October. http://www.ipsnews.net/2009/10/brazil-agribusiness-driving-land-concentration/

54 Schönleitner, G. (1997). “Discussing Brazil’s Agrarian question: land reform is dead, long live family farming? A critical review of recent trends in policy and debate.” Essay submitted in partial fulfillment of the requirements of the degree (1 September 1997). MSc in the Faculty of Economics (Development Studies) 1997. The London School of Economics and Political Science. Accessed at: http://r1.ufrrj.br/esa/art/199804-057-093.pdf

55 Romig, B. S. (2006). “Agriculture in Brazil and Its Effect on Deforestation and the Landless Movement: A Government’s Attempt to Balance Agricultural Success and Social Collateral

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Damage.” Drake Journal of Agricultural Law, Vol. 18, pp. 81-105. http://students.law.drake.edu/aglawjournal/docs/agVol11No1-Romig.pdf

56 Herrera, D. and Lombardi, M. (2012). “An Agrarian Policy for Brazil: And What About Brazilians?” Fair Observer, 3 July. http://www.fairobserver.com/article/agrarian-policy-brazil-and-what-about-brazilians

57 Frank, J. (2002). “Brazil: Two Models of Land Reform and Development.” Z magazine, November. http://www.zcommunications.org/brazil-two-models-of-land-reform-and-development-jeffrey-frank-by-jeffrey-frank.html

58 Sauer, S. “The World Bank’s Market-Based Land Reform in Brazil” chapter 9 in Rosset, Peter M., Patel, Raj and Courville, Michael (eds) Promised Land: Competing Visions of Agrarian Reform. Pp. 177-191. USA: Food First/Institute for Food and Development Policy. Accessed at: http://www.foodfirst.org/files/bookstore/pdf/promisedland/9.pdf

59 Groppo, P. (1996). “Agrarian reform and land settlement policy in Brazil: Historical Background.” SD Dimensions, FAO, June. http://www.fao.org/sd/ltdirect/ltan0006.htm

60 “Rural poverty in Brazil.” Rural Poverty Portal, IFAD. http://www.ruralpovertyportal.org/country/home/tags/brazil

61 Araujo, C., Bonjean, C. A., Combes, J., Motel, P. C. and Reis, E. J. (2010). Does Land Tenure Insecurity Drive Deforestation in the Brazilian Amazon? CERDI, Etudes et Documents, E 2010.13. http://www.cerdi.org/uploads/pagePerso/28/2010.13.pdf

62 Ibid.63 USAID (2011). Brazil Country Profile: Property Rights and Resource Governance, USAID

Land Tenure and Property Rights Portal. http://usaidlandtenure.net/brazil

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© 2013, RIS.

Vikas Kumar* and Kunal Sinha**

Agricultural Biotechnology, Intellectual Property Rights and Seed Industry in India

Abstract: It is contended that while Green Revolution was led by public sector, Gene Revolution in agriculture is led by private sector. While increased emphasis on intellectual property rights protection over seeds and germplasm by the private sector, the seed industry dominated by private sector would deliver more of inputs like seeds and improved varieties that bring in more revenue. In this article we discuss the growth of agri-biotechnology in India and the changing profile of seed industry in cereal crops. We find that favourable policy frameworks and liberalisation have resulted in more investment by private sector in R&D for developing new varieties and seeds and this mirrors the trends elsewhere. While incentives are necessary for private sector to invest in R&D corresponding measures like effective competition policy are also required so that benefits of biotechnology reach small and medium farmers for whom affordability and accessibility of seed a key input is important. The challenge lies in harmonising commitments under WTO Agreements and Convention on Biological Diversity with effective measures that would make biotechnology based inputs affordable and accessible. Otherwise this may be a barrier in diffusion of agricultural biotechnology.

Key words: Agriculture, Biotechnology, Seed, Intellectual Property Rights, Research and Development.

* Research Scholar, Centre for Studies in Science, Technology and Innovation Policy, School of Social Sciences, Central University of Gujarat, Gandhinagar, India. Email: [email protected]

** Assistant Professor, Centre for Studies in Science, Technology and Innovation Policy, School of Social Sciences, Central University of Gujarat, Gandhinagar, India. Email: [email protected]

IntroductionScientific advances in plant breeding led to the Green Revolution (GR), which is regarded as one of the most important achievements to feed the world during the last century. The approach of this revolution appears to have been exploited close to its limits, and other alternative approaches are required to continue improving plants and livestock for the agriculture of the 21st century. It is pointed out by some scholars that the green revolution


technologies have increased productivity and have helped to reduce poverty in the last forty to fifty years (Desai 2005). The benefits of these technologies have levelled off. Within this context, biotechnology facilitates a new and better means to complement classical breeding tools for the genetic improvement of both crops and livestock. It offers new means for achieving a higher intensity of selection such as through in-vitro techniques, or for a more objective selection of individuals through genetic markers. Likewise, genetically engineered [so-called transgenic or genetically modified organisms (GMO)] plants offer new methods for inserting new genes to the breeding pool, thus enhancing the quality of the new variety.

More prominently there are two visions for biotech1, one as a driver of growth in the knowledge economy and second, as a science based boost to lagging agriculture sectors as being a part of the future success of the Indian economy, in some way. Both views are supported by well-connected networks of actors and driven by particular commercial and political interests and they occupy the centre stage in the international arena too. However, development of biotechnologies has been accompanied by a stronger intellectual property rights (IPR) regime. This may pose severe challenges for developing countries as advances in this technology are largely in the private sector and these new trends in the IPR regime seems to foreclose the entry of public sector in this domain.

In this context, the role of Research and Development (R&D) in agriculture has been also raised. The idea is such that whichever countries develop and use new technologies, they define their paths of technological development. This dynamism reflects on the cumulative pattern of production and skills acquired over time and sketches out their technological trajectories. The increasing role of knowledge in agricultural production and the growing challenge of environment management in particular have to be acknowledged. This trend suggests that it has become increasingly important to bring dynamism in the functioning of science and technological systems at the national level. While the existence of a strong physical infrastructure is necessary for the development of an effective science and technology system, the critical factors remain the institutional set-up that supports this system, and the cohesion between the overall developmental objectives, and the R&D endeavours in different streams. In fact, these factors play a far

63

more significant role in frontier technologies, biotechnology in particular, than in case of any of the traditional technologies.

Thus, this article is an attempt to look into these aspects more closely, as several achievements in biotechnology promise to take agricultural system out from the various technological challenges, it is facing in India. Section II discusses the promises that biotechnology made in the last decade or so, while Section III attempts to throw light on the growth of agricultural biotechnology and its share of private sector. Various facets of industrial structures and innovation in the cereal crops are discussed in Section IV and the challenges of agricultural biotechnology are discussed in section V. The last section summarises the discussion.

Indian Biotechnology SectorThe development in the area of biotechnology has become important in India where agriculture, with stagnating productivity, and crops confronting many biotic and abiotic stresses, aims for higher growth. The development of this technology was first covered in Sixth Five Year Plan (Kumar 1988). The plan document proposed to strengthen and develop capabilities in areas such as immunology, genetics, communicable diseases, etc. within context, referring to the Council of Scientific and Industrial Research (CSIR), the document suggested to ensure coordination on inter-institutional, inter-agency and on multi-disciplinary basis, full utilisation of existing facilities and infrastructures in major areas including biotechnology. In India, the programmes in the area of biotechnology include as mentioned in the document, application of tissue culture for medicinal and economic plants, fermentation technology and enzyme engineering for chemicals, antibiotics and other medical products development; agricultural and forest residues and slaughterhouse wastes utilisation and genetic engineering and molecular biology.2

Since then the biotechnology sector, in India, has come a long way.It is being seen as a major force for economic development in India, despite the fact that there is a strong limitation of funding, infrastructural facilities and experienced manpower. Since last decade biotechnology has shown positive changes at compounded growth rate of 20-22 per cent in India (ABLE report 2012). This sector has provided US $4 billion dollars in 2011 which is higher than a mere US $530 million dollars in 2003. Similarly, it also

Agricultural Biotechnology, IPR and Seed Industry in India


consists of more than 300 firms that are spread all across India with almost half of them concentrated in and around Bangalore. The sector consists of firms from all aspects of Indian biotechnology, viz. biopharmaceuticals (vaccines, biosimilars, medical device, stem cells), bio-services (CROs and clinical trial management firms), bio-agri and bioinformatics including systems biology firms.

From the Figure 1, one can see that the revenue is continuously increasing, when compared with 2003 to 2011. It has increased more than six times from 2003 to reach more than US $4 billion. If the pace of growth continues, then in such a scenario there is bound to be an immense opportunity for the Indian biotechnology to play a positive and an important role in the Indian economy as well as in the global economy. However, if the industry of biotechnology operating landscape becomes more innovation friendly spurred by government’s policies and nudges, then the compound and annual growth rate of the industry could possibly grow at 30 per cent. It consists of both multinational companies such as Astra Zeneca, Novozymes, Monsanto as well as indigenous firms such as Serum Institute, Biocon, Bharat Biotech, EcronAcunova, Metahelix and Strand Life sciences to name a few. Many firms are exploring exciting areas of stem cell biology, synthetic biology, agri-biotechnology systems biology and exploring evidence based traditional medicine.

Figure 1: Growth of the Indian Biotechnology Sector from 2003-2011

Source: ABLE Survey Report 2012.

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As is clear from the data (Figure1) that emergence of biotechnology has given lot of hope to the developing countries. However, the international environment in which these technologies are being developed is considerably different from the one which saw the adoption of the GR. The most significant difference is that unlike the Green Revolution varieties, which were primarily developed in the public funded organisations, developments in biotechnology are being spearheaded by commercial companies, as seen in the following section.

Growth of Indian Agricultural Biotechnology SectorSince the last decade, biotechnology is being perceived as a mechanism for addressing food security concerns and consequently as a significant component in the poverty reduction strategy. Various achievements in biotechnology are encouraging, especially keeping in view the growing productivity stagnation in agriculture in the last few years. Indian agricultural biotechnology sector, mainly plant biotechnology segment,is set for a major process of transformation. As the country’s agricultural biotechnology sector made strides in the 1990s in r-DNA, transgenic and molecular marker assisted plant breeding process and Government of India responded with a matching policy support and regulatory framework that was designed to make the path of progress in R&D, sustainable and bio-safe. To a large extent, developments in the policy front have been induced by a vibrant non-governmental sector that intensely intervened on the sensitivities of modern biotechnology. Biotech can improve crop production by promoting the use of disease resistant crops, enhance the flavour and nutritional value of food products and subsequently impact global health and economies, especially among developing nations (see Figure 2).3 Thus, biotechnology can have a lasting impact on the global agriculture sector and can play a significant role in improving economies across the globe.

In last one decade or so, the rate of transfer of biotechnology to the field has gone up many times. The revenue generated from the bio-agri sector of India in FY 2010-2011 totalled US $516.67 million, thereby recording a year on year growth of 10.98 per cent over the previous financial year (see Figure 3).



Indian Bio-Agri IndustryIn Indian bio-agriculture technology both multinational and national companies are involved (e.g such as Monsanto, Nuziveedu Seeds, Rasi Seeds, Mahyco, Metahelix, Ankur Seeds, Advanta, JK Agri-Genetics, DuPont and Krishidhan Seeds, etc.). At present, Indian agricultural companies are among the fastest growing, with companies like Ankur Seeds having a record revenue growth of 197 per cent in 2010-11 compared to the previous fiscal year.4

Figure 2: Benefits of Biotech in Agricultural Sector

Source: http://www.ctahr.hawaii.edu/oc/freepubs/pdf/BIO-3.pdf cited in ABLE Report 2012.

Figure 3: Growth of Indian Agricultural Biotechnology Sector

Source: ABLE Survey Report 2012.

0 100 200 300 400 500 600

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Revenue in US $ Million

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Since 2002 there has been an increase in the level of horizontal and vertical integration among seed, agbiotech, and agribusiness firms operating in India. Multinational firms have expanded their presence in the Indian seed sector through acquisitions, whereas domestic firms have leveraged technical alliances with foreign and domestic agbiotech companies and research institutions to access new technologies (Spielman et al. 2011). It is found that the technological advances and stronger intellectual property rights (IPRs) in recent years have attracted more private investment into agricultural R&D (Ramaswami 2002), resulting in a sizeable private-sector presence in the seed market for many crops. As many scholars argue, the rapid adoption of Bt cotton effectively eliminated those companies who were not marketing Bt cotton seed from the industry (Murugkar et al. 2006).

On the one hand it is also pointed out that the top 10 firms in India accounted for just 25 per cent of the total volume of seed sold by the private sector in 2005 (Rabobank 2006). Even though there are conflicts over where India’s seed and agri-biotech industries are regulated, some industrial experts and analysts offer an optimistic outlook on the future of India’s seed and agbiotech industries. For example, Gadwal (2003) finds the greatest potential for growth in the application of modern biotechnology, provided that a more conducive regulatory system and closer public-private cooperation are forthcoming. Rao and Dev (2009) emphasise the need for a more active public-sector role to serve the needs of poorer farmers. On the other hand, they predict that rapid growth will be driven by the private sector, primarily through the continued improvement of cotton, maize, and rice hybrids. Developments in biotechnology, however, have been accompanied by a stronger intellectual property rights (IPR) regime. In fact, with the advancements in this technology stronger instruments are being used for the protection of technology which is highly exclusionist in their approach.

IPR and Agri-biotechnologyIntellectual property rights (IPRs) are a set of laws that confer exclusive rights on inventors or products of inventors for a given period of time (Balkeney 2011). The role of IPRs became prominent in the protection of plant varieties in the second half of 20th century.5 Introduction of IPRs, particularly for agricultural research tools and databases through different patenting systems has led to the expression of concerns among different



communities such as farmers, universities, plant scientists, industries and governments, particularly in the developing countries. As shown in Figure 4, the private companies operating in India’s seed and agribiotech industries have recently begun to seek legal IPR protection for their innovative outputs under the 2001 Protection of Plant Varieties and Farmers’ Rights (PPV&FR) Act. Private firms in India’s seed and agribiotech industries may now look next to the country’s Patents Act for protection of their intellectual property. Although the Patents Act of 1970 did not initially allow for patenting in the agricultural sector, this was reversed by amendments in 2002 and 2005 that made India’s laws compliant with the Trade-related Aspects of Intellectual Property Rights (TRIPs) agreement. These amendments may possibly pave the way for using patented genes from micro-organisms while, in principle, exempting seeds, varieties, and species from patenting (Spielman et al. 2011).

Protection of Plant Varieties and Farmers’ RightsLegislation for Protection of Plant Varieties and Farmers’ Rights was enacted in 2001, which provides for the establishment of sui generis and an effective system for protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties. PPV&FRA registers plant varieties to protect plant breeders’ rights. It also provides for protection of rights of the farmers in respect of their contribution made in conserving, improving and making available plant genetic resources.

Figure 4: Top Six Agribiotech/Seed Companies by Revenue

Source: ABLE Bio-Spectrum Survey 2011.

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A total of 57 crop species have been notified for registration purposes by the authority (State of Indian Agriculture Report 2012-13). A linkage with private seed industry is very important and as of now 67 private companies have applied for registration for protection under the Act. Applications received for registration of varieties – year wise and registration certificates issued crop wise are given in Figures 5 and 6, respectively.

Figure 5: Applications Received for Registration of Varieties at PPV&FRA 2007-2012

Source: State of Indian Agriculture Report 2012-13.

Figure 6: Crop-wise − Registration Certificates Issued

Source: State of Indian Agriculture Report 2012-13.

Wheat, 58

Sorghum, 22

Sesame, 2

Rice, 27

Pigon pea, 13

Pearl Millet, 27

Maize, 63

Len�l, 10

Kidney bean, 5

Jute, 7

Greengram, 20

Field pea, 20

Co�on, 34

Chick pea, 19Black gram, 11



Similarly, registrations of pesticides have increased rapidly since the 1980s as shown in Figure 7. Twice as many pesticides were registered in the first decade of the 21st century as were registered in the 1980s. These registrations, all by private companies, are primarily new formulations of active ingredients, but some new active ingredients and formulations for new crops, especially horticulture crops, have been developed.

The data (Figure 5) indicates that the largest number of applications were submitted for crops where hybrids are most common, indicating that private hybrids dominate the agricultural innovation market. One of the reasons behind this is that the private companies are more involved in R&D sector and they have well field trails. Another one is that about 24 public-sector institutions are working on GM crop research targeting four genetic traits: pest and disease resistance; tolerance of the abiotic stresses such as drought and salinity; post-harvest traits such as increased shelf life and delayed ripening; and improving protein and micronutrient content (Rabobank 2007). However, output from the GM technology pipeline in India has been driven by the private sector, which has a demonstrated capacity to move seed and seed technology products from discovery into product development and, ultimately, to delivery to farmers.

Beyond the recent changes in India’s IPR regime, an important indicator of growth is the extent to which India’s seed and agri-biotech industries are exploiting new research materials and conducting cutting-edge research.

Figure 7: New Pesticide Registrations by Decade, 1968–2010

Source: Pray and Nagarajan 2012.

130 105 104

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IPRs have generally not played much of a role in crop improvement in India over the last several decades (Kolady et al. 2010). Yet for maize and pearl millet, yields have increased significantly over time due to the combination of effective public hybrid breeding programmes, biological IPRs conferred by hybridisation that encouraged private-sector R&D investment in maize and pearl millet improvement, and policies that encouraged private investment in the seed industry. Although the potential for hybridisation in rice and wheat is far more limited than for maize and pearl millet, the effects of strong legal IPRs, in addition to some form of biological IPRs for these crops, may be needed to encourage greater private investment in their improvement. In other words, a necessary condition for the replication of the maize/pearl millet experience with rice and wheat in India will require credible enforcement of legal IPRs through the certification of private varieties and hybrids and through the adjudication of infringement cases brought to the courts under the 2001 PPV&FR Act.

R&D and BiotechnologyPrivate sector investment in R&D has significantly increased since India took up economic reforms (Pray et al. 2001). The number of private seed companies engaged in R&D increased from nine in 1985 to 40 in 1995. The corresponding growth in R&D expenditure (in actual terms) between 1987 and 1995 was from Rs. 13.1 million to Rs. 46.5 million (Rao1987). In India both Indian and multinational companies have contributed to R&D growth. Indian firms have the largest shares of R&D in all sectors except animal health. R&D by individual Indian companies in almost every agribusiness sector has grown dramatically, with the largest Indian investors in R&D−UPL/Advanta, Mahindra & Mahindra, Escorts Group, and Praj−conducting research for both the Indian and international markets (Pray and Nagarajan 2012). MNCs have expanded R&D in India to develop innovations tailored to the Indian market and to some international markets. In addition, during the last decade a number of MNCs have made India a part of their global research system, these include Monsanto, DuPont, Shell (biofuel), Syngenta, Isagro, John Deere, Pfizer Animal Health, and Nestle.

Figure 8 clearly indicates that the investment in R&D has increased, particularly in the case of seed biotechnology since 1985 to 2009. One of the reasons behind this is that in India, because of the restrictions imposed



by the licensing policy of the government operated from the 1960s, the role of the private sector in the seed industry was limited to a few companies involved in the development of superior hybrids of maize, sorghum and bajra. The Seeds Act of 1966, aimed at regulating the growth of the seed industry, specified that seeds should conform to a minimum stipulated level of physical and genetic purity and assured percentage germination, with either compulsory labelling or voluntary certification (Shiva and Ramprasad1993).

Although private sector investment has substantially increased, there is still a dearth of strong R&D in the private sector in India. Small private companies cannot afford R&D, which is capital intensive. This situation hinders biotechnology development that is highly dependent on research and requires trained manpower, which, however, is available to public sector institutions and traditional universities. Thus, the demand for highly skilled workforces, and the capital-intensive and applied nature of biotechnology research necessitated the emergence of another model, the necessary collaborations which are still in the bargaining stages in many developing countries like India. However, Indian seed companies that have developed capacity for working with transgenics (perhaps through their experience with Bt cotton) and that are active in the retail seed market should be able to compete on their own or in collaboration with the multinationals through strategic alliances, mergers, and acquisitions (Spielman et al. 2011).

Figure 8: Sectoral Private Agricultural Investment in R&D, in millions of US dollars

Source: Complied by Authors based on Pray and Nagarajan 2012.

Seed Biotechnology

Pes�cides

Fer�lisers

Agriculture

Machinery

Biofer�lizer and

biopesticides

Poultry and

feeds

Animal health

SugarBiofuel

s

Food beverages and planta�

ons

Total

1984/85 1.3 9 6.8 3.7 0 0.9 0.9 0 1.3 23.9

1994/95 4.9 17 6.7 6.5 0 3.5 2.7 2.5 0 10.3 54.1

2008/09 88.6 35.7 7.9 40.5 1.3 7.8 18.6 10.8 13.1 27 251.3

0

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D in

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Structure of Seed Industry and Biotechnology in Rice and WheatThe seed and biotech industry leads private R&D expenditures and growth in India, with current annual investment of more than $88 million.The structure of the seed industry has changed substantially in the last two decades. The private sector has grown rapidly (Pray and Nagarajan 2012).

India’s Rice Seed Sector Rice is the most vital food crop in India. Of the 2.4 million metric tonnes of rice seed used in 2008-2009 in India, 51 percent was purchased. The size of the Indian hybrid rice market during 2008-2009 was estimated at about 35,000 metric tonnes with a total value of $142 million (Francis Kanoi 2009). Although there are no complete estimates for the number of companies marketing hybrid rice seed (Kumar 2008); the figure is put at between 30 and 60. Several of these firms are investing heavily in R&D to improve yield performance, reduce yield variability, and improve grain quality. Many other firms are investing in the expansion of their marketing and distribution networks (Baig 2009; Francis Kanoi 2009).

Table 1: Hybrid Rice Seed Market in Selected States in India, 2008–2009

Region State Hybrid Seed Market Size('000 metric tonnes)

Hybrid Seed Market Value (US$ Millions)

Public Private Public Private

East

Bihar - 4 - 17.01

Jharkhand - 2 - 8.15

North

Uttar Pradesh 23 - 98.59

Punjab 1 2 1.83 6.06

Haryana 0.4 2 1.16 7.66

Uttarakhand 0.02 0.02 0.09 0.09

West

Maharashtra 0.48 - 1.67

India 1.42 33.5 3.08 139.24

Source: Complied by Authors based on Spielman et al. 2011.



Table 1 indicates that the hybrid rice seed industry is a decidedly private-sector venture. There are several implications emerging from these trends in hybrid and GM rice development in India. The two lead firms, Bayer Crop Science and Pioneer/DuPont, are likely to continue to be strong competitors in the expanding hybrid rice market. As the industry evolves and GM traits for rice move into commercialisation, the other multinationals as well as companies that have technology access from agreements with the multinationals or other technology providers should be well positioned to compete in the Indian market. Since the potential hybrid rice market is substantially larger and the number of research-driven seed companies and technology providers is large, the opportunity for a single technology provider to dominate the technology-licensing market is much less likely. Additionally, the IPR situation is becoming less restrictive as first-generation patents on various technologies begin to expire. Therefore, the GM hybrid rice market will likely evolve on the basis of inter plat form competition based on extensive sublicensing among competitors.

India’s Wheat Seed SectorWheat is the second most important food crop in India in terms of production and consumption. Agriculture reports state that as of 2009, wheat was cultivated on more than 28.4 million hectares in India. The low seed replacement rate of 18 per cent in 2006 indicates that the commercial segment of the wheat seed market is small (Seednet 2007). The total market size for wheat seed was estimated at 3.2 million metric tonnes in 1998-1999, of which saved seeds accounted for almost 90 percent. The compound annual growth rate of wheat yield demolished from 3.8 per cent during 1968-1988 to 1.5 percent during 1989-2008 (Kolady et al. 2010). The government aims to achieve this by investing more in R&D, developing better-performing cultivars, and encouraging farmer adoption of improved varieties, especially in regions which were bypassed by the Green Revolution (NFSM 2007).

The lack of success of hybrid wheat to date, for example the weak heterosis found in hybrid wheat and the difficulties in producing hybrid seed, has limited private-sector interest in wheat seed. Moreover, the absence of policy solutions, such as the enforcement of plant variety protection for wheat, has further limited private-sector interest. Only such research centres like the DWR wheat programme, from its inception in 1965 through 2007

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released 344 wheat varieties for cultivation under different production conditions in all the six wheat-growing zones (India, Directorate of Wheat Research 2010).

Despite this improvement in Agro-biotechnology, it is apparent that the tasks of meeting the consumption needs of the projected population are going to be more difficult in India. There is also a growing realisation that previous strategies of generating and promoting technologies have contributed to serious and widespread problems of environmental and natural resource degradation. This implies that in future the technologies that are developed and promoted must result not only in increased productivity level but also ensure that the quality of natural resource base is preserved and enhanced.

Challenges toAgriculture Biotechnology in IndiaAs demonstrated, biotechnology has potential to benefit human development, but there are fundamental challenges that must be properly addressed to ensure that modern technology delivers on its potential. Even though challenges will vary from country to country, most challenges are more likely be faced in developing countries like India largely due to the high level of poverty, political instability, economic instability and limited resources. The challenge in using this technology will not only be in the area of agriculture practices, but also in every aspect of biological innovation. Thus, agriculture biotechnology can face many challenges in the context of India, these are:

Reduction of Poverty and MalnutritionAgriculture has a major role to play in reducing poverty and improving food security, i.e. reducing the probability of succumbing to malnutrition and hunger. In the context of poverty alleviation, therefore, emphasis will be required to be placed both on production of food by the poor as well as on the availability of food for the urban poor. It needs to be recognised that a large proportion of the rural poor are located in regions of low potential for food production, e.g. arid and semi-arid areas, hilly regions, and degraded land and forest areas. Widespread hunger and malnutrition are the direct manifestation of poverty and will call for increasing efforts to produce more food at affordable price. Since the yield growth rates achieved with conventional plant breeding and agronomic practices have been steadily



declining, the next round of yield increases in agriculture will have to rely on the scientific advances offered by biotechnology, precision farming, and production ecology, with most of the gains expected to be derived from the first of these.

Socio-economic RiskIn the case of India the access rate of new technology and infrastructure is lower with the small farmers than big farmers. There is a considerable risk that the introduction of agricultural biotechnology could lead to increased inequality of income and wealth. In such a case, larger farmers are likely to capture most of the benefits through early adoption of the technology, expanded production, and reduced unit costs (Leisinger 1999). Growing concentration among companies engaged in agricultural biotechnology research may lead to reduced competition, monopoly or oligopoly profits, exploitation of small farmers and consumers, and extraction of special favours from governments. Effective antitrust legislation and enforcement institutions are needed, particularly in small developing countries where one or only a few seed companies operate.

Environmental and Ecological RiskThe pressure on India’s land and water resources is seriously threatening native plant and animal diversity. India has a uniquely rich and diverse genetic base. With increasing agriculture and economic development the genetic pool is declining. This decline, if unchecked and poorly managed, can have unforeseen and adverse consequences for the sustainability of agriculture of the region. While there are certainly legitimate ethical and precautionary concerns regarding the use of some biotechnologies in some contexts, it should be kept in mind that there are also ethical implications to categorically withholding or obstructing the dissemination of an entire class of technology to those for whom it could make a material difference in welfare. The ecological risks, that the policymakers and regulators need to assess include, the potential for spread of traits such as herbicide resistance from genetically improved plants to unmodified plants (including weeds), the build-up of resistance in insect populations, and the potential threat to biodiversity posed by widespread monoculture of genetically improved crops.

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ConclusionBiotechnology in the context of agriculture is not a silver bullet for achieving production, but if used in conjunction with traditional or conventional agricultural research methods, it may be a powerful tool in enhancing productivity and food security and hence that should be made available to poor farmers. Though the opinion about biotechnology among the developing countries is mixed, there are experts who actually enlist several factors why biotechnology per se, is not the right technology to ensure food security and reduce poverty in the developing countries. They even go to the extent of saying that this technology has been shaped by a narrow range of private interests that are incompatible with the demands of an ecologically sound and socially just agriculture. India has substantially increasing agro-biotechnology sector since the late 2000. This trend is likely to continue in years to come but the definite support of R&D activities is needed to develop new technology and the poor should be included directly in the debate and decision making about technological change, the risks of that change, and the consequences of no change or alternative kinds of change.

However, in the critical area of product development and commercialisation, much more attention needs to be paid.The ethical dimension of the GMOs has further confounded the ongoing confusion on the relevance of biotechnology for the developing countries. In the last decade or so, the transnational corporations have emerged as a major source of biotechnology products. This trend has, probably, further contributed to the concerns among the developing countries amidst growing reports of bio-piracy. These concerns have been reflected in the wider debate being initiated to assess the relevance of this technology for developing countries.

In such a scenario, it may not be entirely misplaced to observe that since biotechnology is a frontier technology, upcoming in a dynamic international environment, it probably requires an altogether different approach to ensure the growth of the technology along with the desired socio-economic goals. Thus, it poses a two-fold challenge; on one hand, the growth of technology has to be ensured and, on the other, policies would have to be evolved not only to restrict its adverse implications, but also for ensuring growth of the agricultural sector.



Endnotes1 See, Scoones, I. 2005. Science, Agriculture and the Politics of Policy. Pp. 351-363.

New Delhi: Orient Longman.2 India, Sixth Five Year Plan, 1980-85, New Delhi, Planning Commission, p. 326.3 http://www.ctahr.hawaii.edu/oc/freepubs/pdf/BIO-3.pdf4 See ABLEBio-Spectrum Survey, Volume 9, Issue 6, June 2011.5 See, Wright, B.D. et al., 2007. “Agricultural Innovation: Investments and Incentives,”

in Evenson, R., Pingali, P. (eds) Handbook of Agricultural Economics, Vol. 3, pp. 2537–8.

ReferencesAssociation of Biotechnology Led Enterprises (ABLE) Report, May 2012. Indian Biotechnology:

The Roadmap to the Next Decade and Beyond,.Department of Biotechnology, Government of India.

ABLE Bio-Spectrum Survey Report, June 2011, Volume 9, Issue 6, Department of Biotechnology. Government of India

Baig, S.U. 2009.“Hybrid Rice Seed Scenario in India: Problems and Challenges.”Accessed on 10 July 2013 from: www.apsaseed.org/docs/00b9aab6/ASC2009/SIG/HybridRice/Rice_India.pdf

Blakeney, M. 2011. “Recent Development in Intellectual Property and Power in the Private Sector related to Food and Agriculture.”Food Policy, 36, Supplementary 1 Elsevier Ltd.Pp S109-S113.

Desai, P.N. 2005. “Challenges of Agro-Biotechnologies, Intellectual Property Rights and Globalization.”ABDR 7(2), pp. 91-107.

Francis Kanoi (Francis Kanoi Marketing Research). 2009. A Study on Paddy in India: 2009. A Syndicated Report on Seeds. Chennai, India: Francis Kanoi Marketing Research. CD-ROM.

Gadwal, V. R. 2003. “The Indian Seed Industry: Its History, Current Status, and Future.” Current Science,84(3): 399–406.

India, Directorate of Wheat Research. 2010. Brief History of Wheat Improvement in India. Accessed on 10 July 2013

www.dwr.in/index.php?option=com_content&view=article&id=1&Itemid=116

Kolady, D., Spielman, D.J. and Cavalieri. Anthony J. 2010. “Intellectual Property Rights, Private Investment in Research, and Productivity Growth in Indian Agriculture: A Review of Evidence and Options.” Discussion Paper 1031,Washington: International Food Policy Research Institute .

Kumar, N. 1987.“Biotechnology in India.”Development: Seeds of Change (Special issue on Biotechnology), Rome, SID; 4, pp.51-56.

Kumar, I. 2008. Hybrid Rice: An Indian perspective, Accessed on 20 July 2013 from www.apsaseed.org/images/lovelypics/Documents/SCs/Hybrid%20rice_india.pdf

Leisinger, K. M. 1999. “Disentangling Risk Issues.”Biotechnology for Developing-Country Agriculture:Problems and Opportunities (ed. G. J. Persley)— 2020Vision Focus 2, Brief 5 of 10. Washington: International Food Policy Research Institute.

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Murugkar, M., Ramaswami, B., and Shelar, M. 2006. “Liberalization, Biotechnology, and the Private Sector: The Case of India’s Cotton Seed Market”. Indian Statistical Institute Discussion Paper, 06-05.

NFSM (National Food Security Mission, India) 2007. NFSM-Rice. http://nfsm.gov.in/Default.aspx, accessed on 20 July 2010.

Planning Commission of India, Sixth Five Year Plan, 1980-85.

Pray, C. E., Ramaswami, B. and Kelley, T. 2001. “The Impact of Economic Reforms on Research by the Indian Seed Industry.”Food Policy, 26: 587–598.

Pray, C.E., and Nagarajan, L. 2012. “Innovation and Research by Private Agribusiness in India.” Discussion Paper 01181,Washington: International Food Policy Research Institute .

Rabobank. 2006. Indian Seed Industry: Market Overview and Outlook. Industry Note 184 Prepared by the Global Department of Food and Agribusiness Research and Advisory, Rabobank International. Utrecht, the Netherlands: Rabobank.

Rabobank. 2007. Indian Agri-biotech Sector, Emerging Scenarios, Issues, and Challenges. Utrecht, the Netherlands: Rabobank.

Ramaswami, B. 2002. “Understanding the Seed Industry: Contemporary Trends and Analytical Issues.”Indian Journal of Agricultural Economics,57(3): 417–429.

Rao, Hanumantha C. H. 1987. “Science and Technology Policy: An Overall View and Broader Implications in Agricultural Development in India: The Next Stage.”Indian Society of Agricultural Economics, pp. 27–31.

Rao, N.C. and Dev, S.M. 2009. “Biotechnology and Pro-Poor Agricultural Development.” Economic and Political Weekly, 44(52): 56–61.

Scoones, I. 2005. Science, Agriculture and the Politics of Policy. Pp. 351-363. New Delhi: Orient Longman.

Seednet. 2007. Seed Replacement Rates, 2007. Accessed on 30 July 2010 from http://seednet.gov.in/Material/SRR-08.pdf,.

Shiva, V. and Ramprasad, V. 1993. “Vulnerabilities in the Seed Supply System” in Cultivating Diversity, Biodiversity Conservation and Seed Politics, Research Foundation for Science, Technology and Natural Resource Policy, Bulletin, pp. 19–44.

Spielman, D.J. Kolady, Deepthi, Cavalieri, Anthony, and ChandrasekharaRao, N. 2011. “The Seed and Agricultural Biotechnology Industries in India: An Analysis of Industry Structure, Competition, and Policy Options.” Discussion Paper 01103, Washington: International Food Policy Research Institute.

State of Indian Agriculture Report 2012-13. Ministry of Agriculture, Government of India.

Wright, Brian D., Philip G. Pardey, Carol Nottenburg and Bonwoo Koo. 2007. “Agricultural Innovation: Investments and Incentives” in Evenson, R. and Pingali P. (eds.) Handbook of Agricultural Economics, Vol. 3, pp. 2537–8. Elsevier Science B.V.




© 2013, RIS.

We recently co-authored a series of policy-based articles for Trends in Biotechnology on various aspects of bio-based production and bioeconomy matters (see Shaklee 2013). When we discuss bio-based production we mean biofuels and bio-based materials (largely bio-based chemicals and plastics). One of the things that emerged from that exercise was that if a bioeconomy is to succeed in virtually any country, then it relies on international trade and cooperation, which is becoming global. The drivers behind the development of bio-based production are also global: climate change, energy security and independence, the creation of new jobs allied to rural regeneration. At the same time, food security is a grand challenge facing society, and there are ways in which energy and food production come into direct competition (Seidenberger et al. 2008).

Energy SecuritySome Asian countries typify these dilemmas. Thailand has to fuel growth whilst in the grip of high dependency on crude oil imports, accounting for more than 10 per cent of GDP (Siriwardhana et al. 2009). Energy security and rural and economic develop drove Malaysian R&D on biodiesel derived from palm oil as early as 1982. Japan is the world’s third-largest oil consumer, whilst having to import almost all of its crude oil needs. Since the oil crises of the 1970s, the Japanese government has embarked on national projects in developing alternative energy resources with the purpose of

* Science and Technology Policy Division, Directorate for Science, Technology and Industry, OECD, Paris, France.

The opinions expressed and arguments employed herein are those of the authors and do not necessarily reflect the official views of the OECD or of the governments of its member countries.

Perspectives


Jim C. Philp and Krishna C. Pavanan*


raising productivity of bioethanol production. Korea has similar needs. Likewise, China has a huge demand for crude oil that cannot be met through domestic production. But as an agricultural country, China cannot sacrifice food security for energy. Currently, India has turned to biobased energy to reduce dependence on imported oils. India has to import approaching 80 per cent of its crude oil requirements (Ministry of Petroleum and Natural Gas, Government of India, 2009). India leads the way in planting and cultivating the non-food Jatropha plant on an industrial scale for biodiesel production (Wonglimpiyarat 2010).

Many other countries have biofuel policies in place or in formulation. REN21, the Renewable Energy Policy Network for the 21st Century, reported that 73 countries (many of them developing countries) had bioenergy targets as of early 2009 (REN21 2009). In 2012 the Biofuels Digest released its annual review of biofuels mandates1, stating that there were 52 countries with mandates or targets, mostly in the EU, but also 13 in the Americas, 12 in Asia-Pacific and 8 in Africa. So clearly, energy security is a global issue, and an issue with serious consequences for the future of Asia.

Food securityThe impact of bio-based production on food supply is very much a live debate. The international food prices increases that were experienced in 2008 ignited controversy over biofuels production, the so-called food versus fuel debate (e.g. IFPRI, 2010; Mueller et al., 2011). Evidence links first-generation biofuels to the price spike, but the actual extent of the linkage will probably never be known. Next-generation lignocellulosic ethanol production has, as a primary driver, the breakage of this link between land requirements for food and fuel. Due to the much smaller production volumes (and in some cases higher land area efficiency) compared to fuels, bio-based materials production has far smaller consequences for land use, and therefore the potential impacts on food supply are concomitantly lower (see, for example, Endres and Siebert-Raths, 2011).

Opportunities Beyond BiofuelsIn most countries the focus has been to a great extent on biofuels. However, bio-based chemicals and plastics offer exciting opportunities for future

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manufacturing. For example, 96 per cent of all US manufactured goods use some sort of chemical product, and businesses dependent on the chemical industry account for nearly $3.6 trillion in US GDP (Milken Institute 2013). Unusually for a biotechnology sector, the objective is the replacement of existing fossil-based materials with bio-based, therefore, contributing to green house gas (GHG) emissions reductions. Green credentials, however, are not enough to justify their place in the market. The technical, economic and social performances of these materials have to be considered. Bio-based production also promises high-value jobs. Carus et al. (2011) have estimated that materials use of biomass can directly support 5-10 times more employment and 4-9 times the value-added compared with energy uses, principally due to longer, more complex supply chains for material use. A report commissioned for The Blue Green Alliance estimated that shifting 20 per cent of current plastics production into bioplastics would create a net 104,000 jobs in the US economy (Heintz and Pollin 2011).

Bio-based plastics production, whilst dwarfed by petro-plastics, has seen a revolution in recent years. The market of around 1.2 million tonnes in 2011 may rise to 12 million tonnes by 2020, mainly driven by developments in the production of bio-based thermoplastics. Asian countries are both making demand, and setting up conditions for increased future production capacity. The Japanese automotive industry, for example, is creating demand for bio-based plastics for vehicle interiors, prompted by the Biomass Nippon Strategy of 2002.

Thailand has more than 4,000 companies in the plastics industry, and the bio-based plastics industry is considered to be strategic. Thai government initiatives and incentives have led to several investments in bio-based production facilities by both international and domestic firms. The government has also encouraged Thai companies to engage with international bioplastics companies and has promoted close collaboration with international partners. In return, Western bioplastics companies gain access to local expertise and to the large Asian markets. In addition to investment incentives, other government policies have promoted the use of bioplastics and the development of Thai industrial standards for bioplastics and consumer awareness (Ministry of Science and Technology of Thailand 2008).



The bio-based chemicals sector, whilst also small, has been growing much more rapidly than the petrochemicals sector in recent years, and several sources indicate that this trend will continue into the future (Philp et al. 2013). Modern techniques of synthetic biology have opened up the possibilities for the replacement of many fossil-based chemicals with bio-based equivalents. There are developing centres of excellence in synthetic biology in China (Pei et al. 2011), Japan (Mori and Yoshizawa 2011) and Korea (Lee et al. 2011).

There is also a compelling case for bio-based materials manufacturing in integrated biorefineries. The economics of full-scale fossil fuels production, with very small margins that can be toppled out of profit by increases in crude oil price, demonstrate that the production of higher value plastics and chemicals at the same site is a way to improve refinery economics. There is a very marked industry trend in refining and petrochemicals towards integration of the two. There is a lesson here for bio-based production as well – the long-term economics of biofuels production are likely to be similar to fossil fuels production, and it may be necessary to make bio-based materials at the biorefineries to keep them economically viable. Japan has been developing research expertise in biorefining following this concept of multi-purpose facilities, e.g. The Kobe University Biorefinery Center.2

Sustainability and BiomassThe final article in the series (Pavanan et al. 2013) was concerned with the most critical aspect of all, the sustainability of biomass. For example, Koizumi (2013) stressed that the most crucial task for Japanese biofuels development is establishing sustainability criteria for biofuels, which must pay close attention to biodiversity, food availability, and social consequences, as well as GHG emissions.

All of bio-based production is dependent on a stable supply of biomass. There are still many unknowns: just how much biomass can be grown sustainably (Batidzirai et al. 2012); how to measure biomass sustainability (van Dam and Junginger 2011), and; how to deal with the inevitable biomass disputes (Taanman and Einthoven 2012) are all huge problems still to be reconciled.

Sustainable feedstock supply has to be addressed nation-by-nation. It is an imperative for countries that have bioenergy targets. For example,

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one study (Silalertruksa and Gheewala 2010) assessed the security of feedstock supply to satisfy the increased demand for bioethanol production in Thailand. They identified cassava is as the critical feedstock and a need to reduce cassava exports to cope with domestic consumption. Waste materials are rapidly being recognised as an under-utilised source of biomass. Waste biomass is potentially the most sustainable form of biomass of all due to its ability to relieve pressure on land use. The potential for the utilisation of waste biomass has been recognised in India (Singh and Gu 2010). However, there remain issues around the sustainability of collecting the waste biomass. In Japan, it costs more to collect and transport waste biomass than using virgin feedstocks (Kuzuhara 2005).

Water supply is obviously another crucial factor in sustainability of biomass production. The scale of its importance is worth highlighting. As many as two billion people rely directly on aquifers for drinking water, and 40 per cent of the food in the world is produced by irrigated agriculture that relies largely on groundwater. Vast territories of Asia rely on groundwater for 50-100 per cent of the total drinking water (UNEP 2003). Whilst bio-based production has great potential for GHG emissions savings (e.g. Weiss et al. 2012), the production of extra non-food biomass requires a great deal of water, thus potentially putting it in competition with other vital water uses. For example, one study (Gerbens-Leenes et al. 2009) found that, for biodiesel production, soybean and rapeseed (crops mainly grown for food) had the best water footprint. Jatropha, often cited as a great future hope for biofuels production, had the least favourable.

Biomass disputes cover a very wide range of issues: some relate to human rights (land rights, workers’ rights, and local economies), environmental issues (effects on soil, land, air, biodiversity, and climate) and economic issues (international trade, market distortions, property rights, and business-to-business conflicts). Recent controversies surrounding the large scale investments in palm oil plantations serve as examples of sustainable biomass disputes in Asia. With Malaysia and Indonesia accounting for more than 90 per cent of global palm oil production (Lam et al. 2009), exploration of sustainability issues in the industry would give valuable insights into how to increase yields while maintaining and monitoring sustainable plantations. The analyses of Koh and Wilcove (2008) indicated that oil palm plantations in Malaysia and Indonesia have replaced forests and, to a lesser extent, pre-existing cropland.



The global sustainable biomass governance system is a patchwork of many voluntary standards and regulations. Standards and regulations for dispute settlement sometimes exist. However, these regulations are weakened by poor monitoring and with low access or absence of channels to lodge complaints. It is thought that a dispute settlement facility would lend credibility and legitimacy to the current situation.

Closing RemarksFor many OECD countries it is clear that to establish and maintain a bioeconomy will require international trade in biomass. Many European countries are densely populated and have relatively little free land for dedication to non-food biomass purposes. Several Asian countries will be key to this trade. And this is where sustainability is a real life issue. For these countries, this represents a large new business opportunity, but one which must be balanced with domestic necessities, such as food and water security, and good agricultural practice to prevent soil quality deterioration and deforestation.

Our perspective on bio-based production shows the great difficulties in assessing the overall advantages compared to fossil-based production. For Asia, it is perhaps an even more difficult equation. A huge driver in Asia is energy security to fuel future economic growth. But with a large population, food and water security have to come first. At the international level the lack of harmonised tools for measuring sustainability is a major hurdle to be cleared. Life cycle analysis (LCA) is widely believed to be flawed as it overwhelmingly concentrates on environmental criteria, which are more easily calculated than others, especially social criteria.

Asia clearly has a leading role to play in future bioeconomy plans. In everything from research and development to full-scale implementation and biomass production, Asian countries are likely in the long-term to be leaders in bio-based production. With growing commitments to climate change mitigation, Asia can reap the benefits of economic growth, jobs and environmental improvements that bioeconomy plans promise. But careful international coordination and cooperation will be vital.

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Endnotes1 http://www.biofuelsdigest.com/bdigest/2012/11/22/biofuels-mandates-around-the-

world-2012/2 http://www.eng.kobe-u.ac.jp/en/research/biorefinery_center.html

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Endres, H.J. and Siebert-Raths, A. 2011. Engineering Biopolymers: Markets, Manufacturing, Properties and Applications. Munich: Carl Hanser Verlag. ISBN: 978-1-56990-461-9. pp. 27-35.

Gerbens-Leenes, W., Hoekstra, A.Y. and van der Meer, T.H. 2009. “The Water Footprint of Bioenergy”. Proceedings of the National Academy of Sciences, 106, 10219–10223.

Heintz, J. and Pollin, R. 2011. “The Economic Benefits of a Green Chemical Industry in the United States: Renewing Manufacturing Jobs While Protecting Health and the Environment”. Political Economy Research Institute, Amherst, MA.

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Kuzuhara, Y. 2005. “Biomass Nippon Strategy − Why ‘Biomass Nippon’ now?” Biomass and Bioenergy, 29, 331–335.

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Lee, J.W., Kim, H.U., Choi, S., Yi, J. and Lee, S.Y. 2011. “Microbial Production of Building Block Chemicals and Polymers”. Current Opinion in Biotechnology, 22, 758–767.

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Ministry of Science and Technology, Thailand. 2008. National Roadmap for the Development of Bioplastics Industry. Cabinet Resolution No. 24/2551.www.nia.or.th/bioplastics/download/bioplast_roadmap_en.pdf

Mori, Y. and Yoshizawa, G. 2011. “Current Situation of Synthetic Biology in Japan”. Journal of Disaster Research, 6, 476-481.

Mueller, S.A., Anderson, J.E. and Wallington, T.J. 2011. “Impact of Biofuel Production and Other Supply and Demand Factors on Food Price increases in 2008”. Biomass and Bioenergy, 35, 1623–1632.



Pavanan, K.C., Bosch, R.A., Cornelissen, R. and Philp, J.C. 2013. “Biomass Sustainability and Certification”. Trends in Biotechnology, 31, 385-387.

Pei, L., Schmidt, M. and Wei, W. 2011. “Synthetic Biology: An Emerging Research Field in China”. Biotechnology Advances, 29, 804-814.

Philp, J.C., Ritchie, R.J. and Allan, J.E.M. 2013. “Biobased Chemicals: the Convergence of Green Chemistry with Industrial Biotechnology”. Trends in Biotechnology, 31, 219-222.

REN21. 2009. “Global Status Report”. Renewable Energy Policy Network for the 21st Century.

Seidenberger, T., Thrän, D., Offermann, R. Seyfert, U., Buchhorn, M. and Zeddes, J. 2008. “Global biomass potential - Investigation and assessment of data, Remote sensing in biomass potential research, Country specific energy crop potentials”. German Biomass Research Centre.

Shaklee, P.M. 2013. “Biotechnology Policy: Where are We and Why?” Trends in Biotechnology, 31, 1.

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Singh, J. and Gu, S. 2010. “Biomass Conversion to Energy in India − A Critique”. Renewable and Sustainable Energy Reviews, 14, 1367–1378.

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Book Review

Agrobiodiversity and the Law: Regulating Genetic Resources, Food Security and Cultural DiversityJuliana Santilli Earthscan 2012Pp 348+xx60 Pound SterlingHardback ISBN 978-1-84971-372-6

In the recent years there have been many books on policies relating to plant genetic resources, traditional knowledge, and access and benefit sharing and genetic resources, implementation of global treaties on biodiversity conservation and utilization of genetic resources. One reason for this has been the diversity in the responses to provisions of Access and Benefit Sharing, ratification and coming to effect of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and developments like Nagoya Protocol under Convention on Biological Diversity (CBD). This in turn has necessitated studies that look at the implementation of CBD at the national levels and the linkage between them and the obligations under the Conventions and Treaties on one hand, and on the ongoing negotiations in different fora like TRIPS (Trade Related Intellectual Property Rights) Council, IGC (Inter-Governmental Committee on Genetic Resources, Traditional Knowledge and Folklore) of WIPO (World Intellectual Property Organisation) on the other hand. The book under review thus is yet another study that goes into the intricacies of these developments.

While the first three chapters serve as a broad introduction to agrobiodiversity, its importance for sustainability and impacts of climate change on this diversity. Chapter four deals with seed laws and the legislative initiatives in different countries to revise them, and, how some countries have tried to balance interests of different stakeholders in this. In the next chapter, the author discusses the evolution of international law on protecting



© 2013, RIS.


Plant Breeders Rights under UPOV (International Union for Protection of New Varieties of Plants), requirements under TRIPS and how countries have tried to implement the provisions of TRIPS in this regard. While joining UPOV is not a mandatory requirement, countries that are Parties to WTO have to give effect to Article 27.3(b) which provides the option of implementing a sui generis regime for protecting plant varieties. Some countries have chosen to opt for regulations that are in conformity with UPOV 1978. In chapter 6 the author discusses the evolution of regulation of plant genetic resources for agriculture and food and the coming into effect of ITPGRFA after protracted negotiations and the importance of Nagoya Protocol of 2010 on regulating access to plant genetic resources.

Implementing the access and benefit sharing regime for genetic resources is taken up in chapter 7. In this the author provides an extensive analysis of the implementation in Brazil and Peru and the vexing issue of regulating access rights over shared resources and knowledge and suggests that collective benefit sharing mechanisms are necessary at the national level while at the regional level multilateral access and benefit sharing mechanisms are required. The challenge lies in putting to practice and given the different approaches in providing access and sharing benefits this will be a difficult task to accomplish although its need is obvious. Farmers’ Rights are discussed in detail in the next chapter. Farmers’ Rights emerged as a concept in the 1980s in the negotiations over plant genetic resources and sharing of germplasm but as there is no binding treaty that confers this right to farmers, nor compels nation states to guarantee that, it has been left to the nation states to implement it at their national level. This has resulted in Farmers’ Rights being understood and implemented differently in many countries. While the right to save and reuse seed is an important right for farmers the laws on plant breeders’ rights and protection of intellectual property rights have often restricted the scope of this right. Farmers’ Rights are collective rights in nature and need not be limited to their rights over seeds and access to plant genetic resources. As farming communities are also often the custodians and conservers of plant genetic resources, their right to maintain this has to be recognised and promoted. Similarly, participatory plant breeding projects and other innovative projects recognise farmers’ diverse needs and incorporate them in their objectives. Benefit sharing can also be part of implementing Farmers’ Rights. The author takes an expansive

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view of Farmers’ Rights and discusses how countries have addressed this issue and what have been the impacts of these when implemented, including the African Model Law.

Animal genetic diversity is an important topic that is, of late, getting the attention it deserves. The rights of the livestock keepers particularly their stewardship rights need to be recognised and protected. But, unfortunately, not much is happening in this although there has been an unabated extinction of breeds and the consequent erosion of animal genetic diversity. In case of animal genetic diversity the rights of livestock breeders and keepers and the rights of local communities cannot be ignored in any attempt to protect and promote that diversity (chapter 9). The author rightly argues for recognition of stewardship rights of breeders and communities. Although there is no exclusive regime for this, the need for action on this issue cannot be denied. The next chapter is on open source approaches to plant biodiversity which include suggestions to use General Public License (GPL) and development of protected commons in plant genetic resources as alternatives to patents on plant varieties and plant breeders’ rights that limit options for farmers. While the author points out the merits in such proposals she suggests that customary laws and traditional resource governance practices can play an important role in developing such open source systems.

Agricultural biodiversity and its linkage with cultural diversity is not a topic one encounters often in discussions on plant genetic diversity and legal regimes. In chapter 11 the author explores them in the context of UNESCO Convention on Intangible Cultural Heritage and Convention on Protection of World Cultural Heritage. She points out the linkage between food security and cultural diversity and preservation of crop diversity. Brazil has been a pioneer in providing recognition to traditional agricultural system of specific regions through registration. On the other hand, FAO has launched an initiative on Globally Important Indigenous Agricultural Heritage Systems for protecting sites that are historically and culturally important as they embody unique heritages in agriculture and plant diversity. Linking cultural heritage with agricultural practices and agricultural systems and designating landscapes as cultural landscapes will be important to protect such sites and to sensitise the public and governments on the importance of cultural diversity for protecting traditional agriculture and agrobiodiversity.

Book Review


In the absence of much literature on this topic this chapter is an important contribution by the author. The next two chapters are on protected areas and agrobiodiversity and on Geographical Indications (GI) and their relevance for agrobiodiversity. The final chapter ‘Conclusions’ summarises the key points made in the various chapters and serves as a Coda for the book.

While the author has covered many topics in detail, thematically speaking chapters 9, 11, 12 and 13 do not fit well within the overall framework of the book. Chapter 9 discusses an important issue but it is not of much importance for agrobiodiversity. Similarly, chapters 11 and 12 would be ideal for a volume on intangible and cultural heritage and linking that with Chapter 13 would be useful although by now there is substantial literature on GI and implementing GI in developing countries.

To sum up, this volume is certainly a welcome addition to the literature on the subject of legal regimes for agricultural biodiversity.

-Krishna Ravi SrinivasManaging Editor, ABDR and

Associate Fellow, [email protected]

Book Review

Regulating Next Generation Agri-Food Biotechnologies: Lessons from European, North American and Asian ExperiencesEditors: Michael Howlett , David Laycock

Publisher: Routledge (London and New York)

Series: Genetics and Society

Year: 2012

No. of Pages: 288

Price: £85.00

ISBN No. (Hardback): 978-0-415-69361-5

This book offers an introduction to the evolution of regulatory frameworks in the sphere of biotechnology, the need for regulating next generation agri-food biotechnologies and the lessons from European, North American and Asian experiences. Though there are some books already on the related topic such as Evenson’s The Regulation of Agricultural Biotechnology (2004), Somsen’s The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents (2007) or McHughen’s Regulation of Agricultural Biotechnology: The United States and Canada (2012); book fills a more than a small gap in the current literature of comparative studies by bringing into inter-continental perspectives.

The book opens with a very insightful chapter by the editors themselves, Michael Howlett and David Laycock, who have worked extensively in the area of public policy analysis and political economy. The chapter sets out some general perspectives and themes on the need for regulating next generation biotechnologies. It examines whether the next generation developments in regulation can learn from past experiences and comparative, cross-sectoral studies to address the governance challenges associated with biotechnological advances. Citing the development of genomic-based biotechnologies (first, second and third generations) in the agricultural-food sector since 1980s, the authors argue that these developments revealed gaps with traditional regulatory systems related to legitimacy and effective monitoring. In the agricultural sector, for example, second and third generation applications, such as genomic biomarkers,



© 2013, RIS.


animal cloning, commercial development of biofuels, use of nanotechnology and pharmaceutical crops, are all challenging the existing regulating regimes in which they are embedded. The editors argue that ‘qualitatively different environmental, ethical, and social implications entailed by applications of new technologies require elaboration, investigation and analysis’ (p. 7).

Following the opening chapter, the book is divided into five parts: first and second generation agri-food genetic technologies and regulatory regimes; regulatory regime development theory and practice; GMO regulatory regimes in practice; lessons from other high technology sectors; and agricultural biotechnologies and the public.

Tracing the evolution of regulatory frameworks both in spatial and temporal dimensions is the central theme running through a number of the chapters, particularly those in first two parts. Levidow quite diligently traces the trajectory of agricultural biotechnology development in Europe since 1980s. He explains how the US innovation-regulatory model was adopted by the EU as a means to make Europe safe for agricultural biotechnology, thus promoting biotechnology as a symbol of progress. By the 1990s, the author argues that, biotechnology epitomised promises of a ‘knowledge-based society’, promoting capital-intensive innovation as essential for economic competitiveness as well as trade liberalisation agenda and thus European prosperity (p.18). Further, the author elaborated on how the promotion of agricultural biotechnology within a neoliberal framework provoked suspicion and opposition since 1990s and put agricultural biotechnology on trial along three overlapping themes (safety vs. precaution, eco-efficiency vs. agro-industrial hazards, and globalisation vs. democratic sovereignty). These trials and criticisms eventually reshaped the EU regulations. In the next chapter, McHughen argues that ‘if we wish to learn from the mistakes of agri-food biotechnology regulations, we should design safety regulations based on actual scientifically documented risks posed by new products, with a trigger for regulatory scrutiny based on the product not the process by which it is made, and we should impose scrutiny commensurate with the degree of risk actually presented, rather than on the risk perceptions’ (p.35). To substantiate his argument, he cites very insightful examples regarding the discrepancies that exist among countries. He observes that such inconsistencies have caused ‘considerable political and economic problems’ due to disruptions to international trade.

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Michael Howlett and Andrea Migone present a variety of regulatory regime policy models and regulatory lifecycle models. They talk about ‘command-and-control’ regulation, direct government regulation, the use of independent regulatory commission, delegated and voluntary regulation; and say that different regulatory regimes are composed of different kinds of regulatory arrangements. Authors mention various regulatory models such as Berstien lifecycle model, Otway and Ravetz three-stage linear model, their own multi-stage model and also discuss Paarlberg model of policy options and regimes towards GM crops, which generates a country-specific measure of the overall regulatory approach in terms of its orientation towards biotechnology such as promotional, permissive, precautionary and preventive. In Berstien’s lifecycle model, an agency moves from ‘birth’ to ‘adolescence’ stage and then on to ‘maturity’ and ‘decline’ stages. In this model, the initial regulatory arrangements undergo many changes between ‘birth’ and ‘maturity’, after which they are more or less ‘locked in’ (p.51). Otway and Ravetz three-stage linear model comprises scientific phase, technical phase and administrative phase. Here, the specific kinds of regulatory activities are associated with each phase in a standard-building process, from collecting data to monitoring hazard occurrence and to the preparation of codes. Howlett and Migone’s early stage regulatory lifecycle model have five phases, viz. pre-regulatory, adaptive experimentation, standard-seeking, soft regulation and direct state regulation. Further, the authors inform that the US developed a promotional approach, while the EU developed a precautionary approach mixing scientific and social logics (p.59). To substantiate this, various policy initiatives taken by the US and Europe in the course of time were enumerated in the chapter.

This provides the reader with a useful theoretical framework for the subsequent chapter on overview of the development of regulatory regimes of GMOs in the EU by Anders Johansson, where he asserts that controversies in the regulatory process regarding contested technologies emerge from the discourses related to concerns over scientific uncertainties in the prediction of harmful consequences. Johansson traced the development of regulatory regimes for GMOs in the EU and tried to show that how ‘contemporary conceptions of biotechnology are an outcome of social, political, and scientific interpretations and strategies deployed by various actors involved in the regulation of that specific technology’ (p.73).

Book Review


The third part of the book deals with the GMO regulatory regimes in practice in Europe, Asia and North America. Lieberman et al. compare the EU and the US GMO policy and describe that a process-oriented regulatory framework exist in the EU, whereas a product-oriented framework exists in the USA. They investigate the differences between the EU and the USA in the wake of WTO challenge (in 2003, the USA, Canada, and Argentina lodged a complaint against the EU, in which they sought to remove those aspects of the EU GMO policy, which were obstructing free trade between the EU and the USA, Canada and Argentina in GM food and crops and to end the general moratorium on new GM crops and foods) and provide an analysis of the current status to conclude whether or not there has been any change to GMO regulation in either the EU or the USA following WTO challenge.

Tiberghien discusses the development of GMO regulations in China, Korea and Japan. He points out that all the three have taken a turn towards stricter regulatory framework and precaution in the case of GMOs (P125). The author argues that the origin of this regulatory shift towards precaution and labelling was not the result of traditional interest group lobbying, protections or even cultures. Rather, in both Japan and Korea; unprecedented civil society coalitions came together, capturing the agenda-setting and forcing the bureaucracy to initiate a regulatory shift. In China, the author informs, that political sensitivity led to a surprising turn of its regulatory stance towards the precautionary principle after 2000 (p.119). In the wake of this, China has imposed and enforced mandatory labelling. It held back its approval for GM rice until late 2009, and as a result, almost, only grows GM cotton. Thus, the author concludes that the GMO governance in China and its regulatory position is relatively precautionary and closer to that of the EU and Japan.

Kurzer et al. discuss in detail the EU’s formulation of plant biotechnology risk regulation and give an account of the EU’s regulatory approach to plant biotechnology (GM crops and foods). They say that there is a negative European public opinion when it comes to GM foods. The recent proposal to allow member states to opt out of the EU level GMO authorisations and decide on their own is a very significant development. However, the authors are apprehensive that whether this will result in more GMO-friendly Europe.

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Of the two chapters on the ‘Lessons from other high technology sectors’, which is the fourth part, one is an account of the nanotechnology regulation in China provided by Jarvis and Richmond and other covers the lessons from biomedical technology regulation provided by Engeli, Allison and Varone. Jarvis and Richmond are of the viewpoint that nanotechnology in China is intimately tied to a national political agenda, which is not exclusively a science-based initiative (p.157). It seems to have the ‘command and control’ style approach. This in turn, diminishes the space for dissent or for the public to raise questions about risks associated with the impact of nanotechnology on human health and environment as well as limiting spaces for wider consultation or public participation. Further, there is no effort from the government side to educate the general public about nanotechnology and deal with the ‘knowledge deficit’ problem (p.158).

Similarly, Engeli et al. while exploring the lessons from biomedical technology regulation in Europe and North America observe that party politics matter in devising regulatory trajectories by the countries (e.g. secular parties implemented permissive policies in the USA). Secondly, interest groups (e.g. physicians or religious groups) also matter in framing regulation policies. And thirdly, there is no causal relationship between the types of political systems (centralised vs. federalist country etc.) and the regulatory trajectory of assisted reproductive technologies (ART) and embryo related research (p.177).

The final section of the book, i.e. part five, centers on the issue of agricultural biotechnologies and the public. Montpetit tries to explain the legitimacy of Europe’s biotechnology policy on the basis of four conceptions or democratic perspectives given by Mansbridge, viz. promissory, gyroscopic, surrogate and anticipatory forms of representation. Weldon et al. have attempted to make an assessment of benefits and risks in Canadian public opinion on biotechnological innovation. They explain in detail the different approaches of public support for biotechnologies such as ‘deficit model’, which holds that opposition to emerging technologies stems largely from ignorance (information deficits) about their substantial benefits and insubstantial risks. The authors, in their own causal model of support for biotechnology, have classified individuals into a four-fold typology based on whether one perceives a technology’s respective risks and benefits to be high or low. The groups are: ‘tradeoffs’, ‘relaxed’, ‘sceptical’ or

Book Review


‘indifferent’ (p. 209). The authors also make a point that ‘moral risk’ correlates strongly with the risk in general and play a very decisive role on public perception and response. They further find that knowledge not only increases public perceptions of biotechnology’s benefits, but also those about risks. Burgess begins with the premise that public consultation is frequently required in policy development related to science to enhance representation and trustworthiness. He also discusses the various critiques of public engagement. However, he beautifully describes a design for informed public deliberation using mini-publics with the objectives that such design would form a group of participants that reflect the diversity of perspectives to inform the participants of the technical and contextual issues and opinions; to avoid stakeholder capture; stimulate critical appraisals of claims of experts, stakeholders; and to encourage the development of group decisions about what might be the appropriate policy and to identify areas of persistent disagreement (p. 222). The final chapter is by Christoph Rehmann-Sutter who focuses on governance, ethics, and deliberative democracy (p. 242) in order to express the establishment of democratic legitimacy for the decisions concerning biotechnology. He views food GM biotechnology as a socio-technical system.

The comparative analysis of the regulatory regimes and practices in the USA and the EU is an important theme addressed in this book in Chapters 2, 4, 5, 6 and 8. The development of regulatory approach in EU based on precautionary principle, public deliberations and public engagement in biotechnology get the attention they deserve in this volume. The comparative analysis points out those regulatory regimes evolve as a response to various factors and the fundamental difference, i.e. process vs. product approach lies at the core of the USA vs. EU dispute before WTO.

To sum up, I would say that from the public policy point of view, this book has been able to capture various regulatory perspectives and raised the prominence of wider consultation, public debate, deliberations and participation in policy formulations. This is the major lesson a reader can draw from the contents. However, in terms of the structure, the book seems to be slightly biased against Asian experiences as out of total fourteen chapters; there are only two on Asian experiences. The Asian approach could have been dealt in a little more detail, as the issue of regulating next generation agri-food biotechnologies is far more critical for developing countries.

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On the overall assessment, I find this book as an interesting, informative and suggestive volume. In terms of readership, I would recommend the book to researchers, students, academics and policy makers interested in the issues related to the evolution of biotechnology regulatory frameworks and the theoretical underpinnings of such an evolution and development over a period of time. I hope that the publishers would come out with a cheaper paper back version so that the book is affordable.

-Amit KumarResearch Associate, RIS

Email: [email protected]

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Editorial BoardEditorsBiswajit Dhar Director-General, Research and Information System (RIS)

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(e) Unpublished Work: Sandee, H. 1995. “Innovations in Production”. Unpublished Ph.D thesis. Amsterdam: Free University.

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Asian Biotechnology and Development Review (ABDR) is a peer reviewed,

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This issue of the ABDR has four articles that discuss the issues in

bioscience and innovation by examining the GM animals case using the ethical

matrix; patenting of naturally occurring isolated biological materials; GMOs

and sustainability of farm livelihoods in India, China and Brazil; and

agricultural biotechnology, IPR and seed industry in India. The article by Jim

C. Philip and Krishna C. Pavanan in the Perspectives Column discusses the

relevance of bio-based production in a bioeconomy. Besides these, there are

two book reviews also in this issue.


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