See

discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/281621451

Removing Bt eggplant from the face of Indian

regulators
Article in Nature Biotechnology September 2015
Impact Factor: 41.51 DOI: 10.1038/nbt.3331

CITATIONS

READS

173

3 authors, including:
Pushpendra Gupta

Lieve Gheysen

Chaudhary Charan Singh University

Ghent University

271 PUBLICATIONS 6,112 CITATIONS

216 PUBLICATIONS 5,897 CITATIONS

SEE PROFILE

SEE PROFILE

Available from: Pushpendra Gupta

Retrieved on: 04 June 2016

CORRESPONDENCE
Intestine

600,000

Transplant

Carbaglu

450,000

Elaprase

400,000

Soliris
Orfadin

350,000

150,000

1,050,000

Lung

Arcalyst

250,000

Allogeneic bone marrow

Fabrazyme

Liver
Cerezyme

Remodulin

Ilaris

900,000

Myozyme

Aldurazyme

Pancreas

100,000

1,200,000

Cinryze

Naglazyme

300,000

200,000

Drug

Heart

500,000

1,350,000

750,000
600,000

Autologous bone marrow

Kidney

Zavesca

450,000
300,000

Kuvan
Tracleer

50,000

Transplant
cost per patient to 180 days ($)

Orphan therapy
annual cost per patient ($)

550,000

1,500,000

150,000

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

npg

2015 Nature America, Inc. All rights reserved.

Addressable market (patients)

Figure 2 Correlation between the cost of expensive therapies and the size of the addressable target population in the UScomparison between orphan drugs
and transplants: the average cost per patient for selected orphan therapies (annual) and for organ transplants (to 180 days post-transplantation) is plotted in
relation to the number of target patients.

It has been recently suggested that a gene

therapy to prevent blindness or restore vision
in patients suffering from retinal degeneration
diseases leading to irreversible loss of sight
could be priced at $500,000 per dose6. Such
a price is suggested for a population between
1,000 to 3,000 patients. Assuming successful
treatment that dramatically improves quality
of life and functionality for many years, a price
in the range of a heart transplant (a treatment
for a larger population of older patients but life
saving) could, therefore, be accepted by payers.
The introduction of gene therapies will
force payers to rethink their price and
reimbursement approaches initiating a new
era in pharmaceutical economics where costeffective differs widely from affordable. As
stated by one US payer we surveyed, Gene
therapies may be a blessing in disguise.
They could finally push us to the point
where Medicare cannot fund drug therapies
anymore and, therefore, [to] where the US
has to undergo drastic rethinking of drug
benefit evaluation and pricing. Payers will
use approaches developed for gene therapy as
models to limit the overall cost of managing
orphan indications, cancers or even chronic
diseases affecting a large number of people.
In an interesting reversal of thinking, payers
may also use gene therapies to question the
cost of ongoing chronic therapies. Why should
chronic therapy cost more than a product that
restores organ function?
Our survey thus suggests payers might
accept high price tags for gene therapies, but
only if industry develops sound and rational
P&R approaches based on payer perceived
904

value. Prices will be defined neither by health

economic models nor by comparison to
expensive chronic therapies; rather, they will
be defined by therapies or procedures that
bring similar patient benefits (for further
discussion of implications for industry, see
Supplementary Discussion).
Note: Any Supplementary Information and Source Data
files are available in the online version of the paper
(doi:10.1038/nbt.3332).
ACKNOWLEDGMENTS
The authors thank Jean Philippe Combal for helpful
discussions and suggestions.
COMPETING FINANCIAL INTERESTS
The authors declare no competing financial interests.

Nicolas Touchot1 & Mathias Flume2

1groupH, Strategy Consulting, London, UK..

2Kassenrztliche Vereinigung Westfalen Lippe,

Prescription Management, Dortmund, Germany.

e-mail: nicolas.touchot@therachallenges.com

1. Brennan, T.A. & Wilson, J.M. Nat. Biotechnol. 32,

874876 (2014).
2. Yl-Herttuala, S. Mol. Ther. 23, 217218 (2015).
3. Hirschler, B. GSK readies bubble boy drug as big
pharma bets on gene therapy. Reuters (27 April 2015).
http://www.reuters.com/article/2015/04/27/health
genetherapy-gsk-idUSL5N0XK2K120150427
4. Leleu, H. et al. J. Viral Hepat. 22, 376383 (2015).
5. Hanson, S.G. & Bentley, T.S. 2014 US organ and
tissue transplant cost estimates and discussions
(Milliman Research, 30 December 2014).
6. Arons, I. The Ophthalmologist 0515, 601 (2015).

Removing Bt eggplant from the

face of Indian regulators
To the Editor:
India has steadily evolved the biosafety and
regulatory system for genetically modified
(GM) crops along with the commercial
release, in 2002, of Bacillus thuringiensis (Bt)
cotton. Transgenic events were developed in
several crops after the success of Bt cotton
in the hope that these would be released as
commercial GM crops. However, in parallel,
activists have been working against the
commercial use of GM crops, particularly
the food crops. In 2004, a petition in public
interest was filed in the Supreme Court of
India, requesting that the court intervene

with the regulatory system and order a ban

on field trials of GM crops. Under these
difficult conditions, Bt eggplant (Bt brinjal),
which was developed and field tested
indigenously, encountered several regulatory
roadblocks, culminating in a moratorium on
its commercial use by the Indian Ministry
of Environment and Forests (MOEF) on
9 February 2010 (ref. 1). This decision was
based largely on public meetings and thus
considerably undermined the authority of the
institutional system for regulatory oversight.
Here we argue for a return to science-based
regulation of GM crops and a concerted

VOLUME 33 NUMBER 9 SEPTEMBER 2015 NATURE BIOTECHNOLOGY

npg

BdBIC, 2014

2015 Nature America, Inc. All rights reserved.

CORRESPONDENCE

BARI Bt Brinjal-3 Nayantara in farmers field in Rangpur area, Bangladesh.

effort to counter the misinformation

widely promulgated by activists intent on
demonizing GM crops.
Brinjal (Solanum melongena) can become
heavily infested by fruit and shoot borer
(FSB) moths, particularly in South and
Southeast Asia, leading to serious crop losses.
Bt brinjal, expressing the gene cry1Ac (event
EE-1), provides protection against FSB, and
the event was rigorously and extensively
tested in India during 20012009 under
its well-developed regulatory system. The
statutory regulatory body, the Genetic
Engineering Approval Committee (GEAC)
made public the Bt brinjal biosafety dossier
and invited comments from the public for a
period of 45 days, as per the procedure laid
out in the Citizens Charter of India2. After
taking into consideration the test results,
public views and approval by two expert
committees, the GEAC, at a meeting held
in October 2009, concluded that Bt brinjal
event EE-1 was safe for environmental
release3. But the GEAC decision could not be
implemented, as the MOEF did not accept
GEACs approval and instead imposed a
temporary and open-ended moratorium
on the release of Bt brinjal4 that has not
yet been lifted. The moratorium decision
was based on a series of nationwide public
meetings organized by the Centre for
Environment Education, an environmental
nongovernmental organization (NGO), at
the behest of the MOEF. Importantly, the
MOEFs decision to hold public meetings on

Bt brinjal contravened established norms and

procedures by inviting public comment on
experiments of a scientific naturea process
that is mandated for projects or activities
related to infrastructure that require prior
environmental clearance5. In its rejection
of the GEACs assessment of Bt brinjal, the
MOEF relied heavily on the public views
against Bt brinjal that were generated during
the public meetings and took advantage of
the fact that the world-renowned agricultural
scientist M.S. Swaminathan did not come out
unequivocally in favor of Bt brinjal6.
In declaring a moratorium on Bt brinjal,
the MOEF not only undermined the advice
by expert groups but also ignored public
comments received by the GEAC. The MOEF
also overlooked the fact that farmers have
to spray the crop repeatedly with a mixture
of different insecticides to control FSB. The
development of Bt brinjal was aimed at
relieving the burden of repeated sprays with
insecticide, which is not only responsible for
a rise in the cost of cultivation and dwindling
farm incomes but is also a health hazard for
Indias 1.5 million brinjal growers and the
public at large7.
The moratorium on Bt brinjal has had
far-reaching repercussions on the use of GM
crops in India. Between 2010, when it was
implemented, and 2014. the infrequent and
delayed meetings of GEAC (at the behest of
the MOEF) resulted in the discontinuation
of projects and suspension of field trials
for a variety of GM crops. These blocks on

NATURE BIOTECHNOLOGY VOLUME 33 NUMBER 9 SEPTEMBER 2015

GM products were apparently based on the

nonavailability of no-objection certificates
(NOCs) from the states (a requirement
introduced in recent years), the persistence of
debate on the benefits and drawbacks of GM
crops and an antagonistic attitude toward
GM crops in society at large. However, after
the government changeover in May 2014,
the situation improved slightly; the GEAC
granted permission for field trials of GM
crops, leading to their resumption in a few
states in 20142015 (ref. 8).
Despite the economic success of Bt cotton
in India and of GM crops globally9, there
has been continued controversy about
commercial cultivation of GM crops. The
activists opposing Bt cotton have tried to
project the crop as a failure, often incorrectly
attributing a large number of farmer suicides
to the introduction of Bt cotton10. Various
NGOs organized a protest against Bt brinjal
as soon as it was declared safe by the GEAC11.
Substantial resources were mobilized, and a
group of NGOs working in different domains
of agriculture were brought together across
the country. Web-based NGOs, such as the
Coalition for a GM-Free India, the Alliance
for Sustainable and Holistic Agriculture,
India for Safe Food and I Am No Lab Rat,
proliferated to protest Bt brinjal.
These NGOs raised several concerns about
Bt brinjal, including questions about the
chronic toxicity or long-term safety of the
crop, contamination of brinjal biodiversity,
the control of multinational companies
over seed supply and loss of sovereignty
over the seeds. Advertisements in local and
national media by the MOEF invited people
to participate in Bt brinjal consultations,
attracting the general public to the issue
to such an extent that it also motivated
politicians, including the former Prime
Minister of India H.D. Deve Gowda, to
participate (ref. 12). National media coverage
from the meetings, where unsubstantiated
opinions about Bt brinjal were aired,
generated widespread misinformation about
Bt brinjal. The activists were successful in
raising doubt among the general public and
policymakers about the safety of Bt brinjal13.
The motives of scientists who supported
Bt brinjal during the public consultation
were also brought into question; they were
alleged to have direct and indirect pecuniary
interest through involvement with the private
sector. On the other hand, scientists with an
anti-GM stanceeven controversial authors
from outside India, such as Gilles-ric
Sralini14became authorities in the debate.
This led to a further polarized discussion
of the risks and benefits of Bt brinjal in the
905

npg

2015 Nature America, Inc. All rights reserved.

CORRESPONDENCE
country, using no evidence based on science.
The Inter-academy Report on GM Crops,
produced jointly by Indias six top science
academies, endorsed the safety of Bt brinjal
and recommended its limited release15 but
was dismissed by the MOEF on the grounds
that the report lacked scientific rigor16.
The controversy continues to rage today.
Misinformation about Bt brinjal and
other GM crops remains unabated. The
GEAC was demoted from an approval
to an appraisal committee17. Under the
control of the MOEF, the GEAC put off the
regulatory decisions to allow field trials
for dozens of GM crops (developed by
both private and public organizations) that
were recommended and forwarded by the
review committee on genetic manipulation
(RCGM) of the Department of Biotechnology
(DBT)18. Meanwhile, the Supreme Court of
India, while hearing the litigation on GM
crops filed in 2004, held frequent hearings
and passed interim judgments, leading to
further delays in holding GEAC meetings.
The situation was further aggravated when
Indias parliamentary standing committee
(PSC) on GM crops and the technical
advisory committee (TEC) appointed
by the Supreme Court recommended a
10-year ban on field trials of GM crops19.
The MOEF recommended the experts and
the terms of reference of the TEC that were
accepted by the Supreme Court20. The MOEF
ignored completely a large number of other
intervenors when selecting the experts for
the TEC. The TECs bias was reflected in the
interim report they submitted recommending
a 10-year moratorium on field trials with GM
crops. The Supreme Court refused to accept
the interim report and appointed a new TEC
member with expertise in crop sciences
(Rajendra Singh Paroda, former director
general of the Indian Council of Agricultural
Research). Finally, two contradictory TEC
reports were submitted: one recommended
a moratorium on field trials for Bt in food
crops intended for commercialization, and
the other (submitted solely by Paroda on
July16, 2013) recommended the continuation
of scientific experiments with further
improvement in the existing regulatory
system (submitted on June 30, 2013).
Meanwhile, the scientific advisory committee
to the Prime Minister expressed concern
about the lack of a science-informed,
evidence-based approach in the debate
on genetic engineering in agriculture; this,
however, had little effect on the debates
outcome21.
Regulatory oversight of Bt brinjal raises
several questions for the future of all GM
906

crops in India. The multifaceted activities

of NGOs against GM crops, compounded
by the litigation in the Supreme Court of
India, has meant that the regulatory bar for
GM crops has become prohibitively high,
placing the public sector institutions at a
disadvantage. A classified report on the
impact of NGOs on development, submitted
to the Prime Minister of India in 2014 by the
Indian Intelligence Bureau, corroborated
that NGOs received enormous funding
to oppose GM organisms22. NGOs were
also active facilitators of news articles, and
in collaboration with other activists, they
contributed to the temporary and openended moratorium imposed on Bt brinjal in
2010 and the de facto ban on GM crop field
trials that was recommended by the PSC and
the TEC17 (decisions on these two reports
are still pending). Several NGOs have been
working at the international and national
levels to halt field testing and commercial
cultivation of GM crops. Such groups have
been linked to trespassing and destruction
of field trials in several countries, including
India23.
In contrast to the efforts of NGOs in
demonizing the GM crops, developers of GM
crops and public research agencies have not
made adequate efforts to educate the public,
policymakers, NGOs and politicians about
the broad, international consensus on the
safety of GM crops. Scientists have also failed
to convince the public and politicians that the
widely broadcasted threats of chronic toxicity
or possible biodiversity losses due to Bt crops
are not based on science24.
Today, the major challenge for the Indian
regulatory system is to insulate it from the
political discrimination and interference
by special-interest groups that plagued Bt
brinjal. In our view, the delays in field trials
and approvals of GM crops for commercial
cultivation could be curbed by reestablishing
a regulatory system that is independent,
science driven, risk specific and efficient.We
contend that regulations should simply ensure
the safety of GM crops for human health and
environment. In this direction, some positive
steps have already been taken by the new
government of India and Prime Minister (PM)
Narendra Modi: field trials were resumed
in a few states8, and others may follow. The
Biotechnology Regulatory Authority of India
Bill, which was introduced in the Parliament
of India in 2013 and lapsed in 2014, is likely to
be reintroduced to create an autonomous and
statutory regulatory body for organisms and
products of modern biotechnology covering
agriculture, forest and fisheries, human health
and veterinary products and industrial and

environmental applications25. This authority

is supposed to replace existing regulatory
committees, including the RCGM and the
GEAC, which were believed by some to be
prone to political and external influences. In
February 2015, leading agricultural scientists
in India (including P.K.G.) wrote to Modi,
asking that the government lift barriers,
including the requirement of NOCs from state
governments, and the PM acknowledged the
receipt of this communication and assured
that appropriate action would be taken.
Bt cotton has already delivered substantial
benefits to India by reducing reliance on
chemical insecticides and doubling cotton
yields and production11. Similar gains can
be achieved by introducing other GM crops
under development in India, including Bt
brinjal. The differential regulatory treatment
of Bt cotton and Bt brinjalthe latter
influenced by factors other than biosafetyis
an ignominious step backwards for India and
needs to be reversed.
Going forward, both the Indian
government and the scientific community
must also address the issue of how to
communicate and educate the public about
the safety of GM crops for human health,
biodiversity and environment and the ways
adoption of GM crops can benefit farmers
and consumers. This can be achieved by
institutionalizing knowledge sharing on
GM crops in the country. An independent
initiative by the government of India
to share the internationally recognized
facts about GM crops and their health
and environmental safety track record
would contribute immensely to public
understanding of the risks and benefits.
India can ill afford to ignore the potential
of GM technology. Improving public
perception will be an important step toward
building societal acceptance and knowledge
in the broader population, but concerted
efforts will probably be needed to discredit
and counteract those who promulgate
misinformation, break laws and foment fears
about this technology while ignoring credible
science and evidence.
ACKNOWLEDGMENTS
P.K.G. recognizes the award of INSA Senior Scientist,
India. B.C. and G.G. acknowledge support of Marc
Van Montagu, IPBO, Ghent University, Belgium.
COMPETING FINANCIAL INTERESTS
The authors declare no competing financial interests.

Pushpendra Kumar Gupta1,

Bhagirath Choudhary2,3 &
Godelieve Gheysen2,3
1Department of Genetics and Plant Breeding,

Chaudhary Charan Singh University, Meerut,

VOLUME 33 NUMBER 9 SEPTEMBER 2015 NATURE BIOTECHNOLOGY

CORRESPONDENCE

npg

2015 Nature America, Inc. All rights reserved.

India. 2Department of Molecular Biotechnology,

Faculty of Bioscience Engineering, Ghent
University, Gent, Belgium. 3Institute of Plant
Biotechnology Outreach, Ghent University, Gent,
Belgium.
e-mail: b.choudhary@cgiar.org
1. Ministry of Environment and Forests. Decision on
commercialisation of Bt brinjal. (Government of India,
2010). http://www.moef.nic.in/downloads/publicinformation/minister_REPORT.pdf
2. Ministry of Environment and Forests. Citizens/clients
charter for 20112012 (Government of India, 2011)
3. Genetic Engineering Approval Committee. Report of the
expert committee on Bt brinjal and consideration of the
proposal for environmental release of Bt brinjal event
EE-I developed by M/s Mahyco, TNAU Coimbatore and
UAS Dharwad, Agenda Item No. 4.1. Decisions taken
in the 97th Meeting of the Genetic Engineering
Approval Committee (GEAC) held on 14.10.2009.
(MOEF, Government of India, 2009). http://www.envfor.
nic.in/divisions/csurv/geac/decision-oct-97.pdf
4. Bagla, P. Science 327, 767 (2010).
5. Ministry of Environment and Forests. Notification S.O.
1533. (Government of India, 2006). http://envfor.nic.
in/legis/eia/so1533.pdf
6. Barik, S. Dont hasten introduction of Bt brinjal:
M.S. Swaminathan, The Hindu (1 February, 2010).
7. Choudhary, B. & Gaur, K. The development and
regulation of Bt brinjal in India. ISAAA Brief No. 38
(International Service for the Acquisition of Agri-biotech
Applications, 2009).
8. Kumar, S. Nature 521, 138139 (2015).
9. James, C. The global status of commercialized biotech/
GM crops: 2013. ISAAA Brief No. 46 (International
Service for the Acquisition of Agri-biotech Applications,
2013).
10. Shiva, V. & Jalees, K. Seeds of Suicide: The Ecological

and Human Costs of Seed Monopolies and Globalisation

of Agriculture. (Navdanya, 2006).
11. Choudhary, B., Gheysen, G., Buysse, J., van der Meer, P. &
Burssens, S. Plant Biotechnol. J. 12, 135146 (2014).
12. Anonymous. Chaos, deep divisions at consultation on
Bt brinjal. The Hindu (6 February 2010).
13. Shantharam, S. Curr. Sci. 98, 996997 (2010).
14. Sralini, G.-. et al. Food Chem. Toxicol. 50, 4221
4423 (2012).
15. Indian Academy of Sciences et al. Inter-academy report
on GM crops (updated) (2010). http://www.ias.ac.in/
academy/inter_academy/GMCrops-interAcademyreport-updated.pdf
16. Shetty, P. Indian academies GM crop report slammed.
Nature News Blog (28 September 2010). http://blogs.
nature.com/news/2010/09/post_64.html
17. Anonymous. From approval to appraisal. Business
Standard (11 August (2010).
18. Kurmanath, K.V. Over 100 GM crop trials pending as
nodal body fails to meet. The Hindu Business Line
(6 June 2013).
19. Bagla, P. Science 337, 789 (2012).
20. The Supreme Court of India. Order, Writ Petition (Civil)
No. 260/2005 (10 May 2012).
21. Press Information Bureau, Government of India.
Meeting of Scientific Advisory Council of PM on biotechnology and agriculture. (9 October 2012). http://
pib.nic.in/newsite/erelease.aspx?relid=88271
22. Anonymous. Foreign-aided NGOs are actively stalling
development, IB tells PMO in a report. Indian Express
(7 June 2014).
23. Alberts, B. et al. Science 341, 1320 (2013).
24. Mendelsohn, M., Kough, J., Vaituzis, Z. & Matthews,
K. Nat. Biotechnol. 21, 10031009 (2003).
25. Government of India. The Biotechnology Regulatory
Authority of India Bill
(2013). http://www.
prsindia.org/uploads/media/Biotech%20Regulatory/
Biotechnology%20Regulatory%20Authority%20of%20
India%20Bill.pdf

The nonsensical GMO pseudocategory and a precautionary

rabbit hole
To the Editor:
The term genetically modified organisms
(GMOs) is a useless and imprecise category
used to pigeonhole products (mostly
crops) that have had their genetic content
engineered to cancel undesirable phenotypic
traits (e.g., allergenicity or toxicity) or to
express desired added traits (e.g., resistance
to pests, herbicide tolerance, improved
nutritional properties or better performance
under abiotic stress, such as flooding,
drought or heat). It is theoretically and
practically impossible to precisely specify
a supposed common denominator for all
these products; thus, the awkwardness and
contradictions of the two main current
pseudo-definitions by the European Union1
(Brussels) and the Cartagena Protocol2. On
the one hand, these two botched regulations
lump together, in a very mixed pile, a whole
range of green biotech products with very
different characteristics just because they all
have spliced DNA; on the other, they omit

everything with often similar or identical

properties, obtained through genetic
manipulation that is neither direct nor
targeted (e.g., traditional cross-breeding and
hybridizations, cell culture, and physical or
chemical mutagenesis).
As formulated in the Rio Declaration
on Environment and Development, the
precautionary principle (PP) states: In
order to protect the environment, the
precautionary approach shall be widely
applied by States according to their
capabilities. Where there are threats of
serious or irreversible damage, lack of
full scientific certainty shall not be used
as a reason for postponing cost-effective
measures to prevent environmental
degradation3. Originally created with the
aim of protecting the environment, the
PP has subsequently been broadened by
the European Union to cover also policies
for safeguarding consumers, and human,
animal and plant health. However, the PP has

NATURE BIOTECHNOLOGY VOLUME 33 NUMBER 9 SEPTEMBER 2015

sometimes been invoked inappropriately, for

example, in situations of generic, undefined
alarm. For this reason, the European
Commission (Brussels) recommends: A
decision to invoke the PP does not mean that
the measures will be adopted on an arbitrary
or discriminatory basis; instead, a decision
to apply the PP should be based on detailed
scientific and other objective information4.
That is not the case for GMOs. Any attempt
to apply the PP to this fake container as a
supposed coherent object is meaningless.
Nowhere is this more evident than in a
recent paper entitled The precautionary
principle (with application to the genetic
modification of organisms), the main author
of which is renowned scholar and popular
author Nassim Nicholas Taleb5.
In the very first sentence of the paper,
Taleb et al.5 seek to reformulate the meaning
of PP. Thus, in the authors view, the PP
states that if an action or policy has a
suspected risk of causing severe harm to the
public domain (affecting general health or
the environment globally), the action should
not be taken in the absence of scientific nearcertainty about its safety. This is a major
change in the spirit and the letter of the
original and extended principle. The PP does
not recommend waiting for near-certainty
about the safety or health impact of the
possible action that implies a suspected risk
(which, moreover, can be local, not global);
instead, it says that the lack of scientific
certainty about the risk of an action must not
in itself preclude states from intervening in
order to contain such a risk preventatively.
Even if the authors reformulation of the
PP definition were acceptable, they do not
provide a clear justification for it.
In any case, for arguments sake, let us
accept their re-interpretation of the PP
a principle that, the authors state, must
be invoked only when extreme danger is
predicated, the consequences of which can
involve total irreversible ruin, such as the
extinction of human beings or all life on the
planet5. Thus, we understand that the PP
should, in short, be applied only in the case
of an apocalyptic prospect. To distinguish
the cases in which the PP should not be
applied, and those instead where it must
be considered applicable, the article enters
into a detailed eight-page discussion on the
assessment of riskswhich may be more or
less catastrophicof human activities, with
particular regard to planetary environmental
scenarios. We wont enter into the merits
of their explanation; let us accept it en bloc,
and turn to the applications they choose for
discussion.
907