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Dec 14, 2012 (4 years and 8 months ago)

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From replication to innovation: Paradigm
shift in protection and regulation of
technologies in India

N.Chandrasekhara

Rao

Centre for Economic and Social Studies

Hyderabad, India

E
-
mail:
raonch@gmail.com



Presentation at the 16th conference of ICABR
-

June 24
-
27, 2012

The Political Economy of the
Bioeconomy


Plan of presentation



National Innovation system (NIS)


framework



Evolution of S&T policies



Joining WTO as an opportunity



Move towards NIS approach



Failure in creating appropriate


protection and regulation



Conclusions


NIS framework



Dynamic networks of policies, institutions and


people that mediate knowledge flows across


national
borders&within

domestic industries



4 pre
-
requisites for a
n effective NIS:


-

Strong competition in domestic market;


Skilled
human capital;


-

Strong links between institutions, industry &


researchers; & access to foreign technologies



Feudal setting, ‘lack of scientific
temper’



‘weak state’





Evolution of policy on S&T



Broadly three stages in S&T policy


evolution


1. Up to mid
-
60s (Nehru era);


2.
Upto

end 70s


3. Two phases:


-

Incremental reform since 1980


-

Liberalisation

since 1991



Technology adaptation and not generation


The first phase



After Independence, emphasis on creating


scientific base (SPR of 1958)



Liberal import of technology & FDI



In
-
house R&D not part of T/T
agrements



R&D to help SME and with
short pay
-
off




Established process patent framework
-



Patents Act,1970




Second phase


The
BoP

crisis due to successive
wars&famines


‘Import substitution research’



‘Self
-
reliance in technological development’



Change of words
-

‘scientific development’ to


‘technological development’



Import&adaptation

of seed
-
fert
. technologies



First 5 year S&T plan in 1973 by CS formed


NCST

Incremental reforms
-

1980s



Negligence of basic science
recognised



Increasing efficiency of R&D included in goals


1983 TPS
-
linkages between academia and


industry



Formation of ministry & scientific advisory


council



Deregulation industries & lifting restrictions


on technology imports and foreign equity



1988
-

Seed policy is a result of the changes

Liberalisation

era since 1991


Industrial policy 1992



Deregulation and de
-
licening
.



More industries are open for private sector



Several fiscal incentives for R&D in private sector.



‘Consortium approach’ to research
visualised



Joining WTO (1995) meant altering incentive


structure for innovation


New patent laws



Notion of ‘permissive IPR’ is dispensed with


Three patent amendments
-

1999, 2002, 2005


Product patents allowed with 20 yrs. validity.


Process patents continue


Exemption for food, drugs and GM crops
removed


Plant varieties protection and famers rights
act, 2001
-

PVPFR authority


Problems with the framework



Pre
-
grant opposition as well as post
-
grant


opposition allowed. Revocation



Patents for NCEs only and not for incremental


innovations



Restricting Indians to getting patents abroad



Criticisms
-

Protection given more than TRIPS



Argued from a perspective of bargaining in


WTO framework than innovation framework

Move towards NIS



Mehta (2001)
-

NIS beyond S&T
per se




2003 S&T policy
-

creation of NIS.



2010
-
2020
-

decade of innovation



1
. The National Innovation Act of 2008


2. The Protection and
utilisation

of publicly


funded intellectual property bill of 2008


(Modeled on
Bayh

Dole Act,1980 of USA)


3. The universities for research and


innovation bill, 2012



Components of NIA 2008

1.
National annual integrated S&T plan

2. Measures for supporting innovation
-



-

Special innovation zones


-

National innovation fund (100
mn

USD)

3.
PPPs

4.
Confidentiality and confidential


information and remedies and offences


Proposed ‘innovation strategy’





The aim is to re
-
define innovations to go
beyond R&D laboratories and factories to
offer novel solutions that lead to inclusive
growth for the people and by the people;
foster appropriate eco
-
system across
domains and sectors to strengthen
entrepreneurship; focus on key drivers to
ensure scalability, sustainability,
durability and quality and expand the
space for dialogue and discourse on
innovation.



Seed bill, 2004



Introduced

in

upper

house

in

December

2004




Standing

committee

report

in

2006



Revised

bill

introduced

in

Parliament

in

2008



Revised

and

introduced

in

2010



Objections
-

AP,

MP,

Kerala,

Odisha



Many

objections

&

campaigns

are

by

NGOs


on

GMOs,TRIPS

and

MNCs



Latest

version

February

2011
,

in

upper

house


Seed bill, 2004
-

salient features



Supposed to replace seeds act, 1966



Definition of farmer widened



All seeds to be registered & to meet min. standards



Allows for registration of transgenic plants



Farmers can save, exchange and sell without


brand name



Compensation in CPA, 1986 unlike PVPFR Act



Permission for self certification by accredited


agencies and certification by foreign agencies

Seed bill, 2004 contd..



Seed producer and dealer and horticulture nursery


to be registered



Proposed
commercialisation

period 30/36 yrs, later


reduced to 15/18 years in subsequent draft



Critics argue for provisions to control prices



Major problems due to overlap with PVR and


FR Act and
biosafety

regulation for GM crops


Regulation of biotechnologies



One

among few developing countries to have


some regulation with ‘precautionary principle’



Regulation by 4
part
-
time

committees


1.
RDAC
-

Recommends
biosafety

guidelines


2.
IBSC
-

Clearance for any research


3.
RCGM
-

guidelines for research, controlled


field trials, imports for research


4.
GEAC
-

LS field trials, com., and import



Institutions of ICAR generate data


Need of Biotech regulatory authority



Regulation widely believed to be inadequate
.



P
roducers complain many agencies & delays



Civil society wanted regulatory authority



For
eg
.,


-

Bhargava
-

National Biotech Com. 2002


-

MSS
-

2003 Task Force Report



While
Bhargava

envisioned committee of


‘men of integrity’ MSS said ‘all stakeholders’


Proposed regulation in BRAI bill, 2008



BRA to be headed by five member committee (3+2)



It is proposed to have:


-

inter
-
ministerial governing board, advisory council


-

3 divisions each for
agric.,forestry,fisheries
/human


health&veterinary
/
industry&environment


-

Risk assessment unit, enforcement unit,


monitoring office, product ruling committee,
envtl
.


appraisal panel, scientific advisory panel,


state biotech regulatory advisory committee


-

Appellate tribunal

Point of controversy

“If a person, in connection with a
requirement or direction under this Act
,
provides any information or produces any
document that the person knows is false of
misleading, he shall be punishable with
imprisonment for a term which may extend
to three months and also with fine which
may extend to five
lakh

rupees”






Clause 62 of BRAI Bill

Other controversies



No role for state governments. Despite


state level biotech advisory committees



Demands for disclosure of confidential commercial


information:


Clause 28(2): ‘If the Authority is satisfied that the


public interest outweighs the disclosure of CCI or


such disclosure shall not cause harm to any person,


it may refuse to retain that information as CCI




Public consultation [Clause 27(5)]

Paralysing

existing regulation



Bt
brinjal

is a watershed in biotech regulation



GEAC approved Bt
brinjal

based on data
-

Oct,2009



“The tests have been conducted over nine years and


I think the scientists have done a thorough job”

Mr.Prithviraj

Chavan


Union Minister for Science and Technology



How
MoEF

entered regulation?



The GEAC, in its 97th meeting held on October
14, 2009 on the issue of commercial release of Bt egg
plant, observed that

“as this decision of the GEAC has very important
policy implication at the national level, the GEAC
decided its recommendation for environmental
release may be put up to the Government for
taking a final view on the matter”

Bt egg plant controversy stalls BRAI



Announced public consultation to decide on this



Meetings in 11 cities and huge
mobilisation

2010


January & February



10 states have written against approval of Bt egg pt



February 9, 2010 declared
moratorium on approvals



Changes name from GE approval committee to GE


appraisal committee



The campaigners started terming BRAI bill as an


indirect way of bringing GMOs


Turn of events



M S
Swaminathan
: ‘BRAI bill against the spirit


of Gandhi and
decentralised

governance’


‘Unlike the National Biodiversity Act, the BRAI


does’t

consult with people at
Panchayat

level’



Pushpa

M
Bhargava


‘unconstitutional, unethical, unscientific’


‘The BRAI bill, will adversely affect
agric.,health



of
humans&animals
,
envt
. causing unparalleled


harm’

Fallout of controversies



Five states have declared they wont allow field


trials or open release of any GM crop



Bihar, Madhya Pradesh, Kerala, Karnataka



All these ruled by opposition parties



Controversies in agric. blocking other
techgies



Response to campaign against



Monsantonisation




What is the way out? Is there light at the end?

Dr.Manmohan

Singh on biotech


“Biotechnology has enormous potential, and in
due course of time we must make use of genetic
engineering technologies to increase the
productivity of our agriculture. But there are
controversies. There are NGOs, often funded
from the US and Scandinavian countries, which
aren’t fully appreciative of the developmental
challenges our country faces”


-

Interview in Science

Conclusions



L
earnt lessons from neglecting basic


science



Early indications of NIS approach



Incentivising

innovations by fiscal sops



Joining WTO helped rework protection



Private sector role and role increasing



Some more work on protection is due



Regulatory mechanism for new


technologies to be created





Conclusions contd..



Lack of culture of innovation a challenge



Fears of being outplayed haunts policy


making



Pulls and pressures of democracy with vested


interests being able to hijack the process



Invention
-
seeking research is still very low.


Has a long way to go



Situation might change if NIS is pursued



Thank you