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 an 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 frameworkPatents 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.
• Producers 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
• Learnt lessons from neglecting basic
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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