Knowledge Creation and Innovation in an Emerging Technology: Contemporary and Future Scenario in
NanotechnologyNanotechnology Development in India:
Governance & Regulation
Dr Sujit Bhattacharya
Senior Principal Scientist (NISTADS)Editor-In-Chief Journal of Scientometric Research
CSIR-National Institute of Science Technology and Development StudiesK.S. Krishnan Marg, Pusa Campus, New Delhi-110012, India
*for correspondence: e-mail: [email protected]
Knowledge Creation and Innovation in an Emerging Technology: Contemporary and Future Scenario in
NanotechnologyNanotechnology Development in India: Technology: Contemporary and Future Scenario in Nanotechnology Development in India: Technology: Contemporary and Future Scenario in
Governance & RegulationNanotechnologyGovernance & RegulationNanotechnology
Dr Sujit Bhattacharya
Senior Principal Scientist (NISTADS)Editor-In-Chief Journal of Scientometric Research
CSIR-National Institute of Science Technology and Development StudiesK.S. Krishnan Marg, Pusa Campus, New Delhi-110012, India
*for correspondence: e-mail: [email protected]
Nanotechnology Development in India: Governance & Regulation
Dr Sujit Bhattacharya
Senior Principal Scientist (NISTADS)Editor-In-Chief Journal of Scientometric Research
CSIR-National Institute of Science Technology and Development StudiesK.S. Krishnan Marg, Pusa Campus, New Delhi-110012, India
*for correspondence: e-mail: [email protected]
Outline of the Presentation
Nanotechnology– Promises & Concerns
Technology Development: Definining the Issues
Innovation Governance
Nanotechnology Governance: Different Country Approaches
Nanotechnology Governance: Indian Scenario
Final Remarks
Nanotechnology
Salient Features
• Enormous Technological and
Economic Potential
• Small in Size but Big in
Applications
• Capital Intensive technology
• Transformative, disruptive, generic
& converging technology
• Size and scale dependent
• Knowledge intensive field
• Enormous technological and
economic potential
• ‘Window of Opportunity’
for
developing World
Concerns
• Technology & Market
Uncertainty
• Return to investment
• EHS/ELSI Issues
• Direction and control of the
innovation process
• Equitable and sustainable
• Regulation uncertainty
• Public Acceptability
Bhattacharya et al.2011; Bhattacharya et al. 2012; Jayanthi, Koen & Bhattacharya
2012, Koen & Bhattacharya (Forthcoming)
Emerging Technologies
Emerging
Technology
are science‐based
innovations
that
have
the
potential to
create
a
new
industry
or
transform
an
existing
one.
They
include
discontinuous
technologies
derived
from
radical
innovations as well as more evolutionary technologies formed by
the convergence of previously separate research streams.
Locus of innovation ‐‐‐
No longer a firm but a network of
differentiated agents/insitututions
Many challangesTranslation of laboratory research to commercialisation:
Requires New forms of organisation, New modes of financial
support system …Various forms of uncernities/ concerns as the the said field is in
an early stage of development
Science, Technology
& Innovation
Standard Setting
HumanResources
Institutions ?
Intellectual Property
Inclusive approach
Governance(Risk
Governance)
RegulatoryStructure
Trans‐border linkages
Funding Mechanism
Regulation and Emerging Technology
Regulation essentially relates to government action in the form of laws and
notifications
with
the
objective
of
directing
private
action
for
a
specific
purpose or with certain aim (Brownsword, 2008).
It
can
be
variable
in
nature;
ranging
from
penalty
for
prohibited
acts
to
that
of
providing
a
system
of
incentives
for
preferring
one
kind
of
action
over another.
Soft (incentive based) Hard options (prohibitions)
Regulation
is
generally
perceived
as
a
means
by
which
risks
can
be
controlled.
Regulation in emerging technolgies brings new challenges to the existing
regulatory structure in terms of its ability to adopt itself to the new
technology.
The
presentation
focus
is
on
governance
&
regulation
challanges
in
nanotechnology, approaches
and
examines
them
in
the
Indian
context
Regulation is not restricted only to address risk concerns. We
broaden the canves to examine regulation towards addressing
‘responsible technology development’
, innovation governance.
Defining the Issues
Responsible Technology DevelopmentA development approach that ensures equitable sharing of cost, benefits and responsibilities related to technology development among, developers, promoters, government, industry and users.
Technology Governance
• Science Technology and Innovation Policies
• Capacity building
• Knowledge brokerage (science parks, industry parks, research
platforms, …)
• Occupational health policy
• Public education
• Risk governance policy
• Societal dialogue
Governance
Structures and processes for collective decision making Multi‐agency and Multi‐levels
Governing choices in modern societies is seen as interplay between 1)governmental institutions,2) economic forces 3)civil society actors 4) public
(Nye and Donahue 2009; IRGC 2011, Bhattacharya et al. 2012)
Innovation Governance
• Strategic technological choices to channelize innovation towards
socially
agreed goals. (Green Nanotechnology, Sustainable Nanotechnology)
• Linear to broader conceptualisation of governance (at every level of
innovation value chain)
• Emerging Technology and Innovation Governance
• De‐facto governance and modulated policy Interventions
• Distributed innovation during early stages of technological development
• Not only upstream and mid stream but also downstream, closer to the end
user
(Rafols et al. 2010; Stirling 2011)
Risk Governance
Translation of the terms of governance to the context of risk related decision‐making (IRGC 2012; Roco 2010).
Sole focus on minimising the risks of harmful effects of technologies
Back‐end response to innovation (Rip 2010).
Nanotechnology Regulation‐‐‐‐
Why regulate?
• The
extremely
high
chemical
activity
of
nanomaterails,
because
of
the
large
surface‐to‐volume
ratio,
makes
them
hazerdous
to
human
health.
This
concern
is
not
only
for
biological applications
where
these
materails
are
injected
in
the
human
body
but
also
during
manufacturing
and
large
scale external use. • To anticpate and mitigate adverse implications or unintended
consequences• Public acceptance of nanotechnology innovations
( EHS and ELSI)• Choice
of
applications
and
technology
development
value
chain
Nanomaterials
Nano Silver‐‐‐
Broad spectrumum biocide (thus any applications)
Concerns: Ends up in soil and water bodies in ionic form, toxic to aquatic
life
Titanium Oxide‐‐‐
absorb ultraviolet rays & reflects most of the sun rays
at the nano scale –
transparent
Concerns–
produce ‘free radicals’
in the presence of light that are highly
reactive and shown to dmage DNA and cause cell toxicity
Carbon Nanotubes: Hollow hexagonal cylinders made of carbon atoms that
are among the strongest & stiffest materials around
Concerns‐‐‐
can cause damage/death of kidney cells; inhibit cell growth
Generic actors and main linkages in nanomaterials innovation and governance networks
Rafols et al. 2010
European Steps to Nanotech Regulation
The REACH Protocol and the EU Action Plan for NanotechnologyEuropean Union regulation regulating chemicals and other substances
manufactured in or exported to EU nations.
The REACH system establishes a single regulatory framework for the
registration, evaluation and authorization of chemicals coming to or
from the EU.
It will require corporations to gather and disclose information on the
properties of substances which they manufacture in or import to the EU
in an amount of at least one ton per year and to demonstrate safety of
use.
Dutch Nano‐Dialogue Netherlands
Initiatives in Asian Countries
Country Key Coordinating Body
Supporting BodiesKey Legislations/ Code of Practices
Japan No Specific
Coordinating
Body. Council for
Science &
Technology
Policy- NT
policies
National Institute of Advance Industrial
Sciences
National Institute of Material Sciences
Chemical
Screening and
Regulation Law
China National Steering
committee for
Nanoscience &
Nanotechnology
-Ministry of Science and Technology
-Ministry of Education
-Chinese Academy of Sciences
-National Natural Science Foundation of China
Chinese Initiatives towards Nanotechnology Risk
Governance
•BIO‐Environmental lab of Institute of High Energy Physics
established in 2003.
•Created technical standardization committees and health, safety
and environment institutions.
•In 2005 it created a committee on nanotechnology
standardization (SAC/TC279). It is a coordinated body for drafting
essential nanotechnology standards.
• Nanosafety lab was established in National Centre for NanoScience and Technology in 2006.
Role of Standards in Regulation
• Development
and
delivery
of
protocols
for
whole
life
cycle
assessment
of
nanoscale materials, devices and products.
• Development
and
delivery
of
risk
assessment
tools
relevant
to
the
field
of
nanotechnologies.
• Development
and
delivery
of
protocols
for
containment,
trapping
and
destruction of nanoparticles and nanoscale entities.
• Development
and
delivery
of
occupational
health
protocols
relevant
to
nanotechnologies,
in
particular
for
industries
dealing
with
nanoparticles
and
nanoscale devices.
• Support
regulation
in
the
area
nanotechnologies. ‐
Support
communication
of
accurate and quantifiable information on nanotechnologies
Nanomaterial test methods for risk/regulation
• Particle detection and measurement• Fast, accurate methods for particle “size”
measurement in air, water, food and• the environment:
– Specific Surface Area (SSA)– Particle size distribution– Shape factor– Particulate density/Exposure– Work relevant to
ISO TC 24 SC4
‐
Sieves, sieving and other
sizing methods, active in Particle Characterisation, Size,
Surface area and Zeta potential.
Patenting Issues
• Patent law a significant instrument in regulating nanotechnology
‘machine‐or‐transformation’
test
• The question of definition & classification is a pressing issue with respect to
application of patent law to the field of nanotechnology.
• Concerns over depth of patents granted in respect to nano‐materials
• Potential reach of exclusive monopoly to the fundamental building blocks of
nature
Nanosys – has a portfolio of over 700 patents covering its quantum dot technology
and its process ready components for solid state lighting, electronic display
‘Tragedy of anti‐commons’
Nanotechnology in IndiaMajor initiatives in nanotechnology (2001-2007)
Nanotechnology in IndiaMajor initiatives in nanotechnology (2007-2012)
Nanotechnology Regulation : Indian Picture
Funding process is primarily restricted to upstream research
Regulatory framwork that brings different stakeholders together in developing the
technology completely missing
Concerns regarding risk are not high on the agenda in India.
NSTI Phase (2001‐2006) discussions on risk were totally missing.
Reasons
• Sole priority of the programs ‐
to create a strong institutional base, infrastructure
support and skilled manpower.
• During NSTI and Nano
Mission, government machinery was trying to situate
nanotechnology as a field of research within the network of research institutions
and develop expertise and applications.
Key Actors involved in Risk Governance in India
• MOEF‐
Major risk related areas come under the responsibility of (MOEF),
none
of
the
acts
and
legislation
of
MOEF
has
explicitly
identified
nanoparticles
as a hazard.
• DST‐
DST has supported and funded risk research, however, its mandate
does not primarily include risk governance
• DIT‐
DIT has started some projects in this direction.
• Other stakeholders, including the private sector and civil society, are not
actively involved.
• Lately
some
initiatives
have
been
taken
for
addressing
risk
issues
by
Nano
Mission and key scientific agencies.
• NIPER
is
developing
regulatory
approval
guidelines
for
nanotechnology
based
drugs
and
standards
for
toxicological
tests
in
nano‐based
drug
delivery
systems.
• In
2010,
DST
appointed
a
task
force
which
has
been
asked
to
advice
Nano
Mission Council to develop a regulatory body for nanotechnology in India.
• Firms
involved
in
nanotechnology
based
product
development
primarily
products
addressing
water,
textile,
drug
delivery
have
undertaken
Life
Cycle
Analysis (LCA) partnering with research institutes/universities.
• Standardization
remains
an
area
of
concern.
India,
has
only
taken
initial
first
steps in addressing standardization issue.
Plausible approaches
• Examine the regulations existing in different sectors and to see
what extent they
can address nanotechnology concerns
• Address issues keeping the global market regulation in consideration
• Allocate dedicated funding for EHS/ELSI research
• Standard development – joint mechanisms to develop sector specific standards
• Patent – creating mechanism of exchange with academia and other
stakeholders to develop guidelines
• Public engagement
• Stakeholders engagement at diffeent
stages of the technology development
process