Outline of the Presentation

Transcription

1 Knowledge Creation and Innovation in an Emerging Technology: Nanotechnology Contemporary Development and Future in India: Scenario in Governance Nanotechnology & Regulation Dr Sujit Bhattacharya Senior Principal Scientist (NISTADS) Editor-In-Chief Journal of Scientometric Research CSIR-National Institute of Science Technology and Development Studies K.S. Krishnan Marg, Pusa Campus, New Delhi , India *for correspondence:

2 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

3 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)

4 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 challanges Translation 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

5 Institutions? Standard Setting Governance (Risk Governance) Science, Technology & Innovation Regulatory Structure Human Resources Intellectual Property Inclusive approach Trans border linkages Funding Mechanism

6 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.

7 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.

8 Defining the Issues Responsible Technology Development A development approach that ensures equitable sharing of cost, benefits and responsibilities related to technology development among, developers, promoters, government, industry and users.

9 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

10 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)

11 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)

12 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).

13 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

14 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

15

16 Generic actors and main linkages in nanomaterials innovation and governance networks Rafols et al. 2010

17 European Steps to Nanotech Regulation The REACH Protocol and the EU Action Plan for Nanotechnology European 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.

18 Dutch Nano Dialogue Netherlands

19 Country Key Coordinating Body Initiatives in Asian Countries Supporting Bodies Key Legislations/ Code of Practices Japan No Specific National Institute of Advance Industrial Chemical Coordinating Sciences Screening and Body. Council for National Institute of Material Sciences Regulation Law Science & Technology Policy- NT policies China National Steering -Ministry of Science and Technology committee for -Ministry of Education Nanoscience & -Chinese Academy of Sciences Nanotechnology -National Natural Science Foundation of China

20 Chinese Initiatives towards Nanotechnology Risk Governance BIO Environmental lab of Institute of High Energy Physics established in 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.

21 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

22 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.

23 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

24 Nanotechnology in India Major initiatives in nanotechnology ( )

25 Nanotechnology in India Major initiatives in nanotechnology ( )

26 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 ( ) 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.

27 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.

28 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.

29 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

30 Thanks Looking Forward to your comments and suggestions