N.Chandrasekhara Rao Centre for Economic and Social Studies Hyderabad, India

1. From replication to innovation: Paradigm shift in protection and regulation of technologies in India N.ChandrasekharaRao 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

2. 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

3. 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’

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Proposed ‘innovation strategy’

14. 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

15. 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

16. 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

17. 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

18. 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’

19. 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

20. 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

21. 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)]

22. 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.PrithvirajChavan Union Minister for Science and Technology

23. 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”

24. 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

25. 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’

26. 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?

27. 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

28. Conclusions Learnt 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

29. 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

30. Thank you