From replication to innovation: Paradigm shift in protection and

regulation of technologies in India

N.Chandrasekhara RaoCentre for Economic and Social Studies

Hyderabad, IndiaE-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 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 20081. National annual integrated S&T plan2. Measures for supporting innovation- - Special innovation zones - National innovation fund (100 mn USD)3. PPPs4. 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 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