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ASI

AN

BIOTECHNOLOGY AND DEVELOPMENT

REVIEW

ISSN: 0972-7566 Vol. 18 No. 2 July 2016

Asian B

iotechnology and Developm

ent Review

July 2016

Core IV-B, Fourth FloorIndia Habitat Centre Lodhi Road, New Delhi-110 003Ph.: +91-11-24682177-80Fax: +91-11-24682173-74Email: [email protected] Website: www.ris.org.in

Editorial Introduction K. Ravi Srinivas

PAPERSThe Emergence of the Biosimilars: A Threat or an Opportunity for Biopharmaceutical Innovation SystemPranav N. Desai

Moratorium on Genetically Modified Brinjal in India: Is Evidence-Based Policy making An Adequate Framework?Jacob Kalle and Haribabu Ejnavarzala

Perception of International Stakeholders on Genetically Modified Organisms (GMOs) Ruth Mbabazi, Hashini Galhena Dissanayake, Joe Guenthner, and Karim Maredia

The Future of Genetically Modified Crops: Reflections on the NAS ReportAmit Kumar

Report of Multi-stakeholders’ Roundtable Discussion on “IPR, Access to Technology and Policy Deliberations”

Report of Roundtable on “Resolving Legal Ambiguity related to IPR and Access to Technology in Reference to Seeds”

Asian Biotechnology and Development Review (ABDR) is a peer reviewed,

international journal on socio-economic development, public policy, ethical

and regulatory aspects of biotechnology, with a focus on developing

countries. ABDR is published three times a year with support of Department

of Biotechnology, Government of India and UNESCO by Research and

Information System for Developing Countries (RIS), a New Delhi based

autonomous think-tank, envisioned as a forum for fostering effective policy

dialogue among developing countries on international economic issues.

This issue carries four papers, two reports and a book review. The

emergence of biosimilars and their potential future is reflected upon in the

first paper. The second paper discusses evidence-based policymaking with a

case study on Bt-brinjal. Theme of the third paper is perceptions of

stakeholders on genetically modified organisms (GMOs) and factors that

affect their perception. The fourth paper analyses the future of genetically

modified crops in light of the Report from National Academy of Sciences.

Two reports based on consultations and expert roundtables on access to

technology, licensing and policy and a book review on equitable access to

human biological resources add value to the issue and indicate the diversity

and complexity in themes related to biotechnology and socio-economic

development.

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Asian Biotechnology and Development Review

Editorial BoardEditorSachin Chaturvedi Director General, Research and Information System for Developing Countries (RIS)

Managing EditorK. Ravi Srinivas Consultant, Research and Information System for Developing Countries (RIS)

Assistant EditorAmit Kumar Research Associate, Research and Information System for Developing Countries (RIS)

International Editorial Advisory Board

Aggrey Ambali NEPAD Science, Technology and Innovation Hub

Nares Damrogchai CEO, Thailand Centre for Excellence for Life Sciences (TCELS), Bangkok

Vibha Dhawan Distinguished Fellow and Sr. Director, TERI, New Delhi

Reynaldo V. Ebora Executive Director, Philippine Council for Advanced Science and Technology Research and Development (PCASTRD), The Philippines

Jikun Huang Professor and Director, Centre for Chinese Agricultural Policy (CCAP), China

Dongsoon Lim Dong-EUI University, College of Commerce and Economics, Korea

Diran Makinde Director, African Biosafety Network Expertise (ABNE), NEPAD

William G. Padolina President, National Academy of Science and Technology, Philippines

Ajay Parida Executive Director, M S Swaminathan Research Foundation, Chennai, India

Balakrishna Pisupati Formerly Chairman, National Biodiversity Authority, Government of India

Bambang Purwantara Director, Southeast Asian Regional Centre for Tropical Biology, Indonesia

Sudip K. Rakshit CanadaResearchChair-BioenergyandBiorefining,LakeheadUniversity

T. P. Rajendran Former Assistant Director General, ICAR and Visiting Fellow, RIS

S R Rao Adviser, Department of Biotechnology (DBT), Government of India

M S Swaminathan Chairman, M S Swaminathan Research Foundation, Chennai, India

Halla Thorsteinsdóttir Director, Small Globe Inc and Adjunct Professor at the University of Toronto

This journal is abstracted/indexed in CAB International, Scopus, Elsevier Database and EBSCO host™ database.

The editorial correspondence should be addressed to the Managing Editor, Asian Biotechnology and Development Review, Research and Information System for Developing Countries (RIS). Zone IV-B, Fourth Floor, India Habitat Centre, Lodhi Road, New Delhi-110003, India. Telephones: 24682177-80. Fax: 91-11-24682173-74. E-mail: [email protected] Website: http://www.ris.org.in

Copyright RIS, 2016.

RNI Registration No. DELENG/2002/8824.

The views expressed in the Asian Biotechnology and Development Review are those of the authors and not necessarily those of the RIS or the organisations they belong to.

Guidelines for Contributors1. ABDR is a refereed multi-disciplinary international journal. Manuscripts can be sent, preferably

as email attachment, in MS-Word to the Managing Editor, Asian Biotechnology and Development Review, Research and Information System for Developing Countries (RIS), Core 4B 4th Floor, India Habitat Centre, Lodhi Road, New Delhi 110003, India (Email: [email protected]; Tel. +91-11-24682177-80; Fax: +91-11-24682173/74). Submissions should contain institutional affiliationandcompletemailingaddressofauthor(s).Allsubmissionswillbeacknowledgedonreceipt.

2. Manuscripts should be prepared using double spacing. The text of manuscripts should not ordinarily exceed 7,000 words. Manuscripts should contain a 200 word abstract, and key words up to six.

3. Use ‘s’ in ‘-ise’ ‘-isation’ words; e.g., ‘civilise’, ‘organisation’. Use British spellings rather than American spellings. Thus, ‘labour’ not ‘labor’.

4. Use figures (rather thanword) for quantities and exactmeasurements including percentages (2 per cent, 3 km, 36 years old, etc.). In general descriptions, numbers below 10 should be spelt out in words. Use thousands, millions, billions, not lakhs and crores. Use fuller forms for numbers and dates— for example 1980-88, pp. 200-202 and pp. 178-84.

5. SpecificdatesshouldbecitedintheformJune2,2004.Decadesandcenturiesmaybespeltout,for example ‘the eighties’, ‘the twentieth century’, etc.

References:A list of references cited in the paper and prepared as per the style specified belowshould be appended at the end of the paper. References must be typed in double space, and should be arrangedinalphabeticalorderbythesurnameofthefirstauthor.Incasemorethanoneworkbythesame author(s) is cited, then arrange them chronologically by year of publication.All references should be embedded in the text in the anthropological style–for example ‘(Hirschman 1961)’ or ‘(Lakshman 1989:125)’ (Note: Page numbers in the text are necessary only if the cited portionisadirectquote).Citationshouldbefirstalphabeticalandthenchronological–forexample‘Rao1999a,1999b’.More than one reference of the same date for one author should be cited as ‘Shand 1999a, 1999b’.The following examples illustrate the detailed style of referencing:(a) Books: Hirschman, A. O. 1961. Strategy of Economic Development. New Haven: Yale University Press.(b) Edited volumes: Shand, Ric (ed.). 1999. Economic Liberalisation in South Asia. Delhi: Macmillan.(c) Articles from edited volumes: Lakshman, W. D. 1989. “Lineages of Dependent Development: From State Control to the Open

Economy in Sri Lanka” in Ponna Wignaraja and Akmal Hussain (eds) The Challenge in South Asia: Development, Democracy and Regional Cooperation, pp. 105-63. New Delhi: Sage.

(d) Articles from Journals: Rao, M.G., K. P. Kalirajan and R. T. Shand. 1999. “Convergence of Income across Indian States:

A Divergent View”. Economic and Political Weekly, 34(13): pp. 769-78.(e) Unpublished Work: Sandee, H. 1995. “Innovations in Production”. Unpublished Ph.D thesis. Amsterdam: Free University.(f) Online Reference: World Health Organisation. 2000. “Development of National Policy on Traditional Medicine”.

Retrieved on March 31, 2011 from http://www.wpro.who.int/sites/trm/documents/Development+of+National+Policy+on+Traditional+Medicine.htm

AsianBiotechnologyDevelopment Review

and

AsianBiotechnologyDevelopment Reviewand

Vol. 18 No. 2 July 2016 ISSN: 0972-7566

Editorial Introduction ................................................................................................. 1K. Ravi Srinivas

The Emergence of the Biosimilars: A Threat or an Opportunity for Biopharmaceutical Innovation System ...................................................................... 2Pranav N. Desai

Moratorium on Genetically Modified Brinjal in India: Is Evidence-Based Policy making An Adequate Framework? .......................................................................... 27Jacob Kalle and Haribabu Ejnavarzala

Perception of International Stakeholders on Genetically Modified Organisms (GMOs) ................................................................................................................... 51Ruth Mbabazi, Hashini Galhena Dissanayake, Joe Guenthner, and Karim Maredia

The Future of Genetically Modified Crops: Reflections on the NAS Report ......... 59Amit Kumar

Report of Multi-stakeholders’ Roundtable Discussion on “IPR, Access to Technology and Policy Deliberations” .......................................... 69

Report of Roundtable on “Resolving Legal Ambiguity related to IPR and Access to Technology in Reference to Seeds” .......................................... 77

Book Review ............................................................................................................ 83Equitable Access to Human Biological Resources in Developing Countries: Benefit Sharing Without Undue InducementManjulika Vaz

These are interesting times and challenging times for those following the developments in biotechnology and the contents of this issue partially reflect this.

The paper by Pranav Desai examines the potential of biosimilars and describes how the availability of biosimilars could impact access to healthcare. It also notes a paradox that lies at the heart of the biosimilars revolution, that the access would be better, but not necessarily for those who would need it most. The production, distribution and use of biosimilars are impacted by different factors, including regulation and as the paper points out the important role that can be played by institutions and regulators. The findings of this paper should be of interest to regulators in large and emerging economies such as China, South Korea and India.

While evidence based policy making is a buzz word what counts as evidence for policy making is often a contentious issue. Taking the example of moratorium on Bt brinjal announced in 2010, Jacob Kalle and Haribau Ejnavarzala examine what other evidences were provided, besides the ones provided by the scientists and technocrats, to the government and what was the implication of the process of consultation and seeking evidence for democratising science. They point out that many questions that were raised needed answers that would not be available from a narrow positivist framework/understanding of science, technology and society. Hence, they suggest adoption of Post-Normal Science (PNS) model that is informed by precautionary and participatory approaches. The PNS model has been advocated by some as a better model for decision making in case of controversial technologies but for some, use of such approaches and public participation and engagement undermines the very role of science in decision making (Kuntz 2016). On the other hand, scholars have pointed out the merits and limitations of the PNS model and applying it in policy making and regulation (Turnpenny, Jones, and Lorenzoni 2011)

Editorial Introduction

K. Ravi Srinivas*

Asian Biotechnology and Development ReviewVol. 18 No. 2, pp 1-2

© 2016, RIS.

* Managing Editor, ABDR and Consultant, RIS. E-mail: [email protected]

2 Asian Biotechnology and Development Review

In controversial issues, perception of stakeholders matters and can make a difference. Based on a survey conducted among stakeholders from different countries, Ruth Mbabazi and others point out that concerns over food safety matter most while other concerns such as environmental impacts and farmers’ rights are also important. Besides making some suggestions on improving the understanding of stakeholders, they point out how institutions have been taking steps to communicate effectively with stakeholders.

Recently, the National Academy of Sciences (USA) published a report on Genetically Engineered crops and emerging themes in technology and regulation in agricultural biotechnology. Reflecting on this study, Amit Kumar contextualises the Report, discusses the responses to it and examines its potential impact.

The cost of Bt cotton seeds and their affordability has been a concern for stakeholders including the state governments. Can the government unilaterally fix the norms for licensing and limit the prices of seeds and if so, would that not affect the incentive to innovation? RIS organised two consultations to discuss these issues in the context of the steps taken (since withdrawn) by the Department of Agriculture, Government of India on licensing technology for producing Bt cotton seeds and the price of the seeds. These meetings indicated that the stakeholders have different views although almost everyone agrees that seeds should be affordable to small and marginal farmers. The two reports, in this issue, based on these consultations summarise the issues, the points made by the stakeholders and experts and provide suggestions based on the views expressed and other inputs. In the next issue, we will be publishing an paper on agricultural biotechnology, intellectual property rights and licensing discussing these issues in depth and exploring the various legal and policy options.

Besides these papers and reports, this issue carries an interesting book review on access to human biological resources and benefit sharing.

Your comments and suggestions are welcomed.

ReferencesKuntz, M. 2016. “Scientists Should Oppose the Drive of Postmodern Ideology.” Trends in

Biotechnology, Available online at: http://dx.doi.org/10.1016/j.tibtech.2016.08.008. ISSN 0167-7799.

Turnpenny, J., M. Jones and I. Lorenzoni. 2011. “Where Now for Post-Normal Science?: A Critical Review of its Development, Definitions, and Uses.” Science, Technology and Human Values, 36 (3): 287-306.


© 2016, RIS.

Pranav N. Desai*

The Emergence of the Biosimilars: A Threat or an Opportunity for Biopharmaceutical Innovation System?

* Professor, Centre for Studies in Science Policy, School of Social Sciences - I, Jawaharlal Nehru University, New Delhi. Email: [email protected]

Abstract: Biopharmaceuticals have raised many hopes of improving the quality of life. However, the increasing cost of treatment has raised many questions regarding its access in the context of multiple inequalities. The arrival of the patent cliff in this sector has given rise to biosimilars. This development has not only opened up an enormous global market but also a possibility of a significant drop in their prices, improving the healthcare system by meeting worldwide demand at affordable price, reduction in cost of production and patent maintenance. These possibilities have led to greater rush towards seizing this opportunity by all kind of firms leading to the competitive market environment. Hence, the present paper revolves around crucial questions whether this rush will divert the attention from R&D efforts of the discovery of new drugs and keep the focus away from the neglected diseases? Whether it will widen the medical divide and reinforce the existing inequalities?Keywords: Biosimilars, biopharmaceuticals, historical analogy, India, international innovation system, sustainable development

IntroductionMany scholars around the world hold technological change and globalisation responsible not only for accelerated growth, but also for rising inequalities. These inequalities further manifest in terms of unequal access to science, technology and innovation in various sectors such as agriculture, education, health, industry and transportation and communication. Multiple inequalities, reinforcing each other, act as a powerful force in reducing poverty, inclusive and sustainable development.

In recent times, a major technological change the world has witnessed is the emergence of biotechnology revolutionising several sectors including


the health sector. Technological advances in biotechnology or the modern biotechnology have shifted our attention from agri-biotechnology to biopharmaceuticals1. Today, biotechnology products are the fastest growing segment of the pharmaceutical industry raising hopes of prolonging and improving the quality of life. This development has revolutionised not only the treatment of some of the intractable diseases but has also introduced entirely new approaches and understanding. Some of these serious illnesses include auto-immune disorders such as rheumatoid arthritis and psoriasis, HIV/AIDS, cancer, blood conditions and neurological disorders. New areas like genomics, stem cell therapy and tissue engineering are adding new possibilities. The biopharmaceutical drugs, however, entails premium price given the higher order of investment in terms of R&D and infrastructure and a longer incubation period till the market authorisation orcommercial launch compared to introducing a small molecule (NCE – New Chemical Entity).According to an estimate, biopharmaceutical drug could cost as much as US$ 1.2 billion and 15 years of incubation period as against US$ 800 and 12 years for the small molecule (DiMasi et al. 2003). Since the early 1980s, the production of biologic medicinal products via rDNA route has accelerated the development of the biopharmaceutical industry and the institutional changes at national as well as international level have also bolstered the same process.

However, the biopharmaceutical industry is at the cross-road today with its first patent cliff approaching during the period 2012-20. The patent protection for most of the biopharmaceutical drugs will expire during this period. Though with a varying degree, the regulatory system is also responding favourably encouraging the production of copy version of original or biosimilars in different parts of the world. This development has raised many hopes for improving the healthcare system by meeting worldwide demand at an affordable price, widening access, reduction in the cost of production, patent maintenance and new business opportunity at all levels of firms. These possibilities have led to greater rush towards seizing this opportunity of producing biosimilars by all kind of firms including the large established biopharmaceutical firms leading to the competitive market environment. Nevertheless, the preceding situation has raised many challenges. An attempt is made here to analyse the situation and understand the unfolding of the biosimilars innovation system. An effort

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is made to identify the dominant actors and processes. It is contended that the historical analogy of the impact of generics on pharmaceutical R&D may provide some signals for the future of R&D in biopharmaceutical after the emergence of biosimilars. Hence, foresight methodology of historical analogy is used here.

The present paper revolves around crucial questions whether this rush for the production of biosimilars will divert the attention from substantive R&D efforts of the discovery of new drugs? Who are the dominant actors? Whether hopes of reduction in cost, widening of access and strengthening of innovation system will materialise or will it lead to deepening the process of stratified biomedicalisation (Clarke et al. 2003) and hence widen medical divide? Whether the focus on the blockbuster drug model will continue with the neglect of some of the diseases that affect billions in the developing countries?

Neglected Diseases The global disease patterns markedly differ across the low-, medium- and high-income countries (WHO 2009). In medium- and high-income countries, the most important high risk factors are linked to chronic diseases such as cardiovascular diseases, cancer and diabetes. The leading causes are alcohol, overweight and blood pressure for the high-income countries. The low-income countries suffer more from environmental issues like safe drinking water, sanitation and hygiene and under-nutrition. These factors enhance the risk of infectious diseases. The global disease patterns between countries of different income groups still remain distinct. This is despite the fact that some of the diseases like cardiovascular diseases and cancer are on the increase due to the demographic and epidemiological transition underway in the developing countries. Some forms of cancers, cardiovascular diseases, diabetes and arthritis are dubbed as lifestyle diseases and are attributable to lifestyle, aging and environmental causes. Not only the prevalence but attention paid is also higher for the lifestyle diseases with a larger market share for the same. More importantly, the health infrastructure including R&D expenditure, human resource, drug and medical equipment manufacture is also concentrated in the developed countries with orientation inclined mainly towards their requirement. The 1990 report from the Commission on Health Research and Development

The Emergence of the Biosimilars


revealed that less than 10 per cent of global research spending was targeted at the diseases that are responsible for more than 90 per cent of the global burden of ill-health (WHO 2013). Many national and international institutional efforts are geared towards resolving the neglect of the health issues of the developing countries and still more efforts will be required to continue the process. Hence, it is pertinent here to discuss the features of neglected diseases. This group of diseases is not defined on the biological or medical basis but on the basis of their neglect. Therefore, no strict definition or consensus is available worldwide. The WHO2 has categorised 18 diseases as neglected diseases as one group on the basis of their neglect. Some more diseases could be added to the list like HIV, malaria, tuberculosis, diarrhoea and pneumonia based on the threat perception and as a leading cause of deaths. About 10 million people die each year from neglected diseases, and many more millions are reported having been debilitated. These diseases primarily affect populations in middle and low-income countries of Africa, Asia and Latin America. Not only very little attention is being paid towards R&D efforts for these diseases, but the investment is declining. This is reflected from the fact that only a meagre amount of US$ 1 is spent on these diseases out of US$ 100,000 spent worldwide on R&D and product development. Most of this expenditure comes from the public sector (65 per cent) of the developed countries and some developing countries. With market condition in mind, R&D resources are mainly apportioned (72 per cent) to three diseases namely AIDS, tuberculosis, and malaria and rest to other neglected diseases (Stefanakis et al. 2012).

At the same time, it is encouraging to note that after the emergence of the biopharmaceutical industry, the participation of biopharma companies compared to pharmaceutical companies is reported to be much higher. Most of these R&D efforts are concentrated in the biopharma companies of the USA, UK, India, Germany and Switzerland. It is due to the changed international institutional environment or procurement policies of the multilateral agencies that India today supplies 90 per cent of the global vaccines and sells low-cost anti-malarial and anti-retroviral therapies in Africa. However, only 134 companies or five per cent of the total biopharma companies of the world participate in the R&D and product development for neglected diseases. The major mode through which these attempts are made is the academic research, public sector institutes and Product Development

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Partnerships (PDPs). PDPs were developed specifically for promoting R&D for neglected diseases through pooling funding and managing projects (Stefanakis et al. 2012).

Structure of Global Biosimilars IndustryWith the arrival of the patent cliff during the period 2015-20 for most of the blockbuster biological drugs, a sudden drop in their sales is expected. A new opportunity has arisen on the biopharmaceutical horizon for others wishing to ride on the wave of biosimilars production for early consolidation. As far as forecast of sales is concerned, by 2015 sales of biosimilars were expected to reach between US$ 1.9-2.6 billion, up from US$ 378 million for the year to the first half of 2011 (IMS 2011). As against the initial enthusiasm and robust sales forecasts, there are evidences of hesitant investment moves and partnership withdrawals in various parts of the world including India.3 The reasons explained are competition, low uptake of biosimilars due to efficacy issues, reducing profitability as a result of price adjustment by the originators reducing the price gap. Some of the originators are also enhancing their R&D efforts to face the competition posed by the biosimilars (Emerton 2013).

The rapid growth of biosimilar industry is not only associated with a drop in cost and price but also issues of efficacy, safety, regulatory framework, licensing and labelling or naming.

Biosimilars are therapeutically similar copies of biologic drugs. In order to develop a biosimilar, comparability with the reference product must be demonstrated. The European Medicines Agency (EMA) defines biosimilars as drugs that claim to be “similar” to their reference biological medicinal products. The active drug substance of biosimilars is derived from a living organism using recombinant DNA or controlled gene expression methods. As against this, it is simpler to copy or synthesise “small molecule” pharmaceuticals, and consider them to be equivalent if they have the same chemical structure, composition, and pharmacokinetic profiles as the originator drugs.

As the European region was the first to establish well-defined regulatory guidelines in the year 2005 (Knezevic and Griffiths 2011), Europe dominates the global biosimilars market with around 40 per cent share today. The factors driving the European market are: presence of various biosimilar drugs



such as omnitrope, tevagrastim, and binocrits; numerous pipeline products; and more than 15 biologics going off-patent in the coming years. Although penetration of biosimilars varies by country, it also depends on various other factors, including local pricing and reimbursement policies, stakeholder influence, and attitudes towards the adoption and use of biosimilars. Currently, Germany commands the highest share in the European market due to the presence of a reference pricing4 system. The U.S., on the other hand, has a very restricted biosimilars market owing to the stringent regulatory environment in North America. The Asia-Pacific market is estimated to be the fastest-growing market. Asia-Pacific accounts for an overall share of 29 per cent of the global biosimilars market. This large share of the market is mainly due to the semi-regulatory environment of the region that easily approves similar biologics in the market. In addition, low manufacturing costs and the presence of highly skilled expertise at low costs are also factors that make Asia-Pacific a lucrative destination for the biosimilars.

Across countries, China and India are considered attractive destinations for R&D outsourcing of foreign biosimilar manufacturing companies that look to reduce their growing R&D costs and increase the number of drug applications and approvals. Both the countries are expected to grow at the fastest CAGR of 30 per cent and 29 per cent during the period 2013-18 (MarketsandMarkets 2013). Factors influencing the high growth rate in India and China are the nature of regulatory system with regards to the approval of biosimilars, the low IP protection of biologic compounds in China, semi-regulatory environment to approve biosimilars and S&T human resource in India, and low manufacturing costs, that have enabled domestic manufacturers to market the generic version of biologic compounds at a low price.As far as the small molecule generics are concerned, the price reduction was observed to be as high as 90 per cent (Blackstone and Fuhr 2012). This may not be the case with the biosimilars. The range of average price reduction reported so far is only 10 to 30 per cent compared to the reference product (Mulcahy et al. 2014). Across the biologic class, nevertheless, the price reduction may vary widely depending on various factors like sales, degree of competition and the timing of biosimilar entry. Moreover, it is possible that the advantage of a slightly cheaper product may be outweighed by the assumed increased risk of side-effects of biosimilars (Roger and Mikhail 2007). Biologics are characterised by a defined set of

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proteins and/or polypeptides. The folding, shape, and glycosylation of these proteins and/or polypeptides may impact the pharmacological, non-clinical and clinical properties of the biologic. Even minute structural changes may affect efficacy or safety; therefore, biosimilars cannot be approved and regulated in the same way as generic medicines. The global market is estimated to reach US$ 2 billion by 2018 at a CAGR of more than 20 per cent between 2013 and 2018 (MarketsandMarkets 2013).

The global biosimilars market is segmented on the basis of products, applications, and services. By product, the global biosimilars market is further segmented into recombinant non-glycosylated proteins (insulin, granulocyte colony-stimulating factor (G-CSF), interferon, and human growth hormone), recombinant glycosylated proteins (erythropoietin, monoclonal antibodies, and follitropin), and recombinant peptides (glucagon and calcitonin). The recombinant glycosylated proteins segment is the largest segment and accounts for a share of 40 per cent of the global biosimilars market in 2013 at an estimated US$ 314.2 million and is expected to grow at a CAGR of 17.5 per cent from 2013 to 2018. The biggest factor behind the growth of this segment is the increasing demand for second-wave biosimilar products, such as insulin and interferon, for the treatment of diabetes and infectious disorders. Of all segments under the product category, the monoclonal antibodies segment is the fastest growing segment at an estimated CAGR of more than 40 per cent from 2013 to 2018 (MarketsandMarkets 2013).

By application, oncology is the largest and fastest growing segment and accounts for a share of 25 per cent of the global biosimilars market. This is attributed to the increasing prevalence of oncology along with the rise in aging population and the changing lifestyle.

The factors restricting the growth of the market are high manufacturing complexities and costs, stringent regulatory environment in the U.S. and Europe, innovative strategies used by biologic drug manufacturers to protect their intellectual property, costly purification process, arrival of biobetters, and the presence of low-priced biogenerics that compete with biosimilars in the market.

The key players in the biosimilars market are Sandoz (Germany), Hospira (U.S.), Teva (Israel), Dr. Reddy’s Laboratories (India), Biocon



Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), Intas Biopharmaceultical Ltd. (India), and Innovent Biologics, Inc. (U.S.). In 2013, Sandoz was the highest contributor (50 per cent) to the global biosimilars market (MarketsandMarkets 2013).

Sandoz has emerged as the market leader in the global market and is likely to maintain this leadership position in the coming years. Sandoz entered the biosimilars market in 2006, with the launch of Omnitrope (human growth hormone) – a biosimilar drug – in the European market. Sandoz’s biosimilar product offerings include Zarzio (G-CSF), Omnitrope (human growth hormone), and Binocrit (epoeitin-alpha). Thus, the broad product portfolio enables the company to gain a competitive advantage over other players in the market. The company focusses on strengthening their market position by significantly investing in research and development activities. It has a robust biosimilar pipeline with about ten drugs.

Teva, another major player, has the capability to provide a stiff competition to Sandoz. In 2000, Teva entered the biosimilars market by setting up a clear long-term biosimilar strategy. Since then Teva has undergone several acquisitions and agreements with contract manufacturing organisations as well as various strategic alliances to strengthen their manufacturing unit and R&D capabilities.

Other notable players are Hospira (U.S.), Dr. Reddy’s Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), and Intas Biopharmaceultical Ltd. (India).

Regulatory FrameworksThere was an increasing realisation of the potential of emerging markets of biosimilars in many parts of the world by the turn of the century. The attention of many countries was drawn towards a need for regulatory guidelines and standards for the same. Some of the issues involved were how to license a product that was biologically more complex and inherent problem of biological variability. Even with the advancement of technologies, it is not possible to predict fully biological properties and clinical performance solely on the basis of physicochemical characteristics. Therefore, unless consistency of production is guaranteed, a slight change in production can lead to adverse clinical effects in terms of immunogenicity that will have

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serious safety implications. In addition to scientific aspects, stemming from different jurisdictions, issues of intellectual property and legal aspects are required to be addressed. Other issues that remain unresolved are naming biosimilars and distinguishing them from the innovator or reference biological product. The global consensus is yet to arrive as far as interchangeability and substitutability are concerned.

In the preceding context of hotly debated issues, the European Medicines Agency (EMA) was the first regulatory agency to introduce biosimilar guidelines in 2005. Soon to follow were many countries like Australia that adopted these guidelines. Some emerging markets developed their own regulatory pathways. Simultaneously, many rounds of the international consultation took place under the auspices of the World Health Organisation (WHO). Many countries like Japan, Korea, Malaysia, Singapore, Turkey, Taiwan, reviewed their guidelines on the basis of WHO draft guidelines.In 2009, the WHO developed a set of globally accepted standards to assure the safety, efficacy and quality of biosimilar medicines. These guidelines were mindful of certain national situations and excluded certain provisions. Singapore and Malaysia amended their guidelines mainly in accordance with the EMA guidelines while Brazil and Cuba chose the WHO and Canadian guidelines as the basis for formulating regulations (Knezevic and Griffiths 2011). India had approved around 20 biosimilars for use within India under an ad hoc abbreviated procedure before releasing official guidelines in June 2012.

The USA, currently the world leader in biopharmaceutical innovative R&D and manufacturing, is pursuing the most stringent regulatory pathways. In 2010, the US Congress created an abbreviated regulatory approval process for biosimilar products. This regulatory pathway, established in the Biologics Price Competition and Innovation Act (BPCIA), authorises the US Food and Drug Administration (USFDA) to approve a biosimilar product that references an earlier approved innovative biological product after a set period of time post-innovator approval of 12 years. In spite of a stringent regulatory pathways, the US is expected to face competition not only from the developed countries but also from the developing countries like Brazil, China, India, Singapore and even from Cuba or Thailand. Thus, the US global leadership is likely to be challenged. Moreover, a major technological change in terms of the emergence of biotechnology has radically changed



the existing conditions for the developing countries. Firstly, the search for active ingredients has brought back developing countries into global focus with their rich biodiversity along with their traditional knowledge. This has provided them with leverage for bargaining bolstered by some of the international institutions.5 Secondly, the health crisis including pandemic like HIV/AIDS created a need to make treatment accessible and affordable. Thirdly, a growing need to build domestic biopharmaceutical industry was felt in many of the developing countries after implementing TRIPS in 2005 that made reverse engineering impossible. Fourthly, the same S&T infrastructure is available now for the production of biosimilars while this sector is reaching a patent cliff. It is also pertinent to note an observation (Mytelka 2006) here that the developing countries that are commonly perceived as users of technologies are emerging as producers of innovation after the emergence of technologies such as biotechnology and that multiplicity of pathways exist. This is because innovations are not simply embedded in the S&T infrastructure but in policy and institutional context with country specific triggers and drivers that are playing important roles in this process.

The preceding situation points towards two important implications for the biopharmaceutical innovation system. Firstly, there are multiple pathways and specificity of the different national innovation system (NIS) and that some new visible or at times hidden international loops linking the NIS are also emerging. In the given hierarchical structure of the international system of innovation (Desai 2015), the question arises whether the growth of biopharmaceutical industry or the biosimilar industry will respond to the social and health needs of the developing countries. So far, most of the biosimilars available in the market respond to lifestyle diseases more prevalent in the developed countries. Will the biosimilar industry respond to some of the neglected diseases in the absence of definite institutional mechanism? To answer these future questions, the only available analogy is the history of small molecule generics.

Historical Analogy of Generics DevelopmentThe first medicinal drugs came from natural sources and existed in the form of herbs, plants, roots, vines and fungi. Later in the medieval period, some non-toxic metallic oxides were added to herbs like in Ayurvedic

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medicines in India. In Europe, a precursor to the modern pharmaceutical industries was the apothecaries. Until the mid-nineteenth century, these natural remedies were all that was available to treat some conditions. The first synthetic drug, chloral hydrate, was discovered in1869 and introduced as a sedative-hypnotic. The first pharmaceutical companies were spin-offs from the textiles and synthetic dye industry and owed much to the rich source of organic chemicals derived from the distillation of coal-tar. For many years, the pharmaceutical industry traditionally developed chemical drugs (also referred to as small molecules), including well-known medicines such as acetylsalicylic acid, to treat a wide range of illnesses. Since then the entire pharmaceutical industry, in most parts of the world, has evolved in the absence of patents or weak patent system.

In most cases, generic products are available after the expiration of patent protection accorded to the original developer. The generic drug could be defined as a drug containing the same active ingredients as the original formulation. According to the USFDA, generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. Therefore, generics are to be identical in dose, strength, route of administration, safety, efficacy, and intended use. Though generic drugs are not entirely new, their extensive availability at affordable price materialised only in the mid-1980s. Back in the 1920s, the company that made Bayer aspirin fought vigorously to keep generic versions off the shelves. The company lost in court, and consumers suddenly had an array of choices in generic aspirin. Today, generic drugs are both widely available and carefully regulated.

In other cases, where patents have not expired, many countries around the globe have not permitted IPR protection for pharmaceutical products. Some of the countries have excluded product patents and have authorised process patent for a long period. In many developing countries, the pharmaceutical industry has thrived in the absence of patent protection. This provision enabled many local pharmaceutical firms to build their capability and specialise in generic drugs (Drahos 2002). As a result, these countries also developed their skills and competencies in the area of drug manufacturing. Certain countries like India and China became the exporters of generic drugs to various parts of the world. Not only the developing countries but even some of the developed countries in Europe



did not approve patent protection in the pharmaceutical sector till the late 1970s (Boldrin and Levine 2008). France and Germany started granting protection in this sector only in 1977 and 1978, respectively. According to a WIPO study (1988) in the year 1988, out of 98 members of the Paris Convention for the Protection of Industrial Property, 49 members6 excluded pharmaceutical products from protection. These countries included not only the developing but also some of the developed countries.

It is interesting to analyse the historical development of generic industry in the USA – the world leader in the pharmaceutical industry. It was much easier for the drug companies to launch new products with lesser efforts in testing than it is required today. This was until 1962 when the USFDA had to revamp the Federal Food, Drug, and Cosmetic Act passed originally in 1938. Earlier, only if too many patients complained of bad reactions, the drug was required to be withdrawn from the market. The danger of this approach surfaced and alarmed the administration only when the sedative thalidomide (Clarke et al. 2003) caused thousands of devastating birth defects in Europe, Canada, Latin America, Africa, and Asia. It was after this disaster that the drug testing laws had to be strengthened in terms of proving its safety and effectiveness before releasing it into the market. All new drugs had to undergo a lengthy and expensive process that included large scale clinical trials. Any new generic drug had to go through the same clinical and non-clinical trials as any other drug, even if its active ingredients were identical to an already established brand name drug. Moreover, the generic manufacturer had to wait for the expiry of brand name patent before they could even initiate testing required to produce a generic. This regulation applied both to brand name and generic drugs resulting in a substantial slowdown in the introduction of new generic drugs. Thus by 1983, only 35 per cent of the original drugs with expired patent had a generic competitor. Today, as against this 90 per cent of the prescribed drugs are generic drugs. This dramatic turnaround was due to the Drug Price Competition and Patent Term Restoration Act of 1984, commonly called the Hatch-Waxman Act. This Act provided the much needed boost to the generic industry by streamlining both generic drug approval and patent litigation involving generic drugs.

This Act expedited drug approval for the generic and extended market and patent exclusivity periods for both branded and generic drug

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companies. The Act was expected to raise “hopes of providing a return on their investment and an incentive for future innovation”. Many scholars have hailed this law as a balanced and a significant driver not only for the introduction of low-cost drugs but also for promoting innovations. The post-1984 period has certainly encouraged low-cost generic drugs, fierce competition and an increased level of patent litigation. However, it is essential to analyse its impact on R&D and innovation activity and more importantly treatment of neglected diseases.

Impact of Generics on Innovation ActivityAs against the commonly held view that the rise of generics will dampen R&D expenditure, annual R&D expenditure has grown more rapidly than the rate of inflation. The pharmaceutical industry’s trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), reported six fold increase in expenditure by its members between 1980 and 2004, from about US$ 6 billion (in 2005) to US$ 39 billion. Thus, the growth in expenditure was 8 per cent in real terms but the profits grew by only 4 per cent (Austin 2007). It could be a result of fierce competition introduced by the low-cost generic products. This phenomenon is coupled with the mounting cost of the new drug product, increasing healthcare spending and slowing down of launching of new innovative drugs. This could perhaps be explained in terms of shifting of attention towards the emerging paradigm of biopharmaceutical and not simply towards manufacturing of generics. Different companies have adopted different strategies to generics competition. Some have adopted merger and acquisition route, or other have adopted the path of generic manufacturing. Some of the companies like Abbot, Johnson and Johnson, and Novartis with business interest even outside pharmaceutical production have diversified into consumer products, healthcare services, medical devices and diagnostics. Companies such as AstraZeneca and GlaxoSmithKline have concentrated more on the emerging markets like China and India, respectively.

The period following the rise of generics has witnessed excessive patenting (Kiliç 2011). Patent battles between US multinational and generic companies were rife during this period. These legal clashes are attributed to the low patent quality and a fact it reflects the deteriorating quality of innovativeness. This has correspondence with the theory of noted economist Joseph Stiglitz that the asymmetry between granting of



patents and the legal challenges leads to excessive patenting. Drawing from Samuelson’s theory (Samuelson 1954) of public good, Stiglitz (1999) considered knowledge as global public good whose benefits are enjoyed by but a few and further observed that innovations are more concentrated than even incomes in the world. Moreover, even while manufacturing of drug was internationalising, most of the R&D remained concentrated in the headquarters of the multinationals. R&D remained the most unfragmentable part of drug manufacturing. It was not until the unfolding of globalisation (Desai 2009) process along with the co-evolving technologies like bio, ICT and nanotechnologies emerged that a need was felt to locate and decentralise R&D activities globally and especially in the countries with strong S&T infrastructure.

R&D and patenting are always considered central to any innovative activity by many scholars. As against this view, there are many scholars who do not see any role of patents or strong IPR system in inducing innovations (Mazzoleni and Nelson 1998). There are others who strongly favour prize money instead of IPR as an incentive for the desired drugs. “There is a growing sentiment that something is wrong with the system governing intellectual property (IP). The fear is that a focus on profits for rich corporations amounts to a death sentence for the very poor in the developing the world. So are there better ways of promoting innovation?” (Stiglitz 2006).

Challenges of BiosimilarsThe development of generic industry points towards the fact that the introduction of biosimilars will pose similar challenges to the biopharmaceutical industry but under different socio-economic, political and technological climate. Global pharmaceutical industry, during the last two centuries, evolved under different historical, political, regulatory and technological situation. This allowed the dominance of a few developed countries in production and distribution of drugs. This phenomenon was facilitated by a tight grip on the hierarchical structure of international innovation system. During the period of the 1980s and onward the pharmaceutical industry did not encounter the challenges of generics but also simultaneous emergence and convergence of biotechnologies, information and communication technologies and nanotechnologies. Intermeshed with this was the unfolding of the globalisation process.

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During this period, many developing countries have built up their S&T infrastructure including their capabilities in pharma and biopharma sectors. This is reflected in their increasing S&T output in quantitative as well as qualitative terms. Over the past decade, the number of highly cited academic papers from Brazil, China, India, and South Africa have nearly doubled. Some scholars (Gardner et al. 2007) have ranked countries by USPTO biopharmaceutical patentsper gross domestic product (GDP) per capita. The top fifteen included not only Organisation for Economic Cooperation and Development (OECD) countries, but also India (third), China (fourth), Brazil (eleventh), and South Africa (fourteenth). As far as the publications and patents in absolute terms are concerned, the following situation prevailed (see Tables 1 & 2). Table 1 provides the total publication records in the biopharma sector during the period 1989-2015. These tables reveal that the USA and other European countries have maintained their dominance, but other actors like India and China have emerged and are closely following these five countries. Brazil is another developing country that does not figure in the list of the top fifteen but might soon appear on this list. Today, an overwhelming portion of 97 per cent of the total publications is concentrated in these fifteen countries. A similar situation prevails as far as granting of patents is concerned during the period 2000-2014. The USA and some of the European countries have maintained their lead, but many non-European countries have emerged as significant players. These countries are South Korea, Argentina, India, China, Israel, Dominican Republic, Morocco, Singapore and Cuba. The increasing global share in scientific publication, patenting activities and exports certainly reflect their national S&T capabilities and strengthening of their respective national innovation capabilities and therefore their potential of entering biosimilar markets. However, this does not suggest any corresponding health outcomes or linkages with their local health requirements. At times, the health outcome of these countries may not match their capabilities or may be that their health outcome be equivalent to other advanced countries or even surpass the performance of the advanced countries. Cuba (López et al. 2007) is one example that has equivalent or superior health outcome compared to other developed countries (Cárdenas 2009).



Table 1: Publications in Biopharmaceuticals (1989-2015 )

Sr. No. Country Publication Records1 USA 20462 Germany 5613 England 5174 Switzerland 2695 Netherlands 2516 India 2457 Peoples R China 2158 France (213) 2139 Japan (194) 19410 Canada (172) 17211 Italy (166) 16612 Sweden (146) 14613 Spain (126) 12614 Ireland (125) 12515 Australia (122) 122

Total Records World 5530

Source: Compiled from Web of Science Core Collection, 2015.

Another discernible trend that is emerging in the biopharmaceutical sector is the phenomenon of ‘outsourcing’ or in other terms alliances, partnerships, networked partnership or even global knowledge networks (GKN). Some of the examples that could be cited for such biotech clusters are not only established in the developed countries like the USA (Seattle, San Francisco), Denmark/Sweden (MediconValley), France/Germany Switzerland (Biovalley), but are also emerging in the developing countries like Brazil (Minas Gerais), China (Bejing, Shanghai), Cuba (West Havana), India (Bengaluru, Genome Valley in Hyderabad) and South Africa (Capetown). This networking is also aided by the recent advancement in information and communication technologies.

Due to pressures of global competition, economic crisis, and more importantly because of the very nature of biotechnology the networking needs for R&D, manufacturing and services have increased manyfold. Some of these requirements, for example, target identification and validation, genomics and proteomics research and gene-silencing technology have now been widely used to validate more complex and structurally diverse disease targets. A variety of microarray technologies is also widely used to study the differences in gene expression patterns and gene interactions. Most of these studies are now performed by academic research organisations, specialty biotech companies or professional Contact Research Organisations

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(CROs) (Zhang 2012). Clinical trials is another area that requires global trials, and there are specialised CROs that conduct these activities. With the emergence of biosimilars, the need for CROs and Contract Manufacturing Organisations (CMOs) to enhance their capabilities has become crucial. The activities may not remain restricted to low-end tasks such as the development of cell lines, contract manufacturing of developmental biologic drugs to support clinical development at various stages, and bio-analysis and product characterisation. To take advantage of growing biosimilars market and provide affordable healthcare, the government of India launched a regulatory framework and guidelines for the market authorisation of similar biologics in 2012 (DBT and CDSCO, 2012). Under these guidelines, the manufacturers are required to prove similarity to a reference biologic already approved in India or licensed and sold for at least four years in a regulated market. After proving comparable safety, efficacy and quality of a similar biologic to an authorised reference biologic, a biosimilar may require reduced preclinical and clinical data package as part of submission for market authorisation. Hence, this implies reduced cost of a biosimilar drug.

Price competition is likely to drive biosimilar industry. According estimates in the developed countries, the price reduction in biosimilars would be around 10-30 per cent (Mulcahy et al. 2014). This amount is not any significant decrease compared to price reduction achieved for generics. As against this normal expectation, some of the Indian companies have already started selling biosimilars with about 85 per cent reduction in price (ABLE PriceWaterHouseCooper 2010). There are about 20 biopharmaceutical companies that manufacture biosimilars. Some of the major companies and their biosimilar products are given in Table 3. India is emerging as the top biosimilars producer and exporter given the efficient manufacturing. This will certainly widen the access of these drugs. However, the target areas are mainly lifestyle diseases and, therefore, the beneficiaries would be the high-income group and the developed countries markets.

After the emergence of biosimilars, the hope of reduction in patent litigation is also belied. Rather given the greater complexities in manufacturing and characterising the big molecule compared to the small molecule, the chances of legal battles have all the more enhanced. The very first introduction of the biosimilar in the USA started with the legal battle between Sandoz and Amgen. Sandoz (the generics arm of Swiss pharmaceutical giant Novartis) has refused to reveal the details of its manufacturing method as it is not required by the European laws. However, by the US law it is essential to reveal such details so that the



original manufacturer like Amgen (US company) in the case of filgrastim (Neupogen, an immune-boosting drug for people undergoing cancer treatment made by Amgen) can identify whether any of their patent had been violated (Ledford 2015).

Table 2: Patents* Granted in Biopharmaceuticals (2000-2014)

Country No. of patentsUSA 777France 192Germany 188United Kingdom 99Netherlands 68Canada 54Belgium 44Italy 33Spain 30Denmark 28South Korea 25Australia 23Switzerland 22Argentina 21Sweden 21Ireland 20Czech Republic 18Japan 17India 16China, The Peoples Republic of 15Austria 10Israel 9Dominican Republic 8Morocco 6Russian Federation 6Singapore 6Slovenia 6Cuba 5

Note: *Search by keyword phrase “bio-pharma* OR biopharma*” in Title, Abstract, and Claims.Source: Compiled from Thomas Innovation.

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Table 3: Biosimilar Production in India

Biosimilar Company Product Name

TherapeuticArea

Year of Launch

Insulin WockhardtBioconShreya Life Sciences

WosulinInsugenRecosulin

Diabetes2003 2004 2004

Erythropoietin

Hindustan Antibiotics EmcureWockhardtRanbaxy Intas Pharmaceuticals Shantha Biotechnics

HemaxEpoferWepoxCeritonEpofit&ErykineShanpoietin

Cancer

2000 2001 2001 2003 2005 2005

Granulocyte colony stimulating factor

Dr. Reddy’s Laboratories Intas Pharmaceuticals

GrastimNeukine

Cancer, Neutropenia

2001 2004

Streptokinase

Bharat Biotech Shantha BiotechnicsCadila Pharmaceuticals

IndikinaseShankinaseSTPase

Cardiac disease

2003 2004 2004

Interferon alpha-2b ShanthaBiotechnics Shanferon Hepatitis C 2002

Rituximab (MAb)

Dr. Reddy’s Laboratories Reditux

Leukamia, Lymphoma,Rheumatoid Arthritis

2007

Anti- Epidermal Growth Factor (MAb)

Biocon BioMAB-EGFR Cancer 2006

Source: Bhushan et al. (2014).

There are many biopharmaceutical companies, CROs and CMOs are bracing up for the fierce competition posed by the biosimilars. The efforts will be in terms of production of biobetters or new biological entities with improved dosage or effects. No commonly accepted definition is available for the tem biobetters.7 While the biosimilars attempt to establish similarity, the biobetters target ‘superiority in one or various aspects of their clinical profile. Working with the same target protein, biobetters include structural



changes, bi-functional targeting (with orwithout a biosimilar core) or an improved formulation that may result in an expected improvement in safety and/or efficacy’ (Anour 2014). This process cannot be initiated with lower R&D and innovative activities.

ConclusionThe emergence of biopharmaceutical sector has raised many hopes for treating intractable diseases, widening access and equity leading to sustainable development. After having analysed the development of generic drug industry in order to foresee the trends in the evolution of the global biosimilar industry, it seems that the biosimilar industry is expected to face similar challenges but in different socio-economic, political, regulatory and technological climate. Several new actors have emerged from the developing countries intensifying the competition and the need to form networks of many kinds. In particular, the following observations are made:• As in the case of the generic industry, the R&D efforts will not be

dampened as the biosimilar manufacturers will have to engage in biobetters.

• There is evidence of producing biosimilars at much lower prices than estimated by some of the developed country analysts. This widens the access, but beneficiaries seem to be high-income groups in the local as well as export markets.

• The process of biomedicalisation widening the medical gap will intensify with increasing enmeshing of emerging technologies and globalisation.

• The role of institutions will assume a more significant role in improving the health outcome by linking the biopharmaceutical innovations with socio-economic and health management to achieve more inclusive growth.

Endnotes1 The biotech industry has undergone structural change in the last three decades. In the

early 1980s, BioAgri was the most dominant segment. Currently, BioPharma consists of 62 per cent (Rs. 12,679 crore) and remains the most dominant segment. BioAgri is the third biggest segment with a 15 per cent share (Rs. 3,050 crore) and the growth is currently saturated (Desai 2014).

2 The WHO has prioritised neglected tropical diseases (NTDs) that are endemic in

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149 countries and affect more than 1.4 billion people, costing developing economies billions of dollars every year. These diseases as listed by the WHO are Buruli ulcer, Chagas disease, dracunculiasis, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, schistosomiasis, Taeniasis/cycsticercosis, Trachoma, soil-transmitted helminthiases and yaws as well as zoonotic diseases such as anthrax, brucellosis, cysticercosis, echinococcosis as well as Dengue, chikungunya and rabies. Recent addition to this list is scabies (WHO, 2015) and mycetoma.

3 Pfizer withdrew from a US$ 350 million biosimilar insulin deal with Indian biotech company Biocon.

4 Reference prices are price limits on certain pharmaceutical substance groups. They determine the maximum amount statutory health insurance providers will pay for a pharmaceutical of a certain substance group. The reference price group system was introduced by the Healthcare Reform Act (Gesundheitsreformgesetz, GRG) in 1988 to ensure long-term controls on increasing expenditures for pharmaceuticals. It is solely an instrument for regulating prices and does not place any restrictions or exclusions on prescriptions. According to a statement by the Central Federal Association of Health Insurance Funds in 2012, reference price grouping has resulted in annual savings of around 5.8 billion euros in expenditures on pharmaceuticals. If a pharmaceutical company does not lower the price of a pharmaceutical to the reference price of the group the drug is classified under, insured persons must pay the price difference themselves.

5 Convention on Biological Diversity, 1992 and The Nagoya Protocol on Access and Benefit Sharing, 2014.

6 Pharmaceutical Products (49): Argentina, Australia (where the Commissioner can refuse to grant a patent where the product is a mere mixture of known ingredients), Bolivia, Brazil, Bulgaria, Canada (unless produced by processes also claimed or their equivalents), Chad, China (if obtained by chemical processes), Colombia, Cuba, Czechoslovakia, Ecuador, Egypt (as regards chemical inventions), Finland, German Democratic Republic, Ghana, Greece, Hungary, Iceland, India, Iran, Iraq, Lebanon, Libya (as regards chemical inventions), Malawi, Mexico, Monaco, Mongolia, Morocco, New Zealand(where the Commissioner can refuse a patent where the product is a mere mixture of known ingredients), Norway, Pakistan, Peru, Poland, Portugal, Republic of Korea, Romania, Soviet Union, Spain (until 1992), Syria, Thailand, Tunisia, Turkey, Uruguay, Venezuela, Vietnam, Yugoslavia, Zambia (where the Registrar can refuse a patent where the product is a mere mixture of known ingredients), Zimbabwe (where the Registrar can refuse a patent where the product is a mere mixture of known ingredients).

7 The term biobetters was coined by Mr. G V Prasad, CEO of Reddy’s Laboratory in 2007 and is being widely used since then.

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© 2016, RIS.

Jacob Kalle*Haribabu Ejnavarzala**

Moratorium on Genetically Modified Brinjal in India: Is Evidence-Based Policy making An Adequate Framework?

Abstract: Citizens and their organisations in liberal democratic countries criticise public policies as they have little or no knowledge as to what goes into the public policy making. In this context, questions like what is the nature, origin, status and relative influence of evidence from different sources in the decision-making process assume centrality. The present paper addresses these questions by focussing on the decision of the Government of India in 2010 to impose moratorium on the commercial release of GM brinjal. The present study is ex-post facto analysis of proceedings of the public consultations held in seven cities by the then Minister of State for Environment, Forests and Climate Change (MoEF&CC), Government of India and other sources of data which the Minister made use of in announcing the moratorium. The study explores the interpretation that was given to evidence-based policy making by the Government of India represented by the MOEF&CC. On the basis of the findings, the study argues that the scientific evidence provided by the relevant regulatory committee to the Minister for commercial release was seen by the Minister as inadequate for evolving a policy which has economic, social cultural and environmental implications. The study clearly shows that the evidence-based policy making, based on positivist/empiricist methods has epistemological limitations to deal with socio-economic considerations which are linked to values. The study proposes that the Post-Normal Science (PNS) provides an alternative framework which recognises the significance of fact-value interrelations in the analysis of dynamic interaction between science and society. Keywords: Evidence-based Policy making, Genetically Modified Brinjal, Post Normal Science

* Consultant, Indian Council of Social Science Research (ICSSR) Southern Regional Centre (SRC), Hyderabad. Email: [email protected]

** Professor of Sociology (Retired), University of Hyderabad, Hyderabad, and Adjunct Senior Fellow, RIS. Email: [email protected] and [email protected]

The authors would like to thank Dr. PVS Kumar, Scientist (Rtd), National Institute of Science Communication and Information Resources (NISCAIR) for giving valuable inputs and constructive feedback on the paper and we also owe a great deal of appreciation and gratitude for the staff of the Centre for Environment Education (CEE) Ahmedabad for extending their support in providing us with all the data pertaining to National Consultations on GM brinjal.

IntroductionIn the context of making a policy relating to technology choice and its adoption, policymakers tend to depend on inputs from scientific experts


on pertinent issues like risk assessment and risk management. The trust in scientific assessment is based on their belief that scientific experts have theoretical and methodological wherewithal to evaluate the risk objectively and suggest strategies that minimise the risk. The scientific experts in turn depend on positivist and empiricist methods to quantify observations regarding risk and build probabilistic models to arrive at conclusions on level of risk and/or economic costs. The scientific community believes that these models provide hard, reliable, objective and adequate evidence, on the basis of which the community recommends a model that in its value framework is least risky. The paper makes use of the evidence-based policy (EBP) to examine the dynamics of policy making with respect to commercial introduction of Bt-brinjal in India over the last one decade and delineates its limitations. The paper attempts to explore the potential of Post Normal Science (PNS) as an alternate framework to look at the interaction between science and public policy. The main objectives of the paper are to:

• briefly describe the dynamics of the policy making with respect to commercial introduction of GM Brinjal in India;

• critically evaluate the adequacy of the evidence-based policy making in context of public controversies regarding technology choice and adoption; and

• appraise Post Normal Science (PNS) as an alternative framework which overcomes the limitations of the EBP.

Materials and MethodsThe proposal to introduce GM brinjal, the first genetically modified vegetable in India, has generated extensive debate across the country. The present study is an ex-post-facto analysis of the decision making process to impose moratorium on commercial release of GM brinjal by the Government of India. For the present study proceedings of public consultations held during 2010 in seven cities constitute data. The data is in the form of statements/concerns expressed by a cross-section of stakeholders.

The Centre for Environment Education (CEE), an autonomous organisation engaged in environmental and sustainability education based in Ahmedabad, Gujarat, was entrusted with the task of organising and

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facilitating these consultations and also to summarise the proceedings of the consultations. The concerns that the different stakeholders expressed at consultations, as mentioned above, constitute the database for this study. Proceedings of the public consultations, as summarised by the CEE from the public consultation werein the form of 631 transcribed propositions made by a cross-section of stakeholders on various themes (CEE 2010). The CEE shared the documents connected with the public consultations and other relevant reports with the authors of the present study. In other words, the propositions, arrived at on the basis of public consultations in which several stakeholder groups participated in multiple locations, constitute multiple sources of evidence or testimonies that enhanced the representative character of public consultations and evidence gathering by the government (Kalle 2015).

For the purpose of the present study, these propositions were analysed using the coding method. The present study also examined the other strands of evidence considered by the Minister of State for Environment, Forest and Climate Change (MoEF&CC) to arrive at the moratorium decision on GM Brinjal and these include: (a) the Report of the Expert committee II of the Genetic Engineering Approval Committee (GEAC); (b) views of the independent scientists from India and abroad on risk assessment; (c) views from the state/regional governments, and (d) other kinds of evidence. Various other unpublished reports pertaining to the GM brinjal were also reviewed for the study.

Techniques of Data AnalysisIn qualitative research, coding is the process of reviewing/transcribing/synthesising and dissecting field notes, while maintaining the relationship between the parts, which is the essence of qualitative data analysis (Miles and Huberman 1994). Codes are “tags or labels for assigning units of meaning to the descriptive or inferential information compiled during a study” (Miles and Huberman 1994: 56). In general, there are three methods for creating codes for qualitative data: (a) the a-priori approach; (b) the inductive approach; and (c) one that lies between the first two approaches. Inductive approach (Lofstedt 1996; and Chong 2005) was used for this study. The unit of analysis was a sentence, or a multi-sentence chunk. The 631 transcribed propositions compiled in the CEE report were reviewed

Moratorium on Genetically Modified


line-by-line. Thematic categories, or codes, were created for each statement/concern, or multi-sentence chunk, until a ‘saturation point’ was reached, that is, until the responses of all the stakeholders were exhausted (see Miles and Huberman 1994). Frequencies were developed for each theme, depending on the number of times that it recurred in the data.

GM Brinjal: Dynamics of the Policy making in IndiaThe levels of acceptance of GM food varies across the world. In USA, the GM food crops have become part of the agriculture commodities and are consumed by public. In Europe, there is resistance against GM food (Gaskell et al. 1999). The GM debate entered the public sphere in India on 26 March 2002, when the Genetic Engineering Approval Committee of India (GEAC) recommended for the commercial planting of GM Cotton. As mentioned earlier, GM cotton is the only GM crop that was approved for commercial cultivation in India. The area under Bt Cotton increased from 29,307 hectares in 2002 to an estimated 6.2 million hectares by 2007. In 2012, India cultivated a record 10.8 million hectares of GM Cotton with an adoption rate of 93 per cent (James 2012).

Regarding the brinjal, India accounts for 26 per cent of the world eggplant production next only to China that accounts for 59 per cent (Indian Horticulture Database 2010-11). Brinjal is an important vegetable in the cuisine of all regions of the country and is consumed regularly in various forms on various occasions including religious occasions. It is also used in the preparation of Ayurvedic medicines. Given the significance of this vegetable in the cuisine and the consequent market potential, the company which has proprietary rights over the Bt protein has been trying to seek the approval of the Government of India for commercial introduction of genetically modified brinjal with Bt protein to provide resistance against the Fruit and Shoot Borer (FSB) to minimise yield losses. The nature and control over the technology generated a public debate around GM brinjal in India. In the following paragraphs, we will provide a brief account on the regulatory process that sought to evaluate the GM brinjal for recommending to the government for commercial release.

Following the commercial release of GM cotton, the attempt to seek approval for commercial release of GM brinjal was initiated in the year 2002.

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In 2004, the Review Committee on Genetic Manipulation (RCGM)1 gave its approval for the multi-location trials of seven varieties of GM brinjal developed by Mahyco (a subsidiary of Monsanto). Based on the results, RCGM recommended to the Genetic Engineering Approvals Committee (GEAC)2 for large-scale trials. During 2006, Mahyco, submitted bio-safety data to the GEAC and sought permission to conduct large-scale field trials of GM Brinjal which has Bt toxin on which the company, as mentioned earlier, has a proprietary control. The GEAC posted the data on its website and invited comments from public. Civil society groups raised a number of concerns over Mahyco’s bio-safety dossier. In order to address these concerns, the GEAC constituted an Expert Committee (EC-I). The EC-I felt the need for conducting more studies, however, recommended that large scale trials be allowed. The GEAC directed, the Indian Institute of Vegetable Research (IIVR) to carry out the trials of Mahyco’s GM brinjal at various research institutes across the country. The trial results, submitted by IIVR in 2009, raised several concerns regarding safety and lack of longitudinal trials among national, international experts and Civil Society Organisations (CSOs). In response to the public protest, the GEAC constituted a second expert committee, i.e. Expert Committee-II (EC-II) to examine the biosafety data submitted by the IIVR and address the concerns of various stakeholders. The EC-II in its report submitted to GEAC on 8 October 2009, recommended that GM brinjal was safe for environmental release. The committee stated that “the benefits of GM brinjal event EE-I developed by M/s Mahyco far outweigh the perceived and projected risks”.

Based on the review of EC-II report, within a span one week, on October 14, 2009, the GEAC recommended GM Brinjal for commercial release. But, on the issue of Bt-brinjal the GEAC in its 97th meeting held on 14 October 2009 observed that “ ....as this decision of the GEAC has very important policy implication at the national level, the GEAC decided that its recommendation for environmental release be put up to the Government for taking a final view on the matter”. However, the public release of the EC-II report evoked a sharp response from a variety of stakeholders including small and marginal farmers and CSOs. To enhance the transparency the then Minister of Environment and Forests Mr. Jairam Ramesh posted all the reports on the Ministry’s website and invited comments from the public by December 31, 2009.



The Minister realised that comments from farmers and their organisations, CSOs, consumer organizations and industry and public at large indicated that there was no consensus on the commercial introduction of GM brinjal. The Minister then resolved to gather evidence from more sources - nationwide public consultations, views of the state/regional governments, views of independent scientists from India and abroad to enlarge the evidence base. On the basis of the review of evidence/views from multiple sources, as mentioned above, on February 10, 2010, the Minister, through a detailed nineteen page ‘speaking order’3 overruled the recommendations of the statutory Genetic Engineering Approval Committee (GEAC) and imposed a moratorium on the environmental release of GM brinjal“till such time independent scientific studies establish, to the satisfaction of both the public and professionals, the safety of the product from the point of view of its long-term impact on human health and environment…..” (Ministerial Note, MoEF 2010:17).

Findings and DiscussionAs mentioned above, the primary thrust of the present paper is an ex-post facto analysis of the decision making process based on multiple sources of evidence that have gone into the moratorium decision on GM brinjal in India.

Findings from the Proceedings of the Public ConsultationsThe Minister, in his considered view, as mentioned above, felt the need to enlarge the evidence base, by organising public consultations with the stakeholders across the country in seven locations. With the objective “to arrive at a careful, considered decision in the public and national interest”(Ministerial Note, Para 2, MoEF 2010:1). He further stated “This decision will be made only after the consultations process is complete and all stakeholders are satisfied that they have been heard to their satisfaction” (Ministerial Note, Para 2, MoEF 2010:2).

As per the registration records, about 5920 people belonging to differentstakeholder groups participated in the national consultations across seven locations. As mentioned above,the deliberations of thestakeholders in the national consultations on commercial release of GM brinjal are summed up in 631 propositions. Out of 631, 538 (85 per cent) propositions were against the introduction of Bt brinjal, the remaining 93 (15 per cent) were in support of GM brinjal (Kalle 2015).

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The analysis of the public consultation data indicated that in addition to the health and environmental risks, a wide range of socio-economic, cultural, moral and religious concerns deeply connected to values and beliefs and concerns related to regulatory process also were voiced.

The statements/concerns voiced by those who were opposed to the introduction of Bt brinjal brought out the consequences of adoption of propriety technology for access and affordability; the right to make choice, the right of farmers to save the seeds, sustainability and food security. Further, those who opposed the introduction of Bt brinjal also expressed concerns regarding health risks, especially for children and pregnant women, because of the uncertainties associated with chemicals, such as anti-biotic resistant markers, used in the process of production of GM Brinjal seed. Other concerns on flaws and shortcomings of existing regulatory mechanism which included: lack of an independent testing mechanism for bio-safety, absence of long term tests; lack of transparency, conflict of interests, lack of confidence in the competence and integrity of the Risk Regulating authority, issues regarding IPRs, bio-piracy, absence of post release surveillance and monitoring, absence of a Liability and Compensation mechanism, absence of labelling mechanism, and so on. Some of the summary propositions made by the public are mentioned below:

“The environmental risk, relevance of technology and socioeconomic impacts must be critically looked into prior to approval of commercialization of such crops.” (Proposition No.22CEE, 2010: 67)

“The need for a particular new technology must be discussed right in the beginning when it is proposed by a promoter. If after thorough research, no traditional or alternate solution can be discovered, only then should permission for research be given to the promoter of the concept.” (Proposition No.17 CEE, 2010: 66)

“A system of public participation in decision-making and in regulatory bodies must be put in place.” (Proposition No.34 CEE 2010: 67)

In view of the above concerns, the public demanded a precautionary approach (Principle 15 of the Cartagena Protocol, to which India is a signatory) and upstream4 public engagement prior to the approval of GM crops which the EC-II of the GEAC failed to do.



In the absence of a robust, context based regulatory framework, the GM seed production may gloss over several important health and environmental considerations. In this context, Purkayastha and Rath (2010:48) point out that in the context of GM Brinjal debate, the critical issue concerning the decision to introduce GM crop is not whether or not GM crops are without risks, but whether the regulatory protocols developed and used for evaluating risk are sufficient, or not, in relation to the Indian context. The foundation for framing of issues are intimately related to their interests, meanings, values and beliefs. For the biotechnology industry/Scientists, life forms or parts thereof, such as the seed (irrespective of whether the seed is a hybrid or genetically modified seed), constitute the raw material or physical means of production, whereas for farmers the seed is bio-cultural resource that has been conserved in situ over centuries and for other sections in the society life forms carry religious and aesthetic meanings (Haribabu 2004). Food is a cultural marker and food choices are framed by cultural, social, and material circumstances (Draper and Green 2002). The reductionist approach adopted by the dominant risk discourse reduces all socio-economic considerations (SECs) involved in the governance of emerging technologies to questions of risk (Chaturvediet al. 2012). A decision on the acceptable level of risk is always a negotiated outcome mediated by power relations among the actors and the institutions they represent (Haribabu 2004). In this context, Purkayastha and Rath (2010:45) argue that the problem is not with the GM technology per se, but with the ownership over the technology. According to Kaiser (2005), knowledge about the frequency and probabilities of the impacts, it is necessary to judge what is considered as an acceptable level of risk. Therefore, the decision-making on the novel technologies need to move beyond evaluating bio-safety, as defined by scientific experts to include human and environmental safety and cultural preferences of food.

Maasen and Weingart (2005: 4,10) refer to public participation in technical decision-making as the ‘democratisation of expertise’. By holding a public consultation and also approaching the state governments prior to the decision on GM brinjal, the Minister tried to adhere to Principle 10 (public consultation) of the Cartagena Protocol to which India is a signatory. Visvanathan (2014) argues that the public consultations on Bt-Brinjal in India actually strengthened the democratic process. “Public consultations are mandated in the Cartagena Protocol, to which India is a signatory. The

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Environment Minister is right in setting a precedent like this”, observed Kavitha Kuruganti (DNA 2010).

Evidence from Extended Scientific Peer CommunityThe analysis of the scientific evidence gathered by the Minister to enhance the evidence base in the wake of the debate, clearly shows that there was no consensus within the scientific community about the health and environmental safety of the GM brinjal. The outcome of tests that were conducted on GM brinjal became a major cause of difference of opinion among scientists. While some believed that the tests were abundantly sufficient, others felt that they were absolutely inadequate. For example,the Minister in his Ministerial note stated that “Another fact brought to my attention is that an expert committee set up by the GEAC in 2006 (EC-I) had asked for several tests to be conducted but one-third of the EC-II members who were also members of EC-I chose to discard the need for these studies while evaluating Bt-brinjal as EC-II….”(Ministerial Note, Para 14, Pp: 8-9).

The Minister also consulted several national and international experts, well known in the relevant field, who highlighted several flaws in the scope and adequacy of the Expert Committee-II Report in its evaluation of the environmental and health risks. Ten out of the 18 scientists from abroad, who made submissions to the MoEF, opposed the GM Brinjal. In the Indian context, 10 out of 26 submissions opposed the GM brinjal and 16 supported (Shah 2011:31). Apart from the above, seventeen noted scientists from different countries addressed a joint letter to the Prime Minister on February 8, 2010 giving scientific reasons against the release of GM brinjal (Ministerial Note, MoEF 2010:10). They highlighted several flaws in the Expert Committee-II report in terms of scope and adequacy of the report in evaluating health and environmental risks. Some of the important concerns raised by the experts were: gene flow to wild relatives resulting in threats to brinjal diversity, chronic toxicity, sustainability, lack of labelling, lack of an independent regulatory system, farmers’ dependence on companies, not following the international standards in biosafety (Kalle 2015). There were also a difference of opinion among the R&D organisations of the government, namely, Indian Council of Agriculture Research (ICAR), Department of Biotechnology (DBT), Director-General of Indian Council of Medical Research (DG-ICMR) and Drug Controller to Government of India



(Ministerial Note, MoEF 2010:12). In this context, it is worth mentioning that the review of the global studies5 listed on GM food indicate no evidence of health and environmental safety of GM food. Concerns raised by these studies have not been satisfactorily addressed and have not been followed up by targeted research that could confirm or refute the initial findings. Further, the instances of deep division, lack of transparency, conflict of interests among the Expert Committee members cast doubts on the ability of experts and veracity of scientific advice to provide complete answers to the policy questions. Further, it was pointed out by some NGOs that some of the members of the Expert Committees (EC-I&II) were recipients of research grants from the companies which were promoting GM Brinjal indicating a conflict of interests (Sridevi Seetharam 2010). In other words, there seems to be an alliance between the professional interests of scientists involved in the regulatory process and the promoters of Bt brinjal.

The above analysis clearly indicates the inability of scientific expertise to provide unambiguous and complete answers to policy questions (Alam 2011:111). As mentioned above, policy questions have to take into account not only scientific evidence but also values relating to economy, polity and culture.

Evidence from Extended External Peer Community

Views of the State governmentsIn India, agriculture, being the subject under the purview of the state/regional governments, the Minister sought the views of the State governments on GM brinjal. The analysis indicates that several states, including major brinjal growing states6 have expressed their reservations on GM brinjal. More than 10 States cutting across political affiliations formally communicated to the Minister in 2009-2010 that they would not permit GM brinjal to be released in their regions (Ministerial Note, MoEF 2010:4-5). They expressed concerns on different grounds and called for extreme caution in the matter. While some states disallowed field trials, other states decided to prohibit environmental release of all GM crops to keep their states totally GM free (Ministerial Note, MoEF 2010:4-5).

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Other Kinds of EvidenceThe process of consultation threw up the following issues which in the minister’s view were germane to evolve a robust policy: (a) role of the Judiciary; (b) implications for biodiversity; (c) alternative pest management strategies; (d) Need for a demand driven intervention rather than a supply driven one; (e) inadequate Biosafety tests and lack of independent laboratories; (f) implications for farmers’ autonomy in the choice-making; (g) violation of global regulatory norms, and (h) difference of opinion among line departments. The Minister’s decision took into account the need to empirically examine the above mentioned issues in greater detail.

The judiciary’s role can be seen as an independent and a parallel oversight mechanism to the regulatory process, where citizens can directly appeal .In this context, NGOs played a critical role in highlighting several deficiencies in the GEAC’s regulatory framework. The Minister also referred to the Public Interest Litigation (PIL) filed by the NGOs in the Supreme Court during 2005, to uphold transparency and accountability in the functioning of the GEAC where theMinister said “......Clearly, the decision on Bt-brinjal has to take note of this PIL, that has already been filed”(Ministerial note MoEF 2010:15-16). A 5-member Technical Expert Committee (TEC)7 was appointed by the Apex Court of India in the Writ Petition (Civil) No. 260 of 2005. On July 22, 2013, The Technical Expert Committee (TEC) in its final report has recommended an indefinite moratorium on open field trials of GM crops till the deficiencies in the regulatory and safety systems are effectively addressed and also recommended for mandatory stakeholder participation as part of risk-management strategy.

In addition, he referred to one of the Supreme Court’s decision in A.P. Pollution Control Board vs. M.V.Nayudu (1999(2) SCC718) case, where it invoked the Precautionary Principle as a guiding instrument in environmental decisions by relying on the following:

“There is nothing to prevent decision-makers from assessing the record and concluding there is inadequate information on which to reach a determination. If it is not possible to make a decision with ‘some’ confidence, then it makes sense to err on the side of caution and prevent activities that may cause serious or irreparable harm. An informed decision can be made at a later stage when additional data is available or resources permit further research”.



With regard to preserving the Brinjal diversity8, the Minister pointed out that the diversity-rich regions were likely to experience difficulties in conserving Brinjal diversity by the introduction of Bt-Brinjal due to gene flow. “The loss of diversity argument cannot be glossed over, especially when seen in the light of the experience we have had in cotton where GM Cotton seed has overtaken non-Bt seeds,” said the Minister (Ministerial Note, MoEF 2010:15). Further, the commercial interests of the company that controls technology tend to undermine brinjal diversity by promoting its own products over time.

The Minister considered viable alternatives to control/manage pests as one of the important factors when he pointed out, “Bt-biotechnology is not the only route for reducing pesticide use”. In this context he referred to Non-Pesticide Management (NPM) initiative that was being implemented in the erstwhile state of Andhra Pradesh for its replication on a large scale. In the combined Andhra Pradesh state around 6 lakh farmers are fully practicing Non-pesticide management (NPM) in about 20 lakh acres. “The advantage of NPM is that it eliminates chemical pesticides use completely, whereas Bt-technology only reduces the pesticide spray, albeit substantially,” said the Minister (Ministerial Note, Para 9, MoEF 2010:5).

Lack of Independent laboratories, or the failure/lack of state-of-the-art technologies/equipment in the public R&D institutes to evaluate the safety of the GM crops is another important factor that figured in the Minister’s decision. Keeping in view the importance of Brinjal, which is an item of almost daily consumption of most of the Indians, the Minister felt that the kind of testing done “is not specific or stringent enough to detect toxins”(Ministerial Note, MoEF 2010:5).

The Minister also stressed the endowments of the differentiated farming community, in terms of size of land holdings, education and access to information. There is need to empower the farming communities through participation in the policy-making (Ministerial Note, MoEF 2010:13). Therefore, the Minister stressed the importance of public investment in bio-technology for agriculture. “Public sector products need to be introduced first, if at all, going by the Bt-Cotton experience,” said the Minister (Ministerial Note, MoEF 2010:13).

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The Minister also took into account the need for adherence to Global Regulatory Norms9 pertaining to risk assessment of GM crops, particularly the provisions pertaining to precautionary approach and public consultations prior to the release of GM food crops, he said:“It does appear that the current standards by which the GEAC has formulated the decision to approve Bt-brinjal do not match these global regulatory norms to which India is a party”(Ministerial Note, MoEF 2010:9-10).

At the end of this highly participatory process and relying on the Precautionary Principle, Mr. Jairam Ramesh ordered a moratorium on the commercial release of GM brinjal on 9 February 2010. The moratorium will last,as mentioned earlier, “till such time as independent scientific studies establish, to the satisfaction of both the public and professionals, the safety of the product from the point of view of its long-term impact on human health and the environment, including the rich genetic wealth existing in brinjal in our country,” said the Minister (Ministerial Note, MoEF 2010:17). And the approach outlined above, according to the Minister “is both responsible to science and responsible to society” (Ministerial Note, MoEF 2010:18).

As mentioned above, in the context of lack of consensus among stakeholders the Minister sought to enlarge the evidence base. The Minister, in addition to taking into account the concerns as reported in the above findings of the study, also gathered evidence/ views from other sources both internal to the world of science and external to the world of science to enlarge the evidence base in line with the broad definition adopted by the UK Cabinet Office in its 1999 White Paper on Modernising Government (Cabinet Office 1999a). Therefore, GM brinjal debate in India is an example where the government has realised that decisions on techno-scientific developments can no longer be made by a technocratic model (Millstone 2007) as they are intimately linked to economic, social and cultural domains that are embedded in a system of values.

Critical Appraisal of Evidence-Based Policy MakingMost of the ‘evidence-based policy’ theorists emphasise that positivist ‘scientific evidence’ is objective, reliable and context-independent, which is perhaps the weakness of this genre of literature.10



Evidence-Based Policy making model does not recognise the significance of the local contingencies in particular and context-dependent interaction between the science and society especially in the context of interaction with the organic world.

The raw ingredient of evidence is information related to the selected question that needs to be answered. Good quality policy making depends on answers to questions based on adequate, reliable and high quality information related to the questions. The empiricist/positivist theory of knowledge tends to answer these questions by following the inductive method: observations-verification – generalisation, which cannot exhaust all contexts. That is why probabilistic models are resorted to. The probabilistic models also cannot factor in all possible factors and contexts.

It appears that the Expert Committee-II recommended for the commercial release based on the evidence gathered at a given point in time or cross-sectional data rather than time-series data on trials. One important factor that has to be taken into account is the host-pest interactions as they are co-evolving organisms. As the host equips itself to fight the pest, the pest adapts itself to the changed host’s condition. This can only be understood over time and hence the need for time series data. In fact, the recent introduction of the second generation Bt cotton seed by Mahyco is based on the report of the company’s surveillance staff that the Bollworm has developed resistance against Bt toxin in the first generation Bt cotton seed. This was noticed after five or six years. The EC-II did not factor in the dynamic host-pest interaction over time. The strategy of maintaining refugia planted with traditional varieties to postpone the resistance in the insect pest was found to be operationally challenging and economically unviable given the majority of cotton growers are small and marginal farmers and tenants.

Further, the production of knowledge and its application is a socio-technical process involving a complex interplay of interests, values, beliefs and meanings and technology has to be seen in relation to larger questions of justice and equity, rather than merely as a technical fix (Haribabu 2004). According to Levitt (2003), interests and values are powerful determinants of evidence, policy and practice, even when they are partly hidden from view. He further argues that the scientific evidence has been mostly of little use to provide solution to policy question, in the context of competing

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interests and ideologies. Similarly, the ‘4Is’ framework developed by Weiss (1995) identifies information, interests, ideologies and institutions as key to policy and practice.

The positivist epistemology makes a clear distinction between fact and value. The logical positivist dictum is: “we cannot deduce what ought to be (values) from a description of what is (facts). We should move from a description of what is to what ought to be as we are dealing with norm/rule based ‘institutional facts’ as against tangible facts. For example, a decision on the acceptable level of risk involves, as mentioned earlier, an interplay of values and the outcome is trade-off among competing and sometime conflicting values held by the actors and the institutions and the values they represent and power relations that mediate their interaction. EBP framework should not be considered as a universal and nomothetic model. Several scholars critically reflected on the interrelations between evidence, policy and practice. Nutley (2003:3) argues that policy-making is neither objective nor neutral; it is an inherently political process and it is important to acknowledge that scientific evidence is but one of many factors that influence the policy process. Thus, Levitt (2003) observes that policy making is not necessarily a rational process of assessment leading to action, and better quality evidence does not necessarily produce better quality policy or practice. A. Glover, former Chief Science Adviser of the President of the European Commission, in a critique of science’s use for policy, points out that too often evidence based policy turns into its opposite, policy based evidence and seeks for a more rigid separation of science and policy (Wildson 2014).

The interpretation of EBP by the Minister of MoEF&CC in contrast to the positivist/empiricist model of EBP is an enlarged one and context dependent one.

For instance, the UK government, as part of its move towards modernisation, in a White Paper in 1999 (Cabinet Office 1999a) adopted a very broad definition which includes not only just expert knowledge and published research, but also the outcomes of stakeholders’ involvement and consultations (Cabinet Office 1999b). The UK Cabinet Office defined the evidence as “expert knowledge; published research; existing research; stakeholder consultations; previous policy evaluations; the Internet;



outcomes of consultations; costing of policy options; output from economic and statistical modelling” (Cabinet Office 1999: 33). The breadth of what is considered as evidence is, therefore, wide and dynamic (Shaxson 2005). In the Indian context, the Minister’s interpretation of Evidence Based Policy (EBP) Making is much broader based than the conventional EBP model.

The paper argues that the decision on moratorium was based on an understanding of the interrelations between the science of Genetic modification on the one hand and economic, social, cultural, health and environmental factors on the other. As they are interrelated, variation in one factor would bring changes in other factors by certain magnitude and direction. In a sense the decision recognised the concomitant variation. In this context, Saltelli and Giampietro (2015) argue that evidence based policy has to be replaced by robust policy, where robustness is tested with respect to feasibility (compatibility with processes outside human control); viability (compatibility with processes under human control, in relation to both the economic and technical dimensions), and desirability domain (compatibility with a plurality of normative and value considerations relevant to a plurality of actors).

The fact that the people are questioning the “scientific evidence”, implies that the notion of evidence has to be interrogated, especially in the context of science-society interface. The PNS does talk about the quality of evidence rather than the scientific truth.

ConclusionThis study attempted to give a brief account of the dynamics of GM food policy in India and used the EBP and examined the moratorium decision of the government by deploying extended EBP.

The debate around the proposal to introduce GM brinjal in the Indian context indicates that the public in India seems to argue for an integrated/holistic view, rather than a reductionist one, about the GM food crops. The policy process regarding the moratorium decision on GM Brinjal indicates that the credibility of one group is not adequate and similarly evidence from scientific assessment alone is inadequate, since the scientific community itself may go by its professional interest structure. The conventional evidence-based policy-making tends to privilege evidence provided by positivist science.

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The findings of the study suggest that the policy-making process with respect to GM brinjal in India sought to enlarge the evidence base, by including multiple sources of evidence and from multiple locations: farmers, civil society organisations, consumers, scientific experts, political and elected bodies members, Industry, environmental groups, government officials, students and researchers, and so on. The Minister had used evidence from wide-ranging sources and not just hard research, in line with the broad definition adopted by the UK Cabinet Office in its 1999 White Paper on Modernising Government. Therefore, the Government of India understood the importance of science, transparency and public participation in its decision-making process to enhance the representative character of the evidence. This is an exercise in democratising science.

The instant study showed that one should go beyond the positivist science, since the relevant social groups – end users of technology, and consumers of products made by using the technology – perceive technology in various ways, depending on their interests and meanings.The process of technology development involves a dynamic interaction among diverse interests and systems of meanings and the consequent diversity in interpreting a technology. The closure of the diverse interpretations has to be achieved through a continuous and iterative engagement with diverse stakeholders.

Here, the issue is not only limited to whether to accept or reject Bt brinjal, but that the entire GM approach to agriculture must be debated. It should not be accepted just because Bt gene is available for licensing. A thorough ‘Needs Assessment’ must constitute the first step. Is Bt brinjal really needed? Which problem in agriculture does the transgenic crop attempt to address? Are there alternative approaches? Has the breeding of brinjal based on exploring the variability in the primary gene pool of brinjal been exhausted? What are the public apprehensions on GM brinjal? And how to go ahead with GM food crops? The above questions assume significance in the light of the fact that at present there are many food/non-food GM crops under the regulatory pipeline at various stages. According to one estimate, of the 91 applications for field trials before the GEAC, 44 are GM food crops (GAIN IN 3083). The genetic engineering technology has to be resorted to after comparing its superiority over the efficacy of



existing practices such as NPM and developing open pollinated varieties instead of hybrids.

The study also realises that EBP has limitations as it does not include the value domain in the analysis of issues related to science-society interface. Our Study revealed that Evidence Based Policy (EBP) where evidence meant expert knowledge based on the predictive methods, i.e. risk assessment, cost-benefit analysis, has limitations as the Evidence-Based Policy making does not build in qualitative dimensions relating to values and culture in the model. The notion of evidence has to be redefined in the context of science-society interaction that is very dynamic. Merely lab based evidence is inadequate for interventions when they are applied in real field situations as real field situations have both physical and social dimensions and hence are more complex to control. It is in this context Post Normal Science (PNS) seems to offer an alternative framework to deal with facts and values, risk and uncertainties where “facts are uncertain, values in dispute, stakes high and decisions urgent” (Funtowicz and Ravetz, 1991, 1992, 1993).

PNS contextualises the analysis to understand the dynamics of conflicting interests and values of the different groups through the ‘extended peer community’ process which upholds the values of democratic norms and transparency in decision making on the technological choices. Under such circumstances, scientific and technical discourse is no longer restricted to expert communities, but needs to be inclusive of non-specialist participant stakeholders (Funtowicz and Ravetz 1993). In such a participatory arena, scientific evidence is one of many sources of evidence, which together informs policy decisions. Here, the PNS approach emphasises two aspects, firstly to test the scientific knowledge for its validity and reliability and secondly, the same knowledge also to be tested for its social robustness that takes into account the values. Therefore, the knowledge production is to be organised in a way that guarantees scientific quality and increases the social robustness at the same time. Thus, PNS foregrounds an important risk management approach in policy decisions on emerging technologies. Here, one moves from ‘speaking truth to power’ towards ‘working deliberately within imperfections’ (Funtowicz and Ravetz, 1990, 1993; van der Sluijs et al., 2008;).11 However, the post normal science paradigm has a promise and it is a theory in the making to evolve a model of governance that is robust and addresses the specificities of different contexts in the contemporary

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world.Application of this framework in different contexts will enhance the robustness of PNS framework. In the present study, we used some concepts – extended peer review both internal to the world of science and external to the world of science – of PNS as sensitising concepts. The PNS model recognises that in today’s context, technological policy choices cannot be left to the exclusive domain of scientific expertise, which has its own value system, as the choices have to consider the values associated with the economy and culture. The PNS model motivated by precautionary and participatory approach is appropriate where the scientific uncertainties and conflicting values and interests are openly acknowledged in decision making on the choice of emerging technologies. The democratic norms and transparency are the guiding norms of this approach. It is in this context, the peer review has to be extended beyond the internal world of science to the external world of science to find solutions to the real world problems which vary across time and space.

Endnotes1 The Review Committee on Genetic Manipulation (RCGM), the regulatory body in the

Department of Biotechnology, Ministry of Science and Technology of the Government of India, is concerned with laboratory research, green house experiments, contained field trials and multi-location field trials.

2 In India, the GEAC of the Ministry of Environment and Forests (MoEF) is a statutory body under Rules 1989 of the Environment (Protection) Act, 1986 mandated to regulate the GM crops for the bio-safety and for human consumption. The GEAC is responsible for granting approvals to large-scale field trials, experimental seed production and commercial release by deregulation.

3 The fact of the Speaking order is that it is a detailed written note on the evidence used or citing main reasons for arriving at a particular decision.

4 Zavestoski et al. (2002) and Rowe et al. (2005) argue that upstream public engagement is seen as an opportunity for social values to be disclosed, debated and consciously incorporated into technological development before particular trajectories and attitudes become set. Early public engagement is, therefore, thought to enable a more reflexive and socially robust techno-scientific development.

5 See, for example, Domingo and Bordonaba (2011), Diels et al. (2011), Dona, and Arvanitoyannis (2009), Séralini et al. (2012), Séralini et al. (2013), Hilbeck and Schmidt (2006), Marvier et al. (2007), Zhao et al. (2010), and Hilbeck et al. (2011).

6 West Bengal and Orissa account for 30 per cent and 20 per cent, respectively, of India’s brinjal production. Major brinjal growing states, namely, West Bengal (30 per cent), Orissa (20 per cent), Bihar (11 per cent), Maharashtra (6 per cent), Andhra Pradesh (6 per cent) and Karnataka (4 per cent) have expressed several concerns on GM brinjal.



7 On 22 July 2013, The Technical Expert Committee appointed by the Supreme Court (SC) in its final report has recommended the following: (a) an indefinite moratorium on open field trials of genetically-modified (GM) crops till the deficiencies in the regulatory and safety systems are effectively addressed, (b) suggested for collaborating with the Norwegian government and the GM regulatory body as it “is one of the few that are attuned to considering socio-economic issues that would be important in the Indian context”, (c) trials should be only allowed on land owned by GM crop applicant and not on leased land (d) mandatory stakeholder participation as part of risk-management strategy, and (e) a ban on the environmental release of any GMO where India is the centre of origin or diversity.The TEC finds “herbicide tolerant (HT) crops completely unsuitable in the Indian context as HT crops are likely to exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and environment.” (http://articles.economictimes.indiatimes.com/2013-07-23/news/40749288_1_open-field-trials-bt-food-crops-interim-report)

8 The National Bureau of Plant Genetic Resources of the ICAR, in its report to the Minister, reveals that there are 3951 collections in the Bureau and the number of diversity-rich districts is 134.

9 The international protocols Codex Alimentarius principles and Cartagena Protocol in which India is a signatory, emphasizes the use of the precautionary principle. According to the Codex Guideline (Para 13), though the principle of ‘substantial equivalence’ plays an important role in safety assessment of the new product, it does not imply the absolute safety of the new product. The Codex includes an assessment of indirect effects of novel foods on human health and the environment (CodexAlimentarius Commission 2003); and the Cartagena Protocol recommends an inclusion of ‘uncertain’ effects (Cartagena Protocol on Biosafety 1992, Annex III).

10 For a recent review of this literature, see Strydom et al. (2010); see also Sutcliffe and Court (2005).

11 See also www.nusap.net

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Domingo, J. L. and J. G. Bordonaba. 2011. “A Literature Review on the Safety Assessment ofGenetically Modified Plants.” Environment International, 37: 734–742.

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© 2016, RIS.

Ruth Mbabazi*, Hashini Galhena Dissanayake**,Joe Guenthner***, and Karim Maredia^

Perception of International Stakeholders on Genetically Modified Organisms (GMOs)

* Research Assistant Professor, College of Agriculture and Natural Resources, Michigan State University, Michigan, USA, E-mail: [email protected]

** Research Assistant Professor, College of Agriculture and Natural Resources, Michigan State University, Michigan, USA, E-mail: [email protected]

*** Professor Emeritus, University of Idaho, Moscow, Idaho, USA, E-mail: [email protected]^ Professor, College of Agriculture and Natural Resources, Michigan State University, East Lansing,

Michigan, USA, E-mail: [email protected]

Abstract: Crops derived through genetic modifications (GM) are grown by millions of farmers in developing and developed countries around the world and the area under cultivation of GM crops is growing each year. However, policymakers and other stakeholders in many developing countries are concerned with biotechnology and are debating the acceptance of the technology. There is a lot of misunderstanding, misperception, and fear regarding crops and foods products derived through genetic engineering (GE). This paper presents feedback perception of a diverse group of international stakeholders from more than 25 countries in Africa, Asia, Latin America, and Europe on GM product development process, regulation and communication strategies adopted in their respective countries. The study reveals that negative public perception and anti-GMO activism are the two most dominant forces against the development and adoption of GM crops. Safety of food and environment, farmers’ rights, and monopolies of global agribusinesses were the most serious concerns raised by the stakeholders, with food safety ranked as the number one concern. While the media and scientists were the most dominant sources of information on biotechnology and biosafety issues, scientists were identified as the most trusted sources of information. The findings of this study provide valuable information to designing biotechnology and biosafety education, awareness, and outreach programmes.Keywords: Genetically modified crops, genetic engineering, anti-GMO activism

IntroductionGenetically modified (GM) crops have been adopted by millions of farmers in developed and developing countries. According to the International Service for the Acquisition of AgriBiotech Applications (ISAAA) in 2014,


farmers in 28 countries cultivated a record 181.5 million hectares of GM crops (James, 2014). Some regulatory bodies have evaluated the evidence about risks associated with GM crops and have indicated that commercialised GM crops are as safe as conventionally bred crops (DeFrancesco, 2013; EC, 2010). In a number of studies it has been found that GM crops can save on agricultural inputs and losses from pests hence improving agricultural productivity (Huang, et al., 2008; Morse, Bennett, and Ismael, 2004; Qaim and Traxler, 2005). Despite the positive trends in the adoption of GM crops by farmers, public controversies about the risks and benefits continue to prevail in many developing countries (Andreasen, 2014).

Governments of many developing countries have been showing reluctance to approve cultivation of GM crops. This may be as a result of inadequate safety information about the technology and poor understanding on potential risks and benefits of GM crops. Therefore, there is an increased need for creating awareness and providing science-based information to build trust in the technology and facilitate informed decisions. To bridge the knowledge gap, many national, regional, and international programmes have been initiated during the past two decades. For example, the World Technology Access Programme (WorldTAP) of the College of Agriculture and Natural Resource at Michigan State University has been offering training and capacity building programmes in diverse areas of agricultural research and developmentfor the international community. As the biotechnology science and regulation evolve, continued access and sharing of information become critical for the safe use and adoption of GE crops. A strong communication strategy is, therefore, important not only for advancing biotechnology research and development, but also for addressing any misconceptions and misinformation. In order to design and develop capacity in biotechnology and biosafety communication, it is critical to understand where countries are on the path towards commercialisation, their regulatory status, current sources and mechanisms for information as well as existing constraints for information sharing. This paper attempts to assess and report information from various stakeholders on their perceptions and understanding of the status of biotechnology and effectiveness of various communication, outreach and awareness activities.

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Survey MethodsThe data included in this study was collected using a questionnaire that was distributed to a diverse group of 54 stakeholders from 25 countries in Africa, Asia, Latin America, and Europewho attended various training programmes related to agriculture biotechnology and biosafety at Michigan State University (MSU) during the summer of 2015. The survey included structured and open-ended questions designed to capture the current status of biotechnology and the mechanisms for information sharing. The stakeholders surveyed represented research scientists, academic personnel, journalists, lawyers, economists, regulators, policymakers, government officials, representatives of non-governmental organisations (NGOs), and private sector. The countries represented in the survey included: Brazil, Burkina Faso, China, Ethiopia, Ghana, Guatemala, Hong Kong, India, Indonesia, Kenya, Liberia, Malawi, Mozambique, Namibia, Nigeria, South Africa, Sri Lanka, Sudan, Thailand, Togo, Turkey, Uganda, USA,Vietnam, and Zambia.

ResultsThe results show that the countries represented in this study are at various stages of biotechnology product research and development with majority of participants indicating that their countries are still at laboratory, greenhouse, and confined field trial stages (Figure 1). Only 4 out of 25 countries represented in this study have approved commercial planting of GM crops.

Figure 1: Status of Biotech Crop Development in 25 Surveyed Countries

Perception of International Stakeholders on Genetically Modified Organisms


Figure 2: Challenges Raised on Biotech Crop Development

Figure 2 shows the various forces that impact biotechnology development and adoption of GM crops. The stakeholders identified that public perception and anti-GMO groups were the two dominant forces impacting biotechnology development in their country. Additionally, limited technical capacity, poor infrastructure, and cost of R&D and regulation were identified as limitations to biotechnology development.

Identifying and understanding trusted sources of information is critical to strategising capacity building efforts and selecting delivery mechanisms.The survey respondents stated that they receive information from diverse sources with media and scientists being the dominant ones. However, the information received from scientists was considered most trusted among all sources followed by government public awareness (PA) programmes. Participants reported that activists provide information in their countries but less than 15 per cent found them to be trustworthy (Figure 3).

Among many other factors, stakeholders are concerned and fearful of the potential risks with GMOs. The survey results indicate that more than 50 per cent of the stakeholders were concerned with food safety and environmental safety of GM crops as well as the farmers’ rights on the reuse of seeds (Figure 4). The food safety was ranked the most dominant concern.

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Figure 3: Source of Biotechnology Information

Figure 4: Key Issues and Concerns on Biotech Crops and Food Products Noted among Stakeholders

Discussion and ConclusionThere is a persistent negative perception among the stakeholders on the adoption of GM crops in developing countries. This may be due to inadequate information to the public on the on-going biotechnology product development activities in these countries as well as the lack of reliable scientific and socio-economic information on risks and benefits. A study



focussing on the perceptions of non-Europeans stakeholder on the status of biotechnology R&D activities in Europe indicated that most international stakeholders are unaware of the advancement Europe is making on the biotechnology front and highlighted the need of evidence-based outreach and education programmes to bridge the knowledge gaps (Moualhi, et al. 2014).

The results highlighted the media and the scientists as the most dominant sources of information by various stakeholders. These two groups need to work more closely so that credible science-based information is communicated to the general public. Given that scientists were identified as the most trusted source of information, this is an encouragement to scientists working at government research institutions and universities to be more proactive and timely in communicating and delivering information on biotechnology to media, regulators, policymakers, farmers’ organisations and other stakeholders. The consumers and the general public would greatly benefit from more balanced and consistent information on potential risks and benefits. Almeida et al. (2015) found that some farmers were willing to cultivate GM seeds after receiving information on the potential risks and benefits of the technology.

The results of this study identified food and environment safety as dominant constraints to the adoption of GM crops. As more GM crops are being developed especially for staple food security crops, and crops with centers of origin in specific countries or regions of the world, the stakeholders are raising concerns on the environmental and food safety aspects. Moreover, the anti-GMO groups are using these concerns to counter the adoption of GM crops. Therefore, there is a need to improve the understanding of food safety and environmental safety among target groups such as farmers, consumers, and the general public.

Evidence-based outreach and educational initiatives can play an important role in bridging the knowledge gap, raise trust, and confidence among key stakeholders on the application, use and management of GM technology. Several initiatives have been launched by national government agencies, universities, research institutions, and development agencies to bridge the knowledge gap, and raise awareness and understanding of biotechnology among the general public and provide biotechnology related education to various stakeholders. For over a decade, the WorldTAP programme has been offering international training programmes to educate and inform multiple

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stakeholders in diverse areas of biotechnology research and development, and regulation... Such initiatives are instrumental in providing science-based information and knowledge and creating a platform for exchange of experiences among regulators, scientists, policymakers, academia, and journalists that are dealing with biotechnology issues. Further, the MSU has been partnering with the New Partnership for Africa’s Development (NEPAD) agency of the African Union to institutionalise biotechnology training courses at African universities. Through these collaborative efforts, University of Ghana-Legon, Makerere University in Uganda and Polytechnic University of Bobo-Dioulasso in Burkina Faso have launched biosafety short courses for non-academic stakeholders. Nevertheless, more collaboration and cooperation is needed among government, universities, research institutions, private sector, NGOs and development agencies to bridge the knowledge and information gap on biotechnology and improve public perception towards new science and technologies including GM crops.

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Farmers about Genetically Modified Crops.” Ambiente and Sociedade n São Paulo, XVIII(1), 193-210

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In the last two decades there has been a steady growth in the area under cultivation of genetically engineered (GE) crops although about half a dozen countries account for a lion’s share in this and in case of major crops like wheat and rice, there are no commercially available GE crops. The controversies over GE crops have been many and with Europe virtually rejecting them as crops for cultivation and use as food, trading in GE crops and their derivatives has become a matter of dispute before WTO. Over the years many scholars have done a meta-analysis of the literature on GE crops and the European Commission has also commissioned review of studies on different impacts of GE crops.1 The Inter-Academy Panel has favoured cultivation of GE crops while UN organisations like FAO and WHO have taken a favourable position for their cultivation and use. Still controversies continue and consumer acceptance in Europe eludes GE crop commodities. With development of new technological options, the next generation of GE crops will be available but whether they should be considered and regulated as GE crops or Genetically Modified Organisms (GMOs) is a matter of debate. This in one sense is a continuation of Product vs. Process issue in regulation but new plant breeding techniques and options


© 2016, RIS.

The Future of Genetically Modified Crops: Reflections on the NAS Report

* Research Associate, RIS. Email: [email protected]

Abstract: Amidst the many claims made on the benefits and risks of Genetically Engineered (GE) crops worldwide, various meta-analysis of the related literature have been done in the recent times. The present paper attempts to reflect on one such meta-analysis-based report published by the US National Academies of Sciences (NAS) recently. This report includes the observations and recommendations of the Committee charged for preparing this report on the prospects of genetic engineering and regulation of current and future GE crops. The summary of the observations made by the Report on themes such as agronomic and environmental effects; human health effects and social and economic effects are presented in this paper along with the responses, relevance and implications of the report.Keywords: Genetic Engineering (GE), regulation, agronomic and environmental effect, health effect, social and economic effect

Amit Kumar*


like Genome Editing raise more fundamental questions for regulators. As a result of all these developments the current regulatory framework in USA for biotechnology is being reviewed for revision while in Europe, there has been an ongoing debate on this while the Commission’s position will be known by 2017. Amidst all these turmoil and controversies, countries like India, China, and Korea are investing heavily in GE crops and other biotechnological options in agriculture.

The National Academies of Sciences (USA) has been commissioning studies on different aspects of GE crops and biotechnology since late 1980s and these have contributed to the debates on impacts of GE crops.2 In 2014, the NAS commissioned a study on GE crops with specific tasks and the Committee was mandated to assess the claims made on the benefits and negative effects of GE crops and their accompanying technologies using the evidences accumulated over the last two decades and also to assess emerging GE technologies.

The Committee submitted its report in 2016 after extensive deliberations, including review of literature from around the world, taking into account views of experts and after examining public comments.3 It also placed its observations and recommendations on the prospects of genetic engineering and regulation of current and future GE crops. It must be noted that the experiences with genetic engineering in agriculture that the committee evaluated were related primarily to crops with GE herbicide resistance (Ht), insect resistance (IR) or both traits, as these are the most widely used traits in GE crops. In the following paragraphs the findings and observations are summarised under relevant heads to give an overview of the Report.

Agronomic and Environmental EffectsThe parameters used by the Committee to examine the effect of GE crops for insect resistance (IR) on the agronomy and environment were crop yield, insecticide use, secondary insect-pest populations, evolution of resistance to the GE trait in the targeted insect population (in case of IR trait); and crop yield, herbicide use, weed-species distribution and evolution of resistance to the GE trait in the targeted weed species (in case of Ht trait). It also investigated the contributions to yield of GE against that of conventional breeding and reviewed the effect of GE crops on biodiversity within farms and at ecosystem levels.

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The Committee noted that in addition to the effect of IR trait, the yield differences between Bt and non-Bt varieties may be due to the differences between the farmers who adopt or not adopt Bt varieties and other production advantages or disadvantages such as CO2, water, nutrients, soil toxicity, radiation, temperature, crop features, etc. It found evidence of decreased spraying of synthetic insecticides on Bt maize and cotton and reduction of some insect-pest populations in regions in the US and China. It also found that some secondary (non-targeted) insect pests have increased in abundance, but only in few cases has this increase has posed any agronomic problem. It also noticed that the target insects have been slow to develop resistance to Bt proteins in the US when the government-mandated regulatory strategy required Bt plants to contain a high enough dose of Bt protein to kill insects that have partial genetic resistance to the toxin and the maintenance of refugia in the farms was enforced effectively.

Regarding Ht trait, the Committee observed higher yield owing to the improvement of weed control. This has led to the decrease in total kilograms of herbicide applied per hectare of crop per year, but the decreases have not been sustained. It also observed that for delaying the evolution of resistance in weeds in fields of Ht crops, diverse weed management strategies are required.

On the issue of yield advantage between GE traits and conventional breeding, the Committee witnessed disagreement among the researchers on how much GE traits can increase yields compared to conventional breeding. The Committee examined changes over time in overall yield per hectare of maize, soybean and cotton reported by the US Department of Agriculture (USDA) and found that no significant change in the rate at which crop yields increase could be discerned from the data.

Regarding environmental effect of GE crops, the Committee found no conclusive evidence of cause-and-effect relationship between GE crops and environmental problems. However, no conclusion could be reached as the analysis of any long-term impact was found to be complex.

Human Health EffectsAfter examining the reports and comments, the Committee concluded that there is no evidence of health risks. It mentioned that any testing of GE crops and food derived from GE crops falls into three categories namely



animal testing; compositional analysis; and allergenicity (toxicity) testing and prediction. The Committee observed that even though the design and analysis of many animal-feeding studies were not optimal, the large group of experimental studies available provides sufficient evidence that animals feeding on foods derived from GE crops are not harmed. Similarly, in the compositional analysis too, the Committee found that the differences found in comparisons of transcriptomes, proteomes and metabolomes in GE and non-GE plants have been small relative to the naturally occurring variation found in non-GE crop varieties that is due to genetics and environment. The Committee acknowledged the non-existence of any animal model for predicting sensitisation to food allergens, which makes it very difficult to ascertain the effect of allergic response that could be caused by a protein that is intentionally added to the food by GE or appears in the food as an unintended effect of GE.

Regarding the hypothesis that GE food consumption may lead to higher incidence of specific health problems including cancer, obesity, gastrointestinal tract illness, kidney disease, etc., the Committee concluded that it is difficult to generate unequivocal data to test this hypothesis. However, on examining the epidemiological time-series datasets from the USA and Canada, where GE food has been consumed since the mid-1990s, and similar datasets from the UK and western Europe, where GE food is not widely consumed, the Committee found no evidence of differences between the data from the UK and western Europe and the data from the USA and Canada in the long-term pattern of increase or decrease of any specific health problems after the introduction of GE foods in the 1990s.

Social and Economic EffectsThe Committee assessed the claims associated with the social and economic effects occurring at or near farm level and those related to consumers, international trade, regulatory requirements, IPRs and food security. It found that at the farm level, the available evidence indicates that soybean, cotton, and maize varieties with GE Ht or IR traits (or both) have generally had higher economic returns and/or increase in management flexibility for the adopters. However, there is a high heterogeneity in the outcomes.

The Committee realised that although GE crops have resulted in

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economic benefits to many small-scale farmers in the early years of adoption, any enduring and widespread gains will depend on institutional support, such as access to credit, affordable inputs, extension services and access to profitable local and global markets for the crops. The cost of GE seed has been found to limit the adoption of GE crops among resource-poor smallholders.

The analysis of the gender implications of GE crops was found to be inadequate. It was also found that the supply of non-GE varieties have declined in the USA and Brazil, where the GE varieties have been widely adopted.

The issue of any adventitious presence of even low levels of GE traits in seeds, grains or foods is a serious one for farmers as it will limit the freedom of farmers to decide what crops to grow on the basis of their skills, resources, market opportunities and for economic reasons as markets are differentiated and organic and non-GE crops command a price premium. The Committee also highlighted the issue of trade disruptions related to asynchronous approvals of GE crops and occurrence of violations of an importing country’s tolerance threshold.

The Committee acknowledged the need of a regulatory-approval system which benefits society by preventing harm to public health and environment as well as by preventing economic harm caused by unsafe or ineffective products. It also advocated for the regulations to include a broad array of social, cultural, economic and political factors that influence the distribution of risks and benefits, such as IPR and legal frameworks. However, it was also realised by the Committee that regulations of GE crops and IPR regimes have inherent economic and social costs that can potentially slow the innovation and deployment of beneficial products.

Regarding food security and the ability of GE crops to address it, the Committee held the view that GE crops do not necessarily have greater potential yield than non-GE counterparts. There are other factors such as soil fertility, integrated pest management, market development, storage and extension services that will be needed to be addressed to improve crop productivity, decrease post-harvest losses and increase food security.



Prospects for Genetic EngineeringThe Committee felt that the plant-breeding approaches in the 21st century will be enhanced with the increased understanding of genetic basis of agronomic traits and by the advances in the genome-deciphering tools and techniques. The rapid progress of genome-editing tools, such as CRISPR/Cas 9 and emerging ‘-omics’ technologies would be complementing and extending the contemporary methods of genetic improvements.

In many cases, both genetic engineering and modern conventional breeding techniques could be used to enhance a crop trait. However, the Committee envisaged that more progress in crop improvement could be made by using conventional breeding and genetic engineering jointly rather than in isolation.

Regulation of Current and Future GE CropsThe Committee examined the government regulatory systems used by the US, the EU, Canada and Brazil to regulate GE plants and found some marked differences in their approach. While the EU and Brazil have chosen to regulate GE specifically, excluding conventional and other breeding methods; Canada has chosen to regulate foods and plants on the basis of novelty and potential for harm regardless of the breeding technique used. The USA has a ‘product-based’ policy and has relied on the existing laws to regulate GE crops. All four regulatory systems use guidelines set out by the Codex Alimentarius Commission and other international bodies. All start with comparison of the GE crop variety with a known, conventionally bred variety. They differ in the stringency of testing, types of agencies that conduct risk analysis and in how the public is involved.

However, the Committee realised that the emerging GE technologies are going to challenge the existing regulatory systems as the distinction between GE and conventional plant breeding will get blurred. Therefore, the Committee is of the opinion that the product should be regulated rather than the process and ‘omics’ technologies will be critical for such an approach.

Those who looked for ‘yes’ or ‘no’ type answers to the issues would be disappointed by the Report which often has added caveats and called

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for more studies where it felt that the current evidence is not sufficient to arrive at definitive conclusions. In fact the report does not shy away from acknowledging the need for more.

Responses to the ReportThe responses to the report predictably were mixed. While those opposed to GMOs found fault with its findings and methodology, many others supported the findings and the conclusions drawn by the Report. As a well known expert on the politics of food points out although the overall conclusion calling for more research made sense, it was not helpful in bringing both sides together.4 In fact the chair of the academy committee Fred Gould stated in the preface, “We received impassioned requests to give the public a simple, general, authoritative answer about G.E. crops. Given the complexity of G.E. issues, we did not see that as appropriate.”

As the report neither advocated GE crops as the solution or as the best solution, nor categorised them as harmful and dangerous to environment and human health, its findings would not please those who hold extreme positions on GE crops. The Report also did not categorically state that GE technology boosted yields in all cases. The responses to the report also indicate the contested nature of evidence and acceptable evidence in understanding the impacts of GE Crops. For example, critics accuse that the consensus on the health impact of GM crops is a false consensus and NAS report has evaded questions that should have been raised.5 But they seem to miss that it is impossible to prove that any technology has no unwanted effects or is always safein all contexts. Crops developed through traditional plant breeding do not undergo many tests that are included in the approval process for GE crops.

With respect to new technologies such as genome editing it is likely that the same divide will continue and perhaps the critics would like to classify the products developed using genome editing as GMOs/GM crops even when the category of GM/GM crop may not be relevant. But despite all the criticisms what is relevant is that the NAS report has made it clear that prima facie GM crops are not health hazards. Similarly, in case of environmental impacts also, after due consideration of studies and points made by different stakeholders, the Report has indicated that no linear



cause and effect could be observed in case of environmental impacts of GE crops and it has refrained from making any definite pronouncement on long term environmental impacts of GE crops. The approach that let what can be inferred/known from the studies should be stated clearly without extrapolating the inferences or findings is a sensible approach. This acknowledges that we may not have answers to all questions but we know for sure that this is what the evidences indicate. Thus, on one hand, the Report acknowledges that there are knowledge gaps but on the other hand it refuses to speculate on the basis of the knowledge gaps or create an impression that as there are gaps in knowledge, opposing cultivation of GE crops is a better option.

This pragmatic perspective helps us to understand what can be expected from the technology and what should be done in light of the experience so far. But the most important point is that the Report refuses to state that science has all the answers, nor calls for a narrow techno-scientific perspective when it comes to regulation. In fact, it recognises the need for public engagement and transparency in regulation and suggests that exemptions from public disclosure on account of confidential business information and other factors should be as narrow as possible (Pp 336-337). But such calls for public engagement are not always welcomed particularly by some of the scientists who think that such engagements are unproductive and indicate an ideological shift towards postmodernism and fear that this could be a challenge to science and scientific method (Kuntz 2016). Nevertheless, the call for public engagement in the Report stems from a pragmatic perspective that understands the complex interactions between science and technology, and, different stakeholders. Similarly, the Report’s willingness to address socio-economic impacts shows that many scientists are willing to think beyond narrow techno-scientific perspective.

This Report is the latest one from NAS on agricultural biotechnology and should be read as part of the engagement of NAS with GE crops and agricultural biotechnology over the years. In that sense, it is a continuation of its efforts to provide independent findings for a complex issue, taking into account all dimensions, without wavering between extreme positions and acknowledging what we know and what we should strive to know in understanding the impacts of GE crops.

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This Report addresses the new developments in technology and evaluates the issues before regulators and makes very important suggestions. These are timely as USA is having a thorough relook at its regulatory framework and elsewhere there are debates on regulating the new technological options. The Report’s position that regulation should be product based rather than process based, brings in much needed clarity in the debate.

The structure and the content of the Report and the process adopted can be role models for regulators and policy makers who want to the make a comprehensive study of the impacts of GE crops and the options made available by technological advancements.

Finally, the conclusions and findings of the Report can be cautiously optimistic about the future of the GE crops. In future, GE crops and GMOs are likely to be deployed more widely and regulation will be a contentious issue. It is likely that the GMO vs. non-GMO approach may be replaced by product and features based regulation and this in turn will rekindle the debate on labeling in different applications. Already in the USA there is a move towards labeling from a strict NO to labelling of GM foods. This in turn may result in more demands for labelling in other countries. Regarding trade in GE crops and GM foods, the transatlantic divide may remain, if not widened further.

Endnotes1 European Commission (2010).2 http://nas-sites.org/ge-crops/2014/06/05/related-reports/3 “Genetically Modified Crops: Experiences and Prospects” authored by Committee

on Genetically Engineered Crops: Past Experiences and Future Prospects; Board on Agriculture and Natural Sciences; National Academies of Sciences, Engineering and Medicine and published by The National Academic Press (2016), USA.

4 http://www.foodpolitics.com/2016/05/new-report-on-gmos-safe-but-more-research-needed-sigh/

5 http://sustainablepulse.com/2016/05/27/how-the-national-academy-of-sciences-misled-the-public-over-gmo-food-safety/#.WAW_XVR961s See also https://stijnbruers.wordpress.com/2016/06/23/on-gmos-and-effective-environmentalism/ and Krimsky (2015).



ReferencesEuropean Commission. 2010. A Decade of EU funded GMO Research (2000-2010). EUR

24473 EN. European Commission, Brussels.Krimsky, S. 2015. “An Illusory Consensus behind GMO Health Assessment Science

Technology.” Science, Technology and Human Values, Vol. 40, No. 6, Pp 883-914, November.

Kuntz, M. 2016. “Scientists Should Oppose the Drive of Postmodern Ideology.” Trends in Biotechnology, Available online at http://dx.doi.org/10.1016/j.tibtech.2016.08.008. ISSN 0167-7799.


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Report

Multi-stakeholders’ Roundtable Discussion on “IPR, Access to Technology and Policy Deliberations”4 June 2016 New Delhi

In the wake of recent debates on IPR and access to technology, RIS organised a Roundtable Discussion on ‘IPR, Access to Technology and Policy Deliberations’ on 4 June 2016 in New Delhi. Representatives of the government, industry, academics, research organisations, civil society and media, actively participated in the discussion

The Roundtable began with the introductory remarks by Prof. Sachin Chaturvedi, DG, RIS; followed by presentations of industry perspectives by Dr. Paresh Verma, Head, Management Committee, ABLE-AG and Mr. M Prabhakar Rao, President, NSAI. Both of them presented their views related to this issue in the field of agriculture and seeds. Thereafter, the panellists, Dr. S. R. Rao, Advisor, DBT; Mr. Siraj Hussain, former Agriculture Secretary and Dr. R. R. Hanchinal, Chairman, PPV&FRA expressed their insights. Dr. Montek Singh Ahluwalia, former Deputy Chairman, Planning Commission, delivered his keynote address reflecting on the IPR related issue and price control mechanism especially related to seeds. Other panellists, including Prof. Dinesh Abrol and Prof. T. C. James expressed their concerns. In the discussions and responses from the audience few interesting points were articulated.

Key PointsFive key points that emerged from the discussions are as follows:• Need for clarity on the issue of trait fee, royalty, price control and

licensing guidelines;


• Need for the clarity on the role and scope of Essential Commodities Act;• Role and scope of the Indian Patents Act and PPV&FR Act needs to

be spelt out clearly;• Promotion of healthy competition should be ensured;• Need for proper regulatory framework

i. Issue of Trait Fee, Royalty, Price Control and Licensing GuidelinesBy virtue of rights given for accessing any protected variety under the Section 30 of the Protection of Plant Varieties and Farmers’ Rights (PPV&FR) Act, there is no need for any licensing agreement at all. Therefore, to reward the technology developer/provider, a mechanism called FRAND (Fair, Reasonable and Non-Discriminatory) Licensing system similar to the telecom sector can be adopted. This will allow open access to patented technology to everyone without even signing a license agreement; but it will be mandatory for any user to pay the specified royalty back to the technology developer/provider as fixed by the industry body.

It was argued that if there are competitive processes at work in the seed sector, there is no need to control the price of seeds. One of the better ways to check the price would be to let public sector research system license-out their technologies to private sector, which could then produce seeds at a cheaper rate. If at all, there is logic to control technology/trait fee that logic must operate within the four bounds of law. There is PPV&FR Authority has been set-up, which can look after these issues. Above that authority, there is an Appellate body. It was realised that there is a concern regarding charging of lesser trait-fee in China and USA than in India; and it is important that if in India the trait fee charged is more, it should be regulated through PPV&FR Authority. There is nothing wrong in regulating the trait fee; the seed sale price as such should not be regulated technology and should be left to the market to decide. A uniform seed sale price may compromise the seed quality aspect. There was a suggestion to establish a Seed Price Control Authority to decide on price fixation of seeds to check the negative impact of monopolisation due to IPR.

On the recent Licensing Guidelines as notified by the Ministry of Agriculture, it was argued by some that it is the right thing to do, as it has tried to eliminate the existing confusion on account of multiferous rules and

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regulations relating seeds. The Guidelines were said to have attempted to balance both; ensuring access to technology and adequately rewarding the technology developer under FRAND mechanism.

ii. Role and scope of Essential Commodities ActIt was stated that Essential Commodities Act (ECA), 1995 lists a number of commodities on which the government can, at any time, introduce price control, which is totally an administrative decision. Over time, a lot of items from that list have been deleted. It was suggested that seed should also be de-listed. Countering this suggestion, other participants argued that if seeds are not protected under ECA, ensuring food security will be at stake. It was also clarified that ECA does not only control prices, but many other aspects also, including the quality of cotton seeds. It was in 2009 that the cotton seed was brought within the purview of ECA. However, the use of ECA in order to control seed prices has been very rare.

It was also argued that since any new seed variety is nothing but an innovative product, coming out from research, it should not be treated as commodity. Hence, it should be taken out of the purview of ECA. Counter-argument to this was if it is not commodity then why it should be rewarded by giving monopoly through IPR.

iii. Role and scope of the Indian Patent Act and PPV&FR ActIt has been argued by certain section of seed industry that there is a clear- cut demarcation of the role and scope of both, i.e. Indian Patents Act and PPV&FR Act, both of which are TRIPS compliant. It was stated that TRIPS Agreement itself provided for exempting plant varieties and seeds from patenting. It was also argued that since the foreign trait-specific gene is introduced in the already existing varieties, it should be governed by PPV&FR Act. However, the counter argument placed by another section of seed industry was that the IP related to the biotechnology part of the transgenic crop plant should be regulated by Patents Act while the invention through conventional plant breeding should be regulated by PPV&FR Act.

It was mentioned that the use of any variety registered under the PPV&FR Act by a person for conducting experiments and research is permissible. The variety can also be used as genetic source for the purpose

Report: Multi-stakeholders’ Roundtable Discussion on “IPR, Access to Technology


of creating new varieties. It was also mentioned that there is a provision for issuance of compulsory license.

iv. Promotion of Healthy CompetitionIt was expressed that the government policies and regulations should lead to increased market competition, increased choices for farmers and support market-determined value and price for the new technology. There should not be any intention to bar any company, foreign or national, because this will lead to denying ourselves a source of knowledge and technology. However, while articulating a stance against monopoly, a reference was made to Sections 30 and 39 of the PPV&FR Act, which allow farmers to have a right to save the seeds from his/her farm, use it for re-sowing or even distributing to other farmers. Section 92 of the same Act states that in case of any conflict with other prevailing Acts this Act will enjoy overriding powers.

However, it was argued that though, there is a Competition Policy in place to check emergence of monopoly, it does not address the issue of innovation or IPR unlike in China. In China, the Competition Policy actually safeguards indigenous innovation against the misuse and abuse of IPR. It was also stated that IPR is not the only incentive which matters for the success of any company; the state has to play the entrepreneurial role in the case of seed sector.

It is important to have a proper IPR regime in place, which encourages investment in R&D, which ensures protection of IP and enforcement of IPRs that get created, which will then enable commercial deployment of these IPRs and new technologies so as to provide best value proposition to the customers.

v. Need for Proper Regulatory FrameworkIn order to address/check the issues related to safety and quality, the discussion stressed the need to have a proper regulatory framework in place. It should have wide coverage ranging from access to germplasm to marketing of the product. Important on-going reforms within the regulatory process were shared. Some of these are as follows:

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• A unified online website where one can see the information available on all aspects of IP technologies, crop traits for crops under field trial has been put into place.

• There is a proposal to do all GM trials in notified field testing sites. The sites are to be very well defined and it is to be protected from all other extraneous interferences till the GM bio-safety has been proven.

• Risk assessment and management plan is to be prepared even before the GM field trials are conducted. It will be involving multidisciplinary experts. The government has already put up a multidisciplinary risk assessment unit of 25 scientists who internally examine all declaration on safety issues. The international system of doing the risk assessment plans even before the field trial would be in place.

• There is also a proposal to have a separate Office of Biosafety with more strengthened risk assessment processes.

• All risk assessment documents are proposed to be placed on public domain by the regulator at appropriate stage of evaluation of GM crops.

• A new Bill for establishing Biosafety Regulatory Authority is being examined by the government to be introduced in the parliament.

Key ConcernsThe following key concerns have emerged from the deliberations:• Adequate Reward for Innovation: The innovators and their

innovations should be adequately rewarded for ensuring further R&D and innovation activities. Recent National IPR Policy 2016 is a right move in this direction.

• Affordable Agricultural Inputs for Farmers: Ensuring affordability of agricultural inputs such as seeds to the farmers should be at the primacy of any licensing agreements.

• Clarity on Ambiguity in Interpretation of Existing Laws: The ambiguity in the interpretation of the related existing laws such as Indian Patents Act and PPV&FR Act should be resolved, in terms of defining the exclusivity and inclusivity clauses related to patentability and accessibility of any variety or technology.



Key SuggestionsIn the view of the concerns raised and the persistence of confusion in the policy deliberations within the stakeholders, the following suggestions as the possible way forward can be made.• Need for a Balanced Mechanism: It is strongly recommended to

devise a well-balanced mechanism which will ensure adequate rewards for innovations; while at the same time; ensure the availability and accessibility of innovative agricultural inputs to the farmers at an affordable rate.

• Resolution of Ambiguity within IPR Regime: The statutory regulatory authority, with adequate provisions to deal with the cases of patent infringement of all kinds should be strengthened and mechanisms as per the law should be effectively utilised to arrive at an early resolution of the ambiguity in the interpretation of the related existing laws such as Indian Patents Act (Sections 3j, 3h, 43, 48, 64, 66, 84, 85, 92, 104, 104A, 105), PPV&FR Act (Sections 15, 23, 26, 28, 30, 34, 47, 48, 65), etc.

• Exploring Effective Price Control Instrument: Various state governments have come up with their own legislations/orders to regulate the pricing of seeds in their state. However, it is recommended that modalities for any price control intervention should be best left with the specialised government agencies which have a mandate to look into any issues related to seed pricing and quality. While looking into these issues, this specialised agency should undertake a through interpretation of all the related acts/regulations and orders such as Essential Commodities Act (Section 3), Seeds (Control) Order 1983 (Section 10), Competition Act (Section 4), Seeds Act 1966 (Section 5 and 6,) etc. It should also be taken into consideration that any notification issued under the Essential Commodities Act 1955 impacts the pricing of the whole commodity irrespective of its manufacturing and marketing affiliation. While any notification issued under Competition Act 2002 has a bearing on the manufacturing or marketing company only, not on the commodity itself.

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• Promotion of Healthy Competition: For the promotion of healthy seed market and ensuring adequate availability of seeds to the farmers and seed companies, it is important to address any danger of monopolisation and anti-competitive move by any company. A specialised agency such as Competition Commission of India having a mandate to look into these aspects, while adjudicating any related case should analysis the matter taking into account the modalities provided in various legislations such as Competition Act (Sections 3 and 4), PPV&FR Act (Sections 28, 30, 47 and 48), Indian Patents Act (Section 84 and 92), Department of Industrial Policy and Promotion (DIPP)’s Press Note No. 8 (2009 Series), etc.

-Amit KumarResearch Associate, RIS

Email: [email protected]


Report

Roundtable on “Resolving Legal Ambiguity related to IPR and Access to Technology in Reference to Seeds” 27 July 2016

New Delhi

As a follow-up of the earlier Roundtable Discussion on “IPR, Access to Technology and Policy Deliberations” held on 4 June 2016 RIS organised a second Roundtable Consultation on 27 July 2016 at New Delhi with the experts in biotechnology regulation, agricultural scientists and legal experts and practitioners specialising in intellectual property, for an in-depth discussion on certain legal provisions, contained within the existing related legislations such as Patents Act, PPV&FR Act, Environment Protection Act and Essential Commodities Act. Prof. Sachin Chaturvedi, Director General, RIS, welcomed the experts with his opening remarks setting the agenda for the consultation, followed by the key remarks made by the Chair, Dr. S. R. Rao, Adviser, Department of Biotechnology, Ministry of Science and Technology stating the overall background of the present debate. The set of probing questions was discussed in the roundtable is given in Table 1 and the deliberations tried to bring in consensus.

Key PointsThe various key points emerged during the consultation are as follows:

I. Ambiguity Between Various Related Legislations such as Patents Act, PPV&FR Act, Environment Protection Act and Essential Commodities Act• Most of the experts were of the opinion that there is no ambiguity


© 2016, RIS.


between the existing legislations per se, as all these legislations operate in their respective domain within a defined boundary. However, their interpretations need to be more clearly spelt out.

• There is no question of one Act subsuming another; except in the case of Essential Commodities Act (ECA), when it comes to fixing the price of an essential commodity. Seed is listed as an essential commodity in the Schedule II of the ECA.

• Acts such as Indian Patents Act and Protection of Plant Varieties and Farmers’ Rights (PPV&FR) Act should be seen as complementary to each other. While Patents Act allows for patenting of gene technology, PPV&FR Act allows for patenting of the whole plant variety.

Table 1: List of Probing Questions

Sl. No. Question

1

How Indian laws such as Patents Act and PVP&FR Act confer rights and regulate them with respect to seeds and traits? What is the interface between them and is there any conflict/ambiguity or coherence? In case of conflict/ambiguity how to address them using legal principles and case laws?

2

What are the provisions under different Acts on fixing of fees for traits and are they in conflict or are they coherent? Is using the power to revoke a patent a good solution? What is the role of Competition law and Competition Commission of India (CCI) in this?

3With respect to access to technology and trait, what are the powers available under these legislations and are they subject to any limitations? Do we have case law in India to address these issues?

4

What are the lessons for India from experiences elsewhere on overlaps in IP laws with respect to seeds and plant varieties and in using IP law and competition law to prevent abuse of monopoly and/or to enhance access to technologies and traits? Can case law and experiences in other sectors such as telecommunications help in addressing the issues in case of seeds and plant varieties?

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II. Promoting Healthy Competition• There was an apprehension regarding issuance of the Seed Price Control

Order 2015, which clubbed all varieties of seeds under one category ‘Seed’ and directs for a uniform pricing structure throughout the country. It is perceived to be negatively affecting the spirit of competitiveness among the seed industries to produce better quality seeds.

• It was also expressed that there is only one foreign company which controls more than 98 per cent of the cotton seed sector, owing to its ownership of the Bt technology. Given this fact, all the Indian companies which needs access to this technology, have to sign a contract agreement with the licensor company. This contract agreement is touted as restrictive in nature, as it states that the Indian licensee companies could not access any other alternative technology from any other source. If that happens, the contract will be terminated, which will lead to the destruction of all the germplasm parent lines acquired from that company. This process takes time and may cripple the licensee companies’ market competitiveness in a big way. The Competition Commission of India has prima facie found that this argument is valid and needs further investigation.

III. Ensuring Balance between Incentivising Innovator and Protecting Farmers Interest• There is no denying of the need for a well-balanced mechanism to

address the issue of adequately rewarding the innovator and the issue of farmers’ interest.

• The recent National IPR Policy in its objective 3 emphasises for having strong and effective IPR laws, which balance the interests of IP rights owners with larger public interest.

• A Product Liability Law needs to be discussed and framed given the notion of far-reaching impact of technologies such as GM on the socio-economic status and as well as on environment health and biodiversity. Such liability laws in other countries have huge financial implications for both, licensee and licensor, particularly in the context of low level

“Resolving Legal Ambiguity related to IPR


presence of GM products in non-GM component of trade, organic cultivation and specialised commodity exports, as non-tariff barriers.

• Rather than being reactive, a pro-active technology assessment exercise needs to be undertaken every time a new technology is going to be introduced into the agricultural sector as the needs will change depending upon factors like climate change, supply and demand, agricultural policy and vagaries of monsoon, etc.

IV. Price Control Order and Guidelines for Licensing Agreements• It was argued that bringing a notification for any price regulation is

unwarranted, unless and until all other available means are exhausted. There are provisions of Compulsory Licensing within the Patents Act and PPV&FR Act, which can be invoked to control the prices, if required at all, under the larger interest of public good.

• There are competent authorities such as Controller General of Patents, Designs and Trademarks or PPV&FR Authority, which can take effective decision on this matter. Similarly, for investigating any claim of monopolisation or exploitation of its dominant position by any company, there is a Competition Commission of India; which is mandated to look into the contract licensing agreements and to nullify them if found invalid.

• It is also true that under the Essential Commodities Act (ECA), the government has the power to fix/regulate prices of the listed essential commodities under Section 3; and seed is listed as an essential commodity. However, how justified it would be to use an administrative mechanism like invoking ECA for seeds in the present times needs to be discussed and deliberated, in the light of the farmers’ interest rather than some specific seed industry’s interest.

• It was pointed that the Seed Price Control Order 2015 lowered the seed price marginally, while it brought down the trait fee heavily, which is tantamount to be interpreted as an action only to harm the innovator/licensor company; while there is no real gains for farmers.

• It was also argued that instead of signing individual contract agreements, the companies could have explored the benefit sharing mechanism as mentioned under the Section 26 of the PPV&FR Act, which states that

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the amount of benefit sharing, if any, for which the claimant is entitled will depend on the extent and nature of the use of genetic material of the claimant in the development of the variety relating to which the benefit sharing has been claimed; and the commercial utility and demand in the market of the variety relating to which the benefit sharing has been claimed.

-Amit KumarResearch Associate, RIS


“Resolving Legal Ambiguity related to IPR

Equitable Access to Human Biological Resources in Developing Countries: Benefit Sharing Without Undue InducementAuthor: Roger ChennellsPublisher: Springer International Publishing, SwitzerlandDOI: 10.1007/978-3-319-19725-8Print ISBN: 978-3-319-19724-1Online ISBN: 978-3-319-19725-8Pages: XIX, 197 (hardcover)

As a social scientist, a social activist, and an ethics committee member on a research ethics committee in a medical institution in India, I grapple with the issue of what a research participant gets out of participation in research. To me, it is a matter of justice, of fairness against exploitation and of equitable returns to ensure that participants ‘get back’, particularly in genetic/genomic research since (in the words of the Human Genome Organisation HUGO, stated in the year 2000), “companies investing in genomic research have a huge potential of translating genetic research into new products such as vaccines and drugs and can reap large commercial benefit”. The UNESCO Declaration (2003) takes this issue beyond individuals and states in Article 19 that “benefits resulting from the use of human genetic data…for medical and scientific research”, “…should be shared with the society as a whole”, but the question that remains is, substantively how can this be done, and what does ‘sharing’ mean.

There are the counter arguments that benefit sharing is unnecessary and would lead to the commodification of human biological material on one side and an undue inducement to participate on the other. Or, that there is no exploitation because people give their biological samples with altruistic motives for the common good and that genetic material is a common heritage resource.

This book takes these arguments head on and addresses them by combining bioethics with jurisprudence. It systematically deals with the questions of whether and in what circumstances benefit sharing is

Book Review


© 2016, RIS.


appropriate for human genetic research and whether benefit sharing could in fact coerce or induce potential participants to participate in research, and finally whether concerns of ‘indigenous peoples’ being singled out for genetic research are being addressed by the current guidelines.

Chennells began this journey as a lawyer of the San community of Southern Africa which he has detailed in earlier writings also published by Springer.1 He brings into this book extensive research on other cases of perceived exploitation of indigenous communities, including the islanders of Tristan da Cunha, whose 275 inhabitants descended from just fifteen original families and who show a high incidence of asthma. Academic research, with support from a genomics company identified a predisposing asthma gene in these peoples. This information was then sold to a German pharma company, to develop a genetic diagnostic test. The higher gains of these companies contrasts with the hypothetical potential benefits that the islanders had been promised of free pharmaceutical treatment if drugs were developed based on their research. Similar stories exist of the Nuu-cha-nulth tribe of Vancouver Island in Canada, the Hagahai tribe of Papua New Guinea, and the Havasupai Indians in Arizona, among others. The angst is well expressed by this quote of an Aboriginal leader, John Little who says, “Over the last 200 years, non Aboriginal people have taken our land, language, culture, health and even our children. Now they want to take the genetic material that makes us Aboriginal people as well” (p.21).

Apart from the millions of dollars reaped as commercial gain, there are scholarly papers, dissertations, career path enhancements, institutional grants, and awards, among others, linked with these studies, which prompts Chennells to write: “There are clearly many forms of values locked up in the human genetic resources of certain populations”. (p.23) He goes on to examine the concept of ‘exploitation’ and how the case of Henrietta Lack and the highly profitable cell line derived from her cancerous tumour, challenged the notion of exploitation in that it caused ‘no harm’. This also forces us to reflect on the moral issues of ‘wrongs’ and ‘harm’ and also of ‘theft’ and ‘blackmail’. We are also challenged to consider a broader dimension of ‘beneficence’ that goes beyond a person’s fundamental wellbeing untethered to health and economic considerations but which can include matters of culture, beliefs, values, of dignity exploitation and injustice.

The proposition of a common heritage of humankind has been beautifully exposed in the moral simplicity of the Law of the Sea and Moon Treaty

85

(1979). Complex socio-political issues of state sovereignty, bioprospecting and biopiracy are discussed with examples (including cases from India of the well known neem tree and its medical property and turmeric powder as a wound healing medicine). The conclusion is that there is a close similarity in moral and ethical constructs of human and non human DNA, that patenting leads to commodification of human biological material with an unfair ownership pattern and that the common heritage of humankind can no longer be applied to human genetic resources in a meaningful way.

The ‘altruism argument’ has been shown to have value in affluent or developed countries where the benefit to the contributor of the new knowledge, products and services coming out of the research is ensured by a more open and fair access to health and education. However, this is not true in developing countries where poverty, poor access to health care and a disparity in basic health indicators creates an unequal, inequitable and incomparable situation.

An important issue discussed in the book is whether ‘benefit sharing’ amounts to inducement or coercion of vulnerable populations to provide genetic resources for research? Chennells plainly establishes that it is the narrow manner in which consent to a transaction is carried out that leads to unfairness and coercion. He takes us through the realms of justice, from Roman law and Aristotelian justice to a modern analysis of justice by Thomas Pogge. While we are more familiar with procedural and substantive justice from the ethical point of view, we are informed about the lesser known form of material justice, namely ‘commutative justice’. This is the justice of voluntary exchange between two parties and would be key in guiding benefit sharing. In his words, it “features the restoration of a notional form of equality” (p.88). This is operationalised through the law of contract in which material benefit is a key consideration.

Clarity of ideas, substantiated with theoretical evidence and actual cases, unfolding in a logical, engaging manner is the cornerstone of this book. Each chapter is like a standalone article with an abstract, a conclusion, and its own set of references. It might seem that concepts are repetitive with this form of structuring I found that it helped me get clarity on the concepts and appreciate the newer evidence provided. The closing chapter presents, in a sense, the final arguments and is akin to the closing of a case in court; the representative of the San tribe reiterates the need to be treated fairly and with respect, and to be explained the details of the research and its outcomes

Book Review


so that an understanding of harm can be clear from their perspective. This is followed by a summary of the arguments of earlier chapters which convincingly support the claim for benefit sharing. One thing that the book lacks is an index at the end of the book which would have been made the search for a specific subject easier.

In my view, the value of the book goes beyond DNA related research and provides thought for ethics committees, researchers and policy makers in developing countries to consider benefit sharing or ‘paying back’ in all forms of research, and the need for this to be stated clearly in contractual terms.

This book is a ‘must read’ for academics in the fields of law, ethics, genetic research and international relations and for policy makers, research ethics committee members and community rights advocates, among others. It empowers the “lambs to hold their own against the might of the lions” (attributed to Woody Allen and contextualised by Roger Chennells)!

Manjulika VazLecturer in Health and Humanities

St. John’s Research InstituteSt. John’s National Academy of Health Sciences Bangalore


Endnote1 Chennells, R., V. Haraseb and M. Ngakaeaja (2009). “Speaking for the San: Challenges

for Representative Institutions” in R. Wynberg, D. Schroeder, and R. Chennells (eds.), Indigenous Peoples, Consent and Benefit Sharing: Lessons from the San Hoodia Case. London: Springer.

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