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Here is a term paper on ‘Biotechnology and Business’ for class 8, 9, 10, 11 and 12. Find paragraphs, long and short term papers on ‘Biotechnology and Business’ especially written for school and college students.
Term Paper on Biotechnology and Business
Term Paper Contents:
- Term Paper on the Regulation of Biotechnology in Business Sector
- Term Paper on Explaining and Assessing Biotechnology Regulation for Business
- Term Paper on Capacity Building in Biotechnology
- Term Paper on the Public Regulation for Private Interests
- Term Paper on the Mutual Interests of Business and the State
- Term Paper on the Implications for Effective Public Regulation
- Term Paper on Confronting Public Regulation, Constructing Civil Regulation
Term Paper # 1. Regulation of Biotechnology in Business Sector:
The regulation of biotechnology products at the national and international level inevitably involves private sector companies. Biotechnology firms are, in many ways, the ‘street-level bureaucrats’ of biotechnology, those expected to enforce and implement government regulations regarding biotechnology products.
Not only are they the front-line producers and distributors of the technology, a fact which places them well to provide insights and channel their experience into the design of regulatory systems, but the in-house scientific expertise they have and the level of capital they own, make them key advisers and powerful political players in the politics of biotechnology regulation.
Though firms have been active from the very earliest days of the technology’s development, it is important to differentiate the strategies firms use at the national level from the international level and to explain why they may be more influential with some governments than others.
Work within the business influence literature suggests that although some companies may benefit from international decision making processes that are distant from publics and the intense scrutiny of civil society groups, firms often prefer to engage with national governments where they are based with whom good relations may have been nurtured, trust built up and channels of access and representation familiar and clearly defined.
Many of these advantages do not apply at the international level, where decision-making processes are slow and complex, very legalistic and traditionally not open to extensive inputs from non-state actors. More explicit channels of influence either through legislative hearings or contributions to party funds are also, of course, closed.
Moreover, it can be difficult to influence a government’s agreed negotiating position once multilateral negotiations have begun. Therefore business lobbyists regard it as more important and more effective to influence policy discussions in national capitals before national negotiating stances are agreed.
They tend to see their participation in multilateral negotiating forums as a secondary tactic, useful for monitoring the negotiating process, distributing information to delegates and dealing with urgent or unexpected situations that may emerge from the deliberations.
The key strategic difference, from the point of view of business, is not only between the national and international, however, but the different types of institutional design and organisational culture associated with the US as opposed to the EU, for example.
Though there is potential for the transatlantic integration of capital to nurture common approaches to the regulation of genetically modified organisms (GMOs), and there have been industry-led attempts to facilitate transatlantic dialogues between industries and policy makers in Europe and North America, distinct political cultures and the role of NGOs conspire to create unique challenges which businesses have to comprehend and adapt to in their political strategies.
Before looking further at competing approaches to the regulation of GMOs and the firms driving the ‘gene revolution’ to assess how far, and the ways in which firms have helped to define rules and shape the conduct of the institutions responsible for the international governance of biotechnology, it is worth summarizing the key strengths of firms as political actors in general, for it helps to account for their high profile role in public regulation of biotechnology products as well as the attention they have attracted from civil society groups anxious to check the perceived power of biotechnology multinationals.
Approaches to accounting for business influence can be divided between more pluralist explanations and those which place greater emphasis on the structural power of business actors vis-a-vis the state. Pluralist accounts of the role of business in the policy process emphasise the expertise and resources of firms which make them important players, without attributing them structural power in the way Marxist and neo-Marxist accounts do.
Pluralists emphasise the openness of policy-processes to any actors able to organise themselves and with the resources to represent their concerns. Those with access to high-quality sources of information, more resources and that are better organised internally are likely to be more successful at advancing their case with policy-makers.
Their starting assumption is that no one actor or group of political players is in a position to ensure systematic and privileged access or to secure outcomes favourable to them on a repeated basis.
The developments have led some observers to elaborate the concept of the ‘competition state’ to describe a shift of power between firms and states in which national governments perceive as one of their primary responsibilities the maintenance of a favourable policy and regulatory environment to attract and retain private investment.
But this change aside, the contribution of major firms to the tax base of the state, the growth they generate and the employment they provide, mean that states for reasons of resources, expediency and legitimacy, in many ways, and require the acquiescence of large firms for the success of their political programmes.
The manifestations of these forms of power are many. Predominant in these literatures are concerns about the ‘mobilization of bias’, ideas about ‘non-decision-making’ on issues that are screened out of the policy process by being ignored or not even considered because they may threaten key interests and ‘anticipated reaction’ where state decision makers refrain from making certain decisions on the basis of how a powerful industry might react.
In most such literatures, it is accepted that the idea of what constitutes the interest of capital is not hegemonic as there are of course many fractions of capital each with their own interests. What is significant is the extent to which particular sectors, that are regarded as having high strategic importance to the success of the economy as a whole, are able to project their interests as those of capital-in-general, for the benefit of business as a whole.
In mediating between the interests and concerns of different fractions of capital, such accounts emphasise the way in which state managers are charged with the responsibility of determining what is in the interest of capital-in-general.
The way in which the biotechnology industry has been able to do is discussed below:
In addition to these general accounts of the power of business actors, there are some features of the biotechnology issue which dispose it towards business influence. In a situation of uncertainty, those with access to the necessary expertise to comprehend the dimensions of a problem and propose solutions to it become cast as key knowledge brokers.
Because of their superior access to scientific expertise and capital, firms are able to nurture their own ‘epistemic communities’ of scientists and experts who take a common view of the risks associated with biotechnologies and the forms of regulation that are most appropriate for addressing these.
This makes them indispensable to policy-makers struggling to identify an appropriate response to the new technology, for their expertise can help to identify not only areas of environmental risk but also the political cost and opportunity structure of a problem.
A second key factor is the way in which the biotechnology industry in many states is afforded a privileged position in policy debates because of the strategic importance attached to biotechnology by governments as a key and very profitable opportunity to expand the high-tech knowledge economy.
This means that is easier for major firms wanting to gain access to decision-makers to claim that addressing the needs of their sector is a sure way of doing what is best for the economy in general. In theoretical terms, it is a classic case of a particular fraction of capital being able to project its interests as indistinguishable from those of capital in general.
Thirdly, the major commercial players in the biotechnology market are large chemical companies such as Monsanto and Du Pont that have a long and established history of working with regulators in different political jurisdictions.
Far from being newcomers to the ‘game’ of regulation, therefore, these firms are strongly embedded in important policy networks within and outside government and are situated within established wider social networks which bring business and government personnel together.
The people the firms employ as lobbyists and in their regulatory affairs divisions are therefore known to regulators from frequent interactions across a range of issues facing the chemical industry.
Fourthly and perhaps most importantly is the fundamentally private-sector driven nature of the ‘gene’ revolution. Whereas the last ‘revolution’ in agriculture, with dramatic implications good and bad for the developing world, was heavily managed by public sector research institutions, the biotechnology revolution, in terms of scientific discovery, production and distribution, is largely a result of innovation and capital in the private sector. As is often noted in debates about biotechnology, the balance between actors and their authority in the public and private spheres has been significantly reconfigured in favour of the private.
Term Paper # 2. Explaining and Assessing Biotechnology Regulation for Business:
Some researchers assess the capacity of different approaches to the regulation of the social and environmental risks associated with genetically modified (GM) crops. They start by examining the mechanisms of public regulation that have evolved to date at the national, regional and international level. Public regulation suffers from a number of flaws and limitations and fails to address key public concerns about modern biotechnology.
These weaknesses may be attributed, in large degree, to the influence of the biotechnology industry over the policy-making and regulatory process. Biotechnology regulations have responded more commercial and trade concerns than to public anxiety about environmental and social risks. In this sense much contemporary regulation provides regulation for business rather than regulation of business.
The perceived limitations of public regulation have prompted civil society actors to resort to alternative means to contest the commercialization of GM crops, to influence debates about the appropriate scope and scale of regulation, and to put pressure directly on the biotech firms.
These means include the use of civil liability litigation, direct action against GM crops and forms of ‘civil regulation’. They examine what contribution these techniques and strategies make to the overall regulatory environment and argue that they help to plug ‘governance gaps’ in the existing public regulatory system, as well as perform broader political functions.
These broader functions include democratizing and politicizing the biotechnology debate by challenging the hegemony of prevailing scientist and technicist discourses, and drawing companies into a debate about their social responsibilities as well as economic rights.
Regulation for Business:
The scope of regulatory activity in relation to crop biotechnology covers areas as diverse as the regulation of laboratory research, intellectual property protection, oversight of field trials, and the trade in GMOs, issues of food and feed safety, and product labelling. The structures that exist to regulate genetic technologies include ‘a mass of legal regulations, non-legal rules, codes, circulars, practice notes, international conventions and ethical codes’.
These are generated and overseen by an enormously complex set of advisory bodies, committees, professional bodies and business associations operating at the international, national and sub-national level.
In 2000, the Cartagena Protocol on Biosafety, the international agreement on the management of international trade in GMOs, gave new impetus to many governments to develop national biosafety laws. However, many had developed their own regulations independently during the 1990s.
The US adopted a product-oriented system which focuses on the characteristics and intended use of the end product rather than the recombinant technology deployed to create it.
The US stance has been to regard GM crops as products that are ‘substantially equivalent’ to their conventional counterparts, and that therefore they pose no special risks and no special regulatory regime is required such that regulatory oversight is left to the authority of existing laws and agencies. Under the second broad approach, adopted by the EU, regulatory oversight of a GMO is triggered by the genetic engineering process by which it was created.
This process-oriented approach regulates all products that have been produced using modern biotechnology techniques. EU regulation implements this approach by requiring prior consent and risk assessment for every proposed release, applying broad ecological criteria on a case-by-case basis both before and after a GM product’s release into the environment or a market. This precautionary approach means that controls are put in place even in the absence of definite information about the risks posed.
Despite these differences in approach, broadly speaking, regulation performs three key and closely related functions in the biotechnology context.
These are:
(i) Risk management
(ii) Facilitating commercial transactions and
(iii) Generating public trust in the new technologies.
While these functions overlap in practice, the imperative of facilitating the commercialization of GM products has been allowed to override a fuller consideration of the potential environmental and socio-economic risks associated with GM crops. This has undermined public trust and confidence in the regulation of biotechnology products.
Any public regulatory system designed to establish and enforce environmental safeguards is likely to have weaknesses that undermine its effectiveness or legitimacy. Some may be peculiar to developing countries, where capacity and resource issues represent serious constraints. Others may be related to the nature of the technology in question, or the strategic importance attached to it by the state or by business.
Collectively, these factors help us to understand the limits of effective public regulation and provide the context for the alternative strategies adopted by opponents of biotechnology, who perceive existing forms of public regulation to be weak, poorly enforced and corrupted by private interests.
Term Paper # 3. Capacity Building in Biotechnology:
Governments and regulatory authorities anywhere struggle to keep up with the pace and fluidity of change in the biotech sector. Regulatory systems are slow to evolve and modify, and governments often react to technological change in the private sector rather than drive it.
The practical difficulties of tracking the cross-border trade in GMOs, monitoring where such crops are being grown and enforcing biosafety regulations at farm level presents technical, logistical and administrative challenges to even the most developed countries.
Human and financial constraints magnify these problems for developing countries. A related issue is the ability of biotech companies to evade the regulatory authority of governments. NGOs in particular, have expressed concern that developing countries, which may lack the resources and capacity to oversee field trials and enforce regulations, may be viewed by biotech firms as attractive regulatory havens.
There have already been allegations that GM crops have been grown illegally in parts of sub-Saharan Africa, Latin America and South and East Asia. In India recently, Bt. cotton was found to have been cultivated without authorization in Gujarat.
The cotton seed in question was supplied by an Indian seed company which appeared to have back-crossed illicitly-obtained GM cotton into Indian cotton varieties. The story highlights the degree to which the capacity to carry out micro-surveillance at farm level is required both for the enforcement of biosafety laws and for the effective protection of private companies’ intellectual property.
The issue of capacity building for the effective management and enforcement of a national biosafety system has therefore been a prominent issue in the negotiations for the Biosafety Protocol.
Many less-developed countries lack an indigenous capacity in biotechnology, but find that they need to implement a biosafety regime in order to deal with the arrival of GM seeds and foods on the international market. They find that importers are seeking permission to bring GMOs into their countries, while some export markets are demanding supplies of credibly certified non GM foods and feeds.
Many developing country governments have therefore insisted that they require financial and technical support in order to fulfill their obligations concerning the regulation of this trade. In response, business groups have offered contributions in the form of workshops, training for developing-country regulators, and pilots of software for the Biosafety Clearing House.
It is difficult for LDC governments to turn down such offers of support from the private sector, but although developing country policy-makers regard business involvement with initiatives such as the design of the BCH as relatively unproblematic, most are alert to the risk of being influenced by such forms of support.
An LDC negotiator and an NGO representative they spoke to both also drew a distinction between capacity building in biotechnology and in biosafety. They agreed that capacity building in the former area would involve a genuine transfer of technology and expertise to developing countries, whereas capacity building for biosafety entails a much less substantial transfer of the limited skills and knowledge necessary to enable a technician to carry out a series of simple mechanical procedures and tests.
For its part, the business is cautious about providing direct financial support for individual countries to conduct their national biosafety policy processes. Although business executives are concerned about the stigma that may be attached to corporate funding, they are also reluctant to meet developing-country requests for financial support unless they also have some assurance that the industry’s views and concerns will also be taken on board.
In practice, the decision whether or not to provide financial or other support is generally taken on the basis of a business assessment of the company’s interest in the country concerned.
Although corporate representatives and developing country policy-makers are mutually cautious about being seen to engage with one another, the fact remains that LDC negotiators rely heavily on private sector sources for technical information about biosafety procedures and the implications for the trade in GMOs, particularly from grain traders who have accumulated vast experience in this area.
The biotechnology industry therefore uses the opportunity of multilateral summit meetings to circulate briefing notes and press releases and screen audio-visual presentations which LDC representatives are able to collect and review without having to approach an industry representative directly. One industry lobbyist claimed that their materials were generally snapped up by delegates from developing countries but rarely examined by developed country representatives.
By contrast, representatives from the countries like the US or member-states of the EU were much more likely to talk directly with business participants, but clearly did not depend so heavily for information on the industry’s claims about the likely implications of different outcomes to the Protocol negotiations.
Biotech firms also question the capacity of some developing countries to manage the demand for approvals of GMOs. Regulators in developing countries, in particular, have been subject to business pressure to speed up application procedures for biotech developments, to avoid ‘undue delay’.
The Indian government has been under pressure to create a ‘one-stop’ approval process, thereby consolidating the existing sequential series of regulatory steps. Though concerns regarding capacity may be less acute, similar pressures to accelerate the approval process have been applied to countries such as Canada where, ‘thorough assessment of environmental hazards and meaningful public dialogue have been sidelined by the imperative to market GE crops quickly and competitively’.
Companies also express frustration at the lack of know-how and experience among government regulators, especially in developing countries, and the delays caused by ‘excessive’ caution of officials responsible for risk assessments and approvals.
The biotech industry has also raised concerns over the security and confidentiality of commercially-sensitive data submitted to regulators, especially where decision making is fragmented across different government departments.
In this regard, firms regard with suspicion regulatory scientists who, as fellow biotechnology researchers, are potentially in competition with the private sector. By virtue of being regulators, public sector scientists have access to information and data that may be useful to their own research and would be unavailable by other means.
In the US and Canada, applicants have made extensive use of exclusions on grounds of commercial confidentiality. This is an important barrier to the free sharing of information and, while some information is made public, there remains a tension between transparency on the one hand and protecting the commercial interests of those being regulated on the other.
The reluctance of firms to disclose information about their research and development work inhibits a more participatory and deliberative policy process, and therefore forms a barrier to the exercise of broader and more inclusive forms of public scrutiny and control over the direction and applications of the technology.
The question of state capacity also arises in relation to the participation of developing countries in multilateral negotiating forums. It has been observed in relation to the WTO process in particular that poor countries lack the resources to participate effectively in major negotiations, particularly where a number of sub-committees and working groups, dealing with a variety of specialized technical matters, meet simultaneously in different rooms. The nature of the negotiating process on biosafety issues raises similar concerns.
In an effort to deal with this shortcoming, groups like the G77 or the African Group combine their strength and coordinate their participation in the different negotiations. In doing so, country representatives rely on the ability of delegates from other countries to faithfully represent an agreed negotiating position and provide an accurate report back at the end of a session.
Unlike the EU or the Miami Group, which are relatively small and have only to accommodate a narrow range of interests, large developing country groups can struggle to represent a wide diversity of interests, making them unwieldy and difficult to coordinate.
One observer of the Biosafety Protocol negotiations pointed out that this tends to mean that the G77 can only agree a very general ‘lowest common denominator’ position. In practice, many delegates who lack expertise or are poorly prepared tend to defer to a handful of delegates who have sufficient experience or knowledge to develop a coherent negotiating position.
Term Paper # 4. Public Regulation for Private Interests:
Businesses benefit from clear and transparent regulations that help to make their activities more certain, stable and predictable, enabling them to make more informed, confident investment choices. Regulation can bring order to commercial interactions and lower transaction costs, as well as confer legitimacy upon business transactions.
Internationally, harmonized regulation can reduce barriers to trade by creating common standards and rules of conduct, and prevent the growth of obstacles to investment. However, firms also want regulatory procedures that are quick, entail low transaction costs and create minimal interference with their commercial goals.
For these reasons the private interests that are meant to be the subject of public regulation have been proactively shaping the form and scope of that regulation. Businesses are often keen to ensure that decision-making is as technical and devoid of political conflict as possible.
Therefore business has expressed concern about widening the regulatory circle too far, both in terms of the actors involved and the range of issues considered. During the negotiation of the Biosafety Protocol, industry sought to resist the attempt by countries such as Ethiopia and Malaysia to insert language that would have allowed states to evaluate the socioeconomic impacts of GMOs in their risk assessments.
While the European Commission conceded that, in special cases, it may consider socio-economic aspects of the technology, the European biotech industry has insisted that product regulation should ‘assess only safety, quality and efficacy for man and the environment on the basis of objective scientific criteria’.
‘From industry’s standpoint social need should be determined by the free choice of consumers in the market’. One of the ways in which firms have sought to restrict the scope of systems of public regulation for GM crops, is by invoking international trade rules. Where GM risk assessments do not conform to industry’s preferred standards, and especially if they are considered to include ‘political’ elements, they are prone to be condemned as ‘illegitimate’ trade barriers.
US industry spokespeople attacked the EU’s de facto moratorium on GM crops as a WTO-illegal restriction on trade. From industry’s perspective, the WTO has the advantage that its dispute settlement mechanism can adjudicate on trade disputes and gives priority to trade considerations in all its deliberations.
An essential feature of this approach is that regulation on environmental and food safety risks should be founded on the principles of ‘sound science’. For example, the Technical Barriers to Trade (TBT) and Sanitary and Phyto-Sanitary (SPS) agreements of the WTO stipulate the use of ‘sound science’ criteria as the only legitimate basis on which risks may be invoked as grounds for restricting trade. This narrows the opportunities available to countries to justify restrictions on trade according to other criteria. From an industry point of view, the appeal to science is also key to public credibility.
The appeal to trade rules also reinforces the effort to harmonize risk assessment procedures internationally. Increasingly there is a set of global pressures for establishing common means of identifying and managing the risks associated with GM products, that emanates from the OECD, the ‘Miami group’ and leading companies in the biotech sector.
The biotech industry has lent its support to initiatives such as the OECD guidelines, which are aimed at reducing barriers to trade by making regulatory requirements more transparent, predictable and universal, thus helping to reduce transaction costs for business.
Some argue that ‘harmonization efforts gained impetus from many sources: from free-trade imperatives, from applicants operating across national boundaries and ultimately from marketing applications, which stimulated regulators to try to reconcile their data requirements.’
The way in which particular approaches to regulation and risk assessment are reified as an appropriate model for the world has important implications for the policy discretion of developing countries that are expected to accept and endorse these standards.
The issue is not just one of trust as Jasanoff argues, where ‘Transplanted to other national decision-making contexts, risky technologies are exposed to different underlying conceptions of causation and control as well as to different cultural attitudes about the trustworthiness of regulatory authorities’.
The use of ‘scientific’ principles, which compare the novel aspects of technologies with what we already assume to be safe, has been one device for projecting confidence that any undesirable effects are under control.
The principle of ‘substantial equivalence’ (SE) is used to compare the risks associated with products containing GMOs with those produced with traditional plant-breeding techniques. It is designed, not as a substitute for risk assessment, but rather as a means to provide reassurance that a new food product is comparable in terms of its safety to its conventional counterpart.
The OECD has sought to get SE accepted as an international regulatory concept by establishing a programme on the harmonization of regulatory oversight in biotechnology. The idea is to provide policy-makers with science-based and predictive capacities in any political and ecological setting, thereby encouraging harmonized regulations that facilitate trade.
For Michael Osborne of the OECD, ‘This harmonisation process provides significant savings for countries by avoiding duplication of scientific trials and creating mutually acceptable best practices among regulators’.
In the European context too, efforts at achieving a harmonized approach to biosafety regulation are driven by the broader political and commercial objective of creating a single market. The EC Deliberate Release Directive explicitly constructs procedures to ‘complete the single market’, but also sought to address business concerns that divergent regulatory regimes would hamper access to the European market.
European regulators were under pressure from business groups claiming that companies would shift R&D investment to North America if product approvals were unduly delayed. Differences in implementation of the European model of harmonization by individual member states are thought to produce a ‘different harmonization model’ rather than a deviation from harmonization per se.
The concept of ‘familiarity’ is also used in many regulatory regimes for the dual purposes of projecting confidence in the regulatory process, as well as facilitating the trade in GM products. It has been incorporated into the regulations of several countries as a ‘trigger’ for risk assessments.
Because the only way to gain familiarity with commercial releases is by allowing for commercial releases, ‘familiarity closely binds regulatory oversight with industrial interests and market imperatives’.
These authors find that in practice both substantial equivalence and familiarity, ‘support decisions to de-regulate GE crops by promoting biotechnology as an innovative and competitive technology, while simultaneously downplaying concerns for environmental hazards’.
For them, familiarity and SE function as a type of international currency that facilitates the trade and exchange of GE crops’. The principles act as powerful gatekeeping tools, in so far as risk assessments are only mandatory for GE crops not considered to be familiar or substantially equivalent. Ironically, of course, while trade barriers are to be removed on the grounds that there is essentially nothing new about GM products, for the purpose of protecting intellectual property, they have to be seen as novel and innovative.
The high level of startup capital that is required in crop development drives companies to seek intellectual property protection for their investments from public regulators. This is in order to cover the substantial research and development costs of crop innovation and, for many firms, to satisfy the demands of venture capitalists, whom they are dependent on for start-up money, for a short-term return on their investments.
Biotech firms claim that intellectual property protection is crucial to their business strategies, and even that ‘Implementation of a regulatory framework and administrative procedures to ensure the protection of intellectual properties, are a vital prerequisite for economic development through innovation’.
This commercial imperative explains the support biotech companies have lent to the TRIPs agreement of the WTO which requires member countries to put systems of patent protection in place at the national level.
Regulation for business brings other commercial benefits for firms. Some argues forcefully that major biotech companies have lobbied for more restrictive regulation than could be justified on ‘scientific’ grounds, in order to create a market entry barrier to smaller competitors that are less able to afford the costs of compliance.
Moreover, as Levidow and Tait suggest, ‘Even those who downplay the risks favour such regulation, if only in order to establish clear rules for commercial competition and to allay public fears’.
In this regard, the biotech firm Aventis notes the potential usefulness of labeling. ‘Aventis supports labelling of GMO produced food products, viewing it as a fundamental step in the future acceptance of biotechnology and genetically improved foods’.
Term Paper # 5. Mutual Interests of Business and the State:
The nature of the relationship between the state and business is crucial to understanding why governments have been so responsive to the pressures and demands made by biotechnology companies of public regulators. The relationship is intensified in the case of biotechnology because the interests of industries coincide strongly with governments’ own definitions of their national interest, envisaged as generating growth through hi-tech development in the biotech sector.
The biotech industry has been able to present itself as a key component of the knowledge economy, invoked as a major driver of growth by both European and North American governments, especially the US and UK.
To encourage companies to engage in biotechnology R&D, governments have provided a range of financial incentives, soft loans and other subsidies, supportive infrastructure and policy frameworks, as well as sponsoring public-private partnerships. In many countries of the South too, high hopes are invested in biotech to deliver rapid growth.
Similar to the story in Europe, industry coordination at the international level was initially poor. One industry lobbyist who has followed the Biosafety Protocol process since 1995 described the industry’s performance in consultation meetings with policymakers as ’embarrassing’.
In 1997, business representatives were invited to a meeting with representatives of the EU, but neither side was well- prepared. The EU bureaucrats had arranged the meeting as an opportunity to the industry to represent their views, but the industry representatives had expected merely to be briefed on the EU’s position.
There was no coordination among the business representatives and none of them felt they had a mandate to speak on behalf of the group. The corporate executives left the meeting with the feeling that they had performed badly and needed to be better organized in the future.
Today, firms are key actors in the international institutions engaged with the biosafety issue. Much of the capital and knowledge about GMOs is tied up in the private sector and so it is unsurprising that those with the expertise and whose products are the subject of regulation, are heavily involved in the international governance of crop biotechnologies.
For the purposes of presenting a unified position at the international negotiations on biosafety, national and regional industry bodies formed a Global Industry Coalition in 1998.
The coalition brings together groups such as Europa Bio, Biotechnology Industry Organisation (US) (BIO) and the Bio-industry Association (UK) and works closely at national level with organisations such as the ‘All India Biotech Association’ that have played a prominent part in articulating industry concerns within state level policy processes.
As a result of these forms of political mobilization and the expertise and financial clout of the firms that underpin them, the biotech sector provides further evidence of what has been called the ‘privatization in the United Nations’, where standard-setting is increasingly conducted by corporate representatives, working alongside other governmental and nongovernmental specialists.
Multinational corporations and trade associations are aware of the role that Codex has been given by the WTO agreements as the means by which disputes over trade in food products may be resolved.
It is notable, however, that the work of Codex on labelling, that has been strongly opposed by many industry groups, has been slow to develop as ‘narrow technical issues, once only of interest to specialists, have become public policy issues of huge economic importance’.
At the national level too, ‘Development of relevant legislation has progressed with glacial speed, standards are often only partial, and implementation remains spotty and in most occasions and enforcement is weak if present at all’. The prominent role of industry groups in building the capacity of governments to engage in the trade in GMOs, and working with the GEF on pilot biosafety programmes, also indicates a high level of engagement.
The Biosafety Protocol itself reads in places rather more like an investment agreement for biotechnology, confirming the entry and exit options of MNCs, than an environmental accord. This is attributed by some observers to the influence of biotech firms on the positions of key players in the negotiations, such as the US and Canada from the Miami group, in ensuring that the agreement was consistent with the free trade principles of the WTO.
Key to performing this role has been a degree of organization and cohesion among leading firms involved in the process which has grown over the course of the negotiations. At the first meeting of the Ad Hoc Working Group on Biosafety (BSWG) in Denmark 1996, private sector participation was extremely limited and companies and associations were unsure about what level of resources to commit to the process.
There are issues here, however, of representation relating to priority-setting and decision-making within business associations. Other work on the role of industry associations in international environmental negotiations has found that ‘global’ coalitions are often better at representing the concerns of European and Northern American firms than of the few firms from developing countries among their membership. The case of the biosafety negotiations provides evidence of the same pattern.
Nationally based firms and small and medium-sized enterprises are also underrepresented in these global coalitions and they often lack the resources to track, much less influence, international decision-making processes in their own right. Industries represented in the coalition are principally drawn from seed and pharmaceutical companies, commodity traders and shippers and food manufacturers.
It also appears to be the case that Southern-based firms, including those which are subsidiaries of or involved in a joint venture with a more powerful TNC, have little opportunity to articulate specifically southern perspectives or get their concerns adopted by industry associations that are dominated by large and powerful TNCs based in North America and Europe.
Representatives of southern subsidiaries of biotech multinationals expressed to us their frustration about how the political priorities and lobbying strategies of their firm, and the industry groups to which they belong, are determined.
One industry executive from the South also articulated a scepticism about the way in which individuals from southern firms are put in the spotlight, as ‘voices of the south’, mobilized to support the claims made by the parent company about the appropriateness of biotechnology to developing countries.
Interviews suggest that the priority setting process within industry coalitions does not inherently exclude issues that concern southern members. However, the priorities chosen tend to reflect both the composition of the membership, skewed as it is towards the North, as well as the superior access which Northern firms have to both strategic information and the channels of influence necessary to articulate industry interests effectively.
This balance of power also tends to be reinforced by the role of key individuals within industry organisations, who tend to have a perspective which reflects that of the dominant Northern member-companies.
Individual lobbyists or executives are responsible for tracking the negotiations, feeding back and consulting members about developments, coordinating meetings, email discussions and telephone conferences, and elaborating new positions for the coalition. These individuals therefore have a strong influence over the agenda-setting process. Some individual firms seem to be better equipped to engage with this type of process than others.
Term Paper # 6. Implications for Effective Public Regulation:
The limitations of state capacity, pressure from the private sector and powerful governments, the constraints placed by international trade rules and demands for harmonization, and the tendency of many politicians to equate key strategic national interests with the interests of private companies, raise questions about the extent to which public policymakers can exercise a degree of autonomy to determine what regulations are appropriate and desirable for their own country.
Again, because of their economic weakness and dependence on firms for inward investment and aid from donors in GMO-exporting countries, the autonomy of developing countries is likely to be particularly circumscribed.
One key challenge is the apparent tension in the politics of regulation, between the potentially conflicting goals of promoting a strategic industry and, at the same time, regulating the ecological and social impacts of that industry. This tension between governments’ role as promoter of biotech and protector of the public interest is manifested in competing bureaucratic mandates.
In Germany, for example, these functions are also combined in a single law, affirming ‘the states presumed capacity to undertake these potentially conflicting tasks without compromising the rights or values of its citizens’.
The extent to which this tension will impact upon the effectiveness of public biotechnology regulation will depend partly on the extent to which a government has sufficient capacity for autonomous action. It will also depend on the extent to which there is an active civil society contesting the predominant framings of regulation for business.
Nevertheless, the European and Indian experiences suggest that vocal protest movements may be more effective at engaging with consumer concern than they are at reorienting regulatory systems towards meeting broader notions of the public interest.
Those governments that have sought to take a more restrictive stance on the trade in GMOs, such as Croatia and Sri Lanka have encountered intense opposition from GMO exporters and in many cases have been forced to back down following intense bilateral pressure from the US government, including the threat of a case being brought at the WTO.
Public regulation is in many respects, at this stage, a blunt and ineffective instrument for managing the social and environmental impacts of biotechnology that reflects the privileging of trade and commercial concerns. We have also seen how the scope and nature of regulations adopted by international organisations are often shaped by market needs and the pressures exerted by market actors.
The emphasis of bodies such as the OECD on harmonisation of risk assessments, as a means to facilitate trade, and the preference of UNIDO for a code of conduct on biotechnology, both indicate the ways in which the policy preferences of international organisations and their autonomy of operation are conditioned and affected by prevailing ideologies about what constitutes an acceptable form of regulation, which accord with the preferences of leading market actors.
Term Paper # 7. Confronting Public Regulation, Constructing Civil Regulation:
Some groups have sought to confront the elite and technicist nature of policy discourses around biotechnology by subjecting expert claims to public scrutiny. Groups such as Action Aid have used ‘participatory’ methods to enable poor farmers to assess the professed benefits of GM crops for themselves by cross-examining ‘experts’ from the scientific, corporate and government community.
These methods include ‘citizens’ juries’ and ‘scenario workshops’, facilitated and organized by NGOs, academic institutions, and involving associations of farmers and landless peoples in Karnataka and Andhra Pradesh, Brazil and Zimbabwe.
These events have raised issues of power around access, control and affordability of the crops, as well as the provision of compensation if the crop fails to deliver the claimed benefits. In doing so, they have helped to highlight issues of concern to the ultimate users of GM seeds and contributed to a more inclusive public dialogue about the appropriate social control of the technology.
In India, members of the government’s Department of Biotechnology attended the meeting to provide an account of government actions and hear the concerns expressed by the jurors. Even if such events do not result in an immediate change in public regulation, they help to create a bridge between the formal and informal regulatory arenas, as well as drawing these broader issues into the public debate through the media coverage they attract.
In addition to engaging with corporations directly and facilitating alternative policy processes, civil society groups have also played an important role as watchdogs for the effective monitoring and enforcement of public biotechnology regulations.
India illustrates both the potential weakness of formal public regulation in developing countries, as well as the role of NGOs in demanding enforcement action from public authorities. In November 2001, the Indian NGO Gene Campaign asked the Delhi High Court to order a criminal investigation into the illegal selling of an unauthorized Bt. cotton variety, ‘Navbharat 151’, in Gujarat.
The illegal plantings had been discovered in October, but despite orders from the Government of India that the crop should be destroyed, it was known to have been harvested and sold on the open market. It was feared that the GM seeds had also been marketed in three other Indian states.
The cotton seed in the Gujarat case appears to have been obtained illegally by a seed firm. However, the fact that it was possible for the planting to go unnoticed for up to two seasons gives credence to the concerns of environmentalists, consumer groups and farmers, who fear that the whole apparatus of biosafety regulation may be irrelevant if enforcement is practically impossible and GM ‘contamination’ becomes a widespread fact.
Civil regulation should be seen to be as much about contesting the rights and responsibilities of firms as it is about disciplining their activities through legal means, however. NGOs have succeeded in generating a climate of skepticism about the safety of GMOs.
Through consumer boycotts, shareholder activism, alliances with supermarkets willing to declare their food-stuffs GM-free media battles with biotech companies, they have succeeded in drawing companies into a public debate about the environmental and human safety of GMOs and their ability to address the food insecurity of the poor. This has created new demands of the companies and expectations regarding their conduct.
Consequently, many of the companies find that even where they are in compliance with statutory biosafety regulations, they cannot afford to ignore the extra-governmental demands being articulated by media-savvy and politically-influential NGO groups. The voluntary guidelines were developed by the Supply Chain Initiative for Modified Agricultural Crops, a group representing biotech companies, agricultural suppliers and farmers.
The media has been a key battleground for the biotech debate, from Monsanto’s full page newspaper advertisements claiming to offer ‘food, health and hope’ to NGOs’ success in stigmatizing ‘Frankenstein foods’ and ‘terminator’ seeds.
The history of the terminator technology is a good illustration of the ways in which NGOs have succeeded in holding companies publicly to account for their actions, where public regulation has failed to. ‘Terminator’ is the label originally used by activists at the Rural Advancement Foundation International (RAFI) to describe a genetically engineered trait in which a plant is designed to produce sterile seeds.
RAFI and other NGOs launched a high-profile international campaign challenging the morality of sterile- seed technology, focusing in particular on its likely impact on poor farmers, who would normally save seed for replanting. The NGOs were able to stimulate a bruising public backlash against companies promoting this technology, but despite calls for public authorities to ban its use, governments did not act.
Instead, various firms publicly and unilaterally declared their intention not to commercialize terminator. They appeared to do so out of fear of the damaging public relations consequences of being associated with a technology that had been so roundly condemned.
Hence, while their behaviour was legitimate in a narrow legal and regulatory sense, company strategy was altered by public protest that was ignited and fanned by media savvy NGOs. Indeed, from the quiet beginnings of biotechnology regulation, when the regulatory process was essentially an elite, technical and collaborative process that took place out of the public eye, NGOs have succeeded in opening it up to the scrutiny of much wider publics.
This informal regulation by civil society actors has served to articulate a set of social demands and create normative boundaries within which corporations are expected to act, providing an extra set of non-legal checks and balances on the activities of companies.
In so far as firms internalize the expectations and anticipate the reactions of NGOs and consumers, then a degree of social control over the development of GM technologies can be said to have been exercised, that goes beyond the requirements of formal legal compliance.
However, as with civil regulation in general, it fails to meet the tests of predictability and enforceability, operating instead at the level of socially constructed expectations which companies will find it hard to anticipate and preempt.
In so far as micro-surveillance of GMO testing grounds and exposure of illegal growing by NGOs helps to compensate for the state’s own lack of capacity to monitor the trade in and trials of GMOs, civil regulation may be said to lend support to the infrastructure of public governance. Where informal regulatory arenas are created through citizen juries and the like, the basis for new social contracts between firms and publics is created.
In so far as firms change their behaviour in light of these encounters, a form of civil regulation can be said to have been exercised that extends control beyond what the public system provides. We may find in the future, however, that firms develop further their own forms of direct engagement with resource poor groups, rather than have to react to the agendas of those NGOs that claim to be the mouthpiece of the concerns and needs of poorer farmers.