by Sheila Jasanoff
In May 2003, the United States and several cooperating countries filed a case at the World Trade Organization (WTO) charging the European Union (EU) with maintaining an illegal, non-science based moratorium on genetically modified (GM) food and crops. Almost three years later, in February 2006, the WTO concluded that EU inaction between 1998 and 2004 had constituted “undue delay” in product approvals in violation of treaty requirements. That decision, however, did not immediately open European markets to American GM products. Indeed, in mid-2010 the European Commission proposed a legally controversial plan to allow member states to decide for themselves whether they wished to grow or ban GM crops—a sign of Europe’s continued inability to harmonize national differences concerning the implications of modern biotechnology for agriculture, environment and trade.
Transnational differences were equally evident in the area of medical biotechnology, most famously in relation to research with human embryonic stem cells (hESC). Here, British policy proved most liberal, allowing regulated but relatively unhampered derivation of stem cells from pre-14-day embryos. Italian and German law, by contrast, permitted no derivation of stem cells from embryos within their national territories, whereas U.S. policy regulating the use of federal funds for hESC research, thrown into confusion by a federal court decision (Sherley v. Sebelius) in 2010, seemed powerless to sustain a stable compromise. Controversy also marked the approval of GM animals for food, the patenting of human genes, the screening of embryos through preimplantation genetic diagnosis and direct-to-consumer genetic testing. Clearly, the global march of biotechnology has not brought easy policy convergence in its wake. Economic and technological superpowers cannot agree not only about how to promote biotechnology in agriculture and medicine, but even about what counts as science for regulatory purposes and how science and ethics should be integrated in managing biotechnology.
The seeds of dissension were sown long ago. They took root in the 1980s in divergent framings of the risks of biotechnology in the United States, the EU and its member states. Scientific accounts of the risks of biotechnology became enmeshed at that time with political practices through a process of “co-production.” This theoretical framework for analyzing science and technology in society stresses that knowledge about nature and society both conditions and is conditioned by choices about how people wish to govern themselves. Governance preferences include national civic epistemologies or habits of reasoning by which polities assess their rulers’ policy discourses, evidence and arguments.
Mid-century advances in genetic knowledge profoundly reshaped our understanding of what life is, how it is transmitted and what it means to be human. Attempts to govern the technological applications of this knowledge required the establishment or redesign of political institutions, identities, representations and discourses. Regulatory practices, legal norms and even ideas of statehood were renegotiated along with new biological concepts and constructs in processes that we now recognize as having constitutional significance.
Three distinct framings of biotechnology emerged in the United States, Britain and Germany—as product, process, and program—each resting on nation-specific scientific, administrative, legal and political supports. The product-based approach adopted in the United States went hand-in-hand with a scientific account of genetic engineering as a highly predictable intervention, grounded in molecular biology. In turn, that assumption of specificity underwrote a technological promise of untold benefits, entailing negligible adverse consequences for human health or environment and needing little additional control. Britain and the EU, by contrast, adopted a process-based approach which brought together ecologically oriented experts with a policy posture that recognized more uncertainties and called for a precautionary approach to regulation. Germany took caution a step further by highlighting political and ethical as well as scientific unknowns, evoking the risks of a programmatic alliance between science, technology and the state that might lead to abuses of power unless biotechnology were tightly controlled.
American political culture’s chronic aversion toward incurring opportunity costs, expressed through a laissez faire policy toward private risk-taking, accompanied by the state’s willingness to socialize costs when incurred, significantly lowered threshold barriers to biotechnological innovation. Subsequently, the framing of biotechnology as a stream of commercial products gained ready acceptance in a country where, in areas other than national security, the market routinely outcompetes the state as a model of legitimate social organization. A preference for market solutions grew during the 1980s as the Reagan era’s deregulatory fervor permeated federal administrative practices. With the downfall of communism and the “end of history,” the ideology of the market gained additional force. Pro-market and anti-regulatory tendencies manifested themselves across the entire range of governmental action on biotechnology, from the failure to enact comprehensive federal legislation in the 1970s to the relative laxity of regulation in the 1980s, and from the 1980 Bayh-Dole Act’s facilitation of university-industry technology transfer to the permissive patenting decision in Diamond v. Chakrabarty in that same year.
In Britain, by contrast, developments in agriculture as well as medicine illustrate the impacts of framing biotechnology as a special process. A proactive state policy toward biotechnology, endorsed by the Tories under John Major and enthusiastically embraced by Tony Blair’s New Labour government, contended with a sharply divided public response. In biomedicine, a relatively untroubled, science-friendly legal regime developed around research on human embryos and hESCs, facilitated by people’s ability to grasp the benefits of in vitro fertilization (IVF). It helped, too, that IVF was a homegrown technology for which the pioneering physician Robert Edwards won the 2010 Nobel prize in medicine. In the wake of the “mad cow” crisis, however, agricultural biotechnology suffered from a severe loss of public confidence, necessitating an extraordinary nationwide political consultation, known as GM Nation?, in an effort to restore trust. In each case the state’s legitimacy turned on whether governmental experts could satisfy demands for proofs and arguments that British citizens found persuasive; skepticism in each case reflected the state’s failure to provide compelling public demonstrations.
Germany, too, adopted the process frame along with Britain and the EU, acknowledging that genetic modification calls for special oversight in all domains of application. But taming biotechnology’s risks in Germany proceeded in tandem with taming recalcitrant historical and political memories both before and after the fall of communism in 1989 and the reunification of the divided state in October 1990. Key to the resolution of early political debates was the reaffirmation of Germany as a Rechtsstaat, or state of justice, where the rule of law enjoys supreme respect. This view of the state demands consistent, principled behavior on the part of government and strict adherence to basic constitutional norms such as respect for human dignity. In the German context, critics were able to frame the alliance between science, state and industry as having a programmatic character, risking abuses of power unless biotechnology was stringently controlled. Regulatory debates served, in effect, as staging grounds for struggles over the definition of postwar German democracy and national bioethical sensibilities.
The politics of biotechnology in the EU was subordinated in key respects to that in its member states. Questions about the acceptability of biotechnology’s products and the allowable forms of debate remained preeminently national in character. Yet to omit the EU political scene would be to miss an important element of the turn-of-the-century politics of globalization. Through its regulation of deliberate release of GM organisms and its enactments on labeling and traceability of GM foods, the EU carved out a space for “coexistence” that applied literally to GM and to non-GM products, but also metaphorically to different judgments by member states about the suitability of GM products for their national farms and tables. The US-EU conflict in the WTO can be seen in this light not simply as a battle over free trade but also over different models of multilevel governance in a scientifically united but politically heterogeneous world.
Comparative analysis demonstrates that making peace with biotechnology was never simply a matter of applying old political routines to new agendas; nor was it a case of creaky political institutions playing catch-up with rapid developments in science and technology. Through their attempts to accommodate biotechnology, each political system tested, and to some extent reinforced, deep-seated understandings of what is at stake in public sponsorship of science and technology. In this sense biotechnology itself was co-produced in each state with aspects of political culture and national civic identity.
Sheila Jasanoff is Pforzheimer Professor of Science and Technology Studies at Harvard Kennedy School. This post is an updated abstract from her 2005 book Designs on Nature: Science and Democracy in Europe and the United States. She is also the author of The Fifth Branch: Science Advisers as Policy Makers and Science at the Bar: Law, Science, and Technology in America.
