The analysis of the meaning of biotechnology and its political, social and cultural implications has to take into account its definitions and how they have been constructed. Its definitions, in fact, show the kind of narrative about biotechnology: “technology of the past”
or “technology of the future”, field of research or industrial activity, normal or innovative intervention, risky processes or controllable ones. The descriptive elements are embedded in a narrative frame, with prescriptive implications for institutions and society. The law is one of the fields more affected by the construction of these frames. These frames are significant, as they suggest whether a technology entails risks or not, if regulating it is suitable or not, if its products fall within the definition of patent eligible matter and what kind of policy should be devised and implemented. However, the narratives paths are not so linear, as this section will show.
Several are the definitions of biotechnology proposed by international and national institutions. “Biotechnology”, according to the OECD, is “the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services”.551 This definition, which dates back to 1982, was based on the one offered by the Biosociety Group of the FAST (Forecasting and Assessment in Science and Technology) unit, which was established by the European Commission in 1979, that pointed out the promising technologies and sectors involved:
549 ibid 21.
550 ibid 189-218.
551 OECD, Biotechnology – International Trends and Perspectives, 1982,
<http://www.oecd.org/sti/biotech/2097562.pdf>,1, 18-19.
102
“The meaning that is most widely accepted is that it is the industrial processing of materials by microorganisms and other biological agents to provide desirable products and services. It incorporates fermentation and enzyme technology, water and waste treatment, and some aspects of food technology”.552
The central theme which brings together the two descriptions is the concept of
“transformation” of raw materials at the industrial level, namely the economic dimension of this activity devoted to the production of goods and services. In addition to it, is made a reference to the material means of transformation – microorganisms and other biological agents – and to the techniques of genetic engineering as a resource for expanding biotechnological production.
Several features, which were in Ereky’s definition of the 1910s,553 are embedded in it:
notably the scientific-technological dimension of biotechnology. These definitions, however, are the milestones of a path undertook in the 1970s and, then, pursued in the 1980s, which led to the extension and improvement of biotechnologies and the fulfillment of most of their industrial and commercial promises. They convey, therefore, the institutional acknowledgement that biotechnology had a high economic potential for industry.
Beyond this narrative, however, other ways of interpreting the meaning and implications of biotechnology had been formulated, centered on the innovative character of genetic engineering. In 1984, the U.S. Office of Technology Assessment published a Report entitled
“Commercial Biotechnology: An International Analysis”. The Report distinguishes “the old biotechnology” from “the new biotechnology”, explaining that the discovery and application of rDNA techniques and cell fusion accounted for it.554
The expression “new industrial revolution” largely used in the 1970s, when biotechnology became one of the major areas of policy interest, at the European Community and state levels, well expresses the promises which it in an industrial modernization perspective. The discourse of “modernization” has been very influential in promoting biotechnology as a
“technology of the future”, together with information technologies.
Gottweis555 and Wright556 illustrated how the institutional debate on biotechnology has been inscribed in Europe, at the national and Community level, in the perspective of international
552 Commission of the European Communities, “FAST Subprogramme C: Bio-Society”, FAST/ACPM/79/14-3E, 1979, 1, 3.
553 Bud (n 537) 32.
554U.S. Congress, Office of Technology Assessment, Commercial Biotechnology: An International Analysis (Washington D.C.: U.S. Congress, Office of Technology Assessment, OTA-BA-218, January 1984) 1, 3-5.
555 Gottweis (n 44) 159-163.
103 competitiveness and modernization, as far as declining scientific research and industrial sectors were concerned. The European policies on genetic engineering in the aftermath of the Second World War had been marked, notably in France, Germany and the United Kingdom, by the awareness of the backwardness of European scientific research in molecular biology and of the United States’ worldwide superiority in the field.557
The prospect of modernization contributed to back the narrative of the innovative character of biotechnology. Nevertheless, this narrative also relied on the new representation that rDNA techniques involved.
The innovative potential of a technology can be “normalized” by bringing it back in the circle of previous technologies whose risks have been already assessed and regulated. As a result, the technology does not require any special regulation. However, if the revolutionary feature of the technology is recognized, as well as some new potential risks, it will follow the need to deal with and manage these risks. The policy of biotechnology was affected by these issues.
One of the main divergences regarded the “process approach” or the “product” approach, which was at the core of the contrast between EEC (at present European Union) and the United States. Under the former approach, biotechnology is understood as a technological process, which solicits a special political and legal attention owing to its new inner characteristics; under the latter, conversely, it is considered as “an innocuous means to obtain products, which can be assessed pursuing to already existing regulatory principles”.558 Directive 90/220/EEC on the deliberate release of genetically modified organisms represents an eloquent example of the “process approach”, as the control to which it refers to regards all genetically modified organisms, not single products. This kind of choice is also important as far as the legislative EU competence is concerned, namely the drafting of regulatory bills.
Genetically modified organisms fall within a unique horizontal legislative mandate of the DG XI, whose General Council, which deals with the environment, drafted the two most important directives on biotechnology (even though in collaboration and competition with the DG XII, whose focus is research).
The alternative between “process approach” and “product approach”, which are two different ways of framing, implies as well a selection between horizontal or vertical legislation. A staff member of the Green Party in the European Parliament, in a briefing cited by Gottweis,
556 Susan Wright, Molecular Politics: Developing American and British Regulatory Policy for Genetic Engineering, 1972-1982 (The University of Chicago Press 1994) ix, 19-64.
557 Gottweis (n 44) 153-228.
558 Jasanoff (n 44) 79.
104 pointed out that these were crucial choices in the biotechnological debate:559 “Should the products of the new biotechnology be regulated on the basis of the process by which they were manufactured, requiring a new set of laws covering all GMOs, no matter of their function (horizontal legislation)? Or is it the process by which something is manufactured irrelevant as far as the legislation is concerned? According to this view, regulation should only be concerned with the end product (vertical legislation) and for that, the existing laws need only be slightly adapted to cover GMOs”.560
Fundamental regulatory choices can change in time. As it has been illustrated,561 Directive 2001/18/CE, which superseded Directive 90/220/CEE on the deliberate release of GMOs, introduced a new regulatory regime, in which single products derived from GMOs are regulated by vertical or sectorial provisions, which regard the n categories of products.
These basic choices seem apparently technical, but involve an axiological dimension, as in situations of scientific uncertainty they can strike a different balance among biotechnological production, citizens’ and animal health and environment protection.
What has been called “the micropolitics of meaning”562 emerges through the complex systems of representation that derive from different sectors, such as technoscience, medicine, economics, law, which shape the semantics of a field. Biotechnology has been at the core of this kind of micropolitics.
It is worth noting that, at present, to the term “biotechnology” is preferred the more reassuring expression “life sciences”. After the 1990s, when some political choices about biotechnology were challenged at the European level, as well as in some states, the word
“biotechnology” seems compromised. In the reconstruction of twenty-five years of debate on biotechnology in Europe, a group of sociologists remarked that, paradoxically, exactly when the commercial advent of biotechnology has become inescapable, the companies working in the sector has begun to abandon its use, owing to a negative sense which is associated to it.563 The preference for the new locution “life sciences”, in order to designate the whole productive field, in fact evokes calmer, less conflicting sceneries of medical applications.
This preference has also marked the language of legal monographs concerning the intellectual
559 The Member of the European Parliament is Linda Bullard.
560 Linda Bullard, Briefing for NGOs. Some Lines of Argumentation on Legislation of Pesticides Containing or Consisting of Genetically Modified Organisms (GMO – Pesticides), Memo, Brussels, June 18, 1991, 1, in Gottweis (n 44) 251.
561 Jasanoff, (n 44) 83.
562 Gottweis (n 44) 330.
563 H Torgesen et al., ‘Promise, Problems and Proxies: Twenty-Five Years of Debate and Regulation in Europe’
in M W Bauer and G Gaskell (eds), Biotechnology – the Making of a Global Controversy, (Cambridge University Press 2002) 21, 73.
105 property on biotech inventions, where “life sciences” has substituted, in the title and in the text, the compromised word “biotechnology”.564
Gottweis noticed that the history of biotechnology highlights a specific mode of representing the past by the dominant biotechnology narratives: in an ahistorical way or in monologically historical one. Ahistorical narratives present biotechnology as a “technology of the future”, whose potential will be fulfilled in a distant unspecified time, whereas the monological narratives represent it as “stemming from a long tradition, with beer and cheese production as
‘forerunners’ of genetic engineering”.565 In these kinds of narratives there are significant omissions, which will be accounted for in the next chapters.
564 Paul England (ed), Intellectual Property in the Life Sciences. A Global Guide to Rights and Their Applications (1st edn 2011, Globe Law and Business Limited 2015) 5.
565 Gottweis (n 44) 256.
106 Chapter Three
Imaginaries of Intellectual Property: Patenting Microorganisms and Organisms