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Varieties of Secrets and Secret Varieties: The Case of Biotechnology

Susan Wright and David A. Wallace

Secrecy and Knowledge Production
Judith Reppy, Editor
Peace Studies Program, Cornell University
Occasional Paper #23
October 1999

 

Secrets do not develop in a social vacuum. Rather, the construction of a web of secrecy is a social process that defines relationships between those inside and those outside the web, the conditions under secrets are wholly or partially revealed, and the conditions of access and denial. Probably more often than not, those conditions are formed and perpetuated through extended overt or covert political conflict. To fully understand the social construction of secrets, we must ask how these relations are formed and by whom, how contests of secrecy develop, by what means, in what settings, with what effects.

The evolution of biotechnology is particularly interesting in this respect because its origins were remarkably transparent. The field evolved from what was once a purely academic discipline, molecular biology. Although actual behavior of individual scientists did not always measure up to the traditional norms of scientific inquiry, nevertheless, those norms were influential, supporting not only the (more-or-less) free exchange of research results but also broad public discussion of the social implications of the field.

After the commercial potential of genetic engineering, gene sequencing, and other techniques that provided the basis for biotechnology became apparent in the late 1970s, however, several developments combined to veil the new field in secrecy: first, the transformation of biotechnology from a field with largely academic connections to one with strong corporate connections; second, the U.S. Supreme Court’s establishment, in Diamond v. Chakrabarty, of intellectual property rights for life forms and the subsequent increase in secrecy within academic biotechnology research; third, the limiting of public access to information concerning controls for research and development in genetic engineering.

The first three parts of this paper examine these developments and the ways in which they have supported the formation of a new norm of secrecy for biotechnology. The fourth and final part addresses the implications of secrecy in the biotechnology industry for an important area of public policy, namely, the present negotiations aimed at strengthening the 1972 Biological Weapons Convention through measures designed to increase confidence in compliance.

 

The Social Transformation of Biotechnology

The early development of genetic engineering (a key technique of biotechnology) is unusual for a new technology because it took place in sites to which the public had considerable access–university research laboratories supported by government grants. As a result, the interests and goals of genetic engineering’s pioneers–Peter Lobban, the graduate student at Stanford University who was the first to conceive of a form of genetic engineering that worked effectively, Paul Berg, Stanley Cohen, Herbert Boyer, and Robert Helling–are known through documents that are public, such as a thesis proposal, grant proposals to the National Institutes of Health, and a proposal to the University of Michigan for a sabbatical. 1

This norm of transparency continued for some years as development of the techniques of genetic engineering proceeded. One expression of the persistence of traditional academic norms of research was the willingness of leading researchers to present their proposals for future research to the committee appointed by the National Institutes of Health to advise on possible hazards of genetic engineering. Detailed protocols specifying the genes to be transferred, the means for transferring them, and the recipient organisms were widely circulated not only to peers in the field but also to the larger public. 2

At the same time, industrial applications were widely anticipated and efforts were pursued to demonstrate the potential for using genetic engineering as the basis for a new industry in which microbes would be used as “factories” for making novel proteins. By 1976, two genetic engineering companies–Cetus and Genentech–were starting up and embracing a vision of a commercial future for gene splicing. “We are proposing to create an entire new industry, with the ambitious aim of manufacturing a vast and important spectrum of wholly new microbial products using industrial micro-organisms,” proclaimed a Cetus report circulated to potential investors in 1975. 3 That this vision was not entirely an effect of public relations hype is suggested by other events in this period. Stanford University applied for a patent for the method of inserting foreign DNA into a bacterium developed by two of the pioneers of the field. 4 And by the fall of 1976, at least six transnational corporations–Hoffman-La Roche, Upjohn, Eli Lilly, SmithKline, Merck, and Miles Laboratories–had initiated small research programs in genetic engineering. 5

Nevertheless, at this stage, industrial investments in the field were small. While the pharmaceutical industry was certainly alert to the potential of the new field, a key technique of genetic engineering was missing. From an industry standpoint, it was not enough to be able to transfer DNA from a higher organism into a bacterium. In addition, it was deemed essential that the foreign DNA could reprogram the bacteria to synthesize the products encoded by the DNA. As late as the mid-1970s, it was not clear that this was feasible. 6 Consequently, investors were wary. Conceivably, Cetus’s vision could turn out to be nothing but hype. In any case, for the moment, large corporations were content to watch developments in the universities and start-up companies like Cetus from the side-lines. 7

A turning point in industry perceptions of genetic engineering occurred in the fall of 1977 when Herbert Boyer at the University of California, San Francisco and vice-president for research at Genentech and Keiichi Itakura at the City of Hope Medical Center in Duarte, California, demonstrated that the DNA encoding a small human brain hormone could be used to program bacteria to make the hormone. 8

This achievement, proclaimed by the president of the National Academy of Sciences as “a scientific triumph of the first order,” was announced at a congressional hearing and attended by substantial publicity. From that point on, the technique was used repeatedly to demonstrate the bacterial synthesis of insulin, growth hormone, interferon, and other proteins normally made only by higher organisms. The trickle of investments in genetic engineering turned into a torrent as venture capitalists and transnational corporations raced to position themselves in the field. The transformation of genetic engineering from an area of academic research to an industrial technology was under way. Investments climbed steeply after 1977. By 1980, equity investments in small genetic engineering firms had reached $600 million. They would grow even more rapidly as front runners like Genentech and Cetus entered the stock market in the early 1980s. 9

Start-up genetic engineering companies moved quickly to lure scientists from universities with competitive salaries and stock options. Transnational corporations began to complement their investments in start-up firms with investments in university research. Between 1981 and 1982 alone, they invested some $250 million in biological research in universities and research institutes. These investments were supported by a most congenial economic and political climate shaped by legislation passed by the Carter and Reagan administrations that fostered university-industry cooperation, provided substantial tax credits for research and development, and allowed universities and small businesses rights to patents arising from federally supported research. 10

The torrent of investments in genetic engineering from the late 1970s onwards encouraged practitioners to form a variety of new affiliations with the private sector. Scientists, formerly cloistered in academe, became equity owners, corporate executives, members of scientific advisory boards, and industry consultants. By the early 1980s, it was said to be difficult to find a genetic engineer who did not have a corporate connection.

Considerable evidence shows that these roles introduced new norms for the practice of science. Following the Supreme Court decision on Diamond vs. Chakrabarty in 1980 (see below), the interest of genetic engineering firms and transnational corporations in securing patent coverage for their inventions produced confidentiality arrangements under which employees agreed not to disclose proprietary information or share materials. The start-up Biogen informed investors in 1983 that “in its relations with universities, Biogen seeks to maintain the maximum degree of openness consistent with reasonable protection of proprietary information,” and the company also noted that “trade secrets and confidential know-how may be important to Biogen’s scientific and commercial success.” 11 Universities implicitly supported this new norm by encouraging researchers to seek patent protection for their results. Symptomatic of these changes were the contradictions that began to embroil university research and teaching from the late 1970s onwards. Complaints of researchers’ unwillingness to share ideas and materials were aired. As genetic engineering pioneer Paul Berg, himself a member of the scientific advisory board to the company DNAX, told Newsweek in 1979: “No longer do you have this free flow of ideas. You go to scientific meetings and people whisper to each other about their companies’ products. It’s like a secret society.” 12 Legal struggles over ownership of cell lines flared up. While some universities issued guidelines to minimize conflicts of interest, these measures neither hindered the formation of corporate links with university research nor affected the basic conditions under which these links were formed. As Donald Kennedy, president of Stanford University summarized the social relations of molecular biology and its commercial offspring in 1980: “What is surprising and unique in the annals of scientific innovation so far is the extent to which the commercial push involves the scientists who are themselves responsible for the basic discoveries–and often the academic institutions to which they belong.” 13

In the 1980s a survey of university-industry research relationships in biotechnology by researchers at Harvard University confirmed what a growing body of anecdotal evidence suggested: that corporate linkages in biotechnology were growing and that these linkages were affecting the norms and practices of research in this field. 14 Most notable was the extent of the practice of secrecy of biotechnology, not only in corporations but also in universities. In 1986 the Harvard researchers concluded that “biotechnology faculty with industry support were four times as likely as other biotechnology faculty to report that trade secrets had resulted from their university research.” Furthermore, 68 percent of biotechnology faculty who did not receive industry support and 44 percent of those who did considered that university-industry linkages ran a risk of undermining intellectual exchange and cooperation. 15 Follow-up studies in the 1990s indicated that secrecy in this field continued to grow. 16

If the extent of the industry linkages with university researchers was low, such results might be of minor interest. However, a further study by researchers at Tufts University in 1985-88 demonstrated that the percentage of faculty members with industry affiliations in university departments pursuing research in areas related to biotechnology was high, peaking at 31 percent for MIT’s department of biology. 17 Taken together, the Harvard and Tufts studies indicate a major shift in the social relations of biotechnology, specifically, the formation of strong linkages between academic research in biotechnology and industry. The significance of this shift is discussed further in the following section.

 

The Establishment and Impact of Intellectual Property Rights for Life Forms

Despite claims that the issue of patenting life is solely one of law and technology, it also invokes a deep interplay of economics, social values, and access to information. 18 In 1980 the U.S. Supreme Court very narrowly (5-4) ruled in Diamond v. Chakrabarty that a patent could be obtained under section 101 of the U.S. patent law for a laboratory-created genetically engineered bacterium–that a “live, human made micro-organism is patentable . . . [as it] constitutes a ‘manufacture’ or ‘composition of matter.’” 19 The court argued here that the genetically engineered bacterium under dispute qualified for patent protection as it was not “nature’s handiwork” which produced the organism, but rather it was a “non-naturally occurring . . . product of human ingenuity,” which fell within the wide scope of patentability contemplated by the Congress. 20 Prior to this decision all that could have been obtained was a patent for the process that used the microorganism but for not the organism itself, the established norm at the time being that life was not patentable.

The Court received ten amicus curiae briefs in advance of their decision on this case–nine in favor of the patent and one opposed. A sample of four of these briefs (three pro-patent: Pharmaceutical Manufacturers Association (PMA), Genentech, Inc., and the American Society for Microbiology (ASM); and one anti-patent: The Peoples Business Commission (PBC)) reveals alternative perspectives on the patent’s consequences for openness of information.

Pro-patent briefs argued that patents would increase public knowledge and the exchange of scientific information because the Patent Act was in part an information disclosure statute. 21 Meeting the public reporting requirements for biotechnological inventions, however, is more complex than for other types of patents. Microorganisms and other patentable life forms cannot always be adequately represented by written documents alone. To ameliorate this potentially negative consequence of patented biological entities, one pro-patent brief argued that the depositing of organisms within authorized national culture repositories would help satisfy U.S. Patent and Trademark Office public reporting requirements. 22

More specifically to the point of secrecy, two pro-patent briefs claimed that in the absence of patent protection commercialization of biotechnological inventions would instead be shielded by trade secrecy, which had no public reporting requirement. 23 The anti-patent brief argued that the quest for patent rights to life forms had already inhibited the creation of Federal safety standards to regulate genetic engineering experimentation and implied that oversight of any such standards would be further hampered by corporate claims of protection of proprietary information. 24

The degree to which patenting life invoked a public interest produced an interesting split in the Supreme Court’s thinking at that time. The majority stated that the public interest was not an issue appropriately related to the legal question on whether microorganisms were patentable. They argued that the Court was not the proper arena for challenging the patentability of life forms on the grounds that genetically altered life forms posed “potential hazards.” 25 The dissenting minority held the opposite position. They believed that in this instance it was Congress’s and not the Court’s role to determine “whether and how far to extend the patent privilege into areas where the common understanding has been that patents are not available.” This was deemed especially so when the subject “uniquely implicates matters of public concern.” 26

The decade following the Court’s ruling saw a broad expansion of the scope of patentable subject matter. By 1987, PTO considered “nonnaturally occurring nonhuman multicellular living organisms, including animals, to be patentable subject matter.” 27 Currently, patentable subject matter includes natural, recombinant and synthetic genes and other DNA, cells and cell lines, gene and cell products like proteins and antibodies, as well as novel and preexisting biological “agents” such as plants and animals, and specific parts of plants and animals. 28

Since the Court’s decision in 1979, the growth and scope of the biotechnology industry has been impressive. At present, there are nearly 1,300 biotechnology companies in the U.S., employing over 150,000 workers. In 1998 these companies spent over $9.9 billion on research and development (R&D). The industry relies heavily on private investment seeking high returns, and believes that “patents are among the first and most important benchmarks of progress in developing a new biotechnology medicine.” 29 The successful commercialization of a biotechnology patent requires years of development and an average $300 million investment. 30 Between FY 1994 and FY 1997 the biotechnology industry entered over 48,000 patent applications (12,000 per annum). This is startling when compared to 1978, when only 30 biotechnology patents were requested, and 1988, when the number was just 500. As the biotechnology industry matured, the availability of patent information to the public began to evidence tensions in two areas: depository requirements and researcher secrecy.

In the Supreme Court case discussed above, one of the pro-patent briefs suggested that depository requirements would help biotechnology patents meet the law’s public reporting requirements. However, granting patents on life forms raises thorny questions regarding how and under what circumstances actual biological specimens should be handled in the patenting process and what role authorized bioculture repositories could play in storing the items.

The Patent Act states that reporting requirements for a specification must contain a written description of the invention and the process for making and using it. It must describe the “best mode contemplated by the inventor of carrying out his invention.” 31 It is the specifics as to what exactly satisfies the “best mode” requirement that has proved to be problematic. The law does not aggressively require deposits and the PTO makes determinations on a case by case basis, the argument against them being that deposited cultures are easy prey to infringement given that they are self-replicating entities. 32

In a 1992 symposium on legislative and legal issues in biotechnology patent attorney Albert P. Halluin reviewed recent legal decisions that depositing a bioculture in a registered and authorized culture depository was not necessary to fulfill the “best mode requirement of a patent specification. In one specific case, Amgen, Inc. v. Chugai Pharmaceutical Co., a federal circuit court determined that Amgen did not violate the “best mode” disclosure requirement when it did not deposit cells it had created. 33 Halluin, for one, argued that such a decision “breaks the patent bargain” whereby inventors get exclusive monopoly rights to their inventions for seventeen years in exchange for public reporting of the details of that invention into the flow of scientific information, and that, by not having to make deposits, inventors will receive the benefits of both trade secrecy and patent protection simultaneously. 34

While the issue of researcher secrecy did not receive attention from either the Supreme Court of the amicus curiae briefs in 1980, it has developed into a major issue. Privatization of biological knowledge engendered by the patent development process has hindered the sharing of such knowledge. Such withholding can actually undermine innovations in biotechnology because it limits reporting of research results. Some university-based researchers have become averse to freely sharing samples and delay publication of the research findings until after their patents are awarded. 35

A 1994 survey by Blumenthal found that 90 percent of 210 life-science companies, including biotechnology firms, conducting life-science research had a relationship with an academic institution and that over half of these relationships resulted in “patents, products, and sales” as a direct result of this relationship. An overwhelming majority of these companies sometimes require academics to maintain the confidentiality of information during and after the filing of a patent application, often at rates three times longer than that recommended by the National Institutes of Health. Withholding information in this manner was seen by Blumenthal and his co-authors as potentially denying other researchers the opportunity to conduct peer review that repeats and confirms/disconfirms prior work. Blumenthal concludes that the previous decade’s interaction between universities and industries “may pose greater threats to the openness of scientific communication than universities generally acknowledge.” 36

A related 1997 survey, also authored by Blumenthal, of over 2,000 life science faculty found that nearly 1 out of every 5 faculty reported that they delayed the publication of their results for at least six months; half of this group reported doing so because of patent applications. Faculty who were engaged in the commercialization of their research were found to be more likely to deny access to their research results and were three times more likely to delay publication for at least six months than those whose research was not targeted towards commercialization. 37 A more recent study by Blumenthal found that over half of some 1,000 university scientists who admitted receiving gifts from drug or biotechnology companies stated that these donors expected some influence over their work, ranging from patent rights to pre-publication review. 38

While unforeseen at the time of the Supreme Court ruling, the patenting of life has generally negatively impacted openness in terms of both the scope of patent reporting and the dissemination of research results. The largely unforeseen complications associated with depository requirements, and the increases in academic reluctance to share research results in a timely fashion, are shifting norms away from the traditional transparency that has long been associated with scientific inquiry.

 

Restriction of Public Access to Information Concerning the Development of Genetic Engineering

The early development of genetic engineering is unusual not only because the public had access to knowledge about the new field itself but also because it also had access to the processes through which policies for control of the new field were formed. The U.S. National Institutes of Health (NIH), which assumed responsibility for developing genetic engineering controls, was not a regulatory agency but rather the leading sponsor of biomedical research. The traditional norms of scientific inquiry encouraged openness in the NIH arena and the sunshine laws passed by Congress in the 1960s and 1970s reinforced those norms. Consequently, the meetings of the Recombinant DNA Advisory Committee (RAC) established by the Department of Health, Education, and Welfare to advise the NIH director on the safety of genetic engineering were open. Indeed it was said at the time that one of the best ways to get a sense of the cutting edge of this new field was to attend those meetings, which generated thousands of pages of information about future experiments.

This public face of government policy making for genetic engineering was widely registered in the press coverage of the time and has been the focus of much academic analysis since. There is, however, a less visible, but arguably more influential dimension of the formation of genetic engineering policy. The evidence comes from a series of meetings that took place between government officials and representatives of the pharmaceutical and emerging biotechnology industries in the late 1970s. These meetings were held out of the glare of the public spotlight on this controversial field. Consequently, they were much less registered in the press and in academic analysis. These meetings were, in general, unannounced, and information about them emerged long after they were held and mainly as a result of requests for records under the Freedom of Information Act.(7) 39 Meeting of DHEW General Counsel Peter Libassi, representatives of NIH and FDA, and representatives of the pharmaceutical industry, May 25, 1979, Department of Health, Education, and Welfare. They had little of the drama of the clashes that happened among members of the RAC and between the RAC and members of the public.

While the principal concern of academic scientists involved in genetic engineering was to get on with their research and not to be held back in relation to work in other countries, the principal concern of industry representatives who discussed their concerns with U.S. government officials in this period was quite different: the central theme of all of the meetings examined was the protection of trade secrets. Industry interest in maintaining secrets focused on the openness of the NIH procedures: The NIH controls promulgated in 1976 classified the large-scale culture and the release into the environment of genetically engineered organisms as “prohibited experiments.” This category did not mean that experiments were absolutely prohibited but that permission for an exception could only be granted after full disclosure of technical details and a review, held in public, by the RAC. From the first recorded meeting of pharmaceutical industry representatives with NIH director Donald Fredrickson in June 1976 onwards, industry representatives pressed for a major modification of this requirement. What the industry wanted, and eventually achieved in the 1980s, was review of their projects not by the RAC but only by a local “biosafety committee” appointed by the company pursuing the project.

The ideal policy-making procedure the industry desired was described in some detail at a meeting between Department of Commerce officials and representatives of the pharmaceutical industry in December 1977. 40 Protection of trade secrets was the paramount concern. The industry representatives proposed a system of “voluntary compliance” with the NIH controls, with the responsibility for monitoring the safety of industrial processes transferred to the local level, to biohazard committees appointed by the industry in question. A representative of the Upjohn Company gave as an example of an “apparently successful committee” a group established by Upjohn at its headquarters in Kalamazoo, Michigan, composed of six Upjohn executives and three prominent members of the local community. These people were “the highest type of person who would make sure that the public interest [was] properly served.” 41

From 1976 onwards, representatives of the pharmaceutical and biotechnology industries pressured the NIH director to devise means to protect corporate secrets by threatening to ignore the NIH controls whenever these secrets were at risk. For example, shortly before the NIH controls were issued in June 1976, the executive vice president of Eli Lilly, Cornelius Pettinga, informed the NIH director, Donald Fredrickson, that Lilly would not feel obliged to provide NIH with information about the organisms used in its genetic engineering work; nor would the minutes of its biosafety meetings be necessarily available for public inspection. If convinced of the safety of a genetic engineering process, Lilly would have “no hesitation in conducting” genetic engineering at industrial-scale volumes. Pettinga reminded Fredrickson, some of Lilly’s work would be “proprietary.” 42

Two years later, in October 1978, Genentech, with whom Lilly had contracted to do the development work for production of human insulin, made good on this threat. A front-runner in the race among biotechnology startups for dominance in the field, Genentech informed the NIH that its biosafety committee had approved large-scale production of human insulin with genetically engineered microbes at a containment level that violated the NIH guidelines. Despite NIH insistence to Genentech that large-scale production required prior review and approval by the RAC, the company continued to flaunt the NIH controls. In March 1979 the company informed the NIH that “due to problems of proprietary information, Genentech would make most of the decisions assigned by the . . . Guidelines . . . [by itself].” To the New York Times Genentech justified its action on the grounds that to submit data to the NIH would be to “risk divulging information to Genentech rivals who might force it from the Government under the Freedom of Information Act.” 43

The NIH responded to the Genentech rebellion not by disciplining the company, as it did the occasional unruly scientist–indeed, as a non-regulatory agency, it had no legal authority to do so. Rather, the NIH responded by adjusting its procedures to conform to industry requirements for secrecy. In May 1979, with the Genentech rebellion in full gear, the NIH director proposed to the RAC a “voluntary compliance” scheme in which industry proposals for large-scale work would be reviewed by the committee in closed session, with criminal penalties for committee members who divulged corporate secrets. 44

The largely academic RAC resisted this idea. The committee voted to recommend mandatory controls for the private sector–a signal to the U.S. Congress to take up the industry problem. As the Director of the National Institute of Allergy and Immune Diseases, Richard Krause, observed at a further private meeting with industry representatives a few days later, “this [procedure] represents a significant departure from traditional NIH procedures” and that “some [RAC] members might wish to resign when all of these considerations are brought to their attention.” 45 Krause had correctly read the committee’s response. It took a shrewd personal campaign for over a year on the part of the NIH director to persuade the RAC to accept the idea of keeping industry information secret. The practice of secrecy did not sit well with academics used to the freedom to share ideas–especially when jail terms for divulgence of corporate secrets were part of the bargain. Ironically, the only criminal penalty for violation of the NIH controls was not for the unauthorized release of genetically engineered organisms but for the unauthorized release of information concerning such organisms. 46

In 1982 these issues about public exposure of industry secrets began to disappear when a further major revision of the NIH controls transferred responsibility for industrial-scale uses of genetically engineered organisms to local biohazard committees–the model industry representatives had pressed for all along. A further issue of concern to industry–review of release of genetically engineered organisms into the environment–took several more years to settle. In the early 1980s, release of genetically engineered organisms into the environment was still seen as a significant concern. (After all, release negated one of the basic premises of the NIH controls, containment.) This was an issue on which technical opinion was seriously divided, as indeed it remains to this day. In this case, the White House Office of Science and Technologyolicy intervened and dealt with the problem of protecting industry secrets by taking the problem out of the NIH and putting it in the Department of Agriculture and the Environmental Protection Agency to regulate under existing statutes. 47 That move was hardly an ideal solution but it was no doubt satisfactory from an industry point of view since it served to take industry proposals out of the public spotlight.

In summary, the early NIH controls for genetic engineering were an anomaly in the history of regulation of private industry. The response of the emerging genetic engineering industry to the norm of openness the controls assumed reveals not only the drive towards secrecy by this industry but also the responsiveness of government institutions: when it came down to a choice between protecting traditional academic norms of open review or developing closed procedures, the National Institutes of Health chose the second course, even though a majority of the members of the NIH advisory committee opposed it. It was industry, not academic science, which won the temporary battle for introducing secrecy into the NIH procedures.

 

Effects of Secrecy in the Biotechnology Industry on Public Policy: Negotiations to Strengthen 1972 Biological Weapons Convention

The Biological Weapons Convention (BWC), which bans the development, production, stockpiling, and transfer of biological and toxin weapons, was negotiated in 1969-1972. With the important exception of the high levels of secrecy attached to research and development within biological warfare programs, this was a period when biological research was generally governed by traditional norms of openness, at least in the civilian sector. 48 This is not to say that the pharmaceutical industry at that time was not interested in intellectual property. Even in 1966, a British Foreign Office report referred to “the commercial secrecy with which so much microbiological work in the West is tied up,” dismissing the calls for openness at that time from non-governmental organizations such as Pugwash as “based on exceedingly frail assumptions about the cosmopolitanisms of scientists.” 49 At that point, however, the interests of pharmaceutical corporations focused on products and processes, not genes, cells, and organisms.

Furthermore, molecular biology in the 1960s was an academic field. Attempts to patent the results of “basic” research in molecular biology would have been seen as anachronistic and probably also as a barrier to the “freedom” of scientific inquiry. Harvard molecular biologist Matthew Meselson, who is often credited as an influence on President Richard Nixon’s decision to dismantle the U.S. biological weapons program and to support negotiations leading towards a universal ban on such weapons, has been, over the past three decades, a constant advocate of transparency with respect to biological research, of openness as the route towards strengthening the Convention. 50 And so, during the BWC negotiations, when the Soviet Union and other members of the eastern bloc proposed in March 1971 a draft convention that included an article committing parties to the “fullest possible exchange of equipment, materials, and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes,” 51 not a single country objected. Indeed, the proposal was so uncontroversial that the chief American negotiator, James Leonard, recalled that it provoked no discussion at all. 52

Today, some twenty-seven years after the completion of the BWC, the emergence of strong norms of secrecy in the civilian sector is having a significant impact on the further elaboration of the Biological Weapons Convention, and particularly on the efforts now under way to strengthen the Convention by negotiating a legally binding protocol with compliance and verification provisions. At the end of the cold war such an instrument was seen, particularly by some western states and by some non-governmental organizations, as a promising route to “strengthening” the Convention. This view also gained momentum from the progress being made at that time towards completion of the Chemical Weapons Convention and the Soviet Union’s general reversal of its previous opposition to on-site inspections. Despite reservations aired by the United States in particular, development of a verification Protocol received qualified support at the Third Review Conference in 1991, and following the work of an expert group and a special conference of the states parties in 1994, the negotiation of a Protocol by an Ad Hoc Group comprising delegations from the States Parties began in 1995.

From the outset, it was recognized by many States Parties as well as by leaders of the biotechnology and pharmaceutical industries that verification in the BWC context posed particularly difficult technical problems. Unlike chemical warfare agents, biological agents can be relatively easily produced and also easily destroyed. Quantities of biological agents, therefore, are not significant markers of the presence or absence of a bioweapons program. They may also occur naturally in the environment. Consequently biological verification poses difficult problems of interpreting both false positives and false negatives. Furthermore, both equipment and agents are largely dual-purpose in nature and cannot therefore be used as unambiguous indicators of the presence or absence of a bioweapons program. 53

Beyond these technical problems, the boundaries between permitted and prohibited activities defined by the Biological Weapons Convention itself introduce a further and serious ambiguity. The treaty as written does not draw a sharp boundary between defensive and offensive research and development, or even, in limited quantities, production. 54 Furthermore, by the fall of 1995 the experience of the UN Special Commission on Iraq (UNSCOM) had underscored the point that even highly intrusive, no-notice inspections might raise strong suspicions but were unlikely to produce definitive evidence of violations if the inspected party was intent on hiding evidence of bioweapons activities.

In response to these problems, proponents of verification proposed high levels of transparency in the biological sciences and biotechnology. According to an early and influential proponent of verification, “Full disclosure is the only guarantee of defensive intent . . . If a verification regime is to provide security, it must require and enforce total openness; at the same time, it will obviate the need for secrecy by constituting a better deterrent than any secret defense program.” 55 It is doubtful than any of the states parties would have endorsed such a call for complete openness. Nevertheless, the U.K. and several other states parties (including Australia, Canada, New Zealand, South Africa, the Netherlands, and Sweden), recognizing the major challenges of BWC verification, initially called for high degrees of transparency. In the words of a U.K. working paper, what was needed was “an integrated and balanced package of measures” comprising wide-ranging declarations, on-site inspections (known in this context as “visits”), challenge inspections and investigations of alleged use designed to uncover violations, and implementation by a professional inspectorate. Certainly this early vision of verification suggested that the regime would need to be even more intrusive than that of the Chemical Weapons Convention if it were to function effectively in deterring violations and in enabling states to provide reassurance about their biological defense activities. 56

From the beginning of the negotiations for the BWC Protocol, however, the U.S. biotechnology and pharmaceutical trade associations have opposed development of an intrusive verification regime and have pressed the U.S. Department of Commerce and the U.S. State Department to support their position. At the forefront of this effort have been the Pharmaceutical Research and Manufacturers of America (PhRMA), representing the country’s leading research-based pharmaceutical and biotechnology companies, and the Biotechnology Industry Organization (BIO), representing some 1400 biotechnology firms. Foremost among the industry’s concerns is the risk of loss of intellectual property through information acquired by international inspectors during visits to industrial facilities. 57

Loss of intellectual property was also an important concern for the chemical industry during the negotiations leading up to the Chemical Weapons Convention. However, the growth of the biotechnology industry is currently extremely dynamic, with a ten-fold increase in the global market predicted for the 1990s, 58 and industry leaders have argued that it is more vulnerable to loss of proprietary information than the chemical industry. In a detailed paper sent to the U.S. State Department in 1995, the trade association BIO argued that “the sensitivity to loss of proprietary information is much greater in the pharmaceutical and biotechnology industries than in the basic and fine chemical production industries where numerous non-proprietary intermediates and catalysts are often used. Any implementation of a declaration and verification protocol under the BWC must protect proprietary information for the pharmaceutical and biotechnology industries where the U.S. is the undisputed world-leader.” In an analysis of the various off-site and on-site measures being considered at that time in Geneva as part of a verification package, the paper argued that all on-site measures, such as sampling, interviewing, identification of key equipment, and continuous monitoring as well as auditing off-site, were of greatest concern to the industry. 59

PhRMA and BIO have repeatedly pressed the U.S. government to respond to their interests in protecting their proprietary information. In June 1996, the president of PhRMA, Gerald Mossinghoff, wrote to then-Secretary of Commerce Michael Kantor expressing concern that “the U.S. may not be able to take a forceful leadership role in formulating a protocol that achieves the objectives of strengthening the BWC while protecting U.S. businesses’ legitimate proprietary interests.” The U.S. government was urged to “play a positive role in these negotiations and not stand by while other countries develop an international norm that could prove inimical to our national interests.” And it was also reminded that “the pharmaceutical industry is one of the few remaining U.S. industries with a positive trade balance that has been maintained for over ten years. We are relying on the U.S. Government to help us maintain this position as the BWC is negotiated.” 60

Rather than an extensive and intrusive regime aimed at transparency, the U.S. trade associations have pressed for drastically limiting the reach of such a regime with respect to information concerning industrial processes, equipment, and facilities. In a policy statement circulated in 1996, PhRMA proposed the following conditions:

No routine inspections of any kind.
On-site inspections limited to investigations of non-compliance.
Allegations aimed at an investigation of non-compliance to be subjected to a strong “green-light” filter requiring a vote of three-quarters of the members of an Executive Council of representatives of the States Parties to a Protocol in order to proceed.
Non-governmental inspected facilities to have the right to make the final determination of materials and equipment to be shielded from inspectors because of their proprietary nature. 61

Similar positions were advocated by BIO and by the Material Technical Advisory Committee, a group of senior executives drawn from U.S. industry and academia. 62 The positions taken by the European trade associations, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Forum for European Bioindustry Coordination (FEBC) in 1998 were less specific and somewhat more flexible than that of their American counterparts but nevertheless aired the same concerns. In a position paper circulated in 1998, EFPIA resisted the idea of site visits other than investigations of non-compliance and similarly urged that proprietary information remain under the full control of an inspected company. 63 FEBC specifically rejected routine inspections. 64

These positions contrasted with the support of the chemical industry for the CWC regime. The chemical industry, like its biotechnology counterpart, was certainly sensitive to the need to protect proprietary information. 65 Nevertheless industry leaders accepted such measures as routine visits to declared sites, sampling, and investigations of charges of non-compliance with a “red-light” filter. With a red-light filter, challenge investigations are carried out unless three-quarters of the members of the Executive Council vote against proceeding. They are therefore more likely to take place than with a green-light filter. Industry leaders were also, apparently, satisfied with the procedures for protection of confidential information provided in the “Annex on the Protection of Confidential Information” to the Chemical Weapons Convention. In contrast, measures to protect proprietary information proposed for the BWC Protocol have not so far reassured leaders of the biotechnology industry. The reasons for the differences in the behaviors of the two industries are beyond the scope of this paper to analyze in depth and they are no doubt complex. The Chemical Weapons Convention was completed at the end of the cold war, in a different negotiating climate; the chemical industry is an older, more established, less dynamic industry, and the patent data suggest that it is less dependent on “cutting edge” techniques; industry representatives also claimed that they were concerned about the negative public image that resistance to the CWC might yield; and so forth.

What is clear is that, in the absence of other, over-riding factors, concerns with protection of trade secrets have so far haunted the collective consciousness of the biotechnology industry, and have influenced national policy, perhaps particularly that of the United States. The effects of industry pressure on the U.S. position were evident in a brief White House statement issued in January 1998 that adopted a “green-light” filter for investigations of non-compliance. In addition, the White House paper dropped any requirement for routine inspections aimed at confirming the accuracy of declarations, proposing only “voluntary” visits where access as well as the visit itself would be controlled by the visited party, and “non-challenge clarification visits” designed to clarify ambiguities in declarations. 66 Since a “green-light” filter requires such a large majority vote to be pursued, it is likely to be very difficult to achieve in practice except in the most extreme circumstances. Thus the Clinton proposal amounted to not much more than a system of declarations plus a few clarifying visits.

Even so, the U.S. pharmaceutical and biotechnology industry was not satisfied. In March 1998, PhRMA chairman Sidney Taurel of the huge pharmaceutical corporation Eli Lilly wrote to National Security adviser Samuel Berger and Secretary of Commerce William Daley to express the continuing concern of the industry about “possible adverse impacts on biomedical innovation through harm to our companies’ intellectual property, reputations, and confidential business information.” Specifically, Taurel cited the industry’s “[worries about] non-challenge inspections and our skepticism whether any ‘voluntary’ visit will truly be voluntary.” 67 A United States working paper tabled in Geneva in July 1998 appeared designed to meet PhRMA’s concerns halfway. The paper proposed that clarification visits would be undertaken only after stringent efforts to address issues in other ways and only under conditions that allowed the visited party to protect proprietary information and to decide on access to samples. Furthermore, when the Director of the U.S. Arms Control and Disarmament Agency addressed the Ad Hoc Group in October 1998, his statement was remarkable for its complete silence on the question of visits. 68 In summary, the influence exerted by the U.S. pharmaceutical and biotechnology industries has had the effect of denying the United States a leadership role in Geneva in supporting a Protocol that provides transparency concerning intentions.

Over twenty years ago, before the change in the norms of biological research addressed in this paper had taken place, the Swedish diplomat Alva Myrdal wrote: “Openness is the primary tool for verification of disarmament . . . Immediately accessible to verification by the international community are scientific and technological data available through publications and other media.” Myrdal called for even greater openness, arguing that “the key to control of disarmament is the construction of universal confidence based on the cumulative process of shared information.” 69 The work of the Ad Hoc Group is premised on a similar view. The U.S. biotechnology industry’s desire for protection of industry secrets appears to be on a collision course with the needs of a compliance or verification regime for high levels of transparency. PhRMA and BIO do not represent every single biotechnology company and pharmaceutical corporation. (To this point, one or two have dissented from the trade association position.) But they represent some of the most influential members of a huge industry. It is doubtful that a verification system with the kinds of restrictions proposed by PhRMA could provide either reassurance about a country’s intentions or evidence of a violation, since a prohibited activity could be hidden under the guise of protection of trade secrets. But the negotiations are not yet over, and the industry’s position may yet evolve if the industry can be persuaded that support for a strong verification regime is in its best interests. 70 To this point, however, the evidence suggests that the change in norms of transparency in biotechnology has had the effect of seriously diluting present efforts on the part of governments and non-governmental organizations to strengthen the verification regime for biological weapons.

 

Conclusion

In the post-Cold War world there has been a general trend towards increased transparency by governmental bodies: classified archives are being opened and scholars and the public are developing a richer understanding of our shared recent past. Such initiatives will enable the world's societies to obtain a clearer sense of the reasons behind the ebbs and flows of the Cold War era. Ironically, at the same time that the public sector is generally making more information available about itself, both private industry and academia have witnessed increases in secrecy. The allowance of patents for biotechnology discoveries has had a negative impact on traditional norms of scientific inquiry, typified by openness of research and timely access to the results of research. The quite expensive race to obtain patents in the highly competitive biotechnology industry has led to a narrowing public access not only to the contents of actual patents, but also to the research undergirding the patents. While intellectual property rights serve as an incentive to investments in and commitments to scientific innovation, reducing scientific investigations to largely commercial endeavors whose rewards are largely contingent on obtaining patents will continue to erode informed public and academic discourse. Concerns over patentability have and will continue to drive researchers into non-disclosure and other secrecy commitments with private firms, thus severely concerning the nature of the organisms in use, the genes they carry, the techniques of modification, and the industry’s intentions for the future of the field. Such a trend poses substantial barriers to informed public policy discussion on the advisability and safety associated with life forms that are appropriated as “intellectual property.” Furthermore, as the case study on the Biological Weapons Convention shows, the secrecy now veiling the biotechnology industry may well impact policies in areas that appear remote from the initial sphere of action.

 

Acknowledgements

The authors thank the participants in the Cornell University Conference on Secrecy for a stimulating discussion of the issues and Judith Reppy for generative editorial suggestions.

 

Endnotes:

Note 1: Susan Wright, Molecular Politics: Developing American and British Regulatory Policy for Genetic Engineering, 1972-1982 (Chicago: University of Chicago Press, 1994), ch. 2. Back.

Note 2: These practices continued until the late 1970s when controls for genetic engineering were progressively weakened. By 1982, the responsibility for most decisions on genetic engineering precautions was delegated to local biosafety committees and public circulation of protocols for new research was, therefore, restricted: see Wright, Molecular Politics, chs. 9-10. Back.

Note 3: Cetus Corporation, “Special Report,” (unpub. c.1975). Back.

Note 4: U.S. patent no. 4,237,224, granted to Stanley Cohen and Herbert Boyer and assigned to Stanford University, December 1980. Back.

Note 5: Nicholas Wade, “Guidelines Extended but EPA Balks,” Science 194 (1976): 304. Back.

Note 6: J. Atkins, “Expression of a Eucaryotic Gene in Escherichia coli,” Nature 262 (1976): 256-57. Back.

Note 7: For details, see Wright, Molecular Politics, p. 83. Back.

Note 8: Keiichi Itakura, “Expression in Escherichia coli of a Chemically Synthesized Gene for the Hormone Somatostatin,” Science 198 (1977): 1056-63. Back.

Note 9: For details, see Wright, Molecular Politics, pp. 83-105. Back.

Note 10: David Dickson and David Noble, “By Force of Reason,” in Thomas Ferguson and Joel Rogers, eds., The Hidden Election: Politics and Economics in the 1980 Presidential Election Campaign (New York: Pantheon, 1981), pp. 260-312. Back.

Note 11: Biogen, N.V., Prospectus (October 14, 1982): 14. Back.

Note 12: Paul Berg, quoted in Sharon Begley, “The DNA Industry,” Newsweek (20 August 1979): 53. Back.

Note 13: Donald Kennedy, “Health Research: Can Utility and Quality Co-exist?” Speech given at the University of Pennsylvania, December 1980. Back.

Note 14: David Blumenthal et al., “Industrial Support of University Research in Biotechnology,” Science 231 (17 January 1986): 242-46; David Blumenthal et al., “University-Industry Research Relationships in Biotechnology: Implications for the University,” Science 232 (13 June 1986): 1361-66. Back.

Note 15: Blumenthal et al., “University-Industry Research Relationships,” p. 1364. Back.

Note 16: David Blumenthal et al., “Participation of Life Science Faculty in Research Relationships with Industry,” New England Journal of Medicine 335, 23 (5 December 1996): 1734-39; David Blumenthal et al., “Relationships Between Academic Institutions and Industry in the Life Sciences–An Industry Survey,” New England Journal of Medicine 334, 6 (8 February 1996): 368-73; David Blumenthal et al., “Withholding Research Results in Academic Life Science: Evidence from a National Survey of Faculty,” Journal of the American Medical Association 277, 15 (16 April 1997): 1224-28. Back.

Note 17: Sheldon Krimsky et al., “Academic-Corporate Ties in Biotechnology: A Quantitative Study,” Science, Technology, and Human Values 16, 3 (Summer 1991): 275-86. Back.

Note 18: For a discussion of some of these issues see: Daniel J. Kevles, “Ananda Chakrabarty Wins a Patent: Biotechnology, Law, and Society, 1972-80,” HSPS: Historical Studies in the Physical and Biological Sciences 25, 1 (1994): 111-36. Back.

Note 19: Diamond v. Chakrabarty, 447 U.S. Slip Opinion, pp. I-II. (1980). Inventions patentable under 35 U.S.C. 35 § 101 include discoveries of any “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. . . .” Back.

Note 20: Diamond v. Chakrabarty, 447 U.S. Slip Opinion, pp. 4-7. Back.

Note 21: 35 U.S.C. § 112 states that the patent “specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.” Back.

Note 22: Diamond v. Chakrabarty, Brief on Behalf of the American Society for Microbiology, Amicus Curiae, n.d., pp. 9-11. Back.

Note 23: Diamond v. Chakrabarty, Brief on Behalf of Genentech, Inc., Amicus Curiae, January 23, 1980, pp. 5-6, 14-15; Diamond v. Chakrabarty, Brief on Behalf of the Pharmaceutical Manufacturers Association, Amicus Curiae, n.d., pp. 12-14. Back.

Note 24: Parker v. Bergy and Parker v. Chakrabarty, Brief on Behalf of the Peoples Business Commission, Amicus Curiae, December 13, 1979, p. 20. Back.

Note 25: Diamond v. Chakrabarty, 447 U.S. Slip Opinion, pp. 2, 11. (1980). Back.

Note 26: Diamond v. Chakrabarty, 447 U.S. Dissent, pp. 1-2, 4 (1980). Back.

Note 27: U.S. Congress. Office of Technology Assessment, New Developments in Biotechnology: Patenting Life–Special Report (1989), p. 93. Back.

Note 28: Ned Hettinger, “Patenting Life: Biotechnology, Intellectual Property, and Environmental Ethics,” Environmental Affairs 22, (1995): 277-78. Back.

Note 29: Reported by the Biotechnology Industry Organization (BIO), Introductory Guide to Biotechnology. Available September 5, 1999 at <http://www.bio.org/aboutbio/guidetoc.html>; 1997-1998 BIO Editor’s and Reporter’s Guide to Biotechnology. Available April 1, 1998 at <http://www.bio.org/library/welcome.dgw>. BIO derived these statistics from Kenneth B. Lee, Jr. and G. Stephen Burrill, Biotech ‘97 Alignment: An Industry Annual Report, 11th ed. (Ernst & Young, 1997). BIO is the biotechnology industry’s most important trade and lobbying organization, representing over 700 biotechnology companies, academic institutions, state biotechnology centers, and other entities in over 47 states and 20 countries. BIO states that it “supports efforts of eliminate excessive, irrelevant regulatory burdens that inhibit safe and effective products from reaching the public as quickly as possible.” Back.

Note 30: James Nurton, “Biotechnology Patents: Biotechnology’s Winning Formulas,” Managing Intellectual Property, June 1997. Available March 27, 1998 at www.lawmoney.com/public/contents/publications/MIP/mip9706/mip9706.7.html Back.

Note 31: 35 U.S.C. § 112. Back.

Note 32: U.S. Patent and Trademark Office, “Deposit of Biological Materials for Patent Purposes: Final Rule,” 37 Code of Federal Regulations, Part I, Section 1801, January 1, 1990. Back.

Note 33: Amgen, Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). Back.

Note 34: Rudy Baum, “Knotty Biotech Issues Receive Attention,” Chemical and Engineering News (27 April 1992): 30-31. Back.

Note 35: A.J. Lemin, “Patenting Microorganisms: Threats to Openness,” in Vivian Weill and John Snapper, eds. Owning Scientific and Technical Information : Values and Ethical Issues (New Brunswick: Rutgers University Press, 1989). Cited in Hettinger, “Patenting Life,” (1995) p. 293. Back.

Note 36: David Blumenthal, Nancyanne Causino, Eric Campbell, and Nancy Seashore Louis, “Relationship Between Academic Institutions and Industry in the Life Sciences–An Industry Survey,” New England Journal of Medicine 334, 6 (8 February 1996): 368-73. Back.

Note 37: David Blumenthal, Eric Campbell, Melissa Anderson, Nancyanne Causino, and Karen Seashore Louis, “Withholding Research Results in Academic Life Science: Evidence From a National Survey of Faculty,” JAMA: Journal of the American Medical Association 277, 15 (16 April 1997): 1224-28. Back.

Note 38: “Corporations Swap Gifts for Influence Over Scholars,” New York Times, April 1, 1998. Two out of every three recipients of these gifts, which ranged from pieces of DNA to lab equipment to money, stated that the gift was important or very important to their research. Back.

Note 39: Industry meetings revealed by FOIA requests are as follows:

(1) Meeting of the NIH director, Donald Fredrickson, with representatives of the pharmaceutical and chemical industries, June 2, 1976, National Institutes of Health. This meeting was attended by representatives of Eli Lilly, Dow, General Electric, W.R. Grace, Pfizer, Monsanto, Smith Kline & French, Merck, and other large transnational corporations.

(2) Meeting of the Assistant Secretary for Science and Technology, Department of Commerce, Dr. Betsy Ancker-Johnson, with representatives of 17 firms including Abbott, Cetus, CIBA-Geigy, Dupont, General Electric, Eli Lilly, Merck, Monsanto, Upjohn, Wyeth, Searle, and Pfizer, November 19, 1976.

(3) Meeting of the NIH director, Donald Fredrickson, with representatives of the Pharmaceutical Manufacturers’ Association, November 29, 1976.

(4) Meeting between representatives of the National Institutes of Health, private industry, and the Department of Commerce, November 17, 1977, at the Pharmaceutical Manufacturers’ Association. No records available.

(5) Meeting representatives of the Department of Commerce, the National Institutes of Health, the Office of Science and Technology Policy, and the pharmaceutical and biotechnology industries, December 18, 1977, at the Pharmaceutical Manufacturers’ Association.

(6) Meeting with the General Counsel of the Department of Health, Education, and Welfare, Peter Libassi, and representatives of the pharmaceutical industry, October 13, 1978, Department of Health, Education, and Welfare. Back.

Note 40: Meeting no. 5, previous note. Back.

Note 41: Dr. George S. Gordon, Department of Commerce, Memorandum for the Record, on meeting with representatives of the pharmaceutical industry, December 19, 1977, held at the headquarters of the Pharmaceutical Manufacturers Association. Back.

Note 42: Cornelius W. Pettinga to Donald S. Fredrickson, 4 June 1976, Recombinant DNA History Collection, MC100, Institute Archives and Special Collections, MIT Libraries, Cambridge, MA. Back.

Note 43: Details of the exchanges between Genentech and the National Institutes of Health are given in Wright, Molecular Politics, pp. 324-44. Back.

Note 44: Wright, Molecular Politics, pp. 292-93. Back.

Note 45: Department of Health, Education, and Welfare, Minutes of Meeting of Pharmaceutical Manufacturers’ Association with HEW General Counsel, Peter Libassi, p. 3. Back.

Note 46: For a detailed account, see Wright, Molecular Politics, ch. 10. Back.

Note 47: See, e.g., Valerie Fogleman, “Regulating Science: An Evaluation of the Regulation of Biotechnology Research,” Environmental Law 17, 2 (1987): 229-64. Back.

Note 48: Activities in military contexts were an entirely different matter. The U.S. terminated its highly secret biological weapons program in 1969, but the policy guiding its continuing biological defense program (National Decision Memorandum 35, November 25, 1969) was silent on the question of secrecy. The former Soviet Union also conducted a secret biological weapons program which began in the 1920s and underwent a substantial expansion in the 1970s. For a detailed account of the latter, see Anthony Rimmington, “Invisible Weapons of Mass Destruction: The Soviet Union’s Biological Weapons Programme, 1918 to 1991,” in Susan Wright, ed., Meeting the Challenges of Biological Warfare and Disarmament in the 21st Century (forthcoming). Back.

Note 49: U.K. Foreign Office, Arms Control and Disarmament Research Unit, “Arms Control Implications of Chemical and Biological Warfare: Analysis and Proposals,” ACDRU(66)2 (2nd draft, 4 July 1966), p. 57. Back.

Note 50: See, e.g., Matthew Meselson, Martin Kaplan, and Mark Mokulsky, “Verification of Biological and Toxin Weapons Disarmament,” Science and Global Security 2 (1991): 235-52; Matthew Meselson, “Implementing the Biological Weapons Convention of 1972,” UNIDIR Newsletter 4, 2 (June 1991): 10-13. Back.

Note 51: Bulgaria, Czechoslovakia, Hungary, Mongolia, Poland, Romania, Union of Soviet Socialist Republics, “Draft Convention on the Prohibition of the development, production and stockpiling of bacteriological (biological) weapons and toxins and on their destruction,” 30 March 1971 (CCD/325). Back.

Note 52: Susan Wright, interview with James Leonard, August 1996. Back.

Note 53: United Kingdom, “The Role and Objectives of Information Visits,” 13 July 1995 (BWC/AD HOC GROUP/21). Back.

Note 54: Susan Wright, “Complexity, Ambiguity, Secrecy: The Problem of ‘Strengthening’ the 1972 Biological Weapons Convention,” in Susan Wright, ed., Meeting the Challenges of Biological Warfare and Disarmament in the 21st Century (forthcoming). Back.

Note 55: Barbara Rosenberg and Gordon Burck, “Verification of Compliance with the Biological Weapons Convention,” in S. Wright, ed., Preventing a Biological Arms Race (Cambridge: MIT Press, 1990), p. 304. Back.

Note 56: United Kingdom, “The Role and Objectives of Information Visits,” 13 July 1995 (BWC/AD HOC GROUP/21). For further analysis of the U.K.’s position, see Oliver Thranert, “Issues in the Ad Hoc Group to the BWC: How did the Three Depositary States–the United States, Russia, and the United Kingdom–Approach the Compliance Problem?” in Susan Wright, ed., Meeting the Challenges of Biological Warfare and Disarmament in the 21st Century (forthcoming). Back.

Note 57: The documents supporting this view were obtained by one of the authors (David Wallace) through a request under the Freedom of Information Act filed in 1998. Back.

Note 58: For discussion of these points, see Biswajit Dhar, “The Patent Regime and Implementing Article X of the Biological Weapons Convention: Some Reflections,” in Susan Wright, ed., Meeting the Challenges of Biological Warfare and Disarmament in the 21st Century (forthcoming). Back.

Note 59: U.S. Pharmaceutical and Biotechnology Industries White Paper on Strengthening the Biological Weapons Convention, (n.d.; sent by A. Goldhammer, BIO, to U.S. State Department, 23 June 1995), p. 2 and Appendix 2. Back.

Note 60: Gerald Mossinghoff to Michael Kantor, 12 June 1996. Back.

Note 61: Pharmaceutical Research and Manufacturers Association, “Reducing the Threat of Biological Weapons–a PhRMA Perspective,” 25 November 1996; circulated at the Fourth Review Conference of the Biological Weapons Convention, 25 November-6 December, 1996. For a detailed discussion of these requirements, see William Muth, “The Role of the Pharmaceutical and Biotech Industries in Strengthening the Biological Disarmament Regime,” in Susan Wright and Richard Falk, eds., Responding to the Challenge of Biological Warfare–A Matter of Contending Paradigms of Thought and Action, Politics and the Life Sciences, symposium proceedings, Politics and the Life Sciences (March, 1999). Back.

Note 62: Alan Goldhammer, BIO, to William Reinsch, Under Secretary for Export Administration, U.S. Department of Commerce, 3 July 1997; Alan Hart, Chairman, Materials Technical Advisory Committee and R&D Director, Advanced Materials, Dow Chemical Company, to Steven Goldman, Office of Chemical and Biological Controls and Treaty Compliance, U.S. Department of Commerce, June 27, 1997. Back.

Note 63: European Federation of Pharmaceutical Industries and Associations (EFPIA), Statement on the Biological and Toxin Weapons Convention (n.d. c. March 1998). Back.

Note 64: Forum for European Bioindustry Coordination, Position on a Compliance Protocol to the BTWC, Draft, June 30, 1998, cited in W. Muth, “The Role of the Pharmaceutical and Biotech Industries.” Back.

Note 65: See, e.g., Detlef Mannig, “At the Conclusion of the Chemical Weapons Convention: Some Recent Issues Concerning the Chemical Industry,” in Benoit Morel and Kyle Olsen, eds., Shadows and Substance: The Chemical Weapons Convention (Boulder: Westview Press, 1993), pp. 145-46; John Gee, “A Strengthened BWC: Lessons to be Learned from the Chemical Weapons Convention,” UNIDIR Newsletter No.33/96 (1996): 75-80; Ettore Greco, “Protection of Confidential Information and the Chemical Weapons Convention,” in M. Bothe et al., eds., The New Chemical Weapons Convention–Implementation and Prospects (The Hague: Kluwer Law International, 1998), pp. 365-70. Back.

Note 66: United States, Office of the Press Secretary, the White House, “Fact Sheet: The Biological Weapons Convention,” 27 January 1998. Back.

Note 67: Sidney Taurel (Eli Lilly), Chairman, PhRMA to Samuel Berger (Assistant to the President for National Security Affairs) and William Daley (Secretary, Department of Commerce), 9 March 1998; see also Jonathan B. Tucker, “Strengthening the BWC: Moving Toward a Compliance Protocol,” Arms Control Today (January/February 1998): 20-27. Back.

Note 68: United States, Working Paper: Proposed Elements of Clarification Visits, 9 July 1998 (BWC/AD HOC GROUP/WP.294); United States, Statement of John Holum to the Biological Weapons Convention Ad Hoc Group Session XII, 6 October 1998. For a more detailed analysis of the evolution of the U.S. negotiating position, see Oliver Thranert, “Issues in the Ad Hoc Group to the BWC: How did the Three Depositary States–the United States, Russia, and the United Kingdom–Approach the Compliance Problem?” in Susan Wright, ed., Meeting the Challenges of Biological Warfare and Disarmament in the 21st Century (forthcoming). Back.

Note 69: Alva Myrdal, The Game of Disarmament (New York: Pantheon Books, 1976), pp. 302-04. Back.

Note 70: If such a reversal were to happen, we might then learn more concerning the positions of a further sector interested in secrecy–the military agencies around the world responsible for biological warfare programs. Back.