Subject: PATNEWS: Economics and IP of cDNA sequences; Monsanto's soybeans

From: [email-masked] (Gregory Aharonian)
Date: Mon, 25 Nov 1996 02:26:28 GMT

The Summer 1996 edition of Human Genome News (a DoE publication) has an
article by Rebecca Eisenberg, a professor of intellectual property law at
the University of Michigan.  The article is about the patenting aspects of
partial cDNA sequences (expressed sequence tags), where you have a DNA
sequence you know has some function, but not knowing what the function is.
You won't be able to work with anyone to discover the function without
publicizing the DNA sequence, but if you do so, you could lose patent
protection.  But many object to awarding a patent for something for which
the utility is unknown, causing the controversy, a controversy made very
public in 1991 when the National Institutes of Health filed a massive
number of applications on such sequences (an act with its own stories).
In the following article, Prof. Eisenberg analyzes the different cDNA
database-usage strategies undertaken by Merck, Incyte Pharmaceuticals and
Human Genome Sciences.

    Dr. Eisenberg's article is followed by four documents distributed at the
Third Conference of the Parties to the Convention on Biological Diversity in
Buenos Aires raising many concerns with Monsanto's genetically engineered
soybeans.  The articles are the price the biotechnology industry pays for a
generally inept-to-total-lack-of public education, a price that is going to
increase in time as even more socially troubling genetic innovations become
public (and the biotechnology industry has lucked out that no one in these
environmental/third world movements ever reads PCT applications).  These
controversies are just one more reason why the full text of patents belong
on the Internet - the texts of biotechnology patents provides the best
starting points for discussing the social implications of such innovations.
And I would be glad to get in the middle with help from BIO :-)

Greg Aharonian
Internet Patent News Service
(for info on free subscription, send 'help' to   [email-masked] )
(for prior art search services info, send 'prior' to [email-masked] )
                              ====================

            Commercial strategies aim to spin DNA threads into gold
                    Rebecca Eisenberg, University of Michigan

    Intellectual property issues have been unusually conspicuous in the
recent history of genomic advances, even by the standards of the patent-weary
genetics and molecular biology communities.  Controversy has been particularly
acute over intellectual-property rights in the results of large-scale cDNA
sequencing.

    Beginning in 1991 with NIH's filing of patent applications on the first
batch of Expressed Sequence Tags (ESTs) from Craig Venter's laboratory, each
new development has been met with lively speculation about its strategic
significance from an intellectually property perspective.  Are cDNA fragments
of unknown function patentable, or must they undergo further research or
characterization before they satisfy patent-law standards?  Will patents on
such fragments promote commercial investment in product development or
interfere with scientific communication and collaboration and retard the
overall research effort?

    In the absence of patent rights, how might the owners of private cDNA
sequence databases earn a return on their investment while still permitting
other investigators to obtain information access on reasonable terms?  What
are the rights of those who contribute such resources as the cDNA libraries
that are used to create the databases and of those who formulate appropriate
queries to identify interesting sequences from the morass of information?
Will the disclosure of ESTs in the public domain preclude patenting of
subsequently characterized full-length genes and gene products.  And why
would a commercial firm invest its own resources in generating an EST
database for the public domain?

    Two factors have contributed to the fascination with intellectual property
issues in this setting.  First is a perception that some pioneers in large
scale cDNA sequencing have sought to claim intellectual property rights that
reach far beyond their own actual achievements to cover the future discoveries
of others.  For example, the controversial NIH patent applications claimed
not only the ESTs for specified sequences by also the corresponding full
length cDNAs and smaller portions that might not even include the disclosed
ESTs.  More reecntly, private owners of cDNA sequence databases have
conditioned data access on advance agreements offering either a license or
right of first refusal to any resulting intellectual property.  These actions
raise questions about the fairness and efficiency of the system to protect
intellectual property.  Such concerns are particularly compelling to research
scientists, who have more than commercial interests at stake.

    Second is the surprising alignment of interests in the data. NIH, a public
institution, initially took an aggressive position in favor of patenting
discoveries that some industry representatives thought were unpatentable and
should remain unpatented.  Merck ultimately took on the quasigovernmental
function of sponsoring a university-based effort to place comparable
information in the public domain. These topsy-turvy positions raise intriguing
questions about the proper roles of government and industry in genomics
research and about who stands to benefit - and to lose - from the private
appropriation of genomic information.

Promoting R&D Through Exclusive Rights

    Research scientists who work in public institutions often are troubled by
the concept of intellectual property because their norms tell them that
science will advance more rapidly if researchers enjoy free access to
knowledge.  By contrast, the law of intellectual property rests on an
assumption that, without exclusive rights, no one will be willing to invest
in research and development (R&D).

    Patenting provides a strategy for protecting inventions without secrecy.
A patent grants the right to exclude others from making, using and selling
the invention for a limited term, 20 years from application filing date in
most of the world.  To get a patent, an inventor must disclose the invention
fully so as to enable others to make and use it.  Within the realm of
industrial research, the patent system promotes more disclosure than would
occur if secrecy were the only means of exclusing competitors.  This is less
clear in the case of public-sector research, which typically is published
with or without patent protection.

    The argument for patenting public sector inventions is a variation on the
standard justification for patents in commercial sectors.  The argument is
that postinvention development costs typically far exceed preinvention
research outlays, and firms are unwilling to make this substantial investment
without protection from competition.  Patents thus facilitate transfer of
technology to the private sector by providing exclusive rights to preserve
the profit incentives of innovating firms.

Nonpatent Strategies For Commercial Exploitation

    No patents have been issued so far on cDNA fragments of unknown function,
although a number of private firms have pending patents applications that
claim thousands of such fragments.  Meanwhile, three firms - Human Genome
Sciences (HGS), Incyte Pharmaceuticals, and Merck - are pursuing different
non-patent strategies for exploiting the value of these sequences as
unpatented information. These strategies are exclusive licensing, nonexclusive
licensing, and dedication to the public domain, and it is still too early to
tell how each will pay off. We can see, however, how different firms are
placing their bets, and we also have some idea of the sizes of those bets.

    HGS and Incyte are exploiting their databases commercially by controlling
access to them, in effect using contracts and trade secrecy to protect their
intellectual property.  The viability of these strategies may be limited by
Merck's sponsorship of a competing cDNA sequencing effort at Washington
University dedicated to the public domain.  The commercial value of the
private databases is likely to decline as public-domain information increases.
Although public-domain databases are growing rapidly, the private ones remain
larger at this point and claim to offer superior products.  These products
include longer sequences of contiguous cDNA fragments; more complete sequence
annotations, including information about expression in different types of
tissues; high-powered bioinformatics capabilities; and user-friendly software.

    A significant limitation on the value of public domain databases is the
pending patent applications of private database owners.  If these applications
ripen into issued patents, they could preempt the use of any covered
sequences, even if those sequences were disclosed publicly before the patent
was issued, as long as the patent applicants are able to establish their
priority.

    U.S. patent applications are confidential until a patent is issued, so
determining which sequences are the subject of patent applications is
impossible.  Those who use sequences from public databases today risk facing
a future injunction if those sequences turn out to be patented by HGS or
Incyte on the basis of previously filed patent applications.  The same
uncertainty applies to sequences obtained from private databases; for
example, sequences that are obtained from the Incyte database may turn out
to be covered by a previously filed HGS patent.  Because the Merck initiative
got off to a late start, its sequences are more likely to be covered by
other firms' prior patent applications.

Exclusive Licensing

    For $125 million over a 3 year period plus royalties on product sales,
HGS has licensed exclusive rights to access its database to SmithKline
Beecham (SB).  SB also gained the right of first refusal to develop and
market protein therapeutic and diagnostic products from information in the
database.  HGS has entered into separate collaborative agreements with other
research partners for gene-therapy and other DNA-based product development.

    During the period of SB's exclusive license, investigators in academic
and nonprofit institutions may obtain access to some of the same sequence
information through a separate database maintained by The Institute for
Genomic Research (TIGR) under the terms of a Database Access Agreement.
The TIGR database includes sequences that are similar to previously published
sequences and accessible to nonprofit investigators with minimal restrictions
on use.  It also includes proprietary sequences that are accessible only to
those who sign more restrictive agreements giving HGS rights to prepublication
review and an option to negotiate a license to any resulting inventions.
Some academic investigators also have obtained access to sequences in the
separate HGS proprietary database by signing a Materials Transfer Agreement
granting HGS "a sole and exclusive worldwide right and license" to develop
any resulting products on terms to be negotiated in the future.

    An obvious advantage of this exclusive licensing strategy for HGS is that
it has generated a lot of revenue;  SB placed what appeared to be a very large
bet 3 years ago.  An obvious concern is that restricting database access to
such a degree may limit the value that can be extracted during the term of
the license.  Perhaps this concern motivated SB and HGS to enter into
collaborative agreements announced this past summer to share the database
with four additional firms {Takeda Chemical Industries, Merck KGaA, Schering
Plough, and Synthelabo}.  With the signing of these agreements, SB appears
to have made its money back even before bringing any new products to market -
the agreements call for payments totalling $140 million plus royalties on
product sales.

Nonexclusive Licensing

    Incyte has offered nonexclusive licenses to as many firms as will take
them, at a much cheaper price than SB paid for its exclusive deal with HGS.
So far ten pharmaceutical firms have signed on as subscribers, including
Pfizer, Pharmacia & Upjohn, Novo Nordisk, Hoechst, Abbott Laboratories,
Johnson & Johnson, BASF AG, Hoffman-La Roche, Zeneca and Schering AG Berlin.
Financial terms for most of these agreements have not been disclosed, but
press accounts report that they total more than $160 million, excluding
contigent payments such as milestones and product royalties.

    Although each Incyte subscriber has placed a smaller bet than SB did,
in the aggregrate they may well provide more funds for the development of
Incyte's genomic databases.  From a broader social standpoint, of course,
the more interesting question is not the size of the bets but the ultimate
payoffs.  Which approach will yield more discoveries or more commercial
products?

Public Domain

    The Merck strategy of putting sequence information into the public domain
is the newest approach and, at first glance, the most puzzling.  How does
this strategy advance Merck's own interests?  By placing data in the public
domain, Merck can generate the sequence information more cheaply - indeed,
almost unbelievably cheaper.  Merck is placing a very small bet, somewhere
under $10 million, but by positioning itself as a public benefactor, the
company is able to take advantage of existing infrastructure at Washington
University, put in place with public funds, for its sequencing efforts.

    Apart from generating sequence information more cheaply, Merck expects
to promote research and derive more benefit by distributing the data widely.
As Merck sees it, sequence information will not yield products for commercial
development until further fundamental research is done to understand functions
and biological pathways associated with the partially sequenced genes. Merck's
interest is in developing specific drugs at a later stage in the R&D process.
Nothing obligates researchers to bring any potential products to Merck for
commercial development, but Merck is confident that it can capture an adequate
share of resulting products to justify the company's modest investment in
generating the database.

    Some observers have suggested the more cynical possibility that Merck
may seek to undermine the value of its commercial competitors' investments
in existing sequence databases.  HGS and Incyte will be dependent on patents
to protect their proprietary positions in the long run, and Merck may be
betting that the two companies will not obtain much in the way of patent
rights.

    Preliminary indications suggest that the public data is generating
considerable interest, with EST-database accessions showing a dramatic
increase.  A big part of the increase has come in daily anonymous FTP
downloads of the entire database, a form of query likely to be popular with
commercial users who do not want to leave an electronic record of what they
are looking for.

    The most obvious benefit of disseminating information in the public
domain is that free availability encourages widespread use of information,
minimizes transaction costs, and makes R&D cheaper and faster.  Of particular
relevance to research science, a vigorous public domain can supply a meeting
place for people, information, and ideas that might not find each other in
the course of more organized, licensed encounters.

    Finally, information in the public domain is accessible to users who
otherwise would be priced out of the market.  In emphasizing intellectual
property rights in the past, we may have underestimated the value of a rich
public domain to private as well as public sectors.  We may need now to
reconsider the limits of private appropriation of new information as a means
of promoting commercial development.

==============================================================================

Dear Friends,

   The Conference of the Parties to the Convention on Biological Diversity met
at Buenos Aires 4-15 November 1996. I was at the Conference as an NGO observer
representing Ecoropa (coordinating their biodiversity/biotechnology/biosafety
programme). I worked in close cooperation with many other NGOs, especially
with Third World Network. 

   This autumn, the US company Monsanto tried to forcefully flood the European
market with its herbicide-resistant transgenic soybeans.  Many delegates and
NGOs felt that they did not have enough information neither on the scientific
findings concerning potential health and environmental impacts nor on the very
successful public action taken by European consumers and environmentalists for
keeping these gene-beans out of the European market and their shopping baskets
and meals. 

   Dr. Beatrix Tappeser (Eco-Institute,Freiburg) and I wrote the following
documents which were published in Third World Network Briefings (document 1-3)
and in "ECO 4" (doc. 4). I hope that some of you will find this information
useful.  Feel free to reprint any of the papers but please let me know that
you intend to do so and, on publication, send me a copy of the reprint
(to: Ecoropa, attn. Christine von Weizsaecker, Postfach 130165, 53061
Bonn/Germany).

   You may want to have a look at our web-page "Everything you never wanted
to know about biosafety": http://slc.p2p.de/~franz/biosafety.

With best regards,

Christiane von Weizsaecker     Tel:  +49-228-9181033
Postfach 130165                Fax:  +49-228-9181034
53061 Bonn, Germany            Email:     [email-masked]

==============================================================================
Document #1

Published as Third World Network Briefing No. 4, 8 November 1996 at the Third
Conference of the Parties to the Convention on Biological Diversity in Buenos
Aires

                          Monsanto's Genetech-Soybeans
                              Safe for Consumers?
                           SAFE FOR The Environment?

Gap Analysis and Flaw Identification in Monsanto's Testing 
    by Beatrix Tappeser and Christine von Weizsaecker

    The US company Monsanto applied for a permit to introduce genetically
engineered soybeans into Europe. The application has been approved by the
European authorities. The first cargo ship with Monsanto's genetically
engineered soybeans have already crossed the Atlantic. 

Possible Human Health Impacts of
Monsanto's Transgenic Glyphosate-Resistant Soybeans 

Numerous studies have been carried out by Monsanto on the transgenic soybean
and its potential impact on human health.  However, going through the reports,
one can easily identify a blatant scientific omission in the design of these
tests: 

        Consumers will ingest transgenic soybeans that will be 
        grown on glyphosate-sprayed fields. However, the tests 
        were done on transgenic soybeans that were grown without
        the application of glyphosate. 

This is a scientific error of major proportion which makes the results void.
The beans tested are not the transgenic beans from glyphosate-sprayed fields
which will be consumed.

Four problem areas associated with the use of glyphosate on legumes and with
the impacts of transgenic food crops in general have already been identified:

1.  Glyphosate was ranked third worst among all pesticides causing severe
health problems among those working in agriculture in the State of California.

2.  The application of glyphosate causes the production of phyto-estrogens in
legumes. These phyto-estrogens mimic the role of hormones in the bodies of
mammals who ingest them. Hence, they may cause severe reproductive system
disruptions. The data on estrogen-content of the plants submitted by
Monsanto does not reflect the real scope of this problem, because the tested
plants were grown in a glyphosate-free environment (see above). 

3.  The adequacy of Monsanto's testing for allergenic potential is
questionable. Rendering a plant herbicide-resistant, as in the case of
the glyphosate resistant bean, means that a new protein (or enzyme) is
introduced into the plant. The presence of a new protein in the plant and in
the foods the plant produceshas potential for causing allergic reactions.
Monsanto only tested people known to be allergic to soybeans. However, they
cannot test for the reaction to new proteins with the test design they used.
Everyresearcher active in the field knows that you cannot adequately test in
advance for allergic reaction to proteinsnever before consumed by humans.
Moreover, recent studies published by Swiss scientists have evaluated the
differences in allergy potential between traditionally bred and genetically
engineered crops. The scientists concluded that the use of genetic engineering
techniques causes a higher incidence of allergy problems. 

4.  A further problem consists in the fact that genetic engineering produces
"position effects". In living organisms, genes are intricately linked in
finely balanced networks. The introduction of new gene constructs (often
consisting of parts of genetic material of 4 to 5 different types of
organisms) at a random place on the long stretch of the DNA-molecule is
known to change the fine-tuning of the balanced network. The "position
effect" may lead to unintended shifts in the concentration of plant
metabolic products. This seems to be the case in Monsanto's transgenic
soybeans. The beans show some differences in oil-composition compared to
non-transgenic beans, but not all data has been included in Monsanto`s
European application file. There are also differences in the level of
trypsin-inhibitors, proteins that inhibit the degrading activities of
proteases - the first step in the digestive pathway. Trypsin-inhibitors have
been characterized as anti-nutritive. Again however, figures given in the
application file are incomplete. 

Governments, farmers and consumers should consider these problems carefully.
They may not want to take a course of action which turns people into
experimental Guinea pigs. 

Possible Environmental Impacts of
Monsanto's transgenic Glyphosate-Resistant Soybeans

Glyphosate, like other herbicides, is meant for weed control, i.e. it is
meant to reduce biological plant diversity in and around fields. Herbicides
do so with devastating success. Unlike other herbicides, glyphosate could
not be used in fields with growing crops since it kills not only a selected
group but all green plants. The introduction of a glyphosate-resistance-gene
now allows a widened range of application. 

A very different aspect of herbicide use should also not be forgotten: Many
plants that are called "weeds" by those promoting high-input monoculture for
the worldmarket are called "salad", "medicine", "animal feed", "compost" and
"flower-bed" by many farmers in the world. Loss of plant diversity also
invariably means loss of animal diversity and diversity of soil organisms. 
Herbicides are known to be self-abolishing technologies: Invariably, weeds
learn to cope, and the herbicide has to be replaced by yet another one.
Rye-grass in Australia already has asserted its weedy vitality by becoming
glyphosate resistant.

Transgenic soybeans, like all other transgenic plants, are associated with a
specific biosafety risk if planted in centres of origin. Scientific studies
have shown that transgenes are transmitted to wild relatives with
potentially disruptive effects on the endemic flora and on agriculture. 

Besides its plant killing potential, glyphosate was shown to have other
direct impacts on biological diversity: It is poisonous to fish. It persists
in the soil for long  periods of time: Salad, barley and carrots planted on
soil one year after the application of glyphosate have been shown to have
incorporated small quantities of this chemical. The degradation of
glyphosate leads to metabolites like AMPA (amino-methyl-phosphonic acid)
which can persist in the soil for 3 years. 

Governments, farmers and consumers should consider these problems carefully.
They may not want to take a course of action which 

    -   causes an increase in the use of the herbicide glyphosate
    -   which may add to biosafety problems
    -   and which are associated with the accumulation of largely
        unstudied metabolites with have already demonstrated some
        toxic effects in our soils and waters.

Dr. Beatrix Tappeser is Head of Department on Risk Assessment in Genetic
    Engineering at the Institute for Applied Ecology, Freiburg, Germany.

Christine von Weizsaecker is Head of Ecoropa's
    Biodiversity/Biotechnology/Biosafety Programme, Vice-Chair of the
    Advisory Council of the German Consumer Testing Group

==============================================================================
Document #2

Published as Third World Network Briefing No. 5, 11 November 1996 at the Third
Conference of the Parties to the Convention on Biological Diversity in Buenos
Aires

MONSANTO'S GLYPHOSATE-RESISTANT TRANSGENIC SOYBEANS

        77% of German Consumers refuse to eat them.
                            ***
        94% of German Consumers want them labelled.
                            ***
        Scientists can identify them in processed foods.
                            ***
        Greenpeace "labels" and blocks ships carrying them.
                            ***
        Food processing companies promised not to use them.
                            ***
        Food Chains will exclude them or at least label them.
                            ***
        Worldmarket prices reward soybean farming areas which were
        kept free of them.

by Christine von Weizsaecker and Beatrix Tappeser

The German word for soybean is Soja. The word has a very positive connotation:
So-Yes.  Why is it that "SO-Yes turned into SO-NO" for German environmental
groups like Greenpeace and Friends of the Earth, Germany, for the German
Consumers' Organisation, for Health Food Stores Associations and other Food
Chains, and for practically all companies specializing in foods for babies?

The NO is addressed to a very special company: Monsanto, USA. The NO goes to
a very special soybean: a soybean that has been genetically engineered to be
resistant to the herbicide Roundup/Glyphosate, produced by the same company.
Monsanto applied for a permit to introduce genetically engineered soybeans
into Europe. This application has been approved by the European authorities.
Soon after this year's harvest, the first cargo ships with Monsanto's
genetically engineered soybeans began to cross the Atlantic. Yet, these
specific soybeans had no clearance from environmentalists and from consumers.

CONSUMERS' OPINIONS AND MOTIVATIONS: In Germany - as in many countries of
Europe - more than 90% of consumers want the general labelling of genetically
engineered foods.  Why do they want them labelled?  Because 77% of consumers
definitely do not want to eat them, and do not want to offer them to their
families and friends. The results of a recent Emnid opinion poll show that
amongst those who do not want the gene-bean 45% will avoid them as best as
possible and a further 28% will, additionally, consistently boycott every food
that may has a trace of gene-beans in it. More than 50% will boycott products
from firms that bring these products to market without labelling them. Only
5% think Monsanto's transgenic soybeans may taste better or be healthier. 

Although consumers are not aware of much of the scientific data on health
and environmental risks they have a very keen commitment to the precautionary
approach and they insist on prior informed consent. Consumers want
food-sovereignty. And they want the right to influence the choice of public
research priorities and technological and agricultural pathways. These
priorites have traditionally been determined, top-down. But citizens with
their shopping baskets are now giving a strong message that they want bottom
up decision-making. 

The growth of civil society and the environmental debate of the last decades
has had some success. Many people actively strive for participation and
sustainable consumption patterns; they see their responsibility for the
whole life cycle of products including socio-economic and environmental
impacts. These people cannot at all see that Monsanto's gene-beans produced
in the United States and consumed by German cattle and people are a
contribution to solving the World Food Problem, an aim often invoked by
genetic engineers. Some are even aware of the fact, that capital-intensive
globalized technologies have demonstrably not been Pro-Poor in the past. 

About half of all consumers are fully aware of potential negative
environmental impacts of releases of living modified organisms into the
environment. They are convinced that Monsanto's beans mean high-input,
pesticide-dependent agriculture. And lastly, they noted that Monsanto's
transgenic Bt-cotton failed in the field, thereby throwing doubt on the
benefits derived from gene technology and on the predictive capacity of
scientists. 

THE EU-DEBATE ON "NOVEL FOOD": Many European women and men were made very
angry when a member of the European Commission said "We cannot have hysterical
and panicky European consumers not eating what the European Commission
considers safe". Their anger increased when a European Novel Food Directive
was submitted which does not guarantee general labelling of genetically
engineered foods.

Monsanto's transgenic soybeans were on their way. The strategy of the
managers of Monsanto, of the oil-mill in Hamburg and of some major food
processing companies was to mix genetically engineered soybeans with all
other soybeans. This strategy made consumers angrier. They felt that this
plan was obviously designed to produce individual and public confusion and
resignation in the face of a large and complicated task. They were faced
with governments that did not adequately protect their citizens against
forced consumption of genetically engineered foods and that had approved of
Monsanto's application. 

FIGURES ON SOYBEAN PRODUCTION AND TRADE: According to a Monsanto spokesperson
"at the moment only one to two percent" of soybeans in the US are genetically
engineered. How much is that? Monsanto's transgenic soybeans have been planted
by 8 000 of the 300 000 soybean farmers. Next season, more transgenic soybeans
and other transgenic crops are expected. US soybean production is expected to
reach 62 million tons of the 135 million tons worldwide. 

Two percent of US production is nearly one percent of world production, i.e.
roughly 1 million tons. Europe only has minor soybean production in France
and Italy. European oil-mills processed 15 million tons of soybeans in 1995.
They import 60% of these beans from the US. Germany imports 10% of US
production. Approximately 30% of European imports come from Brasil and
Argentina. Argentina - by the way - already started seed-production of
Monsanto's glyphosate-resistant transgenic soybean. However, beans have not
yet come to market.

HOW MANY AND WHICH FOODS CONTAIN SOYBEANS? The German Consumers Initiative
has calculated that approximately 20 to 30 thousand foods contain processed
soybeans. Soybean-oil can be found in mayonnaises, breadspreads and salad
sauces. Soybean-meal is used in tinned and deep-frozen foods. Lecithin from
soybean can be found in chocolates and ice-cream. 80% of all soybeans imported
into Europe is fed to cattle and other animals.

IDENTIFICATION OF TRANSGENIC SOYBEANS IN FOODS: A small German research
company named "Hydrotox", situated in Freiburg/Breisgau, developed a testing
system which allows identification of lecithin derived from transgenic
soybeans, a scientific achievement that Monsanto's huge laboratories had
declared impossible. The ability to differentiate between Monsanto's
transgenic bean and all non-transgenic soybeans lays the technological
ground for targeted consumer boycotts.

FINDING ALLIES: In Germany, the environmental movement and consumers joined
forces in an unprecedented way. A very wide alliance was formed. Large
environmental groups like Greenpeace Germany and Friends of the Earth
Germany joined with hundreds of local environmental groups. The German
Consumers' Organisation with all their local branches and infrastructure
became active.

ASSERTING CONSUMPTION ALTERNATIVES: Groups and associations of health food
stores and other smaller food producers and traders organized ways by which
to guarantee that no transgenic soybean entered the products they sold. A
Swiss oil-mill guaranteed genetech-free soybean products.

PUBLIC CAMPAIGN: The Soybean-Campaign started in September 1996. At this
point more than 100,000 German Citizens have signed onto it. Press conferences
and web-sites have spread the information and further increased public
awareness. On 5th November, the cargo ship "Ideal Progress" with Monsanto's
transgenic soybeans on board was "labelled" by Greenpeace activists on
entering Hamburg harbour. The label read "No Gene-Soybeans in our Foods".
Two days later, November the ship "Ziemia Zamojska", registered in Poland,
tried to unload its gene-beans at Cargill's site in Amsterdam harbour.
Greenpeace activists blocked the entrance to Amsterdam harbour and unrolled
a banner "Genetic experiment - Don't buy it". 

MARKET IMPACT: But even before these events, nearly all major food processing
companies serving the German market -- Unilever, Nestle, Jakobs/Kraft/Suchard
-- had already been forced by public opinion to guarantee to exclude
Monsanto's beans from their products. One after the other they realized that
these soybeans would destabilize the market for processed foods in a very
decisive but unpleasantly unpredictable way. Major food chains in Germany and
Switzerland committed themselves to gene-bean-free food. Even Dr. Ruettgers,
German Minister for Research, a stark supporter and funder of genetic
engineering, now argues that labelling is advisable because it would mellow
the debate on modern biotechnology in food and agriculture and reconciliate
consumers. The world market for soybeans has had to adapt and change its
prices. Traders who can offer soybeans from areas that do not use Monsanto's
glyphosate-resistant transgenic beans are making now profits far beyond
expectations.

NEXT STEPS: A worldwide coalition of women has gathered at the Word Food
Summit in Rome. They call for food sovereignty and for general labelling of
genetically engineered food. The signatures gathering for the Soybean Campaign
in Germany is still snowballing. Corresponding initiatives are under way in
the United States. Citizens in many countries will demand general labelling,
strict liability, appropriate biosafety regulations and practices. Most
urgently, they want freedom to say no to foods that they neither consider
safe nor necessary. 

Christine von Weizsaecker coordinates Ecoropa's Programme on 
    Biodiversity/Biotechnology/Biosafety and is Vice-Chair of the 
    Advisory Council of the German Consumer Testing Group
    
Dr. Beatrix Tappeser is Head of Department on Risk 
    Assessment in Genetic Engineering at the Institute for Applied 
    Ecology, Freiburg, Germany.

==============================================================================
Document #3

Published as Third World Network Briefing No. 9, 12 November 1996 at the Third
Conference of the Parties to the Convention on Biological Diversity in Buenos
Aires

Addendum on European Public Opinion and Genetically Engineered Food:

A Lay People's country report from Norway
Paying due respect to socio-economic impact assessment

by Beatrix Tappeser and Christine von Weizsaecker

The Norwegian National Committee for Research Ethics presented the results
of Norway's First Lay People's Conference on Genetically Modified Food in a
press release of 1 November 1996 and will make the full report available on
request. The results of this conference can be condensed into one single
sentence: "No Way for genetically modified food into Norway."

The lay people's conference was organised jointly by the National Committee
for Research Ethics and the Norwegian  Biotechnology Advisory Board. The
conference was designed along the lines of thirteen People's Conferences
organized by The Danish Board of Technology. The lay panel consisted of
eight women and eight men from different parts of Norway, who differed in
age, education and occupation. They had one thing in common, however: They
were chosen for having no close connections to any biotechnology stakeholder
group and no special knowledge on the topic. After questioning a wide range
of experts, made available to them, the lay panel issued recommendations to
Norwegian politicans and the food industry. The lay panel

       -   anticipating the necessity to react to potential 
           introduction of genetically engineered foods into 
           Norway, recommended that all foods containing genetically
           modified organisms and/or derived from a manufacturing
           process using gene technologies be labelled. 
    
       -   rejected the introduction of genetically modified food 
           stuffs into Norway.
    
       -   insisted that environmental and ethical concerns be 
           prominent in the decisions on genetically modified foods.
    
       -   called for adherence to the precautionary principle.

       -   recommended research programmes on long term health 
           and environmental effects of genetically modified foods.
    
       -   recommended to attribute greater credibility to 
           ecologists than to biotechnologists.
    
       -   applauded the clauses in the Norwegian Gene Technology 
           Act which preclude genetic engineering unless proven 
           to be "of benefit to the community" and "a contribution
           to sustainable development" and called for applying these
           clauses to prevent all imports of genetically engineered
           products into Norway.

"This is a historic occasion and perhaps a small victory for democracy,"
said Professor Reidar Almas, Head of the Centre for Rural Research, as the
document was presented to the experts. He added that the conference has
proven that ordinary citizens are capable of understanding complicated
processes and of producing valuable advice. 

==============================================================================
Document #4

Buenos Aires, 13 November 1996
Article by Christine von Weizsaecker, Bonn, and Beatrix Tappeser, Freiburg
          
published in "ECO 4" at COP3 of CBD, Buenos Aires, 14 November 1996 

Citizens' Guide to successful action against Genetically Manipulated Foods

The application of gene technology in the field of food and agriculture is
an arena in which public opinion and private and public investment policies
collide.

A vast and stable majority of European citizens prefer their foods not to be
genetically engineered. They consider gene-food to be unnecessary and
hazardous to health and to biological diversity. In Norway, The Lay People's
Conference on Genetically Manipulated Foods firmly reasserted citizens' NO.
The lay panel was complimented by scientific and other experts on its
excellent grasp on the complex and interrelated legal, socio-economic,
ethical, environmental and health issues involved. In Germany, 77% of
consumers do not want to eat genetically manipulated foods; 94% want them
strictly labelled to allow identification and choice. More than 50% of
citizens intend to boycot firms that bring these products to the market
unlabelled.

The private sector and governments have heavily invested in modern
biotechnology in the field of food and agriculture. Consistent intellectual
efforts and financial investments went into the promotion of public
acceptance for genetic engineering. These efforts have demonstrably failed.
Economists tell us that market mechanisms are fastest and best suited to
respond to and cater for consumers' choices. One would therefore expect that
such severe mis-allocation of funds be identified and immediately redressed.

In reality, however, a cynical alliance between European authorities and the
US firm Monsanto has been formed with the intent to force down genetically
manipulated foods into unwilling and angry German consumers' mouths. 

European legislation does not ensure strict labelling of such foods, thus
not allowing identification and avoidance. A member of the European
Commission said "We cannot accept hysterical and panicky European consumers
not eating what the European Commission considers safe." Monsanto applied
for and attained permission to introduce its herbicide-resistant transgenic
soybean into Europe, in spite of the fact that independent scientists
identified a blatant scientific omission in the design of Monsanto's tests
concerning health effects and in disregard of obvious hazards to the
environment: e.g. increased herbicide-dependence and biodiversity reduction
which goes with it, additional biosafety problems, accumulation of largely
unstudied metabolites in the soil. 

Monsanto, in alliance with large oil-mills and food processing companies,
designed a strategy to successfully flood the German market with 30 000
different food products processed from its gene-beans - ranging from oil to
ice-cream. Only 1-2% of this year's US soybean production consists of
Monsanto's gene-beans, however, these were strategically mixed with the rest
of the harvest. 60 000 tons of this mix already reached German oil-mills.
According to Monsanto, science has not tests which might tell whether its
transgenic soybeans were used in the processing of a given food. 

Did citizens accept the role they were cast for: victims of unavoidable
forced consumption of genetically engineered foods? No! 

Since September 1996 German citizen activists successfully defended their
food sovereignty. What were the main elements of their successful struggle?

1.  Alliance of Environmentalist and Consumers' Organisations joining
    their multifacetted talents: Greenpeace and Friends of the Earth,
    Germany, The German Consumers Organisation and many small
    initiatives joined forces.
    
2.  Collection of signatures and initiation of opinion polls:
    180 thousand signatures by 12/11/96).
    
3.  First allies in the field of food producers, processors and 
    food chains, willing to guarantee gene-bean-free food
    alternatives: organic farmers associations, a Swiss oil-mill, 
    baby food firms and some food chains. Recently, the 
    Speaker of the German Farmers' Association called for 
    labelling so that farmers have a choice in animal feeds.
    
4.  Independent scientific expertise and a testing system that 
    allow the identifation of Monsanto's gene-bean in the 
    processed foods: such a testing system was developped by the 
    Freiburg based research company "Hydrotox".
    
5.  Public visibility and press work: On entry into Hamburg 
    Harbour Greenpeace activists "labelled" the cargo ship "Ideal
    Progress" carrying Monsanto's gene-beans (5/11/96); others
    blocked access of the freighter "Ziemia Zamojska" into 
    Amsterdam Harbour (7/11/96); and yet another group demonstrated
    citizens' protest in front of Hamburg oil-mill (12/11/96).
    
6.  Persuasion of food processors and food chains: by now, all 
    major food processing companies (Unilever, Nestle, Danone, 
    Jakobs/Kraft/Suchard, Schwartau) and many of the major 
    supermarkets and food chains (Edeka, Karstadt) serving the 
    German market somewhat reluctantly gave in to public opinion 
    and promised to keep shelves gene-bean-free.
    
7.  Impact on the world market: Traders who can provide soybeans 
    from areas that can guarantee a gene-bean-free cargo of 
    soybeans are now making profits far beyond expectations. Ships 
    carrying gene-bean-free soybean cargo are on their way.
    
8.  Finding international allies: A Soybean-Campaign is on its way 
    in the US; a worldwide Coalition of Women for Food Sovereignty
    has gathered at the Food Summit in Rome.  Women say NO to genetic
    engineering in their fields, gardens and foods.  They call for
    strict labelling as a minimum rule of decency paying due respect
    to their judgement and choice.