In 1994, negotiators of the Uruguay Round agreement of the GATT established
global rules requiring member nations to award bio-engineers exclusive
rights to monopolize the development and commercialization of "plant
varieties either by patents or by an effective sui generis system..."3
("Sui generis" is a Latin phrase meaning "of like kind.") Governments that
choose to ensure that the benefits of genetically-manipulated plants accrue
to the public may be subject to challenge in the GATT's system of dispute
resolution. This "TRIPs" chapter of the GATT -- which stands for
"Trade-Related Intellectual Property Rights" -- must be reviewed in 1999.
Patenting Human Cell Lines
Putting questions of inventiveness aside, these trends have enabled
scientists to hold patents for a wide variety of life forms, including
almost 5% of the entire human genome. There is now a rush for control of
the remaining 95% of the human genome.
In 1993, a patent claim was filed under the name of U.S. Secretary of
Commerce Ron Brown, on the cell line of a 26 year old Guayami woman from
Panama. Patent Claim WO 9208784 A1 was lodged for the Human T-Lymphotropic
Virus Type 2, drawn from the "immortalized" DNA of the Guayami woman. Her
cell line is of interest because some Guayami people carry a unique virus
and whose antibodies may prove useful in AIDS and leukemia research.
International protest and action by the Guaymi General Congress and others
led to the withdrawal of the patent claim in November 1993.
On behalf of the U.S. Department of Commerce, Secretary Ron Brown filed
patent claims on the human cell lines of indigenous people from the Solomon
Islands.4 The Government of the Solomon Islands has demanded the
withdrawal of the patent applications citing an invasion of sovereignty,
lack of informed consent, and moral grounds as the reasons for protest. The
Government of the Solomon Islands also demanded the repatriation of the
genetic samples. However, in a response letter dated March 3, 1994 to the
Ambassador of the Solomon Islands, Secretary Ron Brown states "there is no
provision for considerations related to the source of the cells that may be
the subject of a patent application." In other words, how the genetic
samples were obtained is of no legal concern to him, in accordance with
existing patent laws.
"Bio-Prospecting"
The Human Genome Diversity (HGD) Project is taking blood and tissue samples
from indigenous peoples of 722 communities throughout the world for genetic
studies.5 This raises troubling questions regarding the definition of
genetic materials as "property", the ownership of the genetic samples
themselves, and who stands to profit from the commercialization of products
derived from the samples. The HGD Project puts the raw resource, that is,
the human genes of indigenous people, in the hands of anyone who wants to
experiment with them. In doing so, the HGD Project is opening the doorway
for widespread commercialization and potential misuse of the samples and
data. While the HGD Project does not plan to do genetic engineering, no
safeguards exist to prevent others from doing so with the genetic samples
collected.
It appears the colonizers, this time as well-funded and equipped
"bio-prospectors", have their eyes on appropriating the natural resources
of indigenous people to benefit those in the developed world. The HGD
Project enables the staking of claims on the natural genetic resource base
of indigenous peoples. Some of those claims will strike it rich, in the
form of patentable genes. The research, manipulation and inevitable
commercialization of the genetic data or samples will benefit those who can
afford it, and the developers and investors who commercialize it. There
will be minimal or no direct benefit to the people from which the natural
resource is taken.
The HGD Project suggets that contract law is one way for indigenous peoples
to protect their intellectual property rights, and to maintain control over
the use of the genetic samples. Given the lack of any international
policies or regulations governing the trade of human genetic materials,
contracts may well afford the best legal protections and tool for defining
the terms of exchange. However, indigenous peoples must be reminded that
previous experience with contract law, treaties and other legal agreements
have afforded negligible protection in the past, particularly on the
domestic levels. International enforcement and monitoring of these
agreements or contracts would most likely prove much more difficult.
The Case of John Moore
In 1984, John Moore filed a lawsuit claiming that his blood cells were
misappropriated while he was undergoing treatment for leukemia at the
University of California, Los Angeles Medical Center.6 During his
treatment, Moore's doctor developed a cell line which proved valuable in
fighting bacteria and cancer. The UCLA Board of Regents filed a patent
claim on this cell line and commercially developed valuable antibacterial
and cancer-fighting pharmaceuticals. Moore claimed that he was entitled to
share in profits derived from commercial uses of these cells and any other
products resulting from research on any of his biological materials.1 In
a significant 1990 California Supreme Court decision, the court established
that a donor does not have a "property right" in the tissues removed from
his or her body.7 The court further reasoned that to favor John Moore's
claim would "...hinder research by restricting access to the necessary raw
materials," thereby interfering with the progress of science.8
Indigenous people must be aware that it may be extremely difficult or
impossible to recover or repatriate the genetic samples, our blood,
tissues, or body parts, once they are removed from our bodies and are out
of our control.
Recommendations
Indigenous people must call for a world-wide moratorium on the collection,
databasing, manipulation, and commercialization of human cell lines and
their genetic resources.
Indigenous peoples need to determine the extent of existing international
protections for genetic resources, and participate in the development of
international policies which fully protect the resources of indigenous
peoples from further theft, appropriation and exploitation.
Indigenous peoples must assert their sovereign right to manage and protect
their peoples, resources and knowledge, as stewards of their territories
and their people's future generations, and these rights must be respected
and protected by non-indigenous peoples and nations as ethically, legally
and morally correct.
Intellectual property rights represent Western notions that one can have
"ownership and property right(s)" extended to all facets of the natural
world. Western laws are paradoxical to Indigenous cosmologies which revere
the sanctity of all life, and mandate human responsibility to serve as
stewards, not owners, of the natural world. The infringement of Western
law on indigenous peoples over the past few hundred years has created a
complex political and legal framework of existence for indigenous peoples.
However, it is important to remember that, most fundamentally, indigenous
peoples inherently have full rights and authority to control and manage
their own natural resources and internal affairs, free from external
interference and control.
Sources:
1 Kimbrell, Andrew, The Human Body Shop: The Marketing and Engineering of
Life. San Francisco: Harper, 1994.
2 Diamond v. Chakrabarty, 477 U.S. 303 (1980).
3 Uruguay Round Final Act. Marrakesh, Morroocco. (April 15, 1994).
4 Publication Number WO-9215325-A, Priority Application No. US-052368 .
5 "Patents, Indigenous Peoples, and Human Genetic Diversity," RAFI
Communique, Rural Advancement Foundation International, Ottawa, Canada.
(May 1993).
6 New Developments in Biotechnology: Ownership of Human Tissues and Cells,
Office of Technology Assessment, PB87-207536. (March 1987).
7 Moore v. Regents of the University of California et al., California
Supreme Court. (1985).
8 Moore vs. Regents of the University of California, 793 P.2d 479, 271
Cal. Rptr. 146 (1990).
For More Information Contact:
Debra Harry, Consultant and Trainer
Current Kellogg Foundation National Fellow
P.O. Box 72
Nixon, NV 89424 USA
Tel: 702-574-0309
E-mail: dharry@igc.apc.org
Jeannette Armstrong
En'owkin Centre
257 Brunswick Street
Penticton, BC V2A 1P2 Canada
Tel: 604-493-7181
Rural Advancement Foundation International
Suite 504-71 Bank Street,
Ottawa, ONT K1P 5N2 Canada
Tel: 613-567-6880
One in a series of info sheets on Intellectual Property Rights available
from the Institute for Agriculture and Trade Policy. For a complete
listing, send email to: ipr-info@igc.apc.org
Dale Wiehoff
Communications Director
Institute for Agriculture and Trade Policy (IATP)
1313 5th St.,SE, Suite 303
Minneapolis, MN 55414-1546 USA
Tel: (612) 379-5980 Fax: (612) 379-5982
E-mail: dwiehoff@iatp.org
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
INFORMATION ABOUT INTELLECTUAL PROPERTY RIGHTS No. 6
Subject: The Human Genome Diversity Project and
Its Implications For Indigenus Peoples
by Debra Harry, Northern Paiute Nation, Nevada
January 1995
The Human Genome Diversity (HGD) Project is an international consortium of
scientists, universities, governments and other interests in North America
and Europe organized to take blood, tissue samples (cheek scrapings or
saliva), and hair roots from hundreds of so called "endangered" indigenous
communities around the world.
On the assumption that indigenous peoples are inevitably going to disappear
and some populations are facing extinction sooner than later, scientists
are gathering DNA samples from the living peoples before they disappear.
The HGD Project refers to indigenous populations as "isolates of historic
interest (IHIs)" and expresses a sense of urgency in collecting the DNA
samples of indigenous peoples in order to "avoid the irreversible loss of
precious genetic information" due to the danger of physical extinction.
The blood samples taken by the HGD Project will be "immortalized" for
future study utilizing a technique of cell conservation which keeps certain
cells of an organism alive and capable of multiplying, thus generating
unlimited amounts of the organism's DNA. The immortalized cell lines will
be stored at various gene banks, located mostly in the US.
Research teams are going into indigenous communities to collect samples
from 50 persons from each of 722 identified populations. When asked about
the scientific rationale for selecting 50 persons per group, Dr. Luca
Cavalli-Sforza, a principal founder of the project, stated "One person can
bleed 50 people and get on the airplane in one day." 1
Indigenous Communities Targeted for DNA Collection
Africa 165 South America 114
Asia 212 North America 107
Oceania 101 Europe 23
TOTAL 722
Source: RAFI-Canada 2
Known in some places as the "Vampire Project," the HGD Project was formally
adopted by the Human Genome Organization (HUGO) in January 1994. HUGO is a
multi-national, multi-billion dollar initiative by scientists which seeks
to sequence the DNA in the entire human genetic structure. The HGD Project
seeks to map the variance, that is, the genetic differences of groups that
differ from the monotype genome that will be identified by the HUGO effort.<
R>
The HGD Project states that it will make the genetic samples available to
"the public." This policy of open access will make the data and materials
available to any one requesting it, in perpetuity. However, there will be
minimal control of access to the genetic materials once they are stored in
the gene banks. Scientists will need only to demonstrate the validity of
their scientific research in order to gain access to the samples.
Prior Informed Consent and the Right to Refuse
Anthropologists, linguists or other individuals trusted by the targeted
group help provide entree to the targeted communities.
Although the HGD Project will seek the consent of the individuals and
populations to be sampled, what constitutes "prior informed consent?" Who
is authorized to give consent? Should consent be required only by the
individual being sampled, or also include the governing body of that
particular indigenous nation? Can consent be granted by government
officials of the nation-state in which the indigenous nation is located?
How will the project be explained in the local language? Will the full
scope of the project and the short and long term implications and potential
uses of the samples be fully disclosed? Will potential donors be fully
informed of the potential for profits that may be made from their genetic
samples? And finally, will a decision not to consent be respected in full?<
R>
The HGD Project North American Committee has secured a grant from the J.D.
and C.T. MacArthur Foundation to develop a model protocol (rules) for the
collection of genetic samples from indigenous groups. Project organizers
plan to meet with indigenous people to explain the project. This process
will help project organizers to identify key concerns of indigenous people,
but will primarily be used to seek their cooperation in the project.
Creation and Evolution
The HGD Project states that the research will help reconstruct the history
of the world's populations, address questions about the history of human
evolution and migration patterns, and identify the origins of existing
populations.
While the HGD Project is looking for answers about human evolution,
indigenous peoples already possess strong beliefs and knowledge regarding
their creation and histories.
The cosmologies of indigenous people are environmentally and culturally
specific and are not congruent with popular Western theories, such as the
Bering Strait migration theory or Darwin's theory of evolution. The
assumptions posed by the HGD Project that the origins and/or migrations of
indigenous populations can be 'discovered' and scientifically 'answered' is
insulting to groups who already have strong cultural beliefs regarding
their origins. Questions arise concerning the impact of the findings on
indigenous communities. For example, will theories of migration be used to
challenge aboriginal territorial claims or rights to land?
Medical and Military Science
The project will also gather information of potential or actual medical
interest, possibly leading to medical applications. In terms of reciprocal
benefits to donor groups, the HGD Project will offer token benefits such as
providing medicines, or treating easily diagnosable medical problems.
If indigenous people were interested in genetic research for a genetic
question specific to their group, they do not need the HGD Project to do
this work. The technology and expertise is widely available to groups
interested in genetic research.
Many in the indigenous communities are worried the research may identify
genetic information that may be used against genetically distinct
populations. The HGD Project raises the spectre of misuse of the genetic
materials or data for racist purposes, and even raises the possibility of
genocide by biological warfare.4 While scientists disagree on the
feasibility of such uses, it is difficult to predict what will be
technologically possible in ten years, or twenty. Biological warfare has
been used on indigenous peoples in the past, a reminder of the potential
threat presented by such scientific projects.
Conclusions and Recommendations
Genetic manipulation raises serious ethical and moral concerns with regard
to the sanctity of life. For indigenous peoples, any violation of the
natural law and the natural order of life is abhorrently wrong. Scientists
are genetically manipulating existing life forms, altering the course of
natural evolution, and creating new life forms. Genes are living organisms
which reproduce, migrate and mutate. The full impact of genetically
manipulated life forms cannot possibly be anticipated.
Indigenous people must engage in community education and discussion about
the full scope of this project and the potential dangers of genetic
manipulation. It is imperative that indigenous communities become fully
aware of the implications of this project, and learn whether any genetic
sampling is being conducted or is proposed to take place in their areas.
Every effort should be made to alert indigenous communities worldwide of
the work of the Human Genome Organization and the Human Genome Diversity
Project. The communities must be free to reject the taking of their
genetic materials by such projects or by free-lance scientists. Groups
from which any genetic materials have already been taken may wish to ensure
the return to their possession of these materials.
Indigenous communities need to stand together and call upon the Human
Genome Diversity Project and the Human Genome Organization to halt
collection efforts. These organizations must work directly in consultation
with indigenous people and organizations which reflect the diversity of the
world's indigenous populations to develop appropriate domestic and
international policies which protect the best interests of indigenous
peoples.
Indigenous people must raise international awareness of these efforts and
develop support among all people to prevent the further violation and
assault of their human rights, further appropriation of their natural
resources, and to protect the integrity of life.
Sources:
1 "Glorification of the Genes?" Alan H. Goodman, Ph.D., presented at the
SWISSAID/WWF International Symposium "Patents, Genes and Butterflies."
Berne, Switzerland. (October 1994).
2 "Patents, Indigenous Peoples, and Human Genetic Diversity," RAFI
Communique. Rural Advancement Foundation International, Ottawa, Canada.
(May 1993).
3 Helland, Dag and Allan W. Hey, "A Short Review of Biotechnological
Methods of Relevance to Modern Vaccine Development," Scandanavian Journal
of Infectious Diseases 76, supplement (1990): 32-38.
4 Douglass, Joseph D., Jr., "The Challenges of Biological Warfare," Global
Affairs. International Security Council, New York. (Winter 1988).
For More Information Contact:
Debra Harry, Consultant and Trainer
Current Kellogg Foundation National Fellow,
P.O. Box 72, Nixon, Nevada 89424; (702) 574-0309;
email: Debra_Harry@Together.or
or dharry@igc.apc.org
Jeannette Armstrong, En'owkin Centre, 257 Brunswick Street, Penticton, BC
V2A 1P2; (604) 493-7181
Rural Advancement Foundation International, Suite 504-71 Bank Street,
Ottawa, Ontario K1P 5N2; (613) 567-6880
One in a series of info sheets on Intellectual Property Rights available
from the Institute for Agriculture and Trade Policy. To receive a complete
listing, send email to: ipr-info@iatp.org.
Dale Wiehoff
Communications Director
Institute for Agriculture and Trade Policy (IATP)
1313 5th St.,SE, Suite 303
Minneapolis, MN 55414-1546 USA
Tel: (612) 379-5980 Fax: (612) 379-5982
Email: dwiehoff@iatp.org
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
INFORMATION ABOUT INTELLECTUAL PROPERTY RIGHTS No. 8
Subject: Genetic Engineering
A Production of the Shiva Working Group on Global Sustainability,
University of Minnesota Ecology Department
January 1995
What is genetic engineering? Sometimes called "biotechnology," genetic
engineering is a high-tech process by which humans move specific genes from
one organism into another organism. Conceivably, any gene from any organism
can be moved into any other organism. These processes create some risks.
Major areas of activity include:
*Agriculture - in which crops, livestock, and related
micro-organisms are altered to increase production, influence disease
patterns and environmental impacts, and so on;
* Medicine - with major efforts in pharmaceutical production using
living organisms and human gene therapy;
* Pollution cleanup - using genetically engineered micro-organisms
to degrade harmful chemicals, such as PCBs (relatively little work is going
on in this area now);
* Mining - to develop genetically engineered micro-organisms that
can concentrate rare metals and repressurize spent wells to revitalize
depleted mines; and
* Biological weapons - adding to the arsenal of biological warfare
agents, such as anthrax, by designing diseases to target selected
populations of humans.
WHY IS GENETIC ENGINEERING RISKY?
Ecological systems are extremely complex. Impacts at one level of the "food
chain" can reverberate throughout the system. For example, changes in the
invisible plankton in the sea can affect fish, and therefore affect humans.
Likewise, the introduction of a genetically engineered organism in a
particular ecosystem can have unforseen impacts on various species in that
ecosystem Even when controlled experiments are concluded successfully,
there is no guarantee that the novel organism will not create a problem in
a different ecological setting.
Genetic engineering is unique among all of the major technologies that have
been unleashed on society. Unlike the nuclear power industry or the
pesticide industry, where major social problems occurred before the
industries were regulated, there have been no disasters as yet from genetic
engineering. However, the potential risks are so significant that efforts
are emerging now to regulate the development and use of biotechnology at
the international, national and state levels.
PROBLEMS TO PREVENT
FOOD: The FLAVR SAVR tomato, trademarked by its designer, is genetically
engineered to withstand longer storage without rotting. This delayed
ripening also increases the transportability of food, allowing delivery of
un-fresh foods to even farther destinations.
Genes for "antifreeze" proteins from Atlantic salmon have been transferred
to Pacific salmon to enable this fish a wider range in aquaculture.
Fish genes have been also been moved into chickens. Pig and chicken genes
have been moved into plants. Religious proscriptions may be violated, and
food preferences, such as vegetarianism, may become difficult to follow.
BR>
In addition to genes altering key features of the target organism, other
genes that produce novel proteins are usually transferred as well so that
the genetic engineer can know that a gene has been successfully
transferred. These novel proteins may cause allergic reactions in
unsuspecting people.
Most of these products are still in the experimental phase. Labeling is
not now required on these products when they come to market.
ENVIRONMENT: Plant breeders can select genes which confer herbicide in new
crop varieties. In theory, the new varieties allow the substitution of
less toxic, less persistent and more "environmentally-friendly" herbicides
for more problematic ones, such as 2,4-D. Recent analysis, however,
suggests that the new crops are likely to increase herbicide use. Most
herbicides are used before planting because they would harm the plant if
applied later. Herbicide tolerance allows a person to apply herbicides both
pre-planting and post-emergence. With increased herbicide use comes a
greater risk of groundwater contamination.
The introduction of novel organisms can also affect the ecology of a field
and its environs. For example, one microorganism engineered to better
convert crop wastes to ethanol was found by its designers to also harm a
beneficial fungi in the soil, reducing the capacity of nearby plants to
absorb essential nitrogen.
HUMAN GENE THERAPY: Molecular biologists are defining an increasing number
of human diseases as genetic. While some cures may be found through genetic
engineering, it can also lead to indifference regarding prevention. For
example, as the genetic causes of cancer are more fully understood,
researchers may give less consideration to the impacts of carcinogens. What
causes cancer? A molecular biologist will say, "Your genes!" Others would
say, "Asbestos!" "Tobacco!" "Industrial wastes!" If a genetic disease can
be treated with gene therapy, then the environmental components of disease
and human difference can be ignored.
SUSTAINABLE AGRICULTURE: Corn that has been made resistant to the European
corn borer is expected to increase corn yields in the U.S. central corn
belt by 5%. This is expected to reduce corn prices, resulting in lower feed
costs for pig and beef producers. While lower feed costs could be passed on
to the meat eating consumer, lower corn prices will also increase
government farm program payments. A recent economic analysis suggests that
the potential benefits to the meat eating consumer are about the same size
as the increased farm payments from the government. Thus, transgenic insect
resistant corn would cause a transfer of wealth from the general public to
the meat-eating public.
ANIMAL WELFARE: Animal biotechnology promises to transform farmyard animals
as we know them. Recombinant bovine growth hormone (rBGH) increases the
incidence of the disease mastitis in cows. Porcine growth hormone or
"somatatropin" (PGH or PST) produces lean pork and crippled pigs. These
products benefit larger producers with modern mechanized operations.
Animals may be penned up permanently in overcrowded conditions subject to
artificially rapid growth, poor health and early butchering.
FARMING AND RURAL LIFE: Many of these genetic engineering feats are meant
to make farm production more "efficient," which will enable factory farms
to grow larger and larger, concentrating the industry, encouraging vertical
integration, and eliminating small family producers. Small towns will
continue to decline. Overproduction of manure, increasing use of machinery
and chemicals, and the introduction of novel genetic impacts will worsen
environmental conditions in rural areas.
RECOMMENDATIONS
You have a right to know if your neighbors are producing genetically-
engineered crops or animals. They may affect your health, the environment
in which you live, and the future of your community. If you farm, they may
affect your crops or the prices you can get for your animals or animal
products.
In the U.S., only Minnesota and North Carolina have as yet regulated the
development and use of genetic engineering. To find out what regulations
may be under consideration in your area, contact your state legislators and
local extension agents.
As soon as possible, governments, in cooperation with scientific experts
and non-governmental organizations, should develop and adopt an
international, legally binding protocol to control genetic engineering and
the release of genetically engineered organisms to the environment.
Such a protocol must address the risks of genetically engineered organisms
to the environment, human health and the economies of less developed
countries, as the philosophy of sustainable development demands.
Until such strict regulations are in place covering the transfer, handling
and use of genetically engineered organisms, there must be a worldwide
moratorium on their release to the environment.
*The Shiva Working Group on Global Sustainability is a coalition of
faculty, students and community leaders in Minnesota.
One in a series of info sheets on Intellectual Property Rights available
from the Institute for Agriculture and Trade Policy. To receive a complete
listing, send email to: ipr-info@iatp.org
Dale Wiehoff
Communications Director
Institute for Agriculture and Trade Policy (IATP)
1313 5th St.,SE, Suite 303
Minneapolis, MN 55414-1546 USA
Tel: (612) 379-5980 Fax: (612) 379-5982
Email: dwiehoff@iatp.org
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
INFORMATION ABOUT INTELLECTUAL PROPERTY RIGHTS No.9
Subject: Releases of Genetically Engineered Plants and Their Impacts on Less
Developed Countries
Isabelle Meister and Dr. Sue Mayer
Greenpeace International
April 1995
"DESIGNER" ORGANISMS AND GENETIC POLLUTION
Genetic engineering is being turned from a laboratory technique into a
commercial process at an alarming speed. In this process genetic material
can be transferred between unrelated species, an ability which has been
seized upon by industry as a way of introducing new characteristics into
plants, animals and micro-organisms. Many of these are intended for large
scale commercial production leading to the release of enormous numbers of
living 'designer' organisms into the environment.
There has already been scientific, socio-economic and ethical concerns
expressed about the technology. For example, it is possible that new pests
will be produced and, since they are living organisms, these will not be
able to be recalled to the laboratory - a new form of 'genetic pollution'
is looming. If northern crop plants are engineered to make products like
cocoa or vanilla, the economies of some less-developed countries may be
seriously compromised. The proponents of genetic engineering are anxious to
reassure people that these concerns are misconceived and that genetic
engineering will be used to help feed the world.
WINNERS AND LOSERS
A study1 was undertaken to establish what is happening with genetic
engineering of plants in the world today and the implications of those
developments. The areas of focus were: what is taking place; who are the
major stakeholders in the technology; and how the releases of such
genetically engineered crop plants are regulated across the world. These
areas were chosen as the major indicators of who will be the winners and
losers as the biotechnology industry develops, whether the promised
benefits are likely to be realised, and whether environmental safety is
being properly taken into account. Plants were studied because they
represent one of the fastest growing applications of genetic engineering
with the possibility of causing serious environmental damage.
The research involved bringing together the available data on releases of
genetically engineered plants worldwide, determining the financing of the
technology, investigating the details of a selection of patents which have
been granted on plants and establishing, where possible, what regulations
exist. Because much of the information is commercially confidential, it has
not been possible to make a fully comprehensive inventory; however we
believe the results contained here provide an accurate picture of the
progress and control of the technology today.
The emphasis of the study was to determine the implications for the
environment and economies of less-developed countries and to make
recommendations to the First Conference of Parties of the Convention on
Biological Diversity in the Bahamas in November 1994 to ensure that the
environment is properly protected.
STUDY FINDINGS
* All of the world's major food crops have been genetically engineered,
including maize, wheat and rice, which together form 50% of the world's
food intake.
* Field trials with genetically engineered plants have taken place in at
least 18 developed countries and have taken place or are expected to take
place shortly in about 35 developing countries. At least 90 releases of
genetically engineered plants have taken place in non-OECD countries and
Mexico, at least a third of which were by northern-based multinational
corporations such as the United States' companies Monsanto and Calgene and
the Swiss company, Ciba-Geigy.
* Chemical industries now dominate research and development in plant
genetic engineering. The spending of the top six companies in biotechnology
research and development - Monsanto, Enimont, Du Pont, Sandoz, ICI and
Ciba-Geigy - together accounted for 63% of the total spent by the top 15
companies in 1989.
* One of the most common developments is the production of herbicide
resistant crop plants. Many agrochemical companies active in this area are
engineering resistance to their own herbicides including Rhone Poulenc,
Hoechst and Monsanto. Monsanto has tested their herbicide resistant cotton
in Belize and Costa Rica. Calgene has tested cotton resistant to Rhone
Poulenc's herbicide bromoxynil in Argentina and Bolivia.
* Other major areas of development involve altering characteristics which
make crops either more suitable for northern markets (such as the
production of tomatoes which rot more slowly than normal) or which make it
possible to grow crops in a wider geographical range. Crops which have been
restricted to hot conditions may in this way be grown in cooler climates.
* Patent protection for genetically engineered plants and the means of
producing them is often obtained in countries that are not members of the
Organization of Economic Cooperation and Development (non-OECD states) by
transnational corporations which have their headquarters in OECD states - a
form of genetic colonialism. Patent protection often covers crops which are
particularly important in developing countries such as cotton, sorghum,
cassava, millet, banana and rye. Such patents will ensure that northern
countries can control and profit from their use and secure import
monopolies by preventing local production.
* Regulation of releases of genetically engineered organisms is in place in
OECD countries but many less developed countries do not have any controls.
Apparently unregulated releases (where there was no scrutinization process
to ensure environmental safety) have taken place in six countries - Belize,
Dominican Republic, Guatemala, Pakistan, Puerto Rico and South Africa.
* Illegal releases of genetically engineered organisms have taken place in
Argentina (a vaccinia-rabies virus in 1986); Kenya (3 illegal cases since
1989, one involving ornamental plants from Argentina); and India (80
different genetically engineered species of microbes were illegally
imported from Japan and released into crop fields).
ENVIRONMENTAL HAZARDS
Despite the lack of controls to protect the environment in many countries,
many northern companies appear to be using the less developed countries as
testing grounds for crops designed to suit their home markets. It is of
very great concern that a situation of 'double standards' is evolving where
developed countries are taking measures to protect their own environments
but allowing their corporations to threaten the more vulnerable
environments of less developed countries.
Genetically engineering organisms (GEOs) are living, with the ability to
reproduce. Once in the environment they will not be able to be recalled or
collected. They present ecological threats that will magnify, not decay
over time. The organisms will not respect national borders, and growing
international travel and trade increases the chance of movement of
organisms from one country to another.
RECOMMENDATIONS
Governments, in cooperation with scientific experts and non-governmental
organizations should adopt an international, legally binding protocol to
control genetic engineering and the release of genetically engineered
organisms to the environment. Such a protocol must address the risks of
genetically engineered organisms to the environment, human health and the
economies of less developed countries, as the philosophy of sustainable
development demands.
Abuses involving GEOs are already occurring. Although internationally
binding regulations are no guarantee against the exploitation of developing
countries and the enforcement of such regulation would be difficult, the
framework for legal redress would be in place and nations would have a tool
for defending themselves against transnational giants.
Until such strict regulations are in place covering the transfer, handling
and use of genetically engineered organisms, there must be a worldwide
moratorium on their release to the environment.
1"Genetically Engineered Plants: Releases and Impacts on Less Developed
Countries." Meister, Isabelle and Dr. Sue Mayer, submitted to the First
Conference of Parties of the Convention on Biological Diversity. Nassau,
The Bahamas. (1994).
For further information, please contact:
Isabelle Meister, Greenpeace Switzerland
Muellerstrasse 37, Postfach 276
8026 Zurich, Switzerland
Phone: 41-1-241-3441; Fax: 41-1-241-3821
Dr. Sue Mayer, Greenpeace UK
Canonbury Villas, London N1 2PN U.K.
Phone: 44-71-354-5100; Fax: 44-71-696-0012
The Institute for Agriculture and Trade Policy
1313 5th St. SE, Suite 303, Minneapolis, MN 55414-1546
(612) 379-5980 fax (612) 379-5982
email iatp@iatp.org
One in a series of info sheets on Intellectual Property Rights available
from the Institute for Agriculture and Trade Policy. For a complete
listing, send email to ipr-info@iatp.org
Dale Wiehoff
Communications Director
Institute for Agriculture and Trade Policy (IATP)
1313 5th St.,SE, Suite 303
Minneapolis, MN 55414-1546 USA
Tel: (612) 379-5980 Fax: (612) 379-5982
Email: dwiehoff@iatp.org
INFORMATION ABOUT INTELLECTUAL PROPERTY RIGHTS No.11
Subject: International Policy on Plant Genetic Engineering
by Michelle Thom, Institute for Agriculture and Trade Policy
May 1995
During the 1970s and 1980s, developing nations expressed concern about the
free flow of plant genetic resource materials, or germplasm, from the South
to the North. Why, they asked, were patented seeds of southern origin
bringing tremendous profits to multinational seed companies without
compensation for the developing world? 1 In the culmination of what was
dubbed the Seed Wars of the 80s, Third World leaders managed to air their
concerns in an international arena via the United Nations Food and
Agriculture Organization (FAO).
In 1983 the FAO established the Global System for the Conservation and
Utilization of Plant Genetic Resources. It includes a legally non-binding
set of guidelines called the "International Undertaking on Plant Genetic
Resources" (Undertaking) and an intergovernmental Commission on Plant
Genetic Resources. The Commission was created to monitor the
implementation of the Undertaking and more generally, to discuss the use,
control and conservation of plant genetic resources. It operates on the
principle of one country, one vote.
The purpose of the Undertaking2 is to "ensure that plant genetic resources
of economic or social interest, particularly for agriculture, will be
explored, preserved, evaluated and made available for plant breeding and
for scientific purposes." The underlying notion is the common heritage
principle - that "plant genetic resources are a heritage of mankind and
consequently should be available without restriction." The principle is
extended to include not only native plant materials, but also
farmer-developed varieties and new products of biotechnology. This
guarantee of access without restriction caused eight industrialized
countries to register reservations; the U.S. and Canada still do not adhere
to the Undertaking.
FARMERS' RIGHTS
Two annexes to the Undertaking were adopted in 1989. A third was adopted
in 1991. A fourth is presently being negotiated. One annex addressing
Farmers' Rights recognizes the right of farmers to be compensated for
developing and conserving plant genetic resources. It is well known, for
instance, that over generations, Andean potato farmers developed
frost-resistant varieties for growing in flat bottomlands where frost is
common, and Chiapan farmers bred at least a dozen varieties of corn, which
were heavily utilized by local farmers.
The notion of farmers' rights emerged in part as a mechanism for equitably
sharing the benefits of utilizing plant genetic resources acquired by seed
breeders in the North with the people from whom the resources were
obtained. As such, farmers' rights are acknowledged in the Convention on
Biological Diversity, which emerged during the 1992 Earth Summit in Rio de
Janeiro, Brazil, and extended to include indigenous communities. The
Biodiversity Convention states that contracting parties will:
"... Respect, preserve and maintain knowledge, innovations and practices
of indigenous and local communities embodying traditional lifestyles
relevant for the conservation and sustainable use of biological diversity
and promote their wider application with the approval and involvement of
the holders of such knowledge, innovations and practices and encourage the
equitable sharing of the benefits arising from the utilization of such
knowledge, innovations and practices."3
Despite such recognition in the Biodiversity Convention, the idea of
farmers' rights is still considered a source of continued tension
surrounding the use and control of plant genetic resources.4
PLANT BREEDERS' RIGHTS
The Plant Breeders' Rights annex acknowledges the significance of the
contributions of plant breeders, such as those who work for private
entities like Pioneer Hi-Bred and Northrup King, and their work in
international agricultural research. Plant breeders were concerned that
farmers' rights could represent a wholesale transfer of wealth from the
North to the South. This annex acknowledges that the rights of plant
breeders are not incompatible with farmers' rights and allows for legal
protection of patented seed varieties. 5
Quantifying the South's contribution to seed development and how to collect
and distribute compensation remains an issue. As a result, the idea of
farmers' rights remains just that - an idea. With the exception of the
Biodiversity Convention, farmers' rights have not achieved overt
recognition in other international dealings, such as trade agreements like
the General Agreement on Tariffs and Trade (GATT). Because the GATT
strengthens the intellectual property rights of the plant breeding
industry, many Southern nations have questioned the commitment of the North
to the Undertaking.
STATE SOVEREIGNTY
The third annex, adopted in 1991, reaffirmed the concept of "common
heritage" but made it subject to the sovereign rights of nations over their
plant genetic resources. In other words, nation states have the right to
determine how to preserve, protect and be compensated for innovations
utilizing their native plant genetic resources as part of the world
community. It recognizes that countries of origin have legal ownership of
the plant genetic resources found within their borders and thus have the
right to control the use of and access to these materials. This concept is
also endorsed in the Biodiversity Convention, which in its preamble
reaffirms that "States have sovereign rights over their own biological
resources."6
THE UNDERTAKING TODAY
A fourth revision to the Undertaking is now underway. It will take place
in three stages. Stage I will integrate the annexes and harmonize the
Undertaking with the Biodiversity Convention. Many developing countries
have suggested that the Undertaking adhere strictly to the Biodiversity
Convention. The U.S. has suggested that, while this would be beneficial,
the North may not be able to guarantee compensation. At last November's
First Extraordinary Session of the FAO Commission, U.S. spokesperson Henry
Shands said, "The international community cannot be in a position to ensure
benefits. We can support but cannot necessarily ensure benefits." 7
Thereafter, Stage II of the fourth revision will discuss the question of
how to enforce farmers' rights and equitable access to plant genetic
resources, while Stage III will consider making the Undertaking a legally
binding agreement, such as a protocol to the Biodiversity
Convention.
Because a great deal of germplasm utilized by plant breeders of the North
originated in the South, developing nations have a key role to play in
ensuring the fourth revision addresses their concerns about access to and
control over their native plants. In the fourth revision, representatives
of developing countries are asking for the following: the regulation of
access to plant genetic resources through an international forum such as
the Biodiversity Convention, a clarification and realization of farmers'
rights, and technology transfer to enable the conservation and sustainable
use of plant genetic resources for food and agriculture.8
Comments on the fourth revision from FAO delegates will be incorporated
into a draft of the proposed revised Undertaking and submitted to the
Secretariat as a paper in June 1995.
THE NGO ROLE
Because the undertaking relies on the "common heritage" principle, it is
necessary to ensure that the Undertaking adequately addresses the rights of
farmers and indigenous communities who have traditionally understood the
value and utility of plant genetic resources. Specifically, these
communities should in some way receive compensation for their knowledge of
plant genetic properties, the conservation of biodiverse resources and the
numerous products that have resulted from this knowledge, which are
primarily therapeutic or medicinal, and have brought significant profit to
multinational pharmaceutical companies located in the North.
The Undertaking and related events provide nongovernmental organizations
(NGOs) with a unique opportunity to respond in a way that empowers
citizens, indigenous communities, and farmers throughout the world. Many
NGOs, including the Rural Advancement Foundation International (RAFI) and
Genetic Resources Action International (GRAIN), have already taken part in
past meetings with the FAO Commission.
The Keystone Symposia, for example, involved governmental, nongovernmental
and academic participants in exploring the question of preserving the
world's plant genetic resources prior to the 1992 Rio Earth Summit. The
group of 41 individuals from 22 different countries concluded that the
current situation calls for a Global Initiative for the Security and
Sustainable Use of Plant Genetic Resources.9
Likewise, the Crucible Group, made up of intergovernmental officials, NGOs
and industry representatives, is working to identify the trends, concerns
and opportunities related to intellectual property issues relevant to plant
breeding and plant genetic resources. This effort resulted in the
publishing of the book People, Plants, and Patents.10
In June 1996, government officials and NGOs will meet in Leipzig, Germany
for the Fourth International Technical Conference on Plant Genetic
Resources. Up for discussion will be two major documents: the First Report
on the State of the World's Plant Genetic Resources, and the Global Plan of
Action (GPA).
The Report is expected to be a critical assessment of the status of the
world's plant genetic resources and the multilateral institutional capacity
to preserve and develop these resources.
The GPA is a combination of recommended programs, priorities and projects
to conserve and develop plant genetic resources. Envisioned as a major
component of the FAO's contribution to the implementation of the
Biodiversity Convention, the GPA will also address means of compensating
developing countries for their native germplasm.11
In order to facilitate NGO participation in this process, the FAO has
established the International Conference and Programme for Plant Genetic
Resources (ICPPGR), which will coordinate activities and develop a range of
initiatives and agreements designed to generate consensus and commitment
for the Leipzig conference.12
SOURCES
1 See Neil Hamilton, "Who Owns Dinner: Evolving Legal Mechanisms for
Ownership of Plant Genetic Resources," Tulsa Law Journal 28 (1993)
discussing Hope Shand, "There Is a Conflict Between Intellectual Property
Rights and Rights of Farmers in Developing Countries," Journal of
Agricultural & Environmental Ethics 133 (1991).
2 Report of the Conference of FAO, 22nd Session, Agenda Item 6, United
Nations Document c/83/REP, 1983.
3 Convention on Biological Diversity, June 5, 1992.
4 Food and Agriculture Organization of the United Nations, Interpretation
of the International Undertaking on Plant Genetic Resources, Rome, 25th
Session, U.N. Doc. C 89/24, November 11-30, 1989.
5 Ibid.
6 Ibid.
7 "PGRs Undertaking Gets First Reading," South-NorthDevelopment Monitor,
November 15, 1994.
8 Ibid.
9 Keystone International Dialogue Series on Plant Genetic Resources, Final
Consensus Report: Global Initiative for the Security and Sustainable Use
of Plant Genetic Resources, Third Plenary Session, Oslo, Norway, May
31-June 4, 1991.
10 See The Crucible Group, People Plants and Patents, International
Development Research Centre, 1994.
11 Pesticide Action Network, "Preparations for Plant Genetic Resources
Action Plan," PANUPS, May 8, 1995 or "Go Between #49, December 1994-January
1995; PGR, March 1995.
12 Ibid.
For more information on the Undertaking, contact:
Institute for Agriculture and Trade Policy,
1313 5th Street S.E., Suite
303, Minneapolism, MN 55414;
Telephone: (612) 379-5980; fax: (612) 379-5982;
email: mthom@iatp.org
International Conference and Programme for Plant Genetic Resources, FAO,
AGP Division, Viale delle Terme di Caracalla, 1-00100 Rome, Italy, Tel:
(39-6) 5225 5871, fax: (39-6) 5225 5533, Email: icppgr@fao.org.
One in a series of info sheets on Intellectual Property Rights available
from the Institute for Agriculture and Trade Policy. To receive a complete
listing, send email to: ipr-info@iatp.o
g.
Dale Wiehoff
Communications Director
Institute for Agriculture and Trade Policy (IATP)
1313 5th St.,SE, Suite 303
Minneapolis, MN 55414-1546 USA
Tel: (612) 379-5980 Fax: (612) 379-5982
Email: dwiehoff@iatp.org
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
INFORMATION ABOUT INTELLECTUAL PROPERTY RIGHTS No. 10
Subject: GATT and Retail Food Cooperatives
by Jim Glassman
Minnesota Food Association
June 1994
Why should anyone involved with retail food cooperatives be concerned about
GATT?
The General Agreement on Tariffs and Trade (GATT)is a multi-lateral
agreement governing the conduct of international trade. Last December, the
"Uruguay Round" of the GATT negotiations concluded with a call for the
creation of a World Trade Organization (WTO) to govern global trade.
Retail food cooperatives vary somewhat in their missions, but the trade
regime which the WTO will oversee will have potentially great effects on
activities of significance to all coops - ranging from effects on the
viability of their efforts to guarantee the quality of foods they carry, to
the effectiveness of their promotion of local and sustainable agriculture,
to the potential of their attempts to encourage more democratic
participation in basic affairs of society.
GATT and democracy
For some coops, one of the central purposes is to provide an opportunity
for people to play a more active role in the basic decisions effecting
their lives, in this case, decisions about the character of their working
environment. Insofar as coops wish to extend their concern about
participatory democracy to the world at large, they have good reason to
consider GATT a serious threat. GATT represents a danger to any notion
that citizens in general have a right to control the world around them.
<
R>
The WTO arbitration panels signify what this danger is about. The panels
are composed of three trade representatives who are not elected and who are
obliged to rule in favor of measures facilitating trade, with other issues
being subordinate. There is no provision under arbitration provisions for
introduction of alternative perspectives, such as amicus briefs from
non-governmental organizations, which might raise concerns about
environmental or labor conditions.
Furthermore, GATT forces governments to amend laws and even rewrite their
constitutions to ensure that they are in line with GATT principles.
Paragraph 4 of Article XVI states: "Each member shall ensure the
conformity of its laws, regulations and administrative procedures with its
obligations as provided in the annexed Agreements." The North American
Free Trade Agreement (NAFTA) provides a good example of the pressures this
will create on governments and citizens. In anticipation of NAFTA,
Mexican President Carlos Salinas de Gortari and his ruling Institutional
Revolutionary Party (PRI) changed a provision in the Mexican constitution
which protects collective farms (ejidos). The ejidos, though often
functioning imperfectly, have been an important form of protection for
small Mexican farmers confronted by the increasing industrialization of
Mexican agriculture. With the repeal of the ejido law, it is now possible
for Mexican or foreign investors to buy up the ejidos, thus potentially
displacing millions of farmers.
It was in part in reaction to this that the Zapatista rebels in Chiapas.
Mexico took over the town of San Cristobal de Las Casas last January. The
Zapatistas called for renegotiation of NAFTA and focused the world's
attention on the huge economic burdens faced by the victims of Mexico's
neoliberal economic policies. A world ruled by GATT principles seems
destined to produce more moves like those of the PRI and more reactions
like those of the Zapatistas.
GATT principles may. not protect collective forms of property like ejidos,
but they do protect international investors with stringent requirements for
the maintenance of Intellectual Property Rights (IPRs). The insistence on
IPRs forces governments to recognize patent claims on products developed by
companies and individual inventors, even if the product is developed from
materials created by local producers over generations. Thus, for example,
a University of Wisconsin scientist took out a patent on the neem tree,
used for generations in India, simply on the basis of having participated
in the development of a mass production process for neem. Indians who
process neem themselves and use it for myriad purposes can thus be required
to pay royalties for use of neem products. No one in India receives
royalties for the generations of work which have gone into finding the
various uses of neem. Appropriately, some commentators have referred to
this usurpation of traditional people's rights to use their own crops as
"the second enclosure of the commons." Codifying this enclosure movement,
and thus strengthening the position of transnational corporations at the
expense of local groups, is one of the major purposes of GATT and the WTO.
Finally, it is worth noting that both the NAFTA and GATT negotiation and
approval processes are in and of themselves tremendous affronts to the
notion that average citizens are entitled to a say in affairs effecting
their lives. NAFTA was negotiated by the Bush administration under advice
from business leaders with virtually no input from labor or environmental
groups. The Bush administration made sure that there would be little labor
input by violating federal requirements and failing to present a draft of
NAFTA to the US Labor Advisory Committee on NAFTA in timely fashion. NAFTA
was approved under "fast-track" procedures which prevented the US Congress
from attempting to change any of its provisions as a condition for its
implementation. Thus, the public was prevented from participating in the
creation of the trade accord. Even so, it required shameless vote-buying
by the Clinton administration to push the agreement through Congress.
Food coops which consider themselves to be part of a citizens' movement for
greater empowerment have good reason to be concerned that GATT represents
the antithesis of their own efforts.
GATT and food safety
Under GATT, acceptable standards of food safety will be determined by the
Codex Alimentarius, a United Nations organization which is heavily
influenced by industry. Many of the food safety standards established by
this body are weaker than existing US standards. Once the WTO is in place,
countries which maintain standards more stringent than those of Codex will
be subject to challenges from other governments for establishing barriers
to trade. Under these circumstances, a WTO arbitration panel would decide
how to rule in the dispute. If the panel decided against the country with
tougher food safety standards than the Codex, that country would be forced
to either change its standards or else face sanctions and retaliation.
In addition, the WTO could make it more difficult for food coops to
maintain the confidence of their customers in the safety and quality of
their products. It has been suggested, for example, that an existing
Minnesota law regulating the field release of genetically engineered
organisms could be ruled a trade barrier under GATT principles. Extending
this claim, it seems reasonable to suspect that laws attempting to regulate
the use of genetic engineering in food production might be found to inhibit
trade. Given the concern of many consumers about potential allergic
reactions to foods with unidentified additives, this should be a matter of
interest to coops.
In principle, coops could deal with this concern by promoting labeling of
foods that are genetically engineered or produced using genetic
engineering. But recent challenges to the labeling of milk as not
containing Bovine Growth Hormone (BGH) show that this approach could be
treacherous. Furthermore, the possibility that GATT rules could be used to
interpret labeling laws themselves as barriers to trade should not be ruled
out at this point. Similar issues could be raised with regard to the
viability, under GATT of attempts to promote organic agriculture and to
certify foods as organically grown.
GATT, Local Agriculture and Sustainability
Many coops see their missions as not only involving the promotion of good
food but also of locally-grown produce. GATT threatens this project by
making it difficult for countries to maintain subsidies or forms of
protection for local growers. Indeed, GATT requires that the United States
import a minimum of 5 percent of domestic consumption for every crop
consumed.
The potential impact of measures such as this has already been discussed
extensively in the case of the NAFTA. NAFTA will force the Mexican
government to abandon subsidies to small farmers producing corn. The
likely impact of this on these farmers is that they will be driven out of
business by cheaper imports of corn from the United States and Canada. In
Minnesota, likely victims of NAFTA and GATT would include sugar beet
producers, who currently benefit from subsidies and other measures that
inhibit cheaper sugarcane imports. In addition, programs supporting local
agriculture, such as "Minnesota Grown," could be challenged as trade
barriers under NAFTA and GATT.
Sustainable agricultural practices will be threatened under GATT as well.
Any attempts by states or countries to control imports on the basis of the
process or method of production is referred to under GATT as a "technical
barrier to trade" (TBT). Any attempts to insure that imported products are
produced sustainably could be ruled a TBT by the WTO. In addition,
attempts to promote local sustainable agriculture through subsidies or
other measures would be a violation of GATT principles. Yet such subsidies
to sustainable and organic producers may be necessary to offset the
artificially cheap price of manyconventional products, which only cost as
little as they do because the price of problems like soil erosion, ill
health from pesticides, and fossil fuel pollution are not internalized but
passed on to society in general. GATT would make it difficult to maintain
programs that would level the playing field for sustainable and organic
practices.
For all of these reasons, then, retail food cooperatives should be
concerned about the potential passage of GATT. Passage is not a fait
accompli, however, nor is GATT irreversible if it does gain US
Congressional approval. By working with groups which are organizing in
opposition to GATT, coops can play a role in preventing GATT from
undermining the viability of attempts to insure availability of safe food,
produced sustainably and on ways compatible with the development of a
politically and economically democratic society.
For more information, contact:
Minnesota Safe Food Link, 1313 Fifth Street SE, Suite 303,
Minneapolis, MN. USA 55414. Telephone: (612)379-5980; fax: (612) 379-5982.<
r>
Institute for Agriculture and Trade Policy, 1313 Fifth Street SE, Suite
303, Minneapolis. MN. USA 55414. Telephone: (612)379-5980; fax: (612)
379-5982.
One in a series of info sheets on Intellectual Property Rights available
from the Institute for Agriculture and Trade Policy. For a complete
listing, send email to: ipr-info@igc.apc.org
Dale Wiehoff
Communications Director
Institute for Agriculture and Trade Policy (IATP)
1313 5th St.,SE, Suite 303
Minneapolis, MN 55414-1546 USA
Tel: (612) 379-5980 Fax: (612) 379-5982
Email: dwiehoff@iatp.org
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
INFORMATION ABOUT INTELLECTUAL PROPERTY RIGHTS NO. 13
Subject: Patent Nonsense: On the Patenting of Life by Dr. Phil Bereano
>
Council for Responsible Genetics
Washington Biotechnology Action Council
--who acknowledges the work of colleagues around the world.
In August of 1993, Pat Mooney of the Rural Advancement Foundation
International (RAFI) was examining a patent database when he came across
an
application filed by the U.S. Secretary of Commerce on the cell line of a
26-year old Guaymi Indian woman from Panama.1 (A cell line is a group of
cells taken from a human body that are capable of being sustained and
grown
in laboratory culture media, and are therefore said to be "immortal;" a
line of cells contains the complete genetic code, the genome, of the
individual from whom the cells were taken.)
Thus, for the first time, an applicant was attempting to establish
monopoly
ownership over the genome of a living person. These cells were believed
to
contain special anti-viral qualities. Although two individual men were
listed in the application as "inventors," it is not clear that their
actions in taking the woman's blood when she went to the hospital for
treatment and the subsequent isolation of these cells amounts in any
sense
to what would be considered as "invention."
When contacted, the Guaymi had no idea they were candidates for
monopolization and demanded that the U.S. withdraw its patent claim and
return the cell line to the tribe. The Guaymi President reflected, "I
never
imagined people would patent plants and animals. It's fundamentally
immoral, contrary to the Guaymi view of nature, and our place in it. To
patent human material . . . to take human DNA and patent its products . .
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
INFORMATION ABOUT INTELLECTUAL PROPERTY RIGHTS NO. 14
Subject: Towards A Biosafety Protocol
by Kristin Dawkins
Institute for Agriculture and Trade Policy
What are the Risks?
To date, biotechnology companies have released small numbers of more than
2,700 experimental genetically engineered organisms.1 Even when
controlled
experiments are concluded successfully, there is no guarantee that the
engineered organism will not create a problem in a different ecological
setting.
In one case, scientists in Germany designed genetically engineered
bacteria
that convert crop wastes into ethanol. Later, scientists at Oregon State
University tested the organism under different conditions and discovered
that the "designed" bacteria also reduced the amount of a beneficial
fungus
in the soil that is essential to plant development. "So if the bacterium
had been released," said one of the scientists, "and spread widely, very
likely we would be unable to grow crops without a control measure for
this
organism."2
Genetically-engineered fish and shellfish pose even greater ecological
risks, since all aquatic organisms are undomesticated and have the
capacity
to survive in nature, moving easily from the controlled environment to
the
wild. For example, of 46 exotic fishes which have successfully invaded
U.S.
waters to date, 22 escaped from aquaculture facilities. No fish farmer
can
ensure sea pens are indestructible. A 1988 storm tore apart hundreds of
sea
nets and their moorings at a Norwegian facility, allowing a million
farmed
salmon to escape; catches in later years have shown that these animals
spread very widely. A similar accident with transgenic fish, such as the
Chinook salmon which grows 11 times faster than normal or the Atlantic
salmon with an antifreeze gene from winter flounder, could lead to global
disruptions of salmon communities and their capacity to reproduce
normally.3
Although scientists are developing techniques to sterilize
genetically-engineered fish, there is as yet no guarantee of sterility in
100 percent of the cases. An accidental release, therefore, could lead to
catastrophic impacts on a wild population. In some cases, a transgenic
breed may be able to transfer the altered genes to wild relatives,
diluting
specialized adaptations that evolved in response to specific survival
needs. In other cases, a transgenic breed might significantly strengthen
a
wild relative, enabling it to out-compete native species for food and
breeding sites within a habitat. Even sterile transgenic fish could pair
with fertile relatives, reducing the numbers of young produced by an
already endangered species. Numerous examples of such ecological
disruptions have already been documented where exotic species were
released
into a new environment.
Requirements of the Convention on Biological Diversity * Article 8(g) of
the Convention on Biological Diversity, signed by 156 countries upon its
publication in Rio de Janeiro in June 1992, commits the parties to
"establish or maintain means to regulate, manage or control the risks
associated with the use and release of living modified organisms
resulting
from biotechnology..."
* Article 8(h) commits the parties to "prevent the
introduction of, control or eradicate those alien species which threaten
ecosystems, habitats or species."
* Article 19(3) commits the parties to
"consider the need for and modalities of a protocol setting out
appropriate
procedures, including, in particular, advance informed agreement, in the
field of the safe transfer, handling and use of any living modified
organism resulting from biotechnology..."
Debating the Need The U.S., not a party, has insisted that there is no
need
for a protocol on biosafety, despite a series of opinions to the
contrary.
The U.S. objected to the U.N. Environment Programme's 1993 Panel IV
report
on grounds that it was not a "consensus document;" the majority of this
panel of experts had concluded that "the purpose of strengthened
international cooperation in the field of biotechnology and biosafety is
best served by the adoption of a legally binding instrument."4 And the
vast
majority of the parties attending the First Conference of the Parties
(COP1) in the Bahamas last year spoke in favor of moving away from
discussions of "need" and towards substantive discussion of the specific
modalities.
As a result, COP1 established an "ad hoc open-ended group of experts
nominated by governments" to reconsider the question in May 1995 in
Cairo.
Noting that the COP1 had "expressed deep concern and interest about the
need for the safe transfer, handling and use of all living modified
organisms (LMOs) resulting from biotechnology," these experts concluded
with some ambiguity that although "the potential risks posed by LMOs are
often environment-dependent and ... an organism that is safe in one
country
is not necessary [sic] safe in another country," methodologies for "risk
assessment are well defined and are not fundamentally different from
those
in other technologies." This panel emphasized the need for expert advice,
capacity building at the national level, and an "appropriate
international
framework" with which to "address the movement of LMOs across national
boundaries."5
A regionally-representative group of government delegations then met in
Madrid in July 1995 to consider the Cairo experts' report in order to
bring
a formal recommendation to the Second Conference of the Parties (COP2.)
All
of these delegations noted "the urgent need to give attention to the
issue
of transboundary movement of LMOs resulting from modern biotechnology."
The
final report notes that the "large majority of delegations favored the
development ... of a protocol under the Convention on Biological
Diversity"
although "those delegations who did not yet have a position on whether
there is a need for a protocol or not" suggested COP2 consider four
options: coordination and strengthening of existing arrangements; new
voluntary international arrangements; a new legally binding instrument
(protocol); or "a combination of some of the above."6 In Madrid, the U.S.
publicly announced its continuing opposition to a protocol.7
The Jakarta Decision In Jakarta, Indonsia, the 2nd COP called for "a
negotiation process to develop in the field of the safe transfer,
handling
and use of living modified organisms, a protocol on biosafety,
specifically
focusing on transboundary movement of any living modified organism
resulting from modern biotechnology that may have adverse effect on the
conservation, and sustainable use of biological diversity, setting out
for
consideration, in particular, appropriate procedure for advance informed
agreement." This language is a compromise: Northern governments had
argued
that the scope of the agreement should reference "transboundary transfer
of
any" living modified organisms (LMOs); Southern governments preferred a
protocol encompassing "the safe transfer, handling and use" of LMOs.
The COP2 agreed to establish an Open-Ended Ad Hoc Working Group to build
upon the work of the Cairo and Madrid intersessional meetings of 1995,
which should take into account the precautionary principle while seeking
to
minimize unnecessary negative impacts on biotechnology research and
development and not hindering access to and transfer of technology.
Despite these decisions, the U.S. stated in the closing Ministerial
segment
of the Jakarta conference that governments must still develop a framework
for deciding whether the need for a protocol is established and how to
proceed.7
U.S. Policy at Home Domestically, the U.S. is aware of the need for
regulating the release of LMOs although there is a good deal of political
pressure to weaken existing regulations. Three federal agencies now
address
genetically engineered organisms.
* The U.S. Department of Agriculture,
for
example, now requires permits for shipping genetically engineered
organisms
between states and for some releases into the field although releases
involving corn, soybeans, tobacco, cotton, tomatoes and potatoes merely
require the company to file a notice; a proposed rule change would exempt
almost all transgenic plants from this permitting process, exempt most
viral genes (including those not yet discovered) from risk assessment,
and
expedite the commercialization of crop varieties "closely related" to
those
already commercialized.
* The U.S. Environmental Protection Agency (EPA)
regulates organisms containing altered DNA as "new" chemical substances
and
reviews and registers genetically engineered plant and microbial
pesticides
although it may soon exempt virus and herbicide-resistant plants. It is
worth noting that some scientists at the EPA recently charged that the
agency "lacks a sound process to assess the risks these organisms may
pose
to human health and North American ecosystems."
* The U.S. Food and Drug
Administration's policy is to treat genetically-engineered products
intended for human or animal consumption as traditional and safe,
requiring
no pre-market tests, notification or labeling - unless the producer
itself
declares that there may be some risk.8
NGOs and Scientists Demand Action Non-governmental organizations and
scientists from around the world have joined many developing country
delegations in arguing urgent movement towards specific rules and their
adoption. Many agree that a legally binding protocol requires, at least:
prior notification, locally-specific testing, comprehensive impact
assessment, full public disclosure, and fully informed advanced agreement
of affected nations and communities for every experimental and commercial
release and transfer of a LMO or its products; * developing a
comprehensive
methodology for the case-by-case evaluation of each LMO or its product,
addressing the purported need relative to existing alternatives as well
as
the socio-economic, human health, and ecological impacts of its full life
cycle including disposal on environments other than that in which it was
developed;
* establishing an international roster of independent
personnel
from the broadest possible range of disciplines which, at the request of
a
party, can be assembled as a team to assist with compliance as well as
capacity-building at the national level;
* adherence to the precautionary
principle, giving all nations and communities the right to determine what
is an acceptable level of risk and the right to refuse any release or
transfer of a LMO or its product;
* adherence to the polluter-pays
principle, obligating the commercial developer and/or the commercial
exporter of the LMO or its product to invest in implementation of the
protocol and strict liability;
* on-going monitoring of LMO performance,
impacts, and range of habitat after any release or transfer; * national
reports, compliance reviews, mechanisms for enforcement and dispute
resolution; and
* the full participation of all interested persons
through
transparent and accountable processes at the international, national, and
community levels for every element of implementation including
notification, impact assessment, consent and refusal, methodological
evaluation, roster nominations, team selection, risk management,
post-release performance monitoring, mitigation procedures,
capacity-building, national reports, compliance reviews, and dispute
resolution.
To join the effort, please consider joining the National Biosafety
Council
- a non-profit group whose members sign on to the following pledge:
"We commit ourselves as members of the National Biosafety Council (NBC)
to
support the adoption of an international biosafety protocol. We believe
the
protocol should be enforceable through standards that bind every country
to
comply with safeguards that are effectively managed. Release of
genetically
modified organisms in the absence of a biosafety protocol could have
unpredictable, catastrophic consequence on the environment and health. If
a
protocol is not forthcoming or should its administration be inadequate,
we
will call upon all nations to adopt a moratorium on all release of
genetically engineered organisms."
To sign on, as an individual or as an organization, please send your
name,
affiliation if any, address, telephone, fax and e-mail if any to:
National Biosafety Council, c/o Institute for Agriculture and Trade
Policy,
1313 Fifth Street SE, #303, Minneapolis, MN 55414 USA FAX: 612-379-5982.
BR>
Dale Wiehoff
Communications Director
Institute for Agriculture and Trade Policy (IATP) 1313 5th Street SE,
Suite 303
Minneapolis, MN 55414-1546 USA
Tel: (612) 379-5980 Fax: (612) 379-5982
Email: dwiehoff@iatp.org
URL: http://www.iatp.org/iatp
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Subject: Genetic Engineering Regulations by Michelle Thom Institute for
Agriculture
and Trade Policy
MINNESOTA REGULATIONS The Minnesota Department of Agriculture (MDA) has
proposed new rules for regulating the agricultural biotechnology industry
in the state. These rules will determine how a company can commercialize
genetic engineering: what will be sold and how it can be sold. This is
the
most critical decision that is made in the development of any technology
into a salable product.
According to Minnesota's Genetic Engineering Law [Minnesota Statutes
116.91-.96], an agency's rules must protect the environment and humans.
New
rules would provide industry with a clear path to develop commercial
products. They do not provide for effective public consultation and have
minimal public notification requirements. In some cases, MDA would not
even
have to notify the public of its decisions at all.
Industrial commercialization proceeds through several stages: testing of
potential products in the laboratory, selecting promising ones for
outdoor
testing (field releases), testing in the field with further selection and
increasingly larger field tests, and preliminary market testing. At some
point, the industry will decide that the product is so promising that
they
will want to sell it.. Given this developmental process, the regulations
should require permitting first, notification second and commercial use
exemption last - only after enough information has been collected to
convince experts and the general public that a particular genetically
engineered product is safe and beneficial.
The proposed MDA rules create one big loophole through which industry can
slip: the commercial use exemption. The rules provide alternative
regulatory systems, but obviously most industries would prefer an
exemption. The three systems are:
* Commercial use exemption - Industry requests that MDA exempt them from
any regulation. Industry provides MDA with specified information. MDA
determines if the product is safe, and can approve, not approve, or add
conditions to the industry request.
* Permit - Industry decides that it wants to conduct a field release,
determining the size, location, and scope of the experiment. Industry
provides MDA with specified information. MDA evaluates the potential
effects of their proposed release on the environment and humans. MDA only
evaluates that particular release, and can provide the industry with a
permit to conduct the release.
* Notification - MDA requires that industry send written notice to MDA
informing where, when and how industry will conduct a release. Industries
keep MDA informed of any further field testing of allowed organisma.
(Now,
notification is allowed for only certain genetically engineered
modifications of six crops: corn, tobacco, cotton, tomatoes, potatoes and
soybeans.)
NORTH CAROLINA REGULATIONS 1 In 1989, North Carolina adopted the
Genetically Engineered Organisms Act [NC General Statutes Chapter 106,
Article 62], revising a 1987 policy which gave complete power over
releases
to the North Carolina Department of Agriculture (NCDA) and provided no
opportunity for citizen input.
The 1989 Act requires a permit for the release or commercial use of
genetically engineered organisms; public notice and comment; a state role
that carries a minimum burden; and no "undue governmental interference
with
the progress and commercial development of biotechnology." In most cases,
the law also requires that a review take place within the time frame
established by federal agencies for reviewing companies' applications for
releasing genetically engineered organisms.
The Act granted the NCDA sole authority for regulating the release of
genetically engineered organisms. A Genetic Engineering Review Board
(GERB)
was also established under the law; it has tended to delegate most of its
oversight authority to the NCDA and has had minimal representation by the
public interest sector.
Although the public is entitled to review release applications with
Confidential Business Information deleted, state bureaucrats wield
enormous
procedural power. Hearings, for example, are scheduled only when the
agriculture "commissioner determines that significant public interest and
justification exist."
The law contains a five-year sunset provision, which means it expires in
September 1995. Reports indicate there is little organized support for
continuing the Act and organized opposition by the biotechnology
industry.
Public interest groups that have historically played a role in the
development and implementation of North Carolina's law are having trouble
mustering support as the Act has fallen far short of expectations. They
say
NCDA has acted as a surrogate for the biotechnology industry. About the
only thing the Act has accomplished, they say, is that it has enabled
citizens to obtain information faster than through a federal Freedom of
Information Act (FOIA) request.
NATIONAL REGULATIONS 2: USDA, FDA and EPA One of the primary reasons
states
like Minnesota and North Carolina pursued their own regulatory strategy
is
the fragmented and convoluted nature of federal oversight.. It is often
unclear which agency is responsible for what. Furthermore, federal
agencies
take the burden of proof for safety off companies by requiring companies
to
notify the agency only when they think there may be a problem. Thus,
consumers become the guinea pigs.
Under the federal system, three agencies are responsible for various
aspects of regulating genetically engineered organisms: the U.S.
Department
of Agriculture (USDA), the Food and Drug Administration (FDA), and the
Environmental Protection Agency (EPA).
USDA Within USDA, three departments handle oversight: the Animal and
Plant
Health Inspection Service (APHIS) oversees agricultural products; the
Food
Safety and Inspection Service (FSIS), oversees animal products; the
Agricultural Biotechnology Research Advisory Committee (ABRAC) is a
scientific advisory body.
Most of the regulatory activity occurs within APHIS. The main law
granting
authority for oversight to APHIS is the Plant Pest Act, which requires
permits for genetically engineered organisms that are shipped interstate
or
used in the environment. As of 1992, companies are only required to
notify
the agency if they want to field test atypical modifications of six
crops:
corn, soybeans, tobacco, cotton, tomatoes and potatoes. Companies that
want
to field test other genetically engineered crops, such as squash and
canola, are required to submit to a permitting process. FSIS regulates
genetically engineered animals and animal products; however no such
product
has been commercialized yet and no formal policy has been adopted. ABRAC
merely offers scientific guidance to APHIS and FSIS.
FDA FDA regulates the products of biotech intended for human and/or
animal
consumption. Authority to regulate genetically engineered products is
granted by the Food Drug and Cosmetic Act (FDCA). Under this Act, FDA
typically reviews each product on a case-by-case basis, but provides
companies with a great deal of flexibility. For example, Calgene, which
developed the genetically engineered delayed-ripening tomato Flavr Savr,
was not required to undergo an FDA review prior to commercialization; the
company did so on a voluntary basis in an attempt to allay the fears of
consumers.
The agency's policy is that products of genetic engineering should be
treated as traditional and safe, with emphasis on the end product, not
the
process by which the product was derived. The agency does not require
pre-market safety tests, notification or labeling A 90-day pre-market
notification policy is reportedly being discussed at FDA.
EPA The EPA also regulates genetically engineered agricultural products.
Jurisdiction is granted by two laws: the Federal Insecticide, Fungicide
and
Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). EPA
typically uses existing FIFRA regulations to review and register
genetically engineered plant pesticides and microbial pesticides.
Proposed
revisions in 1995 would exempt virus and herbicide-resistant plants from
FIFRA oversight. Public interest groups object. Too little is known about
virus-resistant plants they say, and thus, they should not be exempted
until more data is available on their potential risks to the environment.
Under TSCA, EPA regulates organisms containing altered DNA as new
chemical
substances. TSCA's purpose is to regulate chemical substances not
otherwise
regulated as drugs; the Act applies to new genetically engineered
microorganisms used in chemical manufacturing and the environment and to
non-pesticidal organisms, such as nitrogen-fixing bacteria. TSCA may
eventually apply to genetically engineered microorganisms used in
pollution
remediation when such things reach commercialization stage.
No federal agency requires consumer labeling, creating a problem for
people
of various religious persuasions, vegetarians, those with food allergies
and those who simply do not want to purchase the products of
biotechnology
in support of more sustainable methods of food production.
INTERNATIONAL BIOSAFETY PROTOCOL The Convention on Biological Diversity,
signed at the Earth Summit in Rio de Janeiro in June 1992 by more than
150
countries (except the U.S.), states that all "Parties shall consider the
need for and modalities of a protocol setting out appropriate procedures,
including, in particular, advance informed agreement, in the field of the
safe transfer, handling and use of any living modified organism resulting
from biotechnology that may have adverse effect on the conservation and
sustainable use of biological diversity." 3
In 1993, the U.N. Environment Programme convened a panel of experts with
this exact mandate; a majority of the panel found that there was a need
and
defined the "scopes and confines" and the "modalities of and elements to
be
included" in a possible protocol.4 At the First Conference of the Parties
to the Convention, in December 1994, the participating governments formed
two additional panels: another experts panel with the same mandate which
convened in Cairo in May 1995; and a panel of governmental officials
which
will meet in Madrid in July1995 to review this experts' panel report.5
These officials will forward their findings to the Second Conference of
the
Parties, convening in November 1995 in Istanbul.
Non-governmental organizations (NGOs) are circulating a worldwide call
for
a legally binding biosafety protocol:
"We the undersigned NGOs call upon the Conference of the Parties to the
Convention on Biological Diversity to formulate and adopt a legally
binding
biosafety protocol. We believe that the lack of a legally binding
protocol
could result in a catastrophic release of genetically modified organisms.
Therefore, we further call for a worldwide moratorium on all releases of
genetically modified organisms - and call upon all nations to adopt such
a
moratorium - until such a biosafety protocol has been achieved."
To endorse this petition or for more information on the regulation of
genetic engineering, contact:
Community Nutrition Institute, 910 17th Street NW, Suite 413, Washington,
DC 20006; Telephone: 202-776-0595; Fax: 202-776-0599;
Email: cnii@igc.apc.org
Edmonds Institute, 20319 92nd Avenue West, Edmonds, WA 98020; Telephone:
(206) 775-5383; Email: beb@igc.apc.org
BR>
SOURCES 1 Stark, Margo, Ed., In Our Backyard: State Action to Govern the
Release of Genetically Engineered Organisms Into the Environment,
Biotechnology Working Group. February 1993. 2 Food and Allied Service
Trade
(FAST), Biotechnology: A Report on the Future of Food -- Promise or
Peril?
Washington, DC, 1992. 3 Convention on Biological Diversity, Article
19.3.
United Nations. June 1992. 4 UNEP Expert Panels Established to Follow-Up
on
the Convention on Biological Diversity, Report of Panel IV.
UNEP/Bio.Div./Panels/Inf.4 Nairobi, 28 April 1993. 5 Report of the Panel
of
Experts on Biosafety. Cairo, Egypt, 1-5 May 1995. CBD/Biosafety
Panel/5/L.1.
----- One in a series of info sheets on Intellectual Property Rights
available from the Institute for Agriculture and Trade Policy. To receive
a
complete listing, send email to: ipr-info@iatp.org
Dale Wiehoff
Communications Director
Institute for Agriculture and Trade Policy (IATP) 1313 5th Street SE,
Suite 303
Minneapolis, MN 55414-1546 USA
Tel: (612) 379-5980 Fax: (612) 379-5982
Email: dwiehoff@iatp.org
URL: http://www.iatp.org/iatp
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