Genetically
 Manipulated 


 

 
 
 Food


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10 January 2000

Table of Contents

Seed Companies may yet Reap What They Sow
Transposons and Endogenous Virus in Plant Chromosomes
Have GE Foods Undergone Thorough Scientific Tests?
Update on RiceTec Basmati patent - from RAFI
Rush To Claim A Little Slice Of Life
The biotech industry versus the worlds poor

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Date: 8 Jan 2000 10:11:30 U
From: RBBAX@aol.com
Sender: owner-food@foe.co.uk
To: food@foe.co.uk (food)

Seed Companies may yet Reap What They Sow

By Christina Cheddar, Dow Jones, Janaury 7, 2000

NEW YORK – With the controversy over genetically modified foods spreading across the globe and taking a toll on the stocks of companies with agricultural-biotechnology businesses, it's hard to see those companies as a good investment, even in the long term. But analysts, according to this story, think biotech products will play a significant part in future agriculture.

Gene Pisasale, a portfolio manager with Wilmington Trust Corp. was quoted as saying, "The ag-biotech sector looks attractive going forward, and it will look even better," adding that he believes that when rational scientific evidence is debated, stock valuations for companies with ag-biotech businesses will get "more reasonable."

The backlash against transgenic products stems from the perceived uncertainty over their safety - and there is nothing an investor hates more than uncertainty, said analysts. The power of this negative sentiment is so strong that it has dampened stock prices of seed companies whether they genetically alter their seeds or not.

Analysts were further cited as saying that seed companies have been slow to combat negative public opinion, and that Monsanto Co. (MTC) has clearly been the company taking the most hits in the public arena. "Monsanto spearheaded the battle for everybody and is perceived as the big, bad beast," said Stephens Inc. analyst Berry Summerour.

The seed business has knocked about $10 to $15 off Monsanto's stock price, estimates Robert Goodof, a buy-side analyst at Loomis Sayles & Co. in Boston. He believes investors are valuing Monsanto's agricultural operations at zero right now. Without the agricultural business, Goodof thinks Monsanto shares are worth about $55. Recently, Monsanto traded at 36 3/8, about 42.5% off its 52-week high of 63 1/4.

The other major players in the seed sector are DuPont Co. (DD), Dow Chemical Co. (DOW), AstraZeneca PLC (AZN), and American Home Products Corp. (AHP). According to analysts, investors buy shares in those concerns based more on the companies' chemical or pharmaceutical businesses than their agricultural businesses. Of these companies, DuPont shares have probably been most affected by the GMO issue, said analysts; DuPont's high-profile acquisition of Pioneer Hi-Bred gave it the largest market share for corn seed.

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

In case anyone had a mind to, here is the address of: Archer Daniels Midland Co.
4666 E. Faries Pky
Decatur, Illinois 62526-5200
Tel: (217) 424-5200


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Date: 8 Jan 2000 16:47:52 U
From: "j.e. cummins" jcummins@julian.uwo.ca

Transposons and Endogenous Virus in Plant Chromosomes

By Prof. Joe Cummins, January 7, 2000, e-mail: jcummins@julian.uwo.ca

In Nuclear Genes in Plants I described how plant chromosomes are organized and how DNA sequences related to viruses contribute greatly to the organization of chromosomes. In this article I will describe some of the transposons and virus integrated in the plant chromosome.

Transposons are genes that jump from locus to locus in the genome. They are related to retroviruses and pararetroviruses. Endogenous virus are similar to transposons in many cases but they contain a DNA sequence related to known virus surface proteins (called capsid or envelope) while other endogenous virus are integrated DNA virus sequences.

Retroviruses replicate using reverse transcription of RNA to make DNA copies. Retroviruses are common in vertebrates and less common in in invertebrates. The Gypsy endogenous retrovirus is found in the fruit fly, its multiplication is governed by a nuclear gene called flamenco(Lecher 1997). Infectious retroviruses like HIV contain RNA chromosomes that are reverse transcribed to make DNA that is integrated into the chromosome.

The infected cell transcribes RNA copies that are transported to the cytoplasm and there assembled into infectious virus. Endogenous retroviruses , such as Gypsy, are retrovirus sequences integrated in the chromosome but activated by the nuclear gene to produce RNA copies and infectious virus. Many higher plants have Gypsy like retrotransposons that lack the envelope gene sequence required for a complete endogenous virus(Suoniemi et al 1998).

Gypsy like sequences with envelope gene sequences have been found in Arabidopsis thus there is at least one plant endogenous retrovirus ( Wright and Voytas 1998). A retrovirus like gene sequence was reported in soy bean (Bi and Laten 1996).Endogenous retroviruses are found in plants , although such findings are presently rare, while Gypsy like retrotransposons are very common and make up a good part of the genome of many higher plants.

Para retroviruses are similar to retroviruses in replicating by making RNA copies that are then reverse transcribed to make DNA.They differ in two ways, para retroviruses contain DNA in the virus particle , and the infecting DNA does not usually integrate into the chromosome of the infected organism, instead the virus forms a nuclear minichromosome that is transcribed into RNA then transported to the cytoplasm for reverse transcription to make DNA, followed by assembly of the infectious virus particle. Para retroviruses include a number of plant viruses and the Hepadna viruses of animals that cause Hepatitis B, an infection known to cause liver cancer in human.

Hepatitis B virus is known to integrate into mammalian chromosomes by a process different from the efficient integration of retrovirus. Nevertheless, the Hepatitis B integration is associated with elevated liver cancer. Until recently, it was believed plant pararetroviruses did not integrate into plant chromosomes nor were endogenous virus possible.

Both views have been proven to be mistaken. Jacowitsch et al (1999) found that a pararetrovirus DNA was incorporated into tobacco chromosomes at as much as 1000 copies per genome and can contribute significantly plant genome evolution. The pararetrovirus, banana streak badnavirus was found integrated into banana chromosomes as a endogenous virus that could be activated to release infectious virus ( Harper et al 1999 and Ndowora et al 1999).

The Petunia vein-clearing pararetrovirus virus was found to have features characteristic of a retrotransposon including DNA sequences for an integration enzyme and other features similar to gypsy retrotransposons Richert-Poggler 1997). In conclusion, pararetroviruses related to the Cauliflower Mosaic Virus (CaMV) used in genetic engineering of crops are found integrated into plant chromosomes at high copy number and they are also observed as integrated endogenous virus capable of producing infectious virus particles.

Parenthetically, many authorities in GM crops claim that such integration and endogenous retrovirus to not exist, even though the publications contradicting that view are numerous and well established. However, the important facts seem to have been ignored in evaluating the risk of use of pararetrovirus components in GM crops.

The Gemini virus is a single stranded circular DNA virus infecting plants. It is related to the circovirus that attacks plants and its related animal circovirus that is important in animal and human disease.Numerous copies of the Gemini virus sequence have been found integrated into the chromosomes of tobacco by illegitimate recombination (recombination that does not involve recognition sequences and integrase enzyme) according to Bejarano et al 1996).

In conclusion, transposons and endogenous virus sequences are ubiquitous components of the plant chromosome and they play an important role in plant evolution. These DNA sequences have been ignored for the most part in risk evaluation even though pararetrovirus sequences are employed in essentially all of the commercial GM crops. Tunnel vision seems to direct risk evaluators and led them to a path of depraved indifference.

References

  1. Bejarano,E.,Khashogl,A.,Witty,M. and Lichenstein,C. Integration of multiple repeats of geminiviral DNA into the nuclear genome of tobacco during evolution Proc. Natnl Acad Sci. USA 93,759-64,1996

  2. Bi,Y and Laten,H. Sequence analysis of a cDNA containing the gag and prot regions of the soybean retrovirus-like element SIRE-1 Plant MolBiol. 1359-9,1996

  3. Harper,O.,Osuji,J.,Heslop-Harison, J. and Hull,R. Integtration of banana streak badnavirus into the Musa genome molecular and cytogenetic evidence Virology 255,207-13,1999

  4. Jakowitsch,M.,Mette,M.,van der Winden,J.,Matzke,M. and Matzke,A. Integrated pararetroviral sequences define a unique class of dispersed repetitive DNA in plants Proc. Natnl. Acad Sci USA 96,13241-46,1999

  5. Lecher,P.,Bucheton,A.,Pelisson,A. Expression of the Drosophila retrovirus gypsy as ultrastructurally detectable particles in the ovaries of flies carrying a permissive flamenco allele J Gen Virol 78,2379-88,1997

  6. Ndowora,T.,Dahal,G.,LaFleur,D.,Harper,G., Hull,R.,Olszewski,N. ,and Lockhart,B. Evidence that badnavirus infection in Musa can originate from integrated pararetroviral sequences Virology 255,214-20,1999

  7. Richert-Poggeler,K., and Shepherd,R. Petunia vein-clearing virus a plant pararetrovirus with the core sequence for an integrase function Virology 236,137-46,1997

  8. Suoniemi,A.,Tanskanen,J. and Schulman,A. Gypsy-like retrotransposons are widespread in the plant kingdom Plant,J. 13,699-705,1998

  9. Wright,D. and Voytas,D. Potential retroviruses in plants :Tat 1 is related to a group of Arabidopsis thaliana Ty3/gypsy retrotransposons that encode envelope-like proteins Genetics 149,703-15,1998

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Date: 9 Jan 2000 05:48:20 U
From: RBBAX@aol.com

Have GE Foods Undergone Thorough Scientific Tests?

Some interesting points on the safety of GM foods

Sections:
Claim: Ge-foods Have Undergone Thorough Scientific Tests
Claim: GE-foods Do Not Affect Our Immune System
Claim: Labelling Is Not Necessary

Claim: Ge-foods Have Undergone Thorough Scientific Tests

Claim: GE-foods Do Not Affect Our Immune System

-- Twenty two leading scientists recently declared that animal test results linking GE foods to immuno-suppression are valid. (NYTimes full page ad, 18 Oct 1999)

Claim: Labelling Is Not Necessary


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Date: 9 Jan 2000 14:19:46 U
From: jim@niall7.demon.co.uk
From: Judy_Kew@greenbuilder.com (Judy Kew)
From: raven raven@dojo.tao.ca

Update on RiceTec Basmati patent - from RAFI

Basmati Patent

http://www.rafi.ca/web/docus/pdfs/basmatiupFD.pdf

For the latest on the basmati rice patent saga visit above site, pdf file also available above that, from RAFI

4 January 2000

This update on RiceTec's Basmati Rice Patent was produced jointly by RAFI, the Berne Declaration and the Gene Campaign (India).

Controversy Still Steaming over "Counterfeit" Basmati: Indian Government Prepares to Challenge Basmati Patent in US

Sections:
Summary:
Background
Basmati rice
Royal RiceTec Inc.
Public Sentiment Against RiceTec's Monopoly
Government Counters Biopiracy
Protecting Geographical Indication
Berne Declaration and Regula
RiceTec's Basmati Losing Ground?
Analysis of both Kasmati and Texmati
Conclusion
Action Needed

Summary:

Whatever happened to RiceTec's controversial claim on basmati rice? Who controls the patent? Will it be legally challenged? Who has the right to use the "basmati" name? In this update, RAFI, the Berne Declaration, and the Gene Campaign review the problem, the promise and the progress (or lack of it) surrounding the basmati patent dispute.

Background

In September 1997 a Texas-based company, RiceTec Inc., won a controversial US patent (No. 5,663,484) on basmati rice lines and grain. Basmati rice has been grown for centuries in what was the Greater Punjab region, now divided between India and Pakistan. Farmers in this region have selected and maintained Basmati rice varieties that are recognized worldwide for their fragrant aroma, long and slender grain and distinctive taste. RiceTec's basmati patent has become widely known as a classic case of "biopiracy." Not only does the patent usurp the basmati name, it also capitalizes on the genius of South Asian farmers. The patent applies to breeding crosses involving 22 farmer-bred basmati varieties from Pakistan and India. The sweeping scope of the patent extends to such varieties grown anywhere in the Western Hemisphere (although the patent is valid only in the US).

Basmati rice

Basmati is known as the "crown jewel" of South Asian rice. Prized for its exquisite aroma and taste, it commands a premium price in both domestic and international markets. Approximately 1 million hectares in India and 0.75 million hectares in Pakistan are planted in basmati varieties, where it is cultivated by hundreds of thousands of small farmers. In India alone, basmati exports were valued at approximately US$425 million in 1998/99 ; but export markets could be threatened if forced to compete with RiceTec's basmati. (For more background information, see RAFI GenoTypes, "The Basmati Rice Patent," 1 April 1998, http://www.rafi.org and Berne Declaration Press Package (in German), "Das Basmati Patent," 24 September 1999, http://www.evb.ch.

Royal RiceTec Inc.

Royal RiceTec Inc. is a small company with annual sales of US$10 million and 120 employees. "We represent a tiny fraction of the world's basmati rice production," explains Bruce Hicks, spokesman for RiceTec Inc. But RiceTec has a royal bloodline that originates in the tiny mountain principality of Liechtenstein, bordering Switzerland and Austria. Liechtenstein's royal family, headed by the reigning Prince Hans Adam II, is sole owner of RiceTech Inc. The billionaire prince, whose personal fortune is estimated at US $3.75-$4.5 billion dollars, is the largest private landowner in neighbouring Austria.

Public Sentiment Against RiceTec's Monopoly

In May 1998 RAFI launched a basmati postcard campaign in an attempt to demonstrate the intense public sentiment against RiceTec's monopoly on basmati rice. Despite receiving thousands of postcards from all over the world beseeching him to abandon the notorious basmati patent, Prince Hans-Adam has failed to take action. While he is gaining international notoriety for his company's controversial patent, the prince is occupied by political battles closer to home. (On 28 October 1999 Prince Hans-Adam was condemned by the European Court of Human Rights in Strasbourg for violating rights of free expression. In Liechtenstein, Prince Hans Adam's newly proposed constitution - - which seeks to broaden his powers - is opposed by the Liechtenstein government. )

Government Counters Biopiracy

For the past two years, it has been widely rumoured that the governments of India and Pakistan would officially challenge the RiceTec patent. But some suggest that the patent's 20-year term will expire before India officially files its challenge. According to Mohan Lal, the Director of India's Department of Industry and Development, the government is determined to fight the RiceTec patent and will soon file a re-examination petition at the US Patent and Trademark Office (US-PTO) based on technical grounds (that is, the patent does not meet one or more of the technical criteria of being new, useful and non-obvious). In 1998, the Indian government appointed an expert technical committee to review the basmati patent. The committee has compiled and reviewed over 1,500 pages of background information that will form the basis for challenging the US patent.

The Indian government has not divulged any details about the basis for its technical challenge of the RiceTec patent. Observers close to the process indicate that the government will use documented information on Indian basmati varieties to refute RiceTec's claims of novelty. K.R. Bhattacharya, former head of the Department of Grain Science of the Central Food Technological Research Institute (Mysore, India), has prepared a detailed critique of the RiceTec patent which focuses on the patent's claims relating to rice quality - (as opposed to claims on rice lines and grains.) Bhattacharya believes that the main pillar of the patent and the central focus of 15 out of 20 claims, relating to the so-called starch index, "is a skillfully crafted myth." According to the patent, RiceTec's invention includes the discovery that the likely texture of cooked rice can be predicted by measuring a grain's "starch index" - the sum of its percent amylose (PA) and alkali spreading value. Bhattacharya concludes, "It is our contention that the above so-called relation of starch index to rice cooking behaviour is fallacious, artificial, false and fake; and that it is strongly suggestive of being deliberately got up to manufacture a patentable claim."

RiceTec does not waver in defense of its patent, "We are absolutely confident in our patent and its viability and legality - there's no basis for challenging the patent," according to Bruce Hicks, spokesperson for RiceTec.

The Indian government has also launched a new and costly initiative to combat future biopiracy claims. At a cost of US $125 per sample, the Indian Council of Agricultural Research (ICAR) has begun DNA fingerprinting of crop varieties and medicinal plants in its gene bank. ICAR director general, Rajendra Singh Paroda, told Nature Biotechnology, "We are doing this to establish proof of origin of the genetic material, in the event of ownership or patent disputes."

Protecting Geographical Indication

Many critics of the basmati patent have argued that RiceTec's use of the name "basmati" is wrong because only rice grown in northern India and Pakistan can be termed basmati. The Trade-Related Intellectual Property (TRIPs) Agreement of the World Trade Organization provides for protection where a given quality or reputation of an item is attributable to its geographic origin. Well-known examples include "Scotch whiskey" and "French champagne."

However, to gain legal protection under TRIPs, it is preferable for India to have domestic legislation that provides for protection of geographic indications of goods. Motivated by the basmati debacle, the Indian government is preparing to introduce a bill called "the Geographical Indication of Goods' Registration and Protection Act." The legislation seeks to provide protection for goods rendered distinctive by their quality or uniqueness, and would establish a national registry of such items. In addition to basmati, other unique goods of Indian origin could be protected such as Darjeeling tea, Alphonso mangoes, Malabar pepper, and Alappuzha cardamom.

At the TRIPs Council, India, Switzerland, the European Union, Czech Republic, Morrocco and others advocate strongly for strengthening and widening the protection of geographical indications for agricultural products under Article 23.

That article, which currently applies only to wines and spirits, prevents the use of expressions such as 'kind', 'type,' or 'imitation,' which could mislead the public as to the geographic origin of the product. If it were applicable to basmati rice, for example, Article 23 would prevent RiceTec from marketing its Kasmati brand rice as "traditional basmati style" or its Texmati brand as "American basmati." At the TRIPs Council, the widening of protection under Article 23 is opposed by the US, Australia and New Zealand - governments who generally seek to strengthen intellectual property at WTO and who do not object to the use of geographical indications for wines and spirits.

Berne Declaration and Regula

Personal Appeal to the Prince In September 1999 FranÁois Meienberg of the Zurich-based Berne Declaration and Regula Imhof of Liechtenstein's Environmental Protection Society, with support from Suman Sahai of India's Gene Campaign and RAFI, organized a personal meeting with Prince Hans Adam. Meienberg and Imhof met with Prince Hans-Adam at his castle in Liechtenstein for two hours on 24 September 1999.

"We tried to convince the Prince that RiceTec did not "invent" basmati rice, and that it is wrong to appropriate the resources and knowledge of South Asian farmers," said FranÁois Meienberg. "Despite a very cordial reception by the Prince," adds Meienberg, "he continues to believe that basmati is a generic name, and that everything about the patent is legal. He told us that biopiracy is not the problem, and he believes that India would benefit most from strong intellectual property laws and a totally free market. He told us that if India had strong patent laws, RiceTec might even sell products adapted for the Indian market," said Meienberg of the Berne Declaration.

The civil society organizations who met with Prince Hans Adam delivered a personal message from Dr. M.S. Swaminathan, one of the world's leading rice experts, former director general of the International Rice and Research Institute, former independent chairman of the FAO Council, and recipient of the World Food Prize. Swaminathan wrote:

"Please convey to the prince my view that marketing rice varieties developed by crossing semi-dwarf varieties with Basmati rice from India/Pakistan, as American Basmati is unethical. This is designed to kill even the limited opportunities which poor developing countries have for farm exports. I hope the Prince will not be a party to this." – M.S. Swaminathan

Dr. Swaminathan is not the only high-profile individual who opposes the patent.

In June 1999 the president of the US-based Rockefeller Foundation, Dr. Gordon Conway, made a speech to the Board of Directors of Monsanto, in which he stated that the basmati patent is viewed as an "unreasonable" intellectual property claim on crop varieties or traits of distinct national origin. Conway warned, "One might also foresee the possibility of legal actions in the US and Europe against companies that claim intellectual property rights on such traditional crop traits." The Rockefeller Foundation has invested over $100 million dollars over the past 15 years in plant biotechnology research -principally for rice.

RiceTec's Basmati Losing Ground?

Earlier this year the The Economic Times of India erroneously reported that RiceTec, Inc. had entered into a partnership with US-based Uncle Ben's, Inc. - the world's leading manufacturer of rice products. Uncle Ben's is a wholly owned subsidiary of Mars, Inc., a $14 billion multinational food giant. In reality, Mars, Inc. is clearly distancing itself from the RiceTec controversy. Alice Nathanson of Mars, Inc. told RAFI that her company is not involved with RiceTec. "Although we do have basmati, it is purchased only from Pakistan and India," said Nathanson. India exports approximately 45,000 tonnes of basmati to the US annually.

Analysis of both Kasmati and Texmati

The United Kingdom's Ministry of Agriculture Fisheries and Food (MAFF) recently performed a DNA analysis of basmati rice which concludes that RiceTec's two "basmati" style products, Kasmati and Texmati, have a genetic profile with "much more similarity" to US long grain varieties than South Asian Basmati samples. The report concludes, "Analysis of both Kasmati and Texmati in this study have shown that these varieties can both be easily distinguished at the genetic level from Indian or Pakistani based varieties." The DNA analysis conducted by the UK government confirms that it would be more accurate and honest for RiceTec to market its product as a US long grain rice, instead of using the term basmati.

In its Code of Practice for rice, the UK's Grain and Feed Trade Association, one of the world's largest importers of basmati rice, also concludes that basmati rice "shall only be applied to the long grain rice grown in India or Pakistan." Similarly, Saudi Arabia allows basmati rice originating only in the Indian sub-continent to be sold as basmati rice." Saudi Arabia is India's largest market for basmati rice, accounting for 68% of India's basmati exports in 1994. A Greek court reportedly rejected a trademark application by RiceTec for rice it described as American basmati.

Conclusion

There are numerous legal and technical concerns with respect to RiceTec's patent and its use of the name basmati. Ultimately, RAFI, the Berne Declaration and the Gene Campaign conclude that the core issue is morality. Farmers have selected and bred aromatic rice over generations. It is indecent and unacceptable for the genius of millennia to be usurped by an US-based company (controlled by European royalty). RiceTec's patent is predatory on the rights and resources of South Asian farmers, and it should be abandoned.

Action Needed

  1. RiceTec should abandon US patent 5,663,484 and cease using the term "basmati" on all of its rice products and lines.

  2. In the event that RiceTec does not abandon its patent, the Indian and/or Pakistani governments should immediately challenge the US patent on grounds that it is technically flawed and morally unacceptable.

  3. Protection for geographical indications for agricultural products should be strengthened at the national level and under TRIPs.

  4. Civil society organizations should continue campaigns to educate consumers about the basmati patent, and to generate awareness about larger issues of life patenting and biopiracy.

These campaigns include, for example:

Peoples' Movements & NGOs in Southeast Asia (a broad coalition coordinated by MASIPAG) issued a statement to the WTO calling for "No Patents on Life! No Patents on Rice!" For more information, contact MASIPAG/Farmer-Scientist Partnership for Development. Email: masipag@mozcom.com

In Thailand, the Thai Network on Community Rights and Biodiversity (BIOTHAI) has launched a campaign to protect the future of Jasmine rice. Contact: biothai@wnet.net.th

In Europe, the work on basmati is coordinated by the Berne Declaration.

In Canada, the Basmati Action Group is calling for a North America boycott of RiceTec products, and campaigns actively against life patenting. http://www.eciad.bc.ca/~lolin/basmati/home.html email: basmati-action@sfu.ca

RAFI is working on the basmati rice campaign and other biopiracy issues in conjunction with SEARICE (Southeast Asia Regional Institute for Community Education) and its partners in Southeast Asia.

For more information, please contact:

FranÁois Meienberg, The Berne Declaration
Tel: 41 1 277 70 04    Fax: 41 1 2 777 001
Email: food@evb.ch     http://www.evb.ch

Hope Shand, RAFI
Tel: 919 960-5223    Fax: 919 960-5224
Email: hope@rafi.org     http://www.rafi.org

Suman Sahai, The Gene Campaign
Tel: 91 11 6517248    Fax: 91 11 6969716
Email: genecamp@vsnl.com

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Date: 9 Jan 2000 19:56:47 U
From: Colleen Robison crobison@mnsinc.com

Ms. Henig's email address is given on page B4 today under "How to Reach Our Authors and Us." robinhenig@nas.org NAS is apparently National Academy of Scholars.

Robin M. Henig, Author – The People's Health: http://www.hsph.harvard.edu./around/nov96/nov15/henig.html

Rush To Claim A Little Slice Of Life

By Robin Marantz Henig, Sunday, January 9, 2000; Page B05
http://washingtonpost.com/wp-srv/WPlate/2000-01/09/128l-010900-idx.html

The rush to transcribe the entire genetic message of human chromosomes by the end of 2000 has been in full swing ever since the famously flamboyant scientist who heads Celera Genomics Corp. announced in 1998 that he would beat the federal government's effort with a leaner, meaner technique.

But Celera president J. Craig Venter set off more than a race between his company and the publicly funded Human Genome Project. He also stoked a gold-rush mentality in the world of genome science. In this high-stakes game, players try to outsmart each other by laying claim to particular stretches of DNA –iling for gene patents even before they have any idea what most of those stretches do.

What is ultimately at issue here is patenting the blueprint of the genes' makeup or sequence. That knowledge is what will allow scientists to replicate those genes in the lab (a relatively straightforward chemical process), and use them to create new drugs and specifically targeted therapies. It is in this vast new array of treatments that the potential profit lies –oth for private companies and, of course, for patients.

Never before has our 210-year-old patent law been contorted in quite this way, protecting discoveries instead of inventions, biological information instead of machines. At the U.S. Patent and Trademark Office, more than 10,000 provisional patent applications for various segments of the human genome are awaiting action. The applications come from Celera and its two main for-profit competitors, Human Genome Sciences Inc. (which, like Celera, has its headquarters in Rockville) and Incyte Pharmaceuticals Inc., based in Palo Alto, Calif.

In all but a handful of cases, no one at these companies yet understands the function, usefulness or commercial value of the genetic material for which patent applications have been made. The applications serve simply as place holders.

Whoever holds the patent to a sequence that turns out to represent a significant disease gene can eventually sell access to the highest bidder. Pharmaceutical companies will vie for the right to develop more individualized treatments for diseases –r to create handy pills to make folks slimmer or smarter. Not only will straightforward genetic diseases such as cystic fibrosis probably be cured in this way, but so, perhaps, will complex conditions caused by the interactions of several genes: heart disease, cancer, Alzheimer's, maybe even dysfunctional personality traits. Companies will pay millions for the right to develop treatments for such illnesses, knowing the potential profit runs to the tens of millions. That is why genomics companies are hedging their bets with thousands of patent applications.

As Randy Scott, president of Incyte, has said, the winner in this strange endgame will find himself at the helm of "the equivalent of eBay for genes." But is this where we want our astounding new insights into the code of life to lead us –o an auction for the right to manipulate our genes? If not, is it even possible to put the brakes on genetic prospecting? Is there a less wild-eyed way to ensure a fair profit for the investment required to bring gene-based therapies to the marketplace? And is it appropriate to allow anyone to patent a gene's sequence –n effect, patenting life itself?

What gene prospectors hope to patent are arrays of nucleotides, the chemicals that, when strung together in a particular order, constitute the genes. In the most common metaphor for how it all works, nucleotides are said to represent the letters of the genetic alphabet (there are four –, C, T and G), the genes they form are the sentences, the chromosomes on which genes are arrayed are the chapters, and the genome is the whole gigantic book, made up of long strings of letters arranged in a specific and characteristic sequence. The book, in a sense, is the instruction manual of life.

Individual variations in the genome –he addition or deletion of a few key letters or, occasionally, of entire words or phrases –ccount for most diseases. Finding the right order for these nucleotides is what sequencing is all about.

But only about 3 percent of the complete sequence represents functional genes. The rest are so-called "junk DNA." Just a fraction of the provisional patents now on file, then, will turn out to be pay dirt that can be exploited for commercial or scientific gain. But, like the gold that lured prospectors westward a century and a half ago in America, that fraction will turn out to be so lucrative that the gene hunters figure that all their mining will be worth it.

In the dark ages of genome research –hat is, seven or eight years ago –cientists patented genes one at a time, and then only after they had figured out what the genes did. Today, they are using a more scattershot approach. It is like scouring a beach for beautiful shells by scooping up sand with a backhoe, hoping to sift through it later to see if you collected anything worthwhile.

This isn't the way science is usually done. More typical is how the Human Genome Project has worked since it got underway in 1990: as an international, collaborative effort to decode the basic sentence structure of human biology, one hard-earned letter at a time. It is the team of government scientists from this project that is now mounting a preemptive strike against the upstart biotech companies, trying to beat them at their own game.

In early 1996, all nations involved in the public genome project met in Bermuda to decide how and when the sequence should be released: all at once, or a little at a time. Britain, France, Germany and Japan joined the United States in the so-called Bermuda Accord, which upheld the principle of complete, continuous public disclosure for the sake of science.

The accord said that all public laboratories were to post the sequences discovered each day on the Internet that evening. So every 24 hours, thousands of new bits of data are added to the several billion already collected on GenBank, the international Web site maintained by the National Center for Biotechnology (www.ncbi.nlm.nih.gov/genome/guide).

All those bits of raw data are relatively meaningless. But putting them out there for mass consumption has a felicitous side effect. Every time the public sector puts a gene sequence online, it keeps a private company from obtaining the right to patent it. Once a sequence, however unintelligible, is in the public domain, it is no longer new –nd thus no longer patentable.

At the heart of all this is the most basic question of whether anyone has the right to patent life in the first place, even life in so elemental a form as a string of nucleotides. A 1980 Supreme Court decision, which upheld the patenting of a genetically engineered bacterium, set the stage for patent protection for "anything under the sun that is; made by man." It remains to be seen, however, whether the genome sequence can be construed as being made by man. And if so who, if anyone, should be allowed to own it.

In the meantime, gene prospectors are certainly adding to our scientific knowledge by characterizing gene sequences. But they are obstructing further research and understanding of those very sequences by attempting to patent every genetic lump just in case it turns out to be pure gold.

Robin Marantz Henig, who lives in Washington, is the author of "The Monk in the Garden: Mendel's Peas and the Birth of Genetics," to be published in the spring by Houghton Mifflin.

© Copyright 2000 The Washington Post Company


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Date: 9 Jan 2000 22:19:33 U
From: MichaelP papadop@peak.org

The biotech industry versus the worlds poor

World Development Movement, http://www.wdm.org     Email: wdm@wdm.org.uk
December 1999

The Battle for International Rules on GMOs:

Sections:
Seven Years Of Negotiation
The Three Main Players
Safety Versus Trade: What Kind Of Protocol Is This?
Burden of proof
WDMS Demands In Montreal
Scope of the Protocol
Precautionary Principle
Relationship with the World Trade Organisation
Liability

The Biosafety Protocol set out to establish international rules on GMOs, enshrining in international law two very simple basic rights; a countrys right to know what it is importing, and a governments right to refuse an import if its population is threatened.

On the 20 January 1999 negotiators from around the world will meet in a desperate attempt to hammer out agreement on international rules covering the trade in GMOs. They will seek to cut through the clashes of interests that paralysed the last set of negotiations on the Biosafety Protocol in Cartagena, Colombia in February 1999.

The stakes at these negotiations have been considerably raised with the collapse of World Trade Organisation (WTO) talks in Seattle. Following the WTO meeting, negotiations on international agreements will never be the same. Developing countries made it clear that they are fed up with having their interests sidelined in trade deals that are forced on them. Meanwhile citizens want more accountability from negotiations that have an ever-increasing impact on their lives. As Biosafety Protocol talks resume for the final time, negotiators are aware that the issues that paralysed trade negotiations in Seattle are right behind them. In the words of one European delegate: "before the end of November, we knew where we were, now its clear that there is everything to play for."

WDM, along with NGOs throughout the developing world, has been campaigning for a strong Biosafety Protocol. In the run up to the WTO meeting in Seattle we fiercely opposed attempts by the US, Canada and Japan to discuss GM regulation at the WTO. The battleground now shifts to Montreal. Whatever happens, negotiators will be under huge pressure to portray the outcome as a success. The collapse of the Biosafety Protocol negotiations in Cartegena in February 1999 was unfortunate; the collapse of trade negotiations in Seattle was deeply embarrassing. A third failure would be a disaster, not only for the credibility of governments, but also for the prospects of sound regulation on GMOs.

Seven Years Of Negotiation

In 1992, 175 governments signed up to the UN Convention on Biological Diversity (CBD) at the Earth Summit in Rio. Article 19 of this UN Convention commits these countries to developing an international legal regime, or Protocol on the transfer, handling and use of GMOs. This process has been plagued with difficulties.

From the adoption of the UN Convention in 1992, it took concerned countries more than three years to overcome US and industry criticism that a Protocol was unnecessary. The US was included as a negotiating partner in 1995, in spite of its efforts to scupper the process of initiating negotiations and its non-ratification of the CBD. In December 1996, a formal working group began drafting the Biosafety Protocol. The meeting of governments in February 1999 represented the culmination of almost seven years of international effort to formulate an agreement to safeguard the public against a technology whose long-term effects are uncertain and deeply mistrusted. The aim was to sign a Biosafety Protocol, but an illusion of common interests was shattered. Different negotiating agendas crystallised into three blocks.

The Three Main Players

The Miami group of grain exporting countries (led by the US, but also including Canada, Australia, Argentina, Chile and Uruguay) is pushing for a weak agreement which elevates the WTO form of unregulated free trade over considerations of environmental safety or the fears of small farmers. They do not want any regulation of GMOs. It was clear from the outset that the US was going to fight those who wanted safety because it regarded this as a stumbling block to the promotion of its commercial interests.

The US has challenged the basis for a GMO Protocol since they have claimed on numerous occasions that GM products are no different to their non-GM counterparts. They use the term substantially equivalent to claim that all genetic engineering does is mix genes from different individuals, in a similar process to sexual reproduction, and is therefore as old and well tested as life itself. They have used this argument throughout the Protocols formation. Yet ironically, GMOs are sufficiently transformed to be patented by US companies as original creations.

The Like-Minded Group (LMG), which consists of over 100 developing countries and China (excluding members of the Miami group) wants the rigorous regulation of GMOs. This group believes that safety is paramount since most unsafe experimentation is tried out in developing countries. Natural environments in developing countries are generally hotter and more biodiversity-rich, and therefore very different from those of the North. A biosafety agreement that focuses on narrow trade interests will not adequately consider safety in the marginalised South. Nor will it deal with the risks that GMOs pose to the livelihood of local and indigenous communities in developing countries, whose society and economic systems are inextricably linked to the maintenance of biodiversity.

The European group, which includes the UK delegation has often sounded like the Like-Minded Group, but has often supported the position of the Miami Group. Since 1992, Europe has tended to take a more realistic view of the risks involved in genetic engineering than the US. Europe has definitely had second thoughts about the use of the WTO for fully dictating the terms of trade in GMOs. They do not want to see the Biosafety Protocol subjugated to current WTO rules, but at the same time have sought to introduce the essentials of trade into the Protocol and have ignored many developing countries safety concerns.

Government negotiators in Montreal are facing a task greater than agreeing the Protocols text. GM exporters like the US must overcome entrenched positions that prioritise commercial profits over the environment and the welfare of millions of consumers and farmers.

Safety Versus Trade: What Kind Of Protocol Is This?

The Advance Informed Agreement (AIA) procedure

The AIA procedure should be the heart of this Protocol. This means that countries importing GMOs can demand that exporters give them prior notification about the GM product. This will allow the importing country to make a risk assessment of the GMO, before approving the trade.

Throughout the negotiations, the US has sought to undermine the scope of this aspect of the Protocol. They have chipped away at the AIA procedure claiming that it should only apply to GMOs intended for direct release into the environment (GMOs planted in the field, applied to the soil, in mines or in open waters). This would exclude products of GMOs (those destined for food, animal feed and processing). This in practice means excluding over 90 percent of GMOs.

Tewolde Egziabher, a negotiator from Ethiopia. described this AIA exclusion tactic as "perhaps the most blatant disregard by the Miaimi Group of the interests of the [developing countries]." It shows a lack of understanding by the US and later the EU for the situation in many developing countries. Excluding, for example grain, from the Protocol could spell disaster for livelihoods and biodiversity in some of the worlds poorest regions. Grain travels within developing countries unprocessed. It is cleaned at home and often processed at home or in a small village mill.

All this makes it certain that grain will be planted and pollute the genetic make-up of the same or related species. Worst still, there is nothing to stop farmers from planting this grain in their fields. For developing countries, commodities as well as seed have to be regulated by the AIA procedure. If this is not done, the AIA will have little value for developing countries. What ends up in the field as seed often comes into the country originally intended as food.

The position of developing countries is that all GMOs and products made from GMOs must be within the scope of the Protocol and be subject to a prior notification procedure.

The Miami Group, later followed by the EU have suggested that governments use their domestic legislation to regulate GMO products excluded from the Protocol. Yet applying AIA through national legislation, without the provisions and procedures of the Protocol is problematic. Any such national action would be very easy to challenge using WTO rules.

Burden of proof

Underpinning recent international trading agreements is the procedure that in order to reject a product, the importing country must prove that it is unsafe. Without clear evidence, it can be very difficult for a country to refuse a product, even if they feel that it poses potential risks to people or the environment. The Like-Minded Groups negotiating position on the Biosafety Protocol challenges this procedure. It lays the burden of proving a GMOs safety with the company or country wishing to export a product.

The Biosafety Protocol is not a trade agreement. It aims to protect people and the environment from a technology whose risks and impacts are poorly understood. Subordinating the Protocol to current free trade procedures will not only result in a weak agreement, but could seriously undermine food security and have a potentially devastating effect on biodiversity.

WDMS Demands In Montreal

WDMs campaign highlights Developing Country demands for a strong Biosafety Protocol. At the centre of this campaign are two concerns. Firstly, the interests of the worlds poor are consistently marginalised at international negotiations. Developing countries find themselves unable to defend their people in international deals that offer more rights to the rich at the expense of the poor and the environment.

This was central to the breakdown at Seattles WTO meeting and has been a recurring theme at Biosafety Protocol meetings. Secondly, the clashes that have arisen throughout the Biosafety Protocol demonstrate current problems about the kind of international rules that we want - those promoting free trade or those designed to protect people and the environment.

There are at least four areas within the Protocol where developing country demands must be taken seriously if we are to ensure that international rules on GMOs are not hijacked by the US on behalf of its biotechnology industry.

Scope of the Protocol

WDM demand: The AIA, which is at the centre of this Protocol must cover all GMOs and their parts, including commodities being shipped for food use (e.g. soyabeans) and products of GMOs (e.g. flour and other processed items).

Currently on the table is a Miami Group and EU proposal that will confine the Protocol to the narrowest range of GMOs possible. If they wish, countries could require these other commodities to be subject to AIA on a national basis. However, this would make any national action very easy to challenge in the WTO.

Precautionary Principle

WDM demand: It must be clear that it is legitimate for states to refuse a GMO import on the basis of risks to human health, socio-economic and cultural factors (not just scientific evidence). GM crops seriously threaten the ability of small farmers in some of the worlds poorest countries to make informed choices about their farming practices. Therefore, governments should be permitted to take full account of socio-economic impacts within their country and its environment when deciding whether or not to allow the import of GMOs.

Currently on the table: The Precautionary Principle has been continually eroded in the text as the Miami group totally opposes the precautionary approach. The parts of the Protocol which focus on a countrys decision making procedures on imports, have retained a reference to human health, but not to socio economics (which includes the impact on small farmer and rural livelihoods). Socio-economics have been included in a separate article which does not relate directly to a countrys decision making procedure. This would mean that a countrys decision to reject GMOs based on socio-economic concerns could be challenged through the WTO.

Relationship with the World Trade Organisation

WDM Demand: The Biosafety Protocol should take precedence over the provisions of international trade rules should there be conflicts between the two agreements.

Liability

WDM Demand: Companies exporting GMOs should be strictly liable in the event of problems that arise and should provide adequate compensation for any damages to health, the environment or livelihoods. The Protocol must include provisions on strict liability to recognise that genetic engineering is a new technology. Making companies liable is one way to ensure that they undertake adequate testing and minimise potential risks.

Currently on the table is no clear commitment in the Protocol concerning liability and compensation. A time target of four years for developing a stricter liability regime is mentioned, but there is plenty of scope for delaying and avoiding action.

The Campaigns Team