FAIRER DEAL ON PATENTS AND KNOWLEDGE
By Declan Butler
Developing countries which are unhappy with new international treaties
tightening intellectual property rights (IPR) received unexpected support
this week from the bastion of capitalism, the World Bank.
In "Knowledge for Development", the 21st report in the bank's annual series
on world development, the bank argues that stronger international IPR
legislation risks "shifting bargaining power towards the producers of
knowledge, and increasing the knowledge gap" between industrialised and
developing countries. It called on developing countries to take a more
proactive and hardline stance in international IPR negotiations.
Traditionally the World Bank, established at a meeting of world leaders in
1944 as part of efforts to reconstruct the world economy after the Second
World War, has focused largely on promoting economic development, for
example through increased free trade. The new report identifies "knowledge"
as a less tangible, but central, factor for improving health and living
standards.
"Knowledge can make the difference between sickness and health, between
poverty and wealth," Lyn Squire, director of development economics at the
bank, told a press briefing in Paris last week. Internet access alone will
have a revolutionary impact on Third World development, Squire predicted.
And the report warns that the vertiginous growth in global knowledge creates
the risk that poor countries may fall further behind.
The 1994 agreement on trade-related aspects of intellectual property rights
(TRIPS) has created a global regime which sets minimum standards for IPR
protection. It also sets, for the first time, an international legal
mechanism, through the World Trade Organization's dispute settlement
procedure, to sanction countries which fail to abide by the legislation.
The report points out the need to strike a balance between providing
incentives for generating new knowledge, and creating conditions for its
dissemination. A bank study of drug and chemical companies in the United
States, Germany and Japan found that more than a quarter felt that IPR
protection in developing countries was too weak to allow investment or
technology transfer.
But it warns that there is now a risk of excessively strict IPR adversely
affecting follow-on innovations that draw on patents, and actually slowing
down the pace. Of particular concern is the current tendency for patents to
cover not just products but broad areas of technology, in particular
biotechnology.
"So many industrial-country firms are acquiring strong IPR positions, often
covering fundamental research tools as well as marketable products, that it
may prove hard for new firms and researchers to elbow into this new global
industry," says the report.
Furthermore, the report argues that IPR is not an appropriate mechanism to
stimulate research in many areas of health and medicine, such as AIDS or
malaria, where, as it points out, the "social return" of an innovation -- to
all those benefiting from it -- far exceed the returns to investors. Here,
it says, public authorities have a responsibility to subsidize research or
provide financial incentives to the private sector, as recently proposed for
development of antimalarial drugs (see Nature 395, 417-8; 1998).
At the same time, the bank points out that such concerns need to be balanced
against the advantages of stricter IPR. These include greater access to
foreign markets and technology for countries which enforce international IPR
standards, compared with those whose lack of legislation deters investors.
The report proposes no solutions, but calls on developing countries "to
negotiate internationally for intellectual property right regimes that give
adequate consideration to their urgent need to narrow the knowledge gap,"
while maintaining incentives for knowledge producers to invest in research.
They should also keep up to speed on "new issues for negotiation, such as
biotechnology and information technology".
In a bid to practice what it preaches, the bank -- which agreed to loans of
$28,594 billion in 1998 compared with $19,147 billion last year -- has now
set itself the objective of becoming a clearing house for information on
development. It plans to make its vast inhouse expertise and archives, such
as staff reports on various developmental issues, available on the Internet
by 2000.
Developing countries need to be assertive in defending the terms under which
companies are given access to their resources, says the report. In 1990,
world sales of medicines derived from plants discovered by indigenous
peoples amounted to $43 billion, with hardly any financial return to these
groups (see Nature 392, 535-540; 1998).
Declan Butler
Nature - Vol 395 - 8 October 1998 p 529
© Macmillan Publishers Ltd
________________________________________________________
URGENT THINKING REQUIRED ABOUT DEVELOPMENT
A report from the World Bank has highlighted the dangers of a growing
knowledge gap between rich and poor nations. The issue needs to be placed at
the heart of development aid strategies.
[Editorial]
The philosopher of science Francis Bacon put it succinctly at the dawn of
the scientific revolution when he wrote, "knowledge is power". The World
Bank put forward the same idea in a slightly different way this week when it
devoted its annual report [1] on world development to the central role of
knowledge in the development process (see page 529). Its interpretation of
the word is somewhat broader than Bacon's; while the latter was speaking
primarily of what we would now call 'natural science', the bank uses the
term to embrace both technical know-how and knowledge of attributes, ranging
>from the quality of a worker to the credit-worthiness of a company. But its
main theme is surprisingly similar: "knowledge is development".
The message is an important one to remember at a time when the global
economic system is facing its severest crisis since the Second World War.
Ironically, the bank's conclusion is based directly on those East Asian
economies whose current problems have been at the heart of this crisis;
comparing their previous growth rates to that of others, such as the Soviet
Union, better endowed with natural resources, it suggests that the reason
for their previous success was an ability to work not harder but more
smartly. Being able to generate useful knowledge, or take advantage of
others', has become almost by definition the key to survival in a
knowledge-based global economy.
In one sense, that isn't new. Western nations, many taking a lead from the
Asian economies, have long accepted the need to focus on the generation of
scientific knowledge in a way that such efforts are relevant to underlying
social and economic needs (see, for example, page 534). But the central role
of knowledge, and particularly scientific knowledge, in economic and social
development has yet to be properly integrated into the policies of those
global institutions responsible for the welfare of developing nations -- or
indeed into the policies of such nations themselves.
Intellectual property
Take, for example, the question of intellectual property. Almost everyone
accepts that without proper legal protection for innovative ideas, the
private sector would not invest in the research needed to produce them, as
it would lack the means to secure a profit on its investment. But writing
the international rules in a way that those who benefit from them most are
those already the most economically powerful is not necessarily in the best
interests of those who are excluded. Indeed, as the World Bank report points
out, the current rules may in fact be hindering the technological
development of developing countries. Helping poor countries make the
transition to a knowledge-based economy is a tough challenge when the
industrialized world increasingly holds all the cards in the form of patent
portfolios on which are based not only individual products but whole swathes
of technology.
A similar recognition in the limitation of the market lies behind the recent
acknowledgement by the World Bank and other international organizations of
the failure of market forces -- and with it the patent system -- to
encourage the investment needed to develop antimalarial drugs (see Nature
295, 417; 1998). Again, this has highlighted the broad need for more
innovative approaches to investment in research and development into Third
World problems, including in this case the careful application of that
anathema of free marketeers: public interventionism.
Sustainable development
A meeting of the G7countries last weekend emphasized the need to think
innovatively about global economics in the light of the current crisis. Less
dramatically, perhaps, new approaches are required to the role of science
and technology in development. It is not merely a question of pumping
technical aid into the poor nations of the world; too often this aid fails
to take root, and its impact evaporates with the departure of Western
technical experts. Nor is it a question of leaving the choice of
technological priorities to the market-place.
For the World Bank itself, 'sustainable capacity-building' has now replaced
infrastructure projects, such as financing big dams and bridges, as the
focus of its development strategy. But there is an urgent need to understand
better just what sustainable development requires of international science
and technology networks -- whether academic, government or private.
Next year sees a number of important meetings at which such issues will be
on the table, and at which developing countries will have the opportunity to
push their case for better terms adapted to closing rather than widening the
knowledge gap. One is the renegotiation of the 1994 Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS), which
requires members of the World Trade Organization to abide by agreed
standards of patent and copyright protection, while the poorest developing
countries have been given until 2006 to draw their national laws into line.
A second opportunity will be the World Science Conference being organized by
Unesco in Budapest next May. It is important that this conference does not
become trapped in an agenda devoted to science as a primarily cultural
activity or the purely ethical issues raised by biomedical research, at a
time when narrowing the North-South knowledge gap is the most pressing
social and economic aspect of science requiring attention.
The World Bank's report has focused a welcome spotlight on the need for
international organizations -- including the bank itself -- to give the
issues of technology transfer and the central role of science and education
in development the same attention as free trade issues have commanded in the
past. Ultimately, what may be needed is a new set of ground-rules for
research and innovation between the industrialized and developing world.
Such an initiative would be particularly timely, given that foreign
investment in developing countries is likely to become one of the major
victims of the current world financial crisis.
[1] World Bank, "World Development Report 1998/99: Knowledge for
Development" (Oxford University Press).
Nature - Vol 395 - 8 October 1998 p 527
© Macmillan Publishers Ltd
[The World Bank Development Report 1998/99 may be downloaded in PDF format,
or ordered by mail, from http://www.worldbank.org]
_________________________________________________________
ABOUT THIS LISTSERVER -- BIO-IPR is an irregular listserver put out by
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Subject: GE - two articles
Date: Fri, 16 Oct 1998 09:53:47 +0100
From: genetics <genetics@gn.apc.org>
To: genetics@mail.gn.apc.org
1) Biotech Firms Have Their Eyes on Africa, Euro MPs Say
2) New Report Exposes Myths About World Hunger
SCIENCE:
1) Biotech Firms Have Their Eyes on Africa, Euro MPs Say
By Thomas Hirenee Atenga
PARIS, Oct 14 (IPS) - European Union (EU) rules limiting the range of
biotechnological activity appear to be prompting some biotech firms to look
for new locations where they can operate more freely.
In fact, biotech industrialists and researchers have reportedly started
hinting about relocating, possibly to Africa, so as to circumvent strict EU
regulations prohibiting some activities.
Operations banned in Europe include cloning humans, modifying the genetic
identity of a human being and artifically reproducing embryos that have the
same genetic information as another person, whether alive or dead.
Also included on the banned list are inventions whose exploitation or
publication would violate public order or morals, and any modification of
the genetic make-up of animals that would cause them to suffer or to become
physically handicapped where this is of no substantial medical usefulness to
man or animal.
There are also restrictions to the manipulation of vegetable species and
animal breeds.
To get around this arsenal of constraints, transnationals are reportedly
looking towards Africa as the place to go to operate with total impunity,
and they are said to be banking on the elimination of trade barriers under
the World Trade Organisation (WTO) and moves to dismantle barriers to
investment, touted by various developed nations.
This holds dangers for Africa, as some European legislators pointed out at a
late-September session of the European Parliament.
Catherine Lalumiere, president of the Radical Alliance (AR) faction in the
European parliament in Strasbourg, fears that in a world in which
communications technology wipes out distances, there is a high risk that the
biotech companies will go to Africa and carry out research and other
activities banned elsewhere.
She said the United Nations should call a global meeting of decision-makers,
researchers, industrialists, bioethics committees and human rights groups to
draw up an international code of conduct in this area.
Other parliamentarians agreed. Gijs De Vries of the Netherlands felt there
was an imperative need for such a conference otherwise ''the life sciences,
whose aim thus far was to defend certain basic values, would become 'death
sciences' on a continent that has to face other problems.''
The stakes of such a conference are all the higher since biotechnology has
become a huge money-making affair. In Europe alone, the biotech market is
expected to amount to 80 billion ecus in two years time. In 1997 it was a
mere 10 billion ecus.
(One ecu is equivalent to 1.2 U.S. dollars.)
Carlo Casini of the European People's Party said such a meeting needed to be
held urgently ''if we still hope to find solutions for facing up to the
invasion of genetically modified organisms and the rapid advances made daily
in research, for which Africa is, of course, unprepared.''
''What would these multinationals do if a crisis like the mad cow disease
broke out in that part of the world?'' asked Casini.
He pointed out that the United States boasts of having the safest food
system in the world, yet its Food and Drug Administration - the federal body
in charge of food safety - reports millions of cases of food poisoning each
year.
Willi Rothley, vice president of the European Parliament's commission on
legal affairs and citizen's rights, also saw such a meeting as necessary,
although he felt consideration should be given to the fact that setting up
biotech industries on the African continent can improve consumers' lives by
providing them with quality food and keeping them in good health.
''Moreover, thousands of jobs would be created so, at such a meeting, a
distinction would have to be made between what is useful and what could be a
source of danger for these countries,'' he argued.
Global regulations of the type Lalumiere would like to see adopted would
also govern farm products like bananas, tomatoes and oranges that many
African nations export and which genetically modified fruits and vegetables
might end up crowding out of the market.
For example, transgenic varieties of cash crops such as coffee and cocoa
that Nestle is finalising at its centre in Tours, France, threaten African
economies.
Over the next two years, the sale of medicinal drugs and chemicals in Europe
will amount to 23.9 billion and 14.6 billion ecu respectively, said German
parliamentarian Wilfried Telkamper, a member of the Green group in
Strasbourg. However, ''83 percent of the biodiversity and 80 percent of the
resources needed for biotechnological inventions are in African countries in
particular, and in the South in general.''
''Bear in mind that these resources are very often exploited without the
agreement of the local populations,'' said Telkamper. Such a conference,
''could draw up principles enabling these populations to derive benefit from
the exploitation of their patrimony'' so it needs to be held quickly, he
added.
But some observers link this burst of solidarity with Africa to Europe's
desire to seek support in the biotechnology market as it competes against
the United States, the leading force in the sector.
Others note that while parliamentarians in Strasbourg are trying to get a
summit on biotechnology onto the global agenda, in Brussels, the European
Commission plans to spend 206 billion ecus on 152 projects related to
biotechnological development.
This budget line is expected to increase with a view to the implementation
of the EC's 1999-2002 research programme. (END/IPS/THA/NRN/KB/98)
=========================
FOOD:
2) New Report Exposes Myths About World Hunger
By Danielle Knight
WASHINGTON, Oct. 16 (IPS) - The myth that world hunger is the unavoidable
result of the forces of nature, coupled with a population explosion,
prevents policy makers from understanding the real causes of starvation
worldwide, says a new report.
''The way people think about hunger is the greatest obstacle to ending it,''
says Peter Rosset, director of the California-based Institute for Food and
Development Policy, in a report released Thursday - World Food Day.
''As millions of people starve, powerful myths block our understanding of
the true causes of hunger and prevent us from taking effective action to end
it.''Rosset says.
The report - 'World Hunger: Twelve Myths' - says these notions prevent a
true understanding of the real causes of millions of people starving around
the world.
''The true source of world hunger is not scarcity but policy; not
inevitability but politics,'' says the report. ''The real culprits are
economies that fail to offer everyone opportunities, and societies that
place economic efficiency over compassion.''
Abundance, not scarcity, best describes the world's food supply. The world
produces enough grain and many other commonly eaten foods to provide at
least 4.3 pounds of food per person a day, according to the report.
Even as countries have excess food, people still go hungry. In 1997, for
example, the American Association for the Advancement of Science found that,
in the developing world, 78 percent of all malnourished children aged under
five live in countries with food surpluses.
''The problem is that many people are too poor to buy readily available
food,'' says Twelve Myths. ''Even though ''hungry countries'' have enough
food for all their people right now, many are net exporters of food and
other agricultural products.''
Believing that scarcity is the problem, many governments and international
development institutions - like the World Bank - say the answer to solving
the problem is increasing food production. Dramatic production advances of
the 1970s known as the 'Green Revolution', did increase grain supplies.
''But focusing narrowly on increasing production cannot alleviate hunger
because it fails to alter the tightly concentrated distribution of economic
power that determines who can buy the additional food,'' says the report.
This is why that in several of the biggest Green Revolution successes -
India, Mexico, and the Philippines for example - grain production and in
some cases exports, have climbed while hunger has persisted.
That nature is to blame for famine is another popular hunger myth that blurs
the real causes of starvation. ''It's too easy to blame nature; food is
always available for those who can afford it while starvation during hard
times hits only the poorest,'' the report says.
''Millions live on the brink of disaster in south Asia, Africa and
elsewhere, because they are deprived of land by a powerful few, trapped in
the unremitting grip of debt, or miserably paid.''
Natural events rarely explain deaths, they are simply the final push over
this brink. Population growth is another mythical cause of hunger, says the
report.
''Although rapid population growth remains a serious concern in many
countries, nowhere does population density explain hunger,'' it says. ''For
every Bangladesh - a densely populated and hungry country - we find a
Nigeria, Brazil or Bolivia where abundant food resources coexist with
hunger.''
Costa Rica, with only half of Honduras' cropped acres per person, boasts a
life expectancy - 11 years longer than that of Honduras and close to that of
developed countries, explains the report.
About half of the myths listed in the report involve false assumptions used
to develop current food, land and agriculture policy. Large farms, the
free-market, free trade and more aid from industrialised countries, have all
been falsely touted as the ''cure'' to end hunger.
Large landowners who control most of the best land often leave much of it
idle, says Twelve Myths. ''By contrast, small farmers typically achieve at
least four to five times greater output per acre, in part because they work
their land more intensively and use integrated, and often more sustainable,
production systems,'' it says.
Redistribution of land would give millions of small farmers in developing
countries the incentive to invest in land improvements, to rotate crops and
leave land fallow for the sake of long-term soil fertility, according to the
report.
Comprehensive land reform has markedly increased production in countries as
different at Japan, Zimbabwe, and Taiwan. A World Bank study of northeast
Brazil estimates that redistributing farmland into smaller holdings would
raise output by 80 percent.
Free-markets and lifting tariffs on trade have also been touted as the
solution to ending world hunger.
''Such a market is good, government is bad formula can never help address
the causes of hunger,'' says the report. ''Such thinking misleads us into
believing that a society can opt for one or the other, when in fact every
economy on earth combines market and government in allocating resources and
distributing wealth.''
Because the market responds to money not actual need, it can only work to
eliminate hunger when purchasing power is widely dispersed, says the report.
As the rural poor are increasingly pushed from land, they are less and less
able to make their demands for food register in the market.
Promoting free trade to alleviate hunger has proven to be a failure, says
Twelve Myths. In most developing countries exports have boomed while hunger
has continued unabated or actually worsened, its says.
''While soybean exports boomed in Brazil to feed Japanese and European
livestock - hunger spread from one-third to two-thirds of the population,''
says the report.
''Where the majority of people have been made too poor to buy the food grown
on their own country's soil, those who control productive resources will,
not surprisingly, orient their production to more lucrative markets
abroad.''
Pro-trade policies like the North American Free Trade Agreement (NAFTA) and
the General Agreement on Tariffs and Trade (GATT) promotes export crop
production and squeezes out basic food production, it says. Foreign aid from
industrialised countries, often seen as an essential key to ending hunger
and famine, has propped up such free trade and free market policies.
Foreign aid, says the report, ''works directly against the hungry.'' U.S.
aid in particular is used to promote exports and food production - not to
increase the poor's ability to buy food, it adds. ''Even emergency, or
humanitarian aid, which makes up five percent of the total, often ends up
enriching U.S. grain companies while failing to reach the hungry.''
With different policies, says Twelve Myths, the world could feed itself.
''Hunger is caused by decisions made by human beings, and can be ended by
making different decisions,'' says Rosset. ''Informed social movements like
those that fought for and won landmark civil rights legislation or abolished
slavery or helped end the war in Vietnam, can end hunger too.''
Following its own call to action, the Institute for Food and Development
Policy recently launched an ''Economic Human Rights'' campaign in the United
States which calls for an end to hunger and poverty in the wealthiest
country in the world.
''The scientific evidence shows it is possible to eliminate hunger,'' says
Rosset. ''As societies we have to decide that it is a priority.''
(END/IPS/dk/mk/98)
Subject: NAFTA and Indigenous Knowledge
Date: Thu, 12 Nov 1998 07:47:54 -0800
From: Earle Cummings <earlec@water.ca.gov>
To: indknow@u.washington.edu
The clipping below is from the Environmental News Service. This would seem
to be an opportunity for First People to comment intelligently and from
experience on sustainable development, which to all appearances, NAFTA is
NOT about. Earle
PUBLIC INVITED TO U.S./CANADA/MEXICO ROUNDTABLE
The Joint Public Advisory Committee of the Commission for
Environmental Cooperation (CEC) invites you to participate in a
round table discussion on the CEC 1999-2001 Program Plan on
December 3 from 9:00 am to noon at the Radisson Barcelo Hotel in
Washington, DC. Following the round table discussion, the session
will be opened to the public, as observer. At the end of each day,
observers will be able to make comments. The (CEC) was created
in 1994 by a side agreement to the North American Free Trade
Agreement to facilitate cooperation and public participation in
sustainable development. It aims to "foster conservation, protection
and enhancement of the North American environment for the benefit
of present and future generations, in the context of increasing
economic, trade and social links between Canada, Mexico and the
United States."
Good judgment comes from experience; and experience, well, that comes from
bad judgment.
anonymous
Earle W. Cummings, Wetlands Coordination
California Department of Water Resources
3251 S Street, Sacramento CA 95816
Voice (916)227-7519
Fax (916)227-7554
Subject: [BIO-IPR] Biopiratería / Biopiracy Ecuador
Resent-Date: Mon, 16 Nov 1998 18:26:12 -0800
Resent-From: bio-ipr@cuenet.com
Date: Tue, 17 Nov 1998 10:09:09 +0800
From: GRAIN Los Banos <grain@baylink.mozcom.com>
To: bio-ipr@cuenet.com
BIO-IPR docserver ** bilingual
edition **
________________________________________________________
TITULO: Los sapos se llevaron las ranas
TITLE: Biopiracy of Epipedobates tricolor
AUTOR/AUTHOR: Elizabeth Bravo & Lucia Gallardo, Acción Ecológica
PUBLICACION: contribución a BIO-IPR
PUBLICATION: submitted by the authors to BIO-IPR
FECHA/DATE: Noviembre/November 1998
FUENTE/SOURCE: Acción Ecológica, Ecuador
NOTE:
The original text is in Spanish. It is followed by an English translation.
________________________________________________________
LOS SAPOS SE LLEVARON LAS RANAS
Acción Ecológica
Quito, Ecuador
Noviembre de 1998
Se ha patentado en los Estados Unidos un nuevo principio activo llamado
epibatidine. Epibatidine es un cóctel químico secretado por la piel de una
rana neotropical venenosa llamada "Epipedobates tricolor" que habita en los
bosques tropicales desde el sur occidente y las estribaciones occidentales
de los Andes Ecuatorianos hasta el norte del Perú. Esta especie de gran
interés para la ciencia, ha sido utilizada ancestralmente por indígenas
ecuatorianos en sus actividades de caza, en la cerbatana cuyos dardos
venenosos causan la muerte inmediata al entrar en el sistema sanguíneo de su
presa.
Fue el científico del Instituto Nacional de Salud, John Daley, quien
identificó la estructura química de la rana, gracias a la información sobre
los efectos fisiológicos de las secreciones de la misma, proporcionada por
comunidades indígenas y locales. Para aislar el principio activo, se obtuvo
ilegalmente una muestra de 750 ranas que se cree salieron del país vía
valija diplomática, pues no existe evidencia de que el Instituto Ecuatoriano
Forestal de Areas Naturales y Vida Silvestre (INEFAN) haya otorgado una
licencia de manejo para que esta rana fuera explotada con fines comerciales,
requisito básico, al constar esta especie dentro de los apéndices de la
"Convención sobre el Comercio Internacional de Especies Amenazadas de Fauna
y Flora silvestre (CITES)", de la cual el Ecuador es parte desde 1975.
Cabe destacar que el INEFAN desde 1996, prohibió el uso de esta especie como
fuente de recursos genéticos, lo cual incluye actividades de bioprospección.
Sin embargo, los Laboratorios Abbott han efectuado actividades de
bioprospección al sacar al mercado el producto ABT-594, derivado de la
epibatidine. ABT-594 es un analgésico 200 veces más poderoso que la morfina.
Son los mismos Laboratorios Abbott quienes han obtenido la patente sobre
epidatidine.
Este nuevo acto de biopiratería, que incluye un acceso ilegal a nuestros
recursos genéticos desconociendo el país de origen del mismo y las
comunidades que han generado ancestralmente este conocimiento, merece el
repudio de la Sociedad ecuatoriana. Las patentes como conocemos dan a su
titular el uso monopólico de la misma. Por esta razón, exigimos que los
Laboratorios Abbott reconozca y comparta de una manera justa y equitativa
los beneficios derivados de este conocimiento y de la eventual
comercialización de los productos farmacéuticos sintetizados a partir de la
epibatidine, al tenor de lo estipulado en la Convenio sobre Diversidad
Biológica, del cual el Ecuador es parte contratante desde 1993, y de la
Decisión 391 de la Junta del Acuerdo de Cartagena (JUNAC), que está en
vigencia desde 1996. Por otro lado, pedimos la revocatoria de la patente
otorgada al principio activo que se extrajo de la ranas ecuatorianas
Epipedobates Tricolor, por ser un acto de agresión contra la soberanía de
nuestro país y su diversidad biológica.
Para más información:
Elizabeth Bravo
Lucia Gallardo
Campaña Biodiversidad
Acción Ecológica
Casilla 17-15-246C
Quito, Ecuador
Tel: (593-2) 52 75 83
Fax: (593-2) 54 75 16
C.e.: ebravo@hoy.net
________________________________________________________
BIOPIRACY OF EPIPEDOBATES TRICOLOR
Acción Ecológica
Quito, Ecuador
November 1998
A new active principle called epibatidine has been patented by Abbott
Laboratories in the United States. Epibatidine is a chemical mixture
secreted from the skin of a poisonous neotropical frog called Epipedobates
tricolor, which lives in the rainforest spanning from the west of the
Ecuadorian Andes to the north of Peru. This species, of great interest to
science, has been used since ancient times by indigenous Ecuadorians in
their hunting activities: spears dressed with the poison cause immediate
death once they enter into contact with the blood system of the catch.
US National Institutes of Health (NIH) scientist John Daley has identified
the chemical structure of the frog's secretion, thanks to the information
given to him by indigenous and local communities about the physiological
effects of this substance. To isolate the active principle, he illegally
obtained a sample of 750 frogs which we believe left Ecuador by diplomatic
pouch since there is no proof that the Ecuadorian Institute of Natural
Forests
and Wildlife (INEFAN) granted a license for the frog to be commercially
expoited. This kind of license is a basic requirement of Ecuadorian law,
since the frog appears in the annex to the Convention on International Trade
in Endangered Species (CITES), to which Ecuador is party since 1975.
Furthermore, INEFAN banned any bioprospecting activities involving this
species in 1996. Yet it was through such bioprospecting that Abbot
Laboratories in the United States was able to market its drug ABT-594,
derived from epibatidine. ABT-594 is an analgesic two hundred times more
potent than morphine. Abbott Laboratories obtained the patent on epibatidine
after Daley isolated it.
This recent act of biopiracy involves illegal access to genetic
resources, negating the rights of the country of origin and the rights of
the indigenous communities which generated the knowledge being claimed in
the patent. It deserves full condemnation by Ecuadorian society. Patents as
we know them grant monopoly rights to their holder. For this reason, we
demand that Abbott Laboratories recognise and share in a fair and equitable
manner the benefits derived from this knowledge and from the eventual
commercialisation of synthetic forms of epibatidine. This is a requirement
of the Convention on Biological Diversity, which Ecuador ratified in 1993.
It is also required by the Andean Pact Decision 391 on Access to Genetic
Resources, which has been in effect since 1996. We also demand the
cancelling of the US patent granted on the active principle extracted from
the Epipedobates tricolor frog. The patent is an act of aggression against
our national sovereignty and our biological diversity.
For more information:
Elizabeth Bravo
Lucia Gallardo
Biodiversity Campaign
Acción Ecológica
Casilla 17-15-246C
Quito, Ecuador
Tel: (593-2) 52 75 83
Fax: (593-2) 54 75 16
Email: ebravo@hoy.net
_________________________________________________________
ABOUT THIS LISTSERVER -- BIO-IPR is an irregular listserver put out by
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Subject: [BIO-IPR] Implementing TRIPs in developing countries
Resent-Date: Thu, 19 Nov 1998 01:42:39 -0800
Resent-From: bio-ipr@cuenet.com
Date: Thu, 19 Nov 1998 16:06:24 +0800
From: GRAIN Los Banos <grain@baylink.mozcom.com>
To: bio-ipr@cuenet.com
BIO-IPR docserver
________________________________________________________
TITLE: Implementing TRIPs in developing countries
AUTHOR: Dr Carlos M Correa
PUBLICATION: Third World Economics, No 189
DATE: 16-31 July 1998
SOURCE: Third World Network, Penang
URL: http://www.twnside.org.sg/souths/twn/title/ment-cn.htm
________________________________________________________
IMPLEMENTING TRIPS IN DEVELOPING COUNTRIES
With the advent of the WTO TRIPs Agreement, developing country members have
been forced to radically reform their intellectual property rights regimes.
As a result, problems have arisen in the implementation of the TRIPs
Agreement, especially in the areas of protection of plant varieties and
pharmaceutical products. Hence, in the event of a future revision of the
TRIPs Agreement, developing countries are advised to prepare well and fully
exercise their bargaining powers to neutralize any attempts to further
strengthen the current level of protection under the Agreement.
by Dr Carlos Correa
BUENOS AIRES: It is extremely difficult to generalize the likely
implications of the Trade-Related Intellectual Property Rights (TRIPs)
Agreement in developing countries or of a group thereof. Such implications
will substantially vary depending on the divergence existing between the
Intellectual Property Rights (IPRs) laws of a particular country and the
standards of the Agreement, the degree of development in different sectors,
the per capita income, and the structure of the supply (particularly the
presence or not of local suppliers in a given field), among other factors.
Problems in implementation of TRIPs
Developing countries that are Members of the WTO (or which are in the
process of accession) are required to introduce massive reforms in their
IPRs systems. Several problems have arisen in the implementation of the
TRIPs Agreement in four different dimensions.
Normative dimension: Developing countries, by accepting to improve the
standards of protection of IPRs under the TRIPs Agreement, assumed a wide
range of obligations in almost all areas of intellectual property rights:
copyright and "related rights", industrial designs, trademarks, geographical
indications, patents, plant varieties protection, integrated circuits and
undisclosed information.
The countries that have initiated the process of adapting their IPRs
legislation to the Agreement's minimum standards have advanced to a
different degree in this task. Some (for example, Mexico, Trinidad and
Tobago, South Korea) have already enacted legislation that covers all or
most areas dealt with by the Agreement. Others (for example, Argentina,
Brazil, Andean Group members) have modified some of the relevant national
laws, but many areas have not yet been adapted to comply with the new
standards.
Developing countries had no previous legislation in several of the IPRs
areas covered by the Agreement. Most developing countries did not provide
for specific protection for geographical indications and plant varieties.
Moreover, in the case of integrated circuits and undisclosed information,
there were no international instruments in force before the TRIPs Agreement.
Countries that have been able to advance in the reform of IPRs not only face
the task of designing and obtaining the parliamentary approval for new
legislation, but also other daunting problems.
Costs of implementation
Even in countries that have introduced amendments to their substantive laws,
there often remain gaps to be filled with regard to the enforcement of
rights. Compliance with the Agreement on this matter requires the alignment
of national laws with the Agreement in various fields, such as civil and
criminal procedures in courts, administrative procedures, and intervention
of police and customs authorities. They also require increased budgets to
face these new tasks.
The costs of implementing the TRIPs Agreement standards are substantial, as
illustrated in an UNCTAD study titled, "The TRIPs Agreement and Developing
Countries", 1996.
Developing countries and Least Developed Countries (LDCs) were given
transitional periods (Article 65) to implement the Agreement. The Agreement
will become obligatory for the developing countries by 1 January 2000.
Products that are not patentable at that date need to be protected as from
the year 2005.
The provision of such periods was an important element in the delicate
balance reached as an outcome of negotiations. They were included to allow
developing countries time to elaborate and adopt the required legislation,
and to design any other policies necessary to minimize the possible negative
effects of new IPRs rules. This was particularly the case with regard to
products which were not patentable (such as pharmaceuticals, agrochemicals
and food), the protection of which may entail important consequences in
terms of price increases and of the room left for national production, as
discussed below.
The transitional periods granted by the Agreement are automatic, that is,
their application is not subject to any reservation, declaration,
notification or permission. However, many developing countries have been
under pressure by some developed countries to accelerate the pace of
reforms, so as to give immediate application to the TRIPs Agreement
standards.
The US actions
Thus, the US government and the pharmaceutical industry have attempted to
obtain a retroactive recognition of protection for pharmaceuticals that are
already patented (the so-called "pipeline" protection). The Andean Court of
Justice (established by the Cartagena Agreement) declared in a decision
(Process No. 1-AI-96) on 30 October 1996, that the "pipeline" formula was
inherently contradictory with the novelty requirement under patent law, and
thus rejected the retroactive registration of patents in the subregion.
The US has continued to "classify" and threaten some developing countries
under its Trade Act for reasons related to intellectual property rights. US
law determines that a foreign country may be deemed to deny "adequate and
effective protection" of IPRs notwithstanding that the said country complies
with the specific obligations stipulated under the TRIPs Agreement. One
country (Argentina) has been sanctioned in 1997 and many others are on the
list.
One of the basic trade-offs for developing countries in the negotiation of
the TRIPs Agreement was the exclusion of unilateral retaliatory actions,
such as those imposed under Section 301 of the US Trade Act. A basic
obligation of all WTO Members is to channel any controversy relating to IPRs
through the multilateral procedure under the Dispute Settlement
Understanding. While several complaints have been filed under the TRIPs
Agreement involving alleged infractions by developing and developed
countries, only one case has been decided (see below).
Another aspect to be mentioned is the number of demands made by
industrialized countries to developing countries in accession to the WTO.
Several cases have been reported in which the latter countries are pressured
not to apply the transitional periods as well as not to confer levels of
protection higher than that required under the Agreement.
Developing countries voiced their concerns on the socio-economic
implications of a tightened IPRs regime when they entered into negotiations
and finally accepted the Agreement. Those concerns have not vanished and are
still particularly strong in two areas: the protection of plant varieties
and of pharmaceutical products.
Plant varieties
a) Plant varieties:
Most developing countries are dependent on their agricultural sector. While
80%-90% of seeds used in these countries are produced by farmers in an
"informal seed supply system", the introduction of IPRs on plant varieties
may replace better adapted farmers' varieties and reduce the diversity and
sustainability of agriculture.
Article 27.3(b) of the Agreement allows to exclude from patentability plants
and animals other than micro-organisms, and essentially, biological
processes for the production of plants or animals other than non-biological
and microbiological processes. However, Members "shall provide for the
protection of plant varieties either by patents or by an effective sui
generis system or by any combination thereof".
The Agreement further established that this provision shall be reviewed four
years after the entry into force of the Agreement Establishing the WTO (that
is, in 1999).
The exception contained in Article 27.3(b) reflected the strong divergences
existing at the time of negotiations, even among industrialized countries,
on the patenting of plants and animals. Since then the European Union has
come closer to the position of the United States and Japan on these issues.
Nevertheless, differences still remain particularly in a North- South
perspective. Many developing countries that amended their patent laws have
provided an exclusion for the patentability of plants and animals.
One of the most difficult issues in Article 27.3(b) has been, however, the
development of a regime for plant varieties. As drafted, the said Article
left some room to follow different options to protect such varieties.
Protection may be granted by:
* patents;
* patents combined with a breeders' rights regime;
* another modality of a sui generis regime.
Member countries may adopt a International Union for the Protectionist of
New Varieties of Plants (UPOV)-type regime, even without becoming members of
the Union, either by following the model of UPOV 1978 or 1991. They may also
become members of the Union.
However, nothing in the Agreement requires a member to follow the UPOV
standards or to abide by the obligations of the UPOV Convention. Many
proposals have been made, in fact, to develop sui generis regimes on plant
varieties that do not follow the UPOV standards. Such proposals have
included:
* a seal system for plant varieties without requirements of stability
and
uniformity;
* granting remuneration, but not exclusive rights, to plant breeders;
* combining breeders' rights with the recognition of Farmers' Rights,
as
defined in the UN Food and Agriculture Organization (FAO) International
Undertaking on Plant Genetic Resources;
* extending protection to commercial as well as to farmers' varieties
(landraces).
These issues continue to be the subject of intense debate in different fora,
including the FAO.
Pharmaceuticals
b) Pharmaceuticals
The shift from a situation of relative or total freedom to imitate, to the
recognition of an exclusive right on production and commercialization, is
likely to lead to changes in the market structure and in the conditions for
access by consumers to certain (protected) goods. The implications of the
changes in IPRs legislation resulting from the implementation of the TRIPs
Agreement are illustrated by the case of pharmaceuticals, an area that has
attracted the attention of researchers, public institutions and other
interested groups. These implications may be examined with regard to several
aspects:
- Prices
Many studies have been conducted which indicate that the introduction of
IPRs will lead to price increases. Based on studies made in Italy, India and
Argentina, such increases may reach to 100-200% or more for products under
patents, depending on the prior pricing level, the elasticity of demand and
other factors. Other studies, however, predict a more moderate impact, on
the assumption that only a small part of the market will be subject to
patent rights.
- Trade
The strengthening/introduction of patents, without the obligation to
industrially exploit the invention in the country of registration, is likely
to generate or expand trade deficits, as a result of an increased volume and
eventually higher prices for imported finished products and/or active
ingredients.
- Research and development (R&D)
In a field like pharmaceuticals, with high economies of scale in R&D,
patents are very unlikely to stimulate R&D by local or foreign companies in
developing countries. R&D costs are not affordable to the former, while the
latter tend to concentrate R&D in a few locations in industrialized
countries. However, opportunities may arise in areas with lower costs of
research, such as the application of medicinal plants.
- Local production
Production of pharmaceuticals by local firms will be limited to generic
drugs. Foreign patent owners will have the choice, in principle, to produce
locally or to import the product or active ingredients. In some countries
(for example, Chile, Mexico) a number of formulation plants of foreign firms
were closed after the introduction of patent protection. In Argentina and
Brazil instead, new investments by such firms were reported. It seems,
therefore, that the impact of patents on investments and production will
depend on the conditions of each market, but most probably the growth
prospect of local firms will be modest at best, unless they are able to
participate in the most dynamic segments of the market under licensing
arrangements.
- Technology transfer and balance of payments
The granting of patent protection may have an ambivalent effect on the
transfer of technology. On the one hand, it will reinforce the power of the
patentee to decide how to exploit its technology and whether to confer
licenses or not to other parties. On the other hand, the existence of such
protection may be regarded as a condition for such a transfer to take place.
Studies made by the World Bank have indicated a possible important increase
in payments due to royalty and profit remittances.
The situation of the pharmaceutical sector is further complicated by the
uncertainty that exists with regard to the concept of the "exclusive
marketing rights" to be granted according to Article 70.9 of the Agreement.
In the single decision on IPRs taken under the WTO dispute settlement rules,
India was deemed to be in violation of its obligation to provide for a
mechanism of deposit for pharmaceutical patent applications, as stipulated
in Article 70.8. The decision held that India had to adopt positive
legislation in order to implement the so-called "mail box" provision, but
the dispute panel refused to define the scope of "exclusive marketing
rights" (EMRs), since this was not an issue under dispute.
Exclusive marketing rights
For those countries that apply the transitional periods for the recognition
of pharmaceutical (or agrochemical) product patents, the interpretation of
EMRs remains an ambiguous issue. An important point is whether EMRs would be
deemed to have similar effects as a patent, and the extent to which they may
be subject to compulsory licenses and other exceptions. Though opinions on
these issues widely diverge, it seems logical to think that EMRs may not be
equivalent or stronger than patents, since this would nullify, in practice,
the transitional periods.
EMRs may, therefore, be conceived as an exclusive right to obtain a
remuneration from those that use the invention, until the patent is granted
and full use is conferred.
In view of these problems and possible implications, and of the little
impact that the introduction of patents may have in developing countries to
induce R&D by foreign pharmaceutical firms, Prof. Scherer has concluded that
such countries should apply to the full possible extent the transitional
periods allowed under the TRIPs Agreement.
A resolution elaborated by the Executive Board of the World Health
Organization (WHO), under consideration of the World Health Assembly in May
1998, calls for reconsidering the WTO rules as they apply to medicines,
particularly to the WHO listed "essential drugs".
[At the just concluded World Health Assembly, opposition to the resolution
from the powerful TNC pharmaceutical lobbies, and the US and other
governments backing them, resulted in the resolution being referred back to
the Executive Board for further consideration.]
The TRIPs Agreement leaves some room to establish, at the national level, a
number of measures to mitigate the eventual negative effects of changes in
IPRs rules.
First, Article 8.1 states that: "Members may, in formulating or amending
their national laws and regulations, adopt measures necessary to protect
public health and nutrition, and to promote the public interest in sectors
of vital importance to their socio-economic and technological development,
provided that such measures are consistent with the provisions of this
Agreement."
Second, Article 27.2 states that: "Members may exclude from patentability
inventions, the prevention within their territory of the commercial
exploitation of which is necessary to protect ordre public or morality,
including to protect human, animal or plant life or health or to avoid
serious prejudice to the environment, provided that such exclusion is not
made merely because the exploitation is prohibited by domestic law".
Third, by a strict application of the novelty and inventive step
requirements, a member may exclude the patentability of "second uses" of a
known product, as well as of formulations of active ingredients that are
already known.
Fourth, under Article 30 of the TRIPs Agreement, there is considerable
freedom for national legislations to define exceptions to the patentee's
exclusive rights. Based on comparative law and on other proposals, the
following exceptions may be provided for within the scope of Article 30:
* acts done privately and on a non-commercial scale or for a
non-commercial
purpose; l use of the invention for research and experimentation;
* use of the invention for teaching purposes;
* preparation of medicines for individual prescriptions;
* prior use (use of the invention by a third party who started or
undertook
serious preparatory acts - before the date of application for the patent or
of its publication);
* experiments made for the purposes of seeking regulatory approval
during
the lifetime of a patent, in order to market a product immediately after the
expiration of a patent ("Bolar exemption");
* "parallel imports" of a protected product, on the basis of the
principle
of "international exhaustion" (Article 6 of the Agreement).
Built-in agenda: As mentioned, Article 27.3(b) is the only provision in the
TRIPs Agreement subject to an early revision. Though it is uncertain whether
that revision will take place in 1999, the precarious nature of the said
provision indicates the need to elaborate a negotiating position that duly
takes into account the developments under the Convention on Biological
Diversity and the FAO International Undertaking on
Plant Genetic Resources.
It seems unlikely that a consensus will be reached in the Council for TRIPs
for an amendment of this provision in 1999, in isolation from other
negotiations that would start, if launched, after the year 2000.
"Non-violation" complaints
Another issue to be dealt with by the Council for TRIPs is the treatment of
"non-violation" complaints, which were not subject to the settlement of
disputes till the end of the year 1999. A decision should be taken - by
consensus - on whether to extend such period or to determine the disciplines
to be applied.
A positive agenda: At least two proposals have been initiated or supported
by developing countries, aiming at a future revision of the TRIPs Agreement.
On the one hand, within the WTO Committee on Trade and Environment, some
delegations have indicated the need to amend the Agreement in order to
facilitate the access to and use of environmentally sound technologies. On
the other hand, in the framework of WHO, a group of countries has stressed
that public health, rather than commercial interests should be recognized as
the primary concern in the implementation and eventual revision of the
Agreement.
In any case, if the Agreement was opened for revision, developing countries
should be well prepared in terms of the objectives sought, and ensure that
their bargaining power is adequately exercised in order to neutralize any
attempt to increase the level of protection currently required under the
Agreement. (Third World Economics No. 189, 16-31 July 1998)
Dr. Carlos Correa is a professor at Universidad de Buenos Aires, a former
Argentine negotiator on IPRs at GATT and WIPO, and an internationally
acknowledged expert on IPRs. The above, based on his presentations at recent
seminars for Arab region nations (in Beirut) and the Third World Network
seminar for developing countries in Geneva, was written by him for SUNS.
Third World Network
228 Macalister Road
10400 Penang, Malaysia.
Tel: (60-4) 226 67 28 / 226 61 59
Fax: (60-4) 226 45 05
E-mail: twn@igc.apc.org / twnpen@twn.po.my
_________________________________________________________
ABOUT THIS LISTSERVER -- BIO-IPR is an irregular listserver put out by
Genetic Resources Action International (GRAIN). Its purpose is to circulate
information about recent developments in the field of intellectual property
rights related to biodiversity & associated knowledge. BIO-IPR is a strictly
non-commercial and educational service for nonprofit organisations and
individuals active in the struggle against IPRs on life.
HOW TO PARTICIPATE -- To get on the mailing list, send the word "subscribe"
(no quotes) as the subject of an email message to
<bio-ipr-request@cuenet.com>. To get off the list, send the word
"unsubscribe" instead. To submit material to the list, address your message
to <bio-ipr@cuenet.com>. A note with further details about BIO-IPR is sent
to all subscribers.
ABOUT GRAIN -- For general information about GRAIN, you may visit our
wwwsite http://www.grain.org or send an email to <grain@bcn.servicom.es>.
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