The Agreement on Trade Related Aspects of
Intellectual Property (TRIPs)
TRIPs came into effect in 1995. It imposes minimum
standards in seven areas of intellectual property i.e. patents,
copyright, trademarks, geographical indication, industrial design, and
undisclosed information (trade secrets) and covers diverse areas as
computer programming and circuit design, pharmaceuticals and transgenic
crops. TRIPs was devised based on standards of the North and conflicts
with the national interests and needs of the Third World countries. For
instance most Third World countries previously exempted medicines,
agriculture and other products from national patent laws but with TRIPs
almost all knowledge-based production is subject to tight intellectual
property protection. Third World nations have to adjust their laws to
conform with TRIPs by 2000 while the least developed countries by 2016.
The latter will be confronted with severe financial and administrative
constraints (UNCTAD 1996:2-3).
Negative Impact
TRIPs ignores the profound differences in economic
and technological capabilities between the North and the South, and is
an instrument of ‘technological protectionism’ aimed at
consolidating an international division of labour where the North
generates the innovations and the South will be the market for the
resulting products and services. It is a move by US corporate interests
to establish global rules to counter their declining competitive market
edge in world markets (Correa 2000:5).
TRIPs will affect the Third World by increasing the
knowledge gap; and by shifting bargaining power towards the producers of
knowledge most of whom are in the industrialised North (Koivusalo 1999).
This will be most strongly felt in the area of patents and its effects
on the prices of medicines.
Although the positive effects of TRIPs on the South,
have been touted by the North, in terms of technology transfer, foreign
direct investment (FDI) and research and development (R&D)
innovation, there is scant evidence of this taking place. In fact the
strengthening and expansion of intellectual property rights (IPRs) will
affect the access to and use of technology and the Third World’s
prospect for industrial and technological development; stronger IPRs
means higher costs in terms of royalties and other payments and reduce
resources available for local R&D; scientific and technological
protectionism is a growing problem as the increasing economic relevance
of scientific research limits the free dissemination of research results
and constrains the traditional openness of university laboratories where
most basic research is conducted in the North - this will reduce the
Third World’s prospects of improving their social and economic
conditions (Correa 2000:33).
In terms of domestic innovation, most Third World
countries (with the exception of the East Asian ‘Tigers’, India and
Brazil which have built up their R&D) are not likely to improve
their innovative performance on the basis of a stronger and expanded
IPRs regime: Third World countries’ share in world R&D expenditure
is negligible declining from some six percent in 1980 to about four
percent in 1990, they are thus overwhelmingly dependent upon innovations
made in the North (Ibid:5, 38). As for FDI, the UN concluded that
companies in the North will rather sell their products and services that
incorporate innovations than transfer the technology through FDI and
licensing agreements which would result in more exports by the developed
North and less opportunities for transfer of technology to the Third
World (Ibid:27).
The North’s dominance of intellectual property can
be seen from the following data: 97 percent of all patents worldwide is
concentrated in a handful of countries; in 1993, ten countries accounted
for 84 percent of global R&D; 95 percent of patents granted in the
US over the past two decades were conferred on applications from ten
countries which captured more than 90 percent of cross-border royalties
and licensing fees; 70 percent of global royalty and licensing fee
payments were between parent and affiliate in TNCs; and more than 80
percent of the patents that have been granted in the Third World
countries belong to residents of industrial nations. (UNDP 1999:68) The
TRIPs Agreement represented a major victory for the North and their
industrial lobbies. It provides an enabling environment for the TNCs to
tighten their dominance over the ownership and control of technology and
impede and increase the cost of transfer to the Third World (Correa
2000:21; UNDP 1999:34).
Although Article 27.3(a) of TRIPs allows member
states to exclude from patentability diagnostic, therapeutic and
surgical methods used for the treatment of humans and animals, pressure
is expected from industry to expand their rights further to exploit the
innovations emanating from the health care industry. As such, concerns
have been raised regarding moves to broaden the scope of (IPRs) to
include medical and health technologies and issues such as surgical,
diagnostic and therapeutic methods, especially with the development of
gene therapies in the health care industry.
Privatising Knowledge
In the area of medicine and health, stronger and
wider IPR protection will affect the practice of medicine and the spread
of medical knowledge. This will lead to the privatisation of medical
knowledge, restricting its access and removing the free flow of
scientific exchange for the public good. Protectionism of medical
knowledge and medical practice commodifies medicine further and
threatens well being and public health.
This is already happening in the US where patents
have been registered for a number of medical technologies which will
affect the practice of medicine with implications on human health and
welfare. Some example cited from Coleman include:
-
A US surgeon patented a particular type of cataract
operation and warned other surgeons that they have to pay a royalty
for the use of the procedure;
-
A doctor owns the rights to a basic suturing
technique;
-
A doctor own the rights to the technique of making
a slit in a skin graft in order to expand it;
-
A doctor has patented the practice of applying the
anaesthetic lidocaine to the skin to treat nerve pain associated with
shingles;
-
A doctor has the right to the idea of treating a
nosebleed with a catheter wrapped in gauze;
-
A doctor has a patent on a technique to treat
piles;
-
A radiologist owns a patent covering the technique
for determining the sex of a foetus aged 12 to 14 weeks with
ultrasound - which relies upon the radiologist’s ability to
distinguish male genitalia from female genitalia;
-
A Swiss drug firm owns a patent on all ex vivo
human gene therapy, due to its ownership of a patent to treat a rare
genetic disorder - such broad patent rights prohibits any scientist
from repeating the patent owner’s experiment to check results and
verify them;
-
US courts have stopped doctors prescribing life
saving treatments when rival companies claim to own part of the
underlying technology;
-
Cancer patients in the US have been refused
treatment with a drug made by one company because a second company
claimed its rights were being infringed (Coleman April 2000).
Article 39 of TRIPs obligates member states to
protect data and undisclosed information of commercial value. In the
case of pharmacueticals and new chemicals, strict data confidentiality
may hinder or prohibit prompt action especially when there is a reason
to doubt the decision made (e.g. adverse drug reactions of the drug) and
there is a need to re evaluate the licensing decision that have been
made. This problem may arise in relation to medical research and the
assessment of health technology, as much clinical research is funded by
the private sector and research could be corporate driven. Further
protection of IPRs will shift research and innovation from the public
sphere of scientific exchange towards the corporate sector (Koivusalo
1999).
Protection of commercial information could pose a
problem to governments in terms of their ability to regulate contracted
out services in health care. In terms of public health, lack of access
to information can compromise or threaten health for instance when data
or information is necessary to ensure the quality and cost of contracted
services or products that have been purchased by the health service in
areas like pharmaceuticals, blood and tissue products and medication,
waste disposal methods, and food preparation and processes.
Strengthening IPRs can further limit access to information and the
citizen’s right to know the basis of decisions made which can have a
lasting impact on public health and safety.
Trade Marks
TRIPs protection of ‘well known’ trademarks even
if they are known on the basis of publicity and not of effective use in
a country was a major achievement for the TNCs (Correa 2000:13).
Trademarks are increasingly used by the TNCs to promote their products.
These have an impact on public health especially when toxic and
unhealthy products are advertised: companies are resorting to indirect
advertising i.e. through the placement of a logo in tobacco, alcohol and
infant formulas to circumvent national bans on advertising. For
instance, Camel is placed on cigarette lighters, clothes and
accessories like wallets, caps and boots; Malborough is found on
torchlights and cigarette lighters, and caps, Benson & Hedges
runs a coffee place in Kuala Lumpur and promotes sporting activities and
‘Golden Dreams’; Dunhill brand of watches and clothes are
sold; and McDonald’s appears on giveaway toys.
In some countries like Finland, legislation forbids
indirect advertising of tobacco products through the use of similar
trade marks in other products. However, this may cause problems for
member states who initiate public health measures to curb the use of
such trade marks or logos as in the case of tobacco, alcohol; infant
formula, and junk foods. It can be construed as discriminatory measures,
which support local industries to the detriment of foreign producers.
Although disputes over such hazardous products have not made their way
to the DSB, the mere hint of a threat of trade sanctions may be enough
for Third World member states to allow foreign companies better
representation of their products; which has been one of the most
important methods used by tobacco companies to avoid government bans and
restriction of tobacco (Koivusalo 1999).
One of the most crucial area of IPs in the TRIPs is
patents. Under TRIPs, patents must be granted and the conferred rights
will be exercised without discrimination as to the place of invention,
the field of technology or whether the protected product is locally
produced or imported. This limitation clearly indicates the
internationalisation of the patent system and the move by the
industrialised nations to push for a legal system that facilitates
global trade rather than the local working of inventions (Correa
2000:15-16). The US pharmaceutical industry was primarily responsible
for this expansion and strengthening of patent protection and a major
beneficiary (Ibid:15).
Price Increase on Medicines
TRIPs will have the greatest impact on the
pharmaceutical industry and the Third World’s access to medicines.
With the introduction of the TRIPs patent regime ‘prices will be a
regular feature and not an accident’: Third World countries are going
to suffer from substantial price increases and other costs (Ibid:36).
World Bank studies show that the minimum welfare loss to Argentina,
Brazil, India, Mexico, Korea and Taiwan due to the impact of patents on
the prices of medicines, would be no less than US$3.5 billion and a
maximum of $10.8 billion; while the income gains by foreign patent
owners would be between $2.1 billion and $14.4 billion (Nogues 1990).
Welfare and price effects were found to be negative
for Asian countries: price increases estimated for patented drugs ranged
from five to 67 percent. Drug prices in Malaysia where patent protection
existed were 20 to 760 percent higher than in India, reflecting a profit
maximising behaviour based on ‘what the market can bear’
(Subramaniam 1990).
One study in Argentina estimated that the
introduction of pharmaceutical patents would imply an annual additional
expenditure of US$194 million with a reduction of 45.5 percent in the
consumption of medicines, as a result of a price increase of some 270
percent: the increase in remittances of foreign firms abroad would reach
$367 million. Fiscal expenditures would have to increase by about US$200
million annually in order not to affect the current public health level
(Challu 1991).
Annual welfare losses for India (the biggest market)
ranged between $162 million and $1,261 million and annual profit
transfer to foreign firms between $101 million and $839 million
(Subramaniam 1995 a&b). A ‘national health disaster’ has been
anticipated by the Indian Drug Manufacturers’ Association as a result
of the implementation of TRIPs where only 30 percent of the population
can afford modern medicines in spite of the fact that drug prices in
India are one of the lowest in the world (Correa 2000:35).
Thus TRIPs will lead to draining further the
resources of the Third World as a result of the outflow of foreign
exchange; increased costs in medical and health care; as well as
undermine countries’ self reliance in drugs as is the case in India
where both public sector and small drug firms have been forced to close
down or taken over by the TNCs (Jan Swasthya Sabha 2000:40).
Lack of Access to Essential Medicines
Except for China, no Third World country is self
sufficient in essential drugs. Some 2.5 billion people have little or no
access to essential drugs (UNDP 1991). WHO estimates that some
countries pay 150-250 percent more than the world market prices for
essential drugs while others are faced with unreliable suppliers and
poor quality drugs. In the Third World, a full course of antibiotics for
pneumonia can cost a month’s wages. The standard triple treatment for
HIV costs some US$10,000 per year, while the per capita expenditure on
drugs in SSA is only $8. Treatment that can save lives for people with
HIV/AIDS is beyond the reach of many in the poor countries. Medicines
for other life threatening diseases like TB, malaria and meningitis are
equally out of reach. For example, most of the 100,000 TB patients
suffering from multi-drug resistant strains cannot afford the new
standard combination therapy which is estimated at US$15,000 per course.
Apart from the prohibitive costs of drugs, many
drugs, which are essential for the treatment of tropical diseases, have
disappeared from the market because they are not profitable. Take the
case of eflornithine (DFMO) used in the treatment of sleeping sickness,
which is caused by a parasite transmitted by the tsetse fly. DFMO is the
only treatment for advanced sleeping sickness. If left untreated the
disease leads to death. It affects some 30,000 people a year. DFMO was
developed by Merrell Dow (MD) in the mid 1970s for cancer. In 1985 WHO
in cooperation with MD made the drug available when it proved to be
effective against sleeping sickness. In the early 1990s, drug production
ceased, as it was no longer commercially profitable. In 1995, Hoechst
Marion Roussel (HMR) which took over MD offered the technology and
patent rights of DFMO to WHO, but the latter could not get any company
interested to produce the drug. HMR offered the remaining bulk product
for free but is no longer able to put the product in vials. The only
existing DFMO vials in the MSF (Medecins Sans Frontieres) drug
store in Kampala expired by July 1999 (t Hoen: 2000).
Thus medical R&D in drugs today are geared
towards increasing share holder value and profits and not the public
interest. It is highly concentrated in favour of diseases that afflicts
the North and the concerns of the affluent in the South. There is thus a
lucrative market for developing cures to deal with impotence (viagra),
obesity, ageing, jetlag and baldness (Koivusalo 1999). Almost nothing
goes to tropical diseases. While pneumonia, diarrhoea, TB and malaria
account for more than 20 percent of the disease burden of the world,
they receive less than one percent of health research funds; less than
10 percent of the US$56 billion spent yearly on research is aimed at the
health problems affecting 90 percent of the world’s people (The Corner
House 1999). With biotechnology, a new generation of expensive genetics
based medicines will hit the market in the future.
It can be seen that pharmaceuticals account for a
sizable part of the health budgets of Third World governments. Although
essential drugs are outside patents and part of the public domain, drugs
like HIV are not, and diminishing access of Third World countries to
essential drugs is becoming a major health problem. These concerns and
the implications of TRIPs were raised by the WHO which passed a
Resolution on essential drugs in 1998 at the World Health Assembly. This
was strongly opposed and the WHO gave in to US pressure with a revised
version which was unanimously accepted at the 1999 WHO Executive Board
and the subsequent World Health Assembly (see p42 on South Africa).
The EDL (essential drugs list) comprises some 306
mainly generic drugs (about 15 or so are patented products) which are
safe, efficacious and available at reasonable prices. Other Third World
countries produce the medicines themselves eg. India, China, Brazil and
Egypt allow patents on pharmaceutical processes but not the final
products. That means they can produce the drug legally using a different
process from the original used. This supported the development of
national domestic industries to produce generic drugs, which were
cheaper than the branded originals. For instance when Glaxo Wellcome
launched AZT as an AIDS inhibitor, it initially cost US$10,000 per
patient each year (although with increased sales the cost for treatment
fell to US$ 239 per month) which was still unaffordable for many in the
Third World. An Indian company then produced the generic Zidovir 100
reducing cost to US$239 per month. India then exported it to Tanzania,
Uganda and Belgium at less than half the price sold by Glaxo Wellcome.
TRIPs sanctions 20-year patents protection on both
processes and products. Thus the company holding the patent has
exclusive rights to manufacture, sell and distribute the drug. Others
can copy the generic only 20 years later. TRIPs protects the power of
the TNCs to further increase and tighten their dominant ownership of
technology and impede the transfer of technology to the Third World. The
implementation of TRIPs will have serious implications on the access to
drugs and health care in the Third World. TRIPs will undermine domestic
production of medicines and deprive countries of a source of innovative
quality drugs. This will further widen the gap of access between the
North and the South: Third World countries cannot afford to wait 20
years before they can make life-threatening drugs for their people as
the HIV/AIDS pandemic clearly illustrates the magnitude of the public
health crises in many nations.
However, under TRIPs countries can still gain access
to drugs and protect public health under ‘compulsory drugs licensing’.
Article 31 of TRIPs states that member states ‘may use the subject of
a patent without the authorisation of a right holder including use by
the government’ in the public interest. It also says that ‘the right
holders shall be paid adequate remuneration taking into account the
economic value of the authorisation’. Thus governments can grant a
licence to make copies of patented drugs without the approval of the
patent owner and pay a royalty to the latter. ‘Compulsory licensing’
is part of the patent law of many countries. This option has been used
by countries to restrict the monopoly rights of companies (the patent
holders) in the interest of the public good. The US has applied it
domestically in hundreds of cases. Licences on patent have been granted
in areas including biotechnology, pharmaceuticals, aerospace, military
technology, air pollution, computers and nuclear energy. In many cases,
the rights have been granted free of royalty payments.
TRIPs also allow for the import of medicines from
countries other than the country of manufacture without the permission
of the manufacturer. This is called parallel importing and is provided
in article 6, Exhaustion of Rights. Countries resort to parallel imports
when there are price differences for the same product in different
markets. For example, a retail drug prices study for Glaxo Wellcome’s
Zantac (Zinetac) tablets in 11 Asian countries shows the following
variations: US$9 in Bangladesh; $2 in India; $41 in Indonesia; $55 in
Malaysia; $183 in Mongolia; $3 in Nepal; $22 in Pakistan; $63 in
Philippines; $61 in Sri Lanka; $37 in Thailand and $30 in Vietnam. (HAI
News, April 1998). Malaysia could save a considerable sum of money
if it buys Zantac from India instead of in Malaysia. Parallel importing
is common in the EU pharmaceutical retail trade.
Despite this, Third World countries have been
pressured not to use these measures to the detriment of public health.
US Bullies Thailand
Thailand has a million HIV victims out of a total
population of 61 million. Since 1993, the Thai government had supplied
the HIV antiviral zidovidine, which resulted in a drastic drop in price
from $324 in 1992 to $87 in 1995. Meanwhile under threat from the US to
limit its textile imports, Thailand passed a law on product patent
protection in 1992. As a safeguard however, the Thai authorities created
the Pharmaceutical Patent Review Board (PPRB) to collect economic data
including the production cost of medicines. This move was not viewed
favourably by the US either (Wilson et al 1999). Trade pressure
was again applied on Thailand when the latter attempted to produce
generic didanosine. This drug which is used in triple combination
therapy for HIV was developed by the US National Institute of Health
with taxpayers money and patented as DDI. The US government gave the
exclusive licence to Bristol-Myers Squibb (BMS) to make and market DDI
in return for a royalty of five to six percent of net sales. BMS is the
sole supplier of the drug in Thailand and sells it at a monthly cost of
US $136. Thailand wanted to produce the drug thus enabling AIDS patients
to receive one low-tech double therapy combination (AZT/DDI) at an
affordable price. Since July 1997 as a result of the financial crisis,
the daily minimum wage in Thailand had stagnated at $4.50.
In 1998 under threat of increased tariffs on imports
of wood products and jewellery by the US, Thailand dropped the DDI plan.
The threat came at a time when the Thai economy was crippled by the
Asian economic crisis. Under the urging of US trade officials, Thailand
disbanded the PPRB and enacted a law to restrict its rights to issue
compulsory licensing to medicines. This law ironically, is more
restrictive than the rules set out in the TRIPs agreement (Wilson et
al 1999; Bond 1999).
US Threatens South Africa
South Africa was threatened with US trade sanctions
unless the nation amended its Medicines and Related Substances
Control Amendment Act 1997. This law would enable South Africa to
seek the cheapest world price for a drug through parallel importing; and
to grant rights to make copies of patented drugs without the approval of
the patent holder by imposing compulsory drugs licensing. This law would
make life saving medicines affordable to South Africans. Under
compulsory licensing South Africa can reduce the price of drugs by as
much as 90 percent. (Bond 1999).
South Africa has the world’s fastest growing HIV
infection rates. Some 16 percent of the population, 20 percent of
pregnant women, and 45 percent of the armed forces test HIV positive and
black people have the highest risk of dying early from AIDS (Ibid).
An estimated one million people have already died. The standard
multidrug AIDS therapy that cost more than $12,000 a year is out of
reach of almost all South Africans whose average annual income is less
than $3000 (Ibid). The reaction to South Africa’s new law came
first from the 40 pharmaceutical companies which jointly filed a suit in
the African High Court barring the law from taking effect, claiming that
it violates intellectual property rights and was thus unconstitutional.
By 1998, the drug companies had brought their campaign against South
Africa to the White House. In October 1998, US Congress out off foreign
aid to South Africa in an effort to force its hand.
The US Trade Representative Charlene Barshefsky,
denied South Africa tariff breaks on exports to the US worth more than
$3 billion in 1998 and placed it on its ‘watch list’ for unfair
trade practices. Pressure was brought to bear on Pretoria by the
Commerce Secretary, the US Embassy and the Clinton administration tried
to kill a WHO resolution that urged member nations to ‘ensure that
public health interests are paramount in pharmaceutical and health
policies’. In a report dated 5 February 1999, to Congress from the US
Trade Representative: ‘All relevant agencies of the US government have
been engaged in an assiduous concerted campaign’ to get South Africa
to capitulate (L J Davis: 2000). Even the European Commission lent its
weight to the US attack: Sir Leon Brittan, the Trade Commissioner at the
time issued a warning to South Africa’s Vice President in a letter in
March 1998, that Pretoria’s drug law was ‘at variance with South
Africa’s obligations under the WTO and its implementation would
negatively affect the interests of the European pharmaceutical industry’
(Taylor: 2000).
All these measures were taken by the US to prevent
South Africa from exercising its rights under TRIPs. The US charge that
South Africa was violating WTO rules was strongly condemned by AIDS
activists, health and consumer groups, which accused the Clinton - Gore
administration for practising double standards and hypocrisy. The US has
liberally issued compulsory licences at home and countries like Britain
and the Netherlands get eight to ten percent of their drugs through
parallel imports, yet no trade sanctions are leveled against them. In
fact US extensive use of compulsory licensing for governmental use has
brought on complaints from the EU. In a report from the European
Commission Article 31 of TRIPs introduces a requirement to inform
promptly a rights holder about government use of his patent but no
action has been taken by the US so far to bring their legislation into
conformity with this provision’ (Correa 2000:93).
Compulsory patent licensing has been used by the US
in cases involving meprobamate; antibiotics like tetracycline and
griseofulvin; synthetic steroids; and most recently, several basic
biotechnology patents owned by Ciba-Geigy and Sandoz which merged to
form Novartis. The latter would control Chiron, a biotechnology company
and the US Federal Trade Commission (FTC) considered the merger a
violation of its antitrust laws. The FTC required divestiture of several
products and ordered compulsory licenses of IPRs for a number of
healthcare inventions. Ciba-Geigy, Sandoz and Chiron were required to
license a large portfolio of patents, data, and know how relating to
HSV-tk products, haemophilia gene rights and others to Rhone-Poulenc
Rorer. They were also required to grant non-exclusive licences to all
requesters for patent and other rights to Cytokine products.
Similarly, when Dow Chemical acquired shares of the
Rugby-Darby Group, FTC required Dow to license to a potential entrant
intangible dicyclomine assets like formulations, patents, trade secrets,
technology, designs, drawings, quality control data, software,
management information systems, the Drug Master File, all information
relating to USFDA Approvals that are not part of the acquired company’s
physical facilities or other tangible assets.
Upjohn was required to divest certain IP including
patents or the FTC would appoint a trustee to issue an exclusive US
licence and a non-exclusive rest of the world licence for Pharmacia’s
R&D assets related to 9-AC. These requirements would protect
consumers from reduced competition and higher prices for topisomerase
I-inhibitors (Ibid:92).
In contrast, the bullying tactics the US employs
against Third World nations in relation to pharmaceutical patents is
unlawful and hypocritical. It expects conformity and compliance from
others while blatantly disregarding its obligations under TRIPs. Under
TRIPs, Third World countries have a transitional period after the date
of entry into force of the WTO Agreement to apply the obligations
relating to IP protection. For countries, which are bound to introduce
product patent protection in areas of technology not so protected in
their country, the general transition period is further extended to nine
years. This applies to pharmaceutical products in Argentina, India,
Egypt and other Arab nations.
Transitional periods may provide the time necessary
but not the resources, to introduce changes in legislation, develop the
infrastructure for administration of IPRs and introduce other measures
required to reduce any eventual economic losses derived from the new
framework (Ibid:10).
However, the US is threatening several Third World
countries with sanctions under Section 301 of its Trade Act. It requests
among others not only the immediate introduction of the TRIPs standards
for patents, but its retroactive application. Such unilateral actions to
force a member state to adopt the TRIPs minimum standards are illegal
under WTO rules. This has undermined the efforts of countries to amend
IPRs laws before the expiration of the transitional periods and to
provide protection beyond the requirements of the TRIPs Agreement as in
the case of Argentina (Ibid: 10-11).
US Unilateral Action against Argentina
In May 1995, Argentina’s Parliament approved a new
patent law. During the legislative process, the US government repeatedly
threatened Argentina with unilateral trade retaliations claiming the
lack of retroactive (pipeline) protection for pharmaceutical patents,
ignoring the transitional period that Argentina can apply in accordance
with Article 65 of the Agreement. In December 1996, Argentina passed a
law on ‘confidential information’. In January 1997, the US
government announced the partial withdrawal of Argentina’s benefits
under the GSP (Generalised System of Preferences) as a sanction based on
the latter’s failure to protect IPRs in accordance with ‘international
standards’ (Ibid:12).
Under the direct influence of the powerful
pharmaceutical lobby, the US disregards international binding rules and
deprives Third World countries of their right to take the necessary time
to introduce legal reforms and adopt measures that mitigate their
eventual economic and social impact (Ibid:10).
The Thai, African and Argentinian experience confirms
the fact that patent rights are used by the North as a protectionist
measure to enable them to reap monopolistic profits while preventing the
transfer of technology. The world sales in anti HIV drugs total some
US$3 billion a year. In 1998 alone, the three major AIDS drug companies,
Glaxo Wellcome, BMS and Pfizer made $4.43, $3.64 and $3,35 billion
respectively (Bond 1999). Bristol-Myers Squibb which has monopoly rights
to sell DDI and D4T anti HIV drugs at high prices have made enormous
profits from these drugs which were developed through public funding.
Drug companies will continue to pressure the US and other Northern
governments to prohibit countries like Thailand and South Africa access
to life saving drugs through compulsory licensing and parallel imports.
These efforts by the North in collusion with their corporate interests
have undermined the efforts of Third World governments to give their
people better health care. In the wake of the Thai and South Africa
episode there are moves afoot among the European pharmaceutical industry
to lobby the EU on changes to TRIPs.
BioPiracy
Another impact on health concerns the patenting of
life forms. TRIPs requires all member states to adopt a uniform regime
of Intellectual Property Rights (IPRs) which recognises and protects the
privatisation and exploitation of genetic resources for profit. Article
27.3(b) forces all countries to allow the patenting of all
microorganisms invented and to accord protection to plant varieties by
patents or some legal means. These enable the biotechnology lobby and
Northern governments to exert private monopolistic rights over
terrestrial biological resources.
These measures will legitimise the private
appropriation of community-based resources and knowledge and undermine
indigenous and local communities. It gives the North legal right to
plunder the biological heritage of the Third World. For instance, it
will further the patentability of traditional medicines and crops which
in the Third World have been in the public domain for millennia. The
Third World is the source of some 90 percent of the world’s store of
biological resources. Bioprospectors have for many years stolen the
plant knowledge of local people for profitable uses. For example the
rosy periwinkle found in Madagascar contains anti-cancer properties, Eli
Lilly developed a drug from it making $100 million in annual sales but
nothing for Madagascar (UNDP 1999).
The value of the trade in medicinal plants is
currently estimated at US$43 billion a year; whilst the value of crops
varieties improved and developed by traditional farmers to the seed
industry amounts to US$15 billion. Other natural products so derived
like sweeteners, perfumes, biopesticides, fabrics and cosmetics indicate
the immense contribution and value of biological resources from the
Third World (Gray 1991 & Brush 1999). In terms of the contribution
to pharmacology, some three quarters of the plants that provide active
ingredients for prescription drugs drew the attention of researchers
because of their use in traditional medicine; of the 120 active
compounds currently isolated from the higher plants and widely used in
modern medicine, 75 percent show a positive correlation between their
modern therapeutic use and the traditional use of the plant from which
they were derived (Farnsworth et al 1985). Landmark discoveries
were made of an important class of antihypertensive agents - ACE
inhibitors from plant extracts collected from Malaysia, Ghana and Costa
Rica (Howson, Fineburg & Bloom 1998).
What this amounts to is that the process of theft is
now enshrined in international law and Third World countries are forced
to buy back resources that were originally taken from them. Patenting of
agricultural seeds and medicinal plants prevents farmers and local
communities to freely use what belonged to the community originally. For
example, the neem tree of India which has been used for thousands of
years as a natural pesticide; a medicine for a wide range of diseases
including leprosy, diabetes, constipation and contraception was patented
by several Northern corporations. Since 1985, there are over fifty US
patents on neem. Others include kava, barbasco, endod, quinoa and
tumeric all of which are based on plants and knowledge developed and
used by local and indigenous communities.
Health Threats from Biotechnology
Patenting of life forms and biological materials
through genetic engineering, also raises adverse health and
environmental concerns. Transgenic organisms have entered the food
chain: they include bacteria, fungi, animals and fish. The potential for
adverse effects of genetically engineered organisms on the environment
and human health is becoming evident. Genetically modified food can
cause allergies, toxicity and antibiotic resistant organisms.
In one example, the US FDA in 1992 approved the use
of Monsanto’s genetically engineered bovine growth hormone (BgH) in
cows to increase milk supply (BgH is a naturally occurring hormone that
stimulates milk production in cows). Monsanto’s BgH forces the animal
to produce between 10 and 20 percent more milk. The use of this drug had
adverse health effects on the dairy cows and the milk produced was
contaminated with high levels of hormones and antibiotics which poses a
threat to human health. The milk is sold unlabelled to countries the
world over including India, Mexico and Russia.
L-tryptophan, a natural bacteria was genetically
engineered by Showa Denko, a Japanese company. The genetic manipulations
caused the bacteria to produce a highly toxic substance in the
tryptophan which was not detected until after the product was marketed
in 1989. Consumers who took the product were severely afflicted with a
painful and debilitating circulatory disorder called eosinophilia
myalgia syndrome. As a result, 5000 people became ill, 1500 were
permanently disabled and 37 people died (Mayeno & Gleich 1994).
Similarly when a gene from the Brazil nut was inserted into soybeans to
increase their protein levels, the transgenic soybeans also contained
the nut’s allergenic properties.
Genetically engineered crops use genes that are
resistant to antibiotics to help identify whether the genes that have
been introduced have been successfully inserted into the engineered
crops. These marker genes can exacerbate the spread of antibiotic
resistance among humans. The UK rejected Ciba-Geigy’s transgenic
maize, which contains the marker gene for ampicillin resistance (Ho
1997:108)
Many of the genes transferred into the genetic code
of food crops come from plants, microorganisms and animals that have
never before been part of the human diet. Such transgenic foods
especially those that contain human DNA or the DNA of viruses that
attack human beings can pose a danger to human health. For example,
scientists have shown that the genetically engineered DNA of these foods
can break down and enter the blood stream, when eaten. The human gut
contains enzymes that can rapidly digest DNA. However, in a study
designed to test the survival of viral DNA in the gut, mice fed DNA from
a bacterial virus exhibited large fragments of it in the bloodstream.
The DNA had survived in the gut and entered the blood of the mice.
Further studies show that the DNA is present in spleen and liver cells
and white blood cells (Ibid:110).
Thus, transgenic foods and the foreign DNA in them
can be absorbed by gut bacteria, as well as gut cells and into the blood
stream and other cells in the body. The presence of DNA in cells can
lead to the regeneration of viruses or, if the DNA integrates into the
cell’s genome (i.e. all the genes in each cell of an organism), many
harmful diseases can result including cancer (Ibid:111).
Transgenic crop plants are now engineered to be
herbicide resistant, which means that, these crops can withstand heavy
application of powerful herbicides e.g. Monsanto’s Roundup, which is
poisonous to most plants species, poisoning the soil, ground water, and
affecting human health. The immediate danger of herbicide resistant
crops is the spread of transgenes to wild relatives by
cross-hybridisation creating superweeds. Herbicide-resistant transgenic
oilseed, rape, released in Europe has now hybridised with several wild
relatives (Ibid:100).
Transgenic crops are engineered for resistance to
viral diseases by incorporating the gene for the virus’s coat protein.
These viral genes can cause new disease by generating new and virulent
strains. These are readily transmitted by many species of aphids and
other insects that attack plants. These new broad range recombinant
viruses could cause major epidemics (Ibid:109-10). Thus
transgenic crops can become noxious weeds, affect wild ecosystems, and
create new plant disease.
Farmers in the Third World have always relied on the
diversity of crops in agriculture for sustenance. These crops were
highly adapted to local conditions and possess a range of natural
resistance to diseases and pests. This diversity of crops has enabled
them to maintain a balanced nutrition. Genetically engineered crops
threaten this biodiversity and the local ecosystem with superweeds,
toxic pesticides, contamination of soils and water systems and new
virulent viruses.
Patented seeds are expensive as all inputs like
chemicals and the seeds have to be bought. These seeds cannot be saved
(for the next planting season as in traditional agriculture) because
these are genetically engineered not to reproduce themselves as in the
case of the Terminator Seed.
In March 1998, a US patent was granted for TPS or
Technology Protection System. TPS is now known as Terminator
Technology. It is so called because it will produce plants that have
in them seeds that will poison itself, or self-destruct. Thus, seeds of
the next generation cannot be replanted because they are actually
sterile, dead seeds or suicide seeds. Terminator Technology
epitomizes the attempt by big companies to control and ‘own’ lives.
The Terminator will threaten farmers and the food security of the
South, as farmers cannot save their seeds to replant in the next season.
Through the Terminator, companies load their proprietary genetics
traits ie. patented genes for herbicide tolerance or insect resistance,
and enslave farmers, who will be hooked on their seeds and caught in the
chemical treadmill. Terminator Technology has serious
implications for agriculture in the South. The company Delta and Pine
that owns the joint patent with the US Department of Agriculture has
been bought over by Monsanto whose track record for a clean environment,
health and safety has been shocking to say the least.
Because the Terminator has the ability to
switch off and on other transgenic traits, until the plant with the Terminator
Technology is exposed to a specific outside stimulus be it a
chemical, temperature extremes, or osmotic shock, the technology allows
for crop diseases to be exported in the seeds. There is no gainsaying
that the Terminator can be used by the powerful, to undermine the
food security and economies of nation states. Already, the US military
is preparing to use and apply biotechnology for military and security
purposes. These are dangerous and dark trends in biotechnology and such
assaults on Third World food security becomes evident when it is
realised that some 1.4 billion rural people rely on farm-saved seed (UNDP
1999:68).
Thus corporate appropriation and patenting of the
medicinal and agricultural knowledge of local, indigenous and farmer
communities of the Third World have led to the theft of genetic
resources from the South by the North, and threaten the food security
and well being of farmers. Through TRIPs, pharmaceutical companies and
agribusiness will gain monopoly rights over Third World resources.
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