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[SANET-MG] Whose Bird Flu Virus is It Anyways?
ISIS Press Release 02/07/07 http://www.i-sis.org.uk/index.php
Whose Bird Flu Virus is It Anyways?
A battle over the rights to bird flu viruses at the recent World Health
Assembly raises important issues on access to health and medicines for
people in the world’s poorest countries and presents a strong case for
banning patents on disease agents and their genes and genome sequences.
Dr. Mae-Wan Ho
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Struggle for possession of the virus
Indonesia was in the headlines at the beginning of 2007 for refusing to
share the deadly H5N1 avian flu viruses with the World Health
Organisation (WHO) and its collaborating centres in the WHO Global
Influenza Programme. But after an acrimonious debate at the 60th World
Health Assembly, Indonesian Health Minister Siti Fadillah Supari
announced the country would share the viruses again.
“In doing so, we hope that we can trust the WHO and its collaborating
centres to share this sense of responsibility, to prevent any misuse of
the samples by Indonesia and other countries, and to ensuring a
mechanism for the responsible sharing of these viruses from originating
countries,” Supari said [1].
In a bid for equitable access to affordable H5N1 vaccines for developing
countries, Indonesia had placed a motion calling for a new system of
virus sharing that accords more rights to countries that provide virus
samples to the WHO system. Countries like Thailand, Indonesia and
Vietnam worst hit by the bird flu virus have been providing virus
samples freely to the WHO and its collaborating centres. But drug
companies have patented the viruses and gene sequences without their
knowledge or consent and created vaccines to sell back to the countries
at prices they could not afford. Supari called that “an unfair
mechanism” that “violates the spirit in which the virus is given.”
The USA and many countries in Europe that can afford to pay are
stockpiling H5N1 vaccines and the antiviral drug Tamiflu, leaving little
for the poor countries. Though that may be a blessing in disguise, as
the efficacy and safety of both vaccines and Tamiflu are open to
question [2], and there are better ways to prevent the bird flu pandemic
(How to Stop Bird Flu Instead, SiS 35).
Indonesia’s motion was supported by 20 developing countries including
India, Malaysia, Vietnam, Bangladesh, East Timor, and Iran, and
strenuously opposed by the United States [3].
In the course of the debate, WHO admitted that patents have been taken
out on the avian flu virus (see Box 1), and WHO collaborating centres
have also entered into Material Transfer Agreements (MTAs) with vaccine
manufacturers without informing the countries from which the viruses
originated. That was against WHO’s own 2005 Guidance for sharing
viruses, which states that the consent of countries sharing the viruses
had to be obtained first, if the centres wanted to pass on the viruses
to other parties. But when challenged, WHO’s Assistant Director-General
for Communicable Diseases Dr. David Heymann stated that the 2005
Guidance had been removed and replaced with a document of “best
practices”, which now states that the WHO centres receiving viruses
should provide vaccine strains to any requesting vaccine producer, and
does not mention that the WHO centres have to seek permission from the
countries of origin.
This aroused great consternation among delegates from the developing
nations, as Martin Khor, director of the Third World Network explained:
“This in effect prevents countries providing the virus samples from
having benefit-sharing arrangements. So, while those countries are
obliged to share their viruses freely and the WHO centres are obliged to
give vaccine strains freely, the companies which obtain these free
materials are not placed under any obligations whatsoever.”
Heymann and other senior WHO officials had been quoted in the media as
opposing MTAs between the country of origin of the virus and the WHO
centres or the drug companies, a stance adopted by the US. And yet, WHO
collaborating centres such as the Centers for Disease Control in the US
have entered into MTAs with companies involving viruses collected from
Indonesia, Vietnam and China.
Box 1
Patent claims on vaccines and gene sequences of H5N1
The Third World Network has identified at least 5 patent applications
for vaccines as of May 2007 [4]
Influenza Recombinant Subunit Vaccine
US Patent Application 20070042002AI, 22 February 2007
Hawaii Biotech Inc. (USA)
Claims: the vaccine and gene sequences from influenza virus isolated in
Indonesia in 2005 (A/Indonesia/5/05) and another from China in 1997
(A/Hong Kong/156/97)
Modified Influenza for Monitoring and Improving Vaccine Efficiency
US Patent Application 20070031453AI, 8 February 2007
St. Jude’s Children Hospital (USA)
Claims: small changes to influenza HA genes intended to strengthen host
immune reaction, and any HA gene modified, also the modified HA gene
from an influenza virus isolated in Vietnam (A/Vietnam/1203/04)
Vaccines for the Rapid Response to Pandemic Avian Influenza
US Patent Application 20070003576AI, 4 January 2007
University of Pittsburgh (USA)
Claims: human and animal vaccines based on theoretically
replication-deficient adenoviruses incorporating gene sequences from
H5N1, pieces of any influenza HA gene used, and specifically the HA gene
from an influenza virus isolated in Vietnam (A/Vietnam/1203/04)
Influenza Hemagglutinin and Neuraminidase Variants
US Patent Application 20060008473AI,
EU EP1766059, CA2568015, AU2005248377, PCT WO2005116258
Claims: method of producing H5N1 vaccines wherein HA and NA genes are
removed from circulating wild human and/or animal viruses, genetically
engineered and placed into a backbone of a laboratory-adapted strain,
any influenza HA and NA gene modified and used in this way, and specific
H5N1 isolates in Vietnam and China (A/Vietnam/1203/2004, A/Hong
Kong/40/97, and A/Hong Kong/213/2003).
Functional Influenza Virus-like Particles (VLPs)
US Patent Application 20060263804AI
Novavax, Inc. (USA)
Claims: methods of producing virus-like particles from influenza viruses
– proteins that replicate structures of actual viruses prompting much
the same reaction in the human body as the virus itself and can be used
as vaccine - and the Indonesia-derived virus (A/Indonesia/5/2005) used
to generate the VLP.
Intellectual property rights versus health for all
At stake in the World Health Assembly debate was the twin struggle over
intellectual property rights for commercial exploitation on the one
hand, and on the other, the humanitarian goal of providing health for
all, rich and poor alike, which conflicts with maximising profits from
patented vaccines.
The WHO’s Alma Ata ideal of “health for all by 2000” declared in 1978
has been severely compromised, if not totally eclipsed by the
neo-liberal wealth creation agenda of the World Trade Organisation,
aided and abetted by the international financial institutions like the
World Bank and the International Monetary Fund. There has been a great
deal of dissatisfaction within the ranks of the WHO over what they see
as the agency’s “neo-liberal approach to health” [5] (“Let Us Live and
Let Them Die”, SiS 34). Much hope has been pinned on the appointment of
Dr. Margaret Chan as the new Director General of WHO in November 2006;
and her pledge for a renewed emphasis on primary health care was seen by
all delegates to the World Health Assembly as a step in the right
direction towards restoring health for all.
When asked if Indonesia was after a share of intellectual property
rights and royalties over vaccines made from virus samples, Mr. Makaim
Wibisono, Ambassador of Indonesia to Switzerland, said emphatically that
Indonesia was not after royalties, but equitable access to vaccines, for
all developing countries, not just Indonesia.
Why not ban patenting of viruses?
There is an easy solution to the dilemma faced by poor Third World
countries as far as access to vaccines are concerned, and that is to ban
all patents on viruses and gene sequences under the Trade Related
Intellectual Property Rights (TRIPS) agreement of the World Trade
Organisation, so that at least cheap affordable vaccines can be made in
Third World countries themselves. These “patents on life” associated
with biotechnology are indefensible for scientific and other reasons, as
I have argued in detail [6] (Why Biotech Patents Are Patently Absurd)
(see Box 2). The African Group successfully challenged the WTO on this
very issue in 1999 [7], resulting in a still ongoing review of the
relevant Article 27.3B of the TRIPS Agreement [8].
It is entirely feasible to ban the patenting of genes and sequences of
viruses and bacteria that cause diseases on ethical grounds of ensuring
that poor countries should have access to affordable vaccines and
treatments, and as a defence against pandemics. Diagnosis as well as
access to cheap generic medicines are being hampered by patents, so why
not cut the Gordian knot by banning these patents once and for all. An
amendment to the TRIPS Agreement already allows countries to impose
‘compulsory licensing of drug patents’, so the drugs can be reasonably
priced for export to countries that lack the capacity to manufacture the
products
Why biotech patents should be revoked and banned
Biotech patents or “patents on life” are covered under Article 27.3B of
the Intellectual Property Rights (TRIPS) Agreement of the World Trade
Organisation, currently under review. Such patents should be revoked and
banned for the following reasons [6].
All involve biological processes not under the direct control of the
scientist. They cannot be regarded as inventions, but expropriations
from life
The hit or miss technologies do not qualify as ‘inventions’, and are
inherently hazardous to health and biodiversity as recent evidence
indicates [9] (No to GMOs, No to GM Science, ISIS Report)
There is no scientific basis to support the patenting of genes, genomes,
cells and micro-organisms, which are discoveries at best
Many patents are unethical; they destroy livelihoods, contravene basic
human rights including the right to health and access to medicine,
create unnecessary suffering in animals, or are otherwise contrary to
public order and morality
Many patents involve acts of plagiarism of indigenous knowledge and
biopiracy of genetic resources, including plants, animals and
micro-organisms, gene and genome sequences.
At The TRIPS Council meeting on 5 June 2007, a proposal put forward by
11 developing countries to amend the TRIPS Agreement to require
disclosure on the countries of the genetic resources and traditional
knowledge and their informed consent received a big boost when the
41-member African Group decided to co-sponsor it, and the 31-member
Least Developed Nations Group also spoke in support of it [10]. There is
broad agreement in the TRIPS Council on national sovereignty over
biological resources, and concern over “misappropriation of genetic
resources and traditional knowledge” and “the erroneous granting of
patents.”
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