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ISIS Press Release 02/07/07
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.
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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.
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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.
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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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