TWN Info Service
on WTO and Trade Issues (Feb07/14)
23 February 2007
move on bird flu samples highlights key access issues
The reluctance of Indonesia to freely provide bird flu samples
to the World Health Organisation because of the fear that commercial
companies would obtain them to develop patented products is understandable,
since samples of other viruses given to WHO have previously been
used by corporations to obtain patents.
The Indonesian government's announcement that it would stop
sharing bird flu samples with the WHO unless the agency stopped providing
the strains to commercial vaccine makers won the support from health
officials in other Asian countries as well as sympathy from mainstream
media such as the New York Times and New Scientist.
Below is an article
explaining the background to the Indonesian move. A second
article will be posted updating news on the situation.
With best wishes
Indonesia's move on bird flu samples highlights key access issues
By Martin Khor (TWN), Penang, 18 Feb 2007
The reluctance of Indonesia
to freely provide bird flu samples to the World Health Organisation
because of the fear that commercial companies would obtain them
to develop patented products is understandable, since samples of other
viruses given to WHO have previously been used by corporations to obtain
The Indonesian government's announcement that it would stop sharing
bird flu samples with the WHO unless the agency stopped providing the
strains to commercial vaccine makers won the support from health officials
in other Asian countries as well as sympathy from mainstream media such
as the New York Times and New Scientist.
Earlier this month, Indonesia signed an agreement with the US drug company
Baxter Healthcare to develop a human bird flu vaccine. Indonesia would
provide H5N1 virus samples while the company would provide it with technology
and expertise in vaccine production. The WHO and other organizations
would have access to the samples only if they agreed not to distribute
them to commercial companies.
Indonesian health officials explained that the move was to ensure that
the people had access to the vaccine during a pandemic, as otherwise
it would have to buy the vaccines from commercial drug manufacturers
at high prices. They maintain that the WHO's virus-sharing mechanism
has been misused for commercial purposes.
According to an Associated Press article: "Other countries, including
China, Thailand and Vietnam, have previously stalled on sharing viruses.
Like Indonesia, they fear [that] the vaccines and drugs produced from
their viruses would ultimately be unaffordable for them, leaving their
populations dangerously vulnerable - while rich countries add to their
Up to now, WHO Member States that experience bird flu outbreaks provide
samples of the virus isolates to WHO collaborating centres. At these
centres, the isolates are used in the process of creating vaccine seed
stocks, frequently using patented techniques. WHO then provides the
seed stocks to vaccine producers.
But the vaccine producers, say many developing countries, are charging
too much for the vaccines. Several countries raised the issue at the
World Health Assembly last May (See SUNS #6035 dated 29 May 2006).
However, the Indonesian withholding of its samples appears to be short-lived.
On 16 February, the Indonesian Health Minister announced that the country
would resume sharing influenza viruses with the WHO. A joint statement
between Indonesia and the WHO said that in the short term, Indonesia
will discuss with vaccine production companies to meet its vaccine needs
and in the long term, Indonesia will work with WHO to develop its local
vaccine production capacity.
The WHO will also work with Indonesia to develop Material Transfer Agreements
and a meeting of Asian countries will be held to identify mechanisms
for equitable access to influenza vaccine and production.
While Indonesia may resume sending its virus samples to the WHO centres,
the issues it raised will continue to be hotly debated. The WHO and
the corporations that hope to profit from making, patenting and marketing
vaccines were outraged by what they saw as a defiant act, while officials
in other developing countries were encouraged by the Indonesian action
and even some mainstream media provided sympathetic editorials.
An IPS article quoted UNICEF East Asia regional immunization officer
Basil Rodriques as saying that ''Indonesia has tossed the latest salvo
into a debate that has been simmering under the surface for a long time.
It is an issue of relevance that the world needs to come to grips with",
adding that Indonesia's decision forces public health officials to ask
what is best for the public good.
A health official in Thailand was also quoted as saying that the WHO
system of sharing virus samples is positive if the benefits are evenly
shared, but the reality is otherwise because developed countries gain
more from the vaccines produced from virus samples collected from the
IPS also quotes Philippines' health secretary, Francois Duque: ''The
US and Western countries are gobbling up the drug and denying access
to developing countries that need it most. The poor countries once again
have been excluded from the arena.''
Last May, the US-based NGO Sunshine Project revealed that patents had
been granted for anti-viral drugs for the treatment of smallpox and
that a smallpox vaccine had also been granted a European patent.
Many developing countries had handed over to the WHO their stocks of
the smallpox (variola) virus, and the World Health Assembly had mandated
that the remaining smallpox virus stocks would eventually be destroyed.
Meanwhile, two laboratories (one in the US and the other in Russia)
were authorized to maintain stocks of the virus, and to undertake research,
including to develop smallpox vaccines and anti-viral drugs.
In an article in SUNS (No #6034 dated 24 May 2006), Edward Hammond of
the Sunshine Project revealed that several of the drugs (or their components)
that have been developed are under patent, or under patent application.
This will affect the affordability or availability of the drugs in the
event they are needed.
There are two principal compounds (cidofovir analogs and SIGA-246) under
consideration in the US for use as smallpox anti-virals. Both could
be covered by intellectual property claims that could hinder rapid and
free access to the anti-viral drugs. The proprietary claims may conflict
with resolutions passed by the World Health Assembly which requested
that the WHO ensure that the benefits of the smallpox research be made
available to all countries.
Cidofovir analogs for treatment of variola virus infection are covered
by patents issued to the University of California, including two patents
issued in April 2004 and April 2006. International patent applications
have also been filed, including in China, South Africa, Brazil and Mexico.
The university has stated that it intends to seek patents in many other
developing countries, including most of Africa and many countries in
Asia and Latin America.
The other smallpox anti-viral compound under consideration in the US
is SIGA-246 (ST-246) that belongs to the US company SIGA Technologies.
The Danish company Bavarian Nordic also holds a European patent on a
smallpox vaccine, and the company was suing the company Acambis for
infringing its patent. Acambis was then planning to take part in a $1.9
billion contract to provide smallpox vaccines to the US government.
"With several patents granted or pending on smallpox anti-virals
and legal fights taking place over a patent on a smallpox vaccine, it
is clear that there is a range of issues on who owns the stocks of the
smallpox virus, whether patents should be issued on drugs relating to
the virus, and the cost to, and access of, people especially in developing
countries in the event they require the drugs," said Hammond.
The high cost of vaccines for avian flu and the need to prevent commercial
monopoly over the medicines that are developed from stocks of the virus
provided by affected countries was also a key issue at the World Health
Assembly last May (See SUNS #6035 dated 29 May 2006).
Thailand raised the issue of the high costs of vaccines against bird
flu, and insisted that the price of vaccines be brought down.
It proposed an amendment to the WHA resolution on the Application of
the International Health Regulations, suggesting the insertion of the
language "for non-commercial purposes only" in relation to
the dissemination to WHO collaborating centres of information and the
biological materials related to avian influenza and other novel influenza
strains. The amendment would restrict the commercial use of the vaccine
seed stocks developed from the samples provided to the collaborating
In response to the Thai proposal, the WHO Secretariat said that private
sector collaboration was required to produce bird flu vaccines due to
limited global production capacity. Thailand defended its proposed amendment
by noting that under the current system of vaccine seed stock development
and distribution, "the result will be a monopoly", and that
"measures must be implemented" to address the problem. Thailand's
comments drew applause from many delegates.
However, because of objections by other countries, Thailand had to compromise
and the eventual resolution urged member states to develop domestic
influenza vaccine production capacity or work with neighbouring States
to establish regional vaccine; and requested the Director-General to
immediately search for solutions to reduce the current global shortage
and inequitable access to influenza vaccine and also to make them more
affordable for both epidemic and global pandemic.
Thailand stressed that this "trade-off" was "very painful."
It believed that this trade-off was a "win-lose" solution
where the winner was the developed countries which can produce vaccines
and the loser was the developing countries which cannot access the vaccine,
whereas it is the developing countries that are submitting the flu strains
to the WHO collaborating centres. Thailand however said that it did
not want a lose-lose situation where no one has the vaccine and everyone
In response to the Indonesian move, the New York Times in its editorial
on 16 February said: "Indonesia has raised a valid point that needs
to be addressed: if a pandemic should strike, poor countries would be
left without protection." It said however that what may be good
for Indonesia could be harmful to global health - especially if other
countries follow. Unfortunately, the WHO has no good answer to the inequities
that Indonesia has spotlighted.
"If a pandemic struck, the current vaccine makers could produce
only 500 million doses of vaccine per year if they ran 24 hours a day.
That is far short of what would be needed to vaccinate all 6.7 billion
people in the world," said the Times editorial.
"Thus, there seems no doubt that in a crisis, the countries that
are home to the vaccine makers would tend to their own citizens first
- or those willing to pay the highest prices - leaving little or no
vaccine for everyone else. The WHO needs to work much harder to encourage
the transfer of vaccine production technology to countries like Indonesia,
that have the technical ability to use it. That will increase the supply
of vaccine and presumably bring prices down. Even then, we fear, there
still won't be enough."
In its 17 February issue, The New Scientist published an editorial,
"Self defence over bird flu is no crime." It said: "Good
for Indonesia. There, it's been said. The country at the centre of the
H5N1 bird flu storm has stopped sending virus samples to the WHO. Though
this means that scientists cannot track H5N1's increasingly worrying
evolution, which is bad, Indonesia is doing the only thing it can to
protect its people.
"It has also brought an unpalatable truth out into the open. In
a fair world, Indonesia would send its virus to the best labs and share
in any vaccine made from it. In our world, Indonesia sends off its virus,
companies make vaccine from it and sell it to countries that can pay.
Indonesia is not one of them, and neither are the other countries suffering
badly from H5N1.
"Indonesia is treating this as a case of biopiracy. Like other
tropical countries, it is a hotspot of biodiversity. For decades, foreign
companies have helped themselves to its plants, microbes or whatever,
and made lucrative products from them. In response, it has passed laws
to stop exports of genetic material without agreement. It is invoking
such a law to control samples of H5N1 and asking developed countries
to respect the sort of intellectual property rules that they themselves
have imposed for decades..."
"By withholding the virus, Indonesia is leveraging the one resource
it has to obtain flu vaccine, possibly even its own factory. As Lily
Sulistyowati of Indonesia's health ministry put it: 'Indonesia's state-owned
drug maker Bio Farma does not have the technology and expertise to create
the vaccine. We can only offer foreign pharmaceutical companies our
strain of the virus'."
"The country says it is will do this only under material transfer
agreements that ban commercial use except by prior agreement...We need
a system that works for everyone. In its absence, those material transfer
agreements should be signed now. We need to see what H5N1 is up to in
However, the Indonesian move to stop sending its virus samples to the
WHO may be short-lived as it announced that it would resume sharing
A joint statement was issued by Indonesia and the WHO following a meeting
between the Indonesian Minister of Health Siti Fadillah Supari and Dr
David Heymann, WHO Acting Assistant Director-General for Communicable
The statement said that Indonesia's leadership alerted the international
community to the needs of developing countries to benefit from sharing
virus samples, including access to quality pandemic vaccines at affordable
Indonesia recognized that short and long term solutions are needed.
In the short term, Indonesia will pursue discussions with vaccine production
companies to meet its vaccine needs, which WHO fully supports.
Said the statement: "In the long term, Indonesia is working with
WHO to develop its local vaccine production capacity through technology
transfer. Both WHO and the Ministry of Health of Indonesia agree that
local capacity to produce vaccines is the long term solution to ensuring
availability and access to influenza pandemic vaccine.
"The Minister agrees that the responsible, free and rapid sharing
of influenza viruses with WHO, including H5N1, is necessary for global
public health security and will resume sharing viruses for this purpose.
"WHO will continue discussions and work with the Ministry of Health
and other countries to assess and develop potential mechanisms, including
Material Transfer Agreements, that could promote equitable distribution
and availability of pandemic influenza vaccines developed and produced
from these viruses."
To this end, WHO and the Health Ministry will convene a meeting of selected
countries in the Asia and Pacific region to identify mechanisms for
equitable access to influenza vaccine and production.
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