TWN Info Service on Health Issues (Nov07/03)
28 November 2007
WHO: MEET DISCUSSES PROPOSALS TO REFORM WHO'S INFLUENZA SURVEILLANCE
Published in SUNS #6372dated 23 November 2007
The WHO Intergovernmental Meeting on Influenza Viruses and Benefit Sharing
began on 20th November and it discussed the review and reform of the
Global Influenza Surveillance Network (GISN), which pertains the sharing
of influenza viruses.
On the first day of the meeting the Indonesian Health Minister Dr Siti
Fadilah Supari, charged that her country had experienced unfair and
non-transparent treatment by the Network, which had failed to respond
to the needs of humanity. She called for the replacement of the GISN
with a fairer mechanism.
The WHO Director General Dr. Margaret Chan admitted that there were
problems and it was clear that changes had to be made.
Please find below a news report on the meeting. It was published in
SUNS #6372 dated 23 November 2007 and is reproduced here with permission.
Third World Network
WHO: MEET DISCUSSES PROPOSALS TO REFORM WHO'S INFLUENZA SURVEILLANCE
Geneva, 21 Nov (Riaz K. Tayob) -- The World Health Organisation's system
of monitoring and assessing global influenza has come under heavy criticism
at a meeting this week, and WHO Director-General Dr Margaret Chan admitted
that there were problems and it was clear that changes had to be made.
The criticisms of the Global Influenza Surveillance Network (GISN),
which deals with risk assessment and response to avian influenza as
among its tasks, were led by the Indonesian Health Minister Dr Siti
Fadilah Supari, who charged that her country had experienced unfair
and non-transparent treatment by the system, which had failed to respond
to the needs of humanity. She called for the replacement of the GISN
with a fairer mechanism.
The review and reform of the GISN is one of the items being discussed
at the four-day Intergovernmental Meeting on Pandemic Influenza Preparedness:
Sharing of Influenza Viruses and Access to Vaccines and Other Benefits
(IGM) that began on 20 November.
The meeting was mandated by the World Health Assembly last May, after
a heated discussion during which developing countries led by Indonesia claimed that they were not
deriving benefits such as access to affordable vaccines although they
had freely shared their influenza viruses with WHO collaborating centres
under the GISN scheme.
The WHA resolution linked the sharing of viruses by countries affected
by avian flu to the sharing of benefits, such as vaccines, derived from
the use of the viruses. The issue has significant implications especially
as the WHO predicts that a global avian flu pandemic may break out;
and if it does, there will likely be a scarcity of pandemic vaccines
and an expected rush for obtaining them.
Since early this year, Indonesia (the country with the highest number
of human cases of avian flu) has been highlighting the imbalances in
the system in that countries that contribute their avian flu viruses
have not been informed of the use of the viruses, pointing out that
applications have been made by various parties for patents that cover
parts of the viruses, and that vaccines are offered at high cost to
One of the aims of the meeting is to reform the GISN through the formulation
of new terms and conditions of parties involved in virus sharing, risk
assessment of the virus, vaccine research and manufacturing. However,
by the second day, some delegations were also raising questions as to
what exactly constitutes the GISN system and how it operates, which
demonstrates the confusion as to what constitutes the system and how
In a strong opening statement, Dr. Siti Fadilah Supari said that Indonesia had
experienced an unfair and non-transparent mechanism (referring to the
GISN), adding that GISN has failed to respond to the needs of humanity.
WHO needs to find a transparent and equitable mechanism for virus and
benefit sharing, she stressed.
On the issue of what is the GISN, what is being referred to and how
broad the system is, the WHO's Dr. Margaret Chan said that it was clear
that changes had to be made as it had problems, adding the WHA Resolution
had asked member states to review the GISN and to suggest ways and methods
to strengthen and improve it. She said that what could emerge could
be "GISN plus plus plus".
said that it was not in a position to know whether GISN will be strengthened.
It said that it emerged during a meeting in Singapore (to prepare for the present
meeting) that besides the WHO designated laboratories (that are considered
collaborating centres), there were other institutions involved in the
GISN, and on this it had strong objections.
also sought clarification on the GISN's operations and mechanisms. It
said that it did not understand references to "Global Influenza
Programme" i. e. what sort of mechanism is being talked about,
what is the flow of the virus and the governing law under which GISN
is operating, and who makes the seed virus (i. e. the vaccine strains
provided to manufacturers to develop vaccines) - was it the WHO collaborating
centres or some other institutions? Indonesia added
that many issues on the present system had to be clarified in order
that the mechanism can be improved.
sought clarification as to the mechanism by which the GISN was established.
It stressed that there was mandate in the Resolution to re-examine the
GISN mechanism. India
mentioned that the wording in the Resolution to strengthen and improve
could also mean to critically evaluate the GISN.
In contrast to Indonesia's
critical comments, some developed countries seemed to defend the GISN,
saying that its role should be maintained, expanded and strengthened.
that GISN could be defined and it could be proposed as to whether GISN
is expanded and strengthened. Switzerland
said that from the resolution there was no mandate to abolish the GISN.
The Chair of the meeting, Jane Halton of Australia, also supported positions
of developed countries, stating that the language in the resolution
i. e. "to support strengthen and improve" the GISN is a polite
way of saying that issues like transparency and governance should be
fixed, but this would not extend to abolishing, renaming or deconstructing
The questions posed by Indonesia
remained unanswered, with the Chair stating that the issues will be
dealt with during discussion on operational items. The Secretariat was
also asked to prepare a definition on GISN.
This week's meeting is meant to consider the outcome of a smaller preparatory
meeting held in Singapore
on 31 July to 4 August. That Interdisciplinary Working Group (IDWG)
was mandated to formulate Standard Terms and Conditions for virus and
benefit sharing, to suggest an oversight mechanism and revise the Terms
of Reference for WHO collaborating centres and H5 Reference Laboratories.
However, the meeting could not produce an agreed document. What emerged
after the meeting was a Chair's summary which did not enjoy consensus.
Also on this week's agenda is a consideration of two Secretariat reports
(on benefit sharing and on patents on influenza virus and genes) as
well as two other issues - the establishment of international stockpile
of vaccines of H5N1 and other influenza viruses of pandemic potential;
and mechanisms and guidelines for the sharing of vaccines in the event
of a pandemic.
Chan in her opening speech said that avian flu poses a threat to global
health security, adding that a pandemic can reach every corner of the
earth within a matter of months. The meeting has the opportunity to
take a hard look at the GISN. The WHO is aware of the problems of the
past and of the need to operate in a more transparent manner. She added
that the stakes were too high to squander this opportunity.
The Indonesian Minister said that the WHO requires countries to send
the virus from victims to WHO approved laboratories, i. e. collaborating
centres (CCs) under the GISN mechanism. Developing and poor countries
are requested to release viruses and once they arrive at the WHO-CCs
they belong fully to the WHO-CCs.
She added: "Originating countries do not have any right about the
destiny of the shared viruses... We do not really know whether they
are used for researchers and publication or they are shared with vaccine
manufacturers for vaccine production or may be they are utilised for
the development of biological weapons".
However, the moment poor countries need vaccines, they have to purchase
them at high prices, said the Minister, adding: "The unfairness
by WHO could threaten global health security" and this is a "new
type of oppression to developing nations by developed countries".
Siti Supari gave three examples of the system's unfairness and the lack
of transparency. First, when Indonesia urgently
needed to procure Tamiflu, it found that it was unable to because the
stocks were held in stockpiles by the developed countries.
Second, it was unfair that the sequence data information on the H5N1
virus (used for risk assessment and vaccine production) was held exclusively
by a number of scientists within WHO-affiliated institutions and were
not freely accessible by other scientists. Indonesia
itself had to correct that by releasing H5N1 sequence data to a gene
Third, when several companies had offered Indonesia
vaccine and diagnostic kits from the Vietnamese strain, Indonesia again
discovered the unfairness of the system. Supari said that the shared
viruses had become a commercial commodity and the GISN is the only mechanism
to sustain this for more than fifty years.
The Minister added: "Don't you sense that the viruses originated
from our people and therefore they are owned by our country with its
sovereign rights?" She said that Indonesia
understands the notion to sustain GISN by the timely sharing of avian
influenza viruses. "However, this should not overrule our sovereign
rights," she added.
that the unfairness experienced by Indonesia
will also occur in other countries that have suffered from this disease.
Alluding to double standards practised by WHO, she said that Indonesia
requested that a material transfer agreement (MTA) for sharing its viruses
but the WHO refused this and claimed that there is no MTA for developing
countries or affected countries in the GISN mechanism.
was confronted with a request to sign a MTA when it tried to obtain
seed viruses from an institution in the United
Kingdom. The Minister referred to a
letter that Indonesia
received from the United Kingdom Department of Health, which started
that countries that had supplied the original virus should have free
access to the seed virus which has been produced by the GISN, in accordance
with the MTA (prepared by the institution).
The Minister said that the current arrangements of the GISN were an
"expression of unfairness of treatment between developing countries
and developed countries". She added that the "GISN can never
be fair nor transparent and equitable when the states' sovereign rights
and their respective governing laws are taken into consideration and
therefore the GISN "must be replaced and the genesis of a new mechanism
In relation to benefit sharing, the Minister said that the notion of
benefits for developing countries "should be implemented as a part
of the right, rather than a charity or good will of developed countries
where vaccine manufacturers are located.
"We are here today to show the world that we care for the health
of all people in the world and not to negotiate a profitable deal for
companies". The world needs to be aware of the unfairness of the
GISN mechanism that is dangerous for global health, she said.
Indonesia was committed to discuss the issue based on transparency,
fairness and equity but there must be information on how the system
works, said the Minister, adding: "We must have the assurance that
the shared virus will be solely for public non-commercial public health
use in an equitable manner and not only for the benefit of companies'
profits, or rich people in rich countries". The multilateral system
must engender trust for developing countries sharing the viruses that
it must not be at the expense of sovereign rights and at the expense
of their people's health, she said.
She stressed the need to formulate a new system and to get the system
right. Benefits arising from the use of viruses should be equitably
shared, through a fair, transparent and equitable mechanism as that
is the "moral thing to do".
said that it would be happy to see equitable, transparent arrangements
and benefits to prepare for the pandemic. Nigeria said that the equitable sharing
of virus and of the benefits must be made mandatory for all.
The EU said that the virus must be freely shared in a simple and straightforward
system. The US
said patents were critical to preserve the incentive to develop vaccines.
It could not accept any approaches that undermine intellectual property.
The meeting should not focus on vaccines, benefit sharing and intellectual
property rights, but on preparedness. It said that we must maintain
the GISN. Further, withholding the virus is inconsistent with the spirit
underlying the International Health Regulations.
The EU sought clarity from WHO on Members' obligations to share the
flu virus under the International Health Regulations. The WHO's legal
advisor said, in what he called a preliminary view, "there is no
specific obligation to share the virus as such." However, he added
that the objective of the IHR is to allow a public health response to
the international spread of disease and that the most important WHO
function is dissemination of information, which it cannot do unless
the information is shared and needs to be up to date on the strain of
On 20 November, the meeting also took note of the Director-General's
reports on Identification of Frameworks and Mechanisms for Sharing Benefits
(A/PIP/IGM/2), and Patent Issues related to Influenza viruses and their
During the discussions, Germany
said that under mechanisms to ensure broader access to pandemic vaccine,
it could not accept the possibility for member states to agree in advance
to release a pre-defined quantity of pandemic vaccines from existing
On the meeting's objective to formulate standard terms and conditions
(STC) among parties for sharing viruses and benefits, there was disagreement
about which document should be used as the basis for negotiations. Several
developed countries supported using the IDWG Chair's summary (A/PIP/IGM/4)
as the basis for discussion, but this was objected to by some developing
Four proposals on the STC have been submitted by the developing countries
- Indonesia, Thailand,
the Africa Group, and the Group of the Americas.
presented a brief paper containing principles and elements for virus
and benefit sharing. It wanted these elements to be discussed first
before embarking on an exercise to draw up legal texts of the STC.
Among the principles were recognition of sovereign rights; prior informed
consent; mutually agreed terms and fair and equitable benefit sharing;
the authority to determine access to influenza viruses rests within
the national governmental and subject to national law; benefit sharing
must be concrete, specific and provided to developing countries, especially
affected countries and their geographic vicinities.
Some of the fundamental elements proposed include that access to specimen/virus
must be done through an agreement in the form of a standard Material
Transfer Agreement agreed by member states; and that no entity can acquire
intellectual property rights over the virus, parts thereof and their
submitted a paper proposing that the parties to the STC should be member
states and the WHO. The STC would state to whom WHO can transfer virus
to, the mode through which it would be transferred and the terms of
transfer. It also proposed a global fund, to which member states as
well as manufacturers would contribute. The fund would be used to purchase
vaccines, build capacity and licence technology.
On Wednesday, the African Group submitted a paper in the form of legal
texts comprising the proposed STC. The paper proposes two separate contracts:
first, a standard agreement between the country providing the virus
and the WHO collaborating centres and laboratories when the specimen
is transferred; and second, an agreement between the WHO and the manufacturer
(committing the manufacturer to benefit sharing obligations) when the
seed virus (necessary for vaccine development) is transferred.
The Group of Americas also circulated a document, containing points
agreed during a meeting in Buenos
Aires on 5-6 November 2007. The points are: (1)
the WHO Global Influenza Surveillance Network should continue to be
the main network for influenza risk evaluation and the development of
vaccines, medications and other materials; (2) mechanisms should be
aimed at strengthening the network, by increasing its transparency,
accountability and efficiency; (3) benefits should be distributed in
accordance with public health principles regardless of who supplied
the virus; (4) no country including the country of origin or any other
entity may exercise ownership rights over the samples submitted to the
GISN; (5) the importance of building and strengthening vaccine and drug
production capacity, as well as surveillance and the ability to respond
to influenza in the Americas and elsewhere; (6) need to establish technically
competent WHO CC in developing countries; and (7) importance of defining
GISN third parties, of establishing and specifying requirements and
conditions for submitting samples and of defining their responsibilities.
Following some initial disagreement on how to proceed, the meeting agreed
to discuss principles first followed by the operative paragraphs. Discussions
on principles were divided into several clusters i. e. on benefit sharing,
collective action, sovereign rights, capacity building and technology
transfer, virus sharing, intellectual property rights, oversight mechanisms,
There was a significant disagreement on which cluster to begin discussion
on. Developed countries repeatedly insisted to begin discussion on principles
in relation to benefit sharing while developing countries felt that
discussion should proceed on virus sharing, since logically the entire
process begins with virus sharing. Ultimately, the meeting decided to
first discuss virus sharing principles.
Most of the second day was spent discussing virus sharing principles,
scope of the Standard Terms and Conditions that is to be formulated,
the GISN system itself, (i. e. what it is all about) and the parties
that are to be involved as part of the system. A working group was also
formed to discuss the operational aspects of virus and benefit sharing.
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