[A2k] WHO Meet discusses proposals to reform WHO's influenza surveillance system

[Sangeeta]

WHO: Meet discusses proposals to reform WHO's influenza surveillance system

SUNS #6372 Friday 23 November 2007

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 developing countries.

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 it operates.

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".

Indonesia 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.

Indonesia 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.

Brazil 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. Canada proposed 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 GISN.

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 bank.

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.

Indonesia warned 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.

However, Indonesia 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 is inevitable".

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".

China 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 the virus.

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
Genes (A/PIP/IGM/3).

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 purchase contracts.

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
countries.

Four proposals on the STC have been submitted by the developing countries -
Indonesia, Thailand, the Africa Group, and the Group of the Americas.

Indonesia 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
derivatives, etc.

Thailand 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,
and financing.

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. +