[A2k] WHO meeting on avian flu virus sharing ends with no clear outcomes

[Sangeeta]

No clear outcomes in WHO meeting on avian flu virus sharing

SUNS #6311 Friday 10 August 2007

Penang, 9 Aug (Sangeeta Shashikant) -- A meeting organized by the World
Health Organisation to review the terms and conditions and oversight
mechanism for the sharing of avian flu viruses was held last week in
Singapore, and it ended without a clear agreed outcome.

The meeting of an interdisciplinary working group (IDWG) set up by the World
Health Assembly (WHA) met on 31 July to 4 August in an attempt to draft
revised terms of reference for WHO-linked laboratories and draft standard
terms for sharing viruses between originating countries, WHO-designated
laboratories and third parties.

Twenty-four member states of the WHO, chosen from the various WHO regions,
and representatives of WHO- designated laboratories were invited to take
part in the meeting.

The selected countries were Cameroon, Ghana, Nigeria, South Africa, Brazil,
Canada, Chile, USA, Bangladesh, India, Indonesia, Thailand, France, Germany,
Turkey, United Kingdom, Egypt, Iran, Morocco, Tunisia, Australia, China,
Japan and Vietnam.

(The WHO-designated laboratories are national institutions designated by the
WHO as "collaborating centres" or "H5 reference laboratories". The centres
are based in the US, Australia, UK and Japan, while the H5 reference
laboratories comprise the collaborating centres and laboratories in US, Hong
Kong, France, and a US naval medical unit in Egypt.)

The IDWG is the result of a resolution at the WHA last May arising from
criticisms that avian flu viruses contributed by originating countries (so
far, mainly the developing countries) had been commercialized without their
knowledge or permission, and from demands that the present WHO-organised
system for distributing influenza viruses (the Global Influenza Surveillance
Network) be reformed.

Many developing countries had also sought the linkage between the
contribution of viruses and the sharing of benefits arising from the use of
the viruses (such as vaccines) and other benefits (such as technology
transfer to enable local vaccine production).

A draft resolution by over 20 countries, coordinated by Indonesia, at the
WHA, reflected the view that the current practices of the WHO Global
Influenza Surveillance Network (GISN) do not bring about fair results and
that these practices need to be reformed with mechanisms for fairly sharing
the benefits resulting from the use of the viruses.

The WHA adopted a resolution setting up the IDWG with a mandate to revise
the terms of reference of the WHO Collaborating Centres, H5 Reference
Laboratories and other national influenza centres; to formulate draft
standard terms and conditions for sharing of viruses between originating
countries and WHO Collaborating Centres, the latter and third parties; to
devise oversight mechanisms; and to review all other relevant documents.

The resolution also agreed on an inter-governmental meeting (IGM) to
consider the IDWG's report as well as consider a report by the WHO
Director-General on a benefit-sharing framework, vaccine stockpiling and
equitable distribution of vaccines, and a report on patents on viruses and
their parts.

The inter-governmental meeting, to which all member states are to be invited
as participants, is expected to be held in November.

According to some delegates at the Singapore meeting, the discussions were
difficult due to the complexity of the issues, the technicalities involved
in formulating terms and conditions (for contribution of viruses and sharing
of benefits) and above all, the differences in views, particularly as
between several developing and developed countries.

The short notice given to countries about the meeting and the short duration
of the meeting itself made it difficult to complete discussions on the many
issues on the table.

Among the difficult issues were rights of originating countries over the
viruses and their use, the role of the WHO, several intellectual property
issues, the sharing of benefits, and the terms of reference and conditions
for institutions receiving the viruses and products containing parts of the
viruses.

The Chair of the meeting, Dr. Viroj Tangcharoensathien, Director of
International Health Policy Program, Ministry of Public Health, Thailand,
presented a paper containing draft Standard Terms and Conditions (STC) for
discussion on the third day of the meeting.

On the final day, the Chair tabled several documents, including an "Informal
Note" on a summary and conclusions of the meeting, a draft text of standard
terms and conditions (STC) for the transfer and use of biological materials
relating to the GISN, and a document on a list of proposed benefits.

According to several delegates, the meeting concluded without an agreed
outcome, with some delegates disagreeing with significant parts of the
content of the "Informal note" containing final summary of the discussions,
while others insisted that the STC text and other documents presented be all
placed in "brackets" i. e. denoting that they were not agreed on by the
participants.

Several delegates were not clear as to the status of the documents. It was
their understanding that the Chair's summary and conclusions (and possibly
other documents) would be revised and sent to participants for their
comments.

"We hope it is made clear that the documents were prepared by the Chair and
do not reflect the joint views of the participants of the meeting," said one
developing-country delegate after the meeting.

Some delegates were also of the view that the issues under discussion were
extremely complex and technical, requiring knowledge not only of health and
scientific issues, but also an understanding of legal texts and agreements.

Documents put forward for negotiations, let alone as conclusions, had to be
carefully scrutinized by experts in the capitals, and the short duration of
the meeting did not enable this to take place.

The delegates were also worried that future negotiations on such complicated
issues may not conclude in just one inter-governmental meeting, especially
since so many countries will be involved.

Among the most detailed of the papers submitted at the meeting was a set of
documents prepared by Indonesia, which has been one of the leading countries
involved in promoting the issue of linking virus contribution with the
sharing of benefits. The paper was given to the Chair and the Secretariat.

The Indonesian paper proposed binding and mandatory commitments on benefit
sharing as an exchange for the contributing of bird flu viruses.

It proposed that WHO-designated laboratories (which are based in developed
countries) should empower and build the capacity of the laboratories from
the countries contributing the viruses. The rationale for this is that the
best way to deal with a potential pandemic is to develop the capacity of
countries (such as Indonesia, Vietnam, China etc) that are most affected by
the bird flu, rather than their having to rely on the foreign-based
laboratories.

Indonesia also proposed that vaccine manufacturers that wish to obtain the
influenza candidate vaccine virus (for vaccine production and development)
should be bound to return multilateral benefits to all developing and least
developed countries.

Among the proposals are that the vaccine manufacturers that wish to gain
from the GISN should: (1) provide non-exclusive royalty-free access to
IP-protected technology to domestic manufacturers from developing countries
on request; (2) prioritise the supply of vaccines to countries in need at an
affordable price, i. e. at a price no higher than cost per unit plus X% (5%)
for developing countries and at "no profit no loss" for least developed
countries; (3) provide 60% of the production of every batch of vaccines free
of charge to the WHO international stockpile of vaccines, in the event of a
pandemic.

The paper also called for access to and transfer of technology and know-how
to manufacturers from developing and least developed countries.

The Indonesian paper also proposed to keep all influenza viruses contributed
by providing countries and all its components including its genes,
sequences, and products/substances derived from the influenza viruses (such
as diagnostics) or developed from the influenza viruses (such as influenza
candidate vaccine virus or vaccines) free of any IP claims.

The paper is in the format of two agreements containing Standard Terms and
Conditions (STC) for the contribution of the influenza viruses and sharing
of benefits. The first is between the country contributing the virus and the
WHO Collaborating Centre/H5 Reference Laboratory which would use the virus
for risk assessment and development of candidate vaccine virus.

The second is between the WHO Collaborating Centres and the vaccine
manufacturers and is about the transfer of Influenza Candidate Vaccine Virus
from the former to the latter for vaccine development and production.

Both STCs are accompanied by an Implementing Letter, which has to be signed
by the Provider and the Recipient when the transfer of the Influenza viruses
or candidate vaccine virus is made. The Implementing Letter certifies that
the parties accept and agree to the Standard Terms and Conditions
unmodified.

The agreements are aimed at ensuring that the recipients are bound, in
particular, to share the benefits arising from the use of the influenza
viruses and/or candidate vaccine virus. Where the recipient or any party to
the agreement fails to fulfill its obligation, the agreement can be
terminated. There is also provision for a dispute settlement between
parties.

In the first STC, the paper proposes that the material contributed only be
used for the research purposes specified in the Terms of Reference (which is
also to be revised) of the WHO Collaborating Centre and H5 Reference
Laboratory.

Material is defined as "Original Material, isolated viruses, progeny and all
of their genetic and other components (modified or unmodified), including
genes, sequences (and parts thereof) and polynucleotides as well as the
polypeptides they encode . It also includes related information."

According to legal experts, it is important to have specific definitions, as
there are an increasing number of patent claims applied for by the private
sector on little bits and pieces of the viruses, such as pieces of protein.

Research is defined as "non-commercial, scientific use of the Material for
global public health purposes as described" in the Terms of Reference.

The first STC proposed by Indonesia also prevents a WHO Collaborating
Centre/H5 Reference Laboratory that received Material (as defined above),
from distributing or disclosing it to third parties without the consent of
the Providing Country as well as on condition that a separate STC is signed
wherein the subsequent recipient agrees to abide by the Standard Terms and
Conditions.

It also proposed that the Recipient (the WHO Collaborating Centre/H5
Reference Laboratory), the Recipient Scientist and persons working under the
Recipient Scientist's direction or his/her direct supervision "shall not
seek or assert intellectual property rights or other rights over the
Material or on any derived substances, products or any other substances,
processes, products including vaccines, anti-virals, diagnostics developed
through the use of or that contain/incorporate the Material."

This proposed provision is a response to the increasing number of patent
claims on the materials already supplied by providing countries. The paper
also wants to keep any products/substances that are derived from the
Material or that use the Material free from any IP claims.

The paper also proposes that all gene sequences (of the virus) should be
placed in databases that are to be governed by terms and conditions, to
ensure that misappropriation, such as patenting of the sequences does not
take place. The terms and conditions will also ensure that fair and
equitable benefit sharing arising from the use of the sequences will be
shared with the developing countries.

In relation to benefit sharing, Indonesia proposes that the Recipient (in
this case, the WHO Collaborating Centre/H5 Reference laboratory) "empower
and build capacity" of the country providing the virus, in particular, by
conducting the research in the facilities of the Provider Country. The
Recipient should also allow scientists from the provider countries to
participate in its activities.

Regarding the second STC (on the transfer of influenza Candidate Vaccine
Virus developed by the WHO Collaborating Centres, using the viruses provided
by the Provider Country, to vaccine manufacturers), Indonesia proposed that
the Candidate Vaccine Virus only be used for vaccine development and
production.

Key elements of the second STC are that the vaccine manufacturer: (1) agrees
to keep Material Received in confidence ensuring that any part of it is not
transferred, distributed or disclosed to any third party; and (2) that the
manufacturer will not seek or assert IPRs or other rights on Material
Received (i. e. candidate influenza vaccine virus) or on any derived
substances, products or any other substances, processes, products including
vaccines, developed through the use of or that contains/incorporates the
Material Received (i. e. candidate influenza vaccine virus).

The Indonesia paper also proposed that the vaccine manufacturers agree to
the following multilateral benefits:

(I) to grant on request, a non-exclusive, royalty-free license to any
domestic influenza vaccine manufacturer from developing and least developed
countries to use its intellectual property and other protected substances,
products (including technology), know-how, information used in the process
of influenza vaccine development and production;

(ii) on request, to allow access to and transfer of, its technology and
related know-how particularly to domestic influenza vaccine manufacturers
from developing and least developed countries especially to the Providing
Country and other countries in need;

(iii) to set aside X% of vaccines for developing and least developed
countries especially to those in need and particularly during the pandemic
period. These vaccines will be made available at an affordable price for
developing countries and least developed countries. The manufacturer, in
pricing its products, should consider "affordable price" for developing
countries as a price no higher than cost per unit + X% (e. g. 5%), while for
least developed countries, as "no profit no loss", particularly during the
pandemic period;

(iv) to transfer at least 60% of every production batch of vaccines
developed free of charge to the WHO international stockpile prior to
commercialization in the event of a pandemic;

(v) to transfer at least 40% of every production batch of vaccines developed
free of charge to the WHO international stockpile prior to commercialization
during the pre-pandemic period.

Some Indonesian delegates expressed disappointment that many of the paper's
important elements, such as its proposed format, elements on IPRs and
mandatory benefit sharing elements, were either not featured in the text on
STCs presented by the Chair or were featured in a manner that diluted
Indonesia's proposed elements.

In fact, the delegates mentioned that despite Indonesia's attempts to insert
language from Indonesia's elements into the STC text presented by the Chair,
the text failed to reflect these elements.

The controversy over the sharing of avian flu viruses arose when Indonesia
earlier this year announced that it would slow down its contribution of
influenza viruses because the vaccines (which contain part of the viruses)
are too costly for developing countries.

The capacity to do adequate risk assessment of the H5N1 influenza virus is
primarily with the WHO-designated laboratories which are based or owned by
developed countries.

There is a limited supply of vaccines globally, and production is
concentrated in 9 industrialized countries. Many developed countries have
already booked supplies of vaccines with manufacturers, in the event of a
pandemic, but developing countries are unable to afford to do so.

According to WHO data, the global vaccine production capacity is only 350
million doses, which could rise to 500 million doses at full capacity. As
two doses may be needed a year per person, the global vaccine output would
not be enough for the world population in the event of an avian flu
pandemic.

Even with technological advances, in 2008-9, flu vaccine production would be
at most 2.3 billion doses a year, "still several billion doses short of the
expected demand if there were to be a pandemic," said a WHO report.

Developing countries have also been anxious about an increasing number of
patent claims by the private sector (and even from a WHO-designated
laboratory) on many of the viruses and its genes and sequences.

Developing countries, especially those which have already suffered human
deaths from the avian flu, are worried that in the event of a pandemic, the
limited supply of vaccines are already reserved for developed countries, and
little of it may trickle to the developing countries.

They are therefore looking towards a global framework which will better
ensure the supply of affordable vaccines to countries on the basis of need,
and that transfers vaccine production technology to developing countries. +