[Ip-health] Key issues unresolved at WHO meeting on influenza virus sharing

[Sangeeta]

Key issues unresolved at WHO meeting on influenza virus sharing
Published in SUNS #6613 dated 18 December 2008

Geneva, 17 Dec (Sangeeta Shashikant) -- A meeting of member states of the
World Health Organisation on the sharing of influenza viruses and access to
vaccines and other benefits could not resolve some major issues between
developed and developing countries. The meeting will resume during the May
2009 World Health Assembly.

The Intergovernmental Meeting of Pandemic Influenza Preparedness: Sharing of
Influenza Viruses and Access to Vaccines and other Benefits (IGM) met for a
week in Geneva starting 8 December, tasked with establishing a framework for
the sharing of the viruses and the sharing of benefits such as access to
vaccines.

The meeting saw the continuation of divergences of views between developing
countries that are largely providers of the biological materials linked to
the flu viruses, and developed countries that have the laboratories and
manufacturers that receive the biological materials and use these for
producing vaccines and other medical products, and that are supposed to
provide benefits in return for the viruses.

Several issues remained unresolved at the end of the meeting. These include
which parties are entitled to receive the biological materials and their
roles, responsibilities and benefit sharing obligations; the scope of
materials that is to be shared; the issue of sovereign rights of providers
of biological materials; whether the recipients of biological materials have
any ownership rights over the materials and whether they should be allowed
to claim intellectual property rights over the biological materials or over
the products and processes developed using the biological materials.

The framework being developed by the IGM process is to govern the sharing of
viruses, the roles and responsibilities of laboratories receiving the
viruses (i. e. H5 Reference laboratories, WHO Collaborating Centres,
Essential Regulatory laboratories) as well as that of third parties such as
manufacturers or researchers (as agreed by Members) that receive the
biological materials shared through the framework. A standard material
transfer agreement, to be developed by the IGM, is to be signed by the
providing and receiving parties.

As the issues could not be settled at last week's meeting, the IGM suspended
its work and will meet again during the 2009 World Health Assembly. Informal
consultations are expected before that in an effort to bridge differences,
and in particular to address issues that are "political" in nature.
During the meeting, there had been little discussion on some core issues
such as the parties to the framework, the scope of their tasks and the scope
of materials that will be shared. Some members attempted to skirt round the
issues instead of addressing them in detail despite these issues being
raised by other countries on numerous occasions.

Curiously, there was also very little deliberation of the responsibilities
of the vaccine and pharmaceutical manufacturers (most of which are based in
developed countries), although they have the most to gain from the virus
sharing process. Every time the issue of the role of manufacturers was
brought up, it was quickly passed over by Jane Halton of Australia, who is
the Chair of the IGM.

Some developing country delegates thought this was intentional, while other
delegates felt that there was an attempt to rush through the documents
before the IGM to try and obtain consensus on as many paragraphs as possible
rather than have a general understanding of the various elements of the
framework.

The frustration felt over the process led delegations from the South East
Asian region (SEARO) to declare at the end of the meeting that "nothing is
agreed until everything is agreed".

The meeting however did accept the principle that "Member States have a
commitment to share on an equal footing H5N1 and other influenza viruses of
human pandemic potential and the benefits, considering these as equally
important parts of the collective action for global public health."

This principle was accepted after India on behalf of the SEARO pronounced
its perception that the focus is toward consolidating virus sharing, while
the issues of benefit was being relegated to realm of "the vague and
obscure". India added that for this framework to be purposeful, there needs
to be clarity how the issue of virus and benefit sharing is to be
constituted.

India also said that if only virus sharing is obligatory then nothing much
remains to be discussed. It added that virus sharing which has been in place
for 60 years does not to our understanding deliver global public health
protection in times of a pandemic. It also stated SEARO's belief that global
public health protection can easily be achieved when virus sharing and
benefit sharing are treated equally and on the same footing.

At the meeting, the developed countries pushed developing countries for a
commitment to share viruses, but their own commitment (and the commitment of
the entities in their countries that benefit from the use of the virus) to
share the benefits was vague and far from being concrete in the negotiations
on the text.

Several developing country delegates at the meeting noted privately that
unless the benefits are concretized and effectively operationalised, the
outcome is unlikely to be successful.
A decision adopted at the end of the IGM mandated that the meeting resume
during the WHA and acknowledged the need for informal consultations among
interested Member States and relevant regional economic integration
organizations in the inter-sessional period in order to find ways and means
to resolve the remaining issues.

The IGM requested the Director General of WHO "taking into account the
revised IGM text, and if necessary with the advice of the Advisory Group",
to:

-further  develop the traceability mechanism;
- prepare  the detailed terms of reference of WHO Collaborating Centres on
Influenza, the  WHO H5 Reference Laboratories, Essential Regulatory
Laboratories, and the  National Influenza Centres, following the guiding
principles included the IGM  text;
-prepare  a revised version of the technical part of the SMTA, following the
agreed  principles of the IGM text;
*
*
* prepare  a report identifying the needs and priorities for each of the
benefits listed  in Section 6 of the IGM text, in particular concerning the
vaccine stockpile,  as well as options for their financing.

The first day of the meeting agreed to accept text prepared by Halton as the
basis of work. The Chair's text contains sections on principles,
definitions, scope, objectives, on virus sharing, on benefit sharing and
annexes containing a Standard Material Transfer Agreement (SMTA) and the
Terms of References of the various laboratories that are to be receiving the
biological materials.

In the first day the plenary discussed sections on principles, definitions,
scope, objectives. Subsequently two working groups were created, one dealing
with issues of governance and review as well as the TORs, and another
dealing with the rest of the issues in the Chair's text.

One of the main issues raised during discussions was whether there was an
obligation under the International Health Regulations 2005 (IHR) to share
viruses.

The WHO's legal counsel clarified that the IHR did not require the sharing
of viruses but that there was an obligation to share information, adding
that the obligation of states have to be seen in light of the object and
purpose of the IHR which is to prevent the international spread of disease.

[Some experts present at the meeting were of the view that the legal counsel
went a little further in its interpretation of the IHR as it does not have
authority to provide such an interpretation since it is clear from the IHR
that there is no obligation to share viruses and where there is a dispute
pertaining to the interpretation of the IHR, the matter can be brought to
arbitration by the parties in dispute.]
The meeting saw developed countries, in particular the US, Japan and the EU,
being very keen to impute some obligation to share biological materials
under the IHR.

The US also sought the removal of any mention of the sovereign rights of
countries over their biological resources from the section on principles and
objected to language that made reference to the Convention on Biological
Diversity.

France on behalf of the EU also on one occasion (responding to a developing
country delegate that asserted sovereign rights and the right to fair and
equitable sharing of benefits arising from the use of the viruses) claimed
that it did not consider viruses to be a natural resource which is covered
under the CBD.

The US, Japan and the EU also attempted, albeit unsuccessfully, to de-link
virus sharing and benefit sharing by removing any language that spoke of
benefits "arising" or "resulting" from the use of the viruses and they
objected to any reference to "prior informed consent".

According to some delegates present, this attempt was so that the framework
on virus and benefit sharing does not set a precedent for other diseases.

Brazil stressed the inclusion of the principle that the framework and the
CBD should be mutually supportive and nothing in this framework shall be
interpreted as implying in any way a change in the rights and obligations of
the contracting parties under the CBD.

An acute shortcoming of the IGM was that it discussed virus sharing and the
SMTA, without actually taking the time to adequately defining the parties
involved in the framework or the scope of what was being shared.

This led an Indian delegate to exclaim near to the close of the meeting that
"We don't know what we are sharing and with whom we are sharing".

Several countries had repeatedly requested for a better understanding of the
parties involved, which was persistently ignored by others throughout the
IGM.

Indonesia for example repeatedly mentioned that it was not aware of the
parties involved in the virus sharing process while Thailand also made a
request for "a diagram showing movement of materials in the current system"
as it would be "useful for further deliberations".

US perplexed many participants at the meeting when it said it was not
appropriate to ask the DG to provide information on the parties. Some other
countries also mentioned that the issue of parties was a "political issue".

The US response indicates an unwillingness to discuss which recipients would
be receiving the biological materials. This needs to be known in order to
establish governance over the movement of biological materials received from
one party to another party.

This issue is crucial as it would have illuminated clearly to which
laboratories and manufacturers transfers of biological materials are
allowed, and the parties to whom the materials cannot be transferred to.

Halton, the Chair of the IGM, did not insist on making this issue clear from
the beginning, in particular prior to starting the discussions on the SMTA.

Halton also rushed past the definition section which would have clearly
identified not only the parties but also the type of biological materials
being transferred from one party to another party.

The Chair's text contains an extensive definition of "PIP biological
materials", which includes the viruses shared with the system and the parts
thereof i. e. the sequences, peptides, etc.

However, when the meeting came to the definition section of the text, Halton
said that many in the meeting room would not be able to understand the
scientific definitions and so it should be left to the technical persons
(presumably referring to the participants from the WHO Collaborating
Centres, Essential Regulatory Laboratories and the H5 Reference laboratory)
to do the defining.

The definition of "PIP biological materials" is most crucial as it covers
the subject matter that will be governed by the framework including the
SMTA. Any subject matter not a part of "PIP biological materials" definition
such as antibodies, will not be regulated by the framework.

The US proposed a limited definition to replace the definition in the
Chair's text that excluded mention of any parts of the viruses that were
being shared and focussed on the clinical specimen, the influenza virus
isolate, high growth reassortant viruses and candidate vaccine viruses
generated from using the influenza virus isolate. Japan and Canada were also
in favour of a very limited definition.

Thailand's request to know exactly the kind of material that was transferred
was from one laboratory to another laboratory was ignored.

Another issue that was not sufficiently addressed was the Terms of Reference
(TOR) of the various recipients receiving the PIP biological materials. On
this the key issues are the TORs for the WHO Collaborating Centres, H5
Reference Laboratories, the National Influenza Centres of the Essential
Regulatory Laboratories (ERL) and the manufacturers.

This issue was repeatedly raised by developing countries such as Indonesia
and Thailand. However there was some hesitance on having any TOR for the
ERLs and significant resistance against having any TORs for the
manufacturers.
The US strongly objected when Indonesia proposed the inclusion in the SMTA
that material shared with the manufacturers should only be used for the
purposes of developing and producing vaccines, pharmaceuticals and
diagnostics.

The US responded saying that this was not acceptable because it would
prevent manufacturers from obtaining cures for other diseases, for instance
cancer.

The US response brought a strong reaction from several developing countries
that made it clear that they were only sharing their biological materials
for purposes of pandemic preparedness and nothing more.

Nigeria added that other uses of these materials can be done only with the
informed consent of the originating laboratory.

The IGM chair herself, seemed hesitant to set TORs for manufacturer stating
that this is a document agreed by member states and thus TORs cannot be set
for anybody who is not a party.

[Vaccine, pharmaceutical and diagnostic manufacturers are the main
beneficiaries of the virus sharing framework, and would have to follow what
has been agreed in the framework through the SMTA].

Another sticky point was the method of execution of the SMTA. The US, Japan
and EU preferred "self-executed" SMTAs for transfer into, within and out of
the WHO network of laboratories; and when biological materials are
transferred out of the WHO network laboratories to manufacturers and
researchers, the receiving entities will agree in writing to comply with the
SMTA.

Many developing countries could not agree to such a mode of execution
particularly since its legal validity is questionable.

Instead, Indonesia proposed that the "SMTA will be executed, preferably in
electronic form, and shall be duly completed and signed by institutions,
organisations, and entities providing and receiving PIP biological
materials".

African countries proposed that the execution should also be allowed to be
done by way of fax. Nigeria proposed completing the SMTA using an
implementing letter.

The approach proposed by Indonesia and the African countries could not be
accepted by the developed countries, although signing a MTA is standard
procedure in developed countries when biological materials are transferred.+