[Ip-health] IP Watch: Last-Minute Progress Made On Pandemic Flu; More Still To Come

[Sangeeta]

Intellectual Property Watch

15 December 2008

Last-Minute Progress Made On Pandemic Flu; More Still To Come

By Kaitlin Mara
Significant strides were made at last week=B9s World Health Organization
meeting on pandemic influenza preparedness, as assembled delegates searched
for - and found - a way to satisfy member states=B9 differing views on the
need for access to viruses and related biological materials and the need fo=
r
access to vaccines and other benefits. Yet still-contentious issues -
including intellectual property rights and definitions - remain unresolved,
with delegates hoping informal intersessional work will facilitate the
search for consensus when the meeting resumes next May.

The compromise text found on virus and benefit sharing reads: =B3Recognise
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.=B2

The drafting of this language was seen as a key success of the 8-13 Decembe=
r
WHO Intergovernmental Meeting on Pandemic Influenza Preparedness (IGM).

Earlier versions of the phrasing had involved debates over =B3voluntary=B2
versus =B3mandatory=B2 frameworks, and had not been able to bring consensus=
. But
informal discussions between key member states - mainly Indonesia and the
United States - produced mutually acceptable language that was widely haile=
d
as one of the key steps forward in this meeting.

The connection between virus and benefit sharing had been a =B3bone of
contention=B2 between the two states, said Abdulsalam Nasidi, director of
public health in Nigeria.

The commitment language was =B3a breakthrough,=B2 said another delegate. Bu=
t
intellectual property rights issues are =B3still pending,=B2 the delegate s=
aid,
and will be difficult as the positions on them represent two opposite
visions.

Intellectual property is =B3another tough issue,=B2 said Widjaja Lukito, ad=
visor
to the Indonesian minister on health and public policy, one that was =B3too
big=B2 to get into at this meeting. But he added that achieving benefit
sharing was an initial priority and finding compromise in that regard
represented significant progress.

This meeting essentially =B3avoided [the IP issues] in recognition of how
contentious they are,=B2 said a developed country delegate. But the issue w=
ill
have to be addressed in a standard material transfer agreement for the
movement of biological materials, a key outcome of the IGM that has yet to
be finalised, the delegate added.

It was decided in final plenary to suspend the IGM and reconvene it in
connection with the next World Health Assembly, currently scheduled for May
2009. The meeting=B9s concluding progress report, available here [pdf], not=
es
that the IGM as well as two working groups made progress on the chair=B9s t=
ext
[pdf], which is a draft pandemic influenza preparedness framework for the
sharing of influenza viruses and access to vaccines and other benefits. The
group also nearly finalised a set of guiding principles for the framework,
chief among which was the commitment to share viruses and benefits.

In the meantime, the body asked the director general to undertake several
technical measures to prepare for the resumed session, including work on
further developing a mechanism for virus tracing, the preparation of terms
of reference for the network of WHO Collaborating Centers on Influenza, the
WHO H5 Reference Laboratories, Essential Regulatory Laboratories and
National Influenza Centers; the preparation of a revised version of the
standard material transfer agreement=B9s technical section, and to prepare =
a
report identifying needs and priorities - including financing options - for
benefits proposed in the pandemic influenza preparedness (PIP) framework
text.

Intellectual Property Issues Still On Table

The key IP issues for member states relate to what material may be patented
- ie, whole viruses, parts of viruses, or technologies and other products
that could be developed from those viruses or parts - and over what benefit
a source country or a researcher can derive from ownership, meeting Chair
Jane Halton of Australia reported to assembled delegates during a plenary o=
n
the morning of 12 December.

There are technicalities that still need to be clarified before drafting th=
e
language on intellectual property will be possible, she added.

=B3These are such core issues,=B2 said a US delegate during the plenary ses=
sion
=B3there are questions as to whether or not this is even the correct forum =
for
[intellectual property issues.=B2

However, a Brazilian delegate asserted that =B3this is the proper forum,=B2
reminding the plenary that a Global Strategy on Public Health, Innovation
and Intellectual Property had been approved earlier this year, which change=
d
the mandate of what the WHO can discuss. Further, the delegate said, =B3Bra=
zil
maintains the position of talking about anything related to public health a=
t
the WHO.=B2

Perhaps, said Nasidi after the final plenary, it could be that =B3IP is not
the most important issue.=B2 If it could be agreed that vaccine manufacture=
rs
would grant free licences to all countries able to produce vaccines,
especially in the event of a pandemic, and in order to save lives, then thi=
s
allows public health to be a priority without the need to contest IP
ownership.

Standard Material Transfers, Definitions

A delegate from a major developing country cautioned after the end of the
meeting on 13 December not to be =B3over-optimistic=B2 as despite good work
being done, challenges remain. In particular, the delegate said, there is
the issue of making the agreed framework applicable to those outside the WH=
O
network of institutions and research centres that might receive PIP
biological materials. This would require a mechanism being built into the
standard material transfer agreement (SMTA), which is not yet finalised.

Part of the difficulty in settling the SMTA is that an agreed upon
definition of the =B3PIP biological materials=B2 it will cover has yet to b=
e
found. The United States is pushing for a narrow definition of such
materials, one that, among other things, excludes virus proteins and other
parts of the virus, gene sequencing information, cells and cell parts, and
antibodies and proteins derived from the virus in favour of a definition
focussed on =B3wild type=B2 influenza viruses and virus isolates (IPW, WHO,=
 11
December 2008).

There was also discussion over whether institutions, organisations and
entities providing or receiving biological materials through the framework
could seek to claim IP rights over those materials. The US said in plenary
it wants to ensure the SMTA will not affect =B3obligations or restrictions
that arise from=B2 IP rights, and Brazil intervened to say that it wanted
assurance that IP rights will not be claimed over biological materials
shared in the system.

Nigeria said it could accept IP if royalty-free licences are available to
developing countries =B3at all times=8A to use products and processes devel=
oped
from=8A biological materials=B2 shared through the framework.

Kaitlin Mara may be reached at kmara@ip-watch.ch.