[Ip-health] IP-Watch: Health Assembly Tackles Proposals On Avian Flu Virus Sharing

[Thiru Balasubramaniam]

http://ip-watch.org/weblog/wp-trackback.php?p=3D620

16 May 2007
Health Assembly Tackles Proposals On Avian Flu Virus Sharing


By Tove Iren S. Gerhardsen
Early in the 2007 World Health Assembly, the focus has moved to avian
flu virus sample sharing for the development of treatments and access
by both developed and developing countries. A drafting group started
work on combining various proposals, including new drafts from the
United States and an Indonesia-led group of developing countries.

The 14-23 May assembly is the annual meeting and the decision-making
body of the 193 member states of the World Health Organization (WHO).

Draft resolutions were put forward on 15 May by the United States and a
group of developing countries including Algeria, Brunei, Cuba, Korea,
Indonesia, Iran, Iraq, Laos, Malaysia, Myanmar, Maldives, Peru, Qatar,
Saudi Arabia, Solomon Islands, Sudan and Timor-Leste.

In addition, there is a resolution (EB120.R7) on avian flu from the
22-29 January WHO Executive Board meeting. A number of countries
expressed support for this resolution on 15 May. Draft resolutions
(proposals that may lead to agreements) may be discussed by the
Executive Board meeting and forwarded to the assembly, or may be
introduced at the assembly itself.

None of the three resolutions mention intellectual property rights
directly, but discussions during the day, including a technical
briefing, showed that this was an underlying issue. There was also
agreement that globally, current production capacity far from covers
the potential need.

There have been 306 human cases of bird flu in 12 countries, of which
185 have died, according to WHO sources. More than 50 percent of the
production capacity for treatments is found in Europe, the sources
said. In case of a pandemic, it could take 4 to 6 months to develop a
vaccine, sources said.

Earlier this year, Indonesia refused to share virus samples with
international influenza collaboration centres operated under WHO,
fearing it would not be guaranteed vaccines in return. This led to two
high-level meetings in Jakarta and Geneva respectively (IPW, Public
Health, 8 March 2007).

One developed country source told Intellectual Property Watch that the
member-states-only drafting group would look at all three documents and
consider how they could be combined into one. Some had suggested basing
these discussions on the resolution from the Executive Board meeting,
which the source said was agreed to by members there, but would have to
be adopted by the assembly.

The Proposals

The resolution from the Executive Board focuses on best practices and
international health regulations (=93Avian and pandemic influenza:
developments, response and follow-up, application of the International
Health Regulations (2005), best practices for sharing influenza viruses
and sequence data=94).

The Indonesian draft resolution, =93Responsible practices for sharing
avian influenza viruses and resulting benefits=94 (A60/A/Conf.Paper No.2)
focuses on transparency and =93fair and equitable international
mechanisms=94 for the sharing of diagnostics and treatments developed
from shared viruses.

These =93must be made available at an affordable price and in a timely
manner,=94 it says. It also refers to the Convention on Biological
Diversity (CBD) and says that prior informed consent should be obtained
from the country that provided the virus before (parts of) it is given
to parties outside of the WHO centres. The CBD sets out that states
have sovereign rights to biological material.

Industry is concerned about requirements, such as prior informed
consent, that could slow down the production process in an emergency, a
source said.

The draft resolution also says that the WHO collaborating centres,
=93shall neither claim nor obtain any form of proprietary rights over the
virus provided or any parts thereof.=94 It further raises the need for
transferring technology and know-how to developing countries for
vaccine production, and to come up with mechanisms and guidelines in an
intergovernmental process, to be reported to the Health Assembly in
2008.

The US draft resolution, =93Mechanisms to promote access to influenza
pandemic vaccine for developing countries lacking sufficient influenza
vaccine production=94 (A60/A/Conf.Paper No. 1) says avian flu is both a
human health and global security concern.

The US resolution urges member states to help increase access to
vaccines in developing countries without production capacity through
financial and technical support, but also requires =93unrestricted
sharing=94 of viruses with WHO =93in a timely and consistent manner.=94 It
requests the WHO director general to =93design mechanisms=94 to help
developing countries, in particular, with access.

Finally, the draft resolution from the US proposes an =93ad hoc WHO
working group=94 that can advise member states and the director general
on how big the vaccine stockpile should be, how it should be used and
how access to safe vaccines may be promoted. The group should report in
a year=92s time.

The Link to IP

A key issue has been that some of the viruses that have been provided
to any of the WHO labs have been used for products that have been
patented, to which Indonesia protested out of concern for access.

Anyone who wishes to develop an avian flu vaccine may do so as the
virus itself is not patented, but the product could be, a source said.
There are therefore patent concerns, particularly with regard to access
to existing vaccines. India said in a committee meeting that in case of
emergency, countries should be able to produce vaccines themselves
regardless of patents, even if compulsory licensing becomes mandatory.

David Heymann, WHO assistant director general for communicable
diseases, said at the technical briefing that there had been =93some IP
sought=94 on certain parts of the vaccines developed based on virus
samples shared with the WHO collaboration centres. He said it was
necessary that all countries benefit from this scheme, which was a
=93ship being built as we sail.=94

Suwit Wibulpolprasert, senior advisor on health economics at Thailand=92s
Ministry of Public Health, said that a system of sharing that belongs
to everyone was needed, but warned about it becoming a debate of
extremes in which one side referred to =93IP piracy=94 and the other to
=93biopiracy.=94

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.

---------------------------------
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@keionline.org