[Ip-health] IP-Watch: IP Issues May Spark Debate At World Health Assembly

[Thiru Balasubramaniam]

http://ip-watch.org/weblog/wp-trackback.php?p=3D616

10 May 2007
IP Issues May Spark Debate At World Health Assembly

By Tove Iren S. Gerhardsen

Intellectual property rights issues could play a significant role in
the annual World Health Assembly which begins next week. While not the
most prominent topic for the assembly, IP is expected to arise in
discussions on malaria, avian influenza and in the =93mid-term=94 progress
report of a contested working group on IP and public health.

The 14-23 May assembly, the annual meeting of the 193 members of the
World Health Organization (WHO), may also see debate over developing
countries=92 use of international trade flexibilities to allow
importation of cheaper versions of patented pharmaceuticals, sources
said.

Indonesia will propose amendments to a draft resolution on ownership
and sharing of avian flu virus samples for vaccines to ensure access
for developing countries; there is disagreement about language on
intellectual property rights in a malaria draft resolution; and the
one-year progress report of the IP working group will be presented,
sources said.

A top IP priority of the United States for the assembly will be to
focus on innovation issues. =93Our priority related to IPR issues is to
be sure the WHA recognises the importance of IPR to promote
innovation,=94 a US official told Intellectual Property Watch.

IGWG =93Mid-term=94 Review

The progress update on the WHO Intergovernmental Working Group on
Public Health, Innovation and Intellectual Property (IGWG) will be the
most =93direct=94 IP issue on the draft agenda. The group has been tasked
with drawing up a global strategy and plan of action by May 2008 in
order to provide a medium-term framework based on the recommendation of
a previous WHO commission (WHA59.24). The plan and strategy will deal
with the link between public health, innovation and IP, especially as
they relate to the lack of treatments for neglected diseases.

The report will be presented by the WHO secretariat. A seven-page
document (A60/27) has been provided to member states before the
meeting, and this will be the background document for the agenda item
on the IGWG, a WHO official said.

The report chronologically outlines the activities of the group since
May 2006, and what is planned up to its second and last session,
scheduled for 5-10 November. It says that recently submitted comments
by member states will be incorporated into a revised working document,
which a WHO official has said is expected to be ready in July. The
health assembly is invited to =93note=94 the report.

An annex clusters the countries=92 suggested =93areas for early
implementation,=94 meaning areas in which both developed and developing
countries, donors, companies as well as WHO can start working before
the plan is ready. The submissions were made at the time of a March
hearing on the subject and have not been agreed collectively.

The annex suggests that: Developing countries strengthen their research
programmes; WHO help ensure access to =93compound libraries=94; and that
patenting, licensing, patent pools and flexibilities to international
trade laws are all used in ways that foster research into neglected
diseases. On development, public-private partnerships are encouraged to
strengthen and expand donor deals and be more transparent; and
obligations under trade law to transfer technology to developing
countries are highlighted. WHO is asked to monitor the impact of IP on
health, and members to report their related activities.

Separately, a technical briefing on public health, innovation and IP
will be held on 17 May, WHO said.

Also, some sources indicated that the use by developing countries of
flexibilities in international trade law to import cheaper generic
versions of patented medicines for public health may come up under this
agenda item. Thailand (IPW, Public Health, 22 December 2007), Malaysia
and Brazil (IPW, Public Health, 7 May 2007) are among the countries
having done so.

In a 2 May letter to WHO member governments, M=E9decins Sans Fronti=E8res
(MSF) said, =93WHO should be proactive in giving technical and policy
assistance to countries that want to make use of the flexibilities in
patent law to increase access to existing medicines.=94 It added, =93The
IGWG should also support and further develop proposals for pro-health
management of intellectual property.=94

MSF suggests an immediate action for the IGWG to develop and support =93a
global tuberculosis R&D [research and development] strategy as pilot
activity under a global R&D framework.=94

Debate Expected on Avian Flu

The issue of patents, prices and access to avian influenza treatments
appears to become particularly hot for the assembly.

=93Some member states led by Indonesia will be tabling a new resolution
(EB120.R7) on avian flu specifically on the proper handling and
disposition of viral samples,=94 a developing country official told
Intellectual Property Watch. =93The resolution will ensure the proper
handling of the viral samples that are sent to the WHO.=94

Indonesia recently received attention when it declined to share its
avian flu virus samples with the international system run by WHO out of
fear that it would not get access to highly-priced, patented vaccines
developed based on the samples (IPW, Public Health, 8 March 2007). The
issue has apparently since been resolved, but =93Indonesia is not taking
any chances, hence a plan to introduce this resolution at the WHA,=94 the
source said.

An Indonesian health official told Intellectual Property Watch that
developing countries sharing such samples with the international
community should be ensured equal access to vaccines being developed,
at an affordable price. Indonesia is therefore preparing language from
a declaration and recommendations from two high-level meetings held in
Jakarta 26-28 March. He said the system for virus-sharing that have
been in place for the past 50 years had been an =93unfair mechanism=94 as
developing countries did not benefit from, and have access to, the
vaccines themselves. Indonesia wanted some conditions (in addition to
the =93best practices=94 spelled out in EB120.R7) such as insurance that
the samples would not be used for commercial reasons, he said, adding
that Indonesia hoped for support from developing countries at the
assembly, he said. It appears to be garnering support from a number of
developing countries, according to one source.

The official said information had not been received from the capital
that the government had shared its samples with WHO, but he believed
this was still its intention.

April Meeting Sets WHO Agenda on Avian Flu

Under the item avian and pandemic influenza, a draft resolution
(EB120.R7) as well as summary points from a 25 April Geneva meeting on
avian influenza vaccine stockpiling are expected to be discussed. WHO
also said at the Geneva meeting that it would present the next phase of
the H5N1 plan at the assembly, and Director General Margaret Chan
suggested producing a roadmap for the way forward. She suggested WHO
should take =93concrete steps as a matter of urgency=94 after the assembly.

At the April meeting, the issue of intellectual property rights
received little mention, although the Asian Development Bank pointed
out that instead of providing money for developing countries, resources
should be given to accelerate techniques and one has to =93look at the
question of IP.=94

Six developing countries have been given $2.5 million each by WHO,
United States and Japan to develop a three-step plan boosting
production in developing countries. Technology transfer is part of this
plan, a WHO source said.

The French chair of the meeting told Intellectual Property Watch that
influenza virus had traditionally been =93free of IP,=94 and this was also
true for the avian flu H5N1 virus, which exists in birds. He said
companies could mutate the virus and patent it, but it was risky
business as it was likely to mutate again very quickly.

Malaria and TRIPS

There also is a draft resolution on malaria on the table (EB120.R16),
which contains two proposed wordings on intellectual property rights
for the assembly to consider (IPW, Public Health, 6 February 2007).

At the 22-30 January WHO Executive Board meeting, it was mainly the
United States and Kenya that differed on the language, sources said.
The United States referred to language in an earlier agreed resolution
(WHA57.14), which says member states should consider, when necessary,
adapting national legislation to allow them to use trade law IP
flexibilities. But it did not want to link this directly to proposed
language on access to medicines and technologies, which might encourage
the use of the flexibilities, sources said. =93Kenya wanted a language
that =91urges=92 member states to =91include=92 in their legislation TRIPS =
(WTO
Agreement on Trade-Related Aspects of Intellectual Property Rights)
flexibilities in order to improve access to anti-malarial drugs,
diagnostics and technology,=94 a Kenyan source said.

=93I have had some informal discussions with Kenya about the malaria
resolution, but we have not yet reached a meeting of the minds,=94 the US
official said.

Taiwan Ties Avian Flu to WHO Accession

Another issue related to avian flu is Taiwan=92s effort to gain full
membership at the WHO, separately from China. It currently has observer
status but fears that that will not allow it to address concerns about
avian flu outbreaks. Taiwan issued a compulsory license (for the
production of Roche=92s Tamiflu) in 2005 (valid until 31 December 2007),
which it so far has not used, a source said. Taiwan (as Chinese Taipei)
joined the World Trade Organization as a full member just after China
in 2001.

=93We submitted our application in mid-April, but the WHO decided not to
take care of it by quoting WHA25.1 resolution [regarding changes to the
WHO constitution],=94 a Taiwanese health official told Intellectual
Property Watch. =93However, our application has become the common concern
of permanent missions and other organisations.=94

=93We are not included in the WHO=92s Global Influenza Surveillance
Network, though our Centers for Disease Control, as our National
Influenza Center [NIC] applied before,=94 the official said. CDC Director
Steve Kuo requested WHO to include Taiwan in the network. =93However,=94
the official said, =93the NIC is designated by national health authority,
which by WHO=92s definition is in Beijing.=94 Another related issue is the
implementation of International Health Regulations which will start on
15 June, he said, adding, =93We are afraid of being left out of the
system.=94

Side Events

There are several side events being planned for the assembly. An
International Policy Network-organised event with Knowledge Ecology
International (KEI)=92s James Love and Andrew Farlow of the Sa=EFd Business
School, University of Oxford will be held on 17 May. On 16 May, the
International Federation of Pharmaceutical Manufacturers and
Associations is holding an event to launch a clinical trials portal as
well as a new edition of its book, =93Partnerships to Build Healthier
Societies in the Developing World,=94 it said. Also during the week,
Churches=92 Action for Health and KEI are planning events.

Assembly documents are available at: http://www.who.int/gb/

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