[Ip-health] WHO Kicks Off Talks On Flu Pandemic, Benefits, Access To Vaccines

[Thiru Balasubramaniam]

http://ip-watch.org/weblog/wp-trackback.php?p=3D832

21 November 2007
WHO Kicks Off Talks On Flu Pandemic, Benefits, Access To Vaccines

Posted by William New @ 2:34 am
  Link This Article   Leave a Comment   Print

By William New
The politically explosive issue of ensuring everyone benefits from
vaccines in the event of an influenza pandemic is the subject of a
negotiation underway at the World Health Organization this week. The
work of the member governments calls into question a longstanding WHO
system for global sharing of disease strains, and involves questions
of limitations on access from patents imposed on vaccines, in some
cases developed from flu strains shared under the WHO system.

The WHO Intergovernmental Meeting on Pandemic Influenza Preparedness:
sharing of influenza viruses and access to vaccines and other benefits
is being held from 20 to 23 November. The effort was mandated by the
May World Health Assembly. Documents and background for the meeting is
at http://www.who.int/gb/pip.

=93We must never lose sight of what a pandemic can mean under the unique
conditions of the 21st century,=94 WHO Director General Margaret Chan
told the meeting. She said pandemic are recurring and that nations
must prepare themselves for situations where up to 25 percent of the
workforce is incapacitated. There would be a =93meltdown=94 of basic
services and a slowdown of economic activity.

=93For WHO, the biggest issue is the threat that an influenza pandemic
poses for global health security,=94 Chan said. =93Vulnerability is
universal. A pandemic will, by its very nature, reach every corner of
the earth, and it will do so within a matter of months. This shared
vulnerability calls for shared responsibility, and collective action
to fulfil that responsibility. In terms of the risk of disease, we
really are all in the same boat.=94

Under the Global Influenza Surveillance Network (GISN), countries are
expected to send H5N1 virus strains from avian flu victims to WHO-
operated regional collaboration centres. But this mechanism has been
called into question by some developing countries, who suggest it may
not be fair to them in case of a crisis.

=93In term of preparedness, access to vaccines is almost certainly the
greatest concern in countries that lack their own manufacturing
capacity,=94 Chan said. She said the surveillance network was created in
1947 to assess risks through analysis of shared viruses in order to
avoid another devastating global influenza pandemic. She said the
current process is aimed addressing weaknesses identified in that
system and that it is unique that the threats are already known,
giving time to prepare.

Countries already have begun developing pandemic preparedness plans,
she said, such as Uganda, which used its plan to stop dead an August
outbreak of Marburg hemorrhagic fever.

Meeting Labours at Outset

The negotiating meeting, chaired by Jane Halton, who is secretary of
the Australian Health and Ageing Department, spent much of the first
day on procedural matters, trying to establish a base document from
which to work and laying the groundwork for debates to come.

Issues under consideration include benefit sharing, virus sharing,
collective action, sovereign rights, capacity building, intellectual
property, oversight mechanism, technology transfer, transparency and
accountability. The focus turned early to benefit sharing and
principles and objectives.

The meeting took note of an expert report commissioned by the WHO
secretariat on patent issues related to influenza viruses and their
genes. The report, which sought to be neutral, described the current
situation, where there has been a =93rapid, recent increase in patenting
activity=94 relating to avian flu, both in the context of vaccines but
also in diagnosis and treatment.

Several possibilities were explored for a starting document. Some
sought to discuss new proposals by Indonesia and Thailand, some
supported the unapproved chair=92s report from a mid-summer meeting in
Singapore of a subgroup on the issue, and Brazil suggested working
from the text of the May Health Assembly Resolution 60.28, which had
provoked this group=92s creation. The discussion will continue on
Wednesday.

Indonesian, Thai Proposals

There also were new proposals on the first morning from Indonesia and
Thailand. Indonesia=92s proposal is to =93urgently develop a new system
for virus access and fair and equitable sharing of benefits arising
from the use of the virus.=94 The new system, which would replace the
existing system, would emphasise the national sovereign rights of
members over their biological resources. It would involve creation of
a WHO stockpile of vaccines, and allow access to specimens or viruses
through standard material transfer agreements with a number of other
conditions. These include requiring manufacturers to get origin
country consent to obtain seed virus from the system, and the
prevention of intellectual property rights on the virus or any part of
it.

Thailand laid out draft standard terms and conditions for =93the
transfer and use of influenza biological materials and fair and
equitable benefits sharing between member states the WHO.=94 Its
proposal would establish a global influenza vaccine fund with weighted
contributions that would involve advanced purchase agreements to
obtain vaccines. The terms would establish the sovereignty of
governments and provide free access to information on viruses, and
oblige countries to participate in the fund, which would be managed by
a board.

Indonesia Charges Unfair Treatment

The government of Indonesia took a strong position at the outset of
the meeting in favour of ensuring equal access for developing
countries, and charged unfairness in the WHO system. Indonesia has
come under pressure for withholding samples of the avian flu strain
occurring there out of concern that sharing it to the WHO process
would lead it to be expensive and unavailable for its population.

=93As an organisation which governs health care of the world, WHO needs
a fair, transparent and equitable mechanism,=94 Indonesian Health
Minister Siti Fadilah Supari told the meeting. =93Ironically, since
avian influenza existed in Indonesia, we have been experiencing unfair
and non-transparent mechanisms in virus sharing which has been linked
to vaccine production.=94

By sharing virus samples with the global flu network, developing
countries are requested to release their viruses but then lose their
right to them and do not know what they are used for, Supari said.

=93The moment when developing or poor countries need vaccines, they have
to purchase them at high prices, and, one of the financial
consequences is that they may need loans from other developed
countries,=94 Supari continued. =93The unfairness that was given by the
WHO could threaten global health security and also is a new type of
oppression to developing nations by developed countries.=94

Supari named three ways in which her country was treated unfairly. She
charged that when Indonesia needed to procure Tamiflu, seen as
potentially effective against avian flu, it had all been stockpiled by
developed countries. Secondly, the DNA sequence for risk assessment
and vaccine production was held exclusively by WHO-affiliated
scientists, which Indonesia corrected by releasing the H5N1 sequence
data to gene banks. Finally, Supari said, several developed country
companies offered her vaccine and diagnostic kit developed from the
Vietnamese flu strain.

Supari painted an unfavourable image of grieving family members in
Vietnam learning that the viruses shared with the WHO mechanism ended
up as a =93commercial commodity=94 for developed countries. In sum,
Indonesia suggested that a new mechanism is needed.

The Problem with IP and Vaccines

The European Union through its current president Portugal took issue
with an aspect of the WHO secretariat=92s suggestion to pursue with
member states and vaccine manufacturers an advance commitment
mechanism. This mechanism sets a pre-defined quantity of vaccine to be
released by producers, which would guarantee access for countries
lacking manufacturing capacity.

The United States said the =93sense of urgency=94 must be maintained, and
pointed to a variety of preparations for a possible pandemic that
reach beyond access to vaccines, such as rapid response or measures to
mitigate the spread at the community level. It also criticised any
withholding from the global system, but said countries sharing their
samples should not expect something in return every time. Instead,
they could get technical assistance. Finally, the US said, =93We cannot
accept any approach that undermines intellectual property rights.=94

Edward Hammond of the Sunshine Project prepared a report on IP issues
related to avian flu viruses that tracked the recent =93dramatic rise=94
in patent applications related to influenza. As developed countries
funnel public funds into a biomedical research and development system
based on patents, =93some key government players in the WHO GISN are
fuelling the patent surge and, in fact, are politically and legally
obligated to encourage such claims because they are an integral
component of their health systems,=94 Hammond wrote.

The Third World Network and the Sunshine Project, nongovernmental
groups, circulated views at the meeting urging the prevention of
patenting of flu viruses in the global system. In a brief paper that
appeared to echo the Indonesian proposal, they stressed the importance
of national sovereignty over how its viruses are used, and commitments
to fair and equitable benefit sharing from research. The groups called
for the rewriting of terms of reference between the WHO and the
collaborating centres, and material transfer agreements for the
movement of viruses. Furthermore, there should be no IP rights related
to influenza, and tracking of virus transfers by WHO.

Separately, the World Intellectual Property Organization last week
issues a technical report on patents related to influenza viruses and
their genes. It did not advocate any position but provided background,
WIPO said.

Seasonal Vaccine

Another key issue at the meeting is the increasing use of seasonal
vaccines and efforts to reduce prices and increase availability as
manufacturing capacity increases.

The Federation of Pharmaceutical Manufacturers and Associations
(IFPMA), and the Developing Country Vaccine Manufacturers Network are
recognised by the meeting to provide comments if called upon. IFPMA
said in materials provided to negotiators that its Influenza Vaccine
Supply task force members have invested billions of dollars in
developing capabilities to deliver vaccines against seasonal, avian
and pandemic influenza. The group said increased manufacturing for
seasonal flu also will increase manufacturing capabilities for a
pandemic. Industry should have the capacity to produce several billion
doses of pandemic vaccines by 2010, IFPMA said.

=93I fully support any effort that leads to greater and more equitable
access to pandemic vaccines. Vaccines are the best insurance policy
for public health,=94 said Chan, later adding. =93Millions of people
outside this hall depend on us to make progress.=94

William New may be reached at wnew@ip-watch.ch.