[Ip-health] IP-Watch: WHO Members Reach Preliminary Agreement On TRIPS And Malaria

[Thiru Balasubramaniam]

http://ip-watch.org/weblog/wp-trackback.php?p=3D524


21 May 2007

WHO Members Reach Preliminary Agreement On TRIPS And Malaria


By Tove Iren S. Gerhardsen
A preliminary agreement has been reached at the World Health Assembly
on a draft proposal on malaria and the use of flexibilities in trade
law to promote access to preventive technologies, sources said.

After being discussed at the World Health Organization Executive Board
meeting in January (IPW, Public Health, 6 February 2007), there were
two proposals, mainly from the United States and Kenya, for
consideration in the draft malaria resolution heading into the 13-23
May World Health Assembly (IPW, Public Health, 10 May 2007).

The first option, supported by Kenya and others, urged member states to
provide in their legislation for full use of the flexibilities found in
the World Trade Organization (WTO) Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPS), =93in order to increase access
to anti-malarial medicines, diagnostics and preventive technologies.=94

Option two favoured by the United States, Switzerland and Japan, among
others, stated that countries should consider, whenever necessary,
adapting their legislation to allow full use of the TRIPS
flexibilities, but not linking this language to access to the products,
instead inserting a reference in brackets in the following paragraph,
according to the draft resolution (EB120.R16).

Japan also supported this option, saying it was up to member states
whether and how the flexibilities were adopted depending on their
circumstances.

The new draft appears to be a compromise as the language referencing
TRIPS was included in a paragraph linking it to access to =93preventive
technologies,=94 with an explanatory footnote, while the language on
anti-malarial medicines is found in a separate paragraph.

Among the TRIPS flexibilities are the use of compulsory license which
allows use of a patented material under certain circumstances without
the authorisation of the patent holder, or the immediate introduction
of generic medicines upon patent expiry.

But after small-group discussions mainly among the United States and
Kenya, the parties have reached an agreement, resulting in new,
unbracketed (brackets indicate that there is not yet agreement), a
Kenyan official told Intellectual Property Watch, adding that this was
a serious attempt at consensus. The United States was not available for
comment. The new draft will have to be discussed and adopted by all
members.

New Draft

According to the 19 May document, =93Malaria, including proposal for
establishment of World Malaria Day, Draft resolution proposed by a
working group=94 (A60/A/Conf.Paper No.8 Rev 1), there are now two new
paragraphs both parties have agreed to. Member states are urged:

=93To provide, whenever necessary, in their legislation for use, to the
full, of the flexibilities contained in the Agreement on [TRIPS] in
order to promote access to pharmaceutical products,=94 with a footnote
explaining that this would mean any patented product of the
pharmaceutical sector or active ingredients, as stated in the WTO Doha
Declaration from 2001, which explains TRIPS in the context of public
health. This was the paragraph Kenya wanted, the official said.

The next paragraph reads: =93To aim at reducing or interrupting malaria
transmission, wherever feasible, through integrated vector management,
promoting improvement of local and environmental conditions and healthy
settings and increasing access to basic health services, anti-malarial
medicines, diagnostics and preventive technologies in order to reduce
the diseases burden.=94 Preventive technologies include anything that
stops the spread of malaria, such as nets and prophylaxis, a source
said.

Non-governmental Side Events on Patents, Medicines

Separately, the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) held a 16 May event alongside
the assembly, at which it presented new search functions of its
clinical trials portal and where representatives from Sweden, including
the Swedish industry association, LIF, presented its website, which
provides extensive patient information. Sweden is known for its =93open
source=94 and transparency policy as all public documents are supposed to
be available for the public. For LIF, this means transparency and
availability of information on clinical studies to patients, it said.

Anders Milton, president of the European Red Cross and Red Crescent
Societies Network against HIV/AIDS and Tuberculosis, said that it was a
=93fundamental right=94 for patients to have access to information in their
mother tongue.

IFPMA also presented an updated version of the book, =93Partnerships to
build healthier societies in the developing world.=94 Divided into
disease categories, it lists the various initiatives and programmes
from companies towards the United Nations Millennium Development Goals,
for example, which companies are involved in =93Pediatric Formulations or
ARVs [antiretrovirals used against HIV/AIDS].=94

On 18 May, the Christian Medical Commission held a briefing with
nongovernmental organisations including M=E9decins Sans Fronti=E8res,
Oxfam, Third World Network and Knowledge Ecology International, at
which patents=92 effects on medicines prices and access was highlighted.

An Oxfam International representative said that the Philippines, which
has the second highest medicine prices in Asia after Japan, was in the
process of implementing four TRIPS flexibility safeguards in their law,
and was to vote in Congress next month. He called on WHO to get engaged
in the debate. He said the Philippines had been challenged by industry
to have the Bolar provision (immediate introduction of generics once
the patent expires) in its law.

Peter Beyer from Switzerland=92s Intellectual Property Office, speaking
in his own capacity, said Switzerland was in the process of adopting
the Bolar provision in its amended IP law, referring to recommendations
from the WHO Commission on Intellectual Property Rights, Innovation and
Public Health (CIPIH). He said the debate should move from arguing
whether patents are good or bad, and said that WHO =93can=92t really
negotiate TRIPS.=94

Eric Noehrenberg from IFPMA said that as for the industry, =93we are
doing our part,=94 and said that the IP system =93is developing new drugs.=
=94
He said it would never be enough, but said the parties should work
together, =93instead of conflict.=94

Speaking as a Kenyan involved in the process of the WHO
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property, Ahmed Ogwell, head of international health
relations at Kenya=92s Health Ministry, said the process had stopped
being technical, and was now political. He said the parties had to move
out of their =93relatively prejudiced cocoons.=94 He said a lot could be
done by the private sector as well as governments, adding that he hoped
WHO would, =93be an arbiter whose bias is always going to be public
health.=94

On 17 May, the International Policy Network (IPN), a free-market think
tank, held an event entitled, =93A Global Medical Research and
Development Treaty: An answer to global health needs?=94 This is the same
title as a study written for IPN, which is supported by pharmaceutical
companies generally seen as favouring the status quo. Study author
Andrew Farlow of the Said Business School, University of Oxford, faced
off on a panel with James Love, director of KEI, a consumer-oriented
think tank which seeks to change the current system.

Love presented a proposal he has helped develop to establish a medical
R&D treaty that could help reduce prices on drugs by changing the
current system of companies paying for R&D through higher prices. The
proposal is to establish a large =93prize=94 fund to pay companies for
their research so prices could be lower, especially for sick people in
poor countries who now cannot afford treatment. Love tied the problem
of access and pricing to intellectual property rights, and offered a
range of proposals from large to small that could ameliorate the
situation. He referred to the WTO TRIPS agreement as a =9312,000-word R&D
treaty=94 because of its legal effect on that area. =93We want a new deal,=
=94
he said.

Farlow took issue in his study and on the panel with many aspects of
the =93resource allocation=94 treaty proposal, pointing out questions that
remain to be addressed. He focused on issues of implementation, the
setting of weights on countries=92 spending obligations, measurement,
equity and developing country buy-in, and efficiency. He particularly
targeted a suggestion that tradeable government credits for public
health R&D, as are used in global environmental economics, might be a
good model. He also raised issues of enforcement, and said the model
would be overly dependent on the participation of the United States.
Farlow suggested improving the existing system before dramatically
changing it.

But Love argued that change is necessary and that details of how to
address unresolved public health problems are already being negotiated
by governments. =93Unless Bill Gates [the Microsoft chairman who has
funded a foundation addressing public health issues] is going to be the
entire public health system, there=92s going to have to be some sort of
mechanism=94 to address the persistent problems, he said.

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