[e-drug] Five years of Doha Declaration On Public Health

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Five years of Doha Declaration On Public Health
-------------------------------------------------------
[A review by IP Watch of the various responses to the 5th anniversary of the
Doha declaration on public health.

The mentioned OXFAM press release is available at:
http://www.oxfam.org.uk/press/releases/patents141106.htm

The full OXFAM paper "Patents versus patients" at:
http://www.oxfam.org.uk/what_we_do/issues/health/downloads/bp95_patents.pdf

The MSF Campaign press release at:
http://www.accessmed-msf.org/prod/publications.asp?scntid=1411200692472&cont
enttype=PARA&

WB]

Views Mixed On WTO Doha Declaration On Public Health After Five Years 

By William New

A panel of key Geneva actors on policy related to intellectual property
rights and public health on 14 November gave a range of views on the World
Trade Organization Doha Declaration five years after its agreement. 

Several nongovernmental groups and a developing country official saw some
benefits but raised concerns about future access to medicines and about the
health impact of bilateral free-trade agreements being negotiated between
large and small economies. 

Representatives of two key intergovernmental bodies, the WTO and the World
Health Organization, meanwhile, highlighted work being done to improve
access to medicines, especially through technical cooperation. 

The declaration was an outcome of the 2001 WTO ministerial in Doha, Qatar
which launched the now-stalled round of trade-liberalisation negotiations
that were intended to focus on ensuring developing countries benefit equally
from the global trading system. 

In December 2005, WTO members adopted a public health amendment to the
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The amendment instituted an August 2003 WTO agreement on a draft waiver to
TRIPS for public health reasons, which was called for under paragraph six of
the Doha Declaration to allow more export of medicines under compulsory
license to countries without sufficient production capabilities. A
compulsory licence forces the sharing of patented information on a medicine
to allow generic production. 

On the panel, Adrian Otten of the WTO Intellectual Property Division
indicated the positive contribution to public health that the Doha
Declaration has made. The paragraph six solution is to be reviewed every
year, but so far has not elicited concerns from member states, he said. It
was most recently reviewed at the October meeting of the TRIPS Council. An
overall review of the Doha Declaration has not been sought, he said. 

On concerns about bilateral free-trade agreements, Otten said there are a
number of ways for concerns to be raised within the WTO context, such as in
talks about preferential treatment for smaller economies, and through
strengthened monitoring of regional trade agreements. The issue also arises
in countries? regular trade policy reviews, he said. 

The Roles of WTO, WHO 

On the roles of the WTO and WHO, Otten said there is cooperation and that
the WHO has followed the WTO process, providing technical information. 

Howard Zucker, the assistant WHO director general for health technology and
pharmaceuticals, and head of a new WHO working group on intellectual
property rights and public health, discussed the WHO?s work since TRIPS. He
said WHO has focused on policy, training and technical support to help
increase global access to medicines. He cited a number of WHO publications,
including one forthcoming on the implications of WHO decisions related to
TRIPS and public health, and another looking at government use of compulsory
licensing. 

The WHO has helped with local production of medicines, and collected and
provided data, Zucker said. It also monitors all discussions on health at
the WTO. In addition, WHO is working with the European Patent Office and the
World Intellectual Property Organization (WIPO) to identify what drugs are
on patent and when they will come off patent, he said. 

Zucker said the WHO works with the WTO on trade issues and in the field
looks at the use of TRIPS flexibilities. On the IP working group, he said
some member states had not wanted trade issues on the table, and the issues
are ?open to discussion? by the member state-led group. He added that the
working group is not just about intellectual property but also about
innovation and development, with an eye on how to address neglected
diseases. Guilherme Patriota of the Brazilian mission flagged a concern that
the working group not be overly focused on innovation issues but rather look
at the impact of intellectual property on public health. 

Otten said the WTO is invited as an observer to the WHO working group
process, the first meeting of which is 4-8 December. The WTO also invites
the WHO to participate in its technical cooperation activities, and works
with other agencies such as WIPO, the World Bank and nongovernmental
organisations, he said. 

Pressure Not to Use TRIPS Flexibilities? 

Patriota shared several nongovernmental groups? view that developed
countries have pressured developing countries politically and economically
to agree to weaker terms on health than the WTO agreements. 

Patriota and others also noted that no country has yet used the draft waiver
after three years, ?a clear indication of its usefulness,? he said.
?Countries are discouraged from using these flexibilities,? he said. 

In addition, Patriota drew a link to efforts by some developing countries
including Brazil to change the mandate of WIPO to make it more oriented
toward a balance between public and private rights. He said WIPO generally
states that it is focused on the protection of rights. He said WHO should
not ?become a WIPO-plus or WTO-plus institution? or be captured by
private-sector interests. 

He also said there is an inconsistency between intellectual property rights,
which grant a monopoly to the right holder, and trade principles, which are
based on competition. Developing countries are in a ?very difficult
environment,? Patriota said, adding that if one tries to use flexibilities,
?you will be coerced not to use them.? 

There were no developed country or industry representatives on the panel. 

New Oxfam Study Critical of Doha Declaration 

Oxfam issued a new study at the event entitled, ?Patents versus Patients:
Five years after the Doha Declaration.? The report is critical, arguing that
?little has changed? since the signing of the declaration as patented
medicines continue to be priced too high for the world?s poorest
populations, trade rules continue to block access to generic medicines, and
serious diseases continue to rise in developing nations. ?Urgent action is
needed,? the report asserts. 

The report calls for: a WTO review of TRIPS; the United States to stop
pressuring countries adopt stricter intellectual property rules;
clarification by the European Union that it will not push for TRIPS-plus
measures; and political and technical support from wealthy countries use
safeguards under TRIPS. It also urges developing countries to summon the
political will to implement public health safeguards, and calls for an end
to lawsuits by pharmaceutical companies Novartis and Pfizer challenging
developing countries? IP laws. 

An Oxfam representative at the meeting said national governments have the
right to their own interpretation of the TRIPS agreement when implementing
it into national law, and said that India?s interpretation is under attack. 

Ellen ?t Hoen of Médicins Sans Frontières said under WTO rules the right to
use compulsory licensing for public health reasons is left up to the
national government and that it does not have to be for health emergencies
only. 

She also said that while no country has used the paragraph 6 solution. There
are about 15 countries that have used Doha Declaration paragraphs 4, 5 and
7. These all relate to a national government?s right to use the
flexibilities in TRIPS. 

Generics Pipeline Seen Drying Up 

The good news, ?t Hoen said, is that countries that need lower-priced
generic medicines are increasingly able to get them. But the concern is for
the future, she said, as sources are drying up for these medicines, such as
for HIV/AIDS. This is particularly the case with India?s 2005 implementation
of the TRIPS agreement, which will lead to patents on drugs. ?Generic
pipelines are empty for these products,? she said. 

Dr. Tido von Schoen-Angerer, director of MSF?s Campaign for Access to
Essential Medicines, said in a statement, ?We?re seeing many countries make
use of the Doha Declaration to import medicines, but what is the use if soon
there are no generics to buy?? 

In particular, ?t Hoen said, those who need to switch drugs after a failed
first course to ?second-line? drugs are still seeing high prices due to lack
of competition. ?We?re getting back to where we were five years ago,? she
said. ?That should really alarm us.? 

She also raised the possibility that TRIPS is ?a bad bargain? since it has
not kick-started research on neglected diseases, for which product
development is not seen as profitable, and which often occur in developing
countries. The WHO has a key role in addressing the problem areas, and WIPO
also should do more, ?t Hoen added. 

Sangeeta Shashikant of the Third World Network said there are ?very mixed
feelings? after five years as there have been gains but also pressure to
adopt national laws and practices that are more restrictive than TRIPS. 

Shashikant cited cases of developing countries effectively using TRIPS
flexibilities to significantly lower drug prices and increase access. But
she said countries are being pushed in bilateral trade negotiations to adopt
TRIPS-plus rules, such as limiting government use of compulsory licences, or
data exclusivity requirements that block the registration of generic
products even if a compulsory licence is issued. ?It is definitely not the
time to be complacent,? she said. 

Thiru Balasubranamiam of the Consumer Project on Technology said it is too
soon to judge the utility of the TRIPS amendment. He also praised India?s
implementation of TRIPS as it enforced the ability to use compulsory
licences for export of patented pharmaceuticals. In addition, he praised a
2002 amendment adopted by the European Parliament on manufacturing for
export under compulsory licence when requested by the country in need. But
he also cited flaws in the TRIPS amendment such as a prohibition on export
to high-income countries. 

Otten said that ?presumably,? India will become a regular user of compulsory
licences to export as drugs come under patent. 

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

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