[Ip-health] IP-Watch: Views Mixed On WTO Doha Declaration on Public Health After Five Years

[Thiru Balasubramaniam]

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http://www.ip-watch.org/weblog/index.php?p=3D460&res=3D1024_ff&print=3D0

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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=92 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=92s
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 =93open to discussion=94 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=92 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, =93a clear indication of its usefulness,=94 he
said. =93Countries are discouraged from using these flexibilities,=94 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 =93become a WIPO-plus or WTO-plus
institution=94 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 =93very difficult environment,=94 Patriota said, adding that if one tries
to use flexibilities, =93you will be coerced not to use them.=94

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, =93Patents versus
Patients: Five years after the Doha Declaration.=94 The report is
critical, arguing that =93little has changed=94 since the signing of the
declaration as patented medicines continue to be priced too high for
the world=92s poorest populations, trade rules continue to block access
to generic medicines, and serious diseases continue to rise in
developing nations. =93Urgent action is needed,=94 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=92 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=92s interpretation
is under attack.

Ellen =91t Hoen of M=E9dicins Sans Fronti=E8res 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=92s right to use
the flexibilities in TRIPS.

Generics Pipeline Seen Drying Up

The good news, =91t 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=92s 2005
implementation of the TRIPS agreement, which will lead to patents on
drugs. =93Generic pipelines are empty for these products,=94 she said.

Dr. Tido von Schoen-Angerer, director of MSF=92s Campaign for Access to
Essential Medicines, said in a statement, =93We=92re 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?=94

In particular, =91t Hoen said, those who need to switch drugs after a
failed first course to =93second-line=94 drugs are still seeing high prices
due to lack of competition. =93We=92re getting back to where we were five
years ago,=94 she said. =93That should really alarm us.=94

She also raised the possibility that TRIPS is =93a bad bargain=94 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, =91t Hoen added.

Sangeeta Shashikant of the Third World Network said there are =93very
mixed feelings=94 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. =93It is definitely not the time to be complacent,=94 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=92s 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 =93presumably,=94 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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Thiru Balasubramaniam
Geneva Representative
CPTech
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@cptech.org