[Ip-health] Intervention by Brazil at WTO TRIPS Council in June 2009

[Thiru Balasubramaniam]

TRIPS Council
8 and 9 June 2009

Intervention by Brazil


Madam Chair,

My delegation has once more asked for the floor to bring the issue of
seizures of generic drugs in transit through Europe to the attention
of the
TRIPS Council.

We see with grave concern the seizure, since the last session, of a
consignment of generic drugs in transit to Vanuatu in Frankfurt airport.

As we have stated before, we believe that the seizure of goods in
transit on
grounds that they might be violating IP rights conferred by a patent
registered in the country of transit is a serious violation of WTO
disciplines.

The decision to impede the transit of cargos of generic medicines
violates
the freedom of transit, a right enshrined in GATT Article V. Only very
exceptional circumstances warrant restrictions on that freedom. Brazil
is
not aware of any such circumstances in the concrete cases that we have
brought to the attention of the Council.

Our inquiries led to the identification of more than a dozen seizures of
consignments of generic drugs in transit through Dutch territory in
the last
year. The medicines were directed to at least 7 different developing
countries in South America and Africa. Now, we face a new seizure on
German
territory.

It is clear that the losartan case, contrary to EC assertions, was not a
"minor, exceptional and inconsequential" incident. In fact, it seems
like
the tip of an iceberg.

We want once more to recall that trade in generic medicines is perfectly
legal from the intellectual property point of view. Generic must not be
mistaken with counterfeit or pirated. Generic medicines are not
substandard
or illegal.

Last session, in their response to Brazil and India, the European
Communities affirmed their commitment to "facilitating access to
medicines
for countries in need". Unfortunately that doesn't seem to be in line
with
the concrete actions. The dozen-plus consignments of generic drugs in
transit through Dutch territory and the recent seizure at Frankfurt
airport
of a consignment of amoxicillin seem to move in the opposite direction
to
the objective of "facilitating access to medicines for countries in
need".

The Communities claimed to be "one of the main promoters of the Doha
Declaration and the TRIPS flexibilities". Rather than TRIPS
flexibilities,
however, the EC has actively promoted TRIPS-plus standards in
non-specialized multilateral agencies such as the World Health
Organization
(through the IMPACT initiative) and the World Customs Organization
(within
the GT Secure) as well as in plurilateral stances such as ACTA or in
bilateral and plurilateral agreements ("Economic Partnership
Agreements").

In an attempt to justify the seizure of generic medicines in transit,
the EU
claimed that their customs actions have "saved lives in final
destination
countries - often developing countries". This is a blatant attempt to
confound the issue. EC customs authorities' apprehensions have actually
hampered the access of the developing world to affordable life-saving
generic medicines. In none of the cases mentioned was there any issue
with
the quality of the drugs. EC customs authorities did not worry about
quality
- their sole concern was the EC patents.

In fact, this also calls into question EC statistics about seizures of
fake
medicines. The "losartan" and other episodes suggest that EC numbers may
lack accuracy, as EC customs authorities may mistake legitimate generic
medicines for fake products.

Furthermore, the Communities defend the compatibility of EC Regulation
1383/2003 with WTO disciplines and, in particular, with the TRIPS
Agreement.
They make use of the argument that TRIPS is only a minimum-standards
agreement and, for that reason, EC Regulation 1383/2003, which
authorizes ex
officio seizure of goods in transit, would be TRIPS-compliant.
However, let
me recall that the mere seizure of goods in transit - any good; be it a
medicine or not - on grounds that they may be violating IP rights
registered
in the country of transit is, in itself, a violation of GATT Article V
and
other GATT obligations.

The TRIPS Agreement does not allow the detention of goods in transit.
The
seizure of goods in transit on grounds that they may be violating IP
rights
in the country of transit violates the principle of territoriality, a
keystone of the international IP system. Furthermore, it runs counter
to the
objectives and purposes of the TRIPS Agreement. It offends Articles 7
and 8
of the Agreement. Article 7 states that the "enforcement of intellectual
property rights" must be done "in a manner conducive to social and
economic
welfare". Article 8 upholds Members' rights to "protect public health
and
nutrition".

Finally, under the point of "what has happened in the Indian case", the
Communities argued that the consignment of losartan returned to India
because that was the free and autonomous will of the Indian
manufacturer.
According to information we have received, the Indian manufacturer was
given
only two options: either to take the cargo back, or face the costs of
litigation in the Netherlands. A third option - allowing the
consignment to
follow its path to Brazil - was not given to the Indian manufacturer. We
would like to ask for further clarification on that.

The losartan episode and other seizure episodes are a major source of
concern for developing countries because they essentially imperil the
public
health dimension of the TRIPS Agreement.

In light of the above, I reiterate the request for clarification on the
following questions:

(a)	How the European authorities' actions can be reconciled with WTO
disciplines?

(b)	Whether EC Council Regulation 1383/2003 requires or justifies such
actions from the customs authorities of the Communities; and, above all,

(c)	How will the Communities ensure that such actions will not happen
again".

Madam Chair,
Brazil is fully committed to intellectual property protection. It is a
founding-Member of the Paris Convention, and Brazilian legislation
provides
fair and adequate protection to IP rights holders. Brazil also
believes that
a functioning and effective IP international system can only be built
on the
solid basis of a fair balance between private and public interests.
This is
the very foundation of the TRIPS Agreement. The protection of
intellectual
property cannot supersede the protection of more fundamental values,
such as
the protection of life and the right to promote public health.

Thank you.


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997