[A2k] Intervention by European Communities at the TRIPS Council (Dutch seizures)

[lacroix rebecca]

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This intervention for the European Communities and its Member States was ma=
de
by Luc Devigne (http://www.ipr2.org/storage/_LR22810159.jpg) , the EC head =
of
delegation, on 3 March 2009 at the WTO TRIPS Council in Geneva, Switzerland=
.


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TRIPS Council 3-4 March 2009

Agenda item M =E2=80=93 Other Business

Mr. Chairman,

My delegation would like to thank the Brazilian and Indian delegations for
their interventions which give me the opportunity to further explain and cl=
arify
the EU position on this issue, although we have already replied to the same
questions in the WTO General Council.

I) EU commitment to access to medicines

First of all, let me recall that, form the outset, the EU has been fully
committed to facilitating the access to medicines for countries in need. Th=
ere
is no change in our policy in this respect. And I fail to understand why so=
me
delegations believe there are "concerted attempts".

I trust this is well known and those who claim that the EU would intend to
hamper legitimate trade in generic medicines or to create legal barriers to
prevent movement of drugs to developing countries are completely wrong and =
have
only led to raise anxiety among the populations in need of medicines.

1) As you know, the EU has been one of the main promoters of the Doha
Declaration and the TRIPS flexibilities. We have implemented the waiver Dec=
ision
of 30 August 2003 on compulsory licensing into EU legislation (Regulation
816/2006) and we have ratified the Protocol amending the TRIPS Agreement (3=
0
November 2007).

2) We have also adopted a regulation (Regulation 953/2003) on tiered-pricin=
g
which encourages European producers to significantly increase supplies of
medicines at lower prices to countries in need while keeping higher prices =
for
the same products in the EU.

3) The EU has also funded a number of projects and programs in developing
countries from research to production, to procurement and to delivery, incl=
uding
quality control. That is the case for example with the EU Africa Clinical T=
rial
Partnership with a financing frame of 800 million =E2=82=AC and the contrib=
ution of
the EU to the Global Fund for AIDS, Tuberculosis and Malaria of 672 million=
 =E2=82=AC
since 2002.

This being said, we are aware that those measures have to be complemented b=
y
other measures and that the problem of increased access to medicines requir=
es a
wider package of actions. For example, prioritizing national budgetary expe=
nses
to public health and reducing tax and tariffs on drugs imports on medicines=
 are
other examples of action at national level which can contribute to improve
access to medicines.

II) Why do we need to control counterfeit products in transit.

We maintain that it is important to allow the customs authorities to contro=
l
goods in transit suspected to infringe IP rights so that they can stop the
traffic of potentially dangerous products, such as fake medicines, even whe=
n the
shipments are destined for any country, and it is likely that EU customs ac=
tion
have saved lives in final destination countries =E2=80=93 often developing =
countries.

Many dangerous goods, such as counterfeit medicines, are shipped to develop=
ing
countries, often via European ports and airports. Although the control by t=
he
customs is sometimes difficult due to the complexity of the products, we th=
ink
that their role is crucial to prevent the flow of fake medicines in transit=
 from
reaching the populations of developing countries.

In 2007, out the 76 million counterfeit and pirated goods intercepted by th=
e
European customs, 40% were intercepted in transit.

EU customs statistics for 2007 have revealed a significant increase (compar=
ed
to 2006) in trade of fake medicines (+51%). I should add that 34% of these
counterfeit medicines were originating in India.

At the end of last year, the EU customs initiated a two-month operation cal=
led
MEDI-FAKE targeting illegal medicines entering the EU territory. During thi=
s
period, 6 million items concerned medicinal products.

The results of this operation confirm a significant and worrying level of t=
rade
in illegal medicines indicating a potentially serious public health and saf=
ety
issue, which fully justify the control of medicines in transit suspected to
infringe IP rights.

III) I come now to the issue of compatibility of the EU customs legislation=
 on
IPR enforcement with TRIPS.

The EU customs legislation in question (Regulation 1383/2003) aims to prote=
ct
the legitimate trade in goods covered by intellectual property rights, as w=
ell
as health, safety and consumer expectations.

The customs have an internationally recognised and important role to play i=
n
enforcing intellectual property rights at the border and their work has an
incidence on consumers within the EU but also elsewhere.

The EU customs legislation is fully in line with the WTO and TRIPS
requirements, in terms of scope and coverage of customs intervention. The T=
RIPS
Agreement sets out inter alia the minimum requirements for customs border
enforcement of the importation of goods suspected to infringe certain
intellectual property rights. Article 51 TRIPS and footnote 13 clearly allo=
w WTO
Member to apply border measures to goods under other customs situations,
including in transit, which are suspected to infringe other intellectual
property rights, including patents.

To our knowledge, other WTO Members, we believe including India, apply bord=
er
measures for goods in transit suspected to infringe intellectual property
rights.

Of course, under the customs legislation the customs authorities do not dec=
ide
if goods are infringing IP rights. The general procedure is to detain (not
seize) goods, where there is a suspicion that there is an infringement and
contact the right holder. It is indeed up to the right holder to pursue the
matter through the court, under national provisions. If the right holder de=
cides
not to pursue the case, the goods are released by the customs. In case the =
right
holder brings the case to the court, it is then for the court to decide on =
the
future handling of the goods.

Contrary to what some delegations have suggested, I should add that in no w=
ay
the customs authorities could check the legality of the goods in the countr=
y of
origin or destination as this would be contrary to the concept of territori=
ality
of IP rights.

This procedure is fully in line with the relevant TRIPS provisions, in
particular Article 55, which sets out the time-limit of 10 working days for
suspending the release of the goods, as well as the possible extension of a
further 10 working days.

IV) What has happened in the Indian case(s).

In the case(s) referred to by India, it appears that, following a request b=
y a
US company =E2=80=93 not ex officio =E2=80=93 which has patent rights over =
the medicines in
question in the Netherlands, the Dutch customs authorities have temporarily
detained (not seized) the drugs in question whilst on transit. Further to a
settlement between the right holder and the importer, the goods were sent b=
ack
to India, and not seized.

I should underline that in case of abusive complaints by the right holder, =
the
latter would be liable to damages.

V) To conclude, I would like to reaffirm the commitment of the EU to a poli=
cy
to access to medicines to countries in need. This being said, the rising th=
reat
of counterfeit medicines means that customs control, including in transit i=
n
goods, are justified. We remain open to discuss bilaterally any concern tha=
t a
Member might have with the enforcement of EU Customs Regulation.