[Ip-health] Paris Drugs Seizure: India's intervention at TRIPS Council

[Sangeeta]

TRIPS Council intervention of India on =8CPublic Health dimension of the TR=
IPS
Agreement=B9 under Other Business

Madame Chair, there is a reason why we have asked for this agenda item unde=
r
AOB. In the March and June TRIPS Council meetings this year, my delegation
shared with Members the serious impediments to access to medicines created
by the drug seizures at EC ports. We also shared details of the 17 seizures
by the Dutch authorities in the year 2008 on the basis of  EU regulation
1383/2003.  All 17 consignments originated in developing countries and 15 o=
f
the 17 consignments were destined for developing countries.  In this meetin=
g
we wish to update Members on the developments since the June meeting.

We thought that the Amsterdam seizures were the last because the EC had bee=
n
giving us assurances that they are putting in place systems to ensure that
generic medicines are not seized. In May, as Members would recall, a
consignment of a generic antibiotic, Amoxicillin, manufactured in India and
destined for a Least Developed Country, the Republic of Vanuatu in the
Pacific, was seized by customs officials while in transit through Frankfurt=
,
Germany. The seizures were made on grounds of alleged trademark violation
although GlaxoSmithKline (GSK) had confirmed to the German authorities that
GSK is the former patent holder for =B3Amoxil=B2, a brand name for amoxicil=
lin.
There seemed no valid reason for detaining these medicines especially since
the name =B3Amoxicillin=B2 is an international nonproprietary name (INN).

Madame Chair, today we are alarmed to get information of yet another drug
seizure. We have been informed by customs authorities at the Paris-Roissy
airport that they have seized a shipment of 1,740,000 tablets of =AB
Clopidogrel =BB. (Clopidogrel is an antiplatelet drugs used to prevent stro=
kes
and heart attacks in patients at risk for these problems.) The gross weight
was 3829 kgs. The consignment was in transit from Mumbai to Caracas,
Venezuela. The alleged ground was patent violation. The European company
involved was Sanofi Aventis. It may be recalled that this is the same
generic drug that was seized in October last year in Amsterdam and released
7 months later in May this year.

Let me now turn to our efforts to find a satisfactory solution to the
matter. India has continued its bilateral efforts with the EC at the level
of senior officials, Ministers and formal communications.  However, inspite
our persistent urging nothing concrete has been done. There are yet no sign=
s
of review of  EC customs Regulation 1383/2003, inspite of its inconsistency
with  provisions of  GATT, the TRIPS Agreement and the spirit of the  Doha
Declaration on the TRIPS Agreement and Public Health. The demand for the
review of 1383 has been echoed by European and Dutch parliamentarians and
civil society organizations engaged in public health work in the least
developed parts of the world.

The EC informed us last month about an =8CExplanatory Note=B9 dated July 31
issued to Member States on the application of the EC Regulation 1383/2003.
After the Paris seizure earlier this month, how can we draw any comfort fro=
m
the Note. It merely shifts the blame to MSs for applying their national law=
s
and the responsibility for interpretation to the National Courts. The Note
totally disregards the permissiveness of the EC Regulation itself. Prior to
2003, the scope of EC Regulations covered only trademark and copyright
infringements. The EC Regulation 1383 has expanded the scope to additionall=
y
cover patents and other IPRs and also extends to goods in transit and as
shown by the drug seizures, it has provided  a basis for MSs to apply IPRs
extra territorially and to goods in transit. EC=B9s Explanatory Note also
repeats the timelines indicated in TRIPS Art 55 (Duration of suspension)
which were hardly followed by Customs authorities in the various cases of
drug seizures in 2008. However, elaborating in detail on the timelines and
procedures in the Note seems to be an effort at evading the real issue of
the scope and applicability of the Regulation.

The EC has claimed that there have been no drug seizures since December
2008. These claims have been proven hollow with the Frankfurt and Paris
seizures. Anyway, we see no guarantee that there will be no seizures of
generic drug consignments in the future as long as Regulation 1383/2003
exists in its present form. The EC has attributed the seizures in part to
its operation MEDI-FAKE. And here is where lies another one of the roots of
the problem i.e. dealing with sub standard and spurious medicines through
border measures and customs officials who can hardly be expected to be
experts in public health issues. Underlying the drug seizures is also a
deliberate mixing up of the issue of spurious/sub standard drugs etc with
IPRs. Let me also emphasise that the seizure cases involved legitimate
generic medicines which are neither fake, nor counterfeit, nor pirated
medicines. Moreover, the Frankfurt and Paris seizures happened much after
operation MEDI-FAKE.

Madame Chair, yesterday we discussed that the Para 6 system which was
intended to be an expeditious solution for countries with insufficient or n=
o
manufacturing capacity has been used only once in 6 years of its operation.
We are scared  to think about a hypothetical possibility in which an LDC
were to order drugs from another country, using the Para 6 system, and the
drugs were to transit via the EC. In all probability, these drugs would
violate the IPR in the country of transit. If generic drugs have been seize=
d
in the past, such consignments produced under Para 6 would in all
probability also be seized. Would this not constrain countries with no or
insufficient manufacturing capacities from using TRIPS flexibilities? What
assurances do we have from the EC that such consignments will not be seized=
?

In the last TRIPS Council meeting the EC stated its commitment to
=B3facilitating access to affordable medicines for countries in need=B2. Th=
e EC
have also  defined themselves as =B3one of the main promoters of the Doha
Declaration and the TRIPS flexibilities=B2. Actions on the ground contradic=
t
these exalted objectives. What confuses us is the irony that while on the
one hand, EC countries are providing funds for public health programmes of
developing countries, =8A. at the same time barriers are being created to
legitimate trade in generics and to hamper access to medicines. Actually, E=
C
Regulation 1383 promotes  this dichotomy.

ENFORCEMENT and other aspects of the seizures

Madame Chair,

There are also two other larger issues impinged upon by the seizure of
generic drugs and require serious reflection. These are (i) international
humanitarian law and (ii)  current trends in IP enforcement norms.



(i) The issue of seizure of generic drug consignments is not merely a trade
issue. It is much larger than that. The implications on universal access to
affordable and efficacious medicines is a humanitarian issue =8A of immense
public interest=8A=8A and closely related to the Right to health. The seizu=
res,
and the consequent denial of access, run counter not only to the spirit of
the TRIPS Agreement but also the resolution 2002/31 of the Commission on
Human Rights on the right to enjoy the highest standards of physical and
mental health. In this context let me draw your attention to the report of
the Special Rapporteur on the issue submitted to the 11th Session of the
Human Rights Council in June this year. I quote - =B3The Special Rapporteur=
 is
concerned with reports of IP enforcement measures that have resulted in
multiple seizures at some ports of shipments of generic medicines heading t=
o
developing countries and LDCs.=B2 Responding to the drug seizures, a strong
statement (Mar 2009, on website) was made by the WHO, stated  that =B3recen=
t
events related to the handling of medicines in transit and the potential
consequences for the supply of medicines in developing countries are of
major concern to the organization.=B2 The WHO also asserted that =B3Ensurin=
g
that the interests of trade and health are appropriately managed, also mean=
s
that the flow of legitimate medicines, including generic medicines, is not
impeded.=B2

(ii) The next =8Clarger issue=B9 is the implications of TRIPS plus enforcem=
ent
norms. Conceptually, TRIPS provides minimum levels of IP protection. The
concept implies that members may provide more extensive protection. However=
,
such higher levels of protection are clearly qualified in TRIPS Agreement.
Art.1:1,  states that more extensive protection may only be granted
"provided that such protection does not contravene the provisions of this
Agreement". Such higher levels of protection can only disturb the balance o=
f
the Agreement. This =8Cbalance=B9 is elaborated in several provisions. TRIP=
S
Preamble cautions that  TRIPS must =B3ensure that measures and procedures t=
o
enforce intellectual property rights do not themselves become barriers to
legitimate trade=B2 Art.41:1 TRIPS (General Obligations) says that all TRIP=
S
enforcement procedures =B3shall be applied in such a manner as to avoid the
creation of barriers to legitimate trade and to provide for safeguards
against their abuse.=B2

It needs to be borne in mind that the transitional period for developing
countries contained in Art 65 was completed barely 4 years ago, in 2005, by
when developing countries carried out legislative changes to bring their IP
laws in tune with TRIPS Agreement. For the LDCs the transitional period has
not yet expired and they are still in the process of making the necessary
legislative changes. Therefore, while on the one hand developing countries,
including the LDCs are still adjusting to TRIPS, on the other hand, we are
witnessing an increasing spiral of ever-increasing levels of protection,
thereby reducing the flexibilities and policy space left open under the
TRIPS Agreement particularly for developing countries and LDCs.

We also witness an orchestrated campaign for TRIPS plus enforcement norms b=
y
deliberately confusing quality issues with IPRs in international
organisations (WHO), other TRIPS plus initiatives in WIPO, WCO and UPU,
insistence on TRIPS plus elements in FTAs being negotiated and to top it
all, negotiating the ACTA amid secrecy and exclusion of a vast majority of
countries including developing countries and LDCs.

In 2004 the EC DG Trade adopted the Strategy for the Enforcement of
Intellectual Property Rights in Third Countries, which mapped EC future
actions in this field. The Strategy identifies numerous activities includin=
g
identifying the priority countries, action in the context of bilateral and
multilateral agreements, political dialogue, retaliatory measures, dispute
settlement and the creation of public-private partnerships aimed at the
enforcement of intellectual property rights.

Conclusion:

Madame Chair, let me conclude by saying that India attaches the highest
importance to protection and enforcement of IPRs in accordance with the
TRIPS Agreement. However, the framework for this is laid out in Art 1.1 of
TRIPS and Objectives and Principles set out in Art 7 and 8 of the Agreement=
.
TRIPS plus enforcement contradicts Articles 7 and 8 of the Agreement.
Article 7 explicitly mentions that the =B3enforcement of intellectual prope=
rty
rights=B2 must be done =B3in a manner conducive to social and economic welf=
are=B2.
Article 8 upholds Members=B9 rights to =B3protect public health and nutriti=
on=B2.
We do believe that protection and enforcement of IPRs can not override the
fundamental tenets of international humanitarian law, the right of access t=
o
medicines and the balance of the TRIPS Agreement.

The widespread and repeated seizures, under the EC Regulation 1383, have an
adverse systemic impact on (i) the principle of universal access to
medicines, (ii) national public health budgets, (iii) legitimate trade of
generic medicines, (iv) South-South commerce, (v) use of TRIPS flexibilitie=
s
and also (vi) seriously impair the efforts of civil society organisations
engaged in providing medicines and improving  public health in the least
developed parts of the world.

We, once again, call upon the EC to urgently review the Regulation and brin=
g
it in conformity with WTO provisions including GATT, TRIPS Agreement and th=
e
letter and spirit of the DMD on Public Health.
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