[Ip-health] Intervention by India at June TRIPS Council 2009: Seizure of generic drug consignments at EC ports

[Thiru Balasubramaniam]

INTERVENTION by INDIA =96 TRIPS Council June 2009

Agenda item =91M=92 =96 OTHER BUSINESS =96 Seizure of generic drug
consignments at EC ports

Madame Chair,

When India and Brazil raised the issue of seizure of generic drug
consignments at EC ports in the TRIPS Council meeting of March 3, we
did not foresee that we will need to raise the issue again in today=92s
meeting. Going by EC=92s intervention at the last TRIPS Council meeting,
confirming their commitment to the Doha Declaration on Public Health,
we thought that the matter will get the attention it deserves and get
resolved. Regrettably, this has not happened and we are compelled to
raise the issue in this meeting. We have neither received a
satisfactory response from the EC to our formal communication to them
in Brussels, nor have we seen any review of the relevant EC regulation
or actions by Customs authorities. Seizures have continued with the
latest one being at Frankfurt last month.

We have received information that a shipment 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 on 5 May, 2009, while in transit through Frankfurt, Germany.
Amoxicillin is an essential  medicine used to treat a wide range of
bacterial infections. We understand that the consignment worth
approximately 28,000 Euros consisted of 3,047,000 tablets of
Amoxicillin (250 mg), equivalent to 76,000 courses of treatment. The
seizures were made on grounds of alleged trademark violation although
GlaxoSmithKline (GSK) has confirmed to the German authorities that GSK
is the former patent holder for =93Amoxil=94, a brand name for
amoxicillin. There seems no valid reason for detaining these medicines
especially since the name =93Amoxicillin=94 is an international
nonproprietary name (INN).

In the last TRIPS Council meeting, and subsequently in our formal
communications to Brussels, we had asked the EC to provide details of
all drug consignments seized by customs authorities and the grounds of
such seizures. We have not yet received such information from the EC
so far. However, in response to a request made by  Health Action
International (Europe) under the Freedom of Information Act, the Dutch
government have provided limited information. The information shows
that the case of Losartan exported from India to Brazil, and seized at
Amsterdam, was just the tip of the iceberg. We have come to know that
there have been 17 seizures by the Dutch authorities in the year 2008
on the basis of  EU regulation 1383/2003.  Of these 16 consignments
originated in Indian and one in China. These consignments were bound
for Brazil (1 consignment),Peru (x5), Colombia  (x4), Ecuador  (x2),
Mexico (x2), Portugal (x1), Spain (x1) and Nigeria (x1). The drugs
were for diseases such as cardiological ailments, AIDS,  dementia  and
schizophrenia. It needs to be noted that all 17 consignments
originated in developing countries and 15 of the 17 were destined for
developing countries.

We have followed closely the different grounds mentioned by the EC for
such seizures. The grounds stated by EC include counterfeits, fake
drugs, substandard, potentially dangerous products, patent violations
and so on. The EC have also made allegations ofdrug trafficking after
three months of seizure of a particular consignment. These are serious
allegations and we take serious exception to such unsubstantiated and
wild allegations. The fact that the drugs were subsequently released
are a proof that the allegations were baseless.

Seizures have continued to take place at EC ports. The multitude of
allegations and the spread across several EC ports, imply an emerging
pattern to disrupt and create barriers to legitimate trade of generic
drugs and to challenge the Doha Declaration on Public Health. The
basic principle of transparency of procedures has also been violated
by the inability of the authorities to share and explain the specific
cause of action under EU regulations.

EC has sought to justify the action of customs authorities to control
goods in transit suspected of infringing IPRs as a means to stop
=93traffic of potentially dangerous products, such as fake medicines,
even when the shipments were destined for any country.=94 It seems that
it has been ingrained very deeply within the EC authorities that IP
violative products are synonymous with potentially dangerous
substances. This clearly is an untenable logic.  We doubt such
simplistic linkages. Moreover, we are talking about generic medicines,
which neither infringe IPRs nor are they =91potentially dangerous=92. EC
takes pride in its claim that =93EU customs actions in the past had
saved lives in the final destination countries which were often
developing countries.=94  We wish to remind the EC that the concept of
'territoriality' is a key stone in the edifice of the TRIPS Agreement
and a widely understood and accepted principle.  In our view,
sovereign functions of the country of destination should be exercised
by the country itself and other countries may assist in enforcement of
their law, if requested.  It may be farfetched to claim that the
country of transit will have sound understanding of the IPR laws of
country of destination or origin and will have the authority to
enforce them during transit.  It would also be incorrect to presume
that the sovereign countries, to which pharmaceutical goods are
consigned, are not responsible for ensuring health, safety and
expectations of consumers in their countries. In such situations, an
information sharing mechanism is what is needed and definitely not
action under the laws of the country in transit.  If there is a reason
to doubt the quality of goods, enforcement action should follow from
domestic regulations in importing country and not from WTO rules,
which do not provide for the same or from rules of a third country.

The seizures run counter to the spirit of the TRIPS Agreement and 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 Members=92 attention to the report of the Special
Rapporteur on the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health submitted to the
11th Session of the Human Rights Council last week. I quote - =93The
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 to developing countries and
LDCs.=94

Widespread and repeated seizures have an adverse systemic impact on
legitimate trade of generic medicines, South-South commerce, national
public health policies and the principle of universal access to
medicines. The importance of  generic drugs to public health in
developing countries and particularly in the LDCs is obvious.  Such
barriers to legitimate trade of generic drugs will also seriously
impair the efforts of civil society organisations engaged in providing
medicines and improving  public health in the least developed parts of
the world.

I would like conclude by  reminding the EC that trade of generic drugs
is perfectly legitimate. Moreover, it is also desirable from the
public health and access to medicine perspective. It is ironical that
while on one hand WTO has taken steps to promote access to affordable
medicines and remove obstacles to proper use of TRIPS flexibilities,
on the other hand some Members seek to negate the same by seizing drug
consignments in transit and creating barriers to legitimate trade.

Since seizures have been recurring at different ports and on different
grounds, it is therefore clear that rather than just being a problem
of implementing a law by Dutch Customs authorities, it is the EC
regulation 1383/2003 itself that is problematic and can be misused,
and has been misused, to create barriers to legitimate trade. We, once
again, call upon the EC to urgently review the Regulation and the
actions of the national authorities based on the Regulation, and bring
them in conformity with the letter and spirit of the TRIPS Agreement,
the rules based  WTO system and the DMD on Public Health.  Madame
Chair, India attaches the highest importance to protection and
enforcement of IPRs in accordance with the TRIPS Agreement. However,
we do not see the Agreement as divorced from the Objectives and
Principles set out in Art 7 and 8 of the Agreement.  Enforcement of
IPRs in disregard of these Objectives and Principles and efforts to
enshrine new, maximalist TRIPS plus enforcement provisions in other
multilateral forums will seriously undermine the delicate balance in
the TRIPS Agreement and raise systemic issues, particularly for
developing countries.

Madame Chair, my delegation will like this Council to take note of
these points.

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


Tel: +41 22 791 6727
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