[Ip-health] Indian intervention at WTO on seizure of drug consignments

[Sangeeta]

WTO General Council Meeting  (February 03 , 2008)
INTERVENTION by INDIA (under agenda item 'Other Business')


Mr Chairman,
In the last few months, Dutch customs authorities have seized several
consignments of generic drugs of Indian companies on grounds of alleged IP
violations. Seizure of the consignment of losartan potassium in December,
2008 was one such case of what is emerging as a clear pattern. Such
instances cause us great concern due to their systemic and far reaching
implications.  In addition to going against the spirit of a rule based
trading system and impeding free trade, such acts represent a distorted use
of the international IP system and circumscribe  TRIPS flexibilities. Repeat
of such actions may have an impact on exporters' choice of transit routes,
which may affect the economics of trade of pharmaceutical products and
consequently, have a deleterious effect on access to essential drugs and
public health budgets of recipient countries.

Losartan Potassium, used in treatment of hypertension, is a perfectly IP
legitimate generic drug in both India and Brazil. Trade of such a drug is
also perfectly legitimate. The WTO rule based system provides for freedom of
transit by the most economical and convenient routes and without unnecessary
delays and restrictions. The act of seizure by the Dutch authorities is
therefore, a denial of the rule based system which we seek to build and
strengthen in the WTO. The concept of 'territoriality' is a key stone in the
edifice of the TRIPS Agreement.  There are no indications that the drug
consignment was meant for the markets of the EC. Seizure, and initiating
procedures for destruction of such consignments, violates this key
principle. Members have always strived for a balance between public health
concerns and protection and enforcement of IPRs.  The decisions on Public
Heath are a valuable part of the WTO acquis and need to be adhered to in
letter and spirit.   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.
Mr. Chairman, the importance of generic drugs and their essentiality may
vary in inverse proportion to the level of development of a country.
Therefore, high importance is attached to generic drugs in developing
countries and particularly in the LDCs. Barriers to legitimate trade of
generic drugs will seriously impair the efforts of organizations like the
Medecins Sans Frontieres (MSF), Clinton Foundation, Bill and Melinda Gates
Foundation and a whole lot of other organizations engaged in providing
medicines and improving  public health in the least developed parts of the
world.

I would also like to draw the attention of Members to another trend that is
acquiring huge dimensions.  This is the effort to implement the protection
and enforcement of IPRs in a maximalist manner and thereby upset the
delicate balance between rights of IPR holders and the public policy
objectives under the TRIPS Agreement. A coordinated approach is being
witnessed in several international fora like the World Customs Organisation,
World Health Organisation, Universal Postal Organisation etc. to promote the
IP maximalist agenda.  We also note with dismay efforts by some Members to
link safe and efficacious but low cost generics with counterfeit medicines,
which is essentially an IPR issue. There is an attempt to enlarge the
definition of counterfeits beyond its definition in the TRIPS Agreement, to
set maximalist enforcement norms, and to include TRIPS plus provisions in
RTAs. These are subtle and concerted ways of circumscribing the
flexibilities of the TRIPS Agreement. They also run counter to the spirit of
the TRIPS Agreement which is a minimum standards agreement. And, this is
certainly counter to the understanding given to developing countries when
the TRIPS Agreement was being negotiated.

Mr. Chairman, 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.  Efforts to enshrine new, maximalist TRIPS
plus provisions in other forums will seriously undermine the delicate
balance in the TRIPS Agreement and raise systemic issues.

I would like to conclude, Mr Chairman, by reverting to the issue of seizure
of various drug consignments by the Dutch authorities. We have raised the
issue here with the expectation that the EC will urgently review the
relevant regulations and the actions of the national authorities based on
such regulations, and bring them in conformity with the letter and spirit of
the TRIPS Agreement and the rules based  WTO system.