[Ip-health] Intervention of India at MSF workshop at the WTO Public Forum

[Thiru Balasubramaniam]

Intervention of India at MSF workshop at the WTO Public Forum


India delivered the following intervention at MSF's workshop at the
World Trade Organization Public Forum today. The title of the MSF
workshop was "Controversy at customs - the detention of medicines in
transit: what impact on access to medicines?"
WTO Public Forum ( MSF event)

Controversy at customs - the detention of medicines in transit: what
impact on access to medicines?

Wednesday 30 September 2009, 14:15 to 16:15

WTO building, Room A

"Since January this year, much has been said, much has been heard but
practically nothing concrete has been done about reviewing 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.

Several developing countries including India and Brazil have raised it
in the GC, TRIPS Council & other international fora and highlighted
that 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
and also (v) seriously impair the efforts of civil society
organisations engaged in providing medicines and improving public
health in the least developed parts of the world.

Indian efforts with the EC to address the issue:

India has taken up the issue bilaterally with the EC at the level of
senior officials and even at the level of Ministers. We have also
formally written to the EC several times. We have received a few
responses which, other than reiterating commitment to Doha
Declaration, gloss over the issue and do not mention any concrete step
being taken or planned to be taken by the EC to rectify the situation.
The last we heard was two weeks ago when the EC forwarded an
=91Explanatory Note=92 dated July 31 which it had sent to Member States on
the application of the EC Regulation 1383/2003.

The Note provides us no comfort at all. It merely shifts the blame to
MSs for applying their national laws 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.
If EC Regulation 1383 additionally covers patents and other IPRs and
extends to goods in transit, it alone is to blame for the recent drug
seizures since it provides a basis for MSs to apply IPRs extra
territorially and to goods in transit. The Note, in a redundant
exercise, also repeats the timelines indicated in TRIPS Art 55
(Duration of suspension). Elaborating in great detail on the timelines
in the Note seems to be an effort at evading the real issue. It need
not be re-emphasized that these timelines were hardly followed by
Customs authorities in the various cases of drug seizures in 2008.

Q: Is it true that it is only the national laws of MSs responsible for
maximalist enforcement? The Dutch Minister for Foreign Trade, Frank
Heemskerk, responding to some parliament Members earlier this month
said, =93The Dutch customs department acted in accordance with extant EU
legislation, and in particular Council Regulation (EC) No. 1383/2003.=94
The Minister further states that, =93The basis of a solution must
therefore be sought within European legislation itself.=94 We can=92t
think of a clearer articulation of where the problem lies.

The EC even refuses to acknowledge that these were =91seizures=92. They
refer to them as =91temporary detainment=92. We do not understand why some
consignments were detained upto 4 months inspite of the 10+10 day
stipulation of TRIPS. Some consignments never reached the destination
countries. The importers were asked to take them back.

We have asked the EC about the fact that although the Regulation is 6
years old, why have the drug seizures taken place fairly recently. We
are told about the ambitious =91Operation MEDI-FAKE.=92 Yesterday
(29/09/09), at an EC meeting, Patrick Ravillard said =93The Regulation=92s
aim is to stop drugs violating IPRs=94. We get very confusing signals.
Are the seizures to deal with spurious drugs or IPRs? India is as much
against spurious drugs as any other country but here we see 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. Actually, all this does not stop there. It
seems to be a part of a larger design for maximalist enforcement of
IPRs. There seems to be an orchestrated campaign of deliberately
confusing quality issues with IPRs in international organisations
(WHO), 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.

The EC Regulation 1383 is open to interpretation and implementation in
different ways (as in Drugs and Nokia cases), therefore, a Damocles=92
sword is always hanging. Our experience has been that the sword falls
on generic drugs more than mobile phones.

It is also ironical that while on the one hand, EC countries are
providing funds for public health programmes of developing countries,
=85. at the same time they create barriers to legitimate trade in
generics and hamper access to medicines. Actually, EC Regulation 1383
promotes this dichotomy.

The multitude of drug seizures indicate an emerging pattern to disrupt
and create barriers to legitimate trade of generic drugs and to
challenge the Doha Declaration on Public Health. If the EC is
committed to the Doha Decl on PH and supports access to medicines,
what explains the repeated drug seizures of medicines including AIDS
and serious heart aliments. Is it that with the decline in patenting
of =91block buster drugs=92 and =91new chemical entities=92 European pharma
companies see a threat from generic industry as more and more drugs go
off patent. If this is so, it comes at a huge humanitarian cost.

On the issue of WTO compatibility, in our view, EC Regulation
1383/2003 violates GATT Art V that allows Freedom of Transit by most
economical and convenient routes and without unnecessary delays and
restrictions. It also violates border measures enshrined under Art
41-61 of TRIPS. In particular, the application also violates the key
TRIPS principle of =91territoriality=92 and Art 41 which obliges Members
to =91avoid creation of barriers to legitimate trade=92. This is not our
view alone. The European Generic Medicines Association (Feb 2009)
wrote to the EC saying that such and application to drugs which are
IPR compliant in country of origin and destination =91will effectively
create a barrier to the trade in legitimate generic medicines
worldwide=92 and =91is contrary to Art 41 of the TRIPS Agreement.

Coming back to Mr. Rallivard=92s statement yesterday in Brussels, he
outlined several initiatives =93not to disturb the legitimate trade of
generics, also when they are in transit =93 viz. (i) reminding MSs and
national authorities to pay attention to the distinction between
counterfeit/generic, (ii) giving further instructions/information to
customs, (iii) initiating a dialogue with pharmaceutical industries,
associating India and Brazil in this exercise of transparency and
dialogue. We agree that transparency and dialogue are essential.
However, it would be interesting to note that we are yet to hear from
the EC about the details of the seized consignments. Our only
information is the one provided by the Dutch Govt in response to a
request made by HAI (Europe). Mr. Rallivard also mentioned that =93In
addition, the EC is reviewing the whole Regulation and will keep alert
on this dossier.=94 We also hear several MEPs making the demand to
review the Regulation 1383/2003. Mr. Luc Devigne could elaborate on
whether the EC has serious plans to review 1383/2003..

Our conclusions:

The issue of seizure of drug consignments is not merely a trade issue.
It is a humanitarian issue. It is an issue of immense public interest=85=85
of access to affordable and efficacious medicines=85and closely related
to the Right to health. This concern is clearly brought out in 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 in
June this year.

The EC needs to =91walk the talk=92 in its stated commitment to facilitate
access to medicines in developing countries and the DDPH. We see the
EC Regulation 1383/2003 at the root of the problem. To find a lasting
solution to the problem it is imperative that the Regulation 1383/2003
is reviewed and brought in line with GATT/TRIPS and the spirit of the
Doha Declaration on Public Health."


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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