[e-drug] Seizure of Indian generic ARVs in Netherlands en route to Nigeria

E-DRUG: Seizure of Indian generic ARVs in Netherlands en route to
Nigeria
----------------------------------------------------------------

[Your Dutch moderator is embarrassed about this seizure of life-saving
generic ARVs (ordered by UNITAID/Clinton Foundation for Nigeria) by the
Dutch Customs. These products are legally produced in India, and are
legally distributed in Nigeria. They are financed by the International
donor community. The products are prequalified by WHO. The claim that
these products are patent protected in the Netherlands appears to make
them "counterfeits" according to Dutch Customs, who are interpreting the
EU Directives in a very narrow minded way. This is really outrageous,
and makes a mockery of the 2001 Doha Declaration which clearly allowed
countries to put public health above trade interests.

The Dutch customs are in fact preventing legitimate trade, and are endangering the lives
of Nigerian AIDS patients. If this was an isolated incident, it could be
forgiven. But there are several incidents like this in recent months,
and there is a need to urgently expose the politics behind this. This is
an embarrassment for the Netherlands government, which has been very
supportive of developing countries using their rights and flexibilities
under the TRIPS agreement. Maybe India should start a boycott of
Amsterdam airport and fly the goods through Dubai to Africa? Below the
press release by HAI, Oxfam and KEI. Discussion welcome on actions to be
taken to prevent this from happening in the future. WB]

Seizure of UNITAID/Clinton Foundation antiretroviral medicines by Dutch
customs authorities 'unacceptable'
6 March 2009

Call on the EU to allow life-saving generic medicines to reach world's
poorest Oxfam International, Health Action International and Knowledge
Ecology International condemn the unacceptable seizure of legitimate
generic antiretroviral medicines in transit from India to Nigeria by
Dutch customs officials, and call on the European Commission to
immediately review and modify its regulations (Council Regulation (EC)
No 1383/2003 of 22 July 2003) to allow lawful trade of generic
medicines.

Sophie Bloemen from HAI said: "The Dutch government has erroneously
identified these Indian-manufactured generic medicines passing through
their port as counterfeit. This is a grave situation. If the shipment is
not allowed to pass, HIV positive Nigerians will miss out on critical
treatment. We're concerned about what appears to be confusion between
counterfeit medicines that kill people and generic medicines that save
lives."
The seizure is the latest episode in a series of abuses of EU
regulations, which enable customs authorities to seize medicines
in-transit suspected of infringing certain intellectual property rights.
In February this year, Dutch authorities seized a shipment of a
cardiovascular medicine destined for Brazil and this last year there
have been at least 14 other documented cases.
These seizures are particularly threatening the health care systems of
developing countries that rely on generic medicines to legally provide
affordable health care to poor people.

Sophie Bloemen added: "In order to avoid more wrongful seizures of legal
generic medicines in transit through Europe, the European Commission
must immediately review and modify its regulation. Indeed it must modify
the way it applies IP enforcement globally, because it is even demanding
exactly the same provisions of IP enforcement in developing countries
through free trade agreements. This could prove to be disastrous for
access to medicines in their regions.''

Rohit Malpani from Oxfam International commented: "The seizure reflects
a nonsensical encroachment by the European Commission's on the WTO's
Doha Declaration on TRIPS and Public Health, which ensures that
intellectual property rules should not interfere with the ability of
developing countries to protect and promote public health." "This
situation cannot be allowed to continue. It is time that the WTO and WHO
gave strong and clear leadership to ensure that lawful trade in generic
medicines is not blocked" Malpani continued.

KEI spokesperson Judit Rius Sanjuan commented: "The seizure of generic
drugs in transit to developing countries is unacceptable and the Dutch
government and the EU must change their approach to current EU
regulations. We suggest that they invite Pascal Lamy, WTO Director
General, to mediate in this dispute so the governments and organizations
involved can find a solution that respects the commitment included in
the 2001 WTO Doha Declaration on the TRIPS Agreement and Public Health
and the 2008 WHO Global Strategy and Plan of Action on Public Health,
Innovation and Intellectual Property."

"The EC has committed to support universal access to prevention,
treatment and care of HIV and AIDS by 2010. It must deliver on these
commitments by ensuring that all life-saving generic medicines can pass
through Europe onto their final destination," said Rohit Malpani.

For more information from Health Action International, please contact
Terri Beswick, Communications Officer terri@haiweb.org +31 20 489 1077

For more information from Oxfam International, please contact Angela
Corbalan, angela.corbalan@oxfaminternational.org, + 32 473 56 22 60

For more information from Knowledge Ecology International, please
contact Judit Rius Sanjuan, Attorney, Knowledge Ecology
International/Essential Information www.keionline.org www.cptech.org
Phone: +1.202 332 2670, ext 18

E-DRUG: Seizure of Indian generic ARVs in Netherlands (2)
---------------------------------------------------------

dear WB,

A bit of clarification - you say the Dutch Government is embarassed by this action of Dutch Customs.

[No, I wrote that I personally, being a Dutch moderator, am embarrassed, not the Dutch Government! They clearly should be embarrassed, but I have not yet seen an official government response. WB]

Presumably the latter is under the jurisdiction of the former. What stops the Dutch Govt from overruling the actions of one of its arms?

[Good question! I will ask them... WB]

Also what is the international law on this? And what is the EU law that it
violates? Which one gains precedence?

[The Dutch Customs seem to act on the basis of EU Council Regulation (EC) No 1383/2003 of 22 July 2003 titled "Regulation concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights".

This seems to be a measure passed under Article 133 (formerly Article 113) of the EC Treaty. The provision is designed to protect the intellectual property rights of constituents of member nations.

The provision encourages EU Member States to facilitate cooperation between their respective customs agencies in preventing IP infringement.

The provision permits owners of intellectual property rights "to prohibit entry into the EU and the export or re-export from the EU, of goods infringing: trade marks, copyright, patents, national or Community plant variety rights, designations of origin or geographical indications and geographical designations".

The "infringing" products were never meant to be for the EU market, and just happened to be at an European airport. Theoretically this may be an infringement of the Netherland patent law, but obviously this transit shipment should be handled differently.

The interesting question is whether:

(1) the Dutch Customs acted on their own initiative (do they have lists of drugs patented in the Netherlands at hand when medicines are in transit in Amsterdam airport? And do they then consider any potentially infringing product as a "counterfeit" product? That would mean they are acting as "patent police"... Clearly a situation that should be discussed by the Dutch Government, as this goes against many other statements of the Dutch Government in international fora.)

(2) the patent holder knew about the shipment, and asked the Customs to block the transit shipment? This would be a violation of Industry's own assertion that "patents are not a barrier to access to medicines". Would anyone from the pharmaceutical industry want to comment?
WB]

I am told that this action is violative of the International Transhipments Act (or equivalent law) under which you cannot seize goods parked in transhipment zones so designated unless the said goods are suspected to be narcotics or arms meant for elements enimical to the country in question.

[Being a public health physician, I cannot comment on your question.
E-drug welcomes the comments of (IP) lawyers and specialists in this area!

At least it violates the spirit of the Doha Declaration, and also impedes legal international trade. Wilbert Bannenberg]

regards

S.Srinivasan
LOCOST,
India
sahajbrc@youtele.com