TWN Info Service on WTO and Trade Issues (June09/11)
find below a news report on the discussion that took place in last week's
session of the TRIPS Council on the recent seizure of medicines in transit
It was first published in SUNS and is reproduced here with permission.
voiced at TRIPS Council over seizure of drugs
Geneva, 10 Jun (Sangeeta Shashikant*) -- The repeated practice of EC customs officials seizing shipments of medicines while in transit to developing countries on grounds of alleged IP violations in transit countries has once again come under sharp criticism in the WTO.
criticism this time, with a range of developing countries protesting
the EU customs actions, came over the recent seizure of the generic
antibiotic Amoxicillin by customs officials while in transit in Frankfurt
and destined for the
protest by the developing countries came at a formal session of the
TRIPS Council on 8 June, where
The concerns were over the seizure by customs officials on 5 May of a shipment of the generic Amoxicillin (manufactured in India) while in transit through the European Union, specifically in Frankfurt, and on its way to Vanuatu, a least developed country.
to trade officials, the developing countries expressed concern over
the European Union's commitment to the Doha Declaration on TRIPS and
Public Health and the flexibilities inscribed in the TRIPS Agreement.
They also said that the EU was confusing legitimate generic medicines
with counterfeit fakes. Furthermore, the EU was also undermining poor
countries' ability to obtain cheaper generic medicines.
(In a press release on 5 June, Health Action International (HAI), Oxfam International, BUKO Pharma, Medico International and Third World Network urged the German customs authorities to provide full and transparent information about this seizure. They called on the European Commission to take immediate steps to ensure that its regulations and laws do not deny developing countries timely access to essential medicines.
(Sune Sveningsen, Supply Chain Director of Missionpharma, the agency responsible for the Amoxicillin shipment, was quoted in the press release as saying: "These random seizures seriously impact our ability to service the healthcare needs of people living in developing countries in a timely manner, forcing us to consider re-designing our entire supply chain to avoid any transit through European territories.")
News of this latest seizure comes just as it was also revealed by a Freedom of Information Act request filed by Health Action International that the Dutch authorities in 2008 conducted 17 seizures of medicines bound for Brazil, Peru, Colombia, Ecuador, Mexico, Portugal, Spain and Nigeria.
drugs were for diseases such as cardiac ailments, AIDS, dementia and
schizophrenia. Of these, 16 consignments originated from
These seizures were taking place pursuant to the EC Council Regulation No 1383/2003 of 22 July 2003 (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).
They have sparked anxiety among developing countries and civil society alike. It is anticipated that these seizures are likely to increase, particularly as developed countries continue their strong push for a so-called "anti-counterfeit agenda" in international forums such as the World Health Organisation (WHO) in the context of IMPACT (an anti-counterfeit task force), the World Customs Organisation (WCO), the World Intellectual Property Organisation (WIPO), as well as in plurilateral forums such as the Anti-Counterfeit Trade Agreement (ACTA).
In its statement at the TRIPS Council, Brazil said that it believes that the seizure of goods in transit on grounds that they might be violating IP rights conferred by a patent registered in the country of transit is a serious violation of WTO disciplines.
decision to impede the transit of cargoes of generic medicines violates
the freedom of transit, a right enshrined in GATT Article V. Only very
exceptional circumstances warrant restrictions on that freedom,"
said that its inquiries led to the identification of more than a dozen
seizures of consignments of generic drugs in transit through Dutch territory
in the last year. The medicines were directed to at least seven different
developing countries in South America and
It reiterated that trade in generic medicines is perfectly legal from the intellectual property point of view. Generic must not be mistaken with counterfeit or pirated products. Generic medicines are not substandard or illegal.
that at the last session, in their response to
Communities claimed to be "one of the main promoters of the Doha
Declaration and the TRIPS flexibilities". Rather than TRIPS flexibilities,
however, the EC has actively promoted TRIPS-plus standards in non-specialized
multilateral agencies such as the World Health Organization (through
the IMPACT initiative) and the World Customs Organization, as well as
in plurilateral fora such as ACTA or in bilateral and plurilateral agreements
such as Economic Partnership Agreements, said
the EU claim that their customs actions have "saved lives in final
destination countries - often developing countries",
"The TRIPS Agreement does not allow the detention of goods in transit. The seizure of goods in transit on grounds that they may be violating IP rights in the country of transit violates the principle of territoriality, a keystone of the international IP system."
Brazil also sought clarification on the following questions: (a) How the European authorities' actions can be reconciled with WTO disciplines; (b) Whether EC Council Regulation 1383/2003 requires or justifies such actions from the customs authorities of the Communities; and, above all, ( c) How will the Communities ensure that such actions will not happen again.
the last TRIPS Council meeting on 3 March, the Council discussed the
issue of the seizure by Dutch authorities of the generic medicine Losartan
on its way to
this has not happened and we are compelled to raise the issue in this
respect to the seizure of
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.
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
"It may be far-fetched 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."
such situations, said
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, said
"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."
to trade officials,
The EC responded by saying that it remains fully committed to ensuring access to affordable medicines in developing countries. The EC maintained that it is important to continue to allow the Customs Authorities to control goods in transit and ensure that measures can be taken against global trade in counterfeit products, and in particular, fake medicines whose effects mainly hit developing countries.
The EC further maintained that the Customs Regulation is fully in line with WTO/TRIPS requirements, in terms of scope and coverage of customs intervention.
to trade officials, the
Meanwhile, positions at the TRIPS Council remained unchanged over the issue of patents, bio-diversity and traditional knowledge.
According to trade officials, some members have continued to link this issue, in particular the proposal to amend the TRIPS Agreement to require patent applicants to disclose the origin of genetic resources or traditional knowledge used in their inventions, with two proposals on geographical indications (the multilateral register for wines and spirits and extending the higher level of protection currently given to wines and spirits to other products).
For these members, the "disclosure" proposal is essential to prevent bio-piracy and patents being granted when the material and knowledge used are not new. According to trade officials, those who spoke included India, Brazil, the African Group (Egypt speaking), Ecuador, Cuba, Peru, China, Pakistan, Nigeria, Angola, Norway, Switzerland, and the EU.
members continued to oppose the link. According to trade officials,
According to trade officials, the main focus of the discussions is now in consultations chaired by Director-General Pascal Lamy. Some members said that the full membership should be informed as to what is happening in the consultations, which are taking place among a smaller group of members.
(* With inputs from Kanaga Raja.) +