Seizures of legal generic drugs was the focus of heated discussion Monday at the World Trade Organization Council on Trade-Related Aspects of Intellectual Property Rights (TRIPS), raising questions about the implementation of enforcement measures in the European Union.

Both Brazil and India made interventions strongly condemning the seizure of generic medicines in transit through the European Union, which Brazil said was cause for “grave concern” and India said was the result of a simplistic linkage between intellectual property rights concerns and potentially dangerous medicines. Both countries decried the negative effect such delays could have on public health in the developing countries, where the majority of the shipments were heading, and in particular challenged the right of the EU to stop goods in transit.

The “TRIPS agreement does not allow the detention of goods in transit,” Brazil said in the 8 June meeting, adding to do so on grounds of potentially violated IP rights “runs counter to the objectives and purposes of the TRIPS agreement.”

This, said India, has 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” and indicates that the EU regulation allowing for such action is “problematic and can be misused, and has been misused, to create barriers to legitimate trade.”

But the EU countered, telling Intellectual Property Watch that the seizures should be referred to as “temporary detention for customs inspections” as they were not permanently prevented from getting to their destination, and said that the delays in Frankfurt – the location of the latest incident – had been resolved in the 20 working days allowed by the TRIPS agreement for such measures, and were justified by a larger struggle against potentially dangerous fake medicines.

TRIPS Plus or Protection from Fakes?

The issue sparked discussion at the last TRIPS Council meeting on 3 March, when the EU assured countries that the seizure of the generic hypertension drug Losartan (in transit from India to Brazil) in December 2008 in the Netherlands was an isolated and exceptional case and assured them that the issue would be resolved, according to statements made by Brazil and India on 8 June.

But the emergence of a new case of delayed medicines and new information from the Dutch government since March sparked Brazil and India to conclude the Losartan case was just “the tip of an iceberg,” as Brazil’s intervention [pdf], delivered during the meeting, asserted. India’s intervention is available here [pdf].

The new case involved 3 million pills of antibacterial amoxicillin delayed in a port in Frankfurt on a suspected trademark violation on 5 May. The new information released by the Dutch government after a freedom of information act request indicates that there were 17 seizures of generic medicines on charges of patent infringement at ports in the Netherlands during the year 2008 (IPW, Public Health, 6 June 2009). Sixteen of the 17 came from India, according to the Dutch government.

And in the Losartan case, Brazil said, the manufacturer was told either to take the cargo back, or face litigation in the Netherlands. Letting the medication go to the final destination was not an option, it said.

The “decision to impede the transit of cargos of generic medicines violates the freedom of transit,” said the statement of Brazil. The statement adds that the actions fit into a larger EU pattern of promoting so-called TRIPS-plus regulations (stronger than the TRIPS agreement) by supporting actions considered to be TRIPS-plus in other international agencies. These include: the World Health Organization under the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) which drew criticism as overly influenced by industry and developed countries (IPW, 27 January 2009), and the World Customs Organization, via the SECURE Working Group (IPW, Enforcement, 8 January 2009), the Anti-Counterfeiting Trade Agreement, and bilateral negotiations, said Brazil.

Separately, a recently released analysis of the EU-India bilateral agreement under negotiation [pdf] says the text of the draft free trade agreement specifically calls for rights and obligations “beyond” those of the TRIPS agreement. The study by Prof. Carlos Correa of the University of Buenos Aires was commissioned by Oxfam Germany and the Church Development Service.

But EU delegates told Intellectual Property Watch that they had to guard against the prospect of dangerous drugs re-entering by illicit means. “We stop goods in transit” due to the risk of re-entry to Europe via black market or illegal channels, one delegate said. The EU’s statement is available here [doc].

“The EU can’t become a platform for substandard drugs around the world,” the other EU delegate added, saying that on the issue of trademark violations, brand-named items were as likely to be affected as generic named items.

Further, they said, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has said they will not ask customs to control legitimate (not patented in either originating or destination country) generics in transit. After the March TRIPS meeting, EFPIA released a statement saying it was neither their policy nor their practice “to encourage member states to use the powers of detention… to prevent the flow of legitimate generic products from manufacturer to customer outside the EU.

The German case is the first case in 2009, and the first case since the issue was raised in March, EU delegates told Intellectual Property Watch. “The 2008 cases were not repeated in 2009,” they added. Further, the amoxicillin was “released without unnecessary delay” when the rights holder made clear it was not violating any trademark.

Legitimate trade can be affected, the EU delegates acknowledged, as “collateral damage” from policies intended to stop an increasing amount of trade in substandard goods. The cases have to be placed in the context of “us having to fight substandard” medicines, as well as in the number of goods that pass through EU borders, they added.

Brazil called this a “blatant attempt to confound the issue” and said that the customs authorities have hampered access to affordable life-saving medicines.

Enforcement: Making a TRIPS Comeback?

At the end of the day, enforcement was brought up briefly. A developing country delegate told Intellectual Property Watch it was raised by the United States with EU support. But the United States said they had not brought it up, and the EU said that it was in context of the drug seizure debate, which is over whether or not there had been incorrect enforcement measures.

Either way, the developing country delegate said it would be “wiser to deal with it here than at the WCO or UPOV [the International Union for the Protection of Varieties of Plants]” or elsewhere. The problem of “forum shopping” – in which countries look for different bodies in which to pursue the enforcement agenda – is a periodic concern of many developing nations (IPW, Enforcement, 17 September 2008).