NGOs slam EU customs seizures

The European Commission should amend its counterfeiting regulation to ensure it does not have a detrimental impact on developing countries, by excluding border measures for violations of pharmaceutical patents, especially for medicines in transit.

That is the conclusion of a just-published report from Health Action International and Oxfam, which says that the EU is "taking the lead in a global offensive to increase enforcement of intellectual property under the banner of combating counterfeiting through new global rules that could, if implemented, seriously undermine access to affordable generic medicines."

The report comes after several high-profile cases in which legitimate generic drugs, manufactured in and destined for markets outside the EU, have been intercepted at EU borders in transit to their destination.

HAI has repeatedly called for the EU to revisit Council Regulation No. 1383/2003, which covers customs action against goods suspected of infringing IP rights, claiming it lies at the heart of the confusion between counterfeit pharmaceutical products and legitimate generic medicines.

"By applying EC rules at the border via the enforcement agenda, the EC is imposing its internal IP standards on the rest of the world," claims the report, which is available to download here.

In the document, HAI and Oxfam accuse the EU of "cynically" trying to justify new enforcement measures by claiming that the proposals will help combat the trade in counterfeit medicines in the developing world. In reality, the enforcement rules could divert scant funds away from tackling the trade in counterfeit medicines and towards enforcing IP rule, they argue.

The report also refers to "deliberate confusion" surrounding counterfeits and generics, and "state-sponsored harassment" of the legal generic medicines trade.

It cites figures indicating that in recent months, customs officials in the Netherlands and Germany have seized 19 shipments of generic medicines. Of the shipments, 18 were legally manufactured and exported from India (with one shipment from China) and intended for developing countries where they could be legally imported.

The cornerstone of HAI and Oxfam's IP/counterfeiting conflation argument is that counterfeits generally violate trademarks, which is a form of IP distinct from a patent.

"It is not the IP status of a medicine that determines the quality or safety of a medicine," says the report, noting that the World Health Organization defines counterfeit medicines as deliberately mislabelled products with respect to identity or source.

ACTA action

HAI and Oxfam also say the EU must ensure that the controversial Anti‐Counterfeiting Trade Agreement (ACTA) does not set a new global standard for intellectual property rules (IPR) that impedes access to medicines in developing countries.

ACTA cover topics such as the definitions of counterfeiting and piracy and setting out a legal framework for enforcement of IPR, including civil and criminal enforcement and border measures and enforcement practices.

It is currently subject to negotiations between the USA and its trading partners - including the EU, Australia, Canada, Japan, Mexico, Morocco, New Zealand, Singapore, South Korea and Switzerland - and the aim is to ratify it in 2010.

They call for the EU to "ensure that patents are excluded from any agreed framework," in ACTA.