Health advocates have raised alarm over reports that several million pills of generic medicine were held up in Frankfurt airport in May despite being destined for a different port. And new information has come to light indicating Dutch seizures were more numerous than originally thought. These developments have prompted outcry and the assertion that a European-wide law on customs and intellectual property is problematic.

There were 17 cases of medicine seizure in 2008, said Sophie Bloemen of Health Action International, quoting a response of the Dutch authorities to an HAI freedom of information request (Wet Openbaar Bestuur in Dutch). Concerns have risen in recent months over delayed shipments of legal generic medicines passing through the Netherlands from India (IPW, Enforcement, 6 March 2009). The issue could come up at the World Trade Organization Council on Trade-Related Aspects of Intellectual Property Rights, meeting 8-9 June, as it has in the past (IPW, WTO, 3 February 2009).

The Frankfurt seizure is the first reported in Germany under the European Community regulation 1383/2003 [doc], which provides rules and regulations over the authority of customs officers to control goods believed to be infringing IP rights. The latest seizure has escalated calls for a change in the regulation.

An Indian official raised concern to Intellectual Property Watch Friday about “a pattern” of delaying generics, which the official said indicates a “well-thought out strategy” on the part of IP enforcement authorities.

‘’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,” said Sune Sveningsen of Missionpharma, which had supplied the drugs stopped in Germany.

She was quoted in a 5 June press release [pdf] signed by five non-governmental organisations working in public health advocacy: Health Action International, the Third World Network, Medico International, BUKO Pharma-Kampagne and Oxfam Germany.

17 Dutch Seizures

Of the 17 Dutch seizures, 16 were shipped from India and one from China, according to the response of the Dutch government to HAI’s freedom of information request. The Netherlands was not the final destination of any of these shipments. They were instead headed to ports in Peru, Columbia, Ecuador, Mexico, Portugal, Spain, Brazil and Nigeria.

They contained medications related to cardiology, lifestyle, HIV/AIDS, dementia, and schizophrenia, according to a translation of the response by Bloemen. Of these, six “assumed permission” to destroy, which Bloemen said means the generic manufacturer did not react to the rights holder. A copy of the letter from the Dutch government is available here [pdf], but in Dutch only. A translation into English is expected to be posted to the HAI website soon, she said.

Challenging the EU Regulation

“Patent infringement” should be excluded from the EU regulation 1383/2003 “in order to avoid seizures of legitimate generic medicines in transit,” Alexandra Heumber, IP policy adviser to the Médecins Sans Frontières (MSF) Access to Essential Medicines Campaign, told Intellectual Property Watch.

The law that 1383/2003 grew out of, a 1994 regulation 3295/94, was much narrower in scope, she explained. Rather than including all violations of intellectual property, it focussed on counterfeit and pirated goods – generally a trademark issue.

The updated, broader law, is problematic as “we have seen no justification for the extension to this area and no impact assessment of the effects,” she added.

The German Seizure

According to the advocates, the German seizure also shipped from India. Over 3 million pills of Amoxicillin, a generic antibiotic, were stopped in Frankfurt airport on 5 May on the suspicion that they had infringed a brand-name antibiotic, Amoxil, owned by GlaxoSmithKline (GSK).

There is “no valid reason for detaining these medicines,” said the press release. German authorities could not be reached by press time.

GSK, when contacted by authorities, said that there had been no infringement, the press release said. This allowed the medicines to be released to their destination, the island country Vanuatu.

The pills contained in the shipment represent 76,000 courses of treatment, which were delayed by 4 weeks in their journey to the Pacific, according to the press release.

“The EC should urgently provide clear guidance to the customs in order to avoid detainment of legitimate generic medicine in transit,” Heumber said. “Those detainments have an impact on the access to medicines for patients in developing countries.”