New Delhi: UNITAID, the drug purchase arm of the World Health Organization (WHO), reacted sharply on 4 March to Dutch authorities seizing HIV/AIDS medicines of Aurobindo Pharma Ltd meant for use in Nigeria.
The purchase by the Clinton Foundation through UNITAID was confiscated at Amsterdam’s Schiphol airport on 12 November on grounds that it contained counterfeit goods and infringed intellectual property rights (IPRs). It is the sixth reported incident of an Indian drug firm’s exports being seized in transit in Europe for shipments meant for other markets.
Aurobindo’s abacavir tablets, used in HIV/AIDS treatment after initial medication fails, are not counterfeit, UNITAID said on its website. “They are medicines used in second-line treatment of HIV/AIDS manufactured by Indian company Aurobindo. These medicines have been prequalified by the WHO and have received tentative approval by the United States Food and Drug Administration,” it said.
GlaxoSmithKline Plc. (GSK), which holds the patent for abacavir, told Mint by email: “GSK can confirm that it has given a waiver to the Dutch customs authorities for the abacavir tablets in this consignment.”
A spokesperson for UNITAID said the drugs are yet to be released by the Dutch. The shipment was to provide treatment for 166 patients for three months, Ellen T’Hoen, senior adviser on intellectual property and medicines patent pool at UNITAID, said in an email.
A spokesperson for the European Commission declined specific comment on the Aurobindo seizure. “Customs in the EU also contribute to stop the traffic of potentially dangerous products such as fake medicines, even when the shipments are destined elsewhere,” she said in an email. “From a legal point of view, the role of customs under EU legislation is to detain goods that are suspected of infringing certain IPR, not to decide whether an infringement has occurred.”
Previously, consignments of Ind-Swift Laboratories Ltd, Dr Reddy’s Laboratories Ltd, Cipla Ltd and Aurobindo have been seized at Dutch transit points.
Medecins Sans Frontieres’ (MSF) “own medicine procurement activities may be affected by the EU customs authorities’ use of the regulation”, Leena Menghaney, project manager (India) for Campaign for Access to Essential Medicines at MSF said in an email. “Such actions may require alternative and potentially more expensive transit routes to be used that would inhibit the supply of generic medicines to humanitarian organizations such as MSF who have logistical centres based in Europe.”
India has raised the issue with the Netherlands. Civil society organizations have also protested and some have written to Pascal Lamy, director general of the World Trade Organization. Lamy responded on 4 March: “The issue at stake is...important and sensitive...it deserves to be adequately addressed so that efforts to enhance access to medicines are supported and the creation of barriers to legitimate trade in generics is avoided.”