Pharma firms continue to face patent violation charges in Europe

NEW DELHI: Even after India raised concerns with EU, troubles of generic companies which export drugs to developing countries through Europe are far
from over as seizures by Dutch customs still continue. In yet another case, a shipment of popular antibiotic, Amoxicillin was seized in Frankfurt recently. The drugs manufactured by domestic company Medopharm were shipped to Republic of Vanuatu, an island nation in the Pacific Ocean, through Frankfurt. In this recent case, customs authorities seized a shipment of 3,047,000 pills (quantity equivalent to 76,000 courses of treatment) of Amoxicillin (250 mg) worth 25,000 euros, for almost a month before releasing it. Sources said that the consignment was detained on grounds of suspected trademark infringement. Experts pointed out that there was no valid reason for detaining these medicines especially since the name ‘Amoxicillin' is an international non-proprietary name. This seizure is the latest in a long list of cases that demonstrate that EU regulations are actively hampering access to medicines to developing countries. In 2008, there were 16 similar cases of seizures of medicines shipped from India in the Netherlands. (Other recent seizures include those of medicines from Dr Reddy's and Ind-Swift.) When this particular shipment came into Germany, customs noted that the medicines packed are of the same type as the drugs that GlaxoSmithKline in UK has copyrights for, according to an industry source. German customs authorities then informed the company, and gave them a sample of drugs for inspection. The consignment was later cleared and sent to the final destination. These seizures have been driven by an EU regulation on border measures that has empowered customs officials to interfere in legitimate trade of generic medicines, a statement from Health Action Network says. DG Shah, secretary general of Indian Pharmaceutical Alliance says "The EU member states continue to abuse Regulation 1383 of 2003 to create barriers and harass legitimate trade in generics. It is time that the government steps in and takes effective steps to protect India's exports of pharmaceuticals". Customs is incompetent to interpret IPRs and should not be entrusted to enforce the same, he added. The issue has been raised by India at the TRIPS (Trade-related aspects of Intellectual Property Rights) council meeting in February, and thereafter when the Dutch trade minister was on a visit here. Experts pointed out that earlier international public health and consumer groups have raised the issue with World Health Organization (WHO) and the World Trade Organization (WTO) voicing their concerns over seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru. According to manufacturers, all products were ‘‘legitimate generics'' and did not violate any patent rights in the exporting or the importing countries.