Concerned over the continued seizure of generic drug consignments at different European ports on charges of counterfeiting and patents infringement, India has once again raised the issue at the WTO seeking the world body's intervention to ask the European Commission (EC) to urgently review the EC Regulation 1383/2003 and the actions of the national authorities based on the Regulation, and bring them in conformity with the letter and spirit of the TRIPS Agreement.
Even though the Indian government had raised the issue at the WTO's last meeting in March this year, the seizure of Indian drugs destined for other developing countries continued at EU ports. On May 5, a shipment of a generic antibiotic, Amoxicillin, manufactured in India and destined for a least developed country, the Republic of Vanuatu in the Pacific, was seized by customs officials, while in transit through Frankfurt, Germany.
Amoxicillin is an essential medicine used to treat a wide range of bacterial infections. The consignment worth approximately 28,000 Euros consisted of 3,047,000 tablets of Amoxicillin (250 mg), equivalent to 76,000 courses of treatment. The seizures were made on grounds of alleged trademark violation although GlaxoSmithKline (GSK) has confirmed to the German authorities that GSK is the former patent holder for 'Amoxil', a brand name for amoxicillin. Seeking WTO intervention on the issue, the Indian representative at the WTO said that there seems to be no valid reason for detaining these medicines especially since the name 'Amoxicillin' is an international non-proprietary name (INN).
Seizures have continued to take place at EC ports. The multitude of allegations and the spread across several EC ports, imply an emerging pattern to disrupt and create barriers to legitimate trade of generic drugs and to challenge the Doha Declaration on Public Health. The basic principle of transparency of procedures has also been violated by the inability of the authorities to share and explain the specific cause of action under EU regulations.
"EC has sought to justify the action of customs authorities to control goods in transit suspected of infringing IPRs as a means to stop traffic of potentially dangerous products, such as fake medicines, even when the shipments were destined for any country. It seems that it has been ingrained very deeply within the EC authorities that IP violative products are synonymous with potentially dangerous substances," the Indian representative said at the WTO.
Widespread and repeated seizures have 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. The importance of generic drugs to public health in developing countries and particularly in the LDCs is obvious. Such barriers to legitimate trade of generic drugs will also seriously impair the efforts of civil society organisations engaged in providing medicines and improving public health in the least developed parts of the world.
It is ironical that while on one hand WTO has taken steps to promote access to affordable medicines and remove obstacles to proper use of TRIPS flexibilities, on the other hand some members seek to negate the same by seizing drug consignments in transit and creating barriers to legitimate trade, the representative said.