India has registered its strong protest against the recent seizures of drugs consignments by the European authorities describing it an act going against the spirit of 'rules based trading system and impeding free trade', even as the Dutch authorities have reportedly begun procedures to destroy the seized consignments.
"In addition to going against the spirit of a rules based trading system and impeding free trade, such acts represent a distorted use of the TRIPS Agreement and the international IP system and circumscribe flexibilities enshrined in TRIPS," Indian representative to WTO told the recent TRIPS Council meeting. India said it was still waiting for a response from the Dutch government after the matter was taken up bilaterally.
"Dutch customs authorities have 'confiscated' these consignments on grounds of alleged violations of domestic patents and trademarks. This is not a case of 'temporary detention' since some consignments continue to be held for over months. Moreover, procedures for their destruction were also initiated. Four such instances have come to the notice of my Government and all these four instances have been reported from the Netherlands. These consignments were headed for Brazil, Peru and Colombia. While one consignment has been returned to the exporter after being held for over a month, the fate of the other three is still unclear. We pointed in GC last month about the consignment of losartan seized in transit in the Netherlands while it was headed for Brazil. The generic drug in question was perfectly IP legitimate generic drug in both India and the destination country. Also, trade of generic drugs is perfectly legitimate," Indian statement said.
"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. Among other things, the implementation of the WTO's Decision of 30 August 2003 regarding the export of pharmaceutical products to countries with inadequate manufacturing capacity (the Para 6 system), will become even more problematic if patent rights, which are territorial by definition, are enforced for goods in transit. As it is, the Para 6 system has been used only once so far in the last five years," India told the council.
The WTO rules based system provides for freedom of transit by the most economical and convenient routes and without unnecessary delays and restrictions. The act of seizure by the Dutch authorities is therefore, a denial of the rules based system which we seek to build and strengthen in the WTO. Repeat of such actions may have an impact on exporters' choice of transit routes, which may affect the economics of trade of pharmaceutical products and consequently, have a deleterious effect on access to essential drugs and public health budgets of recipient countries.
"This is the effort to implement the protection and enforcement of IPRs in a maximalist manner and thereby upset the delicate balance between rights of IPR holders and the public policy objectives under the TRIPS Agreement. A coordinated approach is being witnessed in several international for a like the World Customs Organisation, World Health Organisation, Universal Postal Organisation etc. to promote the IP maximalist agenda. We also note with dismay efforts by some members to link safe and efficacious but low cost generics with counterfeit medicines, which is essentially an IPR issue. There is an attempt to enlarge the definition of counterfeits beyond its definition in the TRIPS Agreement, to set maximalist enforcement norms, and to include TRIPS plus provisions in RTAs. These are subtle and concerted ways of circumscribing the flexibilities of the TRIPS Agreement. They also run counter to the spirit of the TRIPS Agreement which is a minimum standards agreement. And, this is certainly counter to the understanding given to developing countries when the TRIPS Agreement was being negotiated," the statement said.