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Indian Drugs at Peril as Seizures Continue
While there have been ongoing efforts by India and Brazil to take the matters of seizures of generic drug consignments by EU upto the World Trade Organization, the seizures continue to happen. The latest in the trail has been by France of the generic consignments of Clopidogrel, an anti-platelet drug of Mcleods Pharma again on the grounds of patent infringement. The drug has an existing patent in US and France.
The EC Regulation 1383/2003 allows seizure of infringing material if the same enters the EU territory. However, the concern here is that the consignments of generic medicines are not meant for the EU territory, but they merely pass through it. The destinations of the consignments are Latin American countries where the entry is legally permitted. According to reports, there have been around 17 seizures since September 2008, including those of bigger companies like Aurobindo Pharma, Cipla, Indswift and the like. The seizures have been reportedly affecting the patients who await these life saving drugs and for whom, any interruption in the therapy might be fatal. India and Brazil had joined hands to combat such protectionist measures by EU which are discriminatory and violate TRIPS and the spirit of WTO. Both agreements envisage free movement of goods across borders and dissolution of barriers to trade. Experts say that the EU has been enforcing its regulations in a manner contrary to TRIPS. Articles 50-54 therein provide for border enforcement measures by member states. Article 52 is pertinent here, which states that seizure can take place only if the final importation violates IP in member state. Clearly, the EU has been interpreting its Regulation contrary to TRIPS and the mandate of WTO. Though the EC had assured that they would be putting in place a system so that legitimate generics are not seized, nothing concrete can be seen to be coming out. This is also expected to lead to increase in the prices of these drugs. India's statement at the WTO reflected its lack of confidence in the EC's actions in this regard as long as Regulation 1383/2003 remained unamended. Brazil had earlier released a statement condemning such seizures and together with India has been initiating a dialogue to address the issue at the WTO. India has prepared a brief of the complaint to be taken at the WTO, even as the option of contesting individual cases in Dutch courts also is available to her. ![]() |