Confusion in the EU over whether or not some ‘generic’ drugs intended for the developing world are in violation of intellectual property laws have led to numerous delays and seizures at ports and airports around the region.   Most recently a shipment of 1.74mn tablets of a generic antiplatelet drug—a drug that reduces the risk of strokes and heart attacks due to blood clots—en route to Venezuela from India was seized by French custom’s officials on suspicion of patent infringement.  Just one month prior French agents seized another shipment of 740,000 tablets of the heart medicine Clopidogrel—Plavix—, again originating from India.  It has been reported that there have been at least 18 seizures of Indian drugs shipments in the EU this year.

The issue likely arises due to countries’ varying interpretations of intellectual property rights.  In fact at a recent meeting of the WHO South East Asian Region (SEAR) a resolution was passed that ask member states to not enforce any intellectual property rights, which they believe ‘compromise access to medicine’.  Some industry experts have stated this action is in direct contradiction to the WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT), thus potentially setting the stage for a potential conflict.

Indian officials have indicated they intended to discuss the seizure matter with the WHO’s dispute settlement forum and the WTO sometime in the near future.   Indian media has accused the current policies of blurring the line between counterfeit/sub-standard drugs and generics.  They believe EC Regulation 1383/2003, which allows for the seizure of any goods suspected of IP infringement—designed to prevent the flow of dangerous drugs—is adversely impacting the shipment of legitimate generics.  Presently the EU is conducting a review EC Regulation 1383/2003 and will address any regulatory problems they see fit.

The EU would be remiss to allow the protests of Indian generic drug producers to drown out advocates of patient safety.  Especially considering the fragmentation of India's pharmaceutical industry, which consists of over 20,000 registered entities. If the EU turns away from the progress of its drug safety measures the developing world could continue to be flooded by counterfeit and sub-standard medicines.  If a few generic drug producers need to follow the existing WHO rules to ensure patient safety, it is a small price to pay.