The European Commission, in the process of reframing the current counterfeit goods regulation which led to the seizures of generic drugs from India sometime back, has come out with a consultation paper to seek the views from the concerned stakeholders on the proposed amendment and points raised by India.

Though it is not yet clear how the new regulation would affect the passage of Indian generics to destinations in Africa or Latin America through Europe, it can further increase the anxiety of the domestic industry which suffered a lot at the hands of customs authorities in Europe in the past few years due to the same law. Reports said that producers of brand drugs in Europe have welcomed the move as it would seek to address their concerns in the current system.

The four main areas that the commission seeks to review are the scope of the regulation, the voluntary simplified destruction procedure, provisions concerning small consignments of goods, and the costs of storage and destruction of infringing goods. But the commission has specifically mentioned the seizures of drugs and concerns raised by India while seeking views from the stakeholders, though it is still too early to assume whether India’s points would finally make it into the final regulation and ensure smooth passage of drugs.

“A particular account should be taken of the concerns expressed by some WTO members, namely India and Brazil, relating to controls by European customs on medicines in transit through the European Union,’’ the document says, while explaining the current system. Paragraph 1 of Article 1 of Council Regulation (EC) No 1383/2003 sets out the conditions for action by the customs authorities when goods are suspected of infringing an intellectual property right, it says.

The extent of the competence of customs authorities concerning IPR enforcement is dependant on the scope of the customs intervention, from taking action only when infringing goods are declared to release for free circulation, to all the situations in which infringing goods are under customs supervision (including in particular exportation, transit, transhipment, temporary deposit, customs warehousing procedures, placement in free zones or free warehouses), as per the discussion
paper.

“Any of the options should take into account the following: - the Regulation should not affect substantive IPR law applicable in the Member States and in particular the extent of the rights conferred by such law to the right holders; - the application of the Regulation by customs should never unduly hinder legitimate trade of goods through the territory of the European Union; customs enforcement of IPR should make the best use of available customs resources,’’ it adds.