The European Union, on Friday, said data exclusivity and patent extension was not on the agenda for the India-EU free trade agreement (FTA) negotiations and that both sides were very near to clinching the deal.
“There is a political will on both sides to settle the issues facing the FTA. We are very near to an agreement, and we have to now latch it up. We have not sought any legislative changes on the Indian side and surely data exclusivity and patent extension is not on the agenda,” EU Commissioner for Health and Public Policy Tonio Borg told a select group of journalists here.
Also present was EU Delegation Ambassador to India João Cravinho.
Data exclusivity relates to issues where drug companies generate such data through expensive global clinical trials to prove the efficacy and safety of their new medicine.
By gaining exclusive rights over this data, companies can prevent their competitors from obtaining marketing licence for low-cost versions during the tenure of this exclusivity.
The view within India is that inclusion of data exclusivity provisions would delay, and could even prevent the registration of generic versions of medicines.
Adding to the discussion, Mr. Cravinho said: “No we are not asking for anything whether it concerns data exclusivity or patent extension. We are not asking for anything that would impact the generic medicine industry,” he said.