'India, EU showing political will to seal free trade agreement'
EU Friday said it is not seeking inclusion of data exclusivity provisions in the proposed free trade agreement with India and added there is a political will from both the sides to move on with the pact.
New Delhi: EU Friday said it is not seeking inclusion of data exclusivity provisions in the proposed free trade agreement with India and added there is a political will from both the sides to move on with the pact.
In pharmaceutical sector, 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, innovator companies can prevent their competitors from obtaining marketing licence for low-cost versions during the tenure of this exclusivity.
It is felt that inclusion of data exclusivity provisions would delay, and could even prevent the registration of generic versions of medicines - even when there is no patent on a medicine. It would also hurt the interests of the domestic generic drugs industry.
"No we are not asking for anything whether it concerns data exclusivity or patent extension," Head of EU Delegation to India Jo'o Cravinho said.
He was addressing reporters along with the visiting European Union Commissioner for Health and Consumer Policy Anthony Borg. Borg was here to meet government officials and industry leaders.
There were strong apprehensions from Indian side that EU is pressing for inclusion of this provision in the FTA.
He said that the 27-nation bloc is not asking for anything which will impact Indian generic medicine industry.
India is a major player in this sector. India's generic drug industry is estimated at over USD 20 billion and the country exports 50 percent of its produce.
On the issue of leakage of certain portions of the FTA text, Cravinho said that they do not stand by the veracity of those documents.