Issues related to Intellectual Property Rights (IPR) and the pharmaceutical sector have been sensitive in the context of India-European Union (EU) trade and investment ties. Denis Dambois, First Counsellor, Head of Research & Innovation, Delegation of the EU to India, told The Hindu in a recent interview that India and the EU are engaged in sorting out issues such as the EU ban on some pharmaceutical products clinically tested by GVK Biosciences.
The EU ban had led to India deferring the negotiations on the proposed bilateral Free Trade Agreement (FTA).
Hopeful that the recent meeting by both sides on the FTA talks would help in restarting the negotiations, Dambois said in all its FTA negotiations the EU has always taken into consideration the specific level of economic development of the counterpart, and India was no exception. Edited excerpts
Do you think the GVK issue has led to mutual mistrust on bilateral trade including the FTA?
The EU decision in relation to GVK-Biosciences was based on scientific considerations and patient safety concerns and not trade considerations, and was in accordance with the advice of the scientific Committee of the European Medical Association.
The measure was indeed precautionary. The European Commission has been in constant contact with Indian authorities, and met with GVK representatives, clarifying the process, and the remedies available.
Thanks to industry's active involvement currently only approximately 25-30 per cent of the products or so called presentations are still suspended.
Relations between the EU and India are good. Both India and the EU have strong interest in strengthening cooperation in the pharmaceutical sector and are working closely in this direction.
Most recently, on this (GVK) issue they had a meeting in January 2016 in Brussels and both sides found the discussion constructive and promising for the future. On the EU-India FTA, the chief negotiators from both the sides had a stocktaking meeting on 18th January in Delhi and we remain positive about taking the discussions forward.
There were concerns that the GVK issue would impact the entire Indian pharma exports and what are your views on that?
The (GVK) decision was not based on trade considerations. It was in accordance with the scientific advice from the European Medicine Agency.
It was not an action against the Indian pharmaceutical industry but dealt with issues identified for one particular clinical trial site. Similar suspensions were previously applied in the past in different countries.
Such procedures do not question the reputation of the company nor the countries concerned, nor of generic medicinal products. They are an integral part of a rigorous scientific assessment process.
In the meantime, much progress has been made on this issue.
The European Commission has been in regular touch with the Indian authorities and industry representatives, and many products have been reinstated.
Concerns were also raised on the inclusion of higher IPR standards in the proposed India-EU FTA. How will the EU address these apprehensions? Concerning IPR standards, India has introduced legislation going beyond the TRIPS Agreement, for example to protect music and film against on-line piracy.
On the proposed EU-India FTA, we hope for a mutually advantageous agreement and it is premature to speculate on what will be negotiated on IPR. Secondly, the EU fully endorses the WTO Doha Declaration on the TRIPS Agreement and Public Health, according to which Members are allowed to take measures to protect public health. India retains the right to protect public health; furthermore, in her negotiations the EU has always taken into consideration the specific level of economic development of the counterpart, and India is no exception.
What are your expectations from the proposed national IPR policy of India?
We note that this is a step in line with the “Make in India” strategy that aims to create a good environment for the protection of IPRs by bringing about changes at legislative and policy level.
We are eager to see the final output. The EU has shared contribution during the consultation phase whereby we have offered to provide technical support to this exercise and share the extensive experience of EU institutions and of the EU Member States.
There are several areas where we can share our experience with India. For instance, in the area of Community Trade Marks and Designs, which apply throughout the EU in a unified way and in implementing utility models a s some EU Member Countries apply them in their legislation.
