India Rejects EFTA's Data Exclusivity Demand for Generic Drugs

New Delhi, Feb 15 (PTI) India on Thursday said it has rejected the demand of the four European nations EFTA bloc for inclusion of a 'data exclusivity' provision in proposed free trade agreements, stating that it always protects the interests of the domestic generic drugs industry.

Commerce Secretary Sunil Barthwal said there is no Free Trade Agreement (FTA) in which India will go against the generic drug industry.

The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland. The bloc is negotiating a trade agreement with India.

"They want that there should be data exclusivity, we rejected their demand. We are with our generic industry.

"There is no fear for Indian generic industry (from this agreement). In fact, it is our very important objective to see that generic drug industry flourishes," he told reporters here.

The secretary said the industry is contributing significantly to India's exports, which are also growing.

"So we are there to protect the interest of the industry," he added.

Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products. In the pharmaceutical sector, drug companies generate 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.

Switzerland has some of the major pharma firms of the world and that include Novartis and Roche. Both these firms have a presence in India.

India's generic drug industry is estimated at about USD 25 billion and the country exports 50 per cent of its produce.

An expert said that data exclusivity is beyond the provisions of Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the WTO (World Trade Organisation). India and EFTA have been negotiating the pact, officially dubbed as Trade and Economic Partnership Agreement (TEPA), since January 2008 to boost economic ties.

The 21st round of TEPA negotiations was held here in January. The negotiations were held on various chapters, including trade in goods, rules of origin, trade and sustainable development, intellectual property rights, and trade facilitation.

According to the commerce ministry, the talks at present are at an advanced stage. EFTA has 29 FTAs with 40 partner countries, including Canada, Chile, China, Mexico, and Korea.

Under free trade pacts, two trading partners significantly reduce or eliminate customs duties on the maximum number of goods traded between them, besides easing norms to promote trade in services and investments.

EFTA countries are not part of the European Union (EU). It is an inter-governmental organisation for the promotion and intensification of free trade.

It was founded as an alternative for states that did not wish to join the European community. India's exports to EFTA countries during 2022-23 stood at USD 1.92 billion against USD 1.74 billion in 2021-22.

Imports aggregated at USD 16.74 billion during the last fiscal compared to USD 25.5 billion in 2021-22. The trade gap is in the favour of the EFTA group, according to the data of the commerce ministry.