India rejects demand of European FTA bloc for inclusion of 'data exclusivity' to protect generic drug firms' interest

India has dismissed the request from the European Free Trade Association (EFTA) bloc, consisting of Iceland, Liechtenstein, Norway, and Switzerland, to include a ‘data exclusivity’ provision in proposed free trade agreements.

Commerce Secretary Sunil Barthwal emphasised that India consistently safeguards the interests of its domestic generic drugs industry. He clarified that India will not compromise the generic drug industry’s position in any Free Trade Agreement (FTA).

The EFTA members are currently negotiating a trade agreement with India, but India has rejected their proposal for data exclusivity, reaffirming its support for the generic industry.

“There is no fear for the Indian generic industry (from this agreement). It is our very important objective to see that the 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 protects 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 licences for low-cost versions during the tenure of this exclusivity. Switzerland has some of the major pharma firms in the world including Novartis and Roche. Both these firms have a presence in India.

India’s generic drug industry is estimated at USD 25 billion and the country exports 50 per cent of its produce. An expert said that data exclusivity is beyond the provisions of the 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 the 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.

With inputs from agencies.