Govt rejects EFTA's data exclusivity demand to protect generic drug cos

Commerce secretary Sunil Barthwal on Thursday said that there is no free trade agreement (FTA) in which India will go against the generic drug industry

India will continue to protect the interests of its generic drug firms and has rejected European Free Trade Association (EFTA) nations’ demand to keep “data exclusivity” as a part of the intellectual property (IP) chapter under a proposed bilateral trade deal, a top government official said on Thursday.

Commerce Secretary Sunil Barthwal said that there is no free trade agreement (FTA) in which India will go against the generic drug industry. EFTA comprises Iceland, Switzerland, Norway and Liechtenstein.

“They want there should be data exclusivity, but we rejected their demand. We are with our generic industry. There is no fear for the Indian generic industry (from this agreement). In fact, it is our very important objective to see that the generic drug industry flourishes,” Barthway told reporters.

For over a decade, India has been against the inclusion of data exclusivity provisions in FTAs to protect the interest of the domestic generic drug industry. Through data exclusivity, technical data generated by innovator companies get protection, which stops their competitors from getting cheaper versions of the medicine for a certain time period or till the innovator companies have ‘exclusivity rights’.

Even in the past, India’s discussions on IPR have been a contentious issue in FTA negotiations with countries such as Japan, the United Kingdom (UK) and trade blocs such as the European Union (EU).

According to international medical humanitarian organisation Doctors Without Borders/ Médecins Sans Frontières (MSF), Public Eye, and Delhi Network of Positive People, the draft leaked chapter on IP has provisions on data exclusivity, which can hamper the production of cheap, lifesaving generic medicines from India.

“This would result in generic manufacturers either needing to wait out the exclusivity period or repeat expensive clinical trials. In cases where a new medicine is patented, data exclusivity could block compulsory licences that may be granted to generic manufacturers to produce medicines at lower prices,” said a statement from MSF on Wednesday.

INDIA-UK FTA

The negotiations for the proposed India-UK free trade agreement are at an advanced stage, and both sides are working to iron out differences on the remaining issues.

Barthwal said the negotiations are taking time because the government wants to safeguard India's interest.

“India should commercially gain out of it and we should also be able to safeguard the interest of our farmers, PLI (production linked incentive) scheme goods. So, we are there to see that the deal is a fair deal,” he said.

As far as the United States initiated India-Pacific Economic Framework for Prosperity (IPEF) is concerned, legal scrubbing of text on clean and fair economy agreements is underway and the supply chain resilience pact will come into force from February 24.