NEW DELHI: India has protected the interest of its generic pharma industry by keeping out data exclusivity provisions from the Free Trade Agreement (FTA) with the UK. This is the second FTA in recent times where data exclusivity is not part of the trade agreement.
The UK was pushing for inclusion of Data Exclusivity provisions in the FTA which would have prevented Indian generic drugs manufacturers from using the clinical trial data generated by the pharma patent holders. At present Indian laws allow the use of this data by companies to launch copies of the drugs that go off-patent. This reduces time and costs for generic manufacturers to go to the market. If generic companies were to generate same data independently it would delay their launches and give additional time to patent holders to benefit for their innovation.
“During the negotiations, the UK had asked to include this provision in the trade pact. But India has not accepted that. 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,” the official said.
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.
Earlier, India had also rejected a similar demand from the four-nation European Free Trade Association (EFTA) in their FTA signed in 2024. EFTA members are Iceland, Liechtenstein, Norway, and Switzerland. Among them Switzerland is the hub for most innovative companies in healthcare and even they did not get it.
India’s generic drug industry is estimated at about $ 25 billion and the country exports half of its output. 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 the UK announced the conclusion of the free trade agreement on May six that will substantially liberalise trade between the two countries.
Source: The Financial Express
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