India signs trade deal with Europe (EFTA), generics a point of contention

2024-04-18

On March 10, 2024, India signed a Trade and Economic Partnership Agreement (TEPA) with the European Free Trade Association (EFTA).EFTA was established in 1960 and consists of four member countries - Iceland, Liechtenstein, Norway and Switzerland. India is the fifth largest trading partner of EFTA after the European Union, the United States, the United Kingdom and China.

India's negotiations with EFTA took 16 years and 21 rounds of negotiations. In the negotiations on this agreement, the dispute over Test Data Exclusivity has become one of the biggest focuses and difficulties in the negotiations. The dispute over Test Data Exclusivity was one of the biggest focuses and difficulties in the negotiations.

The four European countries in the agreement called for changes to India's patent and regulatory laws, granting drug makers six years of exclusive rights to trial data on new drugs, which means a significant industrial impact on the world's largest producer of generic drugs, known as the "pharmacy of the world," India. Its domestic drug companies either need to wait for the end of the six-year exclusivity period, or need to carry out repeated and costly clinical trials, greatly delaying the time to market of generic drugs. The Indian government has rejected EFTA's request for "data exclusivity," saying that all free trade agreements under negotiation will protect the interests of India's generics industry, and promising that "no free trade agreement will be detrimental to the interests of the generics industry. ".

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