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Pharma firms demands Data exclusivity

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The research-based pharma companies are mounting pressure for stronger regulatory data protection laws. To promote innovation and investment in the development of new medicines and research, want to make business with FTA and stress on the need for regulatory data protection (RDP). The meetings are still on deciding stages between EU-FTA talks on an agenda which includes data exclusivity in the pharmaceutical sector. The companies now try to ensure that they follow the guidelines laid as the ignorance of regulation of laws in Indian pharma companies is hindering in building trust of companies globally. The EU-FTA demands stronger regulatory data protection to gain confidence of others. The data generated by drug companies should be exclusive and confidential to the innovator company. EU- FTA talks can prove beneficial for the industry as it can prevent competitors from obtaining marketing licenses for low-cost versions during the tenure of this exclusivity. But this can only be achieved if the companies prove efficacy and safety and follow proper guidelines. This would in turn benefit MNCs to increase investments in emerging markets. Also there are analysts who believe it would be generic firms are opposing it as it would make low-cost generic drugs unaffordable.

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