While apprehensions continue over data exclusivity among a section of the domestic pharmaceutical industry, research-based pharma companies are mounting pressure for stronger regulatory data protection laws in order to finalise the EU-India FTA talks. Companies such as Biocon, Glenmark, Dr Reddy?s, Lupin, Bharat Biotech and many others have stressed the need for regulatory data protection (RDP) in order to promote innovation and investment in the development of new medicines and research.
The EU-FTA talks are still on and data exclusivity in the pharmaceutical sector is one of the contentious issues on which there is major disagreement, resulting in delay and finalising the deal. While copycat generic companies have opposed the inclusion of this provision during the talks, research-based pharmaceutical and biotechnology companies are demanding stronger RDP.
Data exclusivity provides protection to the technical data generated by the innovator companies. In the pharmaceuticals industry, it means data generated by drug companies through expensive global clinical trials to prove the efficacy and safety. By gaining exclusive rights over this data, innovator companies can prevent competitors from obtaining marketing licences for low-cost versions during the tenure of this exclusivity.
The pharma industry is divided. While a few say it would be benefit MNCs to increase investments in emerging markets, generic firms are opposing it as it would make low-cost generic drugs unaffordable.
