Regulatory data protection – How adopting regulatory data protection can increase medicine availability, innovation, and investment

Innovation in the biopharmaceutical industry requires significant investments. To incentivise pharmaceutical companies to undergo such investments and continue innovation, intellectual property rights such as regulatory data protection (RDP) have been put in place. While a patent is concerned with the underlying invention that might someday become a medicine, RDP is concerned with the data package associated with the safety and efficacy of the medicine. As separate and independent protections, patents and RDP work together to provide innovators with the certainty that if they succeed in developing a safe and effective new medicine, they will have a sufficient period during which their invention and/or data will be protected to recoup their investments and secure funds to engage in future innovation.

The effects and length of RDP are currently being discussed internationally. Up until now, the effects of introducing RDP remained unclear. Against this backdrop, we have conducted rigorous analyses of over ten years’ worth of data across fifty-three markets to estimate the effects of introducing RDP.

The main conclusions of our study are

The study is commissioned by PhRMA.


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