The Special Regime of Intellectual Property for the Pharmaceutical Industry
This article explores the unique regulatory environment of the pharmaceutical industry, with a focus on the regime in Europe. It examines two sector-specific intellectual property (IP) rights, which are granted in the EU to compensate pharmaceutical companies for the delays inherent in the regulatory system. The pharmaceutical industry is in a different situation from other sectors when it comes to IP, because of the strict regulatory regime that applies to pharmaceuticals and the 15-year delay that can elapse before a new medicine may enter the market. Special regimes of IP protection have been developed, which partially address this problem, and which aim to ensure that research-based pharmaceutical companies can continue to earn a return on their investment and thereby remain able to fund the next generation of drugs. These rules are therefore necessary for the continued existence of the innovative pharmaceutical industry today.
