As Prescribed

The European Union’s new pharmaceutical legislation, the most significant reform of the EU medicines framework in over two decades, will have important implications for M&A, licensing, and other life sciences transactions. Notably, the reforms will reshape the regulatory rewards and incentives that often underpin pharmaceutical asset valuations by revising regulatory data protection, market protection, and orphan drug exclusivity, while also imposing additional obligations relating to supply and market access.

Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical framework for medicinal products, which is currently based on legislation dating back to 2001.