The European Union’s Parliament and Council have reached a provisional agreement to update pharmaceutical legislation for the first time in over two decades. The proposed legislative updates, otherwise known as the ‘Pharma Package’, will have widespread positive implications for innovative medicines. Provisional updates are in line with other EU-wide regulatory shifts which aim to stimulate innovation and create a more competitive environment for pharmaceuticals and technology.

In this whitepaper, Marwood examines how the EU has built out incentives for pharmaceutical manufacturers that introduce novel medicines to all EU markets and how this impacts market access strategies. We dig into how regulatory updates enhance exclusivity incentives to support pharmaceutical innovation and speed patient access, while simultaneously raising expectations for supply resilience, transparency, environmental sustainability, and antimicrobial stewardship.