EU Pharma Package: What Pharmaceutical Companies Should Know

The European Union's landmark pharmaceutical reform is here. After nearly three years of negotiations, the Council and European Parliament reached agreement on 11 December 2025. For pharmaceutical companies, the question is no longer whether change is coming, it is how to prepare for it.

Key Changes

Regulatory Data Protection: 8+1(+1+1) Instead of 8+2(+1)

The reform introduces a new "8+1(+1+1)" framework replacing the existing "8+2(+1)" structure. New medicines will receive eight years of data protection, followed by one year of market protection, a reduction from the previous two-year period. Companies can secure additional one-year extensions if their product addresses an unmet medical need or contains a new active substance meeting requirements for comparative clinical trials conducted across several Member States, with marketing authorisation applied for within 90 days of the first application outside the EU. Market protection can also be extended once by