Changes To EU Pharma Reform: More Questions Than Answers?

In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection.

Fuzzy man walking on hanging bridge vanishing in fog. Focus on middle of bridge. — Uncertainties lie ahead for the EU pharma reform • Source: Shutterstock

The proposed reform of the EU pharmaceutical legislation passed a major hurdle after it was OKd by the European Parliament earlier this month, but there is still a long way to go before it is approved by the member states and finally adopted.

Key Takeaways

Talks on the pharma overhaul between the European Parliament and Council are likely to be protracted, with some lawyers predicting it will be 2028 before the new legislation is implemented.

Given the likelihood of continuing disagreement over key issues such as regulatory data protection (RDP) periods, some legal experts are...