LSAA’s review on the acceptance of the Pharma Leg by the European Parliament and the beginning of the trialogue:
The European Parliament’s adoption of its position on the EU pharmaceutical law review in April 2024 marked a pivotal moment for the Package but from an investor perspective, the outcome was – at best – mixed. Parliaments’ amendments cut the standard protection for new medicines slightly, from 8 years to 7.5, but companies can earn back extra time if their drugs meet certain conditions, such as addressing Unmet Medical Needs or conducting key research in Europe. Even with these add-ons, however, the maximum Regulatory Data Protection would be capped at 8.5 years, which is shorter than today. In principle, the structure rewards innovation, but, in practice, the criteria remain vague and the cap limits upside potential. This makes it increasingly difficult for investors to forecast returns with confidence.
Likewise, the Council (Member States) adopted a somewhat disappointing stance in June 2025, after a long stalwart. Instead of shortening Regulatory Data Protection, the Council proposes to cut the subsequent period of Market Exclusivity, eventually making Europe a less attractive place for medicine innovation and riskier investment. Health industry representatives from Sweden and Denmark – two major European pharma countries – have understandably come out with mixed reactions. They urge the three EU Institutions to come to their senses during the final trialogue negotiation phase where a compromise agreement must be found. Without supportive rules for innovation, they say, Europe will certainly lose its competitive edge in developing next-generation treatments.