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EU Parliament to Extend Data Protection for New Medicines to 7.5 Years, According to Document from ET HealthWorld



EU parliament to extend new medicine data protection to 7.5 years, document says, ET HealthWorld

EU lawmakers have made progress towards addressing concerns from the pharmaceutical industry regarding the exclusivity period for new medicines. The European parliamentary committee is set to vote on its position on March 19, with a plenary vote scheduled for April 11. The proposed legislation aims to speed up the approval process for new medicines, incentivize production for antibiotic-resistant bacteria, improve patient access, and adapt to technological advancements like artificial intelligence.

The draft compromise includes raising baseline data protection to 7.5 years with additional incentives for medications that meet unmet medical needs and conduct clinical trials in the EU. The total exclusivity period for a company would be extended to a maximum of 11.5 years, with three years of protection from generics. The responsibility for launching a new medicine would also shift to member states, streamlining the process.

For orphan diseases, the baseline exclusivity period would be nine years, increasing to 11 years for medicines that fulfill unmet medical needs. The legislation also includes a “regulatory sandbox” to accommodate technological advances like artificial intelligence and machine learning.

EU member states are yet to begin discussions on exclusivity and incentives, as they review the comprehensive proposal. The industry has raised concerns about potential implications on innovation and research in Europe. The final decision will play a significant role in shaping the pharmaceutical landscape in the region.

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