New Attempt to Introduce Unlawful-Patent Linkage in Bolar

Medicines for Europe response to the Strategy for European Life Sciences

5-Point Pharmaceutical Action Plan to Sustain Investment in Europe, for Europe

Note on Proposals to Extend Pharmaceutical Intellectual Property Incentives in reaction to U.S. Tariffs

The Severe Impacts of Potential U.S. Tariffs on Pharmaceuticals

European Parliament Hearing on the Overreliance on Imports of Active Pharmaceutical Ingredients (APIs)

Proposals to Accelerate the EU Integration of the Ukrainian Pharmaceutical Industry

Position Papers on Electronic Product Information (ePI)

Position Paper on the Overreliance on imports of Active Pharmaceutical Ingredients (APIs)

Review of the SPC Manufacturing Waiver: a 2024 Industry Report

The Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation is applicable since 2 July 2022. The SPC Waiver has been introduced with the objective to remove the competitive disadvantage that European manufacturers of generic and biosimilar medicines are facing vis-à-vis third countries’ manufacturers, which can start manufacturing generics and biosimilars earlier due to shorter IP protection periods.

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