Today, April 26, 2023, the European Commission (Commission) published its long-awaited Pharmaceutical Review (Review). In its press conference, the two Commissioners presenting the Review expressed pride at launching the biggest overhaul of European Union (EU) pharmaceutical law since 1965. The Commission’s stated aim is to achieve a balanced outcome with a “Triple A” (better access across the EU, affordability and availability of medicines), a “Triple C” (competitiveness of industry, improved compliance, and combating antimicrobial resistance (AMR)), and one “T” (more transparency). The aims were high.
However, industry sees a missed opportunity, because IP rights are substantially reduced overall, and their duration can be prolonged only by mechanisms that are uncertain and complex. There was no analysis of how the Review affects the industry’s ability to develop innovative product to address unmet medical needs. The one new incentive (a transferable exclusivity voucher for new antimicrobials) is so restrictive that it might not be workable.
This alert summarizes the key changes and risks to be taken into account in the next few months, in which stakeholders will provide feedback to the Commission, the European Parliament, and Member States.
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