Excessive extension of the Bolar clause in the ‘pharmaceutical legislative package’

15 of January, 2026

The Bolar clause allows studies and trials necessary to obtain marketing authorisations for medicinal products to be carried out without infringing patents. Its scope has grown during the passage of the pharmaceutical legislative package, incorporating more actors and more activities, to include participation in public tenders before the patent expires. This extension raises questions about compatibility with the TRIPS Agreement, which only allows limited exceptions to patent rights. Participation in tenders could be considered an offer to sell, thus violating the limits set by that agreement.