Package pharma Reform : what are the implications for the sector?

Our team of experts will provide an in-depth analysis of the key aspects of the reform, including:

• Data and Commercial Protection: new rules on data and market exclusivity for innovative medicinal products and orphans.
• Advertising and Shortages: measures to address and manage medicine shortages, including new obligations and restrictions on advertising.
• Package Leaflet and Antimicrobials: updated requirements for the package leaflet, with a particular focus on antimicrobials and patient information.
• Tenders and Critical Medicines Act: the impact of the reform on public procurement, tenders, and the supply of critical medicines.
• Bolar Exemption: extension of the Bolar exemption and its implications for generic and biosimilar entry.
• Orphan Medicinal Products: changes to the regulatory framework for orphan drugs and incentives for rare disease treatments.

This will be an excellent opportunity to engage with industry specialists, discuss the strategic challenges and opportunities arising from the new legislation, and address your questions during our interactive Q&A session.

We look forward to welcoming you to this conference.

Event details

Date: Wednesday, 10 June 2026
Time: 8.30 - 10.30am CEST
Location: Simmons & Simmons Paris and online (Teams)