The EU Pharma Package has instigated a landmark shift from market-access discretion to increasingly mandated market participation, with new launch and supply obligations raising fundamental questions around legal definitions, liability exposure and antitrust risk for life science companies. As these legislative changes unfold against a global backdrop of U.S. MFN pricing and mounting commercial pressure, legal teams must navigate a complex, evolving intersection between regulatory obligations, market access strategy and wider commercial dynamics.
This session will examine the implications of new EU launch and supply mandates, exploring how these legislative obligations are reshaping decision-making by marketing authorisation (MA) holders regarding launch sequencing and market participation amid global pricing pressures.
-How could enforcement of new launch obligations under the EU Pharma Package interact with European IP strategy and the revised “8+1(+1)(+1) regulatory exclusivity framework”?
- How might Member States interpret and enforce requirements around “adequate” or “sufficient” medicine supply under the new framework?
- What circumstances might constitute an acceptable “exceptional circumstance” justifying delayed launch or non-launch?
- What safeguards will be available to companies seeking to challenge or prevent misuse of launch and supply mandates by national authorities?
- How will new obligations interact with global pricing dynamics, including U.S. MFN policies, to influence where, when and in what geographical order companies choose to launch new products?
- How will new launch and supply obligations interact with competition law frameworks?
Agenda Track No.:
Track 2
Session Type:
General Session (Presentation)
Force Inline Description:
0