Core Challenges for the Life Sciences (1): New EU Life Sciences Legislation – Cross-Practice Perspectives on the Strategic Implications of the EU Pharma Package and Biotech Act | Kisaco Research

The EU Pharma Package and the proposed EU Biotech Act together represent the most significant legislative intervention in the European life science sector in over two decades. Taken together, these initiatives signal a broader policy shift to recalibrate how the EU balances access to medicines and innovation incentives with the long-term competitiveness of its life sciences industry.

Building on the opening keynote, this holistic discussion will examine the strategic policy objectives underpinning the EU Pharma Package and Biotech Act, and explore how they are expected to reshape innovation, access and competition across the European market. Panellists will assess the cross-practice implications of key legislative changes and consider what the combined effect of these landmark reforms might be for competitive dynamics within Europe and the region’s position in the global life sciences market.

- What collective strategic objectives are the EU Pharma Package and Biotech Act seeking to achieve for the European life sciences sector?

- How might the EU Pharma Package reshape the crucial interplay between IP and regulatory exclusivities, and what knock-on effects could this have for broader corporate strategy across the sector?

- How could the combined effect of the Pharma Package and the EU Biotech Act influence the competitive balance between originator, small-molecule generic and biosimilar companies?

- Taken together, will the Pharma Package and Biotech Act be set to strike the right balance between access to medicines, innovation incentives and the EU’s global competitiveness?

Speaker(s): 

Author:

Kristine Peers

General Counsel
EFPIA

Kristine Peers

General Counsel
EFPIA

Author:

Sergio Napolitano

General Counsel & Executive Director, Legal & International Affairs
Medicines for Europe

Sergio Napolitano

General Counsel & Executive Director, Legal & International Affairs
Medicines for Europe
Time: 
9:30am - 10:30am
Agenda Track No.: 
Track 4
Summary: 
The EU Pharma Package and the proposed EU Biotech Act together represent the most significant legislative intervention in the European life science sector in over two decades. Taken together, these initiatives signal a broader policy shift to recalibrate
Session Type: 
General Session (Presentation)
Force Inline Description: 
0