| Page 9 | Kisaco Research

The EU Pharma Package replaces the long-standing certainty of fixed-term RDP and market exclusivity with a more complex and ambiguous system of incentives linked to operational and product requirements. By conditioning additional exclusivities, the reform has introduced a significant new layer of uncertainty that will require companies to recalibrate proactively across IP, regulatory and broader corporate functions.

This session will examine the Pharma Package’s changes to RDP and market exclusivity, and discuss the implications of this marked departure from the status quo for legal strategy across the life sciences sector. Hear expert insights into how the new legislation will alter the complex interplay between your IP, regulatory and overall business strategies, and position your company to respond successfully to an era-defining shift in the European regulatory landscape.

- How feasible will it be for companies to meet the criteria for beyond-baseline extensions to regulatory exclusivities on pharmaceuticals?

- What does “unmet medical need” mean in a legal context? How will this be evaluated in practice?

- How are exclusivities and incentives changing for paediatric medicines, priority antimicrobials and orphan medicinal products?

- How feasible are the criteria for SPC extensions under the EU Biotech Act? How will they be assessed?

Author:

Alexander Natz

Secretary General
EUCOPE

Alexander Natz

Secretary General
EUCOPE

Author:

Axel Korth

Head Legal DACH/UK&I/Nordics & CEE
Biocon

Axel Korth

Head Legal DACH/UK&I/Nordics & CEE
Biocon

Author:

Andrew Williams

Partner
Mewburn Ellis

Andrew Williams

Partner
Mewburn Ellis

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?

Author:

Kristine Peers

General Counsel
EFPIA

Kristine Peers

General Counsel
EFPIA

Author:

Sergio Napolitano

General Counsel & Executive Director
Medicines for Europe

Sergio Napolitano

General Counsel & Executive Director
Medicines for Europe
 

Pascal Weinberger

Deputy CEO
Owkin

Pascal Weinberger is Deputy CEO of Owkin, a leading agentic AI company transforming biomedical research and drug discovery with advanced AI systems that reason across complex biological data. He also serves on the Board of the World Foundation. Prior to his current role, Pascal co-founded Bardeen.ai, a pioneering AI company focused on workflow automation using AI agents to streamline repetitive tasks across web apps.

Pascal Weinberger

Deputy CEO
Owkin

Pascal Weinberger

Deputy CEO
Owkin

Pascal Weinberger is Deputy CEO of Owkin, a leading agentic AI company transforming biomedical research and drug discovery with advanced AI systems that reason across complex biological data. He also serves on the Board of the World Foundation. Prior to his current role, Pascal co-founded Bardeen.ai, a pioneering AI company focused on workflow automation using AI agents to streamline repetitive tasks across web apps.


Before his entrepreneurial journey with Bardeen and Owkin, Pascal built and scaled ventures in AI and led the AI team at Telefonica Alpha, Europe’s first moonshot factory, where he drove breakthrough research and innovation.
An active angel investor, Pascal supports early-stage deep-tech and AI companies around the world.

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Eileen Smink, JD, CHC, CCEP

Vice President of Compliance
Lone Peak Dental Group

Eileen Smink is a seasoned compliance professional with more than 25 years of experience leading compliance and privacy programs across healthcare and other highly regulated industries. As Vice President of Compliance at Lone Peak Dental Group, she oversees enterprise-wide compliance strategy, focusing on centralization, proactive risk management, and operational alignment across a multi-state organization.

Eileen Smink, JD, CHC, CCEP

Vice President of Compliance
Lone Peak Dental Group

Eileen Smink, JD, CHC, CCEP

Vice President of Compliance
Lone Peak Dental Group

Eileen Smink is a seasoned compliance professional with more than 25 years of experience leading compliance and privacy programs across healthcare and other highly regulated industries. As Vice President of Compliance at Lone Peak Dental Group, she oversees enterprise-wide compliance strategy, focusing on centralization, proactive risk management, and operational alignment across a multi-state organization.

Prior to joining Lone Peak in 2024, Eileen served as Government Programs Compliance Officer at GuideWell Source, a Medicare Administrative Contractor. Her career includes leadership roles in compliance, privacy, and legislative affairs at American Insurance Administrators, DermOne, Highmark, and United Concordia. Her expertise spans Medicare and Medicaid compliance, audit and monitoring, privacy and data protection, and enterprise risk management.

Eileen holds a Juris Doctor from Widener University School of Law, a Bachelor of Social Sciences in Public Policy from The Pennsylvania State University, and an Associate of Applied Science in Dental Hygiene from Pennsylvania College of Technology. She is a licensed attorney and holds certifications including Certified Compliance & Ethics Professional (CCEP) and Healthcare Health and Safety Specialist (HHS).

Pharma and Biotech Patent Litigation North America - 2025 Agenda
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Kristine Peers

General Counsel
EFPIA

Kristine Peers

General Counsel
EFPIA

Kristine Peers

General Counsel
EFPIA
 

Imke Salmon

Patent Examiner, Group Leader
German Patent and Trade Mark Office

Imke Salmon

Patent Examiner, Group Leader
German Patent and Trade Mark Office

Imke Salmon

Patent Examiner, Group Leader
German Patent and Trade Mark Office
 

Alexander Natz

Secretary General
EUCOPE

Alexander Natz

Secretary General
EUCOPE

Alexander Natz

Secretary General
EUCOPE