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China is now a well-established and critical life science growth market, but its legal and regulatory landscape continues to evolve at pace. This cross-practice roundtable will examine China’s IP enforcement trends, regulatory reform, competition scrutiny and deal landscape, discussing the core risks and opportunities for companies expanding into and currently operating in this crucial jurisdiction.

From changes to patent systems and licensing to new data exclusivity rules and PTE frameworks, landmark developments across Latin America and APAC are reshaping the global IP and regulatory landscape. This roundtable will examine key jurisdictional updates across these strategically important regions, and explore what key changes mean for your cross-border IP and regulatory strategy.

Deal obligations, such as Commercially Reasonable Effort (CRE), Commercially Diligent Effort (CDE) and “best effort” clauses, play a central role in allocating developmental and commercialisation risk in life science transactions. This discussion will examine how these obligations are defined, managed and enforced, and how teams can mitigate risk exposure under these obligations across collaboration and licensing agreements.

In sensitive, high-value life science transactions, clean rooms require more than technical safeguards; they demand clear governance structures and documented accountability. This discussion will explore how legal teams can design oversight frameworks, define escalation protocols and maintain irreproachable audit trails that withstand third-party scrutiny and post-transaction challenge.

This session examines the legal and structural complexities facing small-to-medium-sized life science companies when pursuing licensing, collaboration, joint venture and M&A agreements with larger, more established players in the market. Participants will examine how life science SMEs can structure transactions strategically to optimise valuation, protect foreground and background IP and retain sufficient governance control to support secondary patent filings and pipeline expansions.

Author:

Louise Jonshammar

Partner, Attorney at Law
AWA

Louise Jonshammar

Partner, Attorney at Law
AWA

This session examines the legal and governance challenges that arise when life sciences companies engage in joint advocacy through trade associations, industry coalitions and collective policy initiatives. Participants will examine how companies can structure regulatory engagement and industry collaboration to support effective advocacy while implementing appropriate safeguards to prevent anti-competitive coordination.

The growth of online pharmacy platforms and sustained parallel trade across the EU has intensified pressure on pharmaceutical trademark rights, particularly where medicines are repackaged and relabelled for distribution across borders. This roundtable will explore the practical strategies companies are deploying to monitor digital marketplaces, challenge unlawful repackaging and coordinate cross-border enforcement while remaining aligned with EU principles on exhaustion and competition law.

Author:

Marcell Komlosi

Patent Counsel
Debiopharm International SA

Marcell Komlosi

Patent Counsel
Debiopharm International SA

This session will examine evolving ESG obligations affecting the life sciences sector, including the revised Urban Waste Water Treatment Directive and its potential cost-allocation consequences for pharmaceutical manufacturers. Participants will explore the new European ESG legislation and discuss how environmental liability exposure, supply chain transparency requirements and new reporting standards are reshaping risk management frameworks and long-term operational planning across the industry.

Ongoing amendments and transitional extensions are continuing to reshape the practical implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) across the EU. This session will outline the latest updates to these legislations and explore the persisting uncertainties and challenges for legal teams managing medical device and IVD portfolios.

The EU Biotech Act introduces both political ambition and significant legal uncertainty, with key questions remaining around its scope and implementation. This roundtable will examine the practical challenges, transitional ambiguity and strategic opportunities arising from the new legislation and assess how biotech companies can leverage the Act to reposition their competitive footprint in Europe.