Armed conflict, pricing interventions, the weaponisation of tariffs and intensifying policy competition between major jurisdictions are rapidly reshaping the global operating environment for life science organisations. As geopolitical tensions rise, companies must ensure that international relations are appropriately factored into their approaches to cross-border transactions, global market planning and long-term legal decision-making.

This cross-practice keynote will examine how geopolitical developments are reshaping legal strategy across the life sciences sector, and what this means for how you and your company should approach international investment and global deal-making.

- How are geopolitical tensions and policy interventions, including U.S. MFN pricing and the BIOSECURE Act, reshaping the legal and commercial risks life science companies must manage across global markets?
- How are life science legal teams adapting global strategy in response to increasing government intervention in drug pricing, trade policy and supply chains?
- How are geopolitical risks influencing how companies structure and execute cross-border life science transactions, including M&A, partnership and licensing agreements?
- How should legal teams balance geopolitical risk with commercial opportunity when pursuing international investment and strategic partnerships?

The EU Pharma Package is poised to reshape the commercial landscape for life science companies operating in Europe, with far-reaching implications for pricing, reimbursement negotiations and market access strategy across Member States. Reforms to exclusivity incentives and measures designed to accelerate generic entry could significantly influence pricing dynamics and the way companies approach reimbursement discussions across the region.

This session will explore how the EU Pharma Package could reshape pricing and reimbursement (P&R) dynamics across the EU, and what these changes may mean for your company’s strategic decisions around launch planning, portfolio prioritisation and long-term participation in the European life science market.

- How could changes to exclusivity incentives and earlier generic entry under the EU Pharma Package affect pricing dynamics across Member States?
- What implications might the reforms have for national P&R negotiations, including tender systems and reference pricing mechanisms?
- How might companies need to adapt their market access strategy and launch planning in response to increased pricing pressure?
- Could the reforms alter how companies prioritise product portfolios and decide whether and when to launch medicines in the European market?

The EU Pharma Package’s controversial expansion of the Bolar exemption has the potential to recalibrate launch timing, litigation leverage and competitive dynamics across the originator-generic divide. The reform directly challenges traditional assumptions about the protective scope of patent rights and the practical meaning of exclusivities in Europe, while inviting direct comparison with the U.S. Hatch-Waxman safe harbor framework.

This session will explore the expanded Bolar exemption and its broad implications across the sector, addressing how national courts are likely to interpret the legislation and how the new provisions compare with established U.S. safe harbor frameworks. Gain an enhanced understanding of how this landmark shift at the interface of IP and regulatory strategy will impact your life science legal work, and receive exclusive advice to help you adjust to the new provisions with confidence.

- What is the scope of the expanded Bolar exemption under the EU Pharma Package, and how does it compare with the U.S. Hatch-Waxman safe harbor?
- Will the expanded provisions actually enable day one generic entry in practice?
- How will expansions to the Bolar exemption play out in the national courts?
- How will incorporating aspects of pricing, public tender and reimbursement into the new provisions interplay with existing IP rules?
- Where do the core risks now lie for innovators, biosimilars and generics? How can they be minimised?
- What are the downstream implications of these legislative changes for patent litigation strategies?

The CMA marks a structural shift in EU life science policy, introducing new definitions, supply obligations, disclosure requirements and procurement mechanisms that will directly impact pricing, manufacturing strategy and governance frameworks. It signals a move from crisis-driven coordination towards a permanent resilience regime, embedding supply security and transparency as enforceable regulatory objectives.

This session will dissect this important new legislative framework, addressing its key aims, uncertainties and implications for your company.

- What will constitute a critical medicine?
- How will the Act work in practice?
- How will the responsibility for its implementation be divided between the Commission and Member States?
- What incentives or other support will companies receive for diversifying their supply chains towards Europe and participating in Strategic Partnerships?
- How will the new public and collaborative procurement initiative influence pricing dynamics?
- How will supply continuity obligations for critical medicines be enforced? Where is the litigation risk, and what is the scope for force majeure?
- What supply chain information will need to be disclosed/reported? What steps will be taken to protect commercially sensitive information?
- How will the Act interplay with the EU HTA Regulations and other legislative frameworks?

Regulatory exclusivity frameworks are evolving at pace, with profound implications for how life sciences companies approach legal strategy across jurisdictions. In Europe, the EU Pharma Package is replacing the long-standing certainty of fixed-term regulatory data protection (RDP) and market exclusivity with a more involved system of conditional incentives linked to product characteristics, launch strategy and public health priorities. Set against this, the regulatory exclusivities landscape in the U.S continues to be shaped by litigation and judicial interpretation, creating new EU-U.S. divergences in how regulatory exclusivities are secured and leveraged.

This session will examine the Pharma Package’s changes to RDP and market exclusivity, and explore how evolving exclusivity frameworks in Europe and the U.S. are reshaping the complex interplay between IP, regulatory and broader business strategy. 

- How feasible will it be for companies to meet the Pharma Package’s 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 across the EU?
- How are EU 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?
- What are the latest developments in U.S. regulatory exclusivity frameworks? How do they compare against evolving approaches in Europe?
- How should companies align lifecycle management and their regulatory exclusivity strategy across European and U.S. frameworks?

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.

This holistic keynote 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?