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?
Richard Anscombe
A graduate of Harper Adams Agricultural College Richard’s career spans both the Agriculture and IT sectors. Working in the commercial field based team at Norsk Hydro Fertilisers, now YARA, Richard then joined a subsidiary IT company, Innovation Systems, which was set up to market the Warehousing and Distribution Software systems, that the parent company developed, into the UK market. After 20 years in IT, with clients spanning the Agri-Food sectors,Richard joined Fram Farmers in 2010, one of the UK’s largest buying Group Cooperatives, as their CEO. Attending Harvard Business School’s Leadership Best Practice Course and Cambridge University Institute of Sustainability Leadership gave Richard both insight and incentive to focus much of his consultancy work into Agri-Food sustainability. Richard joined x-Farm in March of this year as their UK Business Manager to lead an important element of xFarm’s strategy as they enter the UK market with their Farm Management Information System, and Farm Analytics, which enables Grain Trading, Animal Feed, Maltster’s and Food Manufacturing Companies to manage and measure their Scope 3 emissions. XFarm enjoys the support of over 600,000 farmers across Europe and South America.
Richard was awarded Fellowship of the Royal Agricultural Societies ( FRAgS) in 2024 in recognition for his work and support for the Next Generation working within Agriculture and enjoys mentoring younger Managers and Directors as they navigate their careers.
Richard Anscombe
A graduate of Harper Adams Agricultural College Richard’s career spans both the Agriculture and IT sectors. Working in the commercial field based team at Norsk Hydro Fertilisers, now YARA, Richard then joined a subsidiary IT company, Innovation Systems, which was set up to market the Warehousing and Distribution Software systems, that the parent company developed, into the UK market. After 20 years in IT, with clients spanning the Agri-Food sectors,Richard joined Fram Farmers in 2010, one of the UK’s largest buying Group Cooperatives, as their CEO. Attending Harvard Business School’s Leadership Best Practice Course and Cambridge University Institute of Sustainability Leadership gave Richard both insight and incentive to focus much of his consultancy work into Agri-Food sustainability. Richard joined x-Farm in March of this year as their UK Business Manager to lead an important element of xFarm’s strategy as they enter the UK market with their Farm Management Information System, and Farm Analytics, which enables Grain Trading, Animal Feed, Maltster’s and Food Manufacturing Companies to manage and measure their Scope 3 emissions. XFarm enjoys the support of over 600,000 farmers across Europe and South America.
Richard was awarded Fellowship of the Royal Agricultural Societies ( FRAgS) in 2024 in recognition for his work and support for the Next Generation working within Agriculture and enjoys mentoring younger Managers and Directors as they navigate their careers.
Kathleen Hofmann
Divisional filing strategies have become a crucial and often contentious issue at the intersection between life science IP and antitrust law. As patent offices face growing pressure to alter their stance on divisional practice and competitors increasingly scrutinise filing strategies, companies must navigate a complex, high stakes environment where portfolio decisions can significantly impact market exclusivity timelines, public perception and revenues from blockbuster products.
This session will define the legal boundaries between anti-competitive evergreening and strategic portfolio optimisation, discuss how divisional filing strategies should be aligned with regulatory exclusivity and SPC frameworks, and explore the most effective approaches for generics companies seeking to challenge access blocking divisional patent families.
Where does the legitimate boundary lie between portfolio optimisation and anti-competitive “evergreening”?
- How should originator companies design divisional strategies in parallel with regulatory exclusivity and SPC frameworks?
- How should generics companies coordinate IP invalidity, regulatory and competition strategies when confronting large divisional families?
- How does the UPC shift the litigation and competition risk profile of divisional portfolios?
- Are we entering a more interventionist phase in EU scrutiny of patent strategy – what signals should companies be monitoring in this space?
Competition law is no longer a standalone legal discipline within the life science sector. As antitrust scrutiny expands across patent practices, litigation settlements, pricing and deal-making, competition risk has become an increasingly important strategic issue, with significant potential implications for how you and your company approach future IP, regulatory and corporate decision-making.
This holistic, industry-led keynote will bring together private practitioners, regulators and in-house counsel to examine the evolving landscape of life science antitrust and discuss how recent developments in this area are reshaping legal strategy across the sector.
- How are interactions between competition authorities, patent offices and healthcare agencies reshaping the legal operating landscape for life science companies?
- How are industry perspectives on M&As, settlements and other life science transactions evolving?
- How are regulators scrutinising IP and regulatory frameworks in abuse of dominance investigations?
- What global trends are emerging in dawn raids, antitrust litigation and financial enforcement mechanisms targeting anti-competitive conduct in the life sciences sector?
- How should legal teams integrate competition risk into broader IP, regulatory and corporate strategy?