What are the most significant cases, projects and/or transactions that you and/or your legal team have recently been involved in?

Over the past year, our Legal team has been deeply engaged in several high-impact projects that reflect both the company’s strategic ambitions and the increasing complexity of our operating environment. Three initiatives in particular stand out for their scale, cross-functional collaboration, and long-term significance.

Internal Corporate Restructuring Across EMEA: In parallel, we led a comprehensive internal restructuring initiative aimed at streamlining our legal entity footprint across the EMEA region. This involved the rationalisation of operational entities through M&A activity and commercial partnerships for distribution, the reallocation of intercompany financial flows, and the centralisation of certain commercial functions. Our team worked closely with Tax, Finance, and HR to ensure compliance with local corporate, labour, and transfer pricing regulations. This restructuring has positioned us for greater agility in responding to market shifts and regulatory developments.

Legal Support for Landmark Clinical Studies in Cardiology: Our team also provided end-to-end legal support for a series of pivotal clinical studies in the field of interventional cardiology. These studies, recently recognised by the cardiology community as landmark trials with the potential to transform the treatment of coronary artery disease, required meticulous contracting and collaboration with CROs, academics, KOLs, and other key stakeholders, together with a constant focus on full compliance with the regulatory environment. We also supported regulatory submissions across multiple regions. The successful completion of these studies not only advances our scientific leadership but also lays the groundwork for future product approvals and market expansion.

Across all these projects, our Legal team has demonstrated agility, cross-border coordination, and a deep understanding of the business’s strategic priorities. We have also continued to invest in legal operations, implementing new contract lifecycle management tools and enhancing our knowledge-sharing platforms to support scalable growth.

As we look ahead, we remain focused on supporting the business through its next phase of growth.

How do you approach managing legal aspects during periods of instability or crisis to ensure the organisation’s resilience?

Periods of instability and crisis have continuously shaped the legal profession over the past 20 years. From the 2008 global financial crisis and the Eurozone sovereign debt turmoil to the COVID-19 pandemic and recent geopolitical tensions affecting global trade, each wave has triggered regulatory shifts across financial, tax, social, and commercial domains. These events have driven sweeping reforms, requiring legal teams to remain agile, informed, and deeply embedded in strategic decision-making.

We prioritise scenario planning and legal risk mapping, ensuring that our contractual frameworks, governance structures, and compliance protocols remain resilient under stress. During recent challenges – such as navigating regulatory transitions in clinical research and adapting to evolving tax and data protection regimes – we maintained continuity by embedding legal counsel directly within operational teams. This proximity enables rapid decision-making, proactive issue identification, and consistent messaging across jurisdictions.

We also continue to invest in legal operations and knowledge management to enhance agility. Whether responding to supply chain disruptions, data protection incidents, or changes in clinical trial oversight, our team relies on playbooks and escalation protocols refined through experience.

Ultimately, our role is not only to protect but also to enable. By translating complexity into actionable guidance and maintaining composure under pressure, we help the organisation adapt without compromising integrity or strategic momentum.

Based on your experiences in the past year, are there any trends in the legal or business world that you are keeping an eye on that you think other in-house lawyers should be mindful of?

In the healthcare sector, one trend we are closely monitoring is the growing convergence of regulatory, reputational, and operational risk – particularly in areas such as compliance transparency disclosures and cross-border data governance. Legal teams are no longer merely interpreters of law; to some extent, we are becoming architects in environments where stakeholder expectations evolve faster than legislation. In this context, our involvement in representative bodies such as SNITEM and LEM has been instrumental. Through these platforms, we have helped to shape or mitigate legislative proposals and regulatory guidance, particularly concerning clinical data transparency, medical device traceability, and ethical standards in therapeutics. These engagements enable us to anticipate change and influence it constructively.

We are also seeing a shift in how Legal contributes to strategic planning. With tax, trade, and privacy regimes in flux – especially across Europe and the United States – legal input is now essential at the design stage of business models, not merely at execution. This demands deeper collaboration with Finance, Compliance, and Public Affairs.

AI has been taken seriously as a potentially revolutionary technological change in the legal world for a number of years now. Has it had a meaningful impact in how your legal team works in this time?

Yes, AI has begun to meaningfully shape how we work – particularly in legal operations, contract lifecycle management, knowledge sharing, and compliance and regulatory training. We have integrated AI-powered tools to accelerate tasks not only in contract review and template building but also in repetitive workflows, slow or frustrating processes (such as third-party distributor due diligence), and data-heavy decision-making. This allows our team to focus more on strategic advisory work. While we remain cautious about generative AI in sensitive contexts, we see clear value in its ability to enhance efficiency, reduce repetitive tasks, and support faster, more informed decision-making. The key lies in thoughtful implementation – balancing innovation with governance and ethical oversight.