Europe’s biotechnology sector is at the heart of its economic growth and health innovation, driving 86% of advances in healthcare biotech and expanding at more than twice the pace of the wider economy. Yet persistent barriers, fragmented clinical trial regulations, funding gaps, and challenges around intellectual property and digital rules, risk slowing progress and deterring investment. With the forthcoming EU Biotech Act offering a once-in-a-generation chance to streamline pathways, strengthen strategic autonomy, and attract global R&D, the discussion comes at a pivotal moment. Drawing on Europe’s strong biotech ecosystems and the experience of companies that evolved from start-ups to global leaders, the panel explores how the EU can foster a thriving environment for innovation, competitiveness, and patient access to breakthrough treatments.

The science is here. The tools are ready. But political momentum has slipped. And time is running out. New HIV infections are rising in parts of Europe, driven by widening inequalities, missed diagnoses, and inconsistent access to combination prevention, which is an essential but often overlooked pillar of the global HIV response. Despite progress, the region remains far from reaching UNAIDS prevention targets, with significant unmet needs, especially among migrants, women, and marginalised communities. In this context, innovations such as long-acting injectable (LAI) PrEP offer promising new options that could enhance prevention efforts when combined with existing tools and person-centred care. As the 2030 deadline to end the epidemic edges closer, we need to ask the hard questions: What could bold and collaborative EU leadership on HIV prevention look like? And how do we turn that vision into action before it’s too late?

Cardiovascular disease claims 1.8 million lives in the EU each year, and yet momentum to prevent it has flatlined. Despite being Europe’s biggest killer, CVD still lacks a unified strategy, and women are bearing the brunt: they face higher mortality rates, lower treatment access, and are routinely excluded from research. With just 4% of healthcare R&D dedicated to women’s health, conditions like endometriosis remain chronically overlooked. But change is coming. A new EU Cardiovascular Health Plan is on the horizon, and with it, a chance to rewire how Europe approaches prevention, innovation and equity. The tools are there: the Clinical Trials Regulation, Clinical Trial Information System, and digital health solutions can turn fragmented care into coordinated action. But how can we put both heart and gender equity at the centre of the EU health agenda?

For 30 million Europeans living with rare diseases, fragmentation isn’t a policy debate, it’s a daily barrier to diagnosis, treatment, and hope. Patients face years-long diagnostic odysseys, limited therapies, and care that stops at national borders. It’s time to turn rare challenges into real solutions. European Reference Networks show that cross-border collaboration works. Biotech innovation is making faster diagnosis and targeted therapies possible. EU funding can drive the scale needed for true impact. Yet these efforts remain scattered, slowed by national divides and regulatory hurdles. A unified European strategy can make the rare real: connecting data, accelerating research, and ensuring every patient, in every country, can access care. Rare disease patients are Europe’s test of equity and resilience. The question is no longer what’s missing, but whether we’ll act.

The EU’s Tobacco Products Directive is stuck in 2014 – while the market has significantly evolved, and the threat to youth health is increasing. Nearly 700,000 lives are lost each year in the EU due to tobacco use, and now a new wave of recreational nicotine products is fueling addiction in younger generations. Flavoured pouches, sleek disposables, and discreet formats like vapes are widely available and often marketed in ways that attract young people and evade current regulations. This fast-evolving landscape demands legislation that is future-focused and prevention-led. The upcoming review of the Directive offers a once-in-a-generation opportunity to act boldly, shifting from reaction to early intervention. A tobacco-free generation by 2040 is possible - but only if we prioritize prevention now.

The pharmaceutical sector is uniquely positioned to address the dual challenges of improving health outcomes and driving economic growth through continuous innovation. Breakthroughs require ambition and an enabling policy environment that keeps pace with global advancements. As Europe faces rapid technological change and mounting global competition, decisive action is needed to restore its role as an innovation leader by attracting talent, investment and manufacturing capacity, accelerating the translation of scientific excellence into life-changing healthcare solutions, and ensuring timely access to innovative treatments and vaccines for all Europeans.

Europe faces a critical crossroads as U.S. tariffs set a tough new baseline, challenging its role in global trade. At the same time, proposed EU pharmaceutical reforms threaten to cut incentives that fuel innovation, risking a sharp decline in new drug development. If current rules pass, Europe could lose nearly a quarter of its anticipated breakthrough medicines by 2035, undermining its position as a global innovation hub. The continent’s share of global biopharmaceutical R&D could shrink, and small and medium enterprises, vital engines of innovation, are poised to bear the heaviest blow. Meanwhile, rivals in the U.S. and Asia ramp up investment and protect their industries, intensifying the race for leadership. The question looms: will Europe adapt or lose its place at the forefront of the pharmaceutical revolution?

The Critical Medicines Act (CMA) presents an opportunity for accelerating bold, coordinated EU and national actions to ensure steady supply of essential therapies to patients, while realizing the EU’s competitiveness agenda. From value-based procurement and flexible stock management to manufacturing resilience and innovation, the CMA has the potential to unlock long-term economic viability for critical medicines. Delivering on this ambition demands urgent, aligned action with Member States, especially where EU-level initiatives alone may fall short. In the face of unprecedented geopolitical shifts, the need for strategic alignment to deepen the single market and reinforce Europe’s resilience and international competitiveness is evident. Europe stands at a crossroads. Is the EU ready to take the leap?

Europe’s next health challenge lies at the intersection of human, animal, and environmental health. As the continent faces rising antimicrobial resistance (AMR), growing zoonotic diseases, and increasing global health threats, the need for the One Health approach is undeniable. AMR undermines healthcare systems, exposing the deep interconnections between human and animal health. Vaccines and repurposed medicines will be vital, but addressing these challenges requires more than medical innovation. The announcement of the Global Health Resilience Initiative by President von der Leyen underscores Europe’s commitment to stronger biosecurity and health resilience. As biological threats evolve faster than policy, and amid rising geopolitical tensions, Europe must reinforce its defence. One Health is now central to Europe’s pandemic preparedness, emergency response, and health security. And turning this vision into action will require urgent and sustained political will, cross-sectoral collaboration, and a new framework for cross-border health protection.

As the EU entered the eighth year of implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), the sector faces a pivotal moment. The ongoing evaluation of these frameworks sets the stage for critical discussions on the future of medical devices. The MDR and IVDR have transformed the landscape, tightening requirements on traceability, classification, and clinical evidence, whereas horizontal digital legislations add complexity to the environment. While frameworks as the AI Act, Data Act or European Health Data Space Regulation aim at a more trustful and innovative ecosystem, they introduce overlapping requirements for the medical devices sector, potentially impacting resource allocation and product availability. That raises a question: Will Europe succeed in turning digitalization and regulatory innovation into a competitive advantage, enabling patients access to new technology, or will it fall behind more agile markets?

Artificial Intelligence (AI) is transforming healthcare, opening unprecedented opportunities to improve diagnostics, personalise treatments, and enhance patient outcomes. AI-driven tools are increasing the accuracy and speed of disease detection, enabling earlier interventions and more effective patient management. By analysing vast datasets, algorithms can identify patterns and predict individual responses to treatment, laying the foundations for personalised medicine. At the same time, the adoption of AI raises important questions about implementation, trust, and equity, highlighting how technological innovation both can strengthen Europe’s health sector and improve the well-being of citizens across the continent.

Sleep disorders are far more than a quality-of-life issue – they’re a hidden but serious threat to heart health. Sleep is a vital sign of cardiovascular health, yet it remains largely overlooked in prevention strategies. Millions unknowingly live with disrupted sleep, raising their risk of hypertension, heart failure, and stroke. Yet public awareness of this link remains dangerously low. However, there have been recent breakthroughs in clinical research: new evidence shows that consistent treatment of sleep disorders can help prevent cardiovascular emergencies.

Advances in technology are changing the equation. Digital health solutions are moving beyond monitoring - making earlier interventions possible, strengthening prevention, and helping reduce long-term healthcare costs. With Europe’s population ageing, integrating sleep into cardiovascular care - including through the upcoming EU Cardiovascular Health Plan - is not an option: it’s urgent for prevention and sustainability.

Europe stands at a pivotal moment where health is not just a public good but a foundation for economic resilience. Preventable diseases continue to strain health systems, while cancer remains a rising burden with profound economic impact. Smarter investments in oncology show how early diagnosis and better access to innovation can save lives, reduce long-term costs, and support a productive workforce. Yet despite a €2 trillion long-term EU budget and recovery plan, only 2% is allocated to health – and the newly released Multiannual Financial Framework has reduced health funding even further, even as chronic diseases cost over €210 billion annually. The European Cancer Beating Plan, due for revision in 2026, offers a blueprint to tackle cancer more effectively, but will Europe invest like it matters?

Europe’s citizens are ready. Ready to embrace innovation. Ready to rethink healthcare. And ready to make bold trade-offs if it means building a system that is more effective, more sustainable, and more equitable. Bold policies like the Life Science Strategy and the Biotech Act and Pharmaceutical Package reforms could create new momentum and opportunities for progress. But without a laser focus on equitable access and an environment that values innovation and recognises its critical role in driving improvements in health and healthcare, there is a risk that these opportunities will be missed. To create a healthier, stronger, and more resilient Europe, citizens need decision-makers to do more than rethink the future of healthcare. They need us to start building it.