Europe's position as a global healthcare leader is being tested by intensifying competition from both the US and China. As CSL’s Dirk Hoheisel points out, this is not because Europe lacks scientific excellence, industrial strength, or innovative capacity, but – in his opinion – due to a fragmented system that hinders patient access and weakens its investment potential. Drawing on nearly three decades of international experience, Hoheisel reflects on the need for a more holistic approach to healthcare in Europe, the evolution of CSL from its plasma-derived foundations to advanced therapies, and why the continent’s long-term competitiveness will ultimately depend on its ability to align innovation, access, and investment in the service of patients.
What do you see as the most important shifts shaping Europe’s healthcare landscape today?
Europe remains a major economic and scientific powerhouse, underpinned by strong healthcare systems, leading research centres, and significant industrial capacity. Yet its relative attractiveness is increasingly under pressure. The US continues to set the global benchmark in biopharma, while China has advanced rapidly and now competes at a much higher level across research and development, clinical development, and innovation. Against that backdrop, Europe risks becoming less attractive unless it strengthens its competitiveness and addresses some of its structural challenges.
The continent’s foundations remain exceptionally strong. Across Germany, France, the Nordics, the UK, and many other markets, there are outstanding scientific hubs, world-class medical research centres, established manufacturing capabilities, and robust healthcare infrastructures. The difficulty is that Europe remains highly complex and fragmented. The EMA has helped create greater regulatory alignment, but when it comes to reimbursement, pricing, procurement, sustainability requirements, and broader policy frameworks, companies still have to navigate each market individually. Bringing medicines to patients across Europe still often feels like starting from scratch in every country, despite the expectations and promise of EU Joint Clinical Assessments in the coming years
For me, that points to the need for a more holistic approach. Greater alignment between stakeholders, both across Europe and within individual markets, would make a meaningful difference. At the same time, Europe needs to recognise more clearly that sustained investment in healthcare is a prerequisite for competitiveness, not a consequence of it. Even within the same country, health and economic policymakers do not always work towards the same objectives, while healthcare budgets are often dispersed across multiple decision-makers. The more Europe can unite its strengths and make access to medicines more straightforward, the more attractive it will become for long-term investment. Markets that facilitate patient access tend to attract investment, and the US is perhaps the clearest example of that dynamic.
What role does Europe play within CSL’s international footprint, and how do you navigate the realities of operating across such a fragmented region?
Europe is enormously important to us. We have thousands of employees across the region, major facilities in Marburg in Germany, two large sites in Switzerland, operations in the UK, and plasma collection centres in countries such as Germany and Hungary. More importantly, we are present across the full value chain, and we see Europe as a region where we have key commitments and partnership opportunities with governments to continue improving patient access to critical and innovative medicines.
That commitment is closely linked to the nature of our business. Many of our therapies are plasma-derived, which means everything begins with plasma donated by eligible individuals. Donor safety, rigorous screening procedures, and plasma quality sit at the heart of what we do. Unlike conventional pharmaceuticals, plasma-derived medicines rely on complex, highly regulated manufacturing processes that can take nine to twelve months from donation to finished product. This requires substantial investment in plasma collection systems, production capacity, and infrastructure. These are long investment cycles, which is why reliability matters so much. We need confidence not only in the environment we face today, but in the conditions we can reasonably expect several years down the line.
Our priority is clear: enabling access for as many patients as possible. We recognise that Europe’s healthcare landscape is complex and that different markets require different approaches, which means being agile, flexible, and pragmatic in the way we work with stakeholders across the region. We also consistently advocate for two principles that we believe are essential to Europe’s long-term attractiveness: predictability and a willingness to invest in health. Healthcare should not be viewed purely as a cost. Investment in health supports healthier populations, a more productive workforce, and stronger economies. We are not here to maximise short-term returns; we are here for the long term—serving patients, reinvesting in our capabilities, and creating the conditions that allow us to continue bringing innovation forward.
How do you approach such a broad portfolio, spanning plasma-derived medicines, rare diseases, and advanced therapies?
Our portfolio’s strength lies in its diversity. Plasma-derived medicines, which remain the backbone of our business, require substantial and sustained investment to ensure donor safety, rigorous screening procedures, high-quality plasma collection, and reliable manufacturing. Because of the investment involved and the complexity of the process, sudden policy measures, such as unexpected cost containment government measures, like clawbacks, can quickly alter the balance and ultimately affect our ability to continue providing medicines to patients. Recognising the specific nature of plasma therapies is critical to maintaining both access and long-term supply.
At the other end of the spectrum are advanced therapy medicinal products, or ATMPs, including cell and gene therapies, where the discussion shifts from manufacturing complexity to how value is understood and rewarded. Traditional payer systems have largely been designed around chronic treatments with ongoing costs, whereas these therapies may involve a one-time intervention with the potential to deliver benefits over many years. That requires trust in the evidence, flexibility in reimbursement approaches, and openness to mechanisms such as outcome-based agreements, particularly given that these therapies cannot launch with decades of clinical experience behind them. At the same time, every market has its own realities, from national and regional reimbursement structures to individual hospital settings and levels of patient awareness. Our role is therefore to combine local expertise with the flexibility to respond to different systems’ needs, always with the same objective in mind, ensuring that as many patients as could benefit from these treatments, can access them in a timely and reliable way.
What will determine whether Europe can maintain its competitive edge in advanced therapies over the coming years?
I believe Europe already has many of the ingredients needed to succeed in advanced therapies. There is strong scientific expertise, well-established healthcare systems, and specialised infrastructure capable of delivering highly complex treatments. The challenge is that we still operate within a fragmented environment. Companies often have to prepare different dossiers, adapt the same value proposition to multiple healthcare systems, and engage in separate reimbursement discussions in every market. Even when we start these conversations early, the process itself can take years, and national reimbursement decisions are often only one step before patients actually receive treatment. As a result, we inevitably have to sequence launches, directing resources towards markets where the infrastructure is in place, there is a shared understanding of the evidence, and stakeholders are willing to work together to translate innovation into patient access.
Those practical challenges point to a broader issue; Europe would benefit from greater alignment and predictability. This does not mean every country should reach the same conclusions or pay the same prices, because each healthcare system has its own priorities and budget constraints, but there is scope for more consistency in how evidence is assessed and how access discussions are approached, rather than repeatedly starting from scratch. Recent debates around Most Favoured Nation pricing in the US have underscored just how interconnected these decisions have become, with pricing choices in one market carrying implications far beyond national borders. Europe has the scientific expertise, clinical capabilities, and infrastructure needed to remain a leader in advanced therapies. The question is whether it can match those strengths with the clarity, trust, and long-term predictability that encourage investment and ensure that innovative treatments reach patients without unnecessary delay.
Where do you see the future of plasma-derived medicines in Europe, and how is CSL preparing for the next wave of innovation built on those foundations?
I think Europe has made progress in recognising the strategic importance of plasma, but we are still some way from where we need to be. Today, Europe remains heavily dependent on plasma collected elsewhere, primarily in the United States, because we do not yet collect enough plasma domestically to meet the needs of all patients who rely on plasma-derived medicines. That means continuing to implement the frameworks already endorsed at European level, making it easier for people who are willing to donate, and encouraging donation more broadly, while ensuring that sufficient production capacity exists within Europe. It also means recognising that plasma-derived medicines cannot always be viewed through the same lens as other therapies. From plasma collection through to manufacturing and distribution, they require significant investment, long planning horizons, and a framework that reflects their unique characteristics when questions of value, sustainability, and access are considered.
That same long-term perspective also shapes how we think about innovation. It is not only about pursuing entirely new therapeutic approaches, but also about continually improving the treatments patients already depend on. Therapies such as immunoglobulins, which replace non-functioning immune systems, will continue to be needed for decades to come, and much of our focus is on making them easier to administer, less burdensome for patients, more efficient to produce, and more accessible. Alongside that, we continue to invest in the next generation of therapies in areas where we already have deep expertise, rather than moving into entirely new fields. Haemophilia is perhaps the clearest example of that evolution, progressing from plasma-derived clotting factors to recombinant products and now gene therapies. Our approach is to build on the foundations we already have, advancing step by step as science evolves so that patients continue to benefit from the best treatment options available, while remaining focused on the therapeutic areas where we believe we can make the greatest difference, including haematology, immunology, and nephrology.
How has CSL evolved in recent years, and what would you most like policymakers and other stakeholders to understand about the organisation today?
At its core, CSL is one of the world’s leading biotechnology companies, with plasma-derived medicines remaining a fundamental pillar of our expertise. Our strategy has been to build on that foundation, continuing to invest in the therapeutic areas where we have longstanding experience and advancing to the next generation of treatments when science offers better options for patients. Whether that means recombinant therapies or cell and gene therapies, our focus remains the same, to evolve alongside scientific progress while staying rooted in the disease areas we understand best and where we believe we can have the greatest impact.
What would be a message you’d like to address to European policymakers?
If I had one message for policymakers, it would be to view healthcare through a more holistic lens. The medicines we develop improve and extend lives, but they also contribute to healthier populations, stronger economies, and ecosystems that attract research, manufacturing, and long-term investment.
It becomes much more difficult when different parts of the system pursue disconnected objectives or focus too narrowly on individual elements of the value chain. The easier it is for patients to access medicines, the more attractive a market becomes for investment, creating a virtuous cycle that benefits patients, healthcare systems, and society as a whole.
That is perhaps the most important lesson we can draw from regions that have taken a more aligned approach. If Europe acts on this, it can reinforce both its competitiveness and its long-term resilience.
What principles define your leadership approach?
Having worked with teams across different parts of the world for nearly 30 years, I have come to believe that the most important aspects of leadership are listening and learning. People communicate differently, bring diverse experiences, and often approach the same situation from different perspectives, so taking the time to genuinely understand one another is essential.
When individuals have confidence in themselves, trust in their colleagues, and belief in the organisation’s purpose, they create an environment where people can perform at their best, support one another, and ultimately deliver better outcomes for both patients and the organisation.
For me, helping to build that kind of culture remains one of the most rewarding aspects of leadership.
Looking ahead, what would success look like for you in the next few years?
Looking ahead to the next few years, I hope we will have succeeded in bringing more medicines to more patients who need them, not only through the innovative therapies emerging from our pipeline, but also through the established plasma-derived treatments on which many people continue to depend. More broadly, I hope Europe will have recognised that, in a world shaped by the scale and focus of the US and China, its countries are stronger together than apart. If we can strengthen the foundations for investment in healthcare, improve access to medicines, and approach these challenges with a greater sense of shared purpose, I believe Europe can reinforce both its competitiveness and the resilience of its healthcare systems. I am a great believer in Europe, and I sincerely hope that this is the direction Europe will take with clear determination.
