From lab to patient: Why European biotech is at a crossroads
Innovation only succeeds when it demonstrably creates value for both patients and the healthcare system. How can biotech and pharmaceutical players design their R&D strategies so that medical innovation reaches patients faster, more precisely, and in an affordable way? An interview with Jérôme Van Biervliet and Frank Hulstaert.
This article first appeared in Dutch in Kompas Healthcare (author: Lieven Desmet).
Belgium has long ranked among Europe’s leaders in biotech, pharma, and clinical research. With a strong concentration of pharmaceutical companies, top-tier university hospitals, and a well-developed clinical trial landscape, the country plays a key role in the European and global R&D value chain. Yet patients, healthcare providers, and institutions increasingly experience that medical innovation does not automatically translate into fast or equitable access to care.
Following the recent announcement of the European Biotech Act, Frank Hulstaert, senior researcher at the Belgian Health Care Knowledge Centre (KCE), believes Europe recognizes the need to accelerate. “It is certainly a step in the right direction,” he notes. What stands out to him most is the shift in focus. While the past 10 to 15 years were dominated by oncology, the field is broadening again. “Other chronic diseases are coming back into sharper focus,” he says. This is no coincidence. The extremely high prices long accepted in cancer care are increasingly under pressure, while significant innovations are emerging beyond oncology.
Jérôme Van Biervliet, Managing Director at VIB, contributed to shaping the Act and places it in a broader perspective—not as a standalone policy initiative, but as part of a structural repositioning of Europe in innovation, healthcare, and geopolitics. “Innovation does not start with a medicine, but with how fundamental research finds its way into companies and ultimately to patients,” he emphasizes. In his view, structural factors—financing, regulation, and the growing difficulty of conducting clinical trials in Europe—largely determine whether scientific breakthroughs translate into real societal impact.
Towards broader breakthroughs
Van Biervliet describes a clear pattern from an ecosystem perspective. “Breakthroughs only happen because Europe, and Flanders in particular, made deliberate investments in life sciences thirty years ago,” he says. The establishment of VIB focused on combining excellence in fundamental research with active valorization. “Spin-offs, patents, industrial partnerships, and investment funds are integral to that model.”
Both experts stress the critical importance of diagnostics. Hulstaert points out that diagnostics often run about ten years ahead of treatments. “You can only treat a disease if you can first identify it correctly.” At the same time, he warns: “Early diagnosis only makes sense if it has therapeutic consequences.”
Van Biervliet links this directly to data infrastructure. “Innovation depends on access to high-quality, large-scale data.” Initiatives such as the European Health Data Space are crucial, yet much of the potential remains untapped today. “Data and samples are not sufficiently accessible for research, due to legal complexity but also because of entrenched attitudes around publications and valorization.” The COVID-19 pandemic, he notes, clearly demonstrated what is possible through large-scale, coordinated studies.
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Market approval versus reimbursement
Hulstaert distinguishes between two critical steps: market authorization and reimbursement. “Market authorization focuses on benefit versus risk, without comparing to existing alternatives. Reimbursement does the opposite: comparison is central.” According to him, this distinction is still too often underestimated, particularly by small innovative companies. “Single-arm trials are faster and cheaper,” he explains, “but they provide limited evidence for payers.” The result is a growing tension: products reach the market more quickly but fail to secure reimbursement—or only partially—due to insufficient proof of added value. “We saw this in metastatic cancer as well: enormous investments, but often no demonstrable survival benefit.”
Van Biervliet sees this as a clear European challenge. “After years of testing and billions in investment, companies cannot afford to navigate 27 separate reimbursement procedures.” He argues for much greater centralization of clinical studies and reimbursement evaluations. “That would not only be more efficient for companies, but also better for patients.”
Europe in search of balance
Both agree that Europe is engaged in a delicate balancing act. Hulstaert calls for greater transparency in accelerated market access. “If we accept uncertainty, we must communicate it clearly.” Van Biervliet views the Biotech Act as a necessary step forward. “The political momentum is finally there. Competitiveness, strategic autonomy, and societal return are once again high on the agenda.”
In his view, Europe even has a structural advantage. “A publicly organized healthcare system makes it possible to better align data, research, care, and policy.” Hulstaert adds that such alignment is essential for making innovation sustainable. “Regulators and payers ultimately serve the same public interest. If they reinforce rather than counteract each other, both patients and society stand to benefit.”
Gunnar De Winter
