Not every barrier between a patient and the right treatment is clinical. Many are structural built into the policies, frameworks, and incentive systems that govern how healthcare systems decide what to fund, for whom, and when. Shaping those structures, rather than simply working around them, is one of the four areas where Vintura works with life sciences companies.
The Challenges
Healthcare systems were not built for the therapies we have today
The frameworks that most European healthcare systems use to assess the value of new therapies were designed for a different era. When patients were dying faster and treatments were blunt, overall survival made sense as the primary measure. Today, patients live for years even with serious conditions, so the questions that matter are different: what kind of life does the therapy enable; does it reduce the burden on carers and health systems; does it shift treatment from hospital to home?
Most reimbursement frameworks do not yet recognise these dimensions of value. Compounding this, systems often evaluate therapies primarily against immediate budget impact, missing long-term benefits that reduce downstream costs. The result is a structural misalignment between how innovation creates value and how systems choose to measure it. A strong pharmaceutical innovation ecosystem cannot be built without an access system that rewards innovation; when that link breaks, future patients pay the price.
EU HTA adds a layer; it does not simplify
The EU HTA Regulation is now operational for oncology, expanding to orphan drugs from 2028 and all new medicines from 2030. The most important point is that it adds a European layer of review without fully replacing what happens at national level. Economic considerations are explicitly excluded from the European assessment and continue to be evaluated country by country. Companies must now satisfy both processes, and the interplay between them remains uncertain. What was designed to simplify has, to date, added complexity and for our clients, the uncertainty is harder to navigate than the complexity itself.
Evidence plans lag behind value expectations
As therapies become more targeted and patient populations smaller, evidence frameworks have not kept pace. In some oncology settings, properly measuring overall survival still a primary endpoint in many HTA frameworks would require observing a population for more than a decade. That is a scientific reality the system has not yet designed around. Real-world evidence offers a partial response, but it requires data infrastructure most European markets do not yet have. The result is a persistent mismatch between what companies can demonstrate and what systems expect them to prove.
A stakeholder landscape that does not naturally converge
Effective policy shaping requires alignment across four groups whose interests are all legitimate but do not automatically converge. Patients want fast access and support navigating a system not designed with them in mind. Healthcare providers want to deliver the best available care, but operate under real constraints: workforce shortages, operational pressures, and department-level budget accountability. The pharmaceutical and biotech industry needs predictable pathways and healthcare systems that can adapt to accommodate innovation. Payers are accountable for short-term budget lines and want robust evidence of real-world performance before committing.
Success in policy shaping is a journey, not a moment. The first marker is trusted dialogue. The second is a position backed by evidence and endorsed by others. The third and the only one that ultimately counts, is that policy changes in the direction you intended.
What Good Looks Like
Success in policy shaping is a journey, marked by clear milestones.
Trusted dialogue
The first meaningful marker of success is a trusted relationship. Knowing which stakeholders to engage, being in active and credible dialogue with them, and building enough mutual understanding to be taken seriously this is the foundation from which all subsequent progress follows. In practice, it takes years to establish and cannot be shortcut.
A clear position, backed by evidence, endorsed by others
The second stage is translating insight and relationships into a publicly held position. This means producing white papers, commissioning research, and developing evidence-based arguments and, critically, securing endorsement from credible independent voices: clinical leaders, patient organisations, and health economists. Policy influence at the level of legislation or framework change requires a coalition, not a single company’s advocacy.
Policy change in the intended direction
The ultimate measure of success is that a policy arena, whether legislation, implementing decisions, or value assessment frameworks, changes in a direction that was shaped by the work. It is a long journey. The companies that reach it are the ones that began early, sustained their effort consistently, and were willing, when necessary, to adapt their own position rather than only asking others to adapt theirs.
Policy shaping is not only about communicating changes, and not only about asking for them. You need a strong evidence base, showing policymakers and healthcare systems why those changes matter. This is what is most consistently underestimated.
Our Approach
Shaping the environment at two levels simultaneously
Policy shaping operates at two distinct levels, and Vintura works across both. At the product level, we help companies identify, starting in evidence generation where the current policy environment will support access and where it will not. At the sector level, we work with companies and industry associations on the broader conditions needed for pharmaceutical and biotech innovation across Europe. Most organisations focus on only one level, but effective policy shaping requires both.
Anticipate: identify policy barriers as early as evidence generation
The starting point for any policy shaping initiative is an honest assessment of whether the value a company intends to demonstrate will be recognised by the systems into which a therapy will launch. If the current framework will not capture that value, the policy work must begin immediately. Waiting until development is complete leaves no time to change the environment.
Evidence: build the foundation that earns a seat at the policy table
Evidence-based advocacy means generating, structuring, and communicating data that directly addresses the questions policymakers and payers are actually asking, not the questions a clinical team would naturally prioritise. Companies that come to policymakers with compelling evidence for why a change is needed are received very differently from those that come with requests alone.
Align: build a shared understanding of why change is needed
Stakeholder alignment in a fragmented landscape begins with understanding where each stakeholder’s position comes from: what data they are working from, what pressures they face, what they are accountable for. From that foundation, it becomes possible to identify the space where interests can be balanced. Transparent communication about your own position and its evidential basis is equally important. Without it, no coalition holds over time.
Sustain: hold the direction through political cycles and changing landscapes
Policy change does not happen at a product timeline. It follows political dynamics, budget cycles, election cycles, and institutional processes that cannot be accelerated by commercial urgency. What policy shaping requires is patience, consistency, and the organizational commitment to maintain stakeholder relationships and an active presence in policy conversations over years. Companies that treat policy engagement as a campaign to be run around a launch will consistently underperform against companies that treat it as a long-term strategic capability.
Multi-market perspective combined with in-market depth
Effective policy shaping requires two things simultaneously. One, you need a strong and continuously updated view of where different markets are heading and how they influence each other. At the same time, individual market dynamics: the specific actors, structures, regulatory guardrails, and political considerations that determine the rules of the game require genuine in-market experience and relationships. Vintura brings both: a cross-European perspective that identifies patterns and cross-market learning, combined with established connections in the markets where it matters most.
Let’s talk
Your policy journey should have started earlier than you think. Let’s work out where you are now.
Whether you are preparing for your first EU HTA submission, rethinking your evidence strategy in light of meeting payer expectations, or trying to build stakeholder alignment in a market where interests are genuinely fragmented, the best starting point is always a conversation. Jan-Philipp Beck and Ann-Sophie Kuschel lead Vintura’s policy shaping work. Reach out directly, or share where you are and we will take it from there.
