Do you speak European?
At Biotech Showcase this year, I took part in a fireside chat with a simple but revealing title: Do You Speak European? It raised a smile for good reason. Because most biotech leaders know that “going to Europe” is rarely as straightforward as the phrase suggests. Europe is not one decision or one market. It is a set of highly specific systems, expectations and timelines that reward preparation and punish assumption.
What struck me most in the conversations that followed was how often European complexity is underestimated or quietly deferred until it becomes a constraint rather than a choice. At Sciensus, our work spans the full journey from early access through to commercialisation, which gives us a unique perspective to see how European challenges play out repeatedly, across therapies, markets and moments in a company’s lifecycle.
Europe is not complicated. It is precise.
One of the most persistent myths about Europe is that it is bureaucratic for bureaucracy’s sake. In reality, it is exacting. Central approval is only the beginning. From there, access depends on national requirements, reimbursement frameworks, operational readiness and local expectations, all of which vary, sometimes significantly. Treat Europe as a single market and momentum tends to slow quickly.
The companies that do well are the ones that recognise this early. They plan for nuance.
Timing matters more than most people realise
Another theme that resonated strongly during the session was timing, specifically how late many companies start thinking seriously about Europe. Europe tends to reward early engagement. Regulators, HTA bodies and national agencies are often more collaborative than they are perceived to be, particularly when discussions happen before strategies are fixed. Approached early, they can help shape viable paths to access. Approached late, they can only react.
There is also a growing push within Europe to simplify where possible, including mechanisms such as joint clinical assessments. These are not silver bullets but they reflect a broader intent to support innovation, especially when companies are willing to engage early and openly.
Leaving Europe too late does not just add work, it ultimately removes options and limits choices.
Sequencing should follow patients, not precedent
We also spent time discussing sequencing and why default approaches do not always serve companies or patients well. The traditional EU5-first model has its place but it is not universally right. A more effective starting point is often more practical: where are the patients, where is the unmet need most acute and where can access be achieved responsibly and sustainably?
Some countries enable earlier access but require careful planning around obligations and pricing. Others demand patience but provide long-term stability. The order in which markets are entered can materially affect cash flow, pricing integrity and operational complexity.
The key is intent: sequencing should be a strategic choice, not an assumption.
Operations are where credibility is tested
Distribution, pharmacovigilance, storage requirements, serialisation, inspections and cash collection are not secondary considerations in Europe. They are foundational and they take time. One hard-earned lesson is that very little in Europe happens as quickly as planned. Teams that succeed build in flexibility and ensure regulatory, supply chain, clinical and commercial functions are aligned well before launch. Siloed planning almost always shows up later, usually when it is hardest to fix.
Access does not fail in principle. It fails in execution.
Beyond “build or partner”
Finally, we talked about a familiar fork in the road: build a full European infrastructure or partner with a larger organisation and give up control. Both models can work. But they are not the only options. More companies are exploring a third approach, one that allows them to retain control and value while accessing experience and infrastructure where it is actually needed. By building selectively and partnering pragmatically, companies can establish access, generate momentum and scale at the right pace.
For organisations balancing ambition with runway, that flexibility matters.
Speaking European is a mindset
If I had to distil the session into one idea, it would be this: speaking European is not about mastering 27 rulebooks. It is about mindset.
It is about recognising Europe as a high-value region with real appetite for innovation, planning earlier than feels comfortable and being honest about what needs to be built and what does not. The companies that get this right reach Europe faster and build access strategies that last. And in the end, that is what matters, getting the right medicines to patients without unnecessary delay.
In Europe, success is less about having the perfect plan and more about having the right conversations early enough.
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