How to Successfully Launch a Pharma Product in Europe
What Global Biotechs Need to Know
In a recent interview on the Pharma Conversations Podcast, industry expert Charley Maxwell outlined the essential steps non-EU companies must take to successfully launch a product in Europe. His insights, drawn from years of supporting global biotechs, form a practical roadmap for senior leaders preparing their European strategy.
Launching a pharmaceutical product in Europe is one of the most strategically significant and operationally complex moves a biotech company can make. Although the EU is often described as a single market, the reality for pharmaceutical manufacturers is far more fragmented.
Regulatory pathways differ; pricing and reimbursement systems vary widely, and commercial expectations shift from country to country. For companies based in the United States or China, entering Europe requires a level of planning and nuance that is frequently underestimated.
In the interview on the Pharma Conversations Podcast, industry expert Charley Maxwell recommends that companies begin their European planning the same way validation teams approach a User Requirement Specification (URS). Before making any operational decision, companies should step back and define the core outcomes they want from their European footprint.
As he explained, “You might come up with a wish list… we want a location that has an English-speaking workforce… we want incentives… we want to know what operating model we want.” This URS-style thinking forces clarity around workforce availability, tax and regulatory incentives, operating model selection, and route-to-market strategy.
Countries such as Ireland, the Netherlands, and Germany consistently rank high for talent availability, regulatory pragmatism, and ease of doing business. Agencies like IDA Ireland and Enterprise Ireland actively support foreign direct investment and have deep experience guiding pharma companies through European setup. These factors make Europe attractive, but they do not eliminate complexity.
One of the strongest messages Charley delivered is that Europe is not a homogenous commercial environment. Although the EU allows free movement of goods, each country has its own regulatory quirks, distribution rules, and pricing systems. “Europe isn’t one large homogeneous marketplace; every country has its quirks that must be understood.”
Poland, for example, does not allow wholesalers to operate from office blocks; they must be physically located at the holding site. France requires every product to have an exploitant, a legal entity responsible for the product on the French market. Italy has unique Bellini and reimbursement requirements. These differences mean partnership is not optional, it is essential. Companies must work with local regulatory and quality experts who understand these nuances and can guide compliant entry into each market.
Perhaps the most consequential decision a company will make is whether to build or buy its European infrastructure. Charley frames this as the “build versus buy” model. Building a full European footprint, factories, warehouses, laboratories offers maximum control over intellectual property, quality, and manufacturing. But it also requires capital investment, long regulatory timelines, facility qualification, and local hiring. “If you decide to go with the build, that gives you lots of control but that comes at the cost of longer timelines, more regulatory burden, more infrastructure requirements.”
The buy model, by contrast, leverages contract manufacturing organisations (CDMOs), contract laboratories, third-party logistics providers, and contract Qualified Persons (QPs). This model enables rapid entry without building a 50-person office. “It’s faster but you are handing over some control, oversight is key.”
Some companies embed a “person-in-plant” as a dedicated employee stationed at the CMO to oversee quality and production. Others use contract MIA/WDA holders to manage importation and wholesale distribution. Increasingly, consultancies even hold marketing authorizations on behalf of clients, enabling a fully outsourced European footprint.
Once EMA approval is secured, the real challenge begins: navigating national pricing and reimbursement systems. You have got to negotiate the minefield of national pricing. Launch sequence determines a company’s European price floor. If a company launches first in a low-price market, other countries may reference that price and demand similar reductions. Germany and France are often recommended early markets due to swift reimbursement pathways and early access programs.
Benchmarking competitors is equally critical. Launching in a country with a low-value comparator can permanently depress pricing across Europe. For ATMPs and orphan drugs, real-world evidence is increasingly required to justify value, and companies can partner with academic institutions to generate this data.
Local partners play a decisive role in European success. Charley emphasised that non-EU companies cannot succeed without strong quality and regulatory partners. They are going to be your boots on the ground, they don’t just fill in forms, they have lived and breathed inspections. These partners write EU-compliant QMS systems, hold MIA/WDA authorizations, manage importation and batch certification, understand cold-chain requirements, and navigate inspections.
Distribution partners are equally important. Companies must decide whether to sell directly to hospitals and pharmacies, use major secondary distributors, or work with niche distributors for specialist products. Quality partners often advise which distributors are best suited for specific product types.
Charley also highlighted several recurring mistakes U.S. and China-based companies make. The first is treating Europe as plug-and-play. They think it’s plug and play and then they get caught up in the bureaucracy. FDA approval does not translate into automatic European approval. The second mistake is late infrastructure planning. Companies often complete Phase III trials and only then begin thinking about European operations which is far too late.
The third mistake is poor location selection. Choosing capital cities such as London, Dublin, or Amsterdam can lead to higher labour costs, talent competition, and volatile commercial rents. But choosing remote regions with no pharma ecosystem is equally problematic. Finally, an incorrect launch sequence can permanently damage pricing across Europe. We see missteps where they go for a low-price market first, and then that tanks their price floor.
Early engagement with regulators is one of the most powerful tools companies have. You can request scientific advice from the EMA, it’s like showing the chef your recipe before you cook the meal. EMA scientific advice helps companies validate their IMPD-to-dossier strategy, identify regulatory gaps, and align clinical and commercial plans. Local regulators also play a critical role. The HPRA in Ireland, for example, is known for its pragmatic, responsive approach to supporting companies while maintaining compliance.
Three priority actions for leaders
Charley concluded with three priority actions for leaders planning a European entry. Carefully plan your European launch to decide where you’re going to base yourself, decide if you’re going to build or buy. Companies must choose their headquarters country wisely, evaluating tax, talent, regulatory burden, incentives, and ease of doing business. They must decide their operating model build versus buy and map their pricing corridor to protect their price floor and maximize long-term value.
Launching a pharmaceutical product in Europe is not a single event. It is a carefully orchestrated sequence of regulatory, commercial, and operational decisions. Companies that succeed are those that plan early, understand fragmentation, choose the right partners, protect pricing, and engage regulators proactively.
Europe rewards companies that respect its complexity. With the right strategy, the region offers not only commercial opportunity but long-term resilience, diversified revenue, and access to one of the world’s most sophisticated healthcare ecosystems.