Establishing operations and launching a first product in Europe presents unique opportunities and challenges for pharmaceutical, biotechnology, and medical device companies. A successful market entry requires careful planning across several domains.

Corporate structure: Companies must select the appropriate legal entity, such as a GmbH or BV, and complete all necessary corporate filings and registrations. The corporate structure should be designed in a manner that shields the mother company from potential liabilities from operating the business in Europe, while comprehensive insurance and robust risk management strategies help to mitigate operational risks. Establishing a bank account is often one of the most time-consuming steps in the process and should therefore be initiated as soon as possible.

Taxation: Companies must carefully consider corporate income tax, Value Added Tax (VAT), and customs duties, as these vary significantly between jurisdictions and can have a significant impact on both profitability and supply chain management. Thus, thorough planning is essential to tailor corporate structure to these factors. Many life sciences companies maintain a hub in Switzerland, the Netherlands, or Ireland, where taxes may be lower.

Regulatory pathways: Early engagement with regulatory authorities can facilitate participation in access programs and accelerate product approval and availability. In addition to securing marketing approval, other requirements for supplying products in Europe may need to be started earlier, such as ensuring compliance with manufacturing, import, and distribution requirements, and establishing pharmacovigilance systems.

Pricing and reimbursement: Navigating the complex European pricing and reimbursement landscape is vital. The new EU Health Technology Assessment (HTA) and joint clinical assessment processes are increasingly integrating EU-level evaluations with national procedures and dossiers, such as AMONG in Germany and ETS in France. A comprehensive understanding of country-specific requirements is key to securing market access and achieving a profitable reimbursement price. This is particularly relevant in the context of current U.S. MFN schemes.

Compliance: Strict adherence to data privacy laws (such as GDPR), ethical interactions with health care professionals (HCPs), and compliance with advertising regulations are mandatory. Prior to approval, communicating with medical stakeholders about their product is essential, albeit inherently complex due to EU and national legal restrictions on preapproval promotion. Accordingly, early communication should undergo a thorough review in order to prevent a company from being challenged in the courts.

Employment: Drafting compliant employment agreements, providing health care and social security benefits, and managing pensions are essential. Immigration rules and works council requirements must be considered when hiring staff.

Commercial operations: Establishing reliable manufacturing, fill/finish, labeling, and packaging processes is necessary. Selecting appropriate distributors, specialty pharmacies, and warehousing partners ensures efficient product delivery.

By addressing these key areas, companies can lay a strong foundation for successful product launches and sustainable growth in the European market. To achieve this, we recommend developing a roadmap showing all workstreams along with their underlying tasks and timelines, planning from the desired launch date backwards, and using legal/operational project management tools.