Life Sciences — International

Crowell & Moring's U.S., London, and Brussels office lawyers advise life sciences companies, including medical device and pharmaceutical clients, on international and cross-border regulatory, intellectual property, transactional, date privacy, and trade issues.  

Our work includes assisting clients with the application and interpretation of EU directives and regulatory matters concerning marketed products, including labeling and advertising, import and export controls, preparation and negotiation of research, development, licensing, and manufacturing agreements for corporate and commercial transactions; licensing of medical products; and related matters.  

EU Regulatory Framework 

Our team has a detailed understanding of the EU regulatory framework relating to the life sciences and biotechnology sectors. We advise and litigate on all regulatory issues, including marketing authorizations, pricing, and reimbursement decisions, legislative reforms, off-label use questions, and parallel import. We also advise clients on the marketing and advertising of medicinal products, including compliance with the applicable rules and codes of conduct, restrictions regarding promotional offers and hospitality towards health care providers, internal audits, and drafting of company guidelines.

We have represented clients in regulatory matters before the Belgian administrative and civil courts and assisted clients in procedures before the European Medicines Agency (EMA), the Ethical Health platform Mdeon, the Deontological and Pharmaceutical Ethics Committee, and other regulatory and legislative bodies.

International Trade 

Crowell’s international trade team advises life sciences companies on complying with export controls and economic sanctions, navigating multinational supply chain issues, and strategically managing unique pricing, regulatory, tax, and tariff issues arising from cross-border IP licensing, clinical development, manufacturing, and distribution arrangements. We also handle the full spectrum of trade defense and customs issues, including litigation before national and European Courts and the WTO.

Cross-Border Transactions & Investments 

Navigating the complexities of cross-border transactions and foreign direct investment (FDI) is becoming increasingly challenging for companies seeking strategic transactions in the life sciences sector, especially when dealing with critical technology or sensitive data. Crowell provides comprehensive support to both selling and acquiring companies to address compliance with CFIUS, antitrust, tax, and government funding regimes that cover the specific assets, products, or technology included within the proposed combination or collaboration, and to structuring transactions to optimally achieve the parties’ primary strategic goals.

Crowell's experience is particularly beneficial for life sciences companies, including those at early stage and seeking venture financing, who may face CFIUS challenges to potential foreign investment due to their innovative technologies and sensitive personal data. We assist these companies in evaluating whether their technology requires an export license for foreign investors, a task that is often complex due to the lack of prior classification for export control purposes.

Intellectual Property Law 

We provide creative advice on all aspects of IP law and have particular experience with regard to medicinal products and medical services. Our team has developed a reputation for helping clients launch successful strategies and for representing them in litigation relating to the validity and infringement of patents and supplementary protection certificates and on trademark issues relating to parallel imports.

Data Privacy 

Businesses operating in the EU and globally rely on Crowell’s experienced data privacy team to help them navigate the laws that govern the collection, use, transfer, and protection of data both within the various global jurisdictions. We help our clients understand their rights and obligations on the storage and use of data under various global privacy regimes, including GDPR, HIPAA, CCPA, and CalOPPA. We also work with companies to ensure that they are prepared for cyber attack and data breach through risk assessment and crisis management.

Competition Law 

We were involved in the European Commission’s pharmaceutical sector inquiry report, and we regularly advise pharmaceutical companies on matters related to their settlement, distribution and cooperation agreements, and on parallel imports. We also advise on a wide range of transactional activity and represent clients in merger control proceedings. We counsel on compliance with competition law and offer related training specifically tailored to individual companies or associations.

Additional Capabilities 

Crowell Global Advisors represents life sciences, medical device, and digital health innovators—spanning established multinationals to emerging disruptors. The team develops comprehensive solutions to navigate the complexities of the global political and regulatory landscape. They work with clients to develop strategies and manage risk in a variety of international fora, including the World Trade Organization, the Organization for Economic Cooperation and Development, the Asia-Pacific Economic Cooperation forum, and the U.N. negotiations on the Biosafety Protocol.