Overview
Ropes & Gray’s European life sciences practice is an integral part of the firm's global life sciences practice. It provides sophisticated strategic regulatory advice specifically focused on UK, EU and cross-border regulatory issues to pharmaceutical and medical device companies at every stage of their development.
Beyond advising on regulatory issues, we counsel our clients on a wide range of research and development strategies, product life cycle management, product acquisition, and risk and crisis management, including matters relating to:
- Clinical trials
- Product approval
- Advertising and promotion
- Manufacturing
- Safety vigilance
- Health technology appraisal
- Pricing and reimbursement
- Market access
- Regulatory data protection
- Market exclusivity and patent life extension
Our European life sciences team is part of a global one-stop practice offering seamless cross-border regulatory compliance and enforcement advice encompassing litigation, internal investigations and public policy matters. The team regularly conducts due diligence reviews for private equity shops and their portfolio companies engaging in mergers, acquisitions, licensing deals and other corporate transactions. We also advocate before regulatory authorities, advertising/promotional regulatory bodies, the European Commission, European Parliament, and national parliaments.
Experience
Regulatory and Compliance
- Provide guidance on research and development strategies for approval, appeal and dispute resolution in regulatory procedures in Europe
- Advise global pharmaceutical and medical device companies on label claims in the context of complying with advertising and promotional rules in Europe
- Counsel on regulatory data protection, market exclusivity and patent life extension
- Provide crisis and risk management guidance
- Develop global market access strategy
- Negotiate market access agreements and value dossiers to guide pricing and reimbursement
Legislative and Public Policy
- Advocate before regulatory authorities, advertising/promotional regulatory bodies, the European Commission, European Parliament and national parliaments
- Provide independent legal and regulatory expert testimony on matters concerning timely access to treatments for rare disease
Litigation and Contentious Matters
- Advise clients in complaint proceedings against European institutions to European Ombudsman and represent clients in court and arbitration proceedings involving issues relating to European Community law and regulatory policy
- Represent global pharmaceutical and medical device companies in European enforcement, litigation and cross-border litigation matters with regard to compliance with various good practices