healthcare & life sciences

• regulatory clearance, authorisation and approval proceedings at both EU and national level
• product classification and demarcation, including complex borderline issues between medicinal products, medical devices, in vitro diagnostics, foods and cosmetics
• legal market access requirements, including pricing, reimbursement and health technology assessment (HTA)
• qualification and classification of software as medical devices (SaMD), as well as telemedicine, e-health, e-medication, AI-driven solutions and health data regulation, including European Health Data Space (EHDS)
• product safety, vigilance, post-market surveillance and regulatory reporting obligations
• labelling, packaging and advertising compliance, including health claims, CLP-Regulation and promotional activities
• strategic support in product marketing and national and cross-border distribution models, including supply chain compliance
• crisis management, including national and international product recalls, safety corrective actions and authority communications
• representation before national and European authorities and courts, including administrative, civil and regulatory proceedings

• national and cross-border M&A, including buy-side and sell-side mandates and exits
• investments by strategic and financial investors, including venture capital, growth equity and private equity funds, across all stages
• establishment, acquisition and restructuring of healthcare facilities, including outpatient clinics, hospitals, primary healthcare units, nursing and care facilities and fitness studios
• corporate matters, including company formations, joint ventures and group reorganisations
• founder and start-up matters, including establishment, corporate structuring, financing rounds and strategic transactions
• management team matters, including equity participations, management buy-outs and incentive structures
• spin-off transactions, including carve-out structuring and post-separation arrangements
• buy-and-build strategies, including platform acquisitions and add-on transactions
• capital markets transactions, including initial public offerings (IPOs), secondary offerings and equity and debt capital markets issuances
• financing transactions, including acquisition finance, growth financing and structured finance arrangements
• approvals in transactions, including merger control, FDI and industry-specific clearances

In addition, we provide full transactional support, from due diligence and deal structuring to closing and post-closing integration.

• the establishment, operation, restructuring and (cross-border) transfer of group practices, primary healthcare units, hospitals, outpatient clinics, nursing and care facilities
• healthcare facility law, including structural and operational requirements, needs assessments, quality management obligations and licensing and accreditation procedures
• strategic and financial investor acquisitions involving healthcare providers and hospitals
• service and licensing agreements with statutory health insurance funds and private insurers, including reimbursement and billing matters
• public procurement and tendering procedures in the healthcare sector
• physician employment, cooperation and partnership models, including the structuring of group practices and medical centres
• medical law and professional liability matters, including duty of care standards, informed consent and documentation requirements

In addition, we provide representation before national and European authorities and courts, including medical malpractice and professional liability claims.

• clinical trial, research and development, as well as quality, supply and manufacturing agreements, including CMO and CDMO arrangements
• licensing and technology transfer agreements, including in-licensing and out-licensing arrangements, for pharmaceutical, biotech, medical device and digital health products
• commercial and distribution agreements in regulated environments, including exclusive and non-exclusive distribution structures
• co-promotion, co-marketing and co-development agreements
• cooperation agreements with healthcare professionals and healthcare organisations, including consulting, advisory board and speaker arrangements
• service level and outsourcing agreements for healthcare and life sciences operations, including IT services, data management and logistics
• the regulatory aspects of commercial agreements, including advertising restrictions, anti-kickback rules and transparency obligations

• intellectual property law, including the protection, enforcement and strategic management of patents, trademarks, designs and copyrights, as well as IP-related advice in transactions and licensing, including IP due diligence, freedom-to-operate analyses and portfolio management
• protection of trade secrets, confidential information and proprietary know-how
• data protection and patient confidentiality, including GDPR compliance, health data governance and cross-border data transfers
• technology and digital health regulation, AI governance, algorithm transparency and liability frameworks
• cybersecurity, data breach response and regulatory notification obligations
• dispute resolution, including product liability, antitrust, unfair competition and regulatory enforcement proceedings
• representation before national and European authorities and courts
• banking & finance, capital markets and real estate matters