Life Sciences & Health Care

From interest groups to healthcare companies to patients – comprehensive advice across a variety of roles

We advise both private and institutional clients on all matters relating to healthcare and life sciences. Whether hospital law, professional law, (social) insurance law, liability law or a host of other issues of healthcare law – our life sciences and health care team is comprehensively positioned to work with you on tailor-made strategies to achieve your goals.

The “key assets” of our advice lie in the deep academic roots of our team, combined with our deep insight into the market, legal expertise and experience as well as our relentless effort to create  consistent, state-of-the-art, goal-oriented solutions. Our services range from practical guidance on all aspects of health law, including the preparation of legal opinions, the drafting of statements in legislative procedures and contract negotiations to sophisticated representation in all proceedings before authorities and courts.

Our practice group is keeping in view the current trends in healthcare law to get an early glimpse of upcoming new legal challenges. For example, we are currently focusing on  the digitalization of the healthcare sector – both in the area of products and services.

From pharmaceuticals to future medicine – A-Z in product and regulatory law

We offer comprehensive advice at every stage of the process, from product development and clinical trials to market launch, reimbursement as well as throughout the entire life cycle of a product, navigating the most complex legal and regulatory issues. Our deep expertise covers such matters as the ever more complicated reimbursement procedures in Austria, including the reimbursement code, EU HTA and the evaluation board. We also guide you through the maze of regulations in the increasingly digital healthcare sector, from data protection law to the use of artificial intelligence.

We help our clients navigate legal issues in the jungle of national and European regulations,  in an attempt to use legal potentials, avoid conflicts or resolve them to their advantage. Our approach is to make innovation part of the system  in an attempt to avoid the bitter pill.

Our expertise specializes on matters relating to:

Regulatory

• Pharmaceutical law (development, market entry, distribution, advertising, etc.)
• Medical device law (development, market entry, distribution, advertising, etc.)
• Hospital law (establishment and operation of hospitals)
• Pharmacy law (e.g. licenses, in-house pharmacies)
• Professional law of the healthcare professions

Social insurance

• Reimbursement law (medicinal products and medical devices)
• Advice on the relationships between insurance providers
• Individual and collective contract law
• Advice on hospital financing and all other financing structures in the healthcare sector

Antitrust and state aid

• Advice on competition law in connection with distribution (e.g. market dominance, pricing issues, exclusivity, etc)
• Aids and subsidies in the area of research and product development

Employment

• Drafting of employment contracts
• Advice on working time regulations in hospitals and other healthcare facilities

Corporate and / M&A

• Practice cooperations (foundation, participation, succession, etc)
• Corporate structures for pharmacies
• M&A transactions in the healthcare sector (e.g. mergers of hospital operators, reorganization of medical companies)
• Public companies in the healthcare sector

Litigation and dispute resolution

• Advice and representation of hospitals, doctors, medical device and pharmaceutical manufacturers etc in liability cases
• Pre-litigation measures, preservation of evidence
• Product liability
• Dispute resolution of intra-team conflicts in hospitals, surgeries, etc.

Public procurement l

• Advice and representation in the procurement of traditional construction, supply and services as well as sector-specific procurement items (e.g. vaccines, medical products, emergency vehicles, healthcare services, etc.)
• Drafting tenders, designing PPPs, negotiating contracts, assistance with the execution of contracts
• Representation in review proceedings

Data protection

• Comprehensive advice on the handling of sensitive personal data in particular in all healthcare facilities (medical practices, outpatient clinics, hospitals, etc.)
• Advice on the permissibility and limits of the use of telemedicine
• Data security in the processing of electronic health data and genetic data (health telematics)

Intellectual property protection and unfair competition

• Research and development contracts
• Protection of industrial property rights
• Transfer of intellectual property rights

Compliance and internal investigations

• Introduction and development of compliance management systems tailored to the healthcare sector (internal whistleblower systems, compliance guidelines, communication measures, etc.)
• Risk-oriented system analysis and stress tests to assess the effectiveness of existing compliance programs
• Conducting internal investigations to clarify compliance violations as well as assistance and representation before investigating authorities and courts