Life Sciences & Healthcare

Intensive competition, a large und constant capacity for innovation, and at the same time a high degree of regulation: this is the challenging context confronting the life sciences and healthcare sector. Binder Grösswang’s expertise in dealing with the complex legal issues that can arise in this sector has been accrued over many years.

Particularly when operating in such a complex environment, excellent legal advice is essential in order to successfully meet the challenges of the market and take the best possible advantage of the opportunities that emerge. Therefore, Binder Grösswang’s multidisciplinary life sciences team is composed of experts from the entire spectrum of practice areas: from M&A through regulatory, finance, tax and competition law to intellectual property law. This enables us to address the needs of our clients through comprehensive, interdisciplinary counsel.

We support companies and their investors from the entire sector, including the fields of pharmaceuticals, medical technology, biotechnology, diagnostics and healthcare. We advise numerous clients – from start-ups to multinational groups – on a wide range of complex issues, focussing on legally sound, economically resilient solutions.

Our focus
 

• Regulatory
  • Representation of large international pharmaceutical companies against the Federation of Austrian Social Insurance Entities in disputes regarding pricing policies
  • Representation of international pharmaceutical companies in matters of public procurement, including the transfer of numerous awarded contracts to a successor company with the approval of the contracting authority
  • Legal support in obtaining an operating licence pursuant to § 63 of the Austrian Medicines Act (Arzneimittelgesetz, AMG)
  • Counsel on complex issues of competition law and medicines regulation in connection with the sale of medicinal products (distribution systems, pricing, compliance with legal requirements, reimbursement, allocation of quotas, parallel imports, etc.)
  • Counsel to Austrian and international pharmaceutical companies on civil law matters in connection with delivery contracts, distribution agreements, cooperation agreements, R&D contracts, confidentiality agreements and licence agreements in the field of life sciences
  • Counsel pertaining to the approval of pharmaceutical products, clinical studies, compassionate use, etc.
  • Counsel on advertising/marketing activities in the pharmaceutical industry
  • Counsel to non-Austrian manufacturers on the applicable regulations for certain pharmaceutical products
• M&A
   
  • Due diligence in M&A transactions in the life sciences field with regard to regulatory law, environmental and EHS law, foreign trade and payments law, compliance, IP law, data protection law, etc.
  • Counsel on IP and data protection law in the life sciences sector
     
• Compliance
   
  • Compliance work for pharmaceutical companies and operators of public hospitals, e.g.: designation of persons responsible, advice regarding anti-corruption laws, codes of conduct, list of applicable laws to be complied with by official representatives, monitoring of contract negotiations between competitors in the pharmaceutical sector
  • Strategies for the delegation of administrative legal functions from the management of a pharmaceutical group to employees
  • Advice on the division of regulatory responsibilities between a parent company based abroad and an Austrian branch concerned solely with sales activities
  • Guidelines for internal conduct in the case of searches by competition authorities, criminal justice authorities and others
     
• Competition law
  • Numerous merger applications in the field of pharmaceuticals / life sciences
  • Guidelines for internal conduct in the case of searches by competition authorities (dawn raids)
  • Advice on competition law matters concerning various models for the sale/marketing of medicinal products (distribution, agency)
  • Specific compliance advice in connection with using a competitor as a distribution dealer (Chinese walls, no exchange of information, need-to-know principle, strict confidentiality, constant monitoring and regular audits, etc.)
  • Legal counsel on distribution issues in the case of market dominance (pricing, distribution of products among various regions, exclusivity, etc.)
  • Legal counsel regarding sector-specific price regulation in the vertical distribution chain in Austria (vis-à-vis hospitals/physicians and pharmacies through wholesalers)