Examining the Implications of EU Regulatory Reformation: Analyzing the Latest Pharma Law Revisions and the EC’s New Proposed Regulation on Compulsory Licensing of Patents

September 28, 2023 10:30am

Ioana Ratescu
Head of Legal Regulatory, Europe
Novartis Pharma

Jiri Slavik
Senior Manager Intellectual Property
Adalvo

Dr. Andreas von Falck
Partner
Hogan Lovells

  • Understanding the impact of the EU’s New Pharma Legislation reforms on:
    • Incentives for research and innovation for orphan and paediatric drugs
    • The regulatory regime for generics and biosimilars
    • Rules on repurposing
    • Restrictions on comparative advertising
    • Unitary SPCs
  • Analyzing key takeaways of the European Commission’s Proposed Compulsory Licensing Regulation
    • Understanding what the implications will be for pharmaceutical and biotech companies
    • Anticipating next steps and challenges for practitioners