Regulatory data protection
Produced in partnership with Elisabethann Wright, Marta Miglietti, Fabien Roy, Jane Summerfield, Julia Fraser and Richard Welfare of Hogan Lovells
Regulatory data protection

The following Life Sciences guidance note Produced in partnership with Elisabethann Wright, Marta Miglietti, Fabien Roy, Jane Summerfield, Julia Fraser and Richard Welfare of Hogan Lovells provides comprehensive and up to date legal information covering:

  • Regulatory data protection
  • Introduction to the concept of regulatory data protection
  • The '8+2+1 rule'
  • Additional year of market protection
  • Scope of application of the ‘8+2+1’ rule
  • The concept of a 'Global Marketing Authorisation'
  • Interaction of RDP with patent protection
  • Additional periods of data exclusivity protection in the Pharmaceutical Code
  • Market exclusivity periods provided in the Orphan Regulation

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code establishes a period of ‘data exclusivity’ from the initial authorisation of innovative medicinal products during which the pre-clinical and clinical trial data generated and used to support the authorisation of an innovative medicinal product cannot be referred to by an applicant for a marketing authorisation (MA) for a generic product. Data exclusivity therefore serves to offer a guarantee to innovative companies that scientific data generated for the marketing authorisation of the innovative medicinal product is protected and will not be used to assess applications from manufacturers of generic or biosimilar medicinal products until after expiry of the data exclusivity which the innovative