Achieving sustainable drug development through csr: Possibility or Utopia

Abstract

This book chapter looks into corporate social responsibility (CSR) and meta-regulation as legislative technique as a way to implement regulatory incentives of sorts aiming to foster sustainable drug development. The chapter pays particular attention to supplementary protection certificates, the recent manufacturing waiver in the EU, and PRIME. By reviewing these regulatory inccentives, the chapter reflects on the need to include CSR principles in future legislative reforms, which should not focus exclusively in recouping investments but instead in achieving a balance amongst stakeholders’ and patients’ interests, thus proposing meta-regulation as a means to achieve it.