TRENDS : PHARMACEUTICAL SECTOR - INQUIRY - EC FINAL REPORT - REGULATORY FRAMEWORK - GENERICS - INNOVATION PHARMACEUTICAL COMPANIES CONDUCT - NEW CHEMICAL ENTITIES

The outcome of the EC pharmaceutical sector inquiry

On 8 July 2009, the European Commission’s released its long-awaited Final Report on its Pharmaceutical Sector Inquiry. The Final Report suggests that the shortcomings of the regulatory framework are a key explanatory factor for delayed generic entry and limited innovation. Meanwhile the Final Report nuances earlier, provisional, findings, that pharmaceutical companies’ conduct had blocked/limited generic entry and led to a decline in the number of new chemical entities reaching the market. The purpose of the present “Tendances” is to provide an overview of the Final Report and to discuss the Commission’s findings.

“BARK AT THE MOON?” Nicolas PETIT Lecturer, University of Liège (ULg), Co-director, Institute for European Legal Studies (IEJE), Executive Secretary, GCLC, College of Europe 1. On 8 July 2009, the European Commission (the “Commission”) adopted a much awaited Final Report (the “Report” or the “Final Report”) in the context of its sector inquiry into the pharmaceutical sector. This Report formally closes a 18 months-long investigation which, in essence, sought to establish whether originator companies' conduct delayed generics medicines entry and stifled innovation, thereby limiting both originator-generic competition as well as originator-originator competition. 2. Since the early days of its inception, the Commission's sector inquiry - which has subsequently been compared to a “fishing

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Authors

  • DG COMP (Brussels)
  • Liège University - IEJE
  • White & Case (Brussels)
  • French Competition Authority (Paris)
  • Van Bael & Bellis (Brussels)

Quotation

Anthony Dawes, Nicolas Petit, James Killick, Geneviève Wibaux, David Hull, The outcome of the EC pharmaceutical sector inquiry, September 2009, Concurrences Review N° 3-2009, Art. N° 28154, pp. 11-25

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