Europese Commissie: Pharmaceutical Sector Inquiry, Final Report

This document contains the Final Report for the pharmaceutical sector inquiry launched by the European Commission on 15 January 2008. A preliminary version was presented to the general public on 28 November 2008 in Brussels. The document sets out the findings of the sector inquiry, summarises the comments received during the public consultation and makes policy recommendations where appropriate.

The sector inquiry dealt with the alleged obstacles to market entry for prescription medicines for human use. It focused on obstacles for generic products, i.e. products that can enter the market upon loss of exclusivity of the original product (i.e. upon patent expiry, possibly extended by SPC, or expiry of the exclusivity period pursuant to pharmaceutical law3). It also concerned obstacles for innovative products, i.e. obstacles to competition between originator companies. As it is a competition inquiry, it focused on the behaviour of companies. However it is acknowledged that behaviour of companies always takes place against the background of the regulatory environment.

The results of the sector inquiry suggest that the behaviour of originator companies contribute to the obstacles for generic and originator entry, whilst acknowledging that other factors e.g., the regulatory framework, might also play an important role.

Lees het rapport hier.