Sector inquiry and follow-up
On 8 July 2009 the European Commission adopted the Final Report on its competition inquiry into the pharmaceutical sector, pursuant to Article 17 of Regulation 1/2003 EC. Since then, the Commission has been monitoring patent settlements between originator and generic companies and published four Reports (see below). The main objectives of the monitoring exercises are to better understand the use of this type of agreement in the European Economic Area and to identify those settlements that delay generic market entry to the detriment of the European consumer.
This page provides information relating to the inquiry, including reports, press releases, frequently asked questions (FAQ), presentations and speeches and other relevant documents.
Monitoring of patent settlements
Final Report (8 July 2009)
Comments received in the context of the public consultation
In the framework of the public consultation on the Preliminary Report which took place from 28 November 2008 to 31 January 2009, more than 70 submissions were received. Respondents represented a wide variety of stakeholders and included originator companies and associations of originator companies, generic companies and associations of generic companies, business confederations, public bodies such as the European Patent Office, associations of sickness funds, associations representing intellectual property lawyers, law firms and academics.
The contributions received can be found here.
Preliminary Report (28 November 2008)
Public presentation of preliminary findings on 28 November 2008
The Commission presented the preliminary findings at a conference on 28th November 2008 in Brussels.
Presentations and speeches
- Questions from the audience Chaired by Herbert Ungerer, Deputy Director General, DG Competition
- Speech by Heinz Zourek, Director General, DG Enterprise and Industry
- Message by Commissioner Androulla Vassiliou (Health), by Philippe Brunet, Head of Cabinet
- Speech by Commissioner Meglena Kuneva, Commissioner for consumer protection
- Speech by the Rt. Hon. Sir Robin Jacob , Court of Appeal of England and Wales
- Panel discussion Chaired by Lowri Evans, Deputy Director General, DG Competition
- Arthur J. Higgins, President, European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Rory O'Riordan, Vice-President, European Generic Medicines Association (EGA)
- Paolo Martinello, President, The European Consumers' Association (BEUC)
- Edwin Velzel, CEO, UVIT (Dutch health insurance company)
- Bruno Lasserre, President, Conseil de la Concurrence (France)
- Daniel Jacob, Deputy Director General of DG Research
- Martin Power, Head of Cabinet of Commissioner McCreevy
- Questions from the audience to the Panel
- Concluding remarks by Herbert Ungerer
Questionnaires to stakeholders (March/May 2008)
In March 2008 the Commission sent questionnaires to approximately 100 companies that are producers of originator and/or generic medicines. Moreover, approximately 100 questionnaires to other stakeholders were sent in April and May 2008.
Stakeholders that received a questionnaire can download an electronic version on the dedicated websites below.
Opening of the inquiry (January 2008)
On 15 January 2008 the European Commission launched an inquiry into competition in the pharmaceuticals sector.
The inquiry is a response to indications that competition in Europe's pharmaceuticals markets may not be working well: fewer new medicines are being brought to market, and the entry of generic medicines sometimes seems to be delayed. The inquiry will therefore look at the reasons for this.
In particular, the inquiry will examine whether agreements between pharmaceutical companies, such as settlements in patent disputes, have blocked or lead to delays in market entry. It will also look into whether companies may have created artificial barriers to entry (through the misuse of patent rights, vexatious litigation or other means). The sector inquiry does not aim to establish nfringements of EC competition law by individual companies (Articles 81 and 82 EC).
The inquiry's findings will, if necessary, allow the Commission or national competition authorities to focus any future action on the most serious competition concerns, and to identify remedies to resolve the specific competition problems in individual cases.