On 17 January 2011, the Commission announced the launch of the second round of its monitoring of patent settlement agreements between pharmaceutical companies.

Joaquín Almunia, Commission Vice-President in charge of competition policy, said that "patent settlements are an area of particular concern because they may delay the market entry of generic medicines". These generic medicines are generally cheaper; resulting in likely consumer harm should there be a delay.

The second round of the monitoring exercise will assess whether an identified "positive trend", towards a decrease in "potentially problematic agreements" since the Commission's sector inquiry in 2009, has continued. This trend was identified in the course of the Commission's first round of monitoring, carried out in 2010.

To launch the second round of monitoring, the Commission has asked selected originator and generic pharmaceutical companies to submit a copy of all patent settlement agreements relating to the EU/EEA markets and concluded in the period from 1 January 2010 to 31 December 2010. The Commission will analyse the agreements and publish an overview report in the first half of 2011.

The Commission has several investigations in the pharmaceutical sector currently ongoing:

  • In July 2008, the Commission initiated proceedings against Les Laboratoires Servier ('Servier') and a number of generic pharmaceutical companies. The investigation relates to suspected breaches of Articles 101 and 102 of the TFEU regarding Servier's agreements with the generic companies which are suspected of delaying the entry of generic perindopril.  (Separate to this Servier is also being investigated for allegedly providing misleading and incorrect information in reply to a questionnaire that the Commission sent in the context of the pharmaceuticals sector inquiry);
  • In January 2010, the Commission announced that it had decided to open a formal investigation into suspected breaches of Articles 101 and 102 by the pharmaceutical company Lundbeck. The investigation relates to unilateral behaviour and agreements by Lundbeck which may have hindered the entry of generic citalopram; and
  • Dawn raids were carried out by the Commission in November 2010 at the premises of pharmaceutical companies in relation to separate allegations of delayed generic entry. 

The Commission has stated that if a specific settlement which comes to light in this second round of monitoring raises additional questions, a more targeted request for information could follow.

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