Big Pharma’s generic delaying tactics costs patients €3bn, says EC

By Gareth Macdonald

- Last updated on GMT

Related tags: Pharmaceutical industry, European union

Competition commissioner Neelie Kroes said that some drugmakers operating in the EU are deliberately stalling the introduction of generics, costing European patients around €3bn ($3.87bn) a year more to buy medicines.

The preliminary finding from the commission’s antitrust investigation, which began in January this year, is that originator companies used tactics like patent clustering, the submission of multiple claims, to impede the entry of non-branded versions of their products.

In one example given in the report, 1300 patents were filed for a single unidentified blockbuster medicine with the majority occurring late in the products lifecycle.

Another big pharma blocking strategy uncovered by the investigation is the use of litigation. The report revealed that over, the period under examination, 700 patent infringement cases have been filed against EU generics firms, 60 per cent of which were won by the non-branded drugmaker.

However given that the average length of each case was three years, during which the products in question could not be sold, the net result was to extend the market exclusivity of the branded product and delay generic entry.

Kroes said that: “We now have a solid view of what is happening and why​,” adding that while it is still early days “the Commission will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached​.”

The commission’s investigation of European drug industry practices began in January with a series of raids of pharmaceutical firms including Pfizer, GlaxoSmithKline and Sanofi-Aventis.

Last week, it started another round of unannounced inspections with visits to the European offices of owned by Israeli generics giant Teva Pharmaceutical Industries and French non-branded drug manufacturer Servier.

EC spokesman Jonathan Todd told in-PharmaTechnologist that although the most recent actions are not directly related to the antitrust investigation initiated in January, they have arisen as a result of information gathered during the previous inspections.

Related topics: Regulatory & Safety, Lifecycle Management

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