The pharmas have contended that most of the delays—which have been the subject of many high-figure legal settlements in the United States—are due to regulatory and other bureaucratic issues, rather than deliberate action by companies. 

 

"Surprise inspections are a preliminary step in the investigation of suspected anticompetitive practices," an EC spokesman says. "The fact that the European Commission carries out such inspections does not mean that the companies are guilty of anti-competitive behavior, nor does it prejudge the outcome of the investigation itself. The European Commission respects the rights of defense, in particular the right of companies to be heard in the Commission’s proceedings against them."

 

In a report issued in July, EC Commissioner Neelie Kroes said she would not hesitate to go after drugmakers that cut deals with generic drugmakers.  

 

To date, the commission has only launched one specific investigation that probed alleged blocks on generic versions of Servier’s heart drug perindopril.

 

"There is no fixed deadline to complete inquiries into anticompetitive conduct," the EC spokesman says. "Their duration depends on a number of factors, including the complexity of each case, the extent to which the undertakings concerned co-operate with the Commission and the exercise of the rights of defense."

 

In a separate legal development, in what is being considered a victory for the pharmaceutical industry, the European Court of Justice on Oct. 6 rendered a decision telling EU lawmakers to reconsider claims that GSK’s wholesale pricing policy is anticompetitive.  

 

The case centered on different pricing that GSK established in 1998 for products in Spain depending on whether they are used nationally or resold. The company opposed discount drug trading, which exploits a price differential for medical products among countries.  

 

Europe’s Court of First Instance first examined the issue after the EC determined that the practice violated competition law. The court agreed that the practice was anticompetitive, but annulled the EC’s decision, saying that it did not adequately consider the possible advantage of innovation in the industry.  

 

The parties appealed to the Europe’s highest court, which held that although the lower court erred in defining consumer disadvantage as a prerequisite for anticompetitiveness, its decision was otherwise well-founded. The court also dismissed a portion of the appeal asking for a special exemption to European law, saying that an exemption must demonstrate technical or economic progress, the burden of proof for which lies with the requesting company.  

 

The court dismissed the appeal, and the issue has been remanded to the EC.