EC probes industry over perceived innovation delays
European Commission investigators intent on discovering whether underhand practices are holding back competition in the proprietary and generic medicines sectors carried out unannounced inspections at pharmaceutical companies across Europe last week.
The visits follow an EC decision to launch an investigation into why fewer new medicines are coming to market than has historically been the case and why the introduction of generic equivalents often seems to take longer than the commission believes it should.
From 1995 to 1999 an average of 40 new active ingredients came to the market each year. From 2000 to 2004 the number fell to 28 a year. This is the first time that the commission has conducted what it calls a sector inquiry, rather than an inquiry into a specific company, by visiting offices to seize papers and information without warning.
In the UK, AstraZeneca, GlaxoSmithKline, Pfizer and Wyeth have confirmed that their offices were visited by EC officials. Sanofi-Aventis has confirmed that its offices in France were raided. Sandoz, the generics division of Novartis, based in Germany, was also raided. Generics manufacturer TEVA would neither confirm nor deny that its offices had been visited. Each company that confirmed it was involved in the inquiry said that it was co-operating with the commission.
The commission wants to find out whether agreements between companies, such as patent dispute settlements, are illegal under European competition law. It also wants to discover whether companies have tried to prevent competition through misuse of the patent system or vexatious litigation. It expects to produce an interim report in the autumn, with the final results of the inquiry being known in spring 2009.
Competition commissioner Neelie Kroes said: “If innovative products are not being produced and cheaper generic alternatives to existing products are, in some cases, being delayed, then we need to find out why and, if necessary, take action.”
The commission said that the inquiry started with a series of unannounced inspections because companies treated the information it wanted as highly confidential and that it was easy for it to be withheld, concealed or destroyed.
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