After an 18-month probe, E.U. antitrust regulators say they're embarking on a campaign for sweeping change in the pharma business. Generics take too long to get to market, they say, an average of seven months after patents expire, costing consumers and taxpayers billions. And it's not just "pay-for-delay" deals that are to blame, though the patent settlements did come in for severe criticism. The regulators slam drugmakers' flurry of patent apps for the same medicine, too. And they said branded drugmakers often lobbied against generic drug approvals--and if that didn't work, pressured API suppliers and drug wholesalers.
As if to underscore their intent, the watchdogs formally opened proceedings against Les Laboratoires Servier for breaking the rules on "restrictive business practices" and "abuse of a dominant market position." The probe also includes a handful of generics makers, including the world's No. 1 seller of copycat meds, Teva Pharmaceutical Industries. At issue: perindopril, a cardiovascular med developed by Servier.
By all indications, the enforcement won't stop there; E.U. antitrust chief Neelie Kroes vows to throw the book at companies that break the rules. But the antitrust report also acknowledges that governments share the blame. There's too much red tape holding back generic drugs, the report says, and the patent litigation system in Europe is a mess, with multiple courts clogged by lawsuits between the same companies over the same drugs--and national courts often reach conflicting conclusions.
Indeed, Kroes' push for a Community patent could actually help branded drugmakers: Now, pharma companies can file for patents centrally at the European Patent Office. But the patents granted are a "bundle" of national patents that have to be defended on a country-by-country basis. "This is a waste of everyone's time and money," Kroes noted at a press conference. Agreed?