December 21, 2024

Europe Fines Drug Companies for Delaying Generics

On Wednesday, the European Commission fined a Danish pharmaceutical company and a number of generic producers a total of 146 million euros, or $195 million.

The commission said that Lundbeck of Denmark colluded with companies like Ranbaxy of India and Merck of Germany in 2002 and 2003 to delay market entry of a less expensive generic version of a blockbuster antidepressant called citalopram. Joaquín Almunia, the European commissioner for competition, said that Lundbeck also destroyed significant quantities of the low-cost version of the drug.

“All this occurred at the expense of patients who were deprived of access to cheaper medicines,” Mr. Almunia said at a news conference on Wednesday. “It also harmed our public health systems, who for a longer period had to artificially bear the costs of an expensive medicine and one of the most widely prescribed antidepressants.” Lundbeck said it had done nothing wrong and would appeal the decision. “The company acted transparently and in good faith in trying to protect our patents,” Lundbeck said in a statement. “Upon entering the agreements, they were all reviewed by external antitrust experts.”

The case mirrors a decision on Monday by the United States Supreme Court, which empowers the Federal Trade Commission to sue drug makers that engage in so-called pay-for-delay tactics. The Supreme Court decision is likely to increase the number of generic drugs, in that way benefiting consumers. The F.T.C. said that pay-for-delay deals cost Americans $3.5 billion a year in higher drug prices.

Many European governments with socialized medical systems buy or help to pay for prescription drugs used by citizens, which means that the blocking of generics affects those nations’ budgets. Mr. Almunia said that when generic versions of citalopram became available in Britain, during the second half of 2004, prices there dropped by 90 percent.

The scale of savings in Britain helped to ensure that “public health systems can remain economically sustainable in these times of difficult budgetary constraints,” Mr. Almunia said. Peter Kaplan, a Federal Trade Commission spokesman, would not comment on the European decision, but he indicated that officials had been coordinating on the issue of drug pricing. “F.T.C. staffers have had productive policy discussions with their counterparts in the E.U. on the pay-for-delay issue, which is a longstanding enforcement priority at the F.T.C.,” Mr. Kaplan said.

Similarly, European Union officials said their decision on Wednesday was not timed to follow the Supreme Court case.

Early this year, the commission accused the drug giants Johnson Johnson and Novartis of colluding to delay the availability of a generic version of fentanyl, a drug often used to ease severe pain. A year ago, the commission accused the French pharmaceutical company Servier and competitors of delaying the generic entry of perindopril, a cardiovascular medicine. And in 2011, the commission opened an investigation into whether the American pharmaceutical company Cephalon and the generic maker Teva of Israel hindered the entry of the generic version of modafinil, used for the treatment of certain types of sleeping disorders.

Those cases still are pending.

In the Lundbeck case, Mr. Almunia’s office said that various generic makers colluded with the Danish company, agreeing to not enter the market in return for “substantial payments and other inducements from Lundbeck amounting to tens of millions of euros.” Commission officials said that they had found documents referring to a “ ‘club’ being formed and ‘a pile of $$$’ to be shared among the participants.”

The European Commission fined Lundbeck 93.8 million euros, which amounts to roughly 4.6 percent of its 2012 sales. The regulator can fine companies as much as 10 percent of annual sales.

Article source: http://www.nytimes.com/2013/06/20/business/global/eu-fines-drug-companies-for-delaying-generics.html?partner=rss&emc=rss