May 3, 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

E.U. Fines Drug Companies for Delaying Generics

The case mirrors a decision Monday by the United States Supreme Court, which is likely to increase the number of generic drugs in the marketplace to benefit consumers. The timing of the European decision appeared to signal a trans-Atlantic crackdown on so-called “pay for delay” tactics by major pharmaceutical companies that keep prices artificially high.

“It is unacceptable that a company pays off its competitors to stay out of its market and delay the entry of cheaper medicines,” Joaquín Almunia, the European competition commissioner, said in a statement on Wednesday. “Agreements of this type directly harm patients and national health systems, which are already under tight budgetary constraints.”

In a news conference, Mr. Almunia said he welcomed the Supreme Court ruling, which empowered the Federal Trade Commission to sue pharmaceutical companies over pay-for-delay deals. Mr. Almunia said that Europe’s highest court, the European Court of Justice, should take a similar stance.

Lundbeck, which received the largest of the fines assessed Wednesday, 93.8 million euros, said that it would appeal. “The company acted transparently and in good faith in trying to protect our patents,” Lundbeck said in a statement posted to its Web site. “Upon entering the agreements they were all reviewed by external antitrust experts,” it said.

Mr. Almunia also fined generic makers including Ranbaxy Laboratories, the German drug maker Merck, Arrow Group and Zoetis Products a total of 52.2 million euros.

Instead of competing with Lundbeck when its basic patent on the drug citalopram expired, the generic makers agreed with Lundbeck in 2002 not to enter the market in return for “substantial payments and other inducements from Lundbeck amounting to tens of millions of euros,” according to the European Commission, which is the highest antitrust authority in the 27-nation European Union.

As part of their investigation, officials from the commission said in a statement that they had found documents referring to a ” ‘club’ being formed and ‘a pile of $$$’ to be shared among the participants.” Lundbeck also purchased supplies of generic versions of the medicine “for the sole purpose of destroying it,” the officials said.

Agreements to delay the introduction of generic drugs have come under heightened scrutiny in both Europe and the United States in recent years, with regulators on both sides of the Atlantic concluding that such deals are anticompetitive.

In January, the European Commission accused the drug giants Johnson Johnson and Novartis of colluding to delay the availability of a less expensive generic version of a powerful pain-relief medication, fentanyl. At issue were transdermal patches, which deliver the drug through the skin.

That case focuses on monthly payments that a Netherlands-based subsidiary of Johnson Johnson made to Sandoz, a unit of the Swiss company Novartis. While those companies have said the payments were legitimate, Mr. Almunia has said money probably changed hands to keep lower-cost versions of fentanyl off the market in the Netherlands.

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

As Europe Presses Google on Antitrust, U.S. Backs Away

BRUSSELS — Google seems on its way to coming through a major antitrust investigation in the United States essentially unscathed. But the outlook is not as bright for Google here, as the European Union’s top antitrust regulator prepares to meet on Tuesday with Eric E. Schmidt, Google’s executive chairman.

In the United States, the Federal Trade Commission appears to be ready to back off what had been the centerpiece of its antitrust pursuit of Google: the complaint that the company’s dominant search engine favors the company’s commerce and other services in search queries, thwarting competition.

Yet in a statement last spring, Joaquín Almunia, the competition commissioner of the European Union, placed the contentions about search bias at the top of his list of concerns about Google. And in a private meeting this month, Mr. Almunia told Jon Leibowitz, chairman of the F.T.C., that European antitrust officials remain focused on that issue, according to two people told of the meeting, who asked not to be identified because they were not authorized to speak about it.

Mr. Almunia’s tougher bargaining stance, antitrust experts say, is not merely a personal preference.

European antitrust doctrine, they say, applies a somewhat different standard than United States law does. In America, dominant companies are given great leeway, if their conduct can be justified in the name of efficiency, thus consumer benefit. Google has consistently maintained that it offers a neutral, best-for-the-customer result.

In Europe, antitrust experts say, the law prohibits the “abuse of a dominant position,” with the victims of the supposed abuse often being competitors. “The Europeans tend to use competition law to level the playing field more than is the case in the United States,” said Herbert Hovenkamp, an antitrust expert and law professor at the University of Iowa. (Mr. Hovenkamp advised Google on one project, but no longer has any financial connection to the company.)

The European rationale, legal experts say, is that shielding competitors to some degree preserves competition and enhances consumer welfare in the long run.

“Europe has a stronger hand to play with Google because of its standards,” said Keith N. Hylton, a professor at the Boston University School of Law.

The European antitrust regulators, like their American counterparts, have been in negotiations with Google for several months. The F.T.C. is expected to announce its decision within days, while the European timetable seems not as tight and is likely to go into next year.

The investigations in the United States and Europe really started with accusations of search bias. Rivals complain that the search giant gives more prominent placement and display for its online shopping and travel services, for example, than to competitors. The potential antitrust concern is that such specialized, or “vertical,” search services — like Yelp or Nextag — are partial substitutes for Google’s search engine because they also allow people to find information.

In his public statement in May, Mr. Almunia identified four areas of concern in Europe’s antitrust investigation of Google. The first concern he cited was search bias.

“Google displays links to its own vertical search services differently than it does for links to competitors,” Mr. Almunia said in a statement then. “We are concerned that this may result in preferential treatment compared to those of competing services, which may be hurt as a consequence.”

His other three concerns are ones that Google is preparing to address with a set of voluntary commitments in the United States, according to two people briefed on Google’s talks with the F.T.C., who declined to give their names because they were not authorized to speak about them.

Google, according to the people, has agreed to refrain from copying summaries of product and restaurant reviews from other Web sites and including them in Google search results, a practice known as screen scraping.

James Kanter reported from Brussels and Steve Lohr from New York. Claire Cain Miller contributed reporting from San Francisco.


Article source: http://www.nytimes.com/2012/12/18/technology/eu-and-google-to-discuss-antitrust-issues.html?partner=rss&emc=rss