Healthy Skepticism Library item: 17027

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Newman M
EU Steps Up Probe of Drugmakers’ Deals on Generics (Update4)
Bloomberg.com 2010 Jan 12
http://www.bloomberg.com/apps/news?pid=20601202&sid=acoP.pTC1MkM

Full text:

AstraZeneca Plc, GlaxoSmithKline Plc, Sanofi-Aventis SA and other drugmakers received queries from the European Union as part of a probe into strategies that may keep cheaper copies of medicines off the market.

The European Commission said today that it sent questionnaires to pharmaceutical companies, seeking details on agreements that may have slowed the sale of generic medicines. Roche Holding AG and Novartis AG of Switzerland and Germany’s Merck KGaA and Stada Arzneimittel AG also said they received the EU requests.

“This is an issue of critical importance to patents and to health-care authorities in Europe,” Jonathan Todd, a commission spokesman, told journalists in Brussels. “Even a few months’ delay can cost patients or health-care authorities millions of euros because the difference in price between the original drugs and generic copies can be very considerable.”

Antitrust regulators on both sides of the Atlantic are focusing on how settlements between branded-drug makers and generic manufacturers might harm consumers. The commission said in a report last July that companies use a variety of techniques to delay the introduction of generics “for as long as possible.” The commission estimated potential savings of 3 billion euros ($4.4 billion) if generic medicines had entered the market immediately after patent protection was lost.

Patent Agreements

The EU regulator today said it asked companies to submit a copy of all patent settlements made between July 1, 2008, and Dec. 31, 2009. The commission will publish a report based on the responses and may start making annual requests for such documents. The commission didn’t name the companies.

“It’s one more step in what’s probably going to be a long, drawn-out process,” said Frances Cloud, a London-based independent pharmaceutical analyst.

The regulator said it may make a “more targeted request for information” if a settlement raises additional questions.

“Sanofi confirms that it has received a request for information,” spokesman Geoffroy Bessaud said today from Paris. AstraZeneca, based in London, is cooperating with the EU, spokeswoman Sarah Lindgreen said in an e-mail. Glaxo, also based in London, will provide “all relevant information,” spokeswoman Claire Brough said.

Roche, Merck

“Roche is currently checking the request and is confident that, provided any such settlements have been concluded in the first place, no antitrust laws have been violated,” spokesman Alexander Klauser said.

Stada spokesman Axel Mueller, Merck spokeswoman Phyllis Carter and Novartis spokesman Eric Althoff confirmed that their respective companies had also received the EU questionnaire.

The EU last week said it was investigating whether Denmark’s H. Lundbeck A/S, the Nordic region’s second-largest drugmaker, impeded the sale of generic versions of the antidepressant citalopram. Lundbeck said it’s cooperating with the investigation.

Under EU law, the commission can fine companies accused of violating competition rules as much as 10 percent of their annual sales. It typically opts for about 2 percent to 3 percent of sales.

In the U.S., the Federal Trade Commission has filed lawsuits to challenge settlements reached by Solvay SA over the testosterone gel AndroGel and against Cephalon Inc. over the sleep-disorder drug Provigil.

The FTC and U.S. Justice Department, which both handle antitrust issues, have said some settlements that involve money or other promises may be illegal. U.S. courts have upheld such agreements as long as they don’t delay the entry of the generic drug beyond the terms of patents held by the brand-drug companies.