Healthy Skepticism Library item: 14697

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

Tait N, Jack A.
Drugs groups braced for EU competition probes
The Financial Times.com 2008 Nov 25
http://www.ft.com/cms/s/0/39a448ac-ba93-11dd-aecd-0000779fd18c.html?nclick_check=1

Full text:

Drug companies are bracing themselves for European Union probes into anti-competitive behaviour after the publication this week of an intensive inquiry into the pharmaceuticals sector.

Neelie Kroes, EU competition commissioner, is poised to release interim findings from an investigation launched in January to examine practices by innovator and generic drug companies that she suggested could be slowing the launch of new patented and cheaper generic medicines.

The 400-page report – a precursor to final findings to be released next spring – is being watched in the industry for indications that it will spark other investigations and calls for broader policy reform.

“I’m absolutely certain that in the next few months the commission will launch two or three companyspecific cases,” said an executive in one company that was studied in detail.

The inquiry began when commission officials raided the offices of a dozen leading companies in Europe earlier this year and took away confidential information on intellectual property rights, litigation and settlements. Companies affected included AstraZeneca, GlaxoSmith-Kline, Pfizer and Sanofi-Aventis.

These, and many more companies not initially raided, were required to fill out exhaustive questionnaires at short notice under pain of heavy sanctions. Follow-up queries were issued as recently as the start of this month. The industry has made hefty submissions to Brussels, arguing that companies are keen to develop drugs but have been hindered by scientific challenges and regulatory burdens.

Generic companies have complained that innovator companies exploit and extend drug patent rules to delay the launch of cheaper equivalents, but they have rejected suggestions of any exclusive deals with the innovators to cut out rivals.

Lawyers say the commission’s questions have focused on issues including patent settlement deals, whereby drug manufacturers pay sums to generic companies to resolve litigation. A key concern appears to be whether such deals might involve associated agreements under which generic manufacturers consent to stay out of the market for particular drugs.

Another focus has been “vexatious” litigation – where a company uses the courts to delay or frustrate an opponent, rather than seek dispute resolution.