Major Swiss pharmaceutical companies Novartis and Roche were fined a combined $250 million for drug collusion in March, but if Italy’s health ministry has its way, the actual price will be much, much higher.

On May 28, the health ministry announced that it will seek damages of €1.2 billion ($1.6 billion) from the two companies for working together to push the cost of the jointly-marketed drug Lucentis higher. In a statement, the health ministry said that this move is a result of Novartis and Roche had causing “considerable damage” to Italian citizens through their actions.

In the original March guilty verdict, the Italian Competition Authority found that the two companies pushed doctors to exclude other drugs in favor of Lucentis, which treats age-related macular degeneration by blocking the growth of blood vessels in the eye. According to the Authority, Novartis and Roche targeted the drug Avastin, an older, less expensive Roche drug used to treat the same ailments. By creating artificial differences between the products the companies sought to draw customers to Lucentis.

The health ministry claims that it is seeking damages for all incidents occurring between 2012 and 2014. However, its claims will be met with a fight. Novartis told the Wall Street Journal that it “strongly denies allegations about anticompetitive practices between Novartis and Roche in Italy,” and a Roche spokesperson found the health ministry’s claims baseless.

As noted previously on InsideCounsel, Italy’s off-practice label regulations are at the heart of this case. Drug makers, such as Novartis and Roche, are only allowed to market drugs for specific uses that have been approved by regulatory agents. Doctors, however, are free to prescribe approved drugs for whatever they see fit. This disconnect caused Roche to say that the original Authority verdict, “openly encourages and promotes the widespread unlicensed intravitreal use of Avastin contrary to the requirements of European and Italian regulatory law,” and that it “undermines the European regulatory framework designed to protect patient safety.”


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