Three major pharmaceutical companies were imposed a record fine of €444 million by the French competition authority on Wednesday.
The companies – Novartis, Roche and Genentech – are accused of “abusive practices” to “preserve” sales of a drug treating macular degeneration (AMD) to the detriment of a cheaper competing treatment. AMD is an eye disease that leads to vision loss.
“Genentech, Novartis and Roche have implemented a set of behaviours (abuse of collective dominant position) aimed at preserving the position and price of Lucentis, by curbing the off-label use of the cancer drug Avastin,” the authority said.
Lucentis is a treatment for AMD, an age-related retinal disease, developed by Genentech (which has capital ties with the Roche and Novartis groups).
However, doctors realised that another Genentech drug, the anti-cancer drug Avastin, had positive effects on AMD and began prescribing it even though it does not have market authorisation for this disease.
Avastin costs 30 times less than Lucentis: an injection of Avastin costs €30 to €40, compared with €1,161 for Lucentis.
Novartis markets Lucentis worldwide outside the United States and Roche markets Avastin.
Novartis “sought to thwart the initiatives of ophthalmologists who, in the context of their freedom to prescribe, decided to prescribe Avastin, outside the scope of their market authorisation, in ophthalmology,” the competition authority said.
“Novartis, Roche and Genentech were also sanctioned for having implemented a series of blocking measures and for having disseminated an alarming, and sometimes misleading, message to the public authorities on the risks associated with the use of Avastin for the treatment of AMD,” it added.
The authority considers that “the practices in question are particularly serious, as they occurred in the health sector, where competition is limited, and more specifically, in a context of public debate on the impact on social finances of the extremely high price of Lucentis,” which has been reimbursed at 100%.
Novartis will be fined €385,103,250, while Roche and Genentech will have to pay €59,748,726, amounting to a grand total of €444,851,976.
“We are very disappointed by the outcome of the Decision of the French Competition Authority and strongly refute the accusations of the FCA regarding alleged anti-competitive practices,” a spokesperson for Novartis said.
“Novartis firmly believes the company has acted appropriately and in compliance with all applicable regulations. Novartis intends to appeal the FCA Decision before the Court of Appeal in France.”
“For the Belgian investigation Novartis provided full and transparent collaboration to the Belgian Competition Authority. We firmly believe that we acted appropriately and in compliance with all applicable regulations in Belgium,” the spokesperson said. “We remain committed to improving the health of patients, in accordance with high ethical business standards and in compliance with laws and regulations that govern the manufacture of medicines and their safe use in patients.”
The Brussels Times
This story has been updated to include comment from Novartis.