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French Competition Authority fines three pharmaceutical companies €444 million for abusing their collective dominant position

  • France
  • Competition, EU and Trade

07-10-2020

On 9 September 2020, the French Competition Authority (“FCA”) imposed a €444 million fine to three pharmaceutical companies, i.e. Novartis, Roche and Genentech, for abusing their collective dominant position on the French market for the treatment of an eye condition from 10 March 2008 to November 2013.  

In 2007, the Genentech laboratory launched a drug known as “Lucentis” to treat age-related macular degeneration (“AMD”), which is the main cause of vision troubles for people over 50 years old.

In parallel, Genentech also developed an anti-cancer drug known as “Avastin”. This drug actually turned out to be more than an anti-cancer drug since doctors noticed that Avastin had also curating effects on AMD for patients suffering both from cancer and AMD. This discovery led to the development of its use to treat AMD only, even though Avastin did not have a marketing authorisation (“MA”) for this sole use.

According to the FCA, in 2007, an injected dose of Avastin was 30 times less expensive than a shot  of Lucentis, i.e. EUR 30-40 per injection against EUR 1,161.

In this context, public authorities in many countries initiated research projects to test the effectiveness and possible side effects associated with the prescription of Avastin for the treatment of AMD.

However, as a result of Avastin’s potential competitive pressure over Lucentis to cure AMD, Novartis, Roche and Genentech established collective conduct with a view to block the use of Avastin without MA.

Indeed, as stated by the FCA, Novartis, which held the Lucentis licence, would have experienced loss as the company selling the Lucentis drug. Reciprocally, Genentech, as the licensor, would have reduced its royalties gains from Lucentis sales as well. Finally, Roche, as the main - and since March 2009 sole - shareholder of Genentech, benefited from the profits of Novartis. It should also be noted that Novartis held 6.2% of the shares of Roche and 33.33% of the voting rights of Roche Holding.

Based on such legal, economic and financial links, the FCA considered that Novartis, Roche and Genentech formed a collective entity holding a dominant position in the market for the treatment of AMD and sanctioned them for abusing it. It was indeed considered that the three pharma companies had used their collective dominant position in this market to prevent the use of the anti-cancer drug Avastin as a much cheaper alternative to Lucentis.

First, Novartis was said to disseminate disparaging messages to the attention of ophthalmologists, which unjustifiably exaggerated the risks associated with the use of the anti-cancer drug Avastin for the treatment of AMD, and more generally in ophthalmology, as compared with the safety and tolerance of Lucentis for the same use. The FCA noted that, to the detriment of the sale of its own product, Avastin, Roche did not oppose the messages conveyed by Novartis.

This practice had the effect of making ophthalmologists less eager to prescribe Avastin for the treatment of AMD and, more generally, in ophthalmology. Indirectly, it also maintained Lucentis at a supra-competitive and particularly high price, and resulted in the price of Eylea - a competing drug introduced by Bayer on the market in November 2013 -  being set at an artificially high level in turn.

Second, Novartis, Roche and Genentech were found to have implemented a set of “blocking” practices and alarming, and sometimes misleading, communication to the public authorities on the risks associated with the use of Avastin for the treatment of AMD. These practices were aimed at unduly blocking or slowing down initiatives by the public authorities to secure the use of Avastin without MA for the treatment of AMD.

The FCA assessed the fine imposed to Novartis, based on all Lucentis sales made by Novartis in France.

Regarding the Roche/Genentech group, the FCA assessed the fine imposed on the basis of the royalties received by Genentech on sales of Lucentis, on the one hand, and on sales by Genentech of Lucentis' active ingredient, on the other hand.

More generally, the FCA has increased the amount of the fine imposed to the three companies as it considered that the anti-competitive practices concerned were particularly serious. In that respect, the FCA noted that the abuse of their dominant position occurred in the health sector, where competition is said to be limited, and more specifically in the context of a public debate on the impact of the Lucentis price on the public health budget, as it is reimbursed by the French Social Security and a much cheaper drug was available.

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