French Competition Authority - Genentech, Novartis and Roche Fined EUR 444 million in Saga Involving Wet Age-Related Macular Degeneration
The French Competition Authority (Autorité de la concurrence or AdC) imposed this morning a fine of EUR 444 million on Genentech, Novartis and Roche on account of the abuse of a collective dominant position in relation to the treatment of wet age-related macular degeneration (AMD) (see, attached French and English versions of press release as well as decision). The AdC thus took an unusual and audacious approach to tackle conduct which the Italian competition authority and courts, with the blessing of the Court of Justice of the European Union (CJEU), had penalised earlier under anti-collusion rules (see, Van Bael & Bellis Life Sciences News Alert of 24 January 2018).
Genentech, a Roche subsidiary, developed two medicines from related active substances. The first, Avastin® (bevacizumab), was granted a marketing authorisation (MA) for oncological indications. The second, Lucentis® (ranibizumab), was developed later and was granted an MA specifically for the treatment of ophthalmological conditions such as macular degeneration and glaucoma. However, physicians gradually started to prescribe Avastin® for the treatment of eye conditions. Many health authorities permitted, and later encouraged, this “off-label” use, even after Lucentis® had received its own MA and obtained reimbursement for an ophthalmological indication. In Europe, Genentech licensed out commercialisation rights in Avastin® to Roche, while it granted similar rights in Lucentis® to Novartis. Lucentis® was priced many times higher than Avastin®.
Collective dominant position
According to the AdC, Genentech, Novartis and Roche had to be considered as a single entity (“une entité collective”) for purposes of applying the competition rules. AdC based its findings on the licensing agreements existing between the parties and the shareholdings between some of them. This is because Novartis holds a non-controlling 33,33% stake in Roche which, in turn, controls Genentech (Roche had 60% of Genentech’s shares until 2009 when it acquired all of that company’s shares) (see, chart at p. 5 of the press release and p. 43 of the decision).
The finding of collective dominance by the AdC allowed it to dispense with the search for evidence of collusive conduct among the parties, a path which the Italian authorities had pursued. The three defendants were now regarded as a monolithic entity which the AdC found to be dominant on the French market for the treatment of AMD. The next step was for the AdC to demonstrate abuses of that dominant position by this entity.
The defendants were collectively found guilty of two sets of abusive conduct. First, Novartis mounted a communication campaign targeting ophthalmologists, including key opinion leaders, to explain that Avastin® should not be used for treating eye diseases at the expense of Lucentis®. According to the AdC, this campaign did not amount to a bona fide presentation of Avastin® in the interest of public health, but was rather a self-serving tactic discrediting Avastin® and stoking fears over its use in the ophthalmological field. AdC maintains that the campaign of Novartis was successful and reduced the off-label prescriptions of the product.
Second, the three defendants were also found to have directed a series of misleading and “alarmist” messages at various public authorities, thus delaying a critical head-to-head trial comparing Avastin® and Lucentis® and at one point securing the prohibition of the off-label use of Avastin®.
Separately and earlier, the reimbursement of Avastin® for an ophthalmological application not covered by that product’s MA formed the subject of a distinct strand of litigation and also culminated in a judgment of the CJEU which held that under EU law national healthcare insurance systems are allowed to reimburse a medicine for off-label use (see, Van Bael & Bellis Life Sciences News Alert of 21 November 2018).