€444MILLION FINE AGAINST NOVARTIS,ROCHE AND GENENTECH 81 AN ALARMIST AND MISLEADING DISCOURSE BEFORE THE PUBLIC AUTHORITIES Novartis and Roche, aided by Genentech, ini- tiated a series of blocking tactics, and their discourse with regard to the French public authorities was alarmist and misleading These practices were designed to exacer- bate their concerns and block any initiatives undertaken by the public authorities to set up procedures for the safe use of Avastin in the treatment of AMD. These tactics sought to delay the GEFAL trial (comparative study between the two drugs) and influenced the health authorities, amplifying their concerns and influencing them to maintain a posi- tion of extreme prudence even following publication of the first favourable results of trials comparing Avastin and Lucentis. The discourse also had a direct influence on the decision by the Directorate-General for Health (DGS) to prohibit the off-label use of Avastin, in July 2012, and, more generally, in delaying the adoption of provisions designed to control and ensure safety with regard to the off-label use of Avas- tin in the field of Ophthalmology. The laboratories In determining the amount of the fines The fines had mapped out handed down, which totalled €444 million, Through these practices, the three companies the Autorité took into account, inter alia, the ensured that Avastin could not be recognisedthe locations of seriousness of the practices in question and by the French health authorities as an appro-doctors, in order the clear damage they caused to the eco- priate comparator in trials alongside Lucentis, nomy. It also took into account the fact that which would have enabled the authorities into target some of this was not the first time Novartis was in charge of pricing medicinal products to rene-them as a priority: such a situation (it was already sanctioned in gotiate the price of Lucentis to bring it down 2003 for similar practices on the market for substantially at a much earlier date. "the Avastin lovers" ciclosporin in Decision 03-D-35), by increa- These practices occurred at a time of public sing its sanction by 25%. debate over the impact on social security finances of the extremely high price of Lucen- Decision 20-D-11 of 9 September 2020 tis - a drug that is fully reimbursed by the This decision is being appealed (case pending). French Social Security system - while there has been a significantly cheaper medicinal product, Avastin, that can be used in Oph- thalmology. Discover the case in video ACTIVATING TRANSFORMATION