Recent events show that competition authorities actively pursue and heavily punish anti-competitive practices that aim to delay the marketing of generic drugs. The authorities’ interest in pursuing said practices can be explained, among others, by the fact that market penetration of generic drug constitutes a major stake for public finances.
The European Commission has already examined said type of practices as part of its enquiry into the pharmaceutical sector conducted in 2008 and 2009. The French Competition Authority is also currently conducting a sector based enquiry. The European Commission had already imposed a fine of €60 million on AstraZeneca in 2005 for having wrongly delayed the marketing of generic drugs. By a decision of 19 June 2013, it imposed a total fine of €146 million on the Lundbeck pharmaceutical group and also on several generic manufacturers for having set up anti-competitive agreements pursuing a similar purpose.
The French Competition Authority’s decision of 14 May 2013 is an additional illustration of how the authorities combat practices which delay the marketing of generic drugs. In this decision, the Authority imposed a fine of €40.6 million on Sanofi-Aventis for the strategy it implemented to disparage the marketing of generic drugs that competed with its lead drug, Plavix®, the fourth most sold drug in the world.
If the Authority admits that competition law does not require that pharmaceutical laboratories contribute to the development of the generic drugs of their competitors, it considers, however, that they should not manipulate the caution or fears of the medical practitioners and pharmacists by conduct, the aim or effect of which is to cast doubt, without an objective reason, on competitors’ generic products.
In this case, the Authority blames Sanofi-Aventis, via its medical and pharmaceutical representatives, with having provided incomplete information to medical practitioners and pharmacists which discredited the generic drugs that compete with Plavix®, “by unduly casting doubt on their effectiveness and safety” in favour of Plavix® and of the auto-generic drug marketed by Sanofi-Aventis itself. The Authority noted, in particular, that Sanofi-Aventis insisted that there were differences in salts and therapeutic indication between Plavix® and competitors’ generic drugs when said differences had no impact on the substitutability of said drugs but were exclusively related to intellectual property issues.
The Competition Authority noted that said misleading talk curtailed competition at two key stages of the generic substitution mechanism: first of all at the prescription stage, by encouraging medical practitioners to write the words “non substitutable” on prescriptions, then at the substitution stage, by encouraging pharmacists to choose the auto-generic drug marketed by Sanofi-Aventis rather than competitors’ generic drugs. According to the Competition Authority, said practices, which were implemented just at the time of the market launch of generic drugs that compete with Plavix®, damaged the economy, in particular, because, as a result thereof, the market penetration of generic drugs was abnormally low.
Other proceedings relating to strategies to disparage generic drugs are currently pending before the Competition Authority.