The French Competition Authority imposes a fine of €25m on Janssen-Cilag for restricting generic development of its originator Durogesic

The pharmaceutical company Ratiopharm, which became Teva Santé, brought a claim before the French Competition Authority (FCA) on 06 March 2009 for undue interference by Janssen-Cilag into the procedure for issuing a marketing authorization for Teva Santé’s generic version of the drug Durogesic in order to delay the entry of generic competition to Durogesic on the French market.

According to the FCA, whose decision is not yet available in full, Janssen-Cilag intervened several times through the French Agency for Safety of Health Products (AFSSAPS)1, to challenge the decision of the European Commission to grant a marketing authorization for Teva Santé’s generic drug. Janssen-Cilag questioned whether this product and similar products from other providers could be considered generics of Durogesic, and highlighted public health risks to some patients if the substitution became possible.

Following interventions by Janssen-Cilag, the AFSSAPS temporarily refused to recognize the generic status of Durogesic’s generic competitors despite not having the power to do so since the European Commission had authorized the “putting on the market” of this generic in 2007.

It was only one year after the decision of the European Commission that generic status was finally granted by the AFSSAPS to the competing generic versions of Durogesic. However, this authorization was accompanied by a warning recommending careful medical supervision of some patients (including febrile persons, elderly persons and children) in case of a change of generic specialty based on fentanyl (Durogesic’s active substance).

Janssen-Cilag then tried a second route. It disseminated "massively" a speech denigrating competing generic versions of Durogesic to doctors and pharmacists practicing in different towns and hospitals, arguing moreover that the procedure of granting marketing authorizations to generic drugs was not sufficiently protective of the safety and health of patients.

Janssen-Cilag also used a warning issued by the AFSSAPS to alarm health professionals by inaccurately and incompletely presenting the risks related to generics. This misleading speech received important support from health professionals, who were already reluctant to use generics.

The FCA has highlighted the seriousness of these practices, which have allowed Janssen-Cilag to delay by several months the procedure for issuing marketing authorizations in France for competing generic versions of Durogesic and the recognition of their status as generic.

These practices led to an undue prolongation of Janssen-Cilag's monopoly on the relevant markets and thus to a strong effect of foreclosure of its competitors and a shortfall for generic laboratories, coupled with overpayments for patients in a context of chronic deficits in social security accounts.

Moreover, Janssen-Cilag's smear campaign contributed to the low penetration rate on the market for generic Durogesic and to the establishment by the public authorities in 2011 of a flat-rate liability, since their substitution objectives had not been achieved.

This decision was long overdue since it had been announced by the FCA at the end of 2013. This is the third decision punishing the practice of denigrating generics in France, following the Sanofi and Schering Plow decisions of 2013.

1  which has since become the National Agency for the Safety of Drugs and Health Products (ANSM)

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