On 20 December 2017, the French Competition Authority (the FCA) imposed a EUR 25 million fine on a pharmaceutical laboratory, for delaying entry onto the market of the generic version of Durogesic, and for hindering its development through a disparagement campaign.
No public version of the decision is available yet, nonetheless the FCA has already published a detailed press release (available in French).
Durogesic is a powerful opioid analgesic, which active substance is fentanyl, usually prescribed in the form of transdermal patch for the treatment of severe pain, including chronic cancer pain. In 2007, a competing pharmaceutical company launched its generic equivalent.
After receiving a market authorization in Germany, the competing pharmaceutical company started a mutual recognition procedure in the European Union. The European Commission (the Commission) granted the market authorization in October 2007 and instructed the other Member States to do the same within a 30-day deadline. It is in this context that, according to the FCA, the sanctioned laboratory has intervened in order to hinder the market entry and development of the generic in France.
Following a complaint filed by the generic manufacturer, the FCA found two distinct anticompetitive practices:
- A legally unjustified intervention with the French National Agency for Medicines and Health Products Safety
First, the FCA established that, during the market authorization of generic specialties process, the sanctioned laboratory wrote to the French National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé, the ANSM) on several occasions and requested a meeting to discuss the side effects of the generic. During those exchanges, it questioned the decision of the Commission, suggesting that the ANSM could take a different decision, disregarding the fact that the Commission’s decision is legally binding on the ANSM.
To convince the ANSM, the laboratory put forward risks to human health that the substitution could entail for some patients, such as ineffectiveness or adverse effects causing even greater pain.
Sensitive to these arguments, the ANSM, whose mission is to ensure health security, initially refused to acknowledge the generic status to medicines competing with Durogesic, thereby allowing the laboratory to temporarily achieve its objective to delay their market entry in France. More than a year later, the ANSM finally granted the generic status, accompanying its market authorization with a warning message recommending medical supervision of certain patients (including older people and children) in the event of a change of specialty (e.g. a reference specialty by a specialty generic, a specialty generic by a reference specialty, or a specialty generic by another specialty generic) based on fentanyl.
- A global and structured disparagement campaign
Second, the FCA established that, after the issue of the market authorization for the generic, the sanctioned laboratory massively disseminated an alarmist message on the risks of prescribing or dispensing the generic. This characterized a disparagement campaign, which was based on the differences between the originator product and the generic, including the size and the amount of active ingredient present. According to the FCA, the idea was to instill doubts regarding the effects of a possible change of treatment from Durogesic to a generic.
In this context, the laboratory mobilized and formed 300 medical sales representatives to spread the message to all doctors and pharmacists in hospital or private practice. A health information letter was also widely distributed by mail, email, fax and in specialized press. The campaign was further supplemented by distance training of doctors and pharmacists and phone calls.
In addition, the FCA considered that the laboratory misrepresented the content of the warning message issued by the ANSM by circulating an inaccurate and incomplete presentation of the risks associated with the substitution. In the above-mentioned health information letter, only the risk associated with Durogesic’s substitution with generics was emphasized whereas ANSM’s warning message was general and mentioning all cases involving substitution, including the substitution of the generic specialty by the reference specialty.
This misleading message contributed to a very low penetration of the Durogesic’s generic on the market. The substitution objectives were not achieved and the substitution rate observed was even lower than what the fined laboratory anticipated.
Consequently, the FCA imposed a EUR 25 million fine jointly and severally to the pharmaceutical laboratory and its parent company, for delaying the market entry of the Durogesic’s generic and for hindering its development by using a disparagement campaign with an aim to influence doctors and pharmacists in order to slow down as much as possible the generic substitution process.
WHAT THIS MEANS
In this case, the FCA has, for the third time, addressed the issue of the obstruction to generic entry or development through disparagement of competing generics companies’ products. In 2013, Sanofi-Aventis and Schering-Plough were fined by the FCA on similar grounds, respectively EUR 40.6 million and EUR 15.3 million, for their Plavix and Subutex products.
In line with its previous case law and its Opinion No. 13-A-24 of 19 December 2013, the FCA’s decision is a clear illustration of European competition authorities’ increasing skepticism concerning originator companies’ attempts to prevent or delay generic entry. Therefore, pharmaceutical companies should be particularly cautious in their communications with medical professionals, especially when discussing competing generic products.
Moreover, combined with the recent announcement (20 November 2017) by the FCA of the launch of another sector inquiry on the functioning of competition in the medicinal products sector, this decision sends a clear message that the pharmaceutical sector remains one of the FCA’s main priorities.