The competition authority has indications that Boehringer Ingelheim RCV GmbH & Co. has implemented some marketing strategies aimed at influencing prescribing in favor of its drug, Pradaxa, in the area of direct oral anticoagulants, through interactions with healthcare professionals. In this way, the development of the market and the access of patients to other medicines in this range have been limited.
The Competition Council also has indications that Boehringer Ingelheim RCV GmbH & Co. prevented the entry of Spiriva's generic medicine into the market by implementing a strategy to transfer patients to Spiolto Respimat, an innovative product with the same therapeutic indications. Both Spiriva and Spiolto Respimat are medicines intended for the treatment of chronic obstructive pulmonary disease, a condition of the respiratory system.
The innovative drug is a new drug that is protected by the patent when it is launched on the market.
The generic medicine contains the same active substance in the same amount as the medicine
innovative, but no longer protected by patent.
In this context, the Competition Council carried out an unannounced inspection at the headquarters of the branch of the investigated company in Romania.
Unexpected inspections are an important step in the procedures for investigating possible anti-competitive behavior, and their performance does not constitute a preliminary ruling by the Competition Council regarding the existence of an infringement of the Competition Law.
The documents submitted are under the analysis of the Romanian competition authority, within the specific procedures.
The unannounced inspection was authorized by the Bucharest Court of Appeal, being justified by the need to obtain all the information and documents necessary to clarify the possible anti-competitive practice analyzed.
In the event that the Competition Council finds a violation of the competition rules, the company involved risks fines of up to 10% of turnover. However, the company cooperating with the competition authority under the leniency program may obtain immunity from fines or a substantial reduction of the fine.