Competition Council fines Boehringer Ingelheim RCV RON 128 M for abuse of dominant position

The Competition Council has fined Boehringer Ingelheim RCV GmbH & Co KG (Austria) 128,470,123 lei (€25.81 million) for abusing its dominant position in Romania’s market for medicines treating chronic obstructive pulmonary disease (COPD).

The authority found that, between 2017 and 2021, Boehringer Ingelheim limited market access for the generic medicine Spiriva (a lower-cost option) and redirected patients toward Spiolto Respimat, an innovative, more complex, and more expensive drug.

According to the therapeutic guidelines and national protocol in effect at the time, not all COPD patients required a complex (dual therapy) drug as a first treatment option. Some were initially prescribed Spiriva or its generic equivalents (monotherapy).

Boehringer Ingelheim engaged in an intensive communication and promotion strategy to influence physicians’ prescribing decisions, encouraging them to prescribe Spiolto Respimat more broadly.

This approach aimed to hinder the sale of competing generic medicines similar to Spiriva and to direct revenues from this product toward the newer Spiolto Respimat.

Both medications are reimbursed at 50% by the National Health Insurance House, with the remaining cost borne by patients.

“By promoting the early prescription of a more complex and expensive medication, the company compelled some patients to pay more for a drug that was not necessarily indicated for them. Simultaneously, with the budget allocated to reimbursing this new product, the state could have subsidized generic medicines for more patients,” said Bogdan Chirițoiu, President of the Competition Council.

The investigation was also triggered by reports submitted through the Competition Whistleblower Platform, which allows individuals to anonymously report violations of competition law. The platform is accessible at https://report.whistleb.com/ro/consiliulconcurentei.

Innovative medicines are new drugs protected by patents at the time of market launch, making them more expensive.
Generic medicines contain the same active substance in the same dosage as the innovative drug but are not patent-protected, resulting in a lower price.

It is worth noting that Competition Council decisions are enforceable, and the fines imposed are revenues to the state budget. The National Agency for Fiscal Administration (ANAF) enforces the Council’s sanction decisions and collects the fines.