by John R. Fischer
, Senior Reporter | September 29, 2023
Edwards Lifesciences has said it will cooperate with EU antitrust regulators after they raided one of its facilities last week out of concern that it may have violated regulations regarding unfair competition.
According to officials from the executive branch of the EU, Edwards was suspected of actions that clash
with Article 102 of the Treaty on the Functioning of the European Union, which prohibits abuses of a dominant market position.
While the initial news and update do not name Edwards’ specific violations, these abuses may include directly or indirectly imposing unfair purchase or selling prices and trading conditions; limiting production, markets, or technical development based on consumer bias; applying dissimilar conditions for equivalent transactions with other trading parties to create competitive disadvantages; and establishing contracts that require individuals or groups to complete supplementary obligations that are in no way connected to the subject of the contracts.
“We have an unwavering commitment to healthy, fair competition; when innovative companies like ours compete, patients benefit. We remain confident in our business practices and will not be commenting further at this time,” the company told HCB News in a statement.
Reuters broke the news last week of unannounced inspections on a cardiovascular medical device company but the name of the business was not revealed.
Edwards, however, felt the impact, seeing its shares drop 2.5% in premarket trading. The company, which manufactures products for structural heart disease and transcatheter aortic valve replacement (TAVR) in heart surgery, has agreed to cooperate with antitrust regulators, and its stock is now up 0.8%, wrote Reuters in an update
Those found guilty could face fines of up to 10% of their global turnover for infringing EU antitrust laws.
The EC said that unannounced inspections are a preliminary investigative step and do not guarantee that the company is guilty of anticompetitive behavior, but the action is another example of the increasing regulatory scrutiny in both Europe and North America of the pharmaceutical and healthcare industries to ensure they offer products and services at affordable pricing without unfairly pushing out competitors.
The country where the raid took place was not named, but officials from the national competition authority of the member state joined the commission during the inspections.