EU slaps record $476mn fine on Illumina over Grail deal The European Commission has imposed a record-breaking fine of €400 million ($476 million) on Illumina, a US-based biotechnology company, for completing its acquisition of Grail, a cancer detection start-up, without obtaining prior approval from the EU antitrust authorities.

The Commission said that Illumina’s conduct breached the EU Merger Regulation, which requires companies to notify and obtain clearance from the Commission before implementing transactions that may affect competition in the EU.

According to the Commission, Illumina’s acquisition of Grail would significantly reduce competition and innovation in the emerging market for multi-cancer early detection (MCED) tests, which are blood tests that can detect various types of cancer at an early stage.

The Commission also said that Illumina is the only provider of next-generation sequencing (NGS) platforms, which are essential for developing and running MCED tests, and that Grail is one of the leading developers of MCED tests in the EU and globally.

The Commission had opened an in-depth investigation into the proposed transaction in March 2021 and issued a statement of objections in July 2021, expressing its preliminary concerns that the deal would harm competition and innovation.

However, Illumina decided to close the deal on 20 August 2021, without waiting for the Commission’s final decision, which is expected by 23 November 2021. The Commission said that this was the first time that a company had implemented a transaction in breach of the EU Merger Regulation since 1998.

The fine of €400 million is the highest ever imposed by the Commission for a so-called “gun-jumping” violation. The Commission said that it took into account the gravity and duration of the infringement, as well as Illumina’s turnover and its repeated failure to comply with its obligations under the EU Merger Regulation.

The Commission also stressed that the fine does not prejudge the outcome of its ongoing investigation into the substance of the transaction, and that it will continue to assess whether the deal should be prohibited or cleared with conditions.

Illumina said that it strongly disagrees with the Commission’s decision and that it will appeal it in court. The company also said that it believes that its acquisition of Grail is pro-competitive and will benefit patients and healthcare systems across Europe and around the world.