WASHINGTON, D.C. - Last week, Representative Brian Fitzpatrick (R-PA), a Co-Chair of the Congressional Cancer Caucus, and Representative Scott Peters (D-CA), along with a bipartisan group of colleagues, sent a letter to the Secretary of Commerce Gina Raimondo urging intervention in the European Union (EU) case that threatens to harm President Biden’s call to change cancer as we know it.
Through a simple blood draw, MCED tests can locate cancer before it spreads throughout the body– preventing millions of deaths stemming from late-stage cancer diagnosis.
Illumina announced its intent to reacquire GRAIL in 2020, after which the Federal Trade Commission (FTC) brought an administrative action to block the merger. Last month, Illumina and GRAIL prevailed in a trial before the FTC’s Chief Administrative Law Judge, but days later, the European Commission stepped in to rule against the merger, signaling a likely divestment order in direct contradiction of the FTC’s own judge, creating legal inconsistency on both continents.
This letter requests that Secretary Raimondo intervene in the Illumina/GRAIL case to ensure that we do not set a precedent of foreign entities granting themselves boundless jurisdiction over Americans and American companies. This unprecedented interference from the European Commission would also hinder innovation in the early cancer detection sphere.
“Having access to universal screening tests is monumental when it comes to preventing cancer deaths,” said Rep. Brian Fitzpatrick. “We must not allow foreign entities to strip away our research and development efforts and block innovation, particularly when it comes to a disease that impacts every American. I urge Secretary Raimondo to work to intervene so that American companies can continue to forge ahead with lifesaving impacts for the cancer community.”
"If successful, the European Commission's attempt to block a wholly US merger could make the European Commission a gatekeeper for US innovation," Rep. Peters said. "Given longstanding American leadership in health innovation and the Biden Administration's commitment to ending cancer as we know it, I hope Secretary Raimondo will consider intervening in the European Court of Justice's review if the case cannot be brought to a reasonable resolution."
Read the full letter here or below.
Dear Secretary Raimondo,
We appreciate your leadership to strengthen US competitiveness in advanced technology innovation. We are writing to express our concern that the European Union's emerging use of competition regulation as an instrument of industrial policy will undermine US innovation, harm the vital US-EU trade relationship, and provide unfair advantages to China, Russia, and other foreign nations seeking to displace US competitiveness in critical advanced technologies. We therefore support continued advocacy to protect US businesses and workers against discriminatory European competition regulation that unfairly targets American companies.
We are concerned that European Competition Regulators have begun to use unprecedented new powers in the Digital Markets Act (DMA), in conjunction with recently adopted subjective jurisdictional criteria in Article 22 EUMR, to target US innovation with ex ante merger reviews. In February, bipartisan members of both houses of Congress wrote to President Biden proposing that US negotiators use the US-EU Joint Technology Competition Dialogue and the US-EU Trade and Technology Council to convey Congress’s “great concern” that the DMA unfairly targets US workers by “deeming” US companies as “gatekeepers” based on discriminatory, subjective thresholds.
Similar concerns had been expressed by federal officials for several months leading to the congressional letters, including your public expression of “serious concerns” that the DMA unfairly targets American firms. The congressional letters urged that the EU slow down and incorporate revisions in the DMA that would allay the widely-held US concerns. Unfortunately, the EU Parliament did not accommodate US concerns prior to advancing the Digital Markets Act.
Now, the European Commission (EC) has chosen as its “test case” for its expanded Article 22 power a wholly US merger already under review by the Federal Trade Commission (FTC): the Illumina-Grail merger. On July 13, 2022, while the substantive merger review was still pending, the EU General Court rejected the parties’ challenge to the EC’s assertion of Article 22 jurisdiction and endorsed the EC’s expansive interpretation of this extraterritorial tool. The General Court decision has been appealed to the European Court of Justice.
This merger could be of significant importance to the United States and illustrates the potential harm to US competitiveness posed by an expanded interpretation of the EC’s Article 22 powers. In his Cancer Moonshot Initiative, President Biden established a whole-of-government program to accelerate public access to early cancer detection. According to Grail, its Multi-Cancer Early Detection (MCED) test, called Galleri, can identify more than 50 cancers at early stages with a simple blood draw. It can detect the 12 deadliest cancers with about 76% accuracy, and false positives are less than 1%. We’ve been told that Illumina’s acquisition of Grail could accelerate access and affordability for this revolutionary cancer testing that will save both lives and dollars.
The EC’s actions could force Illumina to divest from Grail, which may have the effect of maintaining existing barriers to accessing this critical diagnostic. This move demonstrates the potential for the EC to impede US innovation by imposing a judgment against a merger of companies, one of which does not operate in EU markets.
According to Grail, it has no products or customers in the EU. There currently is no European market for MCED testing. We understand that the EC initiated its own factual review after the FTC's Chief Administrative Law Judge (ALJ) had already begun an exhaustive review of this US-based transaction in Washington. The US review included a lengthy trial with extensive live testimony, cross-examination, voluminous document examination, and comprehensive oral arguments: all governed by rules of procedure and evidence. On September 1, the FTC's Chief Administrative Law Judge issued a lengthy decision rejecting the FTC's assertion that the merger would substantially lessen competition, and dismissed the FTC's complaint.
Now, with the EC actively wielding Article 22 to prevent a wholly-US merger, we hope you will consider advocating among your EU counterparts in favor of prudence, fairness, and timely accommodation of US concerns, recognizing events are trending in what we believe is a harmful direction. We also hope that you consider the possibility of US Government intervention in the European Court of Justice review of Article 22 jurisdictional interpretation.
CC: Lina Khan, Chair, Federal Trade Commission
Francis D’Souza, CEO, Illumina
Bob Ragusa, CEO, Grail
Member of Congress
Scott H. Peters
Member of Congress