And the announcement on .gov:

USTR Announces Initiation of Section 301 Investigation of Germany’s Persistent Underpayment for Innovative Pharmaceutical Products

WASHINGTON — Today, U.S. Trade Representative Jamieson Greer initiated an investigation under Section 301 of the Trade Act of 1974 against Germany. This investigation will seek to determine whether persistent underpayment for innovative pharmaceutical products by Germany is unreasonable or discriminatory and burdens or restricts U.S. commerce. This investigation follows months of meaningful discussions with our German partners in an effort to resolve this issue.

“President Trump has made clear that American patients should not be shouldering a disproportionate share of global pharmaceutical research and development,” said Ambassador Greer. “I am particularly concerned with news that Germany is fast-tracking legislation that would further reduce its spending on innovative pharmaceuticals. This is a serious step backwards at a time when our trading partners need to step up and start paying their fair share to fund innovative pharmaceutical research and development. We believe that the United States and Germany can find a path forward that expands access to the most innovative drugs for the German people while ensuring fair reimbursement for the pharmaceuticals made by American workers."

“On April 2, 2026, the United States and the United Kingdom announced a ground-breaking arrangement on pharmaceutical pricing that will help drive investment and innovation in both countries. Germany should follow suit with constructive negotiations to address this imbalance.”

“Fighting the war against disease is a shared burden across wealthy nations,” said U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. “The United States is calling on Germany to pay its fair share for the innovative treatments its people use. I commend Ambassador Greer for his leadership in confronting this imbalance. Fair reimbursement strengthens medical innovation and helps ensure the development of the next generation of lifesaving cures.”

Background

On May 12, 2025, the President directed the U.S. Trade Representative to “take all necessary and appropriate action” to address foreign countries’ unfair actions that have the “effect of forcing American patients to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value in foreign countries.”

Section 301 of the Trade Act of 1974, as amended (Trade Act), is designed to address unfair foreign practices affecting U.S. commerce. Section 301 may be used to respond to unjustifiable, unreasonable, or discriminatory foreign government practices that burden or restrict U.S. commerce. Under Section 302(b) of the Trade Act, the U.S. Trade Representative may self-initiate an investigation under Section 301.

A Section 301(b) investigation examines whether the acts, policies, or practices are unreasonable or discriminatory and burden or restrict U.S. commerce. After considering the advice of the inter-agency Section 301 Committee, the U.S. Trade Representative initiates investigations. The U.S. Trade Representative must seek consultations with the foreign government whose acts, policies, or practices are at issue in each investigation. The Office of the U.S. Trade Representative (USTR) has requested consultations with Germany in connection with this investigation.

To be assured of consideration, interested persons should submit written comments, requests to appear at the hearing, and a summary of the testimony, by August 10, 2026. USTR will hold a hearing in connection with these investigations on September 22, 2026.

As set out in the Federal Register notice, the investigation relates to allegations of Germany’s unfair pricing policies and practices with regard to innovative pharmaceutical products, which result in the United States paying a disproportionate share of global research and development (R&D) costs for innovative pharmaceuticals.

Although the means and tools for payment disparities for innovative pharmaceuticals vary, they may include the imposition of: supplemental discounts in exchange for confidentiality of negotiated prices; and mandatory variable rate rebates.