US patent infringement investigation targets German drug price control measures


The Office of the US Trade Representative (USTR) has triggered a new active investigation targeting Germany over what it describes as “persistent underpayment for innovative medicines” and other policies discriminatory to US commerce. Underpinning the investigation is a long-standing conviction within the Trump administration that the US shoulders a disproportionate share of global R&D costs for innovative medicines while Europe takes advantage of relatively low prices for branded pharmaceuticals.

The USTR decision to open a Section 301 investigation into pharmaceutical pricing and reimbursement policies in Germany is part of an escalating pattern of US executive orders piling pressure on European governments to accept higher medicine prices as demanded by the Trump administration. USTR head Jamieson Greer declared that the investigation would focus on allegations of “persistent underpayment for innovative pharmaceutical products” by Germany and other “freeloading” policies, which are considered “unreasonable or discriminatory” to the US. If investigators uncover violations, this could enable the USTR to pursue unilateral action against Germany. Options on the table would potentially include US tariffs or import restrictions on Germany. But since it would be difficult for the US to consider tariff-related actions on German imports alone, there is a risk of broader trade implications for the EU.

The trigger for the USTR investigation appears primarily to be over fast-tracked German reforms to reduce spending on innovative pharmaceuticals. But the Section 301 investigation will also assess whether Germany’s AMNOG-derived net prices result in “persistent” and “insufficient” payments for innovative pharmaceutical products.

Greer describes the cost-containment proposals emanating from Berlin as representing a “serious step backwards” that threatens to reduce spending on innovative medicines. For its part, Germany’s Health Minister Nina Warken said that the country’s statutory health insurance system faces a “strained financial situation”, which makes it difficult to pay higher prices. To address this, German policymakers had proposed introducing dynamic discounts on patent-protected medicines. However, broad opposition within Germany had already given rise to credible reports that the struggling coalition government of Chancellor Friedrich Merz was considering abandoning or heavily modifying that plan. Whether the US intervention accelerates a decision to soften the reform proposals is debatable. But in theory, the German government would have time to address US concerns before Section 301 hearings take place in September 2026. On the other hand, there is no sign of Germany wavering in its opposition to pharmaceutical price increases. Germany has offered the US further talks, although Merz billed this as a chance to provide an explanation of the organisation of the health insurance and drug reimbursement system in Germany to the US executive. Already facing a leadership crisis of confidence in his government, it would be very difficult for Merz to be seen making concessions to the US. Therefore, unsurprisingly, he has held the line that the issues identified by the Section 301 investigation are an internal policy matter and that the question of tariffs has been dealt with by the EU–US trade agreement.



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