Drugs: The US puts pressure on Europe, but the real issue is access to innovation

In the United States, the new political offensive on drug prices has reopened a global dossier.The agreements promoted by the Trump administration with various pharmaceutical companies aim to reduce some U.S. prices and link the launch of new drugs to levels practiced in other developed countries. However, this does not mean that the United States already has the world's lowest prices, nor that Europe is automatically destined to pay more.

It means more concretely that the negotiation pressure on drugs has entered a new phase, and Europe will be one of the main battlegrounds.

For Europe, the key point—at least in the short term—is not to expect an immediate increase in prices reimbursed by national health systems. Prices continue to depend on national evaluation, negotiation, and reimbursement procedures. In Italy, this framework remains anchored in AIFA, which regulates price and reimbursability negotiation and has recently updated guidelines for the HTA dossier to support these decisions.

The most realistic risk is another one.

If companies perceive lower margins in the United States for certain therapeutic classes, they could become more selective in launch timelines and conditions in Europe, prioritizing more lucrative markets or delaying the commercial entry of some products. Reuters has reported that this scenario is considered credible by investors and industry operators, especially for the most innovative drugs.

This issue is particularly delicate because Europe already starts from a heterogeneous situation in access to innovative medicines.According to the EFPIA 2025 report, the average time to reimbursability after EMA authorization is 578 days, with a range from 128 to 840 days across different countries. The same report also shows that southern and eastern European countries tend to have longer times, that the availability of oncology drugs has decreased over time, and that orphan drugs still face delays and lower accessibility.​

For Italy, therefore, the most likely scenario is not a direct increase in spending for citizens, at least in the short-to-medium term.

More plausible is to expect tougher negotiations between AIFA and companies, greater attention to selecting eligible patients for the most expensive treatments, more frequent use of equivalents and biosimilars when available, and potentially longer timelines for some high economic-impact innovations. This would mean pressure on access rather than an immediate price hike.

The most sensitive areas will likely be those where prices remain high and clinical value is negotiated with greater intensity—particularly oncology, orphan drugs, and new metabolic therapies like those for obesity. These are the segments where the clash between innovation, sustainability, and access times risks becoming harsher.

The U.S. strategy does not represent an immediate revolution for Europe and does not automatically force European health systems to change their model. But it heightens tension between two different logics: the U.S. market one and the European public negotiation one.

For Italy, the real challenge will not only be defending the sustainability of the National Health Service, but doing so without turning negotiation prudence into further delays in access.

Editorial by Prof. Antonio Giordano