The Trump effect: fewer new medicines are reaching Europe and Italia

The tsunami unleashed by US President Donald Trump a year ago in the world of pharmaceuticals is beginning to take its toll, given that over a third of the new medicines approved in the US have not reached Europe – and therefore Italia. The controversial Most Favoured Nation clause introduced by the American tycoon on 12 May 2025, which requires pharmaceutical companies to align US prices – which are normally higher – with those charged in other developed countries, including Italy – has caused a 35 per cent drop in the number of new treatments reaching the Old Continent compared with the same period last year. Faced with the risk of a backlash, the major pharmaceutical companies have in fact decided to delay the introduction of innovations into European countries. And there is a real risk that some companies may even abandon European markets altogether because they are no longer profitable, unless prices are raised – as the UK, for example, has decided to do, increasing them by 25 per cent.

This is a scenario that is causing such concern in Europe that, in recent days, health ministers have decided to task the European Commission with investigating whether the ‘MFN’ mechanism is causing delays in product launches, significant price increases and reduced access to innovative medicines for European patients. In short, the countries want answers on ‘how it works and what overall impact it has on EU markets’, explained Health Commissioner Olivér Várhelyi. He wants to bring the matter to a close soon: ‘We want to act swiftly, which also means before the summer,’ the Commissioner added.

According to recent figures released by Global Data, the number of new launches across Europe in the 10 months following Trump’s executive order fell by 35 per cent compared with the previous 10 months. This decline rises to 37 per cent when considering the select group of European countries under scrutiny by the US administration (which includes Italia, as well as Denmark, Germany, France, Switzerland and the UK) and rises to as much as 43 per cent when all 14 European countries that the White House is closely monitoring in order to bring down prices across the Atlantic are taken into account. The objective, set out in black and white in a document drawn up by Trump’s Council of Economic Advisers, is to achieve savings of as much as $600 billion on medicines over the next 10 years through this price-alignment measure. And the fact that the United States is taking this matter very seriously is demonstrated by the fact that, just in the last few days, it has launched an investigation into Germany’s drug pricing policies – a country which, in recent months, has been approving discounts on medicines – an investigation announced by US Trade Representative Jamieson Greer following months of talks with ‘German partners in an attempt to resolve the issue’. The investigation is being conducted under Section 301, which allows the US to take action against countries that impose unfair trade barriers.

Of course, these are only early indications, the medium- to long-term effects of which have yet to be assessed. For Italia – according to Global Data, the number of new medicine launches has fallen from 99 to just 33 in 10 months – the risk is that patients will be excluded or will have to wait too long for new innovative treatments. Even now, following approval by the EMA – the EU Medicines Agency – patients in Italy face an average wait of more than a year, to which must be added the time taken for regional authorisation, which on average requires a further 165 days before the medicines are made available to patients. As revealed by the ‘Regional Access Observatory’ project – promoted by Pharma Value in collaboration with the Department of Pharmaceutical Sciences at the University of Milan and due to be presented today – this timeframe varies between 100 and 400 days depending on the region: in short, even with equal rights, the wait can be up to four times longer.