Innovative drugs: almost 400 days to get them in Italia and now the Trump effect is feared

Italians have to wait almost 400 days - 393 to be exact - to have access to newly approved drugs. After the green light from the European Medicines Agency, which normally authorises innovative therapies immediately after the OK from the Food and Drug Administration, the American Fda, it takes more than a year to make them available in our country. These authorisation times are rather long for our drug agency, AIFA, but they are not even among the worst in Europe, where the median wait is 532 days. A 'delayed' access to new treatments that could, however, worsen in the future due to Trump's aggressive policy on drugs with the so-called Mfn (Most Favourable Nation) clause, which envisages lowering the prices of American medicines, bringing them into line with the lower average prices in other countries, including Italia. The result could be an 'America first' for all new therapies.

Taking stock of the time it takes for new medicines to become available is Efpia, the Association representing the European biopharmaceutical industry, which publishes the annual Wait indicator, which in this case photographs access to 168 new medicines that have been authorised between 2021 and 2024 in 36 European countries. The report paints a picture of growing inequalities and no indication of future improvements. They range from just 56 days of waiting for patients in Germany to a whopping 1201 in Romania. In Italia, as mentioned above, the median waiting time for the availability of new drugs is 393 days - in last year's report it was 391 - with times that are in any case below many European countries: in addition to Germany, only Switzerland (212 days), Serbia (235), Austria (259), Denmark (268), England (282), Scotland (298) and Sweden (372) do better than us. Particularly sensitive is the waiting time for new oncological treatments: the median waiting time for access to oncological drugs in Italia is 420 days, against a median in Europe of 598 days. The median for orphan drugs, on the other hand, is 453 days against the European median of 614 days.

In the European comparison, Italia also performs well on overall availability: of the 168 innovative drugs, 133 are available in our country, 79% against an EU average of 45%. However, the positive figure must be looked at in depth because only 66% is considered fully available, while the rest have barriers and obstacles to access for patients. "The figure highlighted by EFPIA's WAIT report confirms the nearly 400-day wait from EMA authorisation to first access in Italia. Reducing this time,' explained the president of Farmindustria Marcello Cattani to Il Sole 24 Ore, 'is a priority that requires faster processes, the introduction of a modern early access scheme, and the elimination of regional differences in order to give everyone equal rights to treatment'. For Cattani, this priority is even more pressing 'in the light of the Most Favoured Nation (MFN) clause, which is already leading to a less favourable environment for access to new products in Europe. European nations must introduce reforms for their citizens, and in this area, Italia is going in the right direction with the Single Pharmaceutical Act, which is a great opportunity to ensure a balance between access, sustainability and attractiveness for our nation'.

This situation of delay in the arrival of therapeutic innovations risks becoming even worse - as Efpia itself emphasises - with US President Trump's introduction of the 'Most Favoured Nation' (MFN) clause, which stipulates that the United States - even in the face of major investments in research - must pay the same price for medicines in other comparable countries, including Italy, which has among the lowest prices. In a recent document prepared by the White House Council of Economic Advisers, an estimated 529 billion dollars in savings over 10 years are estimated with this 'cut' in prices. And the effects of the Most Favoured Nation are already being felt, given that the number of new drugs launched in European markets has fallen significantly over the past year: a trend that can be explained by the fact that launching an innovative drug in a country that has lower prices than in the United States could result in a boomerang for the industry, because under the Mfn clause they would risk finding themselves in the US with automatically lower prices and therefore lower margins. The effect in the medium to long term could therefore be that of an increasing 'America first' that would penalise European patients by making them wait even longer for access to innovative treatments.