Drugs, we remain a country of copiers

Fedaisf editorial staff

March 11, 2015

In Italy, process innovation is mainly done: there are thousands of versions (formulations, enrichments, dosages, etc.) of a molecule that cures, developed elsewhere

DI DANIELA MINERVA – 11 marzo 2015 – L’ESPRESSO

Let's start by saying that finding a new medicine, one that heals the sick and boosts turnover, has a frightening cost: 2.6 billion dollars, is the estimate of Tufts University. Which cover research, increasingly complex trials and failures, because there are few molecules that survive clinical trials and really land on the market. Then, whoever finds a truly innovative drug in hand, those 2.6 billion will repay them in an instant: let's think that in 2014 the new cure for hepatitis C sold, and only in the USA, for 7.6 billion.

The dimensions of pharmaceutical research are impressive: 141 billion spent last year by industries which, however, collected around 750 billion. Obviously none of the Italian mini-pharma has the shooting power to compete. The portrait of the sector traced in these pages tells of the growth and successes of an industry that produces large-scale drugs often conceived and studied elsewhere. How much this will impact on the future of the aforementioned sector remains to be seen. But it is a certainty that we are and remain a country of extraordinary copiers.

On the other hand this is our story, with few exceptions. From the mid-nineteenth century when the German chemical industries were innovating, to the early twentieth century of English penicillin. All the way up to the unfortunate laws of the eighties, when, with the methods revealed by Sanitopoli, the industrialists convinced the politicians to lengthen the duration of the patent and assure them dizzying profits, with the NHS overpaying for drugs discovered abroad but sold in Italy by Italian companies. Facts about the past aside, what matters is that over the decades our production capacity has refined.

What about research? Well, that's another story. It is true that here and there there are small realities, biotech but not only, that get their hands on interesting products. And an exception in the Italian panorama of copiers is Chiesi of Parma, which has put the money for the first drug based on stem cells in the world (Holoclar, studied by scientists at the University of Modena, in the photo on the right) ; who developed the first gene therapy against a rare disease. But, for the rest, what is done in Italy is process innovation: that is, there are thousands of versions (formulations, enrichments, dosages, etc.) of a molecule that cures, developed elsewhere.

And if some brilliant scientist discovers one that has serious therapeutic potential, he hastens to sell it to a Big Pharma: the procedures to verify the product and place it in the hearts of doctors all over the world are too complex and expensive. Made in Italy stops there. So, we slipped to the bottom. And there are no Italians among the top companies that take care of the world: American, Swiss, French, Japanese, German and even Israeli.