now a control room »- Corriere.it

ROME «A world polarized between the US and China. Five of every ten drugs approved are American, two and a half come from Chinese research. Europe has lost the challenge of research and innovation in the last twenty years, we need a change of vision in the rules that truly recognize the value of pharmaceutical innovation and of the entire supply chain ». Marcello Cattani is the president of Farmindustria. He is also number one in Italy of the French Sanofi, he is not used to mincing words. Much less saving on some approaches that come from Brussels where we perceive the apprehension for “a new pharmaceutical legislation that has worrying elements that could act on a reduction in the duration of patents by touching the criteria to support research in the field of orphan and pediatric drugs with the risk of making rare diseases even more rare and without therapy ».

Recurring accusation, however, is it not that the pharma industry has enriched itself beyond measure with the pandemic and now Brussels is trying to put some stakes?

«Far from it. It is a completely distorted view. As is the populist rhetoric that would see our sector enjoy extra profits. The Regulatory Scrutiny Board of the European Commission has branded the latest innovations under study as anti-industrial. Our sector has a global dimension, being the first sector in the world for investments in innovation. Now we need flexible and uniform rules to make Europe and Italy attractive. Our country must overcome the expense ceiling mechanism that generates costs for businesses of 1.3 billion a year in the hospital component. Instead, it is necessary to dedicate more resources to pharmaceuticals with the right recognition in the first role of the importance of innovative drugs and the enhancement of all drugs without price cuts. In this period, the cost increases risk bringing many companies to their knees that could close and interrupt production ».

With Covid vaccines, the approval procedures of the authorities have accelerated: so is it possible or was it an exception?

“Of course. We still need to speed up the times for the availability of new medicines, without the evaluations and delays of the individual Regions. That adds another 10 months to the 13-14 of the national assessment. A cultural change is needed, because Italy is still managed by silos. What is the regional ok after the green light from Ema and Aifa? Germany allows access to medicines throughout the country within 1 month. We are blocked by the therapeutic handbooks, that is the list of drugs adopted by a Region ».

Do we risk apartheid in accessing the most innovative treatments?

“I’ll make this calculation: every euro invested in clinical research turns into almost 3 euro of benefit for the national health system (source Altems). It is a contribution for the whole country-system as well as for the sector, the first for added value and export size, with its 33 billion in the last year. But what you are asking also calls into question the essential levels of assistance (Lea) and here there are six regions which are lagging behind ».

“In 2019, the latest data available, the Ministry of Health assessed Valle d’Aosta, the province of Bolzano, Molise, Basilicata, Calabria and Sicily as failing to guarantee the essential levels of assistance. For this reason, there is an urgent need to define a national strategy that governs pharmaceutical policies in an organic way, to make the role of the Regions homogeneous in the regulation of health services and in guaranteeing uniform access to medicines. Drugs denied, the impossibility of carrying out particular diagnostic tests that lead to medical migration phenomena, for this we need a control room that puts everyone at the same table ».

After years of spending review we would now also have the Health mission of the NRP

«Let me say here an urgency that we have and of which we talk too little: we must adapt professional resources (number of doctors and nurses) and training to the new skills related to connected care. Because the best healthcare professionals will be attracted to the most competitive environment. And our country system risks having them stolen ”.