“Speeding up access to innovative therapies in Italy”

“I think there are two things Italy could do better. Number one is: access to innovation in terms of speed. Our new therapeutic solutions, all the efforts and all the thousands of people working to bring innovation to Italy, they are null and void, they are useless if these therapies do not reach the patient. Therefore the speed of access to innovation is very important”. Thus Peter Guenter, CEO Healthcare of Merck Group, during a meeting with the press at the Merck factory in Guidonia (Rome).

“When your product is approved by the European Medicines Agency – says Guenter – in some countries patients can immediately benefit from these new medicines. In others it takes a long time and unfortunately Italy is one of these countries where it passes long time between European registration and patient access. So my appeal is to shorten this time period from the point of view of price and reimbursement, so that Italian patients with serious diseases can benefit from the fruit of these therapeutic solutions.

“Number two: realistic budgets. We, as a pharmaceutical industry – explains Guenter – run enormous risks when it comes to generating new therapeutic solutions. You can’t do it if you don’t have acceptable prices and margins. Otherwise it is not possible to reinvest and take risks again to generate new innovation”. Therefore, “we also ask that the Italian Government establish a realistic budget starting from the drug budget. We already have relatively low prices in Italy compared to other European countries – highlights the CEO – and in addition we pay a clawback. Why? Because the budget is set artificially low. Therefore, the real expenditure is higher than that budget and part of that difference must be reimbursed by the pharmaceutical companies to the Italian state in the form of clawback. So “my second request, in addition to the speed of access to innovation, is: establish a realistic budget for medicines, so that clawback can be eliminated or significantly reduced.”

Regarding Merck’s commitment in our country, Guenter recalls that Italy “plays a very important role for Merck on a global level. Because Merck in Italy is present in all phases of the entire value chain of pharmaceutical innovation. Let’s get started with Life Science which provides products and services to the world of public and private research, to Italian biotech where innovation truly originates”. We continue with the “fundamental research at our site in Ivrea, then with pharmaceutical development here in Guidonia. We carry out clinical studies with more than 5 thousand patients in Italy. In the end the result of that innovation obviously also reaches the market, the Italian patients who they will ultimately benefit from the fruit of that innovation. We are therefore very proud of what we do in Italy with the 1,200 people who work for Merck in Italy.”

Finally, Guenter addresses the topic of innovation in the pharmaceutical field, analyzing the potential developments of artificial intelligence. “I think that artificial intelligence, next generation AI, big data analysis – he explains – will represent a turning point for many sectors, including the pharmaceutical industry. I can talk about many potential applications in the entire supply chain value of what we do: manufacturing and business operations. I think the biggest potential paradigm shift will be in the research area of ​​what we do. I think with big data analytics and artificial intelligence we will be able to discover new scenarios and new biological targets. We will be able to find and design molecules in a faster and more effective way than today. And we will also ultimately be able to conduct clinical trials more quickly and cost-effectively The revolutionary effect of artificial intelligence and big data will certainly be in the field of research and development in the pharmaceutical industry.”