Italy is a key destination for global clinical trial programs with EUR 700 million invested in 2020 alone according to national industry association Farmindustria, bringing access to medicines, knowledge, skills, and economic benefits. Here, Italy country managers from some of the world’s leading pharma companies weigh in on the pros and cons of conducting clinical studies in the country.
Strong Fundamentals
Sanofi’s President and Managing Director for Italy Marcello Cattani points out that “Italians have long been keen on participating in clinical research.” Recent events have contributed to this trend such as COVID-19 with the “incredible speed at which biological vaccines were developed, manufactured, and supplied” generating an interest in clinical trials as well as a “greater public understanding of the impact and value of medical innovation and biotechnology, especially new advanced therapy medicinal products (ATMPs).”
[COVID-19 has led to] greater public understanding of the impact and value of medical innovation and biotechnology, especially new advanced therapy medicinal products (ATMPs)
Marcello Cattani, Sanofi
This increase in clinical trials has pushed Italy into Amgen’s Top 10 countries for enrolment in investigational and observational trials. General Manager of Amgen Italy Soren Giese notes that “the company has achieved a 14 percent increase in global trial participation in 2021 compared to 2020,” a significant milestone given that Amgen only began conducting Phase I clinical trials in the country two years ago. Giese highlights that “Phase I is really the frontier of medical research and therefore highly complex. We should be very proud of this as it showcases exactly the role we want to play within Italy’s healthcare ecosystem and what Italy as a market can give back to Amgen.”
Lilly’s President and General Manager in Italy Huzur Devletsah takes this further and explains that Lilly “has constant and constructive dialogue with national institutions to find clinical trials opportunities, from phase I to III, in order to have a greater impact on Italian patients.” The company’s approximate USD 20 million invested in R&D in Italy last year demonstrates Lilly’s belief in the country’s competitiveness “in terms of legislation, quality of centres, and highly skilled investigators” and is the reason why Devletsah foresees further investment from the company in the future.
Bureaucracy Bites
However, there is a general consensus among C-level healthcare executives in the country that bureaucracy is hurting Italy’s ability to become more competitive internationally for clinical trials. “Conducting a clinical trial is a very complex project; it involves patients and there ought to be a level of due diligence,” Giese states. “However, that should not mean that the process should be buried under layers of bureaucracy. I would call on the Italian government to do whatever is possible to make it easier and more efficient to do clinical trials in Italy.” Amgen spends close to USD 20 million per year on its clinical trials in the country and Giese believes that the investment “brings know-how to Italy in terms of new treatments, diagnoses, and healthcare technology that would otherwise come years later after those technologies ultimately make it to market.”
I would call on the Italian government to do whatever is possible to make it easier and more efficient to do clinical trials in Italy
Soren Giese, Amgen
Cattani agrees that “while the overall environment is extremely positive, there are still improvements to be made in terms of communicating in a more engaging manner and streamlining some of the bureaucracy around patient enrolment and the various ethical committees. Having 20 different sub-national health systems creates complexity in terms of rules and technicalities, and also leads to political discussions, as these regions are led by different political parties.” He believes that Italy “is perhaps less strong in being able to enrol vast patient populations in short, clearly defined timelines” compared to the globally competitive professional capabilities of its academics, hospitals, and research sites.
Remdesivir, the first COVID-19 treatment recommended for EU authorisation and its rolling review procedure could hold the answer to future drug approvals in the country. Valentino Confalone, vice president and general manager from Gilead Italy, hopes that the company’s experience with remdesivir during the pandemic is the turning point in regard to “reducing bureaucratic hurdles such as redundant ethical committees” as it proved that a single committee was sufficient and effective. “We were able to get trials approved with the same requirements and level of scrutiny in a matter of weeks rather than a year.”
