Research represents the present and above all the future for the country’s development. But how are we doing in our country, in an area that appears healthy as demonstrated by the figures recently released by Farmindustria?
The pharmaceutical industry in Italy (2025 data) has a production of 74 billion euros, with just over 69 linked to exports and with 11.4 billion coming from the foreign surplus. In short, Made in Italy sees the pharmaceutical industry positioned at the top of the European Union and as the fourth hub in the world. All pink, you might say? There is no shortage of good news, but we need to continue on this path, also and above all in terms of investments in research and production (4.2 billion last year).
This was stated by the experts present at the Symposium of the Pharmaceutical Industry Association (AFI), held in Rimini,
A leadership to maintain
The objective is to capitalize on the production leadership achieved, combined with the data on qualified employment which has risen to over 72,000 workers, without losing sight of the risks. In fact, Italy must quickly fill the competitive gap on the digitalisation and attractiveness of clinical research, reducing the impact of bureaucracy.
“New technologies, and in particular artificial intelligence, are profoundly transforming the work of clinical researchers, enabling more efficient data management, greater predictive capacity in study design and a significant reduction in analysis and development times”
comments Giorgio Bruno, AFI president.
“In this path it is essential to look at international best practices, in particular at ecosystems such as the United States, the United Kingdom and some Asian hubs, where the integration between research, regulation and digital innovation is more advanced and structured. In this competitive context, Italy is called to strengthen its attractiveness by acting on regulatory simplification and digitalization of processes, while the national industrial fabric is demonstrating a growing ability to incorporate these innovations, albeit with still important acceleration margins to align itself with the main global competitors and fully exploit its scientific and industrial potential”.
Areas of improvement
“The current scenario of clinical research in Italy highlights high scientific quality and strong potential, but also structural critical issues that limit its international competitiveness”
is the opinion of Paola Minghetti, vice president of AFI.
“The fragmentation of health systems, digital lack of homogeneity between territories and authorization times that are still too long persist, which slow down the start of studies and the attractiveness of the country for investments in R&D. Added to this is the management of health data which is not yet fully interoperable and the adoption of new technologies, including artificial intelligence, which is not uniform and sometimes held back by interpretative uncertainties. On a regulatory level, the reforms that can no longer be postponed concern first and foremost the full harmonization and simplification of testing procedures clinical, with certain times and reduction of duplications at national and regional level. It is also urgent to make the regulatory framework between the AI Act and the European Health Data Area coherent and operational, defining clear, risk-proportionate and truly applicable rules for the use of AI and data in research. Finally, it is necessary to accelerate the construction of a single and interoperable governance of health data, which transforms the information assets into a real accelerator of innovation and not into a further element of administrative complexity”.
According to Fabrizio Greco, President of Assobiotec – National Association for the development of biotechnology, part of Federchimica
“To invest in Italy, biotech companies first of all need a national infrastructure of certainties: certainty in the timing of clinical research, overcoming the delays of local ethics committees, a stable fiscal framework that protects intellectual property and spending governance that considers the innovative drug an investment, not a cost. Only by eliminating the internal bureaucratic risk and mobilizing national capital for scale-up will we be able to transform the country into an attractive global hub”.
