For too long, research in Italy has been regarded as a cost or, at best, a cultural pursuit, rather than as a tool of industrial policy. The pandemic showed how short-sighted this approach was, highlighting how the country’s health autonomy depended on geopolitical balances that had been taken for granted and exposing Italy to a vulnerability that went far beyond the health emergency. This is the result of a trend that began more than thirty years ago, when the West gradually offshore production, including pharmaceutical manufacturing, in the belief that globalisation was irreversible. Today, those countries are no longer just suppliers but technological competitors. Regaining scientific sovereignty therefore means regaining competitiveness, production capacity and strategic autonomy.
A country that innovates but does not industrialise
The Italian paradox is plain to see. Pharmaceutical exports are often cited as proof of the sector’s strength, yet we still rely on imports for a significant share of strategic raw materials and active ingredients. We have retained extraordinary manufacturing capacity, but patents and industrial property are too often developed or exploited elsewhere. We produce well, but we do not fully capture the value of innovation. The problem is not the quality of Italian research, which remains among the best in Europe, but the difficulty of turning a scientific discovery into an industrial product. Insiders call this the “valley of death” of innovation: the stage at which many scientific results stall for lack of translational infrastructure and expertise. We continue to extract this gold in our laboratories, but all too often it fails to become patents, industry and economic growth for the country. It is no coincidence that major Italian groups are increasingly investing in the United States, where a significant share of the most advanced biomedical research is now concentrated.
Faster rules to change course
There is also a regulatory issue. In recent years, Europe has increased compliance requirements just as the United States and Asia were speeding up their decision-making processes. This is not about giving up legality and transparency, but about building a regulatory framework that can keep pace with science. The pandemic showed that speed and safety are complementary, not opposing, concepts. Reversing course requires action on at least three fronts: funding public infrastructure capable of supporting the entire innovation chain, from research to production; developing administrative tools suited to strategic research bodies; and retaining the talent we train by offering credible career prospects in Italy. First and foremost, this is a cultural shift: research is not an item of expenditure, but a strategic investment in industrial policy.
Data and extended intelligence
There is also a fourth pillar, just as decisive: data. Data is now as strategic a resource as physical infrastructure. Without high-quality data, it is impossible to develop new medicines, understand how diseases evolve or identify new health threats early. Building a network that connects institutions, universities, research centres and businesses means rapidly turning data into scientific knowledge and knowledge into tools for prevention and treatment, while fully respecting citizens’ rights. The choice is not between privacy and research; the task is to build secure platforms and clear rules that allow information to be shared responsibly. Making the most of this vast quantity of data requires tools that can analyse it quickly. This is where artificial intelligence comes in, or rather extended intelligence: a technology that does not replace the researcher, but amplifies their ability to analyse complex information and make more informed decisions. The future of health security also depends on this capability.
The Biotecnopolo: a proposed approach
A concrete example of how these challenges can be tackled together is the Fondazione Biotecnopolo di Siena, a body established under the 2021 Budget Law as Italy’s response to the pandemic, which became fully operational in 2024. Its mission is to give the country a permanent capacity to respond to health emergencies through the Centro Nazionale Antipandemico (National Pandemic Centre), linked to the European preparedness system. Building a body of this kind meant creating governance, administrative processes, suitable scientific facilities and a network of relationships with ministries, universities, IRCCS (Italy’s research hospitals, “Istituti di Ricovero e Cura a Carattere Scientifico”), businesses and international partners. The relationship with the Scientific Director, Rino Rappuoli, was decisive: two complementary backgrounds, biotech research and industry on one side and public institutions and regulation on the other, were brought together in a balanced dual governance structure. It shows in practice that scientific and institutional expertise, when they genuinely engage with each other, do not slow decisions down but make them sounder. On human capital, the choice was made from the outset to invest in training by supporting the National PhD Programme in Vaccinology, helping to retain in Italy expertise that too often finds opportunities only abroad. The Foundation does not seek to replace universities, IRCCS or businesses, but to provide them with platforms and infrastructure capable of taking a project from preclinical research to clinical trials and then to production. It coordinates the European Vaccination Hub promoted by HERA, works with leading international partners in pandemic preparedness and runs programmes on the main priority pathogens. This strategy also includes investment in a GMP pilot plant, a facility qualified by AIFA (the Italian Medicines Agency, “Agenzia Italiana del Farmaco”) that can produce, to GMP standards, the biological materials needed to begin clinical trials in humans. This is one of the areas where Europe is currently most vulnerable and where public infrastructure can make the difference.
Building to last
A project can come to an end; a strategic capability remains available to the State, the scientific community and industry whenever the need arises. This is the model Europe is called upon to build: turning an initial public investment into a permanent, autonomous and resilient capability. The real challenge in the years ahead will not be funding new projects, but building infrastructure, skills and industrial capacity designed to last. The life sciences are now an essential component of national security and of the country’s competitiveness, because research creates value only when it becomes innovation, patents, production and skilled employment. This is the gold Italy has long possessed, and which it can no longer afford to leave unfinished.
