The pharmaceutical industry is undergoing a profound transformation, characterized by the acceleration of research, demographic aging, and the redefining of geopolitical balances. Between 2016 and 2025, 677 new active substances were introduced worldwide across numerous therapeutic areas. New technologies, artificial intelligence, and data availability are opening up major opportunities, while increasing longevity and chronic diseases require action on the funding and organization of healthcare systems. In this scenario, health is assuming growing importance not only socially, but also for productivity, economic growth, and strategic security.
International competition is increasingly focused on the ability to attract investment, research, and manufacturing. China is rapidly strengthening its position in research thanks to massive investments and the ability to reduce development times and costs, with the aim of capturing growing shares of the global market. In 2025, Chinese companies introduced 46 new active substances worldwide, compared to 28 from the United States and 16 from Europe. The United States has reacted more promptly than Europe and, through the Most Favored Nation (MFN) policy, has already attracted approximately $500 billion in investments for the next five years.
Europe risks finding itself squeezed between these two major competitors. Between 2019 and 2025, Western Europe’s share of global clinical trials dropped from 33% to 27%, compared to China’s growth from 9% to 17% and the United States’ stability. Contributing factors include market fragmentation, regulatory complexity, and delays in accessing innovation. It is necessary to strengthen the European single market, harmonize procedures, and build an industrial policy capable of supporting research, protecting intellectual property, and ensuring adequate remuneration for innovation. The ability to compete also depends on the availability of scientific, digital, and interdisciplinary skills, as well as collaboration between universities, businesses, and institutions.
Italy possesses an important industrial and scientific heritage, with €74 billion in pharmaceutical production and participation in 38.6% of European clinical trials. However, certain regulatory elements risk undermining its attractiveness, partly due to the fragmentation of the regional system. Simplifying procedures and establishing a coordinated strategy across different ministries—following the Spanish example—would make it possible to intensify clinical research development and overcome bottlenecks. Strengthening clinical research in Italy requires, in fact, a favorable regulatory framework that guarantees faster access to innovative therapies and the elimination of financial burdens.
Consequently, it is necessary to accelerate clinical trial procedures and introduce effective early access mechanisms to allow patients timelier access to innovative therapies, reduce regional disparities, and enhance the Italian system’s attractiveness for research investments. Greater speed in accessing innovation, alongside regulatory simplification, represents a decisive factor for the country’s competitiveness, especially in an international context characterized by the growing mobility of investments.
Crucially, the pharmaceutical payback system must be overcome; it has become a structural factor that introduces uncertainty and penalizes investment, with critical issues accentuated by the MFN policy. As part of a gradual reform path, an initial solution could consist of introducing a maximum cap on payback, making burdens predictable for companies, accompanied by incentive mechanisms that reduce the amounts owed in exchange for investments in research and production. The objective is to shift from governance focused on expenditure containment to a model that values health outcomes and the economic benefits of innovation, while simultaneously safeguarding financial sustainability, industrial competitiveness, and equitable access.
Another necessary transformation involves shifting from a predominantly treatment-oriented healthcare system to one founded on prevention. Population aging makes it essential to intervene before the onset of diseases through immunization, screening, early diagnosis, and the promotion of healthy lifestyles. Prevention is a pillar of sustainability in an aging society because it means improving quality of life, reducing hospitalizations and care costs, combating productivity losses, and easing pressure on welfare systems. This change requires valuing prevention as an investment for society and modifying the economic incentives of the healthcare system to align them more closely with health outcomes.
Health data – which can improve research, support predictive medicine, guide preventive interventions, and measure the effectiveness of public policies – should play a particularly fundamental role. Italy possesses a considerable information asset, but the fragmentation of databases, poor interoperability, and access difficulties limit its potential. The regulatory framework, characterized by numerous and complex provisions, requires rationalization to reconcile the protection of confidentiality, information sharing, and the collective interest in research. The implementation of the European Health Data Space represents a major opportunity that requires investment in infrastructure and skills.
The main operational guidelines converge on the need for integrated governance, multi-year planning, and interministerial involvement, which can help coordinate health, industrial, scientific, and educational policies. A priority is the recognition of health and prevention as an investment, overcoming the limitations of public accounting that records immediate costs but not future savings in terms of avoided hospitalizations, lower social security spending, and greater productivity. From this perspective, a revision of European accounting rules is also desirable.