Objectives: Starting from April 2017, the Italian Medicine Agency (AIFA) has approved new criteria for defining any new medicinal product with an innovative indication. The purpose of the study is to analyze the activity of innovativeness evaluation according to the new approach, to estimate the weight of each criterion considered for innovativeness definition, and to evaluate how the new approach works in terms of consistency and reproducibility.Methods: A retrospective analysis was performed on the final reports evaluating the drug innovativeness assessment published on the AIFA's website between April 2017 and January 2021. Descriptive statistics, chi-square test, whether the conditions were respected, or Fisher's exact test was used to explore the association between characteristics of drugs and the innovativeness status and the association between the three criteria. Profiles of the decision process and their relationship with innovativeness response were described. In order to evaluate the weight of each criterion in predicting the innovativeness status, a Classification Tree (CT) algorithm was applied.Results: Overall, of the 109 published drugs reports, 37 (33.9%) were recognized as fully innovative, 29 (26.6%) were considered conditionally innovative, while for 43 (39.4%) reports innovativeness was not recognized. Considering the three criteria of the decision process, the added therapeutic value was the only criterion statistically associated with a drug's degree of innovation (p < 0.001). The therapeutic need and the quality of clinical evidence were statistically associated (p = 0.008) even if only a mild association was observed. The added therapeutic value was the most important variable in predicting the innovativeness status according to the classification tree (CT) model applied, achieving an accuracy of 89.4%. No difference was found between orphans and non-orphan drugs or oncological and non-oncological drugs.Discussion: The added therapeutic value is the most important criterion of the multidimensional approach for the innovativeness status definition of a new medical product. A mild association was found between the therapeutic need and the quality of evidence. Overall, similar decision profiles bring the same evaluation of innovativeness status, indicating a good consistency and reproducibility between decisions.

Objective This study aims to analyse the impact of the pandemic on the amount of use and new medication dispensation for chronic diseases in the Italian population aged 65 years and older (almost 14 million inhabitants). Methods The “Pharmaceutical Prescriptions database”, which gathers data on medications, reimbursed by the National Health Service and dispensed by community pharmacies, was employed. Data were analysed as amount of use (defined daily dose—DDD per 1000 inhabitants); variation in DDD between 2020 and 2019 was calculated for the 30 categories with major consumption in 2020. Trends in prevalence and incidence of dispensations between 2020 and 2019 were calculated for four categories: antidiabetics, antihypertensives, antidepressants and drugs for respiratory diseases. Results All medications showed a negative variation in DDD/1000 inhabitants between 2020 and 2019 except for anticoagulants (+ 5%). The percentage variation ranged from − 27.7% for antibiotics to − 6.4% for antipsychotics in 85 + year-old persons, but increased for most classes in the youngest (65–69 years). On the other hand, a decrease of the dispensation incidence of antidiabetics, antihypertensives, antidepressants and drugs for pulmonary disease was high, especially in the two extreme age groups, the youngest and the oldest one. Conclusions and relevance Great variation in medication use between 2020 and 2019 was observed probably reflecting the low rate of infectious diseases due to the widespread use of protective devices and self-isolation, reduced healthcare access because of the lockdowns and the fear of going to hospital, and the reduction of screening and diagnostics due to health-care system overload.

This paper analyses the interactions between financial regulation and crises with reference to the experience of the United States in the period after the global financial crisis up to the Covid-19 emergency. In the last few years, a new regulatory system for large banks has arisen in the U.S., reversing some elements of the Dodd-Frank Act and introducing deviations from the international rules. This approach is also confirmed by some of the measures adopted in response to Covid-19. If this trend were to spread to other jurisdictions, the globally harmonized approach to regulation could break down. In the current exceptional circumstances as well, the international standards must not be breached, as they provide the resilience needed to sustain lending to the economy, and to keep banks safe. With the memory of the global financial crisis fading and the long post-crisis economic expansion coming to an end, the pressures to dilute the G-20 rules could grow stronger. The importance of maintaining a consistent approach to banking regulation needs to be emphasized.

This paper presents an overall analysis of the economics of non-bank financial intermediation, and argues that the financial stability concerns stemming from this sector support the need to fill the regulation gap that exists with respect to other segments. It examines the structure of markets, the economic incentives of the agents involved, and the institutional aspects characterizing this form of intermediation as compared with that performed by banks. The policy framework developed so far has been based mainly on micro-prudential tools, looking at individual institutions and activities. The focus of the regulatory actions should not be (or should not only be) the stability of individual entities. Financial regulators should pay more attention to the effects that the collective actions and activities of non-bank financial entities may have on the financial system as a whole and on the real economy. I find that the effectiveness of micro-prudential tools is strengthened if they are accompanied by a framework containing policy measures to address systemic risk.

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