Approval, licensing, and marketing of personal protective equipment in the context of the Covid-19 pandemic outbreak: European and Italian regulations between derogatory and emergency measures.

The COVID-19 pandemic brought unprecedented challenges to global healthcare systems, particularly in the supply, approval, and marketing of personal protective equipment (PPE). This thesis examines the regulatory landscape surrounding PPE in the European and Italian contexts, focusing on the transition from pre-pandemic standards to emergency measures adopted to address the crisis. It explores the evolution of PPE regulation, from Directive 89/686/EEC to Regulation (EU) 2016/425, highlighting how the pandemic exposed the limitations of existing frameworks and prompted the adoption of derogatory measures. A detailed analysis is conducted on the European response to COVID-19, including the implementation of emergency regulatory acts such as EU Recommendation 2020/403 and Commission Implementing Decision (EU) 2020/668. The study also investigates the impact of these measures on the supply chain, market surveillance, and counterfeiting issues, assessing their long- term implications on regulatory practices. The Italian approach is examined in depth, with particular attention to emergency legislation, the role of INAIL and ISS in validating derogatory PPE, and the constitutional legitimacy of temporary regulatory changes. The research further explores ethical considerations, such as PPE allocation fairness, consumer safety, and the transparency of communication during health crises. Concluding with policy recommendations and future research directions, this thesis underscores the necessity of a resilient regulatory framework that ensures rapid response capabilities while maintaining high safety and quality standards for PPE in the face of future pandemics.