Law and Life Science: how to govern the race in the Pharma and BioMed sectors

In an era marked by rapid technological change, global health crises and an increasing focus on sustainability, Life Sciences are emerging as a key sector for the European economy, public health protection and the industrial strategy of the future. It is not only a cutting-edge field, but a genuine social infrastructure, where scientific research, technological development, public governance and fundamental rights converge.

The highly innovative nature of the sector is evident from recent regulatory activism: from the establishment of the European Health Data Space, which marks a turning point in the management and use of health data, to the new Public Contracts Code, aimed at facilitating access to therapeutic innovation through procurement, to the Medicrime Convention against drug counterfeiting, up to the Italian Sunshine Act, which imposes unprecedented transparency in relations between industry and health professionals.

Interventions that show how the law is called upon not only to regulate, but also to facilitate and guide innovation in a rapidly changing sector.

The Executive Course in "Law and Life Sciences. The legal profiles of the pharma & medical devices world", promoted by the "Federico Stella" High School on Criminal Justice of the Catholic University of the Sacred Heart, in collaboration with Portolano Cavallo and Carnà & Partners. The course is designed to train professional figures capable of navigating in a highly regulated, highly dynamic and highly social impact sector. Through a detailed analysis of the reference regulations, including European and international ones, and of operational practices, the programme examines the legal implications affecting the marketing and distribution of pharmaceutical products and biomedical devices, and explores topics such as data protection, intellectual property, procurement, competition, compliance and the criminal and civil liability of operators.

The lectures will address topical issues, including the recently proposed reform of European pharmaceutical legislation, aimed at promoting an innovative policy geared towards the real needs of patients. This is the most wide-ranging reform of the sector in the last 20 years, and key innovations include reducing the period of regulatory exclusivity and promoting the equitable availability of medicines across the European market.