Ateneo - UPO

The course covers the general outline of Italian healthcare and pharmaceutical law, with a focus also on the European and international aspects of the field. The program is divided into four parts. The first will introduce the subject through: i) reconstructing the genesis of public healthcare functions in our legal system; ii) analyzing the motivations and consequences of the constitutionalization of healthcare; iii) examining the two-way relationship between the evolution of the concept of healthcare and the configuration of its legal protection. The second part will examine the sources of healthcare law at the constitutional, supranational, and legislative levels. The third part will focus on the National Health Service, with particular reference to: the legal and institutional evolution of the system; the current organizational structure; and developmental prospects and issues. The fourth part will focus on pharmaceutical law, the discipline of which will be outlined with reference to: general outlines of European and Italian legislation; clinical trials and marketing authorization; early access and off-label prescriptions.

Students attending class will be provided with handouts (taken from textbooks and academic textbooks) by the instructor. Non-attending students must prepare for the exam using the following texts: - R. Balduzzi-G. Carpani (eds.), Manuale di diritto sanitaria, Bologna, 2013, limited to the first chapter of R. Balduzzi, D. Servetti (entitled "The Constitutional Guarantee of the Right to Health and Its Implementation in the National Health Service"). - A. Pioggia (eds.), Diritto sanitaria e dei servizi sociali, Turin, 2024, limited to Chapter I (except paragraphs I-4 and I-5), Chapter II, and Chapter III. - G.F. Ferrari, F. Massimino, Diritto del farmaco, 2024, limited to Chapter I (only paragraphs 1-4) and Chapter III.

The course aims to enable students to achieve the following objectives: acquire an overview of healthcare legislation and understand the general principles of healthcare law; develop a structured knowledge and the ability to critically reflect on: i) the historical genesis, positive regulation, and operating dynamics of the National Health Service; ii) the public function of healthcare protection, including its relationship with the private market; iii) the general features of pharmaceutical law.

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Lectures and discussion of case law.

Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/servicesstudents-physical-or-learning-disabilities Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

Oral exam. Attending students may take a midterm exam, dividing the exam program into two parts.

The course, divided into the four parts listed above, will address the following topics: 1) the origins of public health care functions; 2) the Republican turning point: the constitutional right to health and the supreme principles of the form of the State; 3) relevant constitutional parameters; 4) the structure and content of the right to health; 5) the correlation between the concept of health and the configuration of its legal protection; 6) health care at the international and European level; 7) the evolution of Italian health care legislation, the foundation of the National Health Service (SSN) and its reforms; 8) the guiding principles (universalism, globality, equity, appropriateness) and the structural principles (pre-programming, regionalization, corporatization, integration) of the National Health Service (SSN); 9) health care in the division of jurisdiction between the State and the Regions; 10) the essential levels of health care; 11) health care administration and the organization of the National Health Service (SSN); 12) the main bodies and agency figures of the National Health Service (SSN); 13) social and health care integration; 14) senior management of healthcare agencies, medical and healthcare management, and healthcare professions; 15) contracted staff; 16) relationships with the private sector; 17) NHS funding; 18) repayment regional plans; 19) open prospects, with particular reference to the reorganization of local healthcare funded by the PNRR; 20) general legal framework for drugs and medical devices; 21) clinical trials and marketing authorization; 22) early access and off-label prescriptions

Demonstrate, through the correct use of technical vocabulary and demonstrating reasoning and critical reflection skills, understanding: the general institutions of healthcare law; the historical genesis, positive discipline, and operating dynamics of the National Health Service; the public function of healthcare, including its relationship with the private market; the general features of pharmaceutical law