HEALTH LAW

Donatella Morana, Guido Carpani

Instructional goals

The course aims to make the students familiar with the basic legislation on health, specifically regarding to health protection’s constitutional and administrative profiles, to the European and international dimension as well as investigate some of the most topical issues on the organization of the National Health Service, also on the basis of the reorganization of the same started with the resources from the National Recovery and Resilience Plan - PNRR (Mission 6 health)

Prerequisites

None

Intended learning outcomes

Knowledge and understanding: At the end of the study, the student will have acquired the basic knowledge related to the constitutional right to health also in the light of the constitutional jurisprudence and the modalities of compensation for the relative damage; the limits encountered by the possibility of imposing mandatory health treatments according to the interest of the community; the division of competences on health protection between the State and the regions; the organization and functioning of the NHS from its establishment to date; shared health governance after the regionalization of the Health service of the 1990s; to the government of health expenditure and to the contribution of private individuals to the provision of territorial, specialist and hospital pharmaceutical assistance; to the main reforms (proximity networks, telemedicine, innovation and digitization) that will be implemented with the resources of the PNRR. Ability to apply knowledge and understanding: The course of study will allow the acquisition of a legal/organizational knowledge of the Health Service which will enable student: to understand the management and delivery processes of health treatments of a complicated and multilevel Service, involving multiple territorial entities with constitutional autonomy. work in the public health service or in the state/regional Administrations with which it interfaces, knowing its organization and operating methods; protect the Citizen/user in litigation with the Service; support professional and private operators in various capacities as concessionaires of activities, falling within the NHS; follow the NHS reforms activated with the resources of the PNRR or in its planning by the regions (regional social-health plans); . Autonomy of judgment: the graduate is able to independently integrate knowledge and to analyze the interinstitutional and managerial complexity of one of the major public services prepared by our republican system as a function of a welfare system aimed at overcoming inequalities. Communication skills and learning ability: participation in the course allows the student to acquire a specialized legal language to be used in dialogue with institutions, with the business world, with the actors of the NHS.

Course Contents

Health and health care: historical evolution The Constitutional health care The right to health as a right of freedom and as entitled to benefits Freedom of care, informed consent, advance treatment provisions; mandatory medical treatments. The division of legislative and administrative powers. Connection’s forms between state and local authorities The determination of the essential levels of performance: substantive and procedural’s profiles The organizational structure of the reference public administrations of the national health service (NHS) The organization of the NHS Assistance benefits The private health services' structure The European and international dimension of health protection

Reference Books

For attending students, the program will include the following texts: D. Morana, Health as a constitutional right. Lessons, V edition, Giappichelli, Torino, 2025. Slides and materials presented and discussed during the lessons; Additional readings on specific topics indicated by the teachers during the lessons (and made available on MyLuiss). For not attending students, the program will include the following texts: 1) D. Morana, Health as a constitutional right. Lessons, V edition, Giappichelli, Torino, 2025. 2) E. Jorio, Diritto sanitario. Ordinamento, organizzazione e finanziamento del Servizio sanitario nazionale, FrancoAngeli, Milano, 2026.

Teaching Methods

Lectures in presence. Case studies Examination of judgments and relevant documents, presentations by students and discussion Debate competitions: students are divided into teams, they are assigned a topic to debate on and arguments/positions to support.

Assessment Method

The assessment of student will take place, at the end of the course, through an oral exam. During the exam the student will be required to show that he/she knows and understands notions and principles of Italian Health Law and that he/she is able to apply them to practical cases. The student is expected to be able to identify problems and possible solutions through the appropriate tools provided by the Health Law, thus proving that he/she has acquired the study method and the learning ability for carrying on, also individually, further study of the matter. The following evaluation criteria will be taken into account to assign the final grade, expressed in thirtieths: knowledge and understanding of the notions and principles of the matter and ability to apply them to concrete cases, to be assessed also in light of the activities carried out during the course (student presentations, group work etc.) and active participation in the classroom discussion (60%); appropriate use of the technical and legal vocabulary, ability to analyze and evaluate relevant sources and acquisition of the study method (40%).

Thesis assignment criteria

Participation's evaluation in the course's activities and interest for the teaching

Week 1

Introduction to the Course. Evolution of the concept of health and its protection. Public health and care between the 19th and 20th centuries. The mutualistic system. Health protection in the Constitution. Reasons for the persistence of the patrimonialist-functionalist concept of health. The insurance-pension concept (article 38 of the Constitution.). The slow "emergence" of the right to health as a complex right. Analysis of the case-law on the right to health and of law no. 833/1978 (establishing the National Health Service).

Week 2

Health protection and health damage. Constitutional case-law on the compensation of so-called biological damage. Subjective legal positions based on and related to article 32 of the Constitution. Freedom of health; the voluntary nature of health treatments. Health as a collective interest. Limitations to the freedom of health: mandatory medical treatments and their prerequisites. Mandatory vaccines and vaccine-related injuries: fair compensation under articles 32 and 2 of the Constitution (public health protection and principle of solidarity); extension to merely recommended vaccinations. The riserva di legge in article 32, paragraph 2 of the Constitution. Necessary «respect for the human person» as a limitation to health treatment mandates. Decree-law no. 73/2017 (transposed into Law no. 119/2017) on mandatory childhood vaccinations; Constitutional Court, judgment no. 5/2018. Analysis of the constitutional case-law on mandatory vaccinations. Discussion.

Week 3

Freedom of health, informed consent, refusal of medical treatment. Distinction between mandatory and coercive medical treatments: articles 13 and 32 of the Constitution. The constitutional basis of informed consent. Mental capacity and the refusal of medical treatment; the "Englaro case". Public debate on the so-called living will. Law no. 219/2017, on informed consent and advance healthcare directives. Analysis of the case-law concerning the so-called “Cappato case” and the conditions for access to medically assisted suicide; review of the legislative proposals currently under discussion. Debate competition.

Week 4

Inviolability and fundamental nature of the right to health. The “Ilva case” in constitutional and European case-law. The revision of articles 9 and 41 of the Italian Constitution (Constitutional Law no. 1/2022): health protection as a limitation to the freedom of private economic enterprise (article 41, paragraph 2 of the Constitution). Centrality of the One Health approach underlying the reform: the interdipendence between human health, animal health, and environmental balance. The right to health as a social right: the right to obtain care. “Preceptivity” and programmatic nature of article 32 of the Constitution. Free medical care for the indigent. Meaning of “indigence”. The right to health as a «financially conditional» and/but «incompressible» right: analysis of the relevant case-law, student presentations and discussion.

Week 5

Relationship between legal decision-making and scientific knowledge. “Appropriate” medical treatment and the boundaries of experimental care (the "Di Bella" and "Stamina" cases). Constitutional case-law on medically assisted procreation. Constitutional case-law on (mandatory) anti-Covid vaccinations (judgments no. 14 and 15/2023) and on the nature of the riserva di legge in article 32 of the Constitution (judgments no. 25 and 171/2023). Debate competition.

Week 6

The allocation of legislative and administrative powers between the State and the Regions (Title V, Part II, of the Constitution). «Health protection» (article 117, paragraph 3 of the Constitution) and the «determination of the basic level of benefits relating to civil and social entitlements to be guaranteed throughout the national territory» (article 117, paragraph 2, letter m, of the Constitution). State and Regional powers during the Covid-19 emergency. «International prophylaxis» and anti-Covid measures: the Valle d'Aosta case (Constitutional Court, judgment no. 37/2021). Protection of health and “differentiated regionalism”. Student presentations and discussion. Digitization of health services and early applications of artificial intelligence in healthcare: impact on the constitutional right to health.

Week 7

The administrative procedure for setting the essential levels in the health sector (Lea): evolutionary, substantive and procedural profiles. Control of their provision. The evolution of health protection from the Unification of Italy to date.

Week 8

The organization structure of Local Health Authorities. The organs of the ASL, the choice of the General Director and the health and administrative directors. The financing of the activity of the Local health Authorities. The departmental organization. Relations with the municipalities of the relative territory. The health care administrations, in particular the state administrations: Ministry of Health, Italian National Institute of Health (ISS), Italian Medicines Agency (AIFA), Italian National Agency for Regional Healthcare Services (Agenas), National Institute for Health, Migration and Poverty (INMP) and Experimental Zooprophylactic Institutes (IZS). (testimony of a manager of one of the aforesaid state administrations)

Week 9

The hospitals and hospital-university organizations: organization, activities and remuneration. Scientific nature's institutes of hospitalization and treatment. The research in the national health service. Examination of a Local health Authorities act: illustration of the organizational act by a manager (Administrative Director) and discussion with the students.

Week 10

Assistance benefits: type. Territorial assistance, in particular that of general medicine, pediatric and home care (ADI), proximity networks, telemedicine. The new qualitative and structural standards of territorial assistance. Community Houses, Community Hospital. Territorial continuity unit and palliative care network. The integration of social-health care. The working relationship between general medical and pediatricians and the NHS. Examination of the last collective agreement for general medicine concluded in the SISAC area.

Week 11

The pharmaceutical care. The pharmacies of the company and those on the territory (ownership, location in the territory, the services pharmacy). The activity of the pharmacist. Public and private in the NHS: authorization, accreditation and agreements. The public-private partnership in health care.

Week 12

Financing of NHS: elements. The connection between the state and the regions in healthcare: the role of the state-regions conference.