B4131 - DIRITTO SANITARIO EUROPEO

Learning outcomes

The course is offered as part of the Jean Monnet module on “The protection of Health in Europe: Actors and Legal instruments (HEAL)”. This is an optional course for law students in their final year. The course requires a good knowledge of EU law and aims to equipe students with the intellectual tools necessary to interpret the developing European society and its increasing demand for a stronger EU intervention in the healthcare sector. The course is designed to meet the demand for a more interdisciplinary, multidisciplinary and multilevel approach in the public health sector. The course will offer students a thorough understanding of the pertinent values, applicable principles, competent institutions, bodies and agencies and relevant legal instruments put in place to build a true Health Union By the end of the course, the student will: • have an in-depth knowledge of the foundations of EU health law, with particular reference to the actors involved in this field and the relevance of the notion of “legal preparedness” in addressing health crises; • be able to independently assess (and solve) problems related to cross-border health policy development at European level; • be able to situate the health cooperation mechanisms developed at EU level within the framework developed in the context of the World Health Organisation. Favouring a highly interactive teaching method that engages students in the critical analysis of the ECJ’s case-law or of sector-specific secondary legislation in this field, the course will enhance their analytical skills as well as their oral and written presentation abilities. Students will also be able to assess the overall effects of EU legislation on the Italian legal system and illustrate the main reform trends taking place at European level

Course contents

The course deals with health protection in the European Union. In particular, the following topics will be covered:

• EU constitutional framework for health: EU competences and One Health approach; values, strategies and programmes; EU institutional actors;
• the concept of “legal preparedness”;
• EU and global health governance and institutional actors;
• regulatory competences: pharmaceuticals and medical devices; professionals; patient mobility;
• digital health: eHealth, mHealth, telemedicine; wellbeing apps; health technology assessment, infrastructures, cybersecurity, cloud and platforms and artificial intelligence;
• European Health Union: Conference on the Future of the EU; EU4Health and crisis preparedness; European Health Data Space.

Some lectures will be devoted to the presentation by the students of a case study on specific topics covered in class (e.g. a new legislative proposal from the Commission, a decision of the ECJ, etc.). The course will also include seminars on topics related to EU health law.

Readings/Bibliography

G. Di Federico, S. Negri, Unione europea e salute, Giappichelli, 2019. In particular:

• Chapter 1 “La protezione della salute come obiettivo dell’Unione” (ad eccezione del par. 4);
• Chapter 2 “I superiori valori di universalità, di accesso a un’assistenza di elevata qualità, di equità e di solidarietà” (solo parr. 2-4);
• Chapter 3 “La prevenzione e il controllo delle malattie trasmissibili”;
• Chapter 5 “La libera circolazione dei pazienti nell’Unione europea”;
• Chapter 6 “L’accesso ai servizi sanitari nell’era digitale”;
• Chapter 7 “Qualità, efficacia e sicurezza dei farmaci per uso umano” (solo par. 3).

The textbook is available at Sistema Bibliotecario di Ateneo dell’Università.

Several teaching materials (e.g., judgments, acts and scientific articles) will be uploaded on the Virtuale platform. These will supplement and complete the topics covered in the textbook in the light of what will be discussed in class, paying particular attention to the most topical aspects of each part of the course. Some of these materials, shared with students in advance of the relevant classes, are specifically designed to enable their active participation, in accordance with what stated in the “Teaching methods” section.

For students coming to the University of Bologna for a period of study or internship under the Erasmus+ Program or other international program, the syllabus and textbooks are the same.

Teaching methods

The course will take place in presence and it will be highly interactive. Theoretical issues will be confronted with practical cases in order to allow students to understand how the relevant EU regulations are developed and implemented, and how they impact on public health at the national level.

Moreover, attending students will be asked to actively participate in class discussions on the topics covered during the classes and they will occasionally be asked to prepare in advance judgments or other reading materials uploaded on the Virtuale platform. The course will host (also via webinars) experts and academics from other scientific areas (e.g. medicine, engineering, informatics, psychology, etc.). The dates and topics of the seminars will be timely communicated.

The pedagogical approach adopted can be summarised as follows:

• lectures will be based not only on the critical analysis of theoretical concepts, but also on the discussion of the relevant case law;
• active participation in class is encouraged, with some lectures devoted to the presentation of a case study by students. In addition, approximately 20 minutes at the end of each lecture will be devoted to answering questions and clarifications;
• during the course, tutors (PhD students) will be available to help students, if necessary. Moreover, the Professor will be available to students during weekly office hours dedicated to clarifying doubts.

Assessment methods

The final examination will oral, with questions on the topics related to those mentioned in the “Contents” section. Therefore, attending and non-attending students can refer to the textbook and the teaching materials uploaded on the Virtuale platform (e.g., judgments, acts and scientific articles).

The assessment criteria to assign the final mark (expressed in thirtieths) are:

• knowledge and understanding of the notions and principles of the topics and of the legal concepts on which the questions focus, and ability to apply them to concrete cases (70%);
• appropriate use of technical and legal vocabulary, ability to analyse and evaluate relevant sources and acquisition of the study and research method (30%).

Merely by way of illustration, the award of the final mark will be based on the following criteria:

• poor or barely sufficient preparation on the topics addressed, low critical capacity, difficulty in using technical-legal language → 18-21;
• modest or rather adequate preparation on the topics addressed, fair critical ability, decent use of technical-legal language → 22-25;
• good or more than adequate preparation on the topics addressed, strong critical capacity, command of technical-legal language → 26-29;
• in-depth and comprehensive preparation on the topics covered, strong critical capacity, sound command of the technical-legal language → 30-30 cum laude.

Students shall register via the AlmaEsami platform, in accordance with the conditions and deadlines set by the University. Further information on AlmaEsami.

Teaching tools

Teaching materials (case-law, acts, scientific papers…) will be made available through the Virtuale platform.

Students who experience difficulties in finding the course materials, in participating actively in the course itself, or in taking the examination in accordance with the modalities mentioned above, shall report these difficulties to the Professor by e-mail within the first two weeks of the course.

Office hours

See the website of Giacomo Di Federico