Bioethical and Legal Issues in Biotechnology
A.Y. 2019/2020
Learning objectives
The course will address the legislative, economic and ethical aspects of scientific research and biotechnological applications in medicine with the aim of creating a space to think and promoting the debate on the purposes and risks associated with biotechnologies, as well as on the importance of the role of the biotechnologist in today's society
Expected learning outcomes
The course will provide students with the basic knowledge of the legal regulation for the invention patents, biotechnological inventions and plant varieties, utility models and industrial secrets
Lesson period: Second semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Single session
Responsible
Lesson period
Second semester
Course syllabus
Industrial inventions
Biotechnological inventions
New plant varieties
Utility models
Industrial secrets
Principles and general notions
Ratio of patent institutions
Validity requirements
The subjective profiles of the patent
The inventions of university employees and researchers
The content of the law and its limits
The administrative procedure for granting the national and European title and the task of the authorized representative.
Judicial protection and the task of the technical consultant
Evolution of the concept of health
Fundamentals of welfare systems at public level: how to look at funding
Configuring welfare systems and spending on health
The evolution of health and European legislation over the past 30 years
The macro organization of a healthcare facility
The micro organization of a healthcare facility
The logic of the integrated process and the interdependence of health processes
Principles of business economics applied to welfare models: business costs, budget estimates, and budget
The theoretical foundations of the health economy: functions, spending and performance of health systems
Market dynamics and the peculiarities of the health economy: information asymmetry in the delivery of health services
Efficiency, efficiency and quality of health services
The bioethics module (24 hours) aims to provide an overview of the principles and major regulatory documents in the field of research ethics, as well as to explore the main ethical, legal and social issues posed by the most recent developments in data-intensive biomedicine. Topics covered in the course include the ethical and social implications of genome editing, precision medicine, biobanking, direct-to-consumer genetic testing, Big Health Data. In addition to actively participate in lectures, students are asked to conduct independent research on a topic that has specifically elicited their interest.
Biotechnological inventions
New plant varieties
Utility models
Industrial secrets
Principles and general notions
Ratio of patent institutions
Validity requirements
The subjective profiles of the patent
The inventions of university employees and researchers
The content of the law and its limits
The administrative procedure for granting the national and European title and the task of the authorized representative.
Judicial protection and the task of the technical consultant
Evolution of the concept of health
Fundamentals of welfare systems at public level: how to look at funding
Configuring welfare systems and spending on health
The evolution of health and European legislation over the past 30 years
The macro organization of a healthcare facility
The micro organization of a healthcare facility
The logic of the integrated process and the interdependence of health processes
Principles of business economics applied to welfare models: business costs, budget estimates, and budget
The theoretical foundations of the health economy: functions, spending and performance of health systems
Market dynamics and the peculiarities of the health economy: information asymmetry in the delivery of health services
Efficiency, efficiency and quality of health services
The bioethics module (24 hours) aims to provide an overview of the principles and major regulatory documents in the field of research ethics, as well as to explore the main ethical, legal and social issues posed by the most recent developments in data-intensive biomedicine. Topics covered in the course include the ethical and social implications of genome editing, precision medicine, biobanking, direct-to-consumer genetic testing, Big Health Data. In addition to actively participate in lectures, students are asked to conduct independent research on a topic that has specifically elicited their interest.
Prerequisites for admission
No prerequisites are required
Teaching methods
For bioethics: lectures, some seminars (collective discussion on selected topics) might be foreseen
Teaching Resources
For the legal part, in addition to the notes taken in class: Ghidini Cavani, Industrial law lessons, Milan 2014, Chapters I and VI.
Medicine and Justice, A. Gentilomo - G. Travaini - L. D'auria, Edizioni Cortina.
For the bioethics part, lectures and bibliographical references on the topics will be provided by the teachers
Medicine and Justice, A. Gentilomo - G. Travaini - L. D'auria, Edizioni Cortina.
For the bioethics part, lectures and bibliographical references on the topics will be provided by the teachers
Assessment methods and Criteria
For bioethics: the exam takes place in an oral form, and consists of an individual presentation on a topic chosen by the student, followed by open questions on the topics covered during the course.
The evaluation parameters considered are the following:
20%: participation and interaction during the classes;
40%: oral presentation (breadth and depth of autonomous research carried out by the student, ability to use and connect the notions learned during the course, quality of exposure, appropriateness of language);
40%: answers to open questions (knowledge and ability to link together the different notions learned during the course, critical thinking, quality of exposure, appropriateness of language).
For the legal part: oral exam
The evaluation parameters considered are the following:
20%: participation and interaction during the classes;
40%: oral presentation (breadth and depth of autonomous research carried out by the student, ability to use and connect the notions learned during the course, quality of exposure, appropriateness of language);
40%: answers to open questions (knowledge and ability to link together the different notions learned during the course, critical thinking, quality of exposure, appropriateness of language).
For the legal part: oral exam
AGR/01 - AGRICULTURAL ECONOMICS AND RURAL APPRAISAL
IUS/01 - PRIVATE LAW
MED/02 - MEDICAL HISTORY
IUS/01 - PRIVATE LAW
MED/02 - MEDICAL HISTORY
Lessons: 72 hours
Shifts:
Professor(s)
Reception:
14.30 -15.30
Dipartimento di Diritto Privato e Storia del Diritto, stanza 1117