Medicine and Biotechnology Law

General data

Course ID:	3501-BE-ZK-PMBT
Erasmus code / ISCED:	08.1 Kod klasyfikacyjny przedmiotu składa się z trzech do pięciu cyfr, przy czym trzy pierwsze oznaczają klasyfikację dziedziny wg. Listy kodów dziedzin obowiązującej w programie Socrates/Erasmus, czwarta (dotąd na ogół 0) – ewentualne uszczegółowienie informacji o dyscyplinie, piąta – stopień zaawansowania przedmiotu ustalony na podstawie roku studiów, dla którego przedmiot jest przeznaczony. / (0223) Philosophy and ethics The ISCED (International Standard Classification of Education) code has been designed by UNESCO.
Course title:	Medicine and Biotechnology Law
Name in Polish:	Prawo wobec medycyny i biotechnologii
Organizational unit:	Institute of Philosophy
Course groups:
ECTS credit allocation (and other scores):	(not available) Basic information on ECTS credits allocation principles: the annual hourly workload of the student’s work required to achieve the expected learning outcomes for a given stage is 1500-1800h, corresponding to 60 ECTS; the student’s weekly hourly workload is 45 h; 1 ECTS point corresponds to 25-30 hours of student work needed to achieve the assumed learning outcomes; weekly student workload necessary to achieve the assumed learning outcomes allows to obtain 1.5 ECTS; work required to pass the course, which has been assigned 3 ECTS, constitutes 10% of the semester student load. view allocation of credits
Language:	Polish
Mode:	Classroom
Short description:	The goal of the lecture is to provide students with knowledge of basic concepts, principles and institutions of Polish and European medical law and biotechnology law.
Full description:	The primary goal of the lecture is to provide students with knowledge of basic concepts, principles and institutions of Polish and European medical law and biotechnology law. Also, the lecture is aimed at developing students’ skills necessary to identify and analyze legal problems in contemporary biomedicine. The course covers following topics: I. INTRODUCTION TO LAW (Nature and functions of law. Language of law. Legal norms and legal provisions. Legal system. Branches of law. Sources of law. Legislation process. Interpretation of law. Application and enforcement of law. Legal relations. Legal subjects. Legal acts) II. INTRODUCTION TO MEDICAL LAW (Nature, scope and sources of medical law. Constitutional basis for medical law. European standards of medical law. Organization of health-care system. Medical professions. Patient’s rights) III. PATIENT’S RIGHTS AND DUTIES OF HEALTHCARE PROVIDERS (Right to healthcare. Consent to treatment. Non-consensual treatment. Medical confidentiality. Medical records. Protection of personal data. Medical ethics and professional liability of medical professionals. Civil liability of healthcare providers. Criminal liability of healthcare providers) IV. LAW AND MODERN MEDICINE & BIOTECHNOLOGY (End-of-life legal issues. Diagnosis of death. Legal status of human dead body and its parts. Transplantation law. Mental health protection. Legal status and legal protection of human embryos and fetuses. Reproductive rights. Law and genetics. Non-therapeutic interventions: cosmetic surgeries, transsexual treatment. Biomedical research involving humans. Basics of pharmaceutical law. Intellectual property law. Biotechnological patents)
Bibliography:	(in Polish) OD 2020/2021 1. M. Boratyńska, Wolny wybór. Gwarancje i granice prawa pacjenta do samodecydowania, Warszawa 2012 2. Grzymkowska M., Standardy bioetyczne w prawie europejskim, Wolters Kluwer, Warszawa 2009 3. Karkowska D., Prawa pacjenta. Wyd. 3, Wolters Kluwer, Warszawa 2016 4. Kubiak R., Prawo medyczne, wyd. 3 Wydawnictwo C.H. Beck Warszawa 2017 5. Nesterowicz M., Prawo medyczne. Komentarze i glosy do orzeczeń sądowych, wyd. 3, Wolters Kluwer, Warszawa 2017 6. Nesterowicz M., Prawo medyczne, Wyd. 12, TNOiK, Toruń 2019 7. System Prawa Medycznego (fragmenty), red. E. Zielińska, t. 2, Wolters Kluwer 2019 8. Zielińska E. (red.) Ustawa o zawodach lekarza i lekarza dentysty. Komentarz. Wolters Kluwer, wyd. 2, Warszawa 2014 DO 2019/2020 ‒ Augustynowicz A., Budziszewska-Makulska A., Ustawa o prawach pacjenta i Rzeczniku Praw Pacjenta, CeDeWu.Pl Wydawnictwa Fachowe, Warszawa 2010. ‒ Grzymkowska M., Standardy bioetyczne w prawie europejskim, Oficyna a Wolters Kluwer business, Warszawa 2009. ‒ Karkowska D., Prawa pacjenta. Wyd. 2 poprawione, Oficyna a Wolters Kluwer business, Warszawa 2009 ‒ Kubiak R., Prawo medyczne, Wydawnictwo C.H. Beck Warszawa 2010. ‒ Nesterowicz M., Prawo medyczne, Wyd. 9, TNOiK, Toruń 2010. ‒ Safjan M. (red.) Prawo wobec medycyny i biotechnologii. Zbiór orzeczeń z komentarzami, Oficyna a Wolters Kluwer business, Warszawa 2011. ‒ Zielińska E. (red.) Ustawa o zawodach lekarza i lekarza dentysty. Komentarz. ABC Wolters Kluwer business, Warszawa 2008.
Learning outcomes:	At the end of the course student: KNOWLEDGE -- has knowledge and understanding of basic concepts and institutions of Polish and European medical law and biotechnology law; -- has knowledge of basic principles of law enactment, interpretation, application and enforcement; -- has well-structured knowledge of national and European hard-law and soft-law regulations on medicine, including medical professions and patient’s rights, and biotechnology; -- is acquainted with intellectual property law and understand the need of intellectual property management; -- understands the relations between bioethics and biomedical law; -- understands the importance of legal factors in the practice and development of medicine and biosciences; SKILLS -- identifies, interprets and analyses typical legal problems that appear in medicine and biotechnology; -- applies legal and deontological norms to solve simple legal cases/problems; SOCIAL COMPETENCES -- appreciates the importance and value of legal reflection for the practice and development of biomedicine, and for development of social order based on respect for human dignity and fundamental human rights
Assessment methods and assessment criteria:	(in Polish) OD 2020/2021 Pisemny egzamin testowy; pytania oparte na kazusach i proponowanych rozwiązaniach problemu prawnego, wielokrotnego wyboru, wymagające samodzielnego i nieschematycznego myślenia. Dopuszczalna liczba nieobecności podlegających usprawiedliwieniu: 2 DO 2019/2020 Pisemny egzamin testowy

This course is not currently offered.

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