MV_RHI Regulation of Healthcare Industry

Faculty of Law
Autumn 2024

The course is not taught in Autumn 2024

Extent and Intensity
2/0/0. 4 credit(s). Type of Completion: zk (examination).
Teacher(s)
Mgr. Bc. Michal Koščík, Ph.D. (lecturer)
prof. JUDr. Filip Křepelka, Ph.D. (lecturer)
Guaranteed by
prof. JUDr. Filip Křepelka, Ph.D.
Course Enrolment Limitations
The course is offered to students of any study field.
Course objectives
The course aims to understand the legal standards related to healthcare and medicine from the providers' perspective and the regulating healthcare as an industry by the states and international organisations, with a focus on the European Union.
Learning outcomes
Students will understand the principles of regulation concerning the healthcare industry. Students will be capable of explaining principal regulatory requirements concerning healthcare providers and manufacturers of healthcare-related goods. Students will realise that regulatory affairs need legal expertise to avoid incompliance.
Syllabus
  • Six blocks of 200 minutes (an equivalent of four teaching hours) 1st Block: Introduction law and its layers Law as a regulatory system Features and relations of national, international and supranational laws International organisations relevant to healthcare (WHO, WTO, CoE) Role of the European Union in healthcare and medicine – look at federalism 2nd block: Medical goods and their development Medicinal products I – authorisation, pharmacovigilance, patents, prices, reimbursement Medical devices and other products – similar to medicinal products Development of both – laboratory and clinical studies/trials 3rd block: Professionals, providers Systems of qualifications Mobility of healthcare practitioners – qualification, language Freedom of establishment, investment, Competition, state aid, public procurement 4th block: Public and private financing of healthcare and legal framework for it Public financing and its interconnection – viewpoint of providers Institutions of public financing Rights and entitlements 5th block: Miscelaneous Data protection (GDPR), European Health Data Space Epidemic awareness – covid-19 pandemic experience Other crises (war, climate crisis) 6th block: Evaluation and Colloquium Students will be expected to to prepare case studies in groups of three and present them at the final evaluation Active participation in seminars and class discussions is compulsory. Students need to attend at least five blocks and the final colloquium.
Literature
  • HERVEY, Tamara K. and Jean V. MCHALE. Health law and the European Union. 1st pub. Cambridge: Cambridge University Press, 2004, lxix, 469. ISBN 9780521605243. info
Teaching methods
Lecture, discussion, reading papers.
Assessment methods
Attendance, group work and presentation at the final seminar.
Language of instruction
Czech
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