JJUA55032U EU Health and medical Law
Health and Medical Law is no longer a domestic issue but has now
become an international concern. From a European perspective it can
be seen that beside diseases also medical goods, patients and
health professionals cross boarders. This is incentivised through
the free movement provision of the European Union and the
corresponding secondary legislation to create a European Internal
Market. Hence, many areas of law are no longer governed by only
national law, but are equally influenced by supranational (European
and International) rules. Health/Medical Law is situated
between national welfare policy making and European market
integration and can therefore cause conflicts between the two
levels of governance due to the different interests which cannot be
aligned easily. The objective of this course is to
equip the students with a wide range of knowledge on EU public
health and market integration law and its legal effects. This
course offers the students the opportunity to acquire theoretical
knowledge in the complex field of health/medical law while becoming
familiar with European Union law from a practical perspective. This
combination of specific and general skills allows the student to
directly apply their knowledge in both the discussion of real and
factual cases. Moreover, the students will be able to transfer
their knowledge of health and market law into other social policy
fields, which have been traditionally governed by national law, but
are now encroached by Union rules. The course will take
a broad approach to health law from two distinct but interrelated
perspectives. On one hand the course will discuss the market
integration rules (secondary legislation based on Art. 114 TFEU
which regulates health professions, cross-boarder health care,
medical devises, food and feed security etc.) On the other hand it
also covers public health issues (Art. 168 TFEU) such as combating
obesity, tobacco prevention and control, or pandemic emergency
plans. An important part of this discussion is the institutional
aspect i.e. mapping the responsible agencies and directorate
general to their respective tasks and responsibilities.
Against this background, the course is designed to provide students
with a broad and practical understanding of European policy-making
in Health/Medical Law. The interplay between the levels of
competences and the conflicts that arise thereof are to be
discussed in detail. An integral part of the course
will be the discussion of case-law of the European Union Courts.
Therefore it is expected that the participants actively engage in
the discussions, learn to critically evaluate the decisions and
their consequences. The students are also encouraged to contribute
to the sessions with their own ideas.
The course will be taught in 3 hour lectures once a week, with the final lecture being reserved for questions and answers in relation to the exam/synopsis preparation. The lectures will inter alia encompass the following topics - Health law from a supranational perspective: Council of Europe documents, EU documents and selected issues influenced by the World Health Organisation (WHO) - European Competence in medical law: relevant provisions in the Treaties, historical development of the competence, overview of the Regulations and Directives in health matters, delimitation to national competences. - EU Market Harmonisation and its implication on national health policy making: medical devices, pharmaceutical (e.g. orphan medicinal products), clinical research, data protection, health care professionals, cross-boarder health care etc). - Public health law: influence of the EU to combat obesity, tobacco and alcohol prevention, pandemic control etc., institutional aspect (who is responsible for what within the Union) - The Patient: position of the patient in the EU and international framework, rights and obligations, judicial review The target group of this course is students that are generally interested in Health and Medical Law, Market Integration and EU law. Moreover, the course is equally relevant students from other Faculties, whom would like to learn more about the interdependence of health rules on international and European level. Students who wish to expand their knowledge from the course on “European Pharmaceutical Law and IPR” can do so by attending the present course in order to obtain a more general picture of EU law in the field of life-science. The course takes a supranational perspective and does not cover national law in detail. Students will read and discuss legislative documents and interpret the application of these documents in the case-law. Through the solid theoretical background provided for in the lectures, they will be trained in analytical thinking and in applying the knowledge to practical cases.
- understand and explain the relationship of
EU market integration and social (health) policy.
- identify the legal problems that originate from this division of competence in medical law.
- contextualise the secondary rules discussed in the course as in respect to their impact and their effectiveness in the overall system of EU market integration.
- conceive coherent and systematic legal arguments that can solve the conflict between the national and the Union decision-making process and demonstrate an understanding of the complexity of this interrelationship.
- demonstrate knowledge of the development stages of the different market integration measures and their implication for the individual citizen.
- present and formulate the legal arguments in concise, linguistically correct and in a logical manner when discussing case law in class.
- The course will make use of the book ‘Health Law and the
European Union’ by Tamara K. Hervey and Jean V. McHale. The
students will be given detailed reading instructions for the book.
Additionally some scientific articles or extracts from other books
will be provided, for topics that are not covered in the course
- There will be a list of legal documents which are freely available on eur-lex.eu and the case-law from the CJEU/General Court (www.curia.eu)
- Most of the material will be provided by the teacher through ABSALON. Alternatively, it can be accessed on the internet or via the University library.
- The required readings will not exceed 500 pages. List of additional reading material: - a selection of additional scientific articles, legal documents and case law will be published on ABSALON to allow the students to study some aspects in detail
- This material is optional and will not exceed 200 pages.
- 10 ECTS
- Type of assessment
- Oral defence, 20 minOral exam based on synopsis, 20 minutes
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
- Exam period
- 1. - 5. December 2014 (preliminary dates)