JJUA55032U EU Health and medical Law

Volume 2016/2017

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 borders. 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 commercial policy 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 Intellectual property rights its combined 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 aims to take a broader approach to health law in understanding the interaction between health care, regulation, research and commerce. 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).   – Regulatory Aspects and the Market Approval Procedure, research infrastructures for biomedical research, biobanks, IPRs in the New Health Biosciences  eg.  stem cells related cases like  - WARF, Brustle cases; 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  .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.

Learning Outcome
  • 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 students will be given detailed reading instructions and texts in the introductory class and additional scientific articles , extracts , reports or book chapters will be provided along 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.
  • Category
  • Hours
  • Preparation
  • 241
  • Seminar
  • 34
  • Total
  • 275
Type of assessment
Oral defence, 20 min
Oral exam based on synopsis, 20 minutes
Exam registration requirements

In order to attend the oral examination, it is a prerequisite to hand in the synopsis before the specified deadline.
The deadline is agreed upon with the course lecturer.

Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

December 12 - 16, 2016 (preliminary dates)


Please see "Academic calendar" on KUnet.